Raising the profile of pilot and feasibility studies in relation to the development, evaluation and implementation of patient-reported outcome measures.

OpenAIRE

Jones, GL

2017-01-01

This editorial introduces a new special series on the pilot and feasibility testing of patient-reported outcome measures (PROMs) in the on-line open access journal Pilot and Feasibility Studies. Pilot and feasibility studies are typically implemented to address issues of uncertainty before undertaking a larger definitive study such as a randomised controlled trial or large scale survey. This editorial considers the role that such pilot and feasibility testing plays in relation to the developm...

Self-help group and the quality of life of patients with multiple sclerosis - Pilot study

Directory of Open Access Journals (Sweden)

Anna Eliášová

2015-12-01

Full Text Available Aim: The goal of the pilot study was to compare the quality of life of patients with multiple sclerosis in the Presov region with or without the support of a self-help group. Design: The character of this pilot study on patients with MS was related to the use of self-help groups and their impact on the assessment of the quality of life of the respondents, with the help of a questionnaire (WHOQOL-BREF. Methods: The research was carried out in the Prešov region with the help of the standardized WHOQOL-BREF questionnaire. Ninety-one patients with MS participated in the pilot study (46 respondents attended a self-help group and 35 did not. Results: The groups, when compared, aided by the statistically evaluated WHOQOL-BREF domains, were found to show significant differences in their evaluation of quality of life in three domains: domain one: physical health; domain two: surviving; domain three: social relations. Better scores were achieved in these domains by those who attended a group. In the physical sphere, we noticed significant differences in sleep quality, and sexual satisfaction (p < 0.001, while in social and economic areas, there were significant differences in satisfaction with personal relationships (p < 0.001, and economic circumstances (p < 0.01, self-contentment (p < 0.01, and coping with negative feelings (p < 0.05. Conclusion: Patients with multiple sclerosis can live normal lives provided they are supported by their families, friends, health care professionals, and self-help groups.

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

Science.gov (United States)

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

2014-01-01

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

The atrial fibrillation ablation pilot study

DEFF Research Database (Denmark)

Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard

2014-01-01

AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

Reiki for Cancer Patients Undergoing Chemotherapy in a Brazilian Hospital: A Pilot Study.

Science.gov (United States)

Siegel, Pamela; da Motta, Pedro Mourão Roxo; da Silva, Luis G; Stephan, Celso; Lima, Carmen Silvia Passos; de Barros, Nelson Filice

2016-01-01

The purpose of this pilot study was to explore whether individualized Reiki given to cancer patients at a Brazilian hospital improved symptoms and well-being. Data from 36 patients who received 5 Reiki sessions were collected using the MYMOP and were compared before and after their treatment and also with 14 patients who did not receive Reiki and who acted as a comparison group. Twenty-one patients reported feeling better, 12 felt worse, and 3 reported no change. Of the comparison group, 6 patients reported feeling better and 8 felt worse. The Reiki practice delivered as part of the integrative care in oncology did produce clinically significant effects, although not statistically significant results, for more than half of the patients undergoing cancer treatment.

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

Science.gov (United States)

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…

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study

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Charu Singh

2016-01-01

Full Text Available True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg weekly for a period of 6 weeks and Group B (20 patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study.

Science.gov (United States)

Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

2016-01-01

True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

Vascular anomalies in the mesenteric circulation of patients with Crohn’s disease: a pilot study

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Matilde Zamboni

2017-07-01

Full Text Available Crohn’s disease (CD is a chronic inflammatory bowel disease and its pathogenesis is still not well understood. Previous studies suggested the possibility of the involvement of vascular system, but, todate, the mesenteric circulation has poor been investigated, especially in complicated CD cases requiring colectomy. We investigated the mesenteric circulation in a case-control pilot study, including 19 controls and 7 patients affected by complicated cases of CD. Cases and controls underwent selective angiography of both superior and inferior mesenteric district. Transit time was found either significantly shortened in 2/7 cases (29%, or prolonged 5/7 (71% (P=0.0034 in the superior mesenteric district; P=0.0079 in the inferior mesenteric district, respectively due to the presence of A-V malformations and of a miscellaneous of venous abnormalities, which included thrombosis, hypoplasia and extra-truncular venous malformations. Our study demonstrates the presence of congenital or acquired vascular anomalies in a small sample of CD patients not responder to current treatment and with severe complications. The present pilot study warrants further investigations.

Anti-allergic effect of apple polyphenol on patients with atopic dermatitis: A pilot study

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Takatsugu Kojima

2000-01-01

Full Text Available The aim of the present study was to evaluate the antiallergic effect of apple condensed tannins (ACT in patients with atopic dermatitis (AD as a pilot study. An ACT supplement given to the patients at oral doses of 10 mg/kg per day for 8 weeks reduced the inflammation, lichenification, cracking, itching, sleep disturbance and peripheral blood eosinophil counts. Itching and sleep disturbance scores after ACT supplement even for 2 weeks were significantly decreased compared with the control group. The results suggest that ACT has an anti-allergic effect and that its use improved the symptoms of AD.

Patient-Controlled Biofeedback Device for the Treatment of Fecal Incontinence: A Pilot Study.

Science.gov (United States)

Damin, Daniel C; Hommerding, Felipe; Schirmer, Delber; Sanches, Paulo R S; Silva Junior, Danton P; Müller, André F; Thome, Paulo R O

2017-06-01

Although biofeedback has been used as a first-line therapy for fecal incontinence, it is known to be time consuming and demands attendance to a hospital during the whole period of treatment. In this study, we describe a new biofeedback device specifically developed for home treatment of fecal incontinence, which consists of a microprocessor controlled unit able to register and store the anal pressure waves corresponding to exercises performed by patients at home. In order to test the new device, a pilot study including ten patients with fecal incontinence was conducted. Evaluation of patients before and after the biofeedback training showed significant improvement in manometric and clinical parameters of anal continence. The new method may improve compliance of patients with the training program and reduce their need to be supervised during the treatment. It might represent a new alternative for the treatment of fecal incontinence.

Percutaneous Nerve Stimulation in Chronic Neuropathic Pain Patients due to Spinal Cord Injury: A Pilot Study

NARCIS (Netherlands)

Kopsky, D.J.; Ettema, F.W.L.; van der Leeden, M.; Dekker, J.; Stolwijk-Swuste, J.M.

2014-01-01

Background: The long-term prognosis for neuropathic pain resolution following spinal cord injury (SCI) is often poor. In many SCI patients, neuropathic pain continues or even worsens over time. Thus, new treatment approaches are needed. We conducted a pilot study to evaluate the feasibility and

TRPA1 polymorphisms in chronic and complete spinal cord injury patients with neuropathic pain: a pilot study.

Science.gov (United States)

Vidal Rodriguez, Sonia; Castillo Aguilar, Inmaculada; Cuesta Villa, Luis; Serrano Saenz de Tejada, Francisco

2017-01-01

Pilot study. Single-nucleotide polymorphisms (SNPs) in TRPA1 gene are related to the etiology of chronic pain. The study is a pilot study with the primary objective of analyzing these SNPs in Spanish patients with chronic and complete spinal cord injury (SCI) and neuropathic pain (NPP). Asepeyo Hospital Department of Chronic and Complete SCI. Twelve patients with chronic and complete SCI and NPP, and 12 patients with chronic and complete SCI with no pain were reviewed. International Spinal Cord Injury Pain Classification (LANSS) and visual analog score (VAS) were chosen to classify pain syndrome. SNPs were identified by melting analysis after DNA amplification with real-time fluorescence PCR. There were differences in rs11988795 variant: GG homozygous ( p  = 0.01) and G allele ( p  = 0.001) were more frequent in SCI patients with no pain. There were differences in rs13255063 variant: TT homozygous were prevalent ( p  = 0.03) in patients with NPP. Until now this is the first study to show a description of TRPA1 SNPs in Spanish patients with chronic and complete SCI and NPP. These results suggest that GG genotype in rs11988795 variant and G allele could be protective factors against NPP. TT genotype in rs13255063 variant could be a risk factor for NPP. Neuropathic pain after spinal cord injuries may have genetic contributions.

Leap motion controlled videogame-based therapy for rehabilitation of elderly patients with subacute stroke: a feasibility pilot study.

Science.gov (United States)

Iosa, Marco; Morone, Giovanni; Fusco, Augusto; Castagnoli, Marcello; Fusco, Francesca Romana; Pratesi, Luca; Paolucci, Stefano

2015-08-01

The leap motion controller (LMC) is a new optoelectronic system for capturing motion of both hands and controlling a virtual environment. Differently from previous devices, it optoelectronically tracks the fine movements of fingers neither using glows nor markers. This pilot study explored the feasibility of adapting the LMC, developed for videogames, to neurorehabilitation of elderly with subacute stroke. Four elderly patients (71.50 ± 4.51 years old) affected by stroke in subacute phase were enrolled and tested in a cross-over pilot trial in which six sessions of 30 minutes of LMC videogame-based therapy were added on conventional therapy. Measurements involved participation to the sessions, evaluated by means of the Pittsburgh Rehabilitation Participation Scale, hand ability and grasp force evaluated respectively by means of the Abilhand Scale and by means of the dynamometer. Neither adverse effects nor spasticity increments were observed during LMC training. Participation to the sessions was excellent in three patients and very good in one patient during the LMC trial. In this period, patients showed a significantly higher improvement in hand abilities (P = 0.028) and grasp force (P = 0.006). This feasibility pilot study was the first one using leap motion controller for conducting a videogame-based therapy. This study provided a proof of concept that LMC can be a suitable tool even for elderly patients with subacute stroke. LMC training was in fact performed with a high level of active participation, without adverse effects, and contributed to increase the recovery of hand abilities.

Pilot study of atomoxetine in patients with Parkinson's disease and dopa-unresponsive Freezing of Gait.

Science.gov (United States)

Revuelta, Gonzalo J; Embry, Aaron; Elm, Jordan J; Gregory, Chris; Delambo, Amy; Kautz, Steve; Hinson, Vanessa K

2015-01-01

Freezing of gait (FoG) is a common and debilitating condition in Parkinson's disease (PD) associated with executive dysfunction. A subtype of FoG does not respond to dopaminergic therapy and may be related to noradrenergic deficiency. This pilot study explores the effects of atomoxetine on gait in PD patients with dopa-unresponsive FoG using a novel paradigm for objective gait assessment. Ten patients with PD and dopa-unresponsive FoG were enrolled in this eight-week open label pilot study. Assessments included an exploratory gait analysis protocol that quantified spatiotemporal parameters during straight-away walking and turning, while performing a dual task. Clinical, and subjective assessments of gait, quality of life, and safety were also administered. The primary outcome was a validated subjective assessment for FoG (FOG-Q). Atomoxetine was well tolerated, however, no significant change was observed in the primary outcome. The gait analysis protocol correlated well with clinical scales, but not with subjective assessments. DBS patients were more likely to increase gait velocity (p = 0.033), and improved in other clinical assessments. Objective gait analysis protocols assessing gait while dual tasking are feasible and useful for this patient population, and may be superior correlates of FoG severity than subjective measures. These findings can inform future trials in this population.

Determinants of outcome for patients undergoing lumbar discectomy: a pilot study.

LENUS (Irish Health Repository)

Hickey, Oonagh T

2012-02-03

BACKGROUND AND OBJECTIVE: One-third of patients who undergo lumbar discectomy continue to suffer from persistent pain postoperatively. Greater preoperative warmth thresholds and greater preoperative cerebrospinal fluid concentrations of stable serum nitric oxide metabolites are associated with a worse outcome. The principal objective of this study was to examine the relationship between patient outcome (defined using the Modified Stauffer-Coventry evaluating criteria) and preoperative pain perception threshold to an electrical stimulus. METHODS: A prospective observational pilot study of patients (n = 39) was performed. Quantitative sensory testing, visual analogue scales for anxiety and pain, the Hospital Anxiety and Depression (HADS) Scale and the McGill Pain Questionnaire were completed, and serum nitric oxide metabolites were measured perioperatively. Excised disc tissue was examined histologically, and immunohistochemistry for phospholipase A2 was performed. RESULTS: Ten patients (26%) had an unsatisfactory outcome. Those with a satisfactory outcome had greater preoperative pain perception thresholds over the affected dermatome, which decreased by 2 months postoperatively. These patients also demonstrated a decrease in nitric oxide metabolites from preoperatively to 18 h postoperatively. Greater preoperative HADS scores, and greater pain intensity 4 h and 24 h postoperatively were associated with an unsatisfactory outcome. CONCLUSION: Patients with a satisfactory outcome demonstrate a decrease in pain perception thresholds and plasma concentration of stable nitric oxide metabolites during the perioperative period. Patients with an unsatisfactory outcome following lumbar discectomy experience greater preoperative anxiety and greater pain during the early postoperative period. These findings justify a larger prospective observational study.

The use of telehealth (text messaging and video communications) in patients with cystic fibrosis: A pilot study.

Science.gov (United States)

Gur, Michal; Nir, Vered; Teleshov, Anna; Bar-Yoseph, Ronen; Manor, Eynav; Diab, Gizelle; Bentur, Lea

2017-05-01

Background Poor communications between cystic fibrosis (CF) patients and health-care providers may result in gaps in knowledge and misconceptions about medication usage, and can lead to poor adherence. We aimed to assess the feasibility of using WhatsApp and Skype to improve communications. Methods This single-centre pilot study included CF patients who were older than eight years of age assigned to two groups: one without intervention (control group), and one with intervention. Each patient from the intervention group received Skype-based online video chats and WhatsApp messages from members of the multidisciplinary CF team. CF questionnaires, revised (CFQ-R) scores, knowledge and adherence based on CF My Way and patients satisfaction were evaluated before and after three months. Feasibility was assessed by session attendance, acceptability and satisfaction survey. Descriptive analysis and paired and non-paired t-tests were used as applicable. Results Eighteen patients were recruited to this feasibility study (nine in each group). Each intervention group participant had between four and six Skype video chats and received 22-45 WhatsApp messages. In this small study, CFQ-R scores, knowledge, adherence and patient satisfaction were similar in both groups before and after the three-month intervention. Conclusions A telehealth-based approach, using Skype video chats and WhatsApp messages, was feasible and acceptable in this pilot study. A larger and longer multi-centre study is warranted to examine the efficacy of these interventions to improve knowledge, adherence and communication.

Auricular Acupressure Helps Alleviate Xerostomia in Maintenance Hemodialysis Patients: A Pilot Study.

Science.gov (United States)

Yang, Guowen; Lin, Shaoqin; Wu, Yuchi; Zhang, Shangpeng; Wu, Xiuqing; Liu, Xusheng; Zou, Chuan; Lin, Qizhan

2017-04-01

Xerostomia is one of the most common complaints in maintenance hemodialysis (MHD) patients. This problem contributes to excess fluid intake and results in poor survival outcome. Based on Traditional Chinese Medicine (TCM) theory and literature studies, the authors have been practicing auricular acupressure therapy (AAT) to help patients with xerostomia. This pilot study was conducted to demonstrate the potential of AAT for xerostomia in MHD patients. Eligible subjects who agreed to participate in this study were recruited and provided with AAT for 4 weeks. The Summated Xerostomia Inventory (SXI), as well as measurement of inter-dialytic weight gain (IDWG), daily inter-dialytic weight gain (daily IDWG), percentage of inter-dialytic weight gain (IDWG%), blood pressure, and biochemical parameters, were completed at baseline and after a 4-week intervention. A total of 26 eligible participants were recruited. Of them, 10 men and 16 women (M age  = 52.92 ± 11.80 years; dialysis vintage 81.86 ± 46.05 months) completed the study. After the 4-week AAT intervention, the SXI scores were significantly decreased compared with baseline (from 10.08 ± 2.26 to 9.04 ± 2.14; p xerostomia intensity for MHD patients.

A pilot study to assess the hemostatic function of pathogen-reduced platelets in patients with thrombocytopenia

DEFF Research Database (Denmark)

Johansson, Pär I; Simonsen, Anne Catrine; Brown, Peter de Nully

2013-01-01

Platelet (PLT) support is critical to the care of patients with thrombocytopenia, but allogeneic transfusions carry risk. Pathogen reduction mitigates some transfusion risks, but effects on PLT function remain a concern. This clinical pilot study assessed the effect of pathogen reduction technolo...... with riboflavin plus ultraviolet light using thrombelastography (TEG)....

An intervention to improve care and reduce costs for high-risk patients with frequent hospital admissions: a pilot study

Directory of Open Access Journals (Sweden)

Kostrowski Shannon

2011-10-01

Full Text Available Abstract Background A small percentage of high-risk patients accounts for a large proportion of Medicaid spending in the United States, which has become an urgent policy issue. Our objective was to pilot a novel patient-centered intervention for high-risk patients with frequent hospital admissions to determine its potential to improve care and reduce costs. Methods Community and hospital-based care management and coordination intervention with pre-post analysis of health care utilization. We enrolled Medicaid fee-for-service patients aged 18-64 who were admitted to an urban public hospital and identified as being at high risk for hospital readmission by a validated predictive algorithm. Enrolled patients were evaluated using qualitative and quantitative interview techniques to identify needs such as transportation to/advocacy during medical appointments, mental health/substance use treatment, and home visits. A community housing partner initiated housing applications in-hospital for homeless patients. Care managers facilitated appropriate discharge plans then worked closely with patients in the community using a harm reduction approach. Results Nineteen patients were enrolled; all were male, 18/19 were substance users, and 17/19 were homeless. Patients had a total of 64 inpatient admissions in the 12 months before the intervention, versus 40 in the following 12 months, a 37.5% reduction. Most patients (73.3% had fewer inpatient admissions in the year after the intervention compared to the prior year. Overall ED visits also decreased after study enrollment, while outpatient clinic visits increased. Yearly study hospital Medicaid reimbursements fell an average of $16,383 per patient. Conclusions A pilot intervention for high-cost patients shows promising results for health services usage. We are currently expanding our model to serve more patients at additional hospitals to see if the pilot's success can be replicated. Trial registration

EFFECT OF DANCE EXERCISE ON COGNITIVE FUNCTION IN ELDERLY PATIENTS WITH METABOLIC SYNDROME: A PILOT STUDY

OpenAIRE

Sang-Wook Song; Seo-Jin Park; Jung-hyoun Cho; Sung-Goo Kang; Hyun-Kook Lim; Yu-Bae Ahn; Minjeong Kim; Se-Hong Kim

2011-01-01

Metabolic syndrome is associated with an increased risk of cognitive impairment. The purpose of this prospective pilot study was to examine the effects of dance exercise on cognitive function in elderly patients with metabolic syndrome. The participants included 38 elderly metabolic syndrome patients with normal cognitive function (26 exercise group and 12 control group). The exercise group performed dance exercise twice a week for 6 months. Cognitive function was assessed in all participants...

Improving maintenance medication adherence in adult inflammatory bowel disease patients: a pilot study

Directory of Open Access Journals (Sweden)

Michelle L. Matteson-Kome

2014-01-01

Full Text Available Medication nonadherence in inflammatory bowel disease (IBD may lead to suboptimal control of the disease, decreased quality of life, and poor outcomes. This pilot study evaluated the feasibility, intervention mechanism, and potential effectiveness of a three-month continuous self-improvement (CSI intervention to enhance medication adherence (MA in adult nonadherent IBD patients. Adult IBD patients taking a daily or twice-daily dosed maintenance medication were screened electronically for two months to determine baseline MA levels. Nonadherent IBD participants were randomized to the CSI or the attention control (AC intervention and monitored for three months. The CSI intervention consisted of a data evaluation and system refinement process in which system changes were identified and implemented. The AC group was given educational information regarding IBD disease process, extra-intestinal manifestations of IBD, and medical therapy. Demographic statistics, change scores for within and between- group differences, and effect size estimates were calculated. Nine nonadherent participants (medication adherence score <0.85 were eligible for randomization. The intervention was found feasible and acceptable. Although no statistically significant improvement in MA was found (P=0.14, adherence improved in 3 of 4 of the CSI group and 1 of 2 in the attention control group. The effect size calculation of 1.9 will determine the sample size for future study. The results of this pilot study showed the intervention was feasible and had a positive effect on MA change score and adherence levels. A larger fully powered study is needed to test of the effectiveness of this innovative intervention.

Pilot study of sexual dysfunction in patients with psoriasis: Influence of biologic therapy

Directory of Open Access Journals (Sweden)

Ricardo Ruiz-Villaverde

2011-01-01

Full Text Available Background: Psoriasis is a chronic skin disease that affects 1 to 3% of the population in most industrialized countries. It is commonly associated with a variety of psychological problems including low self-esteem, depression, suicidal thoughts, and sexual dysfunction. Materials and Methods : We have performed a pilot study in which we have tried to assess the impact on sexual dysfunction in patients with psoriasis who have started treatment with biological therapy using validated indexes in Spanish: International Index of Erectile Function for men and female sexual function index in women. Results : Considering the men and women from our study, an improvement in FSFI by an average of 9.5 and 6.3 points is observed, respectively. Conclusion: We considered our series as a first step for a more detailed approach to the study of sexual function in patients with psoriasis.

Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study.

Science.gov (United States)

Baldwin, Ann Linda; Vitale, Anne; Brownell, Elise; Kryak, Elizabeth; Rand, William

This blinded, controlled pilot study investigated the effects of Reiki on 46 patients undergoing knee replacement surgery. Of the 3 groups, Reiki, Sham Reiki, and Standard of Care, only the Reiki group showed significant reductions in pain, blood pressure, respiration rate, and state anxiety, which provides evidence for a full-scale clinical study.

Report of a randomised pilot study of the treatment of patients with supratentorial gliomas using neutron irradiation

International Nuclear Information System (INIS)

Duncan, W.; McLelland, J.; Jack, W.J.L.; Arnott, S.J.; Kerr, G.R.; Williams, J.R.; Gordon, A.

1986-01-01

A randomised pilot study is reported of d(15) + Be neutrons compared with 4 MV photons in the treatment of patients with astrocytoma. Sixteen patients were treated by photons and 18 by neutrons. Both treatments were well tolerated by patients. The median survival after photons was 11 months and after neutrons, 7 months. It was demonstrated that four of nine patients treated by neutrons had evidence at autopsy of radiation-induced brain damage. All had residual cancer. No patient treated by photons had signs of radiation-related morbidity. The trial was, therefore, discontinued prematurely. (author)

Effects of compensatory cognitive training intervention for breast cancer patients undergoing chemotherapy: a pilot study.

Science.gov (United States)

Park, Jin-Hee; Jung, Yong Sik; Kim, Ku Sang; Bae, Sun Hyoung

2017-06-01

Numerous breast cancer patients experience cognitive changes during and after chemotherapy. Chemotherapy-related cognitive impairment can significantly affect quality of life. This pilot study attempted to determine the effects of a compensatory cognitive training on the objective and subjective cognitive functioning of breast cancer patients receiving adjuvant chemotherapy. Fifty-four patients were assigned to either a compensatory cognitive training or waitlist condition. They were assessed at baseline (T1), the completion of the 12-week intervention (T2), and 6 months after intervention completion (T3). Outcomes were assessed using the standardized neuropsychological tests and the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), version 3. Raw data were converted to T-scores based on baseline scores, and a repeated-measures ANCOVA, adjusting for age, intelligence, depression, and treatment, was used for analysis. The effect sizes for differences in means were calculated. The intervention group improved significantly over time compared to the waitlist group on objective cognitive function. Among ten individual neuropsychological measures, immediate memory, delayed memory, verbal fluency in category, and verbal fluency in letter showed significant group × time interaction. In subjective cognitive function, scores of the waitlist group significantly decrease over time on perceived cognitive impairments, in contrast to those of the intervention group. The 12-week compensatory cognitive training significantly improved the objective and subjective cognitive functioning of breast cancer patients. Because this was a pilot study, further research using a larger sample and longer follow-up durations is necessary.

Tampering by office-based methadone maintenance patients with methadone take home privileges: a pilot study

Directory of Open Access Journals (Sweden)

Frank Nathan

2007-10-01

Full Text Available Abstract Methadone Maintenance Treatment (MMT is among the most widely studied treatments for opiate dependence with proven benefits for patients and society. When misused, however, methadone can also be lethal. The issue of methadone diversion is a major concern for all MMT programs. A potential source for such diversion is from those MMT patients who receive daily take home methadone doses. Using a reverse phase high performance liquid chromatography method, seven of the nine patients who were randomly selected to have all of their remaining methadone take home doses (within a 24 hour period analyzed, returned lower than expected quantities of methadone. This finding suggests the possibility that such patients may have tampered with their daily take home doses. Larger prospective observational studies are clearly needed to test the supposition of this pilot study.

Cephalometric risk factors associated with myocardial infarction in patients suffering from obstructive sleep apnea: A pilot case-control study.

Science.gov (United States)

Davoudmanesh, Zeinab; Bayat, Mohamad; Abbasi, Mohsen; Rakhshan, Vahid; Shariati, Mahsa

2017-01-01

Obstructive sleep apnea (OSA) and its craniofacial anatomic risk factors might play a role in several cardiovascular diseases, including myocardial infarction (MI). However, there are no data about cephalometric findings among OSA patients with MI. In this pilot case-control study, about 2000 individuals referred to the sleep center were evaluated according to apnea - hypopnea index (AHI) and other inclusion criteria. Included were 62 OSA male patients (AHI > 10), of whom 6 had an MI history. In both control (n = 56) and MI groups (n = 6), 18 cephalometric parameters were traced. Data were analyzed using independent samples t-test. Compared with control OSA patients, OSA patients with MI showed a significantly larger tongue length (p = 0.015). The other cephalometric variables were not significantly different between the two groups. An elongated tongue might be considered a risk factor for MI in OSA patients. The role of other variables remains inconclusive and open to investigation with larger samples (determined based on pilot studies such as this report) collected in longitudinal fashion.

How to address patients' defences: a pilot study of the accuracy of defence interpretations and alliance.

Science.gov (United States)

Junod, Olivier; de Roten, Yves; Martinez, Elena; Drapeau, Martin; Despland, Jean-Nicolas

2005-12-01

This pilot study examined the accuracy of therapist defence interpretations (TAD) in high-alliance patients (N = 7) and low-alliance patients (N = 8). TAD accuracy was assessed in the two subgroups by comparing for each case the patient's most frequent defensive level with the most frequent defensive level addressed by the therapist when making defence interpretations. Results show that in high-alliance patient-therapist dyads, the therapists tend to address accurate or higher (more mature) defensive level than patients most frequent level. On the other hand, the therapists address lower (more immature) defensive level in low-alliance dyads. These results are discussed along with possible ways to better assess TAD accuracy.

Ultra Low-Dose Naloxone and Tramadol/Acetaminophen in Elderly Patients Undergoing Joint Replacement Surgery: A Pilot Study

Directory of Open Access Journals (Sweden)

Ngozi N Imasogie

2009-01-01

Full Text Available OBJECTIVE: A pilot study was conducted to assess whether both the rationale and feasibility exist for future randomized clinical trials to evaluate the combined use of naloxone infusion and tramadol/acetaminophen as opioid-sparing drugs in elderly patients undergoing lower extremity joint replacement surgery.

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS

NARCIS (Netherlands)

Minneboo, Madelon; Peters, Ron J. G.; Miller-Kovach, Karen; Lemmens, Jeanine; Bucx, Jeroen J. J.

2015-01-01

To quantify the impact of a commercial weight management program on weight change in obese patients with coronary heart disease. An observational, single-center pilot study in the Netherlands. Forty-five patients diagnosed with a recent acute coronary syndrome and a body mass index of >30 kg/m2 were

Increased neutrophil–lymphocyte ratio in delirium: a pilot study

Directory of Open Access Journals (Sweden)

Egberts A

2017-07-01

Full Text Available Angelique Egberts, Francesco US Mattace-Raso Section of Geriatric Medicine, Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands Aim: Delirium is a common and severe complication among older hospitalized patients. The pathophysiology is poorly understood, but it has been suggested that inflammation and oxidative stress may play a role. The aim of this pilot study was to investigate levels of the neutrophil–lymphocyte ratio (NLR – a marker of systemic inflammation and oxidative stress – in patients with and without delirium. Methods: This pilot study was performed within a retrospective chart review study that included acutely ill patients, 65 years and older, who were admitted to the ward of geriatrics of the Erasmus University Medical Center. All patients in whom the differential white blood cell (WBC counts as well as the C-reactive protein (CRP level were determined within 24 h after admission were included in the present study. Differences in NLR between patients with and without delirium were investigated using univariate analysis of variance, with adjustments for age, sex, comorbidities, CRP level, and total WBC count. Results: Eighty-six patients were included. Thirteen patients were diagnosed with delirium. In adjusted models, higher mean NLR values were found in patients with, than in those without, delirium (9.10 vs 5.18, P=0.003. Conclusion: In this pilot study, we found increased NLR levels in patients with delirium. This finding might suggest that an inadequate response of the immune system and oxidative stress may play a role in the pathogenesis of delirium. Further studies are needed to confirm the association between NLR and delirium. Keywords: delirium, pathology, biomarkers, leukocytes, immune system, brain 

Pilot study of a smartphone application designed to socially motivate cardiovascular disease patients to improve medication adherence.

Science.gov (United States)

Fujita, Saki; Pitaktong, Isaree; Steller, Graeme Vosit; Dadfar, Victor; Huang, Qinwen; Banerjee, Sindhu; Guo, Richard; Nguyen, Hien Tan; Allen, Robert Harry; Martin, Seth Shay

2018-01-01

Social support received by patients from family and community has been identified as a key factor for success in improving medication adherence in those patients. This pilot study aimed to investigate the usability and feasibility of PillPal, a smartphone application that uses video-chatting as a social motivation medium to encourage medication adherence in cardiovascular disease (CVD) patients. We additionally gathered feedback on the Physician Calendar, an accompanying web platform that allows clinicians to view patient adherence data generated from the app. Thirty patients were recruited from the Johns Hopkins Hospital (JHH) Lipid Clinic (n=14) and Inpatient Cardiology Service (n=16) to pilot test the app. Data were obtained through in-person interviews in which patients tested out the app and answered standardized questions regarding the app's feasibility as a means to enhance social support, as well as its usability measured in terms of ease of use and patient comfort level with the video-chat technology. Cardiologists (n=10) from JHH were interviewed to gain feedback on the Physician Calendar. We recorded 43.4% participants who stated that PillPal would increase their motivation to take their medications; 96.7% stated the app was easy to use; and 70% stated they were comfortable with video-chatting while taking their medications. Patient factors such as current adherence level, disease severity, and personality were more predictive of positive app reviews than the perceived level of social support. Clinicians generally approved of the Physician Calendar, as they would be able to quickly screen for non-adherence and begin conversations with patients to address the root cause of their non-adherence. Based on pilot testing and interviews, using a smartphone app for video-chatting as a social support medium to improve patient medication adherence is feasible and has potential to increase medication adherence depending on certain patient characteristics. The

Pilot study of a three-step diagnostic pathway for young and old patients with Parkinson's disease dementia: screen, test and then diagnose.

NARCIS (Netherlands)

Robben, S.H.M.; Sleegers, M.J.; Dautzenberg, P.LJ.; Bergen, F.S. van; Bruggen, J.P.; Olde Rikkert, M.G.M.

2010-01-01

OBJECTIVE: To pilot a three-step diagnostic model for young and old patients with Parkinson's disease dementia (PDD). METHODS: Prospective investigator-blinded study. We developed a screening questionnaire for patients with Parkinson's disease (PD) and their caregivers. Further, patients were

Is it acceptable to approach colorectal cancer patients at diagnosis to discuss genetic testing? A pilot study

OpenAIRE

Porteous, M; Dunckley, M; Appleton, S; Catt, S; Dunlop, M; Campbell, H; Cull, A

2003-01-01

In this pilot study, the acceptability of approaching 111 newly diagnosed colorectal cancer patients with the offer of genetic testing for hereditary nonpolyposis colorectal cancer (HNPCC) was assessed. A total of 78% of participants found it highly acceptable to have the information about HNPCC brought to their attention at that time.

A case-control pilot study of low-intensity IVF in good-prognosis patients.

Science.gov (United States)

Gleicher, Norbert; Weghofer, Andrea; Barad, David H

2012-04-01

Low-intensity IVF (LI-IVF) is rapidly gaining in popularity. Yet studies comparing LI-IVF to standard IVF are lacking. This is a case-control pilot study, reporting on 14 first LI-IVF and 14 standard IVF cycles in women with normal age-specific ovarian reserve under age 38, matched for age, laboratory environment, staff and time of cycle. LI-IVF cycles underwent mild ovarian stimulation, utilizing clomiphene citrate, augmented by low-dose gonadotrophin stimulation. Control patients underwent routine ovarian stimulation. LI-IVF and regular IVF patients were similar in age, body mass index, FSH and anti-Müllerian hormone. Standard IVF utilized more gonadotrophins (PIVF demonstrated better odds for pregnancy (OR 7.07; P=0.046) and higher cumulative pregnancy rates (63.3% versus 21.4%; OR 6.6; P=0.02). Adjustments for age, ethnicity and diagnosis maintained significance but oocyte adjustment did not. Cost assessments failed to reveal differences between LI-IVF and standard IVF. In this small study, LI-IVF reduced pregnancy chances without demonstrating cost advantages, raising questions about its utility. In the absence of established clinical and/or economic foundations, LI-IVF should be considered an experimental procedure. Low-intensity IVF (LI-IVF) is increasingly propagated as an alternative to standard IVF. LI-IVF has, however, never been properly assessed in comparison to standard IVF. Such a comparison is presented in the format of a small pilot study, matching LI-IVF cycles with regular IVF cycles and comparing outcomes as well as costs. The study suggests that LI-IVF, at least in this setting, is clinically inferior and economically at best similar to standard IVF. LI-IVF should, therefore, as of this point not be offered as routine IVF treatment but only as an experimental procedure. Copyright © 2012 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Application of patient safety indicators internationally: a pilot study among seven countries.

Science.gov (United States)

Drösler, Saskia E; Klazinga, Niek S; Romano, Patrick S; Tancredi, Daniel J; Gogorcena Aoiz, Maria A; Hewitt, Moira C; Scobie, Sarah; Soop, Michael; Wen, Eugene; Quan, Hude; Ghali, William A; Mattke, Soeren; Kelley, Edward

2009-08-01

To explore the potential for international comparison of patient safety as part of the Health Care Quality Indicators project of the Organization for Economic Co-operation and Development (OECD) by evaluating patient safety indicators originally published by the US Agency for Healthcare Research and Quality (AHRQ). A retrospective cross-sectional study. Acute care hospitals in the USA, UK, Sweden, Spain, Germany, Canada and Australia in 2004 and 2005/2006. Routine hospitalization-related administrative data from seven countries were analyzed. Using algorithms adapted to the diagnosis and procedure coding systems in place in each country, authorities in each of the participating countries reported summaries of the distribution of hospital-level and overall (national) rates for each AHRQ Patient Safety Indicator to the OECD project secretariat. Each country's vector of national indicator rates and the vector of American patient safety indicators rates published by AHRQ (and re-estimated as part of this study) were highly correlated (0.821-0.966). However, there was substantial systematic variation in rates across countries. This pilot study reveals that AHRQ Patient Safety Indicators can be applied to international hospital data. However, the analyses suggest that certain indicators (e.g. 'birth trauma', 'complications of anesthesia') may be too unreliable for international comparisons. Data quality varies across countries; undercoding may be a systematic problem in some countries. Efforts at international harmonization of hospital discharge data sets as well as improved accuracy of documentation should facilitate future comparative analyses of routine databases.

Oral Yeast Colonization and Fungal Infections in Peritoneal Dialysis Patients: A Pilot Study

Directory of Open Access Journals (Sweden)

Liliana Simões-Silva

2017-01-01

Full Text Available Peritonitis and exit-site infections are important complications in peritoneal dialysis (PD patients that are occasionally caused by opportunistic fungi inhabiting distant body sites. In this study, the oral yeast colonization of PD patients and the antifungal susceptibility profile of the isolated yeasts were accessed and correlated with fungal infection episodes in the following 4 years. Saliva yeast colonization was accessed in 21 PD patients and 27 healthy controls by growth in CHROMagar-Candida® and 18S rRNA/ITS sequencing. PD patients presented a lower oral yeast prevalence when compared to controls, namely, Candida albicans. Other species were also isolated, Candida glabrata and Candida carpophila. The antifungal susceptibility profiles of these isolates revealed resistance to itraconazole, variable susceptibility to caspofungin, and higher MIC values of posaconazole compared to previous reports. The 4-year longitudinal evaluation of these patients revealed Candida parapsilosis and Candida zeylanoides as PD-related exit-site infectious agents, but no correlation was found with oral yeast colonization. This pilot study suggests that oral yeast colonization may represent a limited risk for fungal infection development in PD patients. Oral yeast isolates presented a variable antifungal susceptibility profile, which may suggest resistance to some second-line drugs, highlighting the importance of antifungal susceptibility assessment in the clinical practice.

Combined down-regulation by aromatase inhibitor and GnRH-agonist in IVF patients with endometriomas-A pilot study

DEFF Research Database (Denmark)

Lossl, Kristine; Loft, Anne; Freiesleben, Nina L C

2009-01-01

and delivery rate, and endocrine response. The paired T test and Wilcoxon Signed Rank test were used to analyse paired differences. RESULTS: During the combined down-regulation, the endometriomal volume and the serum CA125 level decreased by 29% (3-39%) and 61% (21-74%), respectively (median (95%CI), P=0....... The aim of this study was to test the concept of combined down-regulation prior to IVF in patients with endometriomas. STUDY DESIGN: Prospective pilot study in a university-based tertiary fertility clinic including 20 infertile patients with endometriomas undergoing IVF/ICSI. The patients received...

Referral to a Commercial Weight Management Program in Patients With Coronary Heart Disease: A PILOT STUDY IN THE NETHERLANDS.

Science.gov (United States)

Minneboo, Madelon; Peters, Ron J G; Miller-Kovach, Karen; Lemmens, Jeanine; Bucx, Jeroen J J

2015-01-01

To quantify the impact of a commercial weight management program on weight change in obese patients with coronary heart disease. An observational, single-center pilot study in the Netherlands. Forty-five patients diagnosed with a recent acute coronary syndrome and a body mass index of >30 kg/m2 were recruited. The commercial weight management intervention (Weight Watchers) promotes a hypoenergetic and balanced diet, increased physical activity, and group support. The program included weekly 30-minute in-hospital meetings with an experienced coach. The program was offered in parallel with a cardiac rehabilitation program. Thirty-five patients completed the program. Of these patients, 32 patients (91%) decreased body weight. Mean weight change was -5.8 kg (range: +0.6 kg to -15.4 kg), and 20 patients (57%) achieved the target of 5% weight loss of their initial weight. Twenty-seven patients continued the commercial weight loss program after 14 weeks, the mean followup of these patients was 34 weeks and their mean weight change was -9.1 kg (range: 0.0-23.0 kg). Obese patients, discharged after an acute coronary syndrome, who were referred to a commercial weight management program, achieved significant weight loss. Although this is a nonrandomized pilot study with patients who were selected by motivation and by the ability to participate in the program, the proportion of weight loss is significant and promising.

A 24-h a la carte food service as support for patients at nutritional risk: a pilot study.

Science.gov (United States)

Munk, T; Seidelin, W; Rosenbom, E; Nielsen, A L; Klausen, T W; Nielsen, M A; Thomsen, T

2013-06-01

Undernutrition and insufficient energy and protein intake is a common problem in hospitalised patients. The aim of this pilot study was to investigate whether a novel hospital menu would be an effective strategy for increasing nutritional intake in patients at nutritional risk. A historically controlled intervention pilot study was conducted. Forty patients at nutritional risk were offered a novel hospital menu as a supplement to the ordinary hospital menu. The menu consisted of 36 naturally energy-enriched small dishes served on demand 24 h a day. Energy and protein intake were calculated as the mean over a period of 3 days. No significant difference in energy and protein intake was observed between the groups; however, a significant (P = 0.001) time gradient in total energy intake was observed in the intervention group. Moreover, a significant (P = 0.03) time gradient in energy intake received from the novel menu was observed. The dishes from the novel menu were mainly ordered from 11.00 h to 14.00 h and from 17.00 h to 18.00 h. No overall significant differences in energy and protein intake between the groups were found. However, the present pilot study revealed a significant time gradient in total energy intake (P = 0.001) and in energy intake from the novel menu (P = 0.03). This indicates the need to include a run-in period when investigating novel hospital menus as a support for patients at nutritional risk. Additionally, food service, available 24 h a day, appears to be unnecessary. © 2012 The Authors Journal of Human Nutrition and Dietetics © 2012 The British Dietetic Association Ltd.

Radiographer's impact on improving clinical decision-making, patient care and patient diagnosis: a pilot study

International Nuclear Information System (INIS)

Lam, Daniel; Egan, Ingrid; Baird, Marilyn

2004-01-01

This pilot study attempts to quantify the benefits of a documented radiographic clinical history through the use of the clinical history template form designed by Egan and Baird. Six radiographers completed the clinical history template for 40 patients and four radiologists included the recorded information as part of their reporting process. A focus discussion group was held between the radiographers to ascertain the level of satisfaction and benefits encountered with the use of the template form. A questionnaire was designed for the radiologists to complete regarding the usefulness of the template form with respect to the radiological reporting process. Results/Discussion: 15 cases for which the form was used demonstrated a direct benefit in respect to improved radiographic clinical decision-making. Radiographers agreed the template form aided the establishment of a stronger radiographer-patient relationship during the radiographic examination. Two radiologists agreed the form aided in establishing a radiological diagnosis and suggested the form be implemented as part of the standard departmental protocol. Despite the small sample size, there is evidence the form aided radiographic decision-making and assisted in the establishment of an accurate radiological diagnosis. The overall consensus amongst radiographers was that it enhanced radiographer-patient communication and improved the level of patient care. Copyright (2004) Australian Institute of Radiography

The Importance of Pilot Studies

OpenAIRE

Van Teijlingen, Edwin; Hundley, Vanora

2001-01-01

The term 'pilot studies' refers to mini versions of a full-scale study (also called 'feasibility' studies), as well as the specific pre-testing of a particular research instrument such as a questionnaire or interview schedule. \\ud Pilot studies are a crucial element of a good study design. Conducting a pilot study does not guarantee success in the main study, but it does increase the likelihood. \\ud Pilot studies fulfil a range of important functions and can provide valuable insights for othe...

Exercise capacity before and after an 8-week multidisciplinary inpatient rehabilitation program in lung cancer patients: a pilot study.

Science.gov (United States)

Spruit, Martijn A; Janssen, Paul P; Willemsen, Sonja C P; Hochstenbag, Monique M H; Wouters, Emiel F M

2006-05-01

Although lung cancer is a highly prevalent type of cancer, the effects of an inpatient multidisciplinary rehabilitation program on pulmonary function and exercise capacity have never been studied in these patients. Pulmonary function, 6-min walking distance and peak exercise capacity of 10 patients with a severely impaired pulmonary function following treatment of lung cancer were assessed in this pilot study before and after an 8-week inpatient multidisciplinary rehabilitation program. At baseline, patients had a restrictive pulmonary function and an apparent exercise intolerance (median 6-min walking distance: 63.6% predicted; median peak cycling load: 58.5% predicted). Despite the lack of change in median pulmonary function [FEV1: -0.01L, p = 0.5469], functional exercise capacity [145 m; 43.2% of the initial values, p=0.0020] and peak exercise capacity [26 W; 34.4% of the initial values, p = 0.0078] improved significantly compared to baseline. Future trials have to corroborate the present findings. Nevertheless, patients with lung cancer have a clear indication to start a comprehensive rehabilitation program following intensive treatment of their disease. In fact, based on the results of the present pilot study it appears that these patients are good candidates for pulmonary rehabilitation programs.

User Participation in Pilot Implementation: Porters and Nurses Coordinating Patient Transports

DEFF Research Database (Denmark)

Torkilsheyggi, Arnvør Martinsdóttir á; Hertzum, Morten

2014-01-01

Pilot implementations provide users with real-work experiences of how a system will affect their daily work before the design of the system is finalized. On the basis of a pilot implementation of a system for coordinating the transport of patients by hospital porters, we investigate pilot impleme...... the use of the pilot system because the porters and nurses learned about their needs throughout the pilot implementation, not just during use. Finally, we discuss how the scope and duration of a pilot implementation influence the conditions for participation....

Automatic Calculation of Hydrostatic Pressure Gradient in Patients with Head Injury: A Pilot Study.

Science.gov (United States)

Moss, Laura; Shaw, Martin; Piper, Ian; Arvind, D K; Hawthorne, Christopher

2016-01-01

The non-surgical management of patients with traumatic brain injury is the treatment and prevention of secondary insults, such as low cerebral perfusion pressure (CPP). Most clinical pressure monitoring systems measure pressure relative to atmospheric pressure. If a patient is managed with their head tilted up, relative to their arterial pressure transducer, then a hydrostatic pressure gradient (HPG) can act against arterial pressure and cause significant errors in calculated CPP.To correct for HPG, the arterial pressure transducer should be placed level with the intracranial pressure transducer. However, this is not always achieved. In this chapter, we describe a pilot study investigating the application of speckled computing (or "specks") for the automatic monitoring of the patient's head tilt and subsequent automatic calculation of HPG. In future applications this will allow us to automatically correct CPP to take into account any HPG.

Effect of patient age awareness on diagnostic agreement of chronic or aggressive periodontitis between clinicians; a pilot study

OpenAIRE

Oshman, Sarah; El Chaar, Edgard; Lee, Yoonjung Nicole; Engebretson, Steven

2016-01-01

Background The aim of this pilot study was to test whether diagnostic agreement of aggressive and chronic periodontitis amongst Board Certified Periodontists, is influenced by knowledge of a patient?s age. In 1999 at the International World Workshop age was removed as a diagnostic criteria for aggressive periodontitis. The impact of this change on the diagnostic reliability amongst clinicians has not yet been assessed. Methods Nine periodontal case reports were twice presented to sixteen boar...

Interprofessional Collaborative Practice to Improve Patient Outcomes: A Pilot Study

Directory of Open Access Journals (Sweden)

Jennifer Styron

2014-06-01

Full Text Available This project focused on a pilot project implemented during the 2013-2014 academic year. The overall purpose was to facilitate interprofessional collaborative practice innovations through the development of leadership, core competencies, and the use of technology, especially among nurses. Nursing, medicine, and physician assistant students were educated on the IOM competencies for interprofessional teams and the core competencies identified by the Interprofessional Education Collaborative Expert Panel [1] to develop knowledge, skills, and attitudes needed to practice in the collaborative practice environments. The project addressed four goals: Develop faculty expertise and leadership in interprofessional collaborative practice to provide a current, high quality education to nursing, physician assistant, and medical students; Implement a culturally responsive and respectful collaborative interprofessional practice curriculum to prepare nurses, physician assistants, and medical students to deliver high quality, efficient, team-based care in a dynamically evolving environment; Focus interprofessional collaborative practice education on models and practices that lead to improvement in patient outcomes; and Evaluate the program and disseminate best practices. Findings from this pilot include strategies to engage different health professions' students and faculty, partnering with community agencies, building an effective interprofessional team to guide the project, and seeking funding for extension and expansion of the offerings.

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

Science.gov (United States)

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

2011-08-01

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

A new computer-based counselling system for the promotion of physical activity in patients with chronic diseases--results from a pilot study.

Science.gov (United States)

Becker, Annette; Herzberg, Dominikus; Marsden, Nicola; Thomanek, Sabine; Jung, Hartmut; Leonhardt, Corinna

2011-05-01

To develop a computer-based counselling system (CBCS) for the improvement of attitudes towards physical activity in chronically ill patients and to pilot its efficacy and acceptance in primary care. The system is tailored to patients' disease and motivational stage. During a pilot study in five German general practices, patients answered questions before, directly and 6 weeks after using the CBCS. Outcome criteria were attitudes and self-efficacy. Qualitative interviews were performed to identify acceptance indicators. Seventy-nine patients participated (mean age: 64.5 years, 53% males; 38% without previous computer experience). Patients' affective and cognitive attitudes changed significantly, self-efficacy showed only minor changes. Patients mentioned no difficulties in interacting with the CBCS. However, perception of the system's usefulness was inconsistent. Computer-based counselling for physical activity related attitudes in patients with chronic diseases is feasible, but the circumstances of use with respect to the target group and its integration into the management process have to be clarified in future studies. This study adds to the understanding of computer-based counselling in primary health care. Acceptance indicators identified in this study will be validated as part of a questionnaire on technology acceptability in a subsequent study. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Chiropractic manipulation in Adolescent Idiopathic Scoliosis: a pilot study

Directory of Open Access Journals (Sweden)

Stoline Michael R

2006-08-01

Full Text Available Abstract Background Adolescent idiopathic scoliosis (AIS remains the most common deforming orthopedic condition in children. Increasingly, both adults and children are seeking complementary and alternative therapy, including chiropractic treatment, for a wide variety of health concerns. The scientific evidence supporting the use chiropractic intervention is inadequate. The purpose of this study was to conduct a pilot study and explore issues of safety, patient recruitment and compliance, treatment standardization, sham treatment refinement, inter-professional cooperation, quality assurance, and outcome measure selection. Methods Six patients participated in this 6-month study, 5 of whom were female. One female was braced. The mean age of these patients was 14 years, and the mean Cobb angle was 22.2 degrees. The study design was a randomized controlled clinical trial with two independent and blinded observers. Three patients were treated by standard medical care (observation or brace treatment, two were treated with standard medical care plus chiropractic manipulation, and one was treated with standard medical care plus sham manipulation. The primary outcome measure was Cobb, and the psychosocial measure was Scoliosis Quality of Life Index. Results Orthopedic surgeons and chiropractors were easily recruited and worked cooperatively throughout the trial. Patient recruitment and compliance was good. Chiropractic treatments were safely employed, and research protocols were successful. Conclusion Overall, our pilot study showed the viability for a larger randomized trial. This pilot confirms the strength of existing protocols with amendments for use in a full randomized controlled trial. Trial registration This trial has been assigned an international standard randomized controlled trial number by Current Controlled Trials, Ltd. http://www.controlled-trials.com/isrctn/. The number is ISRCTN41221647.

Prevalence and Severity of Dysphonia in Patients with Cystic Fibrosis: A Pilot Study.

Science.gov (United States)

Willis, John; Michael, Deirdre D; Boyer, Holly; Misono, Stephanie

2015-07-01

To assess the prevalence and severity of dysphonia in patients with cystic fibrosis sinusitis. We hypothesized that patients with CF sinusitis, compared with 2 control groups, would have higher self-reported prevalence of dysphonia and greater severity of dysphonia, according to patient-reported outcome measures as well as auditory-perceptual evaluation by expert listeners. Cross-sectional comparative pilot study. Academic tertiary care clinic. Analysis included 37 study participants: 17 patients with CF sinusitis, 10 healthy individuals, and 10 patients with non-CF sinusitis. All participants completed the 10-item Voice Handicap Index (VHI-10) questionnaire and provided voice samples. On all samples, 6 blinded speech-language pathologists independently performed auditory-perceptual evaluation, using Consensus Auditory-Perceptual Evaluation of Voice. To assess severity of sinonasal symptoms, we used the 20-item Sinonasal Outcome Test (SNOT-20). Standard parametric and nonparametric statistical analysis was performed. The differences between the 3 groups in prevalence of abnormal VHI-10 scores were not statistically significant. SNOT-20 scores were similar in the 2 sinusitis patient groups. VHI-10 scores were highest in patients with CF sinusitis, intermediate in patients with non-CF sinusitis, and lowest in healthy individuals (P = .005). Auditory-perceptual evaluation demonstrated greater overall severity of dysphonia in patients with CF sinusitis compared with the 2 control groups (P = .0005). Cystic fibrosis sinusitis appeared to be associated with worse vocal function as measured by patient self-report as well as auditory-perceptual evaluation of voice compared with patients with non-CF sinusitis and healthy controls. Further investigation in this area is warranted. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

Attentional and physiological processing of food images in functional dyspepsia patients: A pilot study.

Science.gov (United States)

Lee, In-Seon; Preissl, Hubert; Giel, Katrin; Schag, Kathrin; Enck, Paul

2018-01-23

The food-related behavior of functional dyspepsia has been attracting more interest of late. This pilot study aims to provide evidence of the physiological, emotional, and attentional aspects of food processing in functional dyspepsia patients. The study was performed in 15 functional dyspepsia patients and 17 healthy controls after a standard breakfast. We measured autonomic nervous system activity using skin conductance response and heart rate variability, emotional response using facial electromyography, and visual attention using eyetracking during the visual stimuli of food/non-food images. In comparison to healthy controls, functional dyspepsia patients showed a greater craving for food, a decreased intake of food, more dyspeptic symptoms, lower pleasantness rating of food images (particularly of high fat), decreased low frequency/high frequency ratio of heart rate variability, and suppressed total processing time of food images. There were no significant differences of skin conductance response and facial electromyography data between groups. The results suggest that high level cognitive functions rather than autonomic and emotional mechanisms are more liable to function differently in functional dyspepsia patients. Abnormal dietary behavior, reduced subjective rating of pleasantness and visual attention to food should be considered as important pathophysiological characteristics in functional dyspepsia.

Pilot study for the registry of complications in rheumatic diseases from the German Society of Surgery (DGORh): evaluation of methods and data from the first 1000 patients

Science.gov (United States)

Kostuj, Tanja; Rehart, Stefan; Matta-Hurtado, Ronald; Biehl, Christoph; Willburger, Roland E; Schmidt, Klaus

2017-01-01

Objective Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations. Design and participants Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study. Results Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression. Conclusions Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients. PMID:29018066

Protective Isolation for Patients with Haematological Malignancies: A Pilot Study Investigating Patients' Distress and Use of Time.

Science.gov (United States)

Annibali, O; Pensieri, C; Tomarchio, V; Biagioli, V; Pennacchini, M; Tendas, A; Tambone, V; Tirindelli, M C

2017-10-01

Background: Patients with haematological malignancies are often hospitalized in protective isolation until full neutrophil recovery in order to prevent infections. This descriptive pilot study evaluate the level of isolation-related distress and the use of free time in a sample of Italian onco-haematological patients who were hospitalized in protective isolation. Materials and Methods: Participants were 18 patients hospitalized in hematologic ward to receive induction therapy (n=12) or autologous stem cell transplant (n=6). They completed a self-report questionnaire before discharge. Results: Participants reported a moderate level of isolation-related distress, anxiety, and boredom: the more the anxiety and the boredom, the more the distress (r=.77; Psurfing in Internet or using PC (33.3%), and playing games or making cross-words (16.7%). Participants who reported pessimistic thinking had higher isolation-related distress (P=.004) as well as anxiety (P<.001) and boredom (P=.001). Conclusion: Haematology Units should support isolated patients in spending their time in recreational activities, allowing more contacts with immediate relatives and friends, providing free TV and Wi-Fi connection inside the room. In addition, patients should have to keep themselves physically active. Isolation-related distress could also be reduced by providing psychological support.

Feasibility and acceptability of e-cigarettes as an aid to quitting smoking among lung cancer patients: a pilot study

OpenAIRE

Allison Ford; Lesley Sinclair; Jennifer Mckell; Stephen Harrow; Jennifer Macphee; Andy Morrison; Linda Bauld

2018-01-01

Background Many patients diagnosed with lung cancer continue to smoke even though this can make their treatment less effective and increase side effects. E-cigarettes form part of the UK's tobacco harm reduction policy landscape and are, by far, smokers' most popular quit attempt method. This pilot study explores feasibility and acceptability of e-cigarettes to aid smoking cessation among lung cancer patients undergoing chemotherapy. Methods 27 smokers with stage IV lung cancer we...

Resilience and hope during advanced disease: a pilot study with metastatic colorectal cancer patients.

Science.gov (United States)

Solano, Joao Paulo Consentino; da Silva, Amanda Gomes; Soares, Ivan Agurtov; Ashmawi, Hazem Adel; Vieira, Joaquim Edson

2016-08-02

The balance between hope-hopelessness plays an important role in the way terminally ill patients report quality of life, and personal resilience may be related to hope at the end of life. The objective of this study was to explore associations between personal resilience, hope, and other possible predictors of hope in advanced cancer patients. A cross-sectional pilot study was carried out with metastatic colorectal cancer patients in a tertiary hospital. The patients answered the Connor-Davidson Resilience Scale, Herth Hope Index, Barthel Index, an instrument addressing family and social support, visual-numeric scales for pain and suffering, a two-item screening for depression, socio-demographic and socio-economic information about the family. Forty-four patients were interviewed (mean age 56 years; range 29-86). A strong correlation was noted between resilience and hope (0.63; p hope and independence for activities of daily living, support from family and community, and pain and suffering levels. Of the 44 patients, 20 presented with depressive symptoms. These depressive patients had lower resilience (p = 0.005) and hope (p = 0.003), and higher scores of suffering (p hope kept stable after adjusting for age, gender, and presence of depression (p hope, resilience-fostering interventions should be most valued in palliative care settings and should be commenced as soon as possible with cancer patients. Patients with advanced stages of non-malignant conditions would also probably benefit from such interventions.

Cervical kinematics in patients with vestibular pathology vs. patients with neck pain: A pilot study.

Science.gov (United States)

Williams, Grace; Sarig-Bahat, Hilla; Williams, Katrina; Tyrrell, Ryan; Treleaven, Julia

2017-01-01

Research has consistently shown cervical kinematic impairments in subjects with persistent neck pain (NP). It could be reasoned that those with vestibular pathology (VP) may also have altered kinematics since vestibular stimulation via head movement can cause dizziness and visual disturbances. However, this has not been examined to date. This pilot study investigated changes in cervical kinematics between asymptomatic control, NP and VP subjects using a Virtual Reality (VR) system. It was hypothesised that there would be altered kinematics in VP subjects, which might be associated with dizziness and visual symptoms. Pilot cross sectional observational study. Twenty control, 14 VP and 20 NP subjects. Not applicable. Measures included questionnaires (neck disability index, pain on movement, dizziness and pain intensity, visual disturbances) and cervical kinematics (range, peak and mean velocity, smoothness, symmetry, and accuracy of cervical motion) using a virtual reality system. Results revealed significantly decreased mean velocity and symmetry of motion in both planes in those with NP but no differences in accuracy or range of motion. No significant differences were seen between VP subjects and asymptomatic controls. However, correlation analysis showed some moderate correlations between dizziness to selected kinematics in both the NP and the VP groups. These results support that cervical kinematics are altered in NP patients, with velocity most affected. There is potential for VP subjects to also have altered kinematics, especially those who experience dizziness. More research is required.

Weight loss of 5% or more predicts loss of fat-free mass during palliative chemotherapy in patients with advanced cancer: a pilot study

NARCIS (Netherlands)

Buskermolen, Susanne; Langius, Jacqueline A. E.; Kruizenga, Hinke M.; Ligthart-Melis, Gerdien C.; Heymans, Martijn W.; Verheul, Henk M. W.

2012-01-01

The cutoff value of critical weight loss is still subject of discussion. In this pilot study, we investigated whether ≥ 5% weight loss in the past year predicts changes in nutritional status in patients with advanced cancer during treatment with palliative chemotherapy. In 20 patients with advanced

A pilot study on understanding the journey of advanced prostate cancer patients.

Science.gov (United States)

Wagholikar, Amol; Fung, Maggie; Nelson, Colleen

2011-01-01

To understand the journey of advanced prostate cancer patients for supporting development of an innovative patient journey browser. Prostate cancer is one of the common cancers in Australia. Due to the chronic nature of the disease, it is important to have effective disease management strategy and care model. Multi-disciplinary care is a well-proven approach for chronic disease management. The Multi-disciplinary team (MDT) can function more effectively if all the required information is available for the clinical decision support. The development of innovative technology relies on an accurate understanding of the advanced prostate cancer patient's journey over a prolonged period. This need arises from the fact that advanced prostate cancer patients may follow various treatment paths and change their care providers. As a result of this, it is difficult to understand the actual sources of patient's clinical records and their treatment patterns. The aim of the research is to understand variable sources of clinical records, treatment patterns, alternative therapies, over the counter (OTC) medications of advanced prostate cancer patients. This study provides better and holistic understanding of advanced prostate cancer journey. The study was conducted through an on-line survey developed to seek and analyse the responses from the participants. The on-line questionnaire was carefully developed through consultations with the clinical researchers at the Australian Prostate Cancer Research Centre-Queensland, prostate cancer support group representatives and health informaticians at the Australian E-Health Research Centre. The non-identifying questionnaire was distributed to the patients through prostate cancer support groups in Queensland, Australia. The pilot study was carried out between August 2010 and December 2010. The research made important observations about the advanced prostate cancer journey. It showed that General Practitioner (GP) was the common source of

Development of two electronic bladder diaries: a patient and healthcare professionals pilot study.

Science.gov (United States)

Mangera, Altaf; Marzo, Alberto; Heron, Nicola; Fernando, Dayan; Hameed, Khawar; Soliman, Abdel-Hamid A; Bradley, Mike; Hosking, Ian; Abdel-Maguid, Mohamed; Levermore, Martin; Tindale, Wendy B; Chapple, Christopher

2014-09-01

Assess patients' preferences in a pilot crossover study of two different electronic voiding diaries against a standard paper diary. Assess urological health professional (HP) opinions on the electronic bladder diary reporting system. Two different electronic diaries were developed: (1) electronically read diary-a card with predefined slots read by a card reader and (2) e-diary-a handheld touch screen device. Data uploaded from either electronic diary produced an electronic report. We recruited 22 patients split into two cohorts for each electronic diary, 11 completed each type of electronic diary for 3 days either preceded or followed by a standard paper diary for 3 days. Both diaries were completed on the 7th day. Patients' perceptions of both diaries were recorded using a standardized questionnaire. A HP study recruited 22 urologists who were given the paper diary and the electronic reports. Time taken for analysis was recorded along with accuracy and HP preferences. The majority of patients (82%) preferred the e-diary and only 1/11 found it difficult to use. Patients had the same preference for the electronically read diary as the paper diary. The paper diary took 66% longer to analyze than the electronic report (P analyzed with an accuracy of 58% compared to 100%. Slightly more HP (9%) preferred the electronic report to the paper diary. This proposed e-diary with its intuitive interface has overcome previous deficiencies in electronic diaries with most patients finding the format user-friendly. Electronic reports make analysis and interpretation by HP quicker and more accurate. © 2013 Wiley Periodicals, Inc.

Text Messaging (SMS) Helping Cancer Care in Patients Undergoing Chemotherapy Treatment: a Pilot Study.

Science.gov (United States)

Rico, Timóteo Matthies; Dos Santos Machado, Karina; Fernandes, Vanessa Pellegrini; Madruga, Samanta Winck; Noguez, Patrícia Tuerlinckx; Barcelos, Camila Rose Guadalupe; Santin, Mateus Madail; Petrarca, Cristiane Rios; Dumith, Samuel Carvalho

2017-10-09

Cancer treatment is an extremely stressful life experience that is accompanied by a range of psychological, social, physical, and practical difficulties. Cancer patients need to receive information that helps them to better understand the disease, assists them in decision-making, and helps them deal with treatment. Patients are interested in receiving such information. The degree of satisfaction with the information received has been associated with positive health outcomes, specifically regarding quality of life, severity of side effects, and psychological well-being. This study investigates a method of guiding cancer patients, in relation to outpatient chemotherapy treatment, using SMS (short message service) text messaging. A smartphone application called cHEmotHErApp was developed, and its primary function is to send out SMS text messages with guidance for self-care and emotional support for oncology patients undergoing chemotherapy. Thus, the main objective of this study is to evaluate the acceptance and perception of patients of the receipt of these SMS messages, as well as to evaluate the possible benefits reported by the participants. Adult patients diagnosed with cancer, who started the first outpatient chemotherapy treatment scheme between August and November 2016 at the School Hospital (HE) of the Federal University of Pelotas (UFPel), were invited to participate in this pilot study. In total, 14 cancer patients were adherent to this study. Each of these patients received a daily text message on their cell phone with some guidance on encouraging self-care and emotional support. Patients reported that, because of the SMS text messages they received, they felt more confident in their treatment, felt more supported and encouraged, and that the text messages facilitated self-care. In addition, patients reported that the SMS text messages they received helped them to take better care of themselves and to continue further treatment.

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

Science.gov (United States)

Kim, Mikyung; Kim, Jung-Eun; Lee, Hye-Yoon; Kim, Ae-Ran; Park, Hyo-Ju; Kwon, O-Jin; Kim, Bo-Kyung; Cho, Jung Hyo; Kim, Joo-Hee

2017-08-11

Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep. This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment. This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences. KCT0002162; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated

Pilot study of combination transcriptional modulation therapy with sodium phenylbutyrate and 5-azacytidine in patients with acute myeloid leukemia or myelodysplastic syndrome.

Science.gov (United States)

Maslak, P; Chanel, S; Camacho, L H; Soignet, S; Pandolfi, P P; Guernah, I; Warrell, R; Nimer, S

2006-02-01

Epigenetic mechanisms underlying tumorigenesis have recently received much attention as potential therapeutic targets of human cancer. We designed a pilot study to target DNA methylation and histone deacetylation through the sequential administration of 5-azacytidine followed by sodium phenylbutyrate (PB) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Ten evaluable patients (eight AML, two MDS) were treated with seven consecutive daily subcutaneous injections of 5-azacytidine at 75 mg/m2 followed by 5 days of sodium PB given intravenously at a dose of 200 mg/kg. Five patients (50%) were able to achieve a beneficial clinical response (partial remission or stable disease). One patient with MDS proceeded to allogeneic stem cell transplantation and is alive without evidence of disease 39 months later. The combination regimen was well tolerated with common toxicities of injection site skin reaction (90% of the patients) from 5-azacytidine, and somnolence/fatigue from the sodium PB infusion (80% of the patients). Correlative laboratory studies demonstrated the consistent reacetylation of histone H4, although no relationship with the clinical response could be demonstrated. Results from this pilot study demonstrate that a combination approach targeting different mechanisms of transcriptional modulation is clinically feasible with acceptable toxicity and measurable biologic and clinical outcomes.

VIRTUAL AVATAR FOR EMOTION RECOGNITION IN PATIENTS WITH SCHIZOPHRENIA: A PILOT STUDY

Directory of Open Access Journals (Sweden)

Samuel Marcos Pablos

2016-08-01

Full Text Available Persons who suffer from schizophrenia have difficulties in recognizing emotions in others’ facial expressions, which affects their capabilities for social interaction and hinders their social integration. Photographic images have traditionally been used to explore emotion recognition impairments in schizophrenia patients, which lack of the dynamism that is inherent to face to face social interactions. In order to overcome those inconveniences, in the present work the use of an animated, virtual face is approached. The avatar has the appearance of a highly realistic human face and is able to express different emotions dynamically, introducing some advantages over photograph-based approaches such as its dynamic appearance.We present the results of a pilot study in order to assess the validity of the interface as a tool for clinical psychiatrists. 20 subjects who suffer from schizophrenia of long evolution and 20 control subjects were invited to recognize a set of facial emotions showed by a virtual avatar and images. The objective of the study is to explore the possibilities of using a realistic-looking avatar for the assessment of emotion recognition deficits in patients who suffer schizophrenia. Our results suggest that the proposed avatar may be a suitable tool for the diagnosis and treatment of deficits in the facial recognition of emotions.

Health-related quality of life of cancer patients with peripherally inserted central catheter: a pilot study.

Science.gov (United States)

Kang, Junren; Chen, Wei; Sun, Wenyan; Ge, Ruibin; Li, Hailong; Ma, Enling; Su, Qingxia; Cheng, Fang; Hong, Jinhua; Zhang, Yuanjuan; Lei, Cheng; Wang, Xinchuan; Jin, Aiyun; Liu, Wanli

2017-09-11

This pilot exploratory study aimed to compare the health-related quality of life (HRQOL) among patients diagnosed with different types of cancer receiving peripherally inserted central catheters (PICCs). A multicenter cross-section study of cancer patients with PICCs was performed from February 1, 2013 to April 24, 2014. The primary objective of this study was to compare HRQOL in different cancer type patients with PICC. HRQOL was examined based on European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30). Multiple linear regression models were conducted for coping with potential confounding variables. We also examined PICC-related quality of daily life with a self-made questionnaire. Three hundred and fifty-seven cancer patients with PICC completed the survey in nine teaching hospitals. Lung cancer patients with PICC reported the worst dyspnea. Digestive tract cancer patients reported the worst appetite loss. Patients with hematologic malignancy reported the worst emotional, social function, fatigue and financial impact. Breast cancer patients reported better HRQOL. Baseline variables were proven not significant predictors of EORTC QLQ-C30 global health status. In self-made survey, pain after PICC insertion was null or a little in 98.6% of cancer patients. Limitation of upper extremity activity was null or a little in 94.1% of patients. HRQOL varies in different types of cancer patients with PICC. PICC may have a low impact on cancer patients' HRQOL. Further large sample studies are needed.

Feasibility of a patient-centred nutrition intervention to improve oral intakes of patients at risk of pressure ulcer: a pilot randomised control trial.

Science.gov (United States)

Roberts, Shelley; Desbrow, Ben; Chaboyer, Wendy

2016-06-01

Nutrition is important for pressure ulcer prevention. This randomised control pilot study assessed the feasibility of conducting a larger trial to test the effectiveness of a patient-centred intervention for improving the dietary intakes of patients at risk of pressure ulcer in hospital. A 3-day intervention targeting patients at risk of pressure ulcer was developed, based on three main foundations: patient education, patient participation and guided goal setting. The intervention was piloted in three wards in a metropolitan hospital in Queensland, Australia. Participants were randomised into control or intervention groups and had their oral intakes monitored. A subset of intervention patients was interviewed on their perceptions of the intervention. Feasibility was tested against three criteria: ≥75% recruitment; ≥80% retention; and ≥80% intervention fidelity. Secondary outcomes related to effects on energy and protein intakes. Eighty patients participated in the study and 66 were included in final analysis. The recruitment rate was 82%, retention rate was 88%, and 100% of intervention patients received the intervention. Patients viewed the intervention as motivating and met significantly more of their estimated energy and protein requirements over time. This pilot study indicates that the intervention is feasible and acceptable by patients at risk of pressure ulcer. A larger trial is needed to confirm the effectiveness of the intervention in the clinical setting. © 2015 Nordic College of Caring Science.

Conifer Green Needle Complex in Patients with Precancerous Gastric Lesions: An Observational Pilot Study

Directory of Open Access Journals (Sweden)

Vladimir Bespalov

2016-01-01

Full Text Available Objectives. Helicobacter pylori infection is common and can lead to precancerous gastric lesions. Standard antibiotic therapy has a failure rate of more than 25% from antibiotic resistance. The primary aim of this observational pilot study was to test the feasibility of a large-scale clinical trial of Conifer Green Needle Complex (CGNC to treat precancerous gastric lesions. Secondary aims were to investigate H. pylori infection, stomach function, and histopathology of the gastric mucosa. Methods. A tablet form of CGNC (extracted from Pinus sylvestris and Picea abies (L Karst was prescribed to 26 patients with precancerous gastric lesions (two tablets, 100 mg CGNC/tablet, three times per day for six months. Another 24 patients received no treatment. Results. Compared with control patients, CGNC-treated patients showed total or partial regression (using the quantitative Rome III diagnostic criteria of dyspeptic symptoms (92.3%, p<0.0001, eradication of H. pylori infection (57.1%, p<0.03, a reduction in endoscopic signs of gastritis (92.3%, p<0.001, an increase of pepsinogen-pepsin in the gastric juice (57.7%, p<0.05, and total regression or reduction in the degree of intestinal metaplasia (46.2%, p<0.05 and lymphoplasmacytic infiltration (53.8%, p<0.05. Conclusions. This study justifies a randomised-controlled trial with CGNC in patients with atrophic gastritis.

90% Compliance Pilot Studies Final Report

Energy Technology Data Exchange (ETDEWEB)

None

2013-06-01

In early 2010, the U.S. Department of Energy (DOE) announced an opportunity for states to participate in energy code compliance evaluation pilot studies. DOE worked with five Regional Energy Efficiency Organizations (REEOs, formerly referred to as Energy Efficiency Partnerships, or EEPs) to fund pilot studies covering nine states. This report details conclusions stated in individual state reports, as well as conclusions drawn by DOE based on their oversight of the pilot studies, and based on discussions held with the REEOs and representatives from the pilot study states and their contractors.

Fertility preservation: a pilot study to assess previsit patient knowledge quantitatively.

Science.gov (United States)

Balthazar, Ursula; Fritz, Marc A; Mersereau, Jennifer E

2011-05-01

To provide a quantitative assessment of patient knowledge about fertility and fertility preservation treatment options before the initial fertility preservation consultation at a university-based fertility preservation center. Prospective pilot survey containing 13 items assessing patient knowledge about fertility preservation, including the available treatment options and their requirements, success rates, and associated risks. University-based IVF center. Women aged 18 to 41 years with illnesses requiring treatments posing a serious threat to future fertility who were referred for fertility preservation consultation between April 2009 and June 2010. None. Knowledge score. Forty-one eligible patients were identified, and all completed surveys before their consultation. A knowledge score was generated for each patient with 1 point awarded for each correct answer. Overall, patients had poor previsit fertility preservation knowledge (mean score 5.9±2.7). Higher knowledge scores were correlated with personal experience with infertility and previous exposure to fertility preservation treatment information. There was no correlation between knowledge score and age, relationship status, pregnancy history, education, or income. Patients seen for fertility preservation consultation at our university-based center generally tend to be in their early 30s, white, well educated, and married. Previsit knowledge about fertility preservation treatment options was poor and did not correlate with age, education, and relationship status. Copyright © 2011 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Effect of a polyherbal formulation cream on diabetic neuropathic pain among patients with type 2 diabetes – A pilot study

Science.gov (United States)

Viswanathan, Vijay; Rajsekar, Seena; Selvaraj, Bamila; Kumpatla, Satyavani

2016-01-01

Background & objectives: Painful diabetic neuropathy is a common complication of diabetes and can severely limit patients’ daily functions. The aim of this pilot study was to evaluate the safety and effect of using a polyherbal formulation in reducing the symptoms of diabetic neuropathic pain in comparison with placebo among patients with type 2 diabetes. Methods: A total of 50 (M:F = 33:17) consecutive type 2 diabetes patients with painful diabetic neuropathy were enrolled in this study. All these patients had either two or more symptoms of diabetic neuropathy such as pain, burning and pricking sensations and numbness in their feet. They were randomly assigned to two groups: group 1 (n = 26) patients were treated with polyherbal formulation cream and group 2 (n = 24) patients were administered placebo. The patients were followed up for six months. Changes in the symptoms of painful diabetic neuropathy of each patient were recorded at baseline, third and sixth month using the Diabetic Neuropathic Score. Results: The mean age of the patients, duration of diabetes and glycated haemoglobin (HbA1c) were similar in both groups at baseline. During follow up visits, there was a decrease in the HbA1c levels in the study and control groups. The symptoms of painful diabetic neuropathy were also similar in both groups at baseline. A significant decrease in symptoms of neuropathic pain was observed among the group of patients treated with polyherbal formulation cream (76.9 per cent) compared to the placebo-treated group (12.5 per cent) (P<0.001), at the end of the final follow up. Interpretation & conclusions: In this pilot study polyherbal formulation cream was found to be effective as well as safe to treat painful diabetic neuropathy. However, its long term use needs to be evaluated for any further effectiveness and side effects. PMID:27934800

Systemic thrombolysis of portal vein thrombosis in cirrhotic patients: a pilot study.

Science.gov (United States)

De Santis, Adriano; Moscatelli, Rosanna; Catalano, Carlo; Iannetti, Antonio; Gigliotti, Francesca; Cristofari, Francesca; Trapani, Silvia; Attili, Adolfo F

2010-06-01

Portal vein thrombosis is a frequent complication in liver cirrhosis. Encouraging reports of systemic thrombolysis in non-cirrhotic patients suffering from acute portal vein thrombosis led us to start a pilot study on the efficacy and safety of systemic low dose recombinant tissue plasminogen activator (Actilyse, Boheringer Ingelheim, Florence, Italy). Nine cirrhotic patients (6 males and 3 females) with recent portal vein thrombosis were enrolled. Exclusion criteria were portal cavernomatosis, recent (30 days) surgery, active bleeding, hepatocellular carcinoma and cancer in other sites. All cases were treated for a maximum of 7 days by continuous i.v. infusion of 0.25mg/kg/die of r-tPA plus subcutaneous low molecular weight heparin. Efficacy was evaluated by colour doppler sonography monitoring and confirmed by contrast enhanced computerized tomography. The combined r-tPA/LMWH treatment was well tolerated without clinically significant side effects. Complete resolution of thrombosis occurred in 4 cases, partial regression in 4 and none in 1. Retreatment of a complete recurrence in 1 patient was successful. Variceal pressure dropped from 30.7+/-4.5 mmHg to 21.2+/-6.6 mmHg (p=0.012). Our preliminary data demonstrate that thrombolytic treatment of recent portal vein thrombosis with i.v. r-tPA and LMWH in patients with cirrhosis appears to be safe and effective and can significantly reduce pressure in oesophageal varices. Copyright 2009 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Group supervision for healthcare professionals within primary care for patients with psychosomatic health problems: a pilot intervention study.

Science.gov (United States)

Bullington, Jennifer; Cronqvist, Agneta

2018-03-01

In primary health care, efficacious treatment strategies are lacking for these patients, although the most prominent symptoms accounting for consultation in primary care often cannot be related to any biological causes. The aim was to explore whether group supervision from a specific phenomenological theory of psychosomatics could provide healthcare professionals treating patients with psychosomatic health issues within primary care a deeper understanding of these conditions and stimulate profession-specific treatment strategies. Our research questions were as follows: (i) What is the healthcare professionals' understanding of psychosomatics before and after the intervention? (ii) What are the treatment strategies for this group of patients before and after the intervention? The study was an explorative qualitative intervention pilot study. The six participants from a primary healthcare setting in a medium-sized city in Sweden participated in the study. A supervision group was formed, based on a mix of professions, age, gender and years of clinical experience. Supervision consisted of one 75-minutes meeting every month during the course of 6 months. Participants were interviewed before and after the supervision intervention. The study showed two distinct categories emerged from the data. One category of healthcare professionals espoused a psycho-educative approach, while the other lacked a cohesive approach. The supervision improved the second category of healthcare professionals' understanding of psychosomatics. The psycho-educative group did not change their understanding of psychosomatics, although they felt strengthened in their approach by the supervision. Profession-specific strategies were not developed. This pilot study indicates that a relatively short supervision intervention can aid clinicians in their clinical encounters with these patients; however, further research is necessary to ascertain the value of the specific phenomenologically based

A Virtual Ward for Home Hemodialysis Patients – A Pilot Trial

Directory of Open Access Journals (Sweden)

Michael J. Raphael

2015-11-01

Full Text Available Background: Patients with end-stage renal disease (ESRD have a high rate of hospitalization and are prone to care gaps that may occur during the transition from hospital to home. The virtual ward (VW is an innovative model that provides short-term transitional care to patients upon hospital discharge. The VW may be an effective intervention to address care gaps. Objectives: The primary objective of the pilot study was to assess the feasibility and practicality of implementing the Home Dialysis VW (HDVW on a broader scale. Design: The HDVW Pilot Study enrolled home hemodialysis patients following one of four inclusion criteria: 1. Discharge from hospital, 2. Completion of an in-hospital medical procedure, 3. Prescription of an antibiotic, 4. Completion of home hemodialysis training. Patients were followed in the HDVW for 14 days and during this time were assessed serially with a clinician-led telephone interview for one of three transitional care gaps: 1. Requirement for change in hemodialysis prescription, 2. Requirement for coordination of follow-up care, 3. Requirement for medication change. Setting: The study was conducted in Toronto, Ontario, Canada at a quaternary care academic teaching hospital from 2012–2013. Patients: This study included 52 HDVW admissions among 35 patients selected from the existing home hemodialysis program. Measurements: The primary outcome was the identification of the number of care gaps at each HDVW admission. Secondary outcomes included the identification of potential predictors of care gaps and description of clinical adverse events following HDVW admission (readmissions, emergency department visits, unplanned visits to the home hemodialysis in-center. Results: The implementation and execution of the HDVW Pilot Study proved to be technically feasible and practical. A care gap was identified in 35 (67 % of the HDVW admissions. In total, the cohort experienced 85 care gaps. There were no baseline demographic

Pilot study

International Nuclear Information System (INIS)

Hofmeester, G.H.; Swart, A.; Dijk, E. van

1984-01-01

In May 1980 it was decided to organize an intercomparison of personal dosimeters for photon radiations. The Commission of the European Communities initiated the intercomparison by starting a pilot study in which three laboratories NPL (United Kingdom), PTB (Germany) and RIV (The Netherlands) were asked to irradiate a series of personal dosemeters from institutes, GSF (Muenchen), CEA (Fontenay-aux-Roses), CNEN (Bologna) and CEGB (Berkeley). The latter institutes are secondary standard laboratories and have a radiation protection service as well. A new aspect of this pilot study is the fact that the irradiations also take place in front of a phantom. Irradiations took place in July and August 1980. The results of 4 institutes show that the personal dosemeters are quite capable of measuring the backscattered photon components

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

Science.gov (United States)

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 (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.

The effect of individualized patient education, along with emotional support, on the quality of life of breast cancer patients - A pilot study.

Science.gov (United States)

Sajjad, Sehrish; Ali, Asho; Gul, Raisa B; Mateen, Ahmed; Rozi, Shafquat

2016-04-01

This study aimed to determine the effect of individualized patient education along with emotional support on the quality of life (QoL) of breast cancer patients undergoing chemotherapy. It also aimed to determine the intervention's feasibility in the Pakistani context. A quasi-experimental design, with pre- and post-test, in two groups, via time block, was used. The study was conducted at a public hospital in Karachi with a sample of 50 patients; 25 patients each in the intervention and control group. The intervention was delivered over a period of six weeks. It comprised verbal and written patient education, availability of a nurse during patients' chemotherapy administration and over the telephone, and a telephone follow-up of the patients by the nurse. patients' QoL was assessed at baseline and at the sixth week of receiving chemotherapy. Tests indicated a significant improvement in the overall QoL, breast cancer subscale scores, and the physical and emotional well-being of the intervention group, as compared to the control group. The intervention effect size was moderate (0.655) for the QoL. The intervention was found to be effective in improving patients' QoL. However, a larger study, in a multi-center setting, is recommended to ascertain the findings of this pilot study. Copyright © 2016 Elsevier Ltd. All rights reserved.

Periodontal treatment in patients with chronic kidney disease: a pilot study.

Science.gov (United States)

Almeida, S; Figueredo, C M; Lemos, C; Bregman, R; Fischer, R G

2017-04-01

This pilot cohort study evaluated the effect of periodontal treatment on renal function, metabolic markers and asymmetric dimethylarginine (ADMA) in patients with pre-dialysis chronic kidney disease (CKD) presenting chronic periodontitis. Twenty-six patients with CKD and severe chronic periodontitis were selected. Periodontal parameters included plaque index, bleeding on probing, probing pocket depth and clinical attachment level. Estimated glomerular filtration rate (eGFR), triglycerides, total cholesterol, albumin and ADMA levels were evaluated at baseline, 90 and 180 d after periodontal therapy. eGFR was evaluated by the Modification of Diet in Renal Disease equation. All periodontal clinical parameters significantly improved (p periodontal therapy. There was a significant improvement on the median values (25%; 75% percentiles) of eGFR from 34.6 (27; 44.7) mL/min/1.73 m 2 on baseline to 37.6 (29.7; 57) mL/min/1.73 m 2 on day 90, and to 37.6 (28.6; 56) mL/min/1.73 m 2 (p periodontal treatment. No significant differences were observed at the median values of metabolic markers comparing baseline and 180 d after periodontal treatment. The results point to a link of kidney disease with endothelium dysfunction and periodontitis, suggesting that periodontal treatment may be beneficial to the course of CKD. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Associations Among Depressive Symptoms, Wellness, Patient Involvement, Provider Cultural Competency, and Treatment Nonadherence: A Pilot Study Among Community Patients Seen at a University Medical Center.

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Hooper, Lisa M; Huffman, Lauren E; Higginbotham, John C; Mugoya, George C T; Smith, Annie K; Dumas, Tia N

2018-02-01

Treatment nonadherence is a pernicious problem associated with increasing rates of chronic diseases, escalating healthcare costs, and rising mortality in some patients. Although researchers have suggested numerous factors related to treatment nonadherence, several understudied aspects warrant attention, such as primary-care settings, provider cultural competence, and patient involvement. Adding to the research base, the present pilot study examined 88 primarily Black American and White American community patients from a large university medical center in the southern part of the United States. The study explored two research questions: (a) To what extent are there associations among depressive symptoms, wellness, patient involvement, cultural competency, and treatment nonadherence in a racially diverse community patient population? And (b) to what extent do the study exploratory variables and background characteristics predict treatment nonadherence, both separately and jointly? Depressive symptoms, the patient's perception of a provider's cultural competence, and marital/partnered status were found to be statistically significantly associated with treatment nonadherence, but not entirely in the directions expected.

Pilot studies: one swallow does not make a summer... Editorial

NARCIS (Netherlands)

Gelder, T. van; Smits, P.

2003-01-01

What should we expect from pilot studies, done in small series of patients? In the literature there are many examples of small studies with very promising results, that in subsequent larger or better controlled studies proved to be much less promising, or even disastrous. In some instances the

A Pilot Study Assessing ECG versus ECHO Ventriculoventricular Optimization in Pediatric Resynchronization Patients.

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Punn, Rajesh; Hanisch, Debra; Motonaga, Kara S; Rosenthal, David N; Ceresnak, Scott R; Dubin, Anne M

2016-02-01

Cardiac resynchronization therapy indications and management are well described in adults. Echocardiography (ECHO) has been used to optimize mechanical synchrony in these patients; however, there are issues with reproducibility and time intensity. Pediatric patients add challenges, with diverse substrates and limited capacity for cooperation. Electrocardiographic (ECG) methods to assess electrical synchrony are expeditious but have not been extensively studied in children. We sought to compare ECHO and ECG CRT optimization in children. Prospective, pediatric, single-center cross-over trial comparing ECHO and ECG optimization with CRT. Patients were assigned to undergo either ECHO or ECG optimization, followed for 6 months, and crossed-over to the other assignment for another 6 months. ECHO pulsed-wave tissue Doppler and 12-lead ECG were obtained for 5 VV delays. ECG optimization was defined as the shortest QRSD and ECHO optimization as the lowest dyssynchrony index. ECHOs/ECGs were interpreted by readers blinded to optimization technique. After each 6 month period, these data were collected: ejection fraction, velocimetry-derived cardiac index, quality of life, ECHO-derived stroke distance, M-mode dyssynchrony, study cost, and time. Outcomes for each optimization method were compared. From June 2012 to December 2013, 19 patients enrolled. Mean age was 9.1 ± 4.3 years; 14 (74%) had structural heart disease. The mean time for optimization was shorter using ECG than ECHO (9 ± 1 min vs. 68 ± 13 min, P cost for charges was $4,400 ± 700 less for ECG. No other outcome differed between groups. ECHO optimization of synchrony was not superior to ECG optimization in this pilot study. ECG optimization required less time and cost than ECHO optimization. © 2015 Wiley Periodicals, Inc.

Development and pilot testing of a patient-participatory pressure ulcer prevention care bundle.

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Gillespie, Brigid M; Chaboyer, Wendy; Sykes, Mark; O'Brien, Jennifer; Brandis, Susan

2014-01-01

This study developed and piloted a patient-centered pressure ulcer prevention care bundle for adult hospitalized patients to promote patient participation in prevention. The care bundle had 3 core messages: (1) keep moving, (2) care for your skin, and (3) ensure a good diet. A brief video, combined brochure/checklist, and poster were developed as training resources. Patient evaluation identified benefits of the care bundle; however, the combined checklist/brochure was rarely used.

PILOT STUDY: THE TAMPA ASTHMATIC CHILDREN'S STUDY (TACS)

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The Tampa Asthmatic Children's Study (TACS) was a pilot research study that focused on developing and evaluating air pollution exposure assessment methods and participant recruiting tools for children in the age range of 1-5 years old. The pilot study focused on (a) simple, cost-...

Comparing hospital staff and patient perceptions of customer service: a pilot study utilizing survey and focus group data.

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Fottler, Myron D; Dickson, Duncan; Ford, Robert C; Bradley, Kenneth; Johnson, Lee

2006-02-01

The measurement of patient satisfaction is crucial to enhancing customer service and competitive advantage in the health-care industry. While there are numerous approaches to such measurement, this paper provides a case study which compares and contrasts patient and staff perceptions of customer service using both survey and focus group data. Results indicate that there is a high degree of correlation between staff and patient perceptions of customer service based on both survey and focus group data. However, the staff and patient subgroups also provided complementary information regarding patient perceptions of their service experience. Staff members tended to have more negative perceptions of service attributes than did the patients themselves. The focus group results provide complementary information to survey results in terms of greater detail and more managerially relevant information. While these results are derived from a pilot study, they suggest that diversification of data sources beyond patient surveys may enhance the utility of customer service information. If further research can affirm these findings, they create exciting possibilities for gathering valid, reliable and cost-effective customer service information.

THE STUDY "REGISTER OF PATIENTS AFTER ACUTE STROKE (REGION." Part 1. Hospital Prospective Register of Patients after Acute Stroke (According to the Results of the Pilot Phase of the Study

Directory of Open Access Journals (Sweden)

S. A. Boytsov

2016-01-01

Full Text Available Aim. To assess the main features of the clinical course of acute cerebrovascular accident (ACVA, its short-term and long-term outcomes and quality of pharmacotherapy based on hospital register. Material and methods. The hospital register of acute stroke (AS was organized in one of the cardiovascular centers in Moscow city. The results of the pilot part of the study are presented (170 patients hospitalized from January 01, 2014 to September 30, 2014 with ACVA living in the service area of one of the closest outpatient clinics. Presence of cardiovascular diseases (CVD and their risk factors (RF, prehospital therapy, short-term complications including death and pharmacotherapy recommended to survived patients were analyzed using hospital medical records. During ambulatory follow-up (prospective part of the register the vital status and pharmacotherapy were assessed. Results. The majority of patients with AS had concomitant CVD (on average 2 per patient and non CVD (on average 1.2 per patient. Data on the risk factors of CVD and their complications were reflected insufficiently in the medical records. Most patients in the prehospital period did not receive adequate treatment for the reduction in the cardiovascular risk. 90 patients survived and were discharged. 1.5-2 years after discharge, information on the vital status was available for 78 (86.7% patients. 61 of them (78.2% were alive and 17 (21.8% died. Conclusion. The pilot part of the REGION register revealed that the majority of patients with AS have concomitant CVD and non-CVD. The overall quality of pharmacotherapy, primary and secondary prevention of ACVA was far from that recommended in clinical guidelines, especially during follow-up in outpatient clinic.

APpropriAteness of percutaneous Coronary interventions in patients with ischaemic HEart disease in Italy: the APACHE pilot study

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Marino, Marcello; Crimi, Gabriele; Maiorana, Florinda; Rizzotti, Diego; Lettieri, Corrado; Bettari, Luca; Zuccari, Marco; Sganzerla, Paolo; Tresoldi, Simone; Adamo, Marianna; Ghiringhelli, Sergio; Sponzilli, Carlo; Pasquetto, Giampaolo; Pavei, Andrea; Pedon, Luigi; Bassan, Luciano; Bollati, Mario; Camisasca, Paola; Trabattoni, Daniela; Brancati, Marta; Poli, Arnaldo; Panciroli, Claudio; Lettino, Maddalena; Tarelli, Giuseppe; Tarantini, Giuseppe; De Luca, Leonardo; Varbella, Ferdinando; Musumeci, Giuseppe; De Servi, Stefano

2017-01-01

Objectives To first explore in Italy appropriateness of indication, adherence to guideline recommendations and mode of selection for coronary revascularisation. Design Retrospective, pilot study. Setting 22 percutaneous coronary intervention (PCI)-performing hospitals (20 patients per site), 13 (59%) with on-site cardiac surgery. Participants 440 patients who received PCI for stable coronary artery disease (CAD) or non-ST elevation acute coronary syndrome were independently selected in a 4:1 ratio with half diabetics. Primary and secondary outcome measures Proportion of patients who received appropriate PCI using validated appropriate use scores (ie, AUS≥7). Also, in patients with stable CAD, we examined adherence to the following European Society of Cardiology recommendations: (A) per cent of patients with complex coronary anatomy treated after heart team discussion; (B) per cent of fractional flow reserve-guided PCI for borderline stenoses in patients without documented ischaemia; (C) per cent of patients receiving guideline-directed medical therapy at the time of PCI as well as use of provocative test of ischaemia according to pretest probability (PTP) of CAD. Results Of the 401 mappable PCIs (91%), 38.7% (95% CI 33.9 to 43.6) were classified as appropriate, 47.6% (95% CI 42.7 to 52.6) as uncertain and 13.7% (95% CI 10.5% to 17.5%) as inappropriate. Median PTP in patients with stable CAD without known coronary anatomy was 69% (78% intermediate PTP, 22% high PTP). Ischaemia testing use was similar (p=0.71) in patients with intermediate (n=140, 63%) and with high PTP (n=40, 66%). In patients with stable CAD (n=352) guideline adherence to the three recommendations explored was: (A) 11%; (B) 25%; (C) 23%. AUS was higher in patients evaluated by the heart team as compared with patients who were not (7 (6.8) vs 5 (4.7); p=0.001). Conclusions Use of heart team approaches and adherence to guideline recommendations on coronary revascularisation in a real-world setting

Personal abilities in patients undergoing peritoneal dialysis and hemodialysis. A pilot study using the existence scale.

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Schwaiger, Johannes P; Kopriva-Altfahrt, Gertrude; Söllner, Wolfgang; König, Paul

2007-01-01

Personality psychology is increasingly used in various clinical medicine settings to help in decision-making in difficult situations, especially in chronic disease. Patients with chronic renal disease are very dependent on modern medicine, and psychological aspects could help give answers in certain circumstances. Logotherapy and Existence analysis, after Viktor Frankl (Third Viennese School of Psychotherapy), is the theory of the possibilities and conditions for a fulfilled existence and evaluates a different aspect of personality psychology, namely meaning (in life). We used the existence scale questionnaire in this pilot study to investigate the personal abilities self-distancing, self-transcendence, freedom and responsibility in dialysis patients and compared a group of hemodialysis (HD) patients with patients treated with continuous ambulatory peritoneal dialysis (CAPD). We studied a mixed dialysis cohort (24 HD, 24 CAPD) at two Austrian centers (Innsbruck Medical University Hospital and Wilhelminenspital of the City of Vienna). Overall, results for dialysis patients (n = 48) were very close to those reported for healthy persons; however, CAPD patients scored significantly better than HD patients (p = 0.017) on the subscale self-distancing. This significant difference was also seen in the overall scores (p = 0.045). Our results might indicate that contented CAPD patients have personal abilities that predestine them for this type of treatment. The existence scale might help decide between CAPD and HD treatment alternatives.

A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

DEFF Research Database (Denmark)

Qintar, Mohammed; George, Jason J; Panko, Melanie

2015-01-01

, but higher anxiety was associated with recent and total number of shocks. The small pilot study suggested that a simple program of CBT might lower moderate-high anxiety with lasting effects to 1 year and supports the need for a larger trial to validate these results. CLINICAL TRIAL REGISTRATION: Clinical......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study...... consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS...

Psychoeducation against depression, anxiety, alexithymia and fibromyalgia: a pilot study in primary care for patients on sick leave.

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Melin, Eva O; Svensson, Ralph; Thulesius, Hans O

2018-06-01

Feasibility testing of a psychoeducational method -The Affect School and Script Analyses (ASSA) - in a Swedish primary care setting. Exploring associations between psychological, and medically unexplained physical symptoms (MUPS). Pilot study. Three Swedish primary care centers serving 20,000 people. 8 weekly 2-hour sessions with a 5-7 participant group led by two instructors - followed by 10 individual hour-long sessions. Thirty-six patients, 29 women (81%), on sick-leave due to depression, anxiety, or fibromyalgia. Feasibility in terms of participation rates and expected improvements of psychological symptoms and MUPS, assessed by self-report instruments pre-, one-week post-, and 18 months post-intervention. Regression coefficients between psychological symptoms and MUPS. The entire 26-hour psychoeducational intervention was completed by 30 patients (83%), and 33 patients (92%) completed the 16-hour Affect School. One-week post-intervention median test score changes were significantly favorable for 27 respondents, with p 80% participation rates, and clear improvements of self-assessed psychological symptoms and MUPS. The ASSA intervention thus showed adequate feasibility in a Swedish primary care setting. Key Points  A pilot study of a psychoeducational intervention - The Affect School and Script Analyses (ASSA) - was performed in primary care   • The intervention showed feasibility for patients on sick-leave due to depression, anxiety, or fibromyalgia   • 92% completed the 8 weeks/16 hours Affect School and 83% completed the entire 26-hour ASSA intervention   • 9 of 11 self-reported measures improved significantly one-week post intervention   • 7 of 11 self-reported measures improved significantly 18 months post-intervention.

Patient guided Piezo-electric Extracorporeal Shockwave Therapy as treatment for chronic severe patellar tendinopathy: A pilot study.

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Zwerver, Johannes; Dekker, Femke; Pepping, Gert-Jan

2010-01-01

Patellar tendinopathy is a common overuse injury for which no evidence-based treatment guidelines exist. Extracorporeal Shock Wave Therapy (ESWT) seems to be an effective treatment for patellar tendinopathy but the most beneficial treatment strategies still need to be ascertained. Aim of this pilot study was to investigate if patient guided Piezo-electric, focused ESWT, without local anesthesia is a safe and well tolerated treatment which improves pain and function in patients with patellar tendinopathy. Nineteen male athletes with severe chronic patellar tendinopathy received 3 patient guided focused medium to high energy ESWT treatments at a weekly interval. Before and after 3 months VISA-P and VAS (pain) scores were recorded. Data on side effects and complications of treatment were also collected. No serious complications were reported and patients tolerated the treatment well. Mean VISA-P score improved from 36.1 to 50.1 (p patellar tendinopathy.

Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study.

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Wijayasinghe, Nelun; Andersen, Kenneth G; Kehlet, Henrik

2017-02-01

Persistent pain after breast cancer surgery (PPBCS) develops in 15% to 25% of patients, sometimes years after surgery. Approximately 50% of PPBCS patients have neuropathic pain in the breast, which may be due to dysfunction of the pectoral nerves. The Pecs local anesthetic block proposes to block these nerves and has provided pain relief for patients undergoing breast cancer surgery, but has yet to be evaluated in patients with PPBCS. The aim of this pilot study was to examine the effects of the Pecs block on summed pain intensity (SPI) and sensory function (through quantitative sensory testing [QST]) in eight patients with PPBCS. SPI and QST measurements were recorded before and 30 minutes after administration of the Pecs block (20 mL 0.25% bupivacaine). Pain intensity and sleep interference were measured daily before and after the block for 7 days. Patients experienced analgesia (P = 0.008) and reduced hypoesthesia areas to cold (P = 0.004) and warmth (P = 0.01) after 30 minutes. The reported pain relief (P = 0.02) and reduced sleep interference (P = 0.01) persisted for 7 days after the block. This pilot study suggests that the pectoral nerves play a role in the maintenance of pain in the breast area in PPBCS and begs for further research. © 2016 World Institute of Pain.

Use of standardised patients to assess quality of tuberculosis care: a pilot, cross-sectional study.

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Das, Jishnu; Kwan, Ada; Daniels, Benjamin; Satyanarayana, Srinath; Subbaraman, Ramnath; Bergkvist, Sofi; Das, Ranendra K; Das, Veena; Pai, Madhukar

2015-11-01

Existing studies of the quality of tuberculosis care have relied on recall-based patient surveys, questionnaire surveys of knowledge, and prescription or medical record analysis, and the results mostly show the health-care provider's knowledge rather than actual practice. No study has used standardised patients to assess clinical practice. Therefore we aimed to assess quality of care for tuberculosis using such patients. We did a pilot, cross-sectional validation study of a convenience sample of consenting private health-care providers in low-income and middle-income areas of Delhi, India. We recruited standardised patients in apparently good health from the local community to present four cases (two of presumed tuberculosis and one each of confirmed tuberculosis and suspected multidrug-resistant tuberculosis) to a randomly allocated health-care provider. The key objective was to validate the standardised-patient method using three criteria: negligible risk and ability to avoid adverse events for providers and standardised patients, low detection rates of standardised patients by providers, and data accuracy across standardised patients and audio verification of standardised-patient recall. We also used medical vignettes to assess providers' knowledge of presumed tuberculosis. Correct case management was benchmarked using Standards for Tuberculosis Care in India (STCI). Between Feb 2, and March 28, 2014, we recruited and trained 17 standardised patients who had 250 interactions with 100 health-care providers, 29 of whom were qualified in allopathic medicine (ie, they had a Bachelor of Medicine & Surgery [MBBS] degree), 40 of whom practised alternative medicine, and 31 of whom were informal health-care providers with few or no qualifications. The interactions took place between April 1, and April 23, 2014. The proportion of detected standardised patients was low (11 [5%] detected out of 232 interactions among providers who completed the follow-up survey), and

Analysis of post-operative changes in serum protein expression profiles from colorectal cancer patients by MALDI-TOF mass spectrometry: a pilot methodological study

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Marsh Simon

2010-04-01

Full Text Available Abstract Background Mass spectrometry-based protein expression profiling of blood sera can be used to discriminate colorectal cancer (CRC patients from unaffected individuals. In a pilot methodological study, we have evaluated the changes in protein expression profiles of sera from CRC patients that occur following surgery to establish the potential of this approach for monitoring post-surgical response and possible early prediction of disease recurrence. Methods In this initial pilot study, serum specimens from 11 cancer patients taken immediately prior to surgery and at approximately 6 weeks following surgery were analysed alongside 10 normal control sera by matrix-assisted laser desorption ionisation time of-flight-mass spectrometry (MALDI-TOF MS. Using a two-sided t-test the top 20 ranked protein peaks that discriminate normal from pre-operative sera were identified. These were used to classify post-operative sera by hierarchical clustering analysis (Spearman's Rank correlation and, as an independent 'test' dataset, by k-nearest neighbour and weighted voting supervised learning algorithms. Results Hierarchical cluster analysis classified post-operative sera from all six early Dukes' stage (A and B patients as normal. The remaining five post-operative sera from more advanced Dukes' stages (C1 and C2 were classified as cancer. Analysis by supervised learning algorithms similarly grouped all advanced Dukes' stages as cancer, with four of the six post-operative sera from early Dukes' stages being classified as normal (P = 0.045; Fisher's exact test. Conclusions The results of this pilot methodological study illustrate the proof-of-concept of using protein expression profiling of post-surgical blood sera from individual patients to monitor disease course. Further validation on a larger patient cohort and using an independent post-operative sera dataset would be required to evaluate the potential clinical relevance of this approach. Prospective

High-risk human papilloma virus (HPV) and survival in patients with esophageal carcinoma: a pilot study

International Nuclear Information System (INIS)

Dreilich, Martin; Bergqvist, Michael; Moberg, Martin; Brattström, Daniel; Gustavsson, Inger; Bergström, Stefan; Wanders, Alkwin; Hesselius, Patrik; Wagenius, Gunnar; Gyllensten, Ulf

2006-01-01

Human papilloma virus (HPV) in patients with esophageal carcinoma has previously been studied with an average detection rate of 15%, but the role of HPV in relation to survival is less clear. In cervical cancer, lung cancer and tonsil cancer HPV viral load is a predictive factor for survival and outcome of treatment. The primary aim was to study the spectrum of high-risk HPV types in esophageal tumors. Secondary, as a pilot study we investigated the association between HPV status and the survival rates. We compared both the presence and the viral load of high-risk HPV types 16, 18, 31, 33, 39, 45, 52, 58, and 67 in relation to clinical data from patients with esophageal carcinoma. Survival data and tumor samples were retrieved from 100 patients receiving treatment at the Department of Oncology, Uppsala Hospital, Uppsala, Sweden. The tumor samples were investigated for HPV viral load using real-time PCR. HPV 16 was detected in 16% of the patients; no other HPV type was detected. HPV 16 infection had no significant effect on survival (p = 0.72). Also, HPV 16 did not improve survival after treatment (radiotherapy or chemotherapy). Only HPV 16 was detected among the patients. HPV 16 in esophageal carcinoma patients did not influence survival or improve therapy response. However, given the size of the study there is a need to examine a larger cohort in order to understand in more detail the effect of high risk HPV types in esophageal carcinoma

Treatment outcomes in patients with internet addiction: a clinical pilot study on the effects of a cognitive-behavioral therapy program.

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Wölfling, K; Beutel, M E; Dreier, M; Müller, K W

2014-01-01

Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far.

Treatment Outcomes in Patients with Internet Addiction: A Clinical Pilot Study on the Effects of a Cognitive-Behavioral Therapy Program

Directory of Open Access Journals (Sweden)

K. Wölfling

2014-01-01

Full Text Available Internet addiction is regarded as a growing health concern in many parts of the world with prevalence rates of 1-2% in Europe and up to 7% in some Asian countries. Clinical research has demonstrated that Internet addiction is accompanied with loss of interests, decreased psychosocial functioning, social retreat, and heightened psychosocial distress. Specialized treatment programs are needed to face this problem that has recently been added to the appendix of the DSM-5. While there are numerous studies assessing clinical characteristics of patients with Internet addiction, the knowledge about the effectiveness of treatment programs is limited. Although a recent meta-analysis indicates that those programs show effects, more clinical studies are needed here. To add knowledge, we conducted a pilot study on the effects of a standardized cognitive-behavioral therapy program for IA. 42 male adults meeting criteria for Internet addiction were enrolled. Their IA-status, psychopathological symptoms, and perceived self-efficacy expectancy were assessed before and after the treatment. The results show that 70.3% of the patients finished the therapy regularly. After treatment symptoms of IA had decreased significantly. Psychopathological symptoms were reduced as well as associated psychosocial problems. The results of this pilot study emphasize findings from the only meta-analysis conducted so far.

The oral microbiota in patients with pancreatic cancer, patients with IPMNs, and controls: a pilot study.

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Olson, Sara H; Satagopan, Jaya; Xu, Youming; Ling, Lilan; Leong, Siok; Orlow, Irene; Saldia, Amethyst; Li, Peter; Nunes, Pamela; Madonia, Vincent; Allen, Peter J; O'Reilly, Eileen; Pamer, Eric; Kurtz, Robert C

2017-09-01

Poor oral health appears to be a risk factor for pancreatic cancer, possibly implicating the oral microbiota. In this pilot study, we evaluated the characteristics of the oral microbiota in patients with pancreatic ductal adenocarcinoma (PDAC), intraductal papillary mucinous neoplasms (IPMN), and healthy controls. Forty newly diagnosed PDAC patients, 39 IPMN patients, and 58 controls, excluding current smokers and users of antibiotics, provided saliva samples. Common oral bacterial species were comprehensively surveyed by sequencing of the 16S rRNA microbial genes. We obtained measures of diversity and the mean relative proportions of individual taxa. We explored the degree to which these measures differed according to respondent characteristics based on individual interviews. PDAC cases did not differ in diversity measures from either controls or IPMN cases. PDAC cases had higher mean relative proportions of Firmicutes and related taxa, while controls had higher mean relative proportions of Proteobacteria and related taxa. Results were generally similar when comparing PDAC to IPMN cases. Among IPMNs and controls combined, younger individuals had higher levels of several taxa within the Proteobacteria. The only other variable consistently related to mean relative proportions was mouthwash use, with taxa within Firmicutes more common among users. While there were no differences in diversity of the oral microbiota among these groups, there were differences in the mean relative proportions of some taxa. Characteristics of the oral microbiota are not associated with most measures of oral health.

A virtual reality-integrated program for improving social skills in patients with schizophrenia: a pilot study.

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Rus-Calafell, Mar; Gutiérrez-Maldonado, José; Ribas-Sabaté, Joan

2014-03-01

Social skills training (SST) intervention has shown its efficacy to improve social dysfunction in patients with psychosis; however the implementation of new skills into patients' everyday functioning is difficult to achieve. In this study, we report results from the application of a virtual reality (VR) integrated program as an adjunct technique to a brief social skills intervention for patients with schizophrenia. It was predicted that the intervention would improve social cognition and performance of patients as well as generalisation of the learned responses into patient's daily life. Twelve patients with schizophrenia or schizoaffective disorder completed the study. They attended sixteen individual one-hour sessions, and outcome assessments were conducted at pre-treatment, post-treatment and four-month follow-up. The results of a series of repeated measures ANOVA revealed significant improvement in negative symptoms, psychopathology, social anxiety and discomfort, avoidance and social functioning. Objective scores obtained through the use of the VR program showed a pattern of learning in emotion perception, assertive behaviours and time spent in a conversation. Most of these gains were maintained at four-month follow-up. The reported results are based on a small, uncontrolled pilot study. Although there was an independent rater for the self-reported and informant questionnaires, assessments were not blinded. The results showed that the intervention may be effective for improving social dysfunction. The use of the VR program contributed to the generalisation of new skills into the patient's everyday functioning. Copyright © 2013 Elsevier Ltd. All rights reserved.

[Pilot-experience in home care: bedridden aged patients of a basic health unit, Porto Alegre, Brazil].

Science.gov (United States)

Marques, Giselda Quintana; Freitas, Ivani Bueno de Almeida

2009-12-01

The objectives of this study were to describe the development of a pilot-project in home care to bedridden aged patients at a Basic Health Unit, and identify demographic, social and health aspects of these patients, as well as relevant aspects reported by the health team that implemented the home care. The study had descriptive and evaluative characteristics. The patients' enrollment forms and health records and the project's records were analyzed. The pilot-experience permitted to develop the team's skills, in addition to being enriching and of great responsibility for the professionals and caregivers involved. The results indicated the need for continuous home care and adjustments in its organization with the purpose of increasing the areas for health care and improving the population's quality of life.

A pilot study of rebamipide-gargle for chemoradiotherapy-induced mucositis in oral cancer patients

International Nuclear Information System (INIS)

Yasuda, Takashi; Chiba, Hiroshige; Satomi, Takafumi; Matsuo, Akira; Kaneko, Tadayoshi; Miyamatsu, Hironobu

2008-01-01

Mucositis induced by chemoradiotherapy is one of the serious side effects of cancer therapy for oral cancer. It is caused by toxic free radicals (activated oxygen) produced by these therapeutic modalities. Rebamipide is a novel anti-ulcer drug which possesses various cytoprotective activities such as free radical scavenging, induction of prostaglandin-E and acceleration of ulcer healing. We report the results of a pilot study on rebamipide-gargle for inhibition of mucositis induced by chemo-radiotherapy. The present study was conducted on 13 patients (7 men and 6 women; age range 53-88) with oral cancer. They received radiotherapy (30-60 Gy) for the oro-facial area and chemotherapy (docetaxel: 11 cases; tegafur-uracil (UFT): 1 case; radiotherapy alone: 1 case) with simultaneous addition of 1% rebamipide-gargle treatment (10-15 times/day) to prevent the onset of mucositis. Informed consent was obtained prior to entry. Nine cases had grade 1-2 according to the World Health Organization (WHO) criteria, and 4 patients were classified as grade 3-4. No adverse reactions that could be caused by the rebamipide gargle were observed. These results suggested that rebamipide gargle could inhibit the occurrence of stomatitis induced by chemoradiotherapy. (author)

Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study

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Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas

2017-03-01

Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.

Assessment of the clinical relevance of quantitative sensory testing with Von Frey monofilaments in patients with allodynia and neuropathic pain. A pilot study

NARCIS (Netherlands)

Keizer, D.; van Wijhe, M.; Post, W.J.; Uges, D.R.A.; Wierda, J.M.K.H.

Background: Allodynia is a common and disabling symptom in many patients with neuropathic pain. Whereas quantification of pain mostly depends on subjective pain reports, allodynia can also be measured objectively with quantitative sensory testing. In this pilot study, we investigated the clinical

Patients' Perceptions of a Game About Warfarin and Vitamin K: A Pilot Study.

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Faddoul, Badia; Kelemen, Arpad; Connerney, Ingrid; Grover, Brian; Hoffman, Janice

2012-10-01

Digital games to promote healthy behaviors are rapidly expanding in the healthcare industry. One area where health game can be useful is in educating patients about oral anticoagulants such as warfarin. The goal of this pilot study was to develop a game about warfarin and vitamin K interactions and evaluate its usability among adult patients receiving warfarin therapy. The game was developed by an interdisciplinary team. The content of the game was based on published evidence-based practice about anticoagulation education. Kolb's experiential learning theory served as the theoretical foundation of the game, which we developed in Flash and Actionscript 2(®) (Adobe Systems, San Jose, CA) programming and scripting languages, and it is playable on various platforms, including Windows and Macintosh, via Internet Explorer, Mozilla Firefox, and Safari Web browsers. Twenty patients were surveyed using a 7-point Likert scale to evaluate their experience on the Perceived Health Web Site Usability Questionnaire (PHWSUQ). The PHWSUQ measures satisfaction, ease of learning the site, and usefulness. Possible responses ranged from 1 (very unsatisfied) to 7 (very satisfied) and from strongly disagree (1) to strongly agree (7). The overall mean score on the PHWSUQ was 53.6 out of 70 (SD, 11.3), or 76.6 percent. The mean scores for "satisfaction," "ease of use," and "usefulness" subscales were 80.2 percent, 71.2 percent, and 77.4 percent, respectively. The findings suggest that patients were satisfied with the game, which indicates that adult patients on warfarin are open to game use as an educational tool to learn health information.

Predictive value of daily living score in acute respiratory failure of COPD patients requiring invasive mechanical ventilation pilot study

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Langlet Ketty

2012-10-01

Full Text Available Abstract Background Mechanical ventilation (MV is imperative in many forms of acute respiratory failure (ARF in COPD patients. Previous studies have shown the difficulty to identify parameters predicting the outcome of COPD patients treated by invasive MV. Our hypothesis was that a non specialized score as the activities daily living (ADL score may help to predict the outcome of these patients. Methods We studied the outcome of 25 COPD patients admitted to the intensive care unit for ARF requiring invasive MV. The patients were divided into those weaning success (group A n = 17, 68% or failure (group B n = 8, 32%. We investigated the correlation between the ADL score and the outcome and mortality. Results The ADL score was higher in group A (5.1 ±1.1 vs 3.7 ± 0.7 in group B, p  Conclusion Our pilot study demonstrates that the ADL score is predictive of weaning success and mortality at 6 months, suggesting that the assessment of daily activities should be an important component of ARF management in COPD patients.

A Two-Year Randomized Trial of Interventions to Decrease Stress Hormone Vasopressin Production in Patients with Meniere's Disease-A Pilot Study.

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Kitahara, Tadashi; Okamoto, Hidehiko; Fukushima, Munehisa; Sakagami, Masaharu; Ito, Taeko; Yamashita, Akinori; Ota, Ichiro; Yamanaka, Toshiaki

2016-01-01

Meniere's disease, a common inner ear condition, has an incidence of 15-50 per 100,000. Because mental/physical stress and subsequent increase in the stress hormone vasopressin supposedly trigger Meniere's disease, we set a pilot study to seek new therapeutic interventions, namely management of vasopressin secretion, to treat this disease. We enrolled 297 definite Meniere's patients from 2010 to 2012 in a randomized-controlled and open-label trial, assigning Group-I (control) traditional oral medication, Group-II abundant water intake, Group-III tympanic ventilation tubes and Group-IV sleeping in darkness. Two hundred sixty-three patients completed the planned 2-year-follow-up, which included assessment of vertigo, hearing, plasma vasopressin concentrations and changes in stress/psychological factors. At 2 years, vertigo was completely controlled in 54.3% of patients in Group-I, 81.4% in Group-II, 84.1% in Group-III, and 80.0% in Group-IV (statistically I management for Meniere's disease. However, avoidance of stress is unrealistic for patients who live in demanding social environments. Our findings in this pilot study suggest that interventions to decrease vasopressin secretion by abundant water intake, tympanic ventilation tubes and sleeping in darkness is feasible in treating Meniere's disease, even though these therapies did not alter reported mental/physical stress levels. ClinicalTrials.gov NCT01099046.

Improving Sleep for Hospitalized Antepartum Patients: A Non-Randomized Controlled Pilot Study.

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Lee, Kathryn A; Gay, Caryl L

2017-12-15

To evaluate feasibility and efficacy of a hospital-based protocol for improving sleep in high- risk antepartum patients. Sleep measures were compared during 1 week of hospitalization before and after implementing a Sleep Improvement Protocol for Antepartum Patients (SIP-AP). A non-randomized convenience sample of usual care controls was compared to a subsequent intervention sample after the protocol was implemented. Women were eligible if they spoke English, were medically stable, pregnant for at least 20 weeks, and hospitalized at least 24 hours; 25 pregnant women had sufficient data for analyses (11 controls, 14 intervention). Sleep was assessed in 3 ways: the Pittsburgh Sleep Quality Index was completed after obtaining consent to estimate sleep quality prior to hospital admission; sleep diary completed each hospital day; and General Sleep Disturbance Scale completed at 7 days or prior to hospital discharge. Symptoms that could affect sleep were assessed with the Memorial Symptom Assessment Scale. Both groups recorded similar sleep duration (7 hours) but the intervention group had fewer symptoms and significantly ( P = .015) lower sleep disturbance scores (53.1 ± 14.5) than controls (71.9 ± 18.8). Participant feedback about the intervention was positive, although adherence to components of the intervention protocol was variable. This pilot study provides evidence of the feasibility and preliminary efficacy of the SIP-AP intervention for reducing symptoms and improving sleep of antepartum patients during hospitalization. Further detailed evaluation of specific components of this protocol is warranted, and other types of hospitalized patients may benefit from unit-based modifications to this SIP-AP protocol. © 2017 American Academy of Sleep Medicine

Fostering Self-Compassion and Loving-Kindness in Patients With Borderline Personality Disorder: A Randomized Pilot Study.

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Feliu-Soler, Albert; Pascual, Juan Carlos; Elices, Matilde; Martín-Blanco, Ana; Carmona, Cristina; Cebolla, Ausiàs; Simón, Vicente; Soler, Joaquim

2017-01-01

The aim of this randomized pilot study is to investigate the effects of a short training programme in loving-kindness and compassion meditation (LKM/CM) in patients with borderline personality disorder. Patients were allocated to LKM/CM or mindfulness continuation training (control group). Patients in the LKM/CM group showed greater changes in Acceptance compared with the control group. Remarkable changes in borderline symptomatology, self-criticism and self-kindness were also observed in the LKM/CM group. Mechanistic explanations and therapeutic implications of the findings are discussed. Three weeks of loving-kindness and compassion meditations increased acceptance of the present-moment experience in patients with borderline personality disorder. Significant improvements in the severity of borderline symptoms, self-criticism, mindfulness, acceptance and self-kindness were observed after the LKM/CM intervention. LKM/CM is a promising complementary strategy for inclusion in mindfulness-based interventions and Dialectical Behavioural Therapy for treating core symptoms in borderline personality disorder. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Development and pilot-testing of a cognitive behavioral coping skills group intervention for patients with chronic hepatitis C

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Donna M. Evon, Ph.D.

2017-06-01

Full Text Available Psychosocial interventions for patients with chronic hepatitis C viral (HCV infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1 formative work leading to intervention development; (2 preliminary study protocol; and (3 pilot feasibility testing of the intervention and study design. Formative work included a literature review, qualitative interviews, and adaption, development, and review of study materials. A preliminary study protocol is described. We evaluate the feasibility of conducting a randomized controlled trial (RCT of the CBCS-HCV with 12 study participants in Wave 1 testing to examine: (a feasibility of intervention delivery; (b patient acceptability; (c recruitment, enrollment, retention; (d feasibility of conducting a RCT; (d therapist protocol fidelity; and (e feasibility of data collection. Numerous lessons were learned. We found very high rates of data collection, participant attendance, engagement, retention and acceptability, and therapist protocol fidelity. We conclude that many aspects of the CBCS-HCV intervention and study protocol were highly feasible. The greatest challenge during this Wave 1 pilot study was efficiency of participant enrollment due to changes in standard of care treatment. These findings informed two additional waves of pilot testing to examine effect sizes and potential improvements in clinical outcomes, with results forthcoming.

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

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Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

5-fluorocytosine-related bone-marrow depression and conversion to fluorouracil: a pilot study

NARCIS (Netherlands)

Vermes, András; Guchelaar, Henk-Jan; van Kuilenburg, Andre B. P.; Dankert, Jacob

2002-01-01

The aim of this study is to investigate whether fluorouracil (5-FU) could be responsible for bone-marrow depression occurring in fluorocytosine 5-FC) treated patients. Six 5-FC treated patients were included in this pilot study. Toxicity was monitored by means of thrombocyte and leucocyte counts.

The effects of short-term fasting on tolerance to (neo) adjuvant chemotherapy in HER2-negative breast cancer patients: a randomized pilot study

NARCIS (Netherlands)

Groot, S. de; Vreeswijk, M.P.; Welters, M.J.; Gravesteijn, G.; Boei, J.J.; Jochems, A.; Houtsma, D.; Putter, H.; Hoeven, J.J.M. van der; Nortier, J.W.; Pijl, H.; Kroep, J.R.

2015-01-01

BACKGROUND: Preclinical evidence shows that short-term fasting (STF) protects healthy cells against side effects of chemotherapy and makes cancer cells more vulnerable to it. This pilot study examines the feasibility of STF and its effects on tolerance of chemotherapy in a homogeneous patient group

Use of Remote Monitoring to Improve Outcomes in Patients with Heart Failure: A Pilot Trial

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Ambar Kulshreshtha

2010-01-01

Full Text Available Remote monitoring (RM of homebound heart failure (HF patients has previously been shown to reduce hospital admissions. We conducted a pilot trial of ambulatory, non-homebound patients recently hospitalized for HF to determine whether RM could be successfully implemented in the ambulatory setting. Eligible patients from Massachusetts General Hospital (=150 were randomized to a control group (=68 or to a group that was offered RM (=82. The participants transmitted vital signs data to a nurse who coordinated care with the physician over the course of the 6-month study. Participants in the RM program had a lower all-cause per person readmission rate (mean=0.64, SD±0.87 compared to the usual care group (mean=0.73, SD±1.51; -value=.75 although the difference was not statistically significant. HF-related readmission rate was similarly reduced in participants. This pilot study demonstrates that RM can be successfully implemented in non-homebound HF patients and may reduce readmission rates.

Effects of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Levels in Hemodialysis Patients: a Pilot Study.

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Borges, Natália A; Stenvinkel, P; Bergman, P; Qureshi, A R; Lindholm, B; Moraes, C; Stockler-Pinto, M B; Mafra, D

2018-04-12

Components present in the diet, L-carnitine, choline, and betaine are metabolized by gut microbiota to produce metabolites such as trimethylamine-N-oxide (TMAO) that appear to promote cardiovascular disease in chronic kidney disease (CKD) patients. The objective of this pilot study was to evaluate the effects of probiotic supplementation for 3 months on plasma TMAO levels in CKD patients on hemodialysis (HD). A randomized, double-blind trial was performed in 21 patients [54.8 ± 10.4 years, nine men, BMI 26.1 ± 4.8 kg/m 2 , dialysis vintage 68.5 (34.2-120.7) months]. Ten patients were randomly allocated to the placebo group and 11 to the probiotic group [three capsules, totaling 9 × 10 13 colony-forming units per day of Streptococcus thermophilus (KB19), Lactobacillus acidophilus (KB27), and Bifidobacteria longum (KB31). Plasma TMAO, choline, and betaine levels were measured by LC-MS/MS at baseline and after 3 months. While TMAO did not change after probiotic supplementation, there was a significant increase in betaine plasma levels. In contrast, the placebo group showed a significant decrease in plasma choline levels. Short-term probiotic supplementation does not appear to influence plasma TMAO levels in HD patients. Long-term studies are needed to determine whether probiotics may affect TMAO production in CKD patients.

Intracoronary infusion of autologous mononuclear bone marrow cells in patients with acute myocardial infarction treated with primary PCI : Pilot study of the multicenter HEBE trial

NARCIS (Netherlands)

Hirsch, Alexander; Nijveldt, Robin; van der Vleuten, Pieter A.; Tio, Rene A.; van der Giessen, Willem J.; Marques, Koen M. J.; Doevendans, Pieter A.; Waltenberger, Johannes; ten Berg, Jurrien M.; Aengevaeren, Wim R. M.; Biemond, Bart J.; Tijssen, Jan G. P.; van Rossum, Albert C.; Piek, Jan J.; Zijlstra, Felix

2008-01-01

Objective: This study was a pilot trial to determine safety and feasibility of intracoronary infusion of mononuclear bone marrow cells (MBMC) in patients with acute myocardial infarction (MI). Background: Studies reporting the effect of MBMC therapy on improvement of left ventricular (LV) function

A Brief Survey of Patients' First Impression after CPAP Titration Predicts Future CPAP Adherence: A Pilot Study

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Balachandran, Jay S.; Yu, Xiaohong; Wroblewski, Kristen; Mokhlesi, Babak

2013-01-01

Background: CPAP adherence patterns are often established very early in the course of therapy. Our objective was to quantify patients' perception of CPAP therapy using a 6-item questionnaire administered in the morning following CPAP titration. We hypothesized that questionnaire responses would independently predict CPAP adherence during the first 30 days of therapy. Methods: We retrospectively reviewed the CPAP perception questionnaires of 403 CPAP-naïve adults who underwent in-laboratory titration and who had daily CPAP adherence data available for the first 30 days of therapy. Responses to the CPAP perception questionnaire were analyzed for their association with mean CPAP adherence and with changes in daily CPAP adherence over 30 days. Results: Patients were aged 52 ± 14 years, 53% were women, 54% were African American, the mean body mass index (BMI) was 36.3 ± 9.1 kg/m2, and most patients had moderate-severe OSA. Four of 6 items from the CPAP perception questionnaire— regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit—were significantly correlated with mean 30-day CPAP adherence, and a composite score from these 4 questions was found to be internally consistent. Stepwise linear regression modeling demonstrated that 3 variables were significant and independent predictors of reduced mean CPAP adherence: worse score on the 4-item questionnaire, African American race, and non-sleep specialist ordering polysomnogram and CPAP therapy. Furthermore, a worse score on the 4-item CPAP perception questionnaire was consistently associated with decreased mean daily CPAP adherence over the first 30 days of therapy. Conclusions: In this pilot study, responses to a 4-item CPAP perception questionnaire administered to patients immediately following CPAP titration independently predicted mean CPAP adherence during the first 30 days. Further prospective validation of this questionnaire in different

Patient experiences with full electronic access to health records and clinical notes through the My HealtheVet Personal Health Record Pilot: qualitative study.

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Woods, Susan S; Schwartz, Erin; Tuepker, Anais; Press, Nancy A; Nazi, Kim M; Turvey, Carolyn L; Nichol, W Paul

2013-03-27

Full sharing of the electronic health record with patients has been identified as an important opportunity to engage patients in their health and health care. The My HealtheVet Pilot, the initial personal health record of the US Department of Veterans Affairs, allowed patients and their delegates to view and download content in their electronic health record, including clinical notes, laboratory tests, and imaging reports. A qualitative study with purposeful sampling sought to examine patients' views and experiences with reading their health records, including their clinical notes, online. Five focus group sessions were conducted with patients and family members who enrolled in the My HealtheVet Pilot at the Portland Veterans Administration Medical Center, Oregon. A total of 30 patients enrolled in the My HealtheVet Pilot, and 6 family members who had accessed and viewed their electronic health records participated in the sessions. Four themes characterized patient experiences with reading the full complement of their health information. Patients felt that seeing their records positively affected communication with providers and the health system, enhanced knowledge of their health and improved self-care, and allowed for greater participation in the quality of their care such as follow-up of abnormal test results or decision-making on when to seek care. While some patients felt that seeing previously undisclosed information, derogatory language, or inconsistencies in their notes caused challenges, they overwhelmingly felt that having more, rather than less, of their health record information provided benefits. Patients and their delegates had predominantly positive experiences with health record transparency and the open sharing of notes and test results. Viewing their records appears to empower patients and enhance their contributions to care, calling into question common provider concerns about the effect of full record access on patient well-being. While shared

LAM Pilot Study with Imatinib Mesylate (LAMP-1)

Science.gov (United States)

2017-10-01

AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie Strange, MD...regarding imatinib mesylate (imatinib) in the treatment of Lymphangioleiomyomatosis ( LAM ) sufficient to power and design a phase 3 imatinib vs. placebo...clinical trial. The hypothesis is that imatinib will be equivalent to rapamycin in short term efficacy and safety. Currently, most LAM patients are

Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

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Gobbi G

2014-05-01

Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

An ICT and mobile health integrated approach to optimize patients' education on hypertension and its management by physicians: The Patients Optimal Strategy of Treatment(POST) pilot study.

Science.gov (United States)

Albini, Fabio; Xiaoqiu Liu; Torlasco, Camilla; Soranna, Davide; Faini, Andrea; Ciminaghi, Renata; Celsi, Ada; Benedetti, Matteo; Zambon, Antonella; di Rienzo, Marco; Parati, Gianfranco

2016-08-01

Uncontrolled hypertension is largely attributed to unsatisfactory doctor's engagement in its optimal management and to poor patients' compliance to therapeutic interventions. ICT and mobile Health solutions might improve these conditions, being widely available and providing highly effective communication strategies. To evaluate whether ICT and mobile Health tools are able to improve hypertension control by improving doctors' engagement and by increasing patients' education and involvement, and their compliance to lifestyle modification and prescribed drug therapy. In a pilot study, we have included 690 treated hypertensive patients with uncontrolled office blood pressure (BP), consecutively recruited by 9 general practitioners over 3 months. Patients were alternatively assigned to routine management based on repeated office visits or to an integrated ICT-based Patients Optimal Strategy for Treatment (POST) system including Home BP monitoring teletransmission, a dedicated web-based platform for patients' management by physicians (Misuriamo platform), and a smartphone mobile application (Eurohypertension APP, E-APP), over a follow-up of 6 months. BP values, demographic and clinical data were collected at baseline and at all follow-up visits (at least two). BP control and cardiovascular risk level have been evaluated at the beginning and at the end of the study. 89 patients did not complete the follow-up, thus data analysis was carried out in 601 of them (303 patients in the POST group and 298 in the control group). Office BP control (<;149/90 mmHg) was 40.0% in control group, and 72.3% in POST group at 6 month follow-up. At the same time Home BP control (<;135/85 mmHg average of 6 days) in POST group was 87.5%. this pilot study suggests that ICT based tools might be effective in improving hypertension management, implementing positive patients' involvement with better adherence to treatment prescriptions and providing the physicians with dynamic control of patients

Development of an Online, Evidence-Based Patient Information Portal for Congenital Heart Disease: A Pilot Study

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Jonathan R. G. Etnel

2017-05-01

Full Text Available ObjectivesIn response to an increased need for patient information on congenital heart disease in the Netherlands, we initiated a nationwide initiative to develop an online, evidence-based patient information portal, starting with a pilot project aimed at the subgroup of patients with congenital aortic and pulmonary valve disease.Methods and resultsWe developed an information portal that aims to (1 improve patient knowledge and involvement and to subsequently reduce anxiety and decisional conflict and improve mental quality of life and (2 to support physicians in informing and communicating with their patients. The information portal was developed according to the systematic International Patient Decision Aid Standards development process employing Delphi techniques by a multidisciplinary workgroup of pediatric and adult congenital cardiologists, a congenital cardiothoracic surgeon, a psychologist, an epidemiologist, a patient representative, and web and industrial design experts. First, patients and physicians were surveyed and interviewed to assess the current state of patient information and explore their preferences and needs to determine the focus for the development of the information portal. We found that patient knowledge and numeracy are limited, reliable information is scarce, physicians inform patients selectively and patient involvement is suboptimal, and there is a need for more reliable, tailored, and multi-faceted information. Based on the findings of these surveys and interviews, a patient-tailored information portal was designed that presents evidence-based disease- and age-specific medical and psychosocial information about diagnosis, treatment, prognosis, and impact on daily life in a manner that is comprehensible and digestible for patients and that meets the needs expressed by both patients and physicians. The effect of the website on patient outcome is currently being assessed in a multicenter stepped-wedge implementation

A pilot study into measurements of markers of atherosclerosis in periodontitis

NARCIS (Netherlands)

Leivadaros, E; van der Velden, U; Bizzarro, S; ten Heggeler, JMAG; Gerdes, VEA; Hoek, FJ; Nagy, TOM; Scholma, J; Bakker, SJL; Gans, ROB; ten Cate, H; Loos, BG

Background: Periodontitis may be a possible risk factor for atherosclerosis. The current pilot study explored arterial wall thickness and other variables associated with atherosclerosis in healthy subjects with and without periodontitis. Methods: Patients with moderate (N = 34) and severe

a pilot study of the diagnostic accuracy of fine needle aspirate cytol

African Journals Online (AJOL)

2018-06-02

Jun 2, 2018 ... Fibroadenoma of the breast in a South African population -a pilot study of the ... Keywords: Fibroadenoma, diagnosis, breast ultrasonography, fine needle ..... breast cancer among Sudanese patients with breast palpa-.

Participation of informal caregivers in the hospital care of elderly patients and their evaluations of the care given: pilot study in three different hospitals.

Science.gov (United States)

Laitinen, P

1992-10-01

This action research is an ongoing study which will last from 1991 to 1993. The main purpose of the study is to increase the participation of informal caregivers in the hospital care of elderly patients without decreasing the quality of care. The data reported here are from a pilot study. This study had three aims: (a) to test reliability and validity of the measure used, (b) to investigate the current participation of informal caregivers in the hospital care of elderly patients (aged over 75), and (c) to evaluate and compare the quality of care from both the patients' and the informal caregivers' point of view in three different hospitals. The measure of quality of care was developed on the basis of need theories, mainly those of Maslow and Alderfer. Patients and caregivers were also asked to rate the participation of the caregivers in the hospital care of elderly patients. Participation consisted of 18 activities of daily living. The pilot test with 18 elderly hospital patients and seven family members or significant others showed differences between the two groups in perception of care received. Statistically significant differences (P needs, psychic and spiritual needs and totals. The results supported earlier findings that elderly patients are satisfied with and do not criticize their care. The younger generation (i.e. their children) is more demanding and has precise perceptions about the care given. Relatives could be used more in planning, evaluation and even implementation of care; however, their current participation in patient hospital care is minimal.

Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study.

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Łyp, Marek; Stanisławska, Iwona; Witek, Bożena; Olszewska-Żaczek, Ewelina; Czarny-Działak, Małgorzata; Kaczor, Ryszard

2018-02-13

This study deals with the use of a robot-assisted body-weight-supported treadmill training in multiple sclerosis (MS) patients with gait dysfunction. Twenty MS patients (10 men and 10 women) of the mean of 46.3 ± 8.5 years were assigned to a six-week-long training period with the use of robot-assisted treadmill training of increasing intensity of the Lokomat type. The outcome measure consisted of the difference in motion-dependent torque of lower extremity joint muscles after training compared with baseline before training. We found that the training uniformly and significantly augmented the torque of both extensors and flexors of the hip and knee joints. The muscle power in the lower limbs of SM patients was improved, leading to corrective changes of disordered walking movements, which enabled the patients to walk with less effort and less assistance of care givers. The torque augmentation could have its role in affecting the function of the lower extremity muscle groups during walking. The results of this pilot study suggest that the robot-assisted body-weight-supported treadmill training may be a potential adjunct measure in the rehabilitation paradigm of 'gait reeducation' in peripheral neuropathies.

Evaluation of striatal dopamine transporter density using ({sup 123}I)-{beta}-CIT SPECT in schizophrenic patients treated with olanzapine: pilot study

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Kim, Chul Eung; Moon, Hey Won; Choe, Won Sick; Kim, Chang Ho; Chi, Dae Yoon [Inha Univ., Incheon (Korea, Republic of)

2002-08-01

This pilot study was performed to understand the pharmacological effect of olanzapine, an atypical antipsychotic agent, on dopamine transporter in schizophrenic patients. Six patients (3 male, 3 female) with schizophrenia, who had not taken any psychotropic drugs for at least four weeks, were studied. Nuclear imaging using ({sup 123}I)-{beta}-CIT SPECT was obtained before and after 4-week treatment with olanzapine. Analysis of ROI on the striatum, caudate nucleus, and putamen was performed. Post-treatment uptake was significantly increased in all the ROIs compared with pre-treatment uptake. This preliminary study with the small number of schizophrenic patients suggested an increase in uptake of dopamine transporter in the striatum, caudate nucleus, and putamen after 4-week treatment with olanzapine, which warrants a large-scaled controlled study to confirm the current findings.

A pilot study into measurements of markers of atherosclerosis in periodontitis

NARCIS (Netherlands)

Leivadaros, Efstratios; van der Velden, Ubele; Bizzarro, Sergio; ten Heggeler, Johanna M. A. G.; Gerdes, Victor E. A.; Hoek, Frans J.; Nagy, Thomas O. M.; Scholma, Jose; Bakker, Stephan J. L.; Gans, Rijk O. B.; ten Cate, Hugo; Loos, Bruno G.

2005-01-01

Periodontitis may be a possible risk factor for atherosclerosis. The current pilot study explored arterial wall thickness and other variables associated with atherosclerosis in healthy subjects with and without periodontitis. Patients with moderate (N = 34) and severe periodontitis (N = 15) and

Patient engagement with a mobile web-based telemonitoring system for heart failure self-management: a pilot study.

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Zan, Shiyi; Agboola, Stephen; Moore, Stephanie A; Parks, Kimberly A; Kvedar, Joseph C; Jethwani, Kamal

2015-04-01

Intensive remote monitoring programs for congestive heart failure have been successful in reducing costly readmissions, but may not be appropriate for all patients. There is an opportunity to leverage the increasing accessibility of mobile technologies and consumer-facing digital devices to empower patients in monitoring their own health outside of the hospital setting. The iGetBetter system, a secure Web- and telephone-based heart failure remote monitoring program, which leverages mobile technology and portable digital devices, offers a creative solution at lower cost. The objective of this pilot study was to evaluate the feasibility of using the iGetBetter system for disease self-management in patients with heart failure. This was a single-arm prospective study in which 21 ambulatory, adult heart failure patients used the intervention for heart failure self-management over a 90-day study period. Patients were instructed to take their weight, blood pressure, and heart rate measurements each morning using a WS-30 bluetooth weight scale, a self-inflating blood pressure cuff (Withings LLC, Issy les Moulineaux, France), and an iPad Mini tablet computer (Apple Inc, Cupertino, CA, USA) equipped with cellular Internet connectivity to view their measurements on the Internet. Outcomes assessed included usability and satisfaction, engagement with the intervention, hospital resource utilization, and heart failure-related quality of life. Descriptive statistics were used to summarize data, and matched controls identified from the electronic medical record were used as comparison for evaluating hospitalizations. There were 20 participants (mean age 53 years) that completed the study. Almost all participants (19/20, 95%) reported feeling more connected to their health care team and more confident in performing care plan activities, and 18/20 (90%) felt better prepared to start discussions about their health with their doctor. Although heart failure-related quality of life

Pilot study of an Internet patient-physician communication tool for heart failure disease management.

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Wu, Robert C; Delgado, Diego; Costigan, Jeannine; Ross, Heather; MacIver, Jane

2006-01-01

Internet disease management has the promise of improving care in patients with heart failure but evidence supporting its use is limited. We have designed a Heart Failure Internet Communication Tool (HFICT), allowing patients to enter messages for clinicians, as well as their daily symptoms, weight, blood pressure and heart rate. Clinicians review the information on the same day and provide feedback. This pilot study evaluated the feasibility and patients' acceptability of using the Internet to communicate with patients with symptomatic heart failure. Patients with symptomatic heart failure were instructed how to use the Internet communication tool. The primary outcome measure was the proportion of patients who used the system regularly by entering information on average at least once per week for at least 3 months. Secondary outcomes measures included safety and maintainability of the tool. We also conducted a content analysis of a subset of the patient and clinician messages entered into the comments field. Between 3 May 1999 and 1 November 2002, 62 patients (mean age 48.7 years) were enrolled. At 3 months 58 patients were alive and without a heart transplant. Of those, 26 patients (45%; 95% Confidence Interval, 0.33-0.58) continued using the system at 3 months. In 97% of all entries by participants weight was included; 68% of entries included blood pressure; and 71% of entries included heart rate. In 3,386 entries out of all 5,098 patient entries (66%), comments were entered. Functions that were not used included the tracking of diuretics, medications and treatment goals. The tool appeared to be safe and maintainable. Workload estimates for clinicians for entering a response to each patient's entry ranged from less than a minute to 5 minutes or longer for a detailed response. Patients sent 3,386 comments to the Heart Function Clinic. Based on the content analysis of 100 patient entries, the following major categories of communication were identified: patient

Combination Therapy of All-Trans Retinoic Acid With Ursodeoxycholic Acid in Patients With Primary Sclerosing Cholangitis: A Human Pilot Study.

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Assis, David N; Abdelghany, Osama; Cai, Shi-Ying; Gossard, Andrea A; Eaton, John E; Keach, Jill C; Deng, Yanhong; Setchell, Kenneth D R; Ciarleglio, Maria; Lindor, Keith D; Boyer, James L

2017-02-01

To perform an exploratory pilot study of all-trans retinoic acid (ATRA) combined with ursodeoxycholic acid (UDCA) in patients with primary sclerosing cholangitis (PSC). PSC is a progressive disorder for which there is no accepted therapy. Studies in human hepatocyte cultures and in animal models of cholestasis indicate that ATRA might have beneficial effects in cholestatic disorders. ATRA (45 mg/m/d, divided and given twice daily) was combined with moderate-dose UDCA in patients with PSC who had incomplete response to UDCA monotherapy. The combination was administered for 12 weeks, followed by a 12-week washout in which patients returned to UDCA monotherapy. We measured alkaline phosphatase (ALP), alanine aminotransferase (ALT), bilirubin, cholesterol, bile acids, and the bile acid intermediate 7α-hydroxy-4-cholesten-3-one (C4) at baseline, week 12, and after washout. Fifteen patients completed 12 weeks of therapy. The addition of ATRA to UDCA reduced the median serum ALP levels (277±211 to 243±225 U/L, P=0.09) although this, the primary endpoint, did not reach significance. In contrast, median serum ALT (76±55 to 46±32 U/L, P=0.001) and C4 (9.8±19 to 7.9±11 ng/mL, P=0.03) levels significantly decreased. After washout, ALP and C4 levels nonsignificantly increased, whereas ALT levels significantly increased (46±32 to 74±74, P=0.0006), returning to baseline. In this human pilot study, the combination of ATRA and UDCA did not achieve the primary endpoint (ALP); however, it significantly reduced ALT and the bile acid intermediate C4. ATRA appears to inhibit bile acid synthesis and reduce markers of inflammation, making it a potential candidate for further study in PSC (NCT 01456468).

Morpho-functional evaluation of small bowel using wireless motility capsule and video capsule endoscopy in patients with known or suspected Crohn’s disease: pilot study

OpenAIRE

Yung, Diana; Douglas, Sarah; Hobson, Anthony; Giannakou, Andry; Plevris, John; Koulaouzidis, Anastasios

2016-01-01

BACKGROUND AND STUDY AIMS:SmartPill(®) (Given Imaging Corp.,Yoqneam,Israel) is an ingestible, non-imaging capsule that records physiological data including contractions and pH throughout the gastrointestinal tract. There are scarce data looking at SmartPill(®) assessment of patients with known/suspected small-bowel Crohn's Disease (CD). This pilot study aims to investigate feasibility and safety of SmartPill(®) to assess gut motility in this group. PATIENTS AND METHODS:Over 1 year, patients w...

Assessing patients’ experience of integrated care: a survey of patient views in the North West London Integrated Care Pilot

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Nikolaos Mastellos

2014-06-01

Full Text Available Introduction: Despite the importance of continuity of care and patient engagement, few studies have captured patients’ views on integrated care. This study assesses patient experience in the Integrated Care Pilot in North West London with the aim to help clinicians and policy makers understand patients’ acceptability of integrated care and design future initiatives. Methods: A survey was developed, validated and distributed to 2029 randomly selected practice patients identified as having a care plan. Results: A total of 405 questionnaires were included for analysis. Respondents identified a number of benefits associated with the pilot, including increased patient involvement in decision-making, improved patient-provider relationship, better organisation and access to care, and enhanced inter-professional communication. However, only 22.4% were aware of having a care plan, and of these only 37.9% had a copy of the care plan. Knowledge of care plans was significantly associated with a more positive experience. Conclusions: This study reinforces the view that integrated care can improve quality of care and patient experience. However, care planning was a complex and technically challenging process that occurred more slowly than planned with wide variation in quality and time of recruitment to the pilot, making it difficult to assess the sustainability of benefits.

Red blood-cell alloantibodies in multiply transfused patients in the occupied Palestinian territory: a pilot study.

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Yaseen, Ahmad; Suleiman, Sa'd; Zenah, Omar Abu; Abu Taha, Adham

2018-02-21

Red blood-cell transfusion has greatly reduced the mortality and morbidity in multiply transfused patients with thalassaemia and sickle cell disease. However, this can result in red blood-cell isoimmunisation with autoantibodies and alloantibodies, which can lead to serious complications such as delayed haemolytic transfusion reaction. The aim of this study was to assess the frequency and types of alloantibodies in multiply transfused patients living in the north of the West Bank. This pilot study was done at three thalassaemia centres in Nablus, Jenin, and Tulkarm in the occupied Palestinian territory where 300 patients with thalassaemia and sickle cell anaemia regularly receive blood transfusions. Alloantibody screening and identification were done using three-cell and eleven-cell panels (DiaPanel, Bio-rad, Switzerland) respectively. Ethical approval was obtained from Institutional Review Board Centre at Najah University. Written consent was obtained from participants. 131 patients were enrolled. Of the 20 (15%) patients with alloantibodies, 14 (70%) were diagnosed with β-thalassaemia major, three (15%) were diagnosed with sickle cell anaemia, two (10%) were diagnosed with thalassaemia intermedia, and one (5%) was diagnosed with sickle cell thalassaemia. 13 (65%) patients had alloantibodies that belonged to the Rh blood group system (nine [45%] patients had anti-D; two [10%] had anti-E; one [5%] had anti Rh-C; and one [5%] had anti-c). Anti-Kell was found in seven (35%) patients. Our data showed a quite high prevalence of alloimmunisation in multiply transfused patients. Rh and Kell blood group system antibodies were the only alloantibodies identified in this study. To reduce alloimmunisation, it will be essential to introduce a policy for extended red blood-cell phenotyping of these patients and for the issuing of antigen-matched blood (at least for Rh and Kell antigen). Najah National University. Copyright © 2018 Elsevier Ltd. All rights reserved.

Tamsulosin palliates radiation-induced urethritis in patients with prostate cancer: results of a pilot study

International Nuclear Information System (INIS)

Prosnitz, Robert G.; Schneider, Lindsey; Manola, Judy; Rocha, Sean; Loffredo, Marian; Lopes, Lynn; D'Amico, Anthony V.

1999-01-01

Purpose: A pilot study was performed to determine the effectiveness of Flomax (tamsulosin HCl) in the management of acute radiation urethritis in prostate cancer patients undergoing conformal external beam radiation therapy (RT). Potential predictors of response to Flomax were evaluated. Methods and Materials: From January 1998 to April 1998, 26 consecutive patients who developed symptoms of radiation urethritis while undergoing RT for prostate cancer were treated with Flomax, a superselective α 1A -adrenergic antagonist. A genitourinary review of systems served as the instrument used to assess baseline urinary function and treatment response. Results: The initial response rate to Flomax was 62% (16/26) at the 0.4 mg level and 60% (6/10) at the 0.8 mg level. Half of the 16 patients who initially responded to 0.4 mg subsequently progressed. Three-fourths of those patients who progressed, however, achieved a durable response with the 0.8 mg dose. Therefore urinary symptoms were ultimately controlled in 77% (20/26) of the patients. After correcting for the testing of multiple hypotheses (n = 5), the presence of benign prostatic hyperplasia (BPH) approached statistical significance for predicting the initial response to the 0.4 mg dose of Flomax (78% vs. 25%, p = 0.03). Conclusion: Flomax appears to be effective in relieving the symptoms of radiation urethritis. A Phase II trial is justified and in progress

The effect of coix seed on the nutritional status of peritoneal dialysis patients: a pilot study.

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Wu, Yifan; Li, Yin; Tong, Xiaozhen; Lu, Fuhua; Mao, Wei; Fu, Lizhe; Deng, Lili; Liu, Xi; Li, Chuang; Zhang, Lei; Liu, Xusheng

2014-02-01

To observe the effect of coix seed diet therapy on the nutritional status of peritoneal dialysis patients and to discuss the potential reasons. 30 dialysis patients with regular return visit to peritoneal dialysis center of Guangdong Provincial Hospital of Traditional Chinese Medicine were recruited and divided into two groups according to their willingness. 13 patients in control group continued their usual dialysis prescriptions and medications, whereas 30g of coix seed per day was added to the usual therapies of 17 patients in coix seed group. Changes in nutritional status of dialysis patients in two groups were evaluated after a 12-week treatment. Two patients (one in each group) quitted the study because of pulmonary infection. After treatment, the nutritional parameters of serum albumin level (P=0.004), total protein level (P=0.008), and body mass index (P=0.023) were increased significantly in coix seed group. And the statistical differences of serum albumin level and body mass index were significantly compared to control group (P=0.008 and P=0.032, respectively). Moreover, the C-reactive protein level had a significant decrease (P=0.001) and the clinical symptoms of dialysis patients including tiredness, anorexia, xerostomia, and abdominal distension showed a significant improvement (Pnutritional status of peritoneal dialysis patients by relieving digestive tract symptoms, increasing urinary volume, and meliorating micro-inflammatory state. But as a pilot study, the results still need to be validated by further large-scale researches. Copyright © 2013 Elsevier Ltd. All rights reserved.

Assessment of the clinical relevance of quantitative sensory testing with Von Frey monofilaments in patients with allodynia and neuropathic pain. A pilot study

OpenAIRE

Keizer, D.; van Wijhe, M.; Post, W.J.; Uges, D.R.A.; Wierda, J.M.K.H.

2007-01-01

Background: Allodynia is a common and disabling symptom in many patients with neuropathic pain. Whereas quantification of pain mostly depends on subjective pain reports, allodynia can also be measured objectively with quantitative sensory testing. In this pilot study, we investigated the clinical relevance of quantitative sensory testing with Von Frey monofilaments in patients with allodynia as a consequence of a neuropathic pain syndrome, by means of correlating subjective pain scores with p...

Sibutramine in the treatment of antipsychotic-induced weight gain: a pilot study in patients with schizophrenia.

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Biedermann, Falko; Fleischhacker, W Wolfgang; Kemmler, Georg; Ebenbichler, Christoph F; Lechleitner, Monika; Hofer, Alex

2014-05-01

Weight gain represents a frequent side effect of antipsychotic drug treatment. The current trial investigated the effect of add-on treatment with sibutramine in schizophrenia outpatients who had gained more than 7% of weight during the course of treatment. This 24-week placebo-controlled study evaluated the effects of sibutramine added to ongoing antipsychotic treatment. Weight, waist-hip ratio, BMI, blood pressure/pulse and ECG were monitored regularly. In addition, several laboratory tests were performed. Psychopathological symptoms and side effects were assessed frequently. Fifteen patients were assigned randomly to add-on treatment with sibutramine 10 mg or placebo. The two groups did not differ in weight, sociodemographic, or clinical data. Eleven patients were considered for statistical analysis. Significant weight loss was observed in the sibutramine group (mean = -6.1 kg), whereas patients on placebo experienced a mean weight gain of 1.9 kg. A reduction in HbA1c was apparent in the sibutramine but not in the placebo group. No significant between-group differences were found in changes in psychopathology or drug safety. This pilot trial suggests that adjunctive treatment with sibutramine may be safe and effective in schizophrenic patients with antipsychotic-induced weight gain.

Preliminary follow-up study of military pilots with asymptomatic cerebral infarction

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Xiao-min ZHANG

2016-10-01

Full Text Available Objective 　To observe pilots with asymptomatic cerebral infarction (ACI for their short-term prognosis. Methods 　Twenty-two pilots who were diagnosed having ACI by magnetic resonance imaging were enrolled in this study. When they returned to the hospital for regular reexamination, the number of ACI foci , the incidents of acute cerebrovascular disease and grounding of aircraft for any reasons were recorded. According to whether the ACI lesions increased, the patients were divided into two groups. The risk factors for cerebral vascular disease were compared between the two groups. Results 　All the patients were followed for 6-42 months (mean 14.18±8.55 months, and 6(18.18% patients were found to have increase of lesions. No neurological deficit was seen in the two groups, although 3 flight crews were grounded for non-ACI reason. Age and flight time showed statistically significant differences between the lesions increased group and no lesion increased group. Conclusions 　The number of ACI foci of some pilots may increase, which is affected by age and flight time. Further investigations on the long-term prognosis and the impacts on flight are needed. DOI: 10.11855/j.issn.0577-7402.2016.09.16

A pilot study of the impact of high-frequency chest wall oscillation in chronic obstructive pulmonary disease patients with mucus hypersecretion

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Chakravorty I

2011-12-01

Full Text Available Indranil Chakravorty1, Kamaljit Chahal2, Gillian Austin21St George's Hospital, London, 2East and North Hertfordshire NHS Trust, Lister Hospital and Primary Care Trust, Stevenage, Hertfordshire, UKIntroduction: Chronic obstructive pulmonary disease (COPD patients with mucus hypersecretion tend to demonstrate increased frequency of infective exacerbations and a steeper slope of decline in lung function. Enhanced mucociliary clearance with high-frequency chest wall oscillation (HFCWO devices previously used in cystic fibrosis and bronchiectasis patients may offer the opportunity for community-based, self-managed therapy to improve quality of life and lung function.Study design and methods: A randomized controlled crossover pilot study of HFCWO compared with conventional treatment was conducted in 22 patients with moderate to severe COPD and mucus hypersecretion. Patients spent 4 weeks using an HFCWO (SmartVest® device and 4 weeks in a conventional phase with a 2-week washout. Eleven patients started with HFCWO and changed to conventional treatment, whereas the other eleven patients started conventional treatment and crossed over to HFCWO.Results: The patients were elderly with a mean age of 71 (standard deviation [SD] 10 years and were at the upper end of the normal range of body mass index (25 [SD 4.2] kg/m2. The majority of patients had moderate to severe COPD with a mean percentage predicted forced expiratory volume in 1 second of 41 (SD 15.6 and percentage predicted forced vital capacity of 73 (SD 17.7. Baseline sputum production was negatively correlated to lung function and positively to St George's Respiratory Questionnaire. Symptom scores and St George's Respiratory Questionnaire symptom dimension improved significantly (-8, P < 0.05. Sputum production showed a declining trend in the HFCWO phase, although not reaching statistical significance. The HFCWO device was well tolerated with good reported compliance.Conclusion: This pilot study

A five-day inpatient EMDR treatment programme for PTSD: pilot study

NARCIS (Netherlands)

Zepeda Méndez, Mayaris; Nijdam, Mirjam J.; ter Heide, F. Jackie June; van der Aa, Niels; Olff, Miranda

2018-01-01

Conclusions: The majority of patients in our pilot study experienced symptom reduction consistent with reliable changes in this five-day inpatient treatment with EMDR and yoga. Randomized controlled trials - with longer follow up periods - are needed to properly determine efficacy and efficiency of

Patient experiences with self-monitoring renal function after renal transplantation: results from a single-center prospective pilot study.

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van Lint, Céline L; van der Boog, Paul Jm; Wang, Wenxin; Brinkman, Willem-Paul; Rövekamp, Ton Jm; Neerincx, Mark A; Rabelink, Ton J; van Dijk, Sandra

2015-01-01

After a kidney transplantation, patients have to visit the hospital often to monitor for early signs of graft rejection. Self-monitoring of creatinine in addition to blood pressure at home could alleviate the burden of frequent outpatient visits, but only if patients are willing to self-monitor and if they adhere to the self-monitoring measurement regimen. A prospective pilot study was conducted to assess patients' experiences and satisfaction. For 3 months after transplantation, 30 patients registered self-measured creatinine and blood pressure values in an online record to which their physician had access to. Patients completed a questionnaire at baseline and follow-up to assess satisfaction, attitude, self-efficacy regarding self-monitoring, worries, and physician support. Adherence was studied by comparing the number of registered with the number of requested measurements. Patients were highly motivated to self-monitor kidney function, and reported high levels of general satisfaction. Level of satisfaction was positively related to perceived support from physicians (Pself-efficacy (Pmonitoring of creatinine and blood pressure after transplantation offers a promising strategy. Important prerequisites for safe implementation in transplant care seem to be support from physicians and patients' confidence in both their own self-monitoring skills and the accuracy of the devices used.

A randomized, pilot study to assess the efficacy and safety of curcumin in patients with active rheumatoid arthritis.

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Chandran, Binu; Goel, Ajay

2012-11-01

Curcumin is known to possess potent antiinflammatory and antiarthritic properties. This pilot clinical study evaluated the safety and effectiveness of curcumin alone, and in combination with diclofenac sodium in patients with active rheumatoid arthritis (RA). Forty-five patients diagnosed with RA were randomized into three groups with patients receiving curcumin (500 mg) and diclofenac sodium (50 mg) alone or their combination. The primary endpoints were reduction in Disease Activity Score (DAS) 28. The secondary endpoints included American College of Rheumatology (ACR) criteria for reduction in tenderness and swelling of joint scores. Patients in all three treatment groups showed statistically significant changes in their DAS scores. Interestingly, the curcumin group showed the highest percentage of improvement in overall DAS and ACR scores (ACR 20, 50 and 70) and these scores were significantly better than the patients in the diclofenac sodium group. More importantly, curcumin treatment was found to be safe and did not relate with any adverse events. Our study provides the first evidence for the safety and superiority of curcumin treatment in patients with active RA, and highlights the need for future large-scale trials to validate these findings in patients with RA and other arthritic conditions. Copyright © 2012 John Wiley & Sons, Ltd.

[A specific questionnaire to evaluate therapeutic inertia in hypertensive patients: a pilot study].

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Pretorean, T; Claisse, G; Delsart, P; Caudrelier, T; Devos, P; Mounier-Vehier, C

2014-02-01

Therapeutic inertia (TI) is a recent concept still unknown by many physicians. In chronic diseases such as hypertension, it is defined as the tendency of physicians not to increase or change antihypertensive medications when the target blood pressure is not reached. Acting on TI could improve blood pressure control in France. This was a single-center prospective pilot study conducted by hypertension specialist physicians at the University Cardio-Vascular Center in Lille (France). It was conducted between March and June 2011. Data was collected from 161 hypertensive patients (mean age: 61.64±11.18 years; 98 (60.9%) male; 75 secondary prevention patients). Each physician completed a questionnaire on therapeutic inertia. TI was defined as a consultation in which treatment change was indicated (systolic blood pressure [BP]≥140 and/or diastolic BP≥90mmHg in all patients), but did not occur, with absence of an adapted justification of this choice. We considered as an adapted justification: a white coat effect demonstrated by ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring; scheduled reassessment of the BP by ABPM; recent change in antihypertensive treatment (less than 4 weeks); hospitalization needed for complete evaluation of secondary causes of hypertension and a more detailed assessment of potential target organ damage in patients with grade 1 or 2 hypertension. Our study aimed to evaluate rates of TI, to identify factors associated with TI, and to test the TI questionnaire. Therapeutic inertia as defined in this study occurred in 11 consultations (8.3%) of the 133 hypertensive patients having uncontrolled BP above or equal to 140 and/or 90mmHg. Significant factors associated with TI were older age (Z=2.35, PP>0.05) and the number of consultations (Z=1.92, 0.1>P>0.05) exhibited a significant trend to be associated with TI. Although the rate of TI was low in our study conducted in a specialized center, a well-accepted definition of

Effect of patient age awareness on diagnostic agreement of chronic or aggressive periodontitis between clinicians; a pilot study.

Science.gov (United States)

Oshman, Sarah; El Chaar, Edgard; Lee, Yoonjung Nicole; Engebretson, Steven

2016-07-25

The aim of this pilot study was to test whether diagnostic agreement of aggressive and chronic periodontitis amongst Board Certified Periodontists, is influenced by knowledge of a patient's age. In 1999 at the International World Workshop age was removed as a diagnostic criteria for aggressive periodontitis. The impact of this change on the diagnostic reliability amongst clinicians has not yet been assessed. Nine periodontal case reports were twice presented to sixteen board certified periodontists, once with age withheld and again with patient age provided. Participants were instructed to choose a diagnosis of Chronic Periodontitis or Aggressive Periodontitis. Diagnostic agreement was calculated using the Fleiss Kappa test. Including the patients' age in case report information increased diagnostic agreement (the kappa statistic) from 0.49 (moderate agreement) to 0.61 (substantial agreement). These results suggest that knowledge of a patients' age influenced clinical diagnosis, when distinguishing between aggressive periodontitis and chronic periodontitis, which may in turn impact treatment decision-making.

Usefulness of Tinker Toy Test for Schizophrenic Patients: A Pilot Study

OpenAIRE

中村, 泰久; 穴水, 幸子; 山中, 武彦; 石井, 文康; 三村, 將

2017-01-01

　This is the pilot study in order to verify the usability of Tinker Toy Test (TTT). Participants were assigned to schizophrenia and control groups based on propensity scores which was computed using confounding factors. Neuropsychological testing for basic information, TTT, and others was performed in order to compare between two groups, and logistic regression analysis was used to assess the difference between them according to the items which showed significant differences in the neuropsych...

Efficacy of Salvage Interferential Electrical Stimulation Therapy in Patients With Medication-Refractory Enuresis: A Pilot Study

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Hahn-Ey Lee

2013-09-01

Full Text Available Purpose In pediatric patients with enuresis, the protocol for salvage therapy in patients in whom first-line therapy was not successful has not yet been established. Interferential electrical stimulation (IF-ES therapy is advantageous because it is noninvasive and shows high compliance. We aimed to investigate the efficacy and safety of IF-ES therapy on pediatric enuresis in a pilot study. Methods We investigated 10 patients who underwent IF-ES therapy between August 2012 and March 2013 at our clinic. Patients with a history of previous treatment with desmopressin and anticholinergic agents for at least 3 months and those in whom alarm treatment previously failed or was refused by parents were eligible. Electrical current was given starting at approximately 20 mA and was increased until the patient complained of discomfort. Treatment was performed once a week, 20 minutes per treatment, 6 times per cycle. After each cycle, an interview was performed and voiding diaries were filled. The physician in charge evaluated improvement according to the International Children's Continence Society criteria. Results A final analysis was performed in 10 patients (5 male and 5 female patients in whom therapy for nocturnal enuresis had failed. Eight patients had nonmonosymptomatic enuresis and 2 had monosymptomatic enuresis. The mean age of the patients was 8.5±2.4 years, and the mean number of treatments was 10.6±3.6 times. A full response was observed in 1 patient (10%; a good response, in 1 patient (10%; a partial response, in 7 patients (70%; and no response, in 1 patient (10%. Conclusions Our study demonstrated that IF-ES therapy can be a promising treatment for the future, is safe, and can benefit from appropriate clinical trials in carefully selected groups. IF-ES therapy is expected to be a safe and effective treatment modality for children with enuresis.

A dual-task home-based rehabilitation programme for improving balance control in patients with acquired brain injury: a single-blind, randomized controlled pilot study.

Science.gov (United States)

Peirone, Eliana; Goria, Paolo Filiberto; Anselmino, Arianna

2014-04-01

To evaluate the safety, feasibility and effectiveness of a dual-task home-based rehabilitation programme on balance impairments among adult patients with acquired brain injury. Single-blind, randomized controlled pilot study. Single rehabilitation centre. Sixteen participants between 12 and 18 months post-acquired brain injury with balance impairments and a score task home-based programme six days a week for seven weeks. The primary outcome measure was the Balance Evaluation System Test; secondary measures were the Activities-specific Balance Confidence Scale and Goal Attainment Scaling. At the end of the pilot study, the intervention group showed significantly greater improvement in Balance Evaluation System Test scores (17.87, SD 6.05) vs. the control group (5.5, SD 3.53; P = 0.008, r = 0.63). There was no significant difference in improvement in Activities-specific Balance Confidence Scale scores between the intervention group (25.25, SD 25.51) and the control group (7.00, SD 14.73; P = 0.11, r = 0.63). There was no significant improvement in Goal Attainment Scaling scores in the intervention (19.37, SD 9.03) vs. the control group (16.28, SD 6.58; P = 0.093, r = 0.63). This pilot study shows the safety, feasibility and short-term benefit of a dual-task home-based rehabilitation programme to improve balance control in patients with acquired brain injury. A sample size of 26 participants is required for a definitive study.

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

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Kate Fetterplace

2018-02-01

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

Immediate effect of mind sound resonance technique on state anxiety and cognitive functions in patients suffering from generalized anxiety disorder: A self-controlled pilot study

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Vipin Dhansoia

2015-01-01

Conclusion: This pilot study suggests that MSRT may have a potential role in reducing state anxiety and enhancing psychomotor performance in patients suffering from GAD immediately after the practice. These findings need confirmation from studies with a larger sample size and randomized controlled design, which are implicated in the future.

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

Science.gov (United States)

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

2018-04-01

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

The Effects of Modified Melodic Intonation Therapy on Nonfluent Aphasia: A Pilot Study

Science.gov (United States)

Conklyn, Dwyer; Novak, Eric; Boissy, Adrienne; Bethoux, Francois; Chemali, Kamal

2012-01-01

Objective: Positive results have been reported with melodic intonation therapy (MIT) in nonfluent aphasia patients with damage to their left-brain speech processes, using the patient's intact ability to sing to promote functional language. This pilot study sought to determine the immediate effects of introducing modified melodic intonation therapy…

A Serious Exergame for Patients Suffering from Chronic Musculoskeletal Back and Neck Pain: A Pilot Study.

Science.gov (United States)

Jansen-Kosterink, Stephanie M; Huis In 't Veld, Rianne M H A; Schönauer, Christian; Kaufmann, Hannes; Hermens, Hermie J; Vollenbroek-Hutten, Miriam M R

2013-10-01

Over recent years, the popularity of videogames has gone beyond youth and gamers and is slowly entering the field of professional healthcare. Exergames are an attractive alternative to physical therapy. The primary aim of this pilot study was to explore the user experience (usability, satisfaction, level of motivation, and game experience) of the patient with the "PlayMancer" exergame. The secondary aim was to explore the progression of the performed motor skills (walking velocity, overhead reach ability, and cervical range of motion) and the clinical changes (to physical condition, disability, and pain intensity) in a group of patients with chronic musculoskeletal pain using an exergame for 4 weeks. In the European PlayMancer project, an exergame for physical rehabilitation of chronic pain patients was developed. This exergame is controlled by relevant motions of the patient's body captured by a motion suit and several infrared cameras. In three different integrated minigames, the patient can train the following motor skills: Walking velocity, overhead reaching, and neck mobility. Ten patients participated in this study and completed the 4 weeks of gaming. Patients rated the usability of the exergames as good (score of 78.5 [standard deviation 9.7; range, 60.0-97.5]) on the System Usability Scale, and the game motivated all patients to perform their exercises. Patients enjoyed playing and were pleased with both the game environment and the game play. Overall, the patients made a progression in the examined motor skills during the minigames over the 4 weeks of gaming. The "PlayMancer" exergame is a potential tool for achieving physical rehabilitation because it motivates patients to perform their exercises and as a result increases their motor skills and physical condition.

A Pilot Study to Improve Access to Eye Care Services for Patients in Rural India by Implementing Community Ophthalmology through Innovative Telehealth Technology.

Science.gov (United States)

John, Sheila; Premila, M; Javed, Mohd; Vikas, G; Wagholikar, Amol

2015-01-01

To inform about a very unique and first of its kind telehealth pilot study in India that has provided virtual telehealth consultation to eye care patients in low resource at remote villages. Provision of Access to eye care services in remote population is always challenging due to pragmatic reasons. Advances in Telehealth technologies have provided an opportunity to improve access to remote population. However, current Telehealth technologies are limited to face-to-face video consultation only. We inform about a pilot study that illustrates real-time imaging access to ophthalmologists. Our innovative software led technology solution allowed screening of patients with varying ocular conditions. Eye camps were conducted in 2 districts in South India over a 12-month period in 2014. Total of 196 eye camps were conducted. Total of 19,634 patients attended the eye camps. Innovative software was used to conduct consultation with the ophthalmologist located in the city hospital. The software enabled virtual visit and allowed instant sharing of fundus camera images for assessment and diagnosis. About 71% of the patients were found to have Refractive Error problems, 15% of them were found to have cataract, 7% of the patients were diagnosed to have Retina problems and 7% of the patients were found to have other ocular diseases. The patients requiring cataract surgery were immediately transferred to city hospital for treatment. Software led assessment of fundus camera images assisted in identifying retinal eye diseases. Our real-time virtual visit software assisted in specialist care provision and illustrated a novel tele health solution for low resource population.

A pilot study of the use of near-patient C-Reactive Protein testing in the treatment of adult respiratory tract infections in one Irish general practice.

LENUS (Irish Health Repository)

Kavanagh, Kim E

2011-08-31

Abstract Background New approaches are being sought to safely reduce community antibiotic prescribing. A recent study demonstrated that CRP testing resulted in decreased antibiotic prescribing for lower respiratory tract infection in primary care. There is little other published primary care data available evaluating CRP in the treatment of lower respiratory tract infections in routine clinical practice. This pilot study aims to describe the performance of near-patient CRP testing, in a mixed payments health system. Specific areas to be reviewed included the integrity of the study protocol, testing of data collection forma and acceptability of the intervention. Patients Patients over the age of 18 years, with acute cough and\\/or sore throat with a duration of one month or less, in routine clinical practice. Method Design: A pilot with a cross-sectional design. The first 60 recruited patients were treated with routine clinical management, and GP\\'s had no access to a CRP test. For the subsequent 60 patients, access to CRP testing was available. Participants: 3 GP\\'s in one Irish primary care practice recruited 120 patients, fulfilling the above criteria over five months, from January 1 to May 31, 2010. Main outcome measures: The primary outcome was antibiotic prescription at the index consultation. Secondary outcomes were the numbers of delayed prescriptions issued, patient satisfaction immediately after consultation and re-consultations and antibiotic prescriptions during 28 days follow-up. Results The protocol and data collection forms worked well and the intervention of CRP testing appeared acceptable. Thirty-five (58%) patients in the no-test group received antibiotic prescriptions compared to 27 (45%) in the test group. Both groups demonstrated similarly high level of patient satisfaction (85%). Fourteen (23%) patients in the CRP test group re-attended within 28 days compared to 9 (15%) in the no-CRP test group. Conclusion This pilot study confirms the

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

Science.gov (United States)

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

2016-01-01

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

Percutaneous nerve stimulation in chronic neuropathic pain patients due to spinal cord injury: a pilot study.

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Kopsky, David Jos; Ettema, Frank Willem Leo; van der Leeden, Marike; Dekker, Joost; Stolwijk-Swüste, Janneke Marjan

2014-03-01

The long-term prognosis for neuropathic pain resolution following spinal cord injury (SCI) is often poor. In many SCI patients, neuropathic pain continues or even worsens over time. Thus, new treatment approaches are needed. We conducted a pilot study to evaluate the feasibility and effect of percutaneous (electrical) nerve stimulation (P(E)NS) in SCI patients with chronic neuropathic pain. In 18 weeks, 12 P(E)NS treatments were scheduled. Assessment with questionnaires was performed at baseline (T0), after 8 weeks (T8), 18 weeks (T18), and 12 weeks post-treatment (T30). From 26 screened patients, 17 were included. In total, 91.2% questionnaires were returned, 2 patients dropped out, and 4.2% of the patients reported minor side effects. Pain scores on the week pain diary measured with the numerical rating scale improved significantly at T8, from 6.5 at baseline to 5.4, and were still significantly improved at T18. Pain reduction of ≥ 30% directly after a session was reported in 64.6% sessions. In total, 6 patients experienced reduction in size of the pain areas at T18 and T30, with a mean reduction of 45.8% at T18 and 45.3% at T30. P(E)NS is feasible as an intervention in SCI patients and might have a positive effect on pain reduction in a part of this patient group. © 2013 The Authors Pain Practice © 2013 World Institute of Pain.

Medical student use of communication elements and association with patient satisfaction: a prospective observational pilot study.

Science.gov (United States)

Turner, Joseph S; Pettit, Katie E; Buente, Bryce B; Humbert, Aloysius J; Perkins, Anthony J; Kline, Jeffrey A

2016-05-21

Effective communication with patients impacts clinical outcome and patient satisfaction. We measure the rate at which medical students use six targeted communication elements with patients and association of element use with patient satisfaction. Participants included fourth year medical students enrolled in an emergency medicine clerkship. A trained observer measured use of six communication elements: acknowledging the patient by name, introducing themselves by name, identifying their role, explaining the care plan, explaining that multiple providers would see the patient, and providing an estimated duration of time in the emergency department. The observer then conducted a survey of patient satisfaction with the medical student encounter. A total of 246 encounters were documented among forty medical student participants. For the six communication elements evaluated, in 61% of encounters medical students acknowledged the patient, in 91% they introduced themselves, in 58 % they identified their role as a student, in 64% they explained the care plan, in 80% they explained that another provider would see the patient, and in only 6% they provided an estimated duration of care. Only 1 encounter (0.4%) contained all six elements. Patients' likelihood to refer a loved one to that ED was increased when students acknowledged the patient and described that other providers would be involved in patient care (P = 0.016 and 0.015 respectively, Chi Square). Likewise, patients' likelihood to return to the ED was increased when students described their role in patient care (P = 0.035, Chi Square). This pilot study demonstrates that medical students infrequently use all targeted communication elements. When they did use certain elements, patient satisfaction increased. These data imply potential benefit to additional training for students in patient communication.

Healing the heart: a randomized pilot study of a spiritual retreat for depression in acute coronary syndrome patients.

Science.gov (United States)

Warber, Sara L; Ingerman, Sandra; Moura, Vera L; Wunder, Jenna; Northrop, Alyssa; Gillespie, Brenda W; Durda, Kate; Smith, Katherine; Rhodes, Katherine S; Rubenfire, Melvyn

2011-01-01

Depression is associated with increased risk of cardiovascular morbidity and mortality in coronary heart disease. Numerous conventional and complementary therapies may address depression. Few involving spirituality have been tested. The aim of this study was to compare the effects of a nondenominational spiritual retreat, Medicine for the Earth (MFTE), on depression and other measures of well-being six- to 18-months post acute coronary syndrome (ACS). A randomized controlled pilot study of MFTE, Lifestyle Change Program (LCP), or usual cardiac care (control) was conducted in Southeastern Michigan. ACS patients were recruited via local and national advertising (n = 58 enrolled, 41 completed). The four-day MFTE intervention included guided imagery, meditation, drumming, journal writing, and nature-based activities. The four-day LCP included nutrition education, exercise, and stress management. Both retreat groups received follow-up phone coaching biweekly for three months. Validated self-report scales of depression, spiritual well-being, perceived stress, and hope were collected at baseline, immediately post-retreat, and at three and six months. Depression was not significantly different among groups (P = .21). However, the MFTE group had the highest depression scores at baseline and had significantly lower scores at all postintervention time points (P ≤ .002). Hope significantly improved among MFTE participants, an effect that persisted at three- and six-month follow-up (P = .014). Although several measures showed improvement in all groups by six months, the MFTE group had immediate improvement post-retreat, which was maintained. This pilot study shows that a nondenominational spiritual retreat, MFTE, can be used to increase hope while reducing depression in patients with ACS. Copyright © 2011 Elsevier Inc. All rights reserved.

A Pilot Study of an Exercise-Based Patient Education Program in People with Multiple Sclerosis

Directory of Open Access Journals (Sweden)

Stephanie Kersten

2014-01-01

Full Text Available There is increasing evidence that physical exercise leads to numerous positive effects in PwMS. However, long-term effects of exercise may only be achievable if training is implemented in daily routine. Enabling patients to exercise regularly, we developed a patient education program focused on evidence-based information of training. PwMS were educated in neurophysiological effects of physical exercise, exercise-induced benefits for PwMS, and risk factors (e.g., weather. Fifteen PwMS were analyzed before (T0 and after (T1 a 12-week patient education. Afterwards, participants performed their exercises autonomously for 32 weeks and were tested in sustainability tests (T2. Guided interviews were carried out, additionally. Significant improvements from T0 to T1 were found in 6MWT, gait velocity, TUG, fatigue, and quality of life. Significant results of TUG and gait velocity from T1 to T2 demonstrated that participants kept few effects after the 32-week training phase. Qualitative analyses showed improved self-confidence and identified training strategies and barriers. This pilot study provides evidence that PwMS are able to acquire good knowledge about physical exercise and apply this knowledge successfully in training management. One might conclude that this exercise-based patient education seems to be a feasible option to maintain or improve patients’ integral constitution concerning physical and mental health.

The Development of a Tracheostomy-Specific Quality of Life Questionnaire: A Pilot Study.

Science.gov (United States)

Smith, Kristine A; Bosch, John Douglas; Pelletier, Guy; MacKenzie, Marianne; Hoy, Monica Y

2016-08-01

A long-term tracheostomy can be a life-altering event and can have significant effects on patients' quality of life (QOL). There is currently no instrument available to evaluate tracheostomy-specific QOL. To address this deficiency, the objective of this study was to create and preliminarily validate a pilot tracheostomy-specific QOL questionnaire to assess its feasibility. A multidisciplinary team developed the pilot tracheostomy-specific QOL questionnaire (TQOL) in 3 phases: item generation, item review, and scale construction. The survey was administered at 0 and 2 weeks to a pilot group of tracheostomy patients with concurrent administration of a validated general QOL questionnaire at week 0. Convergence validity, test-retest reliability, and internal consistency were the primary outcome measures. A total of 37 patients completed the study (mean tracheostomy duration = 90 weeks). The convergence validity of the TQOL was moderately strong (r = 0.72), and the test-retest reliability was strong (r = 0.75). The TQOL also demonstrated good internal consistency (Cronbach's alpha = 0.82). The TQOL has moderately strong internal consistency, convergence validity, and test-retest reliability. While additional refinement and validation may improve the questionnaire, these initial results are promising and support further development of this tool. © The Author(s) 2016.

Changes in microflora in dental plaque from cancer patients undergoing chemotherapy and the relationship of these changes with mucositis: A pilot study.

Science.gov (United States)

Vozza, Iole; Caldarazzo, Vito; Ottolenghi, Livia

2015-05-01

To assess changes in oral microflora in dental plaque from cancer patients within 7 days of the first course of chemotherapy, and the relationship of the changes with mucositis. Thirty cancer patients, divided into a test group undergoing chemotherapy and a control group no undergoing chemotherapy, were enrolled in this pilot study. Oral microflora were cultured from three samples of dental plaque at t0 (before chemotherapy), t1 (1 day after chemotherapy) and t2 (7 days after chemotherapy). Single and crossed descriptive analyses were used to establish prevalence, and the χ² test was used to establish the statistical significance of the differences observed in distributions (significance level: Pbacterial flora also had periodontal-pathogenic species. No Porphyromonas gingivalis appeared in the test group. Actinobacillus was the least frequently found bacterium among periodontal pathogens in the test group, while Fusobacterium nucleatum was the most frequently found. No significant differences were found in quantitative bacterial changes between t0, t1 and t2 in either the test or control groups, or between the two groups. According to World Health Organization scores, oral mucositis developed in 10 patients (66.6%) in the test group. The results of this pilot study indicate that there were no changes in microflora in dental plaque in cancer patients within 7 days of the first course of chemotherapy. No correlations between oral mucositis and specific microorganisms were assessed.

Behavior management approach for agitated behavior in Japanese patients with dementia: a pilot study

Directory of Open Access Journals (Sweden)

Sato J

2012-12-01

Full Text Available Junko Sato,1 Shutaro Nakaaki,2 Katsuyoshi Torii,1 Mizuki Oka,2 Atsushi Negi,1 Hiroshi Tatsumi,3 Jin Narumoto,4 Toshi A Furukawa,5 Masaru Mimura21Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, 2Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, 3Department of Health Science, Faculty of Psychological and Physical Science, Aichi Gakuin University, Nagoya, 4Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, 5Department of Health Promotion and Human Behavior (Cognitive-Behavioral Medicine, Kyoto University Graduate School of Medicine/School of Public Health, Kyoto, JapanBackground: Agitated behaviors are frequently observed in patients with dementia and can cause severe distress to caregivers. However, little evidence of the efficacy of nonpharmacological interventions for agitated behaviors exists for patients with dementia. The present pilot study aimed to evaluate a behavioral management program developed by the Seattle Protocols for patients with agitated behaviors in Japan.Methods: Eighteen patients with dementia (Alzheimer’s disease, n = 14; dementia with Lewy bodies, n = 4 participated in an open study testing the effectiveness of a behavioral management program. The intervention consisted of 20 sessions over the course of 3 months. The primary outcomes were severity of agitation in dementia, as measured using the Agitated Behavior in Dementia scale (ABID and the Cohen-Mansfield Agitation Inventory (CMAI.Results: The behavioral management program resulted in significant reductions in total scores on both the ABID and CMAI. Although both physically agitated and verbally agitated behavior scores on the ABID improved significantly, symptoms of psychosis did not improve after the intervention.Conclusion: The behavioral management technique may be beneficial to distressed caregivers of

Patients as teachers, medical students as filmmakers: the video slam, a pilot study.

Science.gov (United States)

Shapiro, Dan; Tomasa, Lynne; Koff, Nancy Alexander

2009-09-01

In 2006-2007 and 2007-2008, the authors pilot-tested a filmmaking project, (medical students filmed patients) to assess the project's potential to teach about the challenges of living with serious chronic illness. Two years of second-year medical students (N = 32) from The University of Arizona, working in groups of two or three, were paired with patients and filmed multiple home visits during eight months. Students edited their films to 7 to 10 minutes and added transitions, titles, and music. A mixed audience of students and faculty viewed the resulting 12 films in a "Video Slam." Faculty also used the films in the formal curriculum to illustrate teaching points related to chronic illness. Student filmmakers, on average, made 4.4 visits, collected 5.6 hours of film, and edited for 26.6 hours. Students reported that the project affected what they planned to cover in clinic visits, increased their plans to involve patients in care, enhanced their appreciation for patient-centered care, improved their knowledge of community resources, improved their understanding of allied health professionals' roles, and taught them about patients' innovative adaptations. Overall, students rated the project highly for its impact on their education (mean = 4.52 of 5). Student and faculty viewers of the films (N = 74) found the films compelling (mean = 4.95 of 5) and informative (mean = 4.93 of 5). The authors encountered the ethical dilemmas of deciding who controls the patients' recorded stories and navigating between patient anonymity/confidentiality and allowing patients to use their stories to teach.

Specific Metabolome Profile of Exhaled Breath Condensate in Patients with Shock and Respiratory Failure: A Pilot Study

Directory of Open Access Journals (Sweden)

Brice Fermier

2016-09-01

Full Text Available Background: Shock includes different pathophysiological mechanisms not fully understood and remains a challenge to manage. Exhaled breath condensate (EBC may contain relevant biomarkers that could help us make an early diagnosis or better understand the metabolic perturbations resulting from this pathological situation. Objective: we aimed to establish the metabolomics signature of EBC from patients in shock with acute respiratory failure in a pilot study. Material and methods: We explored the metabolic signature of EBC in 12 patients with shock compared to 14 controls using LC-HRMS. We used a non-targeted approach, and we performed a multivariate analysis based on Orthogonal Partial Least Square-Discriminant Analysis (OPLS-DA to differentiate between the two groups of patients. Results: We optimized the procedure of EBC collection and LC-HRMS detected more than 1000 ions in this fluid. The optimization of multivariate models led to an excellent model of differentiation for both groups (Q2 > 0.4 after inclusion of only 6 ions. Discussion and conclusion: We validated the procedure of EBC collection and we showed that the metabolome profile of EBC may be relevant in characterizing patients with shock. We performed well in distinguishing these patients from controls, and the identification of relevant compounds may be promising for ICC patients.

Ganirelix for luteolysis in poor responder patients undergoing IVF treatment: a Scandinavian multicenter 'extended pilot study'

DEFF Research Database (Denmark)

Nilsson, Lena; Andersen, A.N.; Lindenberg, Svend

2010-01-01

To enhance oocyte yield and pregnancy outcome in poor responder women undergoing IVF treatment, daily low dose GnRH antagonist administration was given during the late luteal phase to induce luteolysis and possibly secure a more synchronous cohort of recruitable follicles. An open extended pilot...... study in four Scandinavian fertility centers was done including 60 patients. Poor response was defined as when 2000 IU FSH. GnRH antagonist (ganirelix) was given, 0.25 mg s.c. daily, from days 3 to 5...... oocyte retrievals resulting in 5 pregnancies (4 delivered). Despite GnRH antagonist administration in the late luteal phase and menstrual bleeding, FSH was not sufficiently reduced to secure a more synchronic cohort of recruitable follicles. Novel GnRH antagonists more specifically targeting FSH release...

Shoulder pain and disability in daily life, following supraomohyoid neck dissection : a pilot study

NARCIS (Netherlands)

van Wilgen, CP; Dijkstra, PU; Nauta, JM; Vermey, A; Roodenburg, JLN

Introduction: The purpose of this pilot study was to assess shoulder morbidity; i.e. pain and disability in daily activities, at least I year after unilateral or bilateral supraomohyoid neck dissection. Patients and methods: 52 patients having been subjected to a supraomohyoid neck dissection

Pupil cycle time and contrast sensitivity in type II diabetes mellitus patients: A pilot study

Directory of Open Access Journals (Sweden)

Hoyoung Lee

2011-01-01

Full Text Available Context: Pupil cycle time (PCT has been widely used for examination of ocular diabetic autonomic neuropathy (DAN. Aims: The primary aim of this study was to evaluate the difference of contrast sensitivity according to PCT results, and the secondary aim was to determine the factors associated with PCT difference for type II diabetes patients. Settings and Design: A clinical pilot study that included a total of 60 eyes of 60 type II diabetes patients. Materials and Methods: We divided all patients into three groups according to PCT results. Group A and Group C were composed of patients who had upper one third PCT and lower one third PCT, respectively. We analyzed difference of age, diabetes duration, hypertension duration, mean best corrected visual acuity (BCVA, mean spherical equivalent (SE, HbA1C, glomerular filtration rate (GFR, stage of diabetic retinopathy, and Cardiac Autonomic Function Score (CAFS. Contrast sensitivity and decrease of visual acuity by glare were also estimated and analyzed for 28 eyes of 28 non-proliferative diabetic retinopathy (NPDR patients. Group [NPDR] A and Group [NPDR] C were defined as those who had lower one third PCT and upper one third PCT, respectively. Statistical Analysis: Statistical analysis was done using SPSS 17.0 software. Results and Conclusions: Each group contained 20 eyes. Significant differences between Group A and Group C were observed in duration of diabetes and CAFS (P ≤ 0.001 and P < 0.001, respectively. Contrast sensitivity in Group [NPDR] A was significantly more than in Group [NPDR] C at all cpds (all P ≤ 0.001. We found that PCT can influence contrast sensitivity or glare in diabetes patients and also confirmed a significant correlation of PCT with CAFS and duration of diabetes.

Low literacy self-care management patient education for a multi-lingual heart failure population: Results of a pilot study.

Science.gov (United States)

Dickson, Victoria Vaughan; Chyun, Deborah; Caridi, Cristina; Gregory, Jill K; Katz, Stuart

2016-02-01

The purpose of this pilot study was to test the impact of language-free, low literacy self-care management patient education materials in an ethnically diverse multilingual heart failure (HF) population. A one group pre-test-post-test design measured changes in self-care, knowledge and health-related quality of life (HRQL) after a 1 month intervention using language-free, low literacy self-care management patient education materials and delivered by a health educator. The ethnically diverse sample (n=21) was predominately male (72%), 48% Black, 42% Hispanic, and 28% marginal/inadequate literacy. There were significant improvements in self-care and knowledge but not HRQL. Language-free, low literacy self-care patient education may facilitate improved self-care and knowledge in diverse populations who are at risk for poor HF outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

Patient information in radiation oncology: a cross-sectional pilot study using the EORTC QLQ-INFO26 module

International Nuclear Information System (INIS)

Adler, Johannes; Paelecke-Habermann, Yvonne; Jahn, Patrick; Landenberger, Margarete; Leplow, Bernd; Vordermark, Dirk

2009-01-01

The availability of alternative sources of information, e. g. the internet, may influence the quantity and quality of information cancer patients receive regarding their disease and treatment. The purpose of the present study was to assess perception of information in cancer patients during radiotherapy as well as media preferences and specifically the utilization of the internet. In a cross-sectional, single-centre study 94 patients currently undergoing radiotherapy were asked to complete two questionnaires. The EORTC QLQ-INFO26 module was used to assess the quality and quantity of information received by patients in the areas disease, medical tests, treatment, other services, different places of care and how to help themselves, as well as qualitative aspects as helpfulness of and satisfaction with this information. The importance of different media, in particular the internet, was investigated by a nine-item questionnaire. The response rate was n = 72 patients (77%). Patients felt best informed concerning medical tests (mean ± SD score 79 ± 22, scale 0-100) followed by disease (68 ± 21). Treatment (52 ± 24) and different places of care and other services (30 ± 36 and 30 ± 30, respectively) ranked last. 37% of patients were very satisfied and 37% moderately satisfied with the amount of information received, 61% wished more information. Among eight media, brochures, television and internet were ranked as most important. 41% used the internet themselves or via friends or family, mostly for research of classic and alternative treatment options. Unavailability and the necessity of computer skills were most mentioned obstacles. In a single-center pilot study, radiotherapy patients indicated having received most information about medical tests and their disease. Patients very satisfied with their information had received the largest amount of information. Brochures, television and internet were the most important media. Individual patient needs should be

Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study.

Science.gov (United States)

Martínez-Fernández, Raul; Rodríguez-Rojas, Rafael; Del Álamo, Marta; Hernández-Fernández, Frida; Pineda-Pardo, Jose A; Dileone, Michele; Alonso-Frech, Fernando; Foffani, Guglielmo; Obeso, Ignacio; Gasca-Salas, Carmen; de Luis-Pastor, Esther; Vela, Lydia; Obeso, José A

2018-01-01

Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease. This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871. Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm

kinesiotaping reduces pain and modulates sensory function in patients with focal dystonia: a randomized crossover pilot study.

Science.gov (United States)

Pelosin, Elisa; Avanzino, Laura; Marchese, Roberta; Stramesi, Paola; Bilanci, Martina; Trompetto, Carlo; Abbruzzese, Giovanni

2013-10-01

Pain is one of the most common and disabling "nonmotor" symptoms in patients with dystonia. No recent study evaluated the pharmacological or physical therapy approaches to specifically treat dystonic pain symptoms. To evaluate the effectiveness of KinesioTaping in patients with cervical dystonia (CD) and focal hand dystonia (FHD) on self-reported pain (primary objective) and on sensory functions (secondary objective). Twenty-five dystonic patients (14 with CD and 11 FHD) entered a randomized crossover pilot study. The patients were randomized to 14-day treatment with KinesioTaping or ShamTaping over neck (in CD) or forearm muscles (in FHD), and after a 30-day washout period, they received the other treatment. The were 3 visual analog scales (VASs) for usual pain, worst pain, and pain relief. Disease severity changes were evaluated by means of the Toronto Western Spasmodic Torticollis Rating Scale (CD) and the Writer's Cramp Rating Scale (FHD). Furthermore, to investigate possible KinesioTaping-induced effects on sensory functions, we evaluated the somatosensory temporal discrimination threshold. Treatment with KinesioTape induced a decrease in the subjective sensation of pain and a modification in the ability of sensory discrimination, whereas ShamTaping had no effect. A significant, positive correlation was found in both groups of patients between the improvement in the subjective sensation of pain and the reduction of somatosensory temporal discrimination threshold values induced by KinesioTaping. These preliminary results suggest that KinesioTaping may be useful in treating pain in patients with dystonia.

Doing A Pilot Study: Why Is It Essential?

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Hassan, Zailinawati Abu; Schattner, Peter; Mazza, Danielle

2006-01-01

A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.

Additional Virtual Reality Sitting Balance Training Using XBox Kinect™ in Patients with Neurological Disorders: A Pilot Study

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Xina Henry Quadros

2017-10-01

Full Text Available Introduction: Sitting balance is a prerequisite to upper extremity function, standing and walking, which is affected in various neurological diseases. It is important to attain a good level of sitting balance before one can proceed to standing. In recent years, virtual reality game training has gained a widespread application. Aim: This pilot study aimed to examine the role of additional virtual reality sitting balance training using a commercial interactive virtual reality system- Xbox Kinect™ in patients with neurological disorders. Materials and Methods: Four patients with sitting balance impairments following neurological disorders received two weeks of virtual reality based therapy along with the conventional physiotherapy. Sitting balance was evaluated using FIST (Function In Sitting Test scores at baseline, one week and after two weeks of intervention. Results: All four patients showed clinically significant improvement in FIST score between the pre and post intervention. Percentage of improvement in FIST score was approximately 27% with a minimum change of 10 points in the FIST score Minimal Clinically Important Difference (MCID=6.5. Conclusion: Additional virtual reality training may improve sitting balance control in neurological patients with balance impairments. It can be used as an adjunct in routine neurorehabilitation.

A pilot study of a Medication Rationalization (MERA) intervention.

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Whitty, Rachel; Porter, Sandra; Battu, Kiran; Bhatt, Pranjal; Koo, Ellen; Kalocsai, Csilla; Wu, Peter; Delicaet, Kendra; Bogoch, Isaac I; Wu, Robert; Downar, James

2018-02-16

Many seriously ill and frail inpatients receive potentially inappropriate or harmful medications and do not receive medications for symptoms of advanced illness. We developed and piloted an interprofessional Medication Rationalization (MERA) approach to deprescribing inappropriate medications and prescribing appropriate comfort medications. We conducted a single-centre pilot study of inpatients at risk of 6-month mortality from advanced age or morbidity. The MERA team reviewed the patients' medications and made recommendations on the basis of guidelines. We measured end points for feasibility, acceptability, efficiency and effectiveness. We enrolled 61 of 115 (53%) eligible patients with a mean age of 79.6 years (standard deviation [SD] 11.7 yr). Patients were taking an average of 11.5 (SD 5.2) medications before admission and had an average of 2.1 symptoms with greater than 6/10 severity on the revised Edmonton Symptom Assessment System. The MERA team recommended 263 medication changes, of which 223 (85%) were accepted by both the medical team and the patient. MERA team's recommendations resulted in the discontinuation of 162 medications (mean 3.1 per patient), dose changes for 48 medications (mean 0.9 per patient) and the addition of 13 medications (mean 0.2 per patient). Patients who received the MERA intervention stopped significantly more inappropriate medications than similar non-MERA comparison patients for whom data were collected retrospectively (3.1 v. 0.9 medications per patient, p < 0.01). The MERA approach was highly acceptable to patients and medical team members. The MERA intervention is feasible, acceptable, efficient and possibly effective for changing medication use among seriously ill and frail elderly inpatients. Scalability and effectiveness may be improved through automation and integration with medication reconciliation programs. Copyright 2018, Joule Inc. or its licensors.

Magnetic Seizure Therapy in Treatment-Resistant Schizophrenia: A Pilot Study

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Victor M. Tang

2018-01-01

Full Text Available ObjectiveElectroconvulsive therapy is effective in treatment-resistant schizophrenia (TRS but use is limited due to stigma and concerns around cognitive adverse effects. Magnetic seizure therapy (MST is a promising new neuromodulation technique that uses transcranial magnetic stimulation to induce therapeutic seizures. Studies of MST in depression have shown clinical improvement with a favorable adverse effect profile. No studies have examined the clinical utility of MST in schizophrenia.MethodsWe conducted an open-label pilot clinical trial of MST in eight TRS patients. Up to 24 MST treatments were delivered depending on treatment response. We assessed clinical outcome through the Brief Psychiatric Rating Scale (BPRS and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q. Cognitive testing included a neuropsychological test battery, the Autobiographical Memory Inventory (AMI, Montreal Cognitive Assessment (MoCA, and reorientation time.ResultsFour patients completed the trial as per protocol. For all patients and for trial completers alone, there was a significant clinical and quality of life improvement. Three met pre-determined criteria for remission (total score ≤25 on the BPRS and one met criteria for response (i.e., ≥25% BPRS improvement from baseline for two consecutive assessments. Pre and post neurocognitive data showed no significant cognitive adverse effects apart from a decrease in AMI scores.ConclusionIn this pilot study, MST demonstrated evidence for feasibility in patients with TRS, with promise for clinical efficacy and negligible cognitive side effects. Further study in larger clinical populations is needed.Clinical Trial Registrationwww.ClinicalTrials.gov, Identifier NCT01596608.

Thermoacoustic CT of the breast: pilot study observations

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Kruger, Robert A.; Kiser, William L., Jr.; Romilly, A. P.; Scmidt, Phyllis

2001-06-01

In order to assess the potential clinical utility of using thermoacoustic computer tomography (TCT) to image the breast, we conducted a retrospective pilot study of 78 patients. We recruited patients in three age groups (50 years). The study population was further segregated into normal and suspicious based on the results of the previous x-ray mammography and ultrasound. Image quality was evaluated qualitatively by consensus of two trained mammographers using a 4-point scale. The appearance of normal anatomy, cysts, benign disease and cancer was noted. Patients were also asked to rate the comfort of the TCT exam and to indicate a personal preference for x-ray mammography or TCT. Analysis of the data indicated that TCT image quality was dependent upon both patient age and breast density, improving with both increasing breast density and decreasing patient age. Fibrocystic disease was well seen, cysts appearing as areas of low RF absorption. Fibroadenomas did not demonstrate contrast enhancement with the exception of one patient with associated atypical hyperplasia. Cancer displayed higher RF absorption than surrounding tissues in 4/7 patients in whom cancer was confirmed, including one patient with a 7-mm ductal carcinoma in situ (DCIS).

Impact of pediatric obstructive sleep apnea on the development of Class II hyperdivergent patients receiving orthodontic treatment: A pilot study.

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Zhao, Tingting; Ngan, Peter; Hua, Fang; Zheng, Jie; Zhou, Shunquan; Zhang, Man; Xiong, Hui; He, Hong

2018-05-22

To conduct a pilot study to determine if the presence of obstructive sleep apnea (OSA) influences the orthodontic treatment outcome of Class II hyperdivergent patients receiving comprehensive orthodontic treatment. Patients between the ages of 12 and 14 who received orthodontic treatment at the Hospital of Stomatology, Wuhan University, China, were included in this study. Patients were divided into two groups: the OSA group and the control group, based on the outcome of pretreatment polysomnography findings and lateral cephalometric radiograph examination. Patients in the control group were matched with the OSA group for age, sex, ethnicity, weight, and height. Cephalometric measurements were used to record the skeletal and dental changes from before to after treatment. Data were analyzed using the t-test. Twenty three OSA patients and 23 control patients were included. After comprehensive orthodontic treatment, the mandibular plane angle (SN-GoMe), articular angle (SArGo), sum of Jarabak angles (SUM) and the lower gonial angle (NGoMe) were found to increase significantly in the OSA group but remained unchanged or decreased slightly in the control group ( P orthodontic treatment outcome of these patients.

Applying interprofessional Team-Based Learning in patient safety: a pilot evaluation study.

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Lochner, Lukas; Girardi, Sandra; Pavcovich, Alessandra; Meier, Horand; Mantovan, Franco; Ausserhofer, Dietmar

2018-03-27

Interprofessional education (IPE) interventions are not always successful in achieving learning outcomes. Team-Based Learning (TBL) would appear to be a suitable pedagogical method for IPE, as it focuses on team performance; however, little is known about interprofessional TBL as an instructional framework for patient safety. In this pilot-study, we aimed to (1) describe participants' reactions to TBL, (2) observe their achievement with respect to interprofessional education learning objectives, and (3) document their attitudinal shifts with regard to patient safety behaviours. We developed and implemented a three-day course for pre-qualifying, non-medical healthcare students to give instruction on non-technical skills related to 'learning from errors'. The course consisted of three sequential modules: 'Recognizing Errors', 'Analysing Errors', and 'Reporting Errors'. The evaluation took place within a quasi-experimental pre-test-post-test study design. Participants completed self-assessments through valid and reliable instruments such as the Mennenga's TBL Student Assessment Instrument and the University of the West of England's Interprofessional Questionnaire. The mean scores of the individual readiness assurance tests were compared with the scores of the group readiness assurance test in order to explore if students learned from each other during group discussions. Data was analysed using descriptive (i.e. mean, standard deviation), parametric (i.e. paired t-test), and non-parametric (i.e. Wilcoxon signed-rank test) methods. Thirty-nine students from five different bachelor's programs attended the course. The participants positively rated TBL as an instructional approach. All teams outperformed the mean score of their individual members during the readiness assurance process. We observed significant improvements in 'communication and teamwork' and 'interprofessional learning' but not in 'interprofessional interaction' and 'interprofessional relationships

Online and smartphone based cognitive behavioral therapy for bariatric surgery patients: Initial pilot study.

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Zhang, Melvyn W B; Ho, Roger C M; Cassin, Stephanie E; Hawa, Raed; Sockalingam, Sanjeev

2015-01-01

The respective rates of obesity in Canada and the United states are estimated to be 24.1% and 34.1%. Due to the increased incidence of obesity, Bariatric surgery has been recognized as one of the treatment options. Despite the success of Bariatric surgery, studies have proposed that it has neglected the contributions of other factors, such as psychological factors in the causation as well as the maintenance of obesity amongst individuals. Cognitive behavioral therapy (CBT) is largely a psychosocial intervention that has been shown to be efficacious, as studies have demonstrated that even brief CBT interventions could help in the reduction of binge eating and maintenance of weight loss. Previously identified problems with regards to the integration and the provision of such interventions include that of geographical barriers. In order to overcome the geographical barriers, telephone-based CBT has been conceptualized. Over the past decade, there has been massive advancement and development in Internet, Web-based and smartphone technologies, but there is still a paucity of applications in this area. Our current research objective is to determine if bariatric surgery patients will be receptive towards an online and smartphone based CBT intervention. The Bariatric Surgery Online CBT portal and Smartphone companion application was developed between July 2013 and December 2013. A low-cost methodology of developing the online portal was adopted. In terms of development, 4 core development phases were adopted. These included that of: a) Formulation of users' requirements, b) System design and development, c) System evaluation and d) System deployment and pilot application. The bariatric surgery workgroup from the Toronto Western Hospital helped with the recruitment of the subjects from the outpatient specialist service. Links to the web-portal was provided to each of the participants recruited. Since the inception of the online portal to date, in terms of usage rates, there

DOING A PILOT STUDY: WHY IS IT ESSENTIAL?

Directory of Open Access Journals (Sweden)

Zailinawati Abu Hassan

2006-01-01

Full Text Available A pilot study is one of the essential stages in a research project. This paper aims to describe the importance of and steps involved in executing a pilot study by using an example of a descriptive study in primary care. The process of testing the feasibility of the project proposal, recruitment of subjects, research tool and data analysis was reported. We conclude that a pilot study is necessary and useful in providing the groundwork in a research project.

Ballroom dancing as physical activity for patients with cancer: a systematic review and report of a pilot project.

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Rudolph, Ivonne; Schmidt, Thorsten; Wozniak, Tobias; Kubin, Thomas; Ruetters, Dana; Huebner, Jutta

2018-04-01

Physical activity has positive effects on cancer patients. Dancing addresses diverse bio-psycho-social aspects. Our aim was to assess the evidence on ballroom dancing and to develop the setting for a pilot project. We performed a systematic review, extracted the data and designed a pilot training based on standard curricula. We included cancer patients during or after therapy. Training duration was 90 min with one regular pause and individual pauses as needed. We retrieved two systematic reviews and six controlled studies. Types of dancing varied. Only one study used ballroom dancing. Dance training might improve well-being, physical fitness, fatigue and coping during and after therapy. Yet, evidence is scarce and data to derive the effect size are lacking; 27 patients and their partners took part in the pilot training. Patients and partners needed more time to learn the steps than is planned in regular ballroom classes. Participants were very satisfied with the adaptation of the training to their physical strength and estimated the training in a sheltered group. No side effects occurred. In spite of a high rate of participants reporting fatigue, 90 min of physical activity with only a few minutes of rest were manageable for all participants. Ballroom dancing may offer benefits for patients with respect to quality of life. Cancer patients prefer sheltered training setting and curricula of regular ballroom classes must be adapted for cancer patients. Strict curricula might reduce motivation and adherence and exclude patients with lower or variable fitness.

E-learning to improve the drug prescribing in the hospitalized elderly patients: the ELICADHE feasibility pilot study.

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Franchi, C; Mari, D; Tettamanti, M; Pasina, L; Djade, C D; Mannucci, P M; Onder, G; Bernabei, R; Gussoni, G; Bonassi, S; Nobili, A

2014-08-01

E-learning is an efficient and cost-effective educational method. This study aimed at evaluating the feasibility of an educational e-learning intervention, focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment, to improve drug prescribing to hospitalized elderly patients. Eight geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control. Clinicians of the two groups had to complete a specific per group e-learning program in 30 days. Then, ten patients (aged ≥75 years) had to be consecutively enrolled collecting clinical data at hospital admission, discharge, and 3 months later. The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer's criteria and of potential drug-drug interactions through a specific computerized database. The study feasibility was confirmed by the high percentage (90 %) of clinicians who completed the e-learning program, the recruitment, and follow-up of all planned patients. The intervention was well accepted by all participating clinicians who judged positively (a mean score of >3 points on a scale of 5 points: 0 = useless; 5 = most useful) the specific contents, the methodology applied, the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing. The pilot study met all the requested goals. The main study is currently ongoing and is planned to finish on July 2015.

Acupuncture in the treatment of rheumatoid arthritis: a double-blind controlled pilot study

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Zhang Lang

2007-11-01

Full Text Available Abstract Background In planning a randomized controlled trial of acupuncture, we conducted a pilot study using validated outcome measures to assess the feasibility of the protocol, and to obtain preliminary data on efficacy and tolerability of 3 different forms of acupuncture treatment as an adjunct for the treatment of chronic pain in patients with Rheumatoid arthritis (RA. Methods The study employs a randomized, prospective, double-blind, placebo-controlled trial to evaluate the effect of electroacupuncture (EA, traditional Chinese acupuncture (TCA and sham acupuncture (Sham in patients with RA. All patients received 20 sessions over a period of 10 weeks. Six acupuncture points were chosen. Primary outcome is the changes in the pain score. Secondary outcomes included the changes in the ACR core disease measures, DAS 28 score and the number of patients who achieved ACR 20 at week 10. Results From 80 eligible patients, 36 patients with mean age of 58 ± 10 years and disease duration of 9.3 ± 6.4 years were recruited. Twelve patients were randomized to each group. Twelve, 10 and 7 patients from the EA, TCA and Sham group respectively completed the study at 20 weeks (p Conclusion This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for RA. Trial registration ClinicalTrials.gov NCT00404443

Contrast-enhanced CMR in patients after percutaneous closure of the left atrial appendage: A pilot study

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Petersen Steffen E

2011-07-01

Full Text Available Abstract Background To evaluate the feasibility and value of first-pass contrast-enhanced dynamic and post-contrast 3D CMR in patients after transcatheter occlusion of left atrial appendage (LAA to identify incorrect placement and persistent leaks. Methods 7 patients with different occluder systems (n = 4 PLAATO; n = 2 Watchman; n = 1 ACP underwent 2 contrast-enhanced (Gd-DOTA CMR sequences (2D TrueFISP first-pass perfusion and 3D-TurboFLASH to assess localization, artifact size and potential leaks of the devices. Perfusion CMR was analyzed visually and semi-quantitatively to identify potential leaks. Results All occluders were positioned within the LAA. The ACP occluder presented the most extensive artifact size. Visual assessment revealed a residual perfusion of the LAA apex in 4 cases using first-pass perfusion and 3D-TurboFLASH indicating a suboptimal LAA occlusion. By assessing signal-to-time-curves the cases with a visually detected leak showed a 9-fold higher signal-peak in the LAA apex (567 ± 120% increase from baseline signal than those without a leak (61 ± 22%; p Conclusion This CMR pilot study provides valuable non-invasive information in patients after transcatheter occlusion of the LAA to identify correct placement and potential leaks. We recommend incorporating CMR in future clinical studies to evaluate new device types.

A pilot study of distributed knowledge management and clinical decision support in the cloud.

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Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

2013-09-01

Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable

Feasibility of a combined aerobic and strength training program and its effects on cognitive and physical function in institutionalized dementia patients. A pilot study.

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Willem J R Bossers

Full Text Available OBJECTIVES: We examined the feasibility of a combined aerobic and strength training program in institutionalized dementia patients and studied the effects on cognitive and physical function. METHODS: Thirty-three patients with dementia, recruited from one nursing home, participated in this non-randomized pilot study (25 women; age = 85.2±4.9 years; Mini Mental State Examination = 16.8±4.0. In phase 1 of the study, seventeen patients in the Exercise group (EG received a combined aerobic and strength training program for six weeks, five times per week, 30 minutes per session, in an individually supervised format and successfully concluded the pre and posttests. In phase 2 of the study, sixteen patients in the Social group (SG received social visits at the same frequency, duration, and format and successfully concluded the pre and posttests. RESULTS: Indices of feasibility showed that the recruitment and adherence rate, respectively were 46.2% and 86.3%. All EG patients completed the exercise program according to protocol without adverse events. After the six-week program, no significant differences on cognitive function tests were found between the EG and SG. There was a moderate effect size in favor for the EG for the Visual Memory Span Forward; a visual attention test. There were significant differences between groups in favor for the EG with moderate to large effects for the physical tests Walking Speed (p = .003, Six-Minute Walk Test (p = .031, and isometric quadriceps strength (p = .012. CONCLUSIONS: The present pilot study showed that it is feasible to conduct a combined aerobic and strength training program in institutionalized patients with dementia. The selective cognitive visual attention improvements and more robust changes in motor function in favor of EG vs. SG could serve as a basis for large randomized clinical trials. TRIAL REGISTRATION: trialregister.nl 1230.

Feasibility of a combined aerobic and strength training program and its effects on cognitive and physical function in institutionalized dementia patients. A pilot study.

Science.gov (United States)

Bossers, Willem J R; Scherder, Erik J A; Boersma, Froukje; Hortobágyi, Tibor; van der Woude, Lucas H V; van Heuvelen, Marieke J G

2014-01-01

We examined the feasibility of a combined aerobic and strength training program in institutionalized dementia patients and studied the effects on cognitive and physical function. Thirty-three patients with dementia, recruited from one nursing home, participated in this non-randomized pilot study (25 women; age = 85.2±4.9 years; Mini Mental State Examination = 16.8±4.0). In phase 1 of the study, seventeen patients in the Exercise group (EG) received a combined aerobic and strength training program for six weeks, five times per week, 30 minutes per session, in an individually supervised format and successfully concluded the pre and posttests. In phase 2 of the study, sixteen patients in the Social group (SG) received social visits at the same frequency, duration, and format and successfully concluded the pre and posttests. Indices of feasibility showed that the recruitment and adherence rate, respectively were 46.2% and 86.3%. All EG patients completed the exercise program according to protocol without adverse events. After the six-week program, no significant differences on cognitive function tests were found between the EG and SG. There was a moderate effect size in favor for the EG for the Visual Memory Span Forward; a visual attention test. There were significant differences between groups in favor for the EG with moderate to large effects for the physical tests Walking Speed (p = .003), Six-Minute Walk Test (p = .031), and isometric quadriceps strength (p = .012). The present pilot study showed that it is feasible to conduct a combined aerobic and strength training program in institutionalized patients with dementia. The selective cognitive visual attention improvements and more robust changes in motor function in favor of EG vs. SG could serve as a basis for large randomized clinical trials. trialregister.nl 1230.

Hemodynamic Effects of Phenylephrine, Vasopressin, and Epinephrine in Children With Pulmonary Hypertension: A Pilot Study.

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Siehr, Stephanie L; Feinstein, Jeffrey A; Yang, Weiguang; Peng, Lynn F; Ogawa, Michelle T; Ramamoorthy, Chandra

2016-05-01

During a pulmonary hypertensive crisis, the marked increase in pulmonary vascular resistance can result in acute right ventricular failure and death. Currently, there are no therapeutic guidelines for managing an acute crisis. This pilot study examined the hemodynamic effects of phenylephrine, arginine vasopressin, and epinephrine in pediatric patients with pulmonary hypertension. In this prospective, open-label, nonrandomized pilot study, we enrolled pediatric patients previously diagnosed with pulmonary hypertensive who were scheduled electively for cardiac catheterization. Primary outcome was a change in the ratio of pulmonary-to-systemic vascular resistance. Baseline hemodynamic data were collected before and after the study drug was administered. Eleven of 15 participants were women, median age was 9.2 years (range, 1.7-14.9 yr), and median weight was 26.8 kg (range, 8.5-55.2 kg). Baseline mean pulmonary artery pressure was 49 ± 19 mm Hg, and mean indexed pulmonary vascular resistance was 10 ± 5.4 Wood units. Etiology of pulmonary hypertensive varied, and all were on systemic pulmonary hypertensive medications. Patients 1-5 received phenylephrine 1 μg/kg; patients 6-10 received arginine vasopressin 0.03 U/kg; and patients 11-15 received epinephrine 1 μg/kg. Hemodynamics was measured continuously for up to 10 minutes following study drug administration. After study drug administration, the ratio of pulmonary-to-systemic vascular resistance decreased in three of five patients receiving phenylephrine, five of five patients receiving arginine vasopressin, and three of five patients receiving epinephrine. Although all three medications resulted in an increase in aortic pressure, only arginine vasopressin consistently resulted in a decrease in the ratio of systolic pulmonary artery-to-aortic pressure. This prospective pilot study of phenylephrine, arginine vasopressin, and epinephrine in pediatric patients with pulmonary hypertensive showed an increase in aortic

Pre-Study Walkthrough with a Commercial Pilot for a Preliminary Single Pilot Operations Experiment

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O'Connor-Dreher, Ryan; Roberts, Z.; Ziccardi, J.; Vu, K-P. L.; Strybel, T.; Koteskey, Robert William; Lachter, Joel B.; Vi Dao, Quang; Johnson, Walter W.; Battiste, V.

2013-01-01

The number of crew members in commercial flights has decreased to two members, down from the five-member crew required 50 years ago. One question of interest is whether the crew should be reduced to one pilot. In order to determine the critical factors involved in safely transitioning to a single pilot, research must examine whether any performance deficits arise with the loss of a crew member. With a concrete understanding of the cognitive and behavioral role of a co-pilot, aeronautical technologies and procedures can be developed that make up for the removal of the second aircrew member. The current project describes a pre-study walkthrough process that can be used to help in the development of scenarios for testing future concepts and technologies for single pilot operations. Qualitative information regarding the tasks performed by the pilots can be extracted with this technique and adapted for future investigations of single pilot operations.

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

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

2010-01-01

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

A pilot study on the effects and feasibility of compassion-focused expressive writing in Day Hospice patients.

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Imrie, Susan; Troop, Nicholas A

2012-06-01

Research has found that writing about stress can confer physical and psychological health benefits on participants and that adopting a self-compassionate stance may have additional benefits. This pilot study evaluated a self-compassionate expressive writing intervention in a Day Hospice setting. Thirteen patients with life-limiting illnesses wrote on two occasions about recent stressful experiences. Half also received a self-compassion instruction for their writing. Outcome measures were taken at baseline and one week after the second writing session, and text analysis was used to identify changes in the types of words used, reflecting changes in psychological processes. Patients given the self-compassion instruction increased in their self-soothing and self-esteem in contrast to patients in the stress-only condition. Happiness broadly increased in both groups although reported levels of stress generally increased in patients given the self-compassion instruction but decreased in patients in the stress-only condition. Those given the self-compassion instruction also increased in their use of causal reasoning words across the two writing sessions compared with those in the stress-only condition. Expressive writing appears to be beneficial in patients at a hospice and was viewed as valuable by participants. The inclusion of a self-compassion instruction may have additional benefits and a discussion of the feasibility of implementing expressive writing sessions in a Day Hospice is offered.

Patient satisfaction with laser-sintered removable partial dentures: A crossover pilot clinical trial.

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Almufleh, Balqees; Emami, Elham; Alageel, Omar; de Melo, Fabiana; Seng, Francois; Caron, Eric; Nader, Samer Abi; Al-Hashedi, Ashwaq; Albuquerque, Rubens; Feine, Jocelyne; Tamimi, Faleh

2018-04-01

Clinical data regarding newly introduced laser-sintered removable partial dentures (RPDs) are needed before this technique can be recommended. Currently, only a few clinical reports have been published, with no clinical studies. This clinical trial compared short-term satisfaction in patients wearing RPDs fabricated with conventional or computer-aided design and computer-aided manufacturing (CAD-CAM) laser-sintering technology. Twelve participants with partial edentulism were enrolled in this pilot crossover double-blinded clinical trial. Participants were randomly assigned to wear cast or CAD-CAM laser-sintered RPDs for alternate periods of 30 days. The outcome of interest was patient satisfaction as measured using the McGill Denture Satisfaction Instrument. Assessments was conducted at 1, 2, and 4 weeks. The participant's preference in regard to the type of prosthesis was assessed at the final evaluation. The linear mixed effects regression models for repeated measures were used to analyze the data, using the intention-to-treat principle. To assess the robustness of potential, incomplete adherence, sensitivity analyses were conducted. Statistically significant differences were found in patients' satisfaction between the 2 methods of RPD fabrication. Participants were significantly more satisfied with laser-sintered prostheses than cast prostheses in regard to general satisfaction, ability to speak, ability to clean, comfort, ability to masticate, masticatory efficiency, and oral condition (Premovable partial dentures may lead to better outcomes in terms of patient satisfaction in the short term. The conclusion from this pilot study requires confirmation by a larger randomized controlled trial. ClinicalTrials.gov. A study about patient satisfaction with laser-sintered removable partial dentures; NCT02769715. Copyright © 2017 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Intraoperative laser speckle contrast imaging for monitoring cerebral blood flow: results from a 10-patient pilot study

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Richards, Lisa M.; Weber, Erica L.; Parthasarathy, Ashwin B.; Kappeler, Kaelyn L.; Fox, Douglas J.; Dunn, Andrew K.

2012-02-01

Monitoring cerebral blood flow (CBF) during neurosurgery can provide important physiological information for a variety of surgical procedures. Although multiple intraoperative vascular monitoring technologies are currently available, a quantitative method that allows for continuous monitoring is still needed. Laser speckle contrast imaging (LSCI) is an optical imaging method with high spatial and temporal resolution that has been widely used to image CBF in animal models in vivo. In this pilot clinical study, we adapted a Zeiss OPMI Pentero neurosurgical microscope to obtain LSCI images by attaching a camera and a laser diode. This LSCI adapted instrument has been used to acquire full field flow images from 10 patients during tumor resection procedures. The patient's ECG was recorded during acquisition and image registration was performed in post-processing to account for pulsatile motion artifacts. Digital photographs confirmed alignment of vasculature and flow images in four cases, and a relative change in blood flow was observed in two patients after bipolar cautery. The LSCI adapted instrument has the capability to produce real-time, full field CBF image maps with excellent spatial resolution and minimal intervention to the surgical procedure. Results from this study demonstrate the feasibility of using LSCI to monitor blood flow during neurosurgery.

Tele consultation and tele follow up of thyroid cancer patients: A pilot study

International Nuclear Information System (INIS)

Pradhan, P.K.; Das, B.K.; Mohanty, B.N.; Mishra, S.K.

2005-01-01

their evaluation and admission could be finalised and instructions for withdrawal of thyroxin could be given to patients. Out of twenty follow up cases, only thirteen patients were required to come to SGPGIMS, Lucknow. Rest of the seven patients could be managed with instructions and need not travel to our Institution. Telemedicine has been utilised for follow up of patients in several areas. Gilmour et al emphasised the importance of telemedicine for diagnosis and management of dermatology cases referred from primary care. Fifty percent of patients could have been managed by single tele consultation without requirement of further specialist intervention. Alen et al reported the utilisation of telemedicine in cancer patients in rural areas. Redlick et al used telemedicine to evaluate patient and physician satisfaction with tele-consultations in follow up of burn cases and to assess the cost and benefit of tele-consultations. Patients were very satisfied with their tele-consultations and found them more economical and time efficient than in person visits. Telemedicine technology has been utilised for diagnosis of thyroid disorders. However, tele-consultation and tele-follow up of thyroid cancer patients before and after radioiodine therapy has never been utilised as per published literature. This telemedicine tool has strong potential for consultations of patients with thyroid cancer and monitoring them subsequently at timed interval following radioiodine treatment.In our pilot study 100% of patients consented and subsequently received radioiodine and 35% of follow up patients did not visit our Institution at Lucknow because of live interaction through telemedicine. The tele-consultation and tele-follow up of thyroid cancer patients provided great degree of patient satisfaction because of direct audio visual contact. Saving of travel expenses as well as inconvenience to travel such long distances could be achieved in 35% of cases. This is substantial both in terms of

Music for surgical abortion care study: a randomized controlled pilot study.

Science.gov (United States)

Wu, Justine; Chaplin, William; Amico, Jennifer; Butler, Mark; Ojie, Mary Jane; Hennedy, Dina; Clemow, Lynn

2012-05-01

The study objective was to explore the effect of music as an adjunct to local anesthesia on pain and anxiety during first-trimester surgical abortion. Secondary outcomes included patient satisfaction and coping. We conducted a randomized controlled pilot study of 26 women comparing music and local anesthesia to local anesthesia alone. We assessed pain, anxiety and coping with 11-point verbal numerical scales. Patient satisfaction was measured via a 4-point Likert scale. In the music group, we noted a trend toward a faster decline in anxiety postprocedure (p=.065). The music group reported better coping than the control group (mean±S.D., 8.5±2.3 and 6.2±2.8, respectively; pMusic as an adjunct to local anesthesia during surgical abortion is associated with a trend toward less anxiety postprocedure and better coping while maintaining high patient satisfaction. Music does not appear to affect abortion pain. Copyright © 2012 Elsevier Inc. All rights reserved.

A pilot study of complementary and alternative medicine use in patients with fibromyalgia syndrome

Directory of Open Access Journals (Sweden)

Wall GC

2007-12-01

. However, a significantly higher proportion of respondents who “ever-used” dietary and herbal supplements discussed CAM with a pharmacist compared to those who never used dietary and herbal supplements [chi square=6.03, p=0.014]. Conclusion: This pilot study suggests that CAM use is common in patients diagnosed with FMS. Compared to other healthcare providers, respondents were least likely to discuss CAM with a pharmacist. However, respondents who used dietary and herbal supplements were more likely to discuss CAM with a pharmacist compared to those who did not, suggesting the potential influence of pharmacist intervention.

Implementing Modular Interactive Tiles for Rehabilitation in Tanzania – a pilot study

DEFF Research Database (Denmark)

Lund, Henrik Hautop; Jensen, Line Steiness Dejnbjerg; Ssessanga, Yusuf

2014-01-01

The pilot study in the Iringa region, Tanzania, indicates how the modular interactive tiles can be used for playful physical rehabilitation for many diverse patient groups (handicapped children, stroke, cardiac, diabetic patients, etc.) in both urban and rural areas, and how it motivates the user...... and adaptive playful technology for rehabilitation in sub-Saharan Africa....... through play to perform the physical rehabilitative actions. The system can be easily used by rehabilitation workers, and through the modularity it is robust to failure (e.g. power failure) in remote areas. The analyses of the use by many different user groups was condensed to a higher abstraction level...... to provide insight on the generalisation over the different user groups, and to provide pointers of opportunities and the means to meet these opportunities through subsequent development in the next cycles in the iterative research method. The pilot study indicates that the system can be a flexible...

The ENIQ pilot study: current status

Energy Technology Data Exchange (ETDEWEB)

Lemaitre, P; Eriksen, B; Crutzen, S [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J [AEA Technology, Warrington (United Kingdom)

1998-11-01

A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

Varenicline for opioid withdrawal in patients with chronic pain: a randomized, single-blinded, placebo controlled pilot trial.

Science.gov (United States)

Hooten, W Michael; Warner, David O

2015-03-01

The objectives of this randomized, single-blinded, placebo-controlled pilot trial were to investigate the effects of varenicline on opioid withdrawal among chronic pain patients undergoing opioid detoxification in an interdisciplinary pain program and the feasibility of varenicline use in this population. Twenty-one patients were recruited (varenicline=10, placebo=11), and 7 patients in the varenicline and 11 in the placebo group completed the study. Opioid withdrawal was quantified using the Clinical Opiate Withdrawal Scale, and varenicline-related adverse effects were assessed. Opioid withdrawal scores tended to decrease over the course of opioid tapering in those receiving varenicline and increase in those receiving placebo. Varenicline was well-tolerated in this population, with no adverse drug effects (including nausea) observed and no effect on improvements in pain severity and depression. This randomized pilot study provides preliminary data for future trials of varenicline in opioid-dependent adults with chronic pain undergoing medically directed opioid detoxification. Copyright © 2014 Elsevier Ltd. All rights reserved.

Intraoperative Vascular Neuromonitoring in Patients with Subarachnoid Hemorrhage: A Pilot Study Using Combined Laser-Doppler Spectrophotometry.

Science.gov (United States)

Schmitz, Emilija; Bischoff, Barbara; Wolf, Dennis; Schmitt, Hubert J; Eyupoglu, Ilker Y; Roessler, Karl; Buchfelder, Michael; Sommer, Björn

2017-11-01

Intraoperative monitoring of cerebral microcirculation in patients with subarachnoid hemorrhage (SAH) may predict the postoperative neurologic outcome. In this pilot study, we examined the value of a novel noninvasive real-time measurement technique for detecting changes in local microcirculation. We used the O2C (Oxygen to see) laser-Doppler spectrophotometry system in 14 patients with Hunt & Hess grade 2-5 SAH who underwent microsurgical cerebral aneurysm clipping. A subdural probe recorded capillary venous oxygenation (SO 2 ), relative hemoglobin concentration, blood cell velocity, and blood flow at a tissue depth of 7 mm. Data were recorded immediately before dural closure. We also recorded somatosensory evoked potentials (SEPs) with median and tibial nerve stimulation. Results were compared with neurologic performance, as measured on the modified Rankin Scale, at the day of discharge from the hospital and 12 months thereafter. Patient functional outcomes after discharge and 12 months were correlated with pathological decreased flow and increased SO 2 values. In 6 of 8 patients, microcirculatory monitoring parameters indicated ischemia during surgery, as shown by electrophysiological SEP changes and infarction detected on the postoperative computed tomography (CT) scan. Pathological SEP results correlated closely with infarct demarcation as seen on CT. Our results indicate the potential benefit of intraoperative combined laser-Doppler flowmetry and spectrophotometry for predicting postoperative clinical outcomes in this small patient sample. Larger-cohort testing is needed to verify our findings and show the possible merits of this novel method. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient satisfaction with a pilot chronic pain management programme in Cape Town, South Africa

Directory of Open Access Journals (Sweden)

R. Parker

2009-01-01

Full Text Available Background: The goals of a chronic pain management clinic includeincreasing patient knowledge about pain, developing pain management skillsand increasing patients’ confidence in their pain management abilities.A  Chronic Pain Management Programme (CPMP based on evidence basedguidelines was developed at a chronic pain management clinic to facilitatepatient discharge to a primary healthcare level. Aim: The aim of this study was to explore patient satisfaction with, acceptability of and the perceived success which could be due to the CPMP developed at the Chronic Pain Management Clinic of Groote Schuur Hospital,Cape Town.Methods: Patients (n=14 were referred to the pilot study from the Chronic Pain Management Clinic. A s a pilot, four courses were run over a period ofone year. In order to reach the research aim, an eleven-question, structuredopen-ended interview was conducted with all participants. Results: Fourteen patients enrolled in the CPMP. Responses were favourable with participants emphasising the roleof increased knowledge about pain, the role of exercise and of stress management techniques. Participants also recog-nised a positive change in behaviours and attitudes following participation in the CPMP.Conclusions: Findings suggest that participants found the format of the course acceptable as regards course content,structure and delivery. Participant responses suggest that the course was acceptable and perceived as useful. However,future courses would benefit from refresher courses or structured support groups.

Benfotiamine in the treatment of diabetic polyneuropathy--a three-week randomized, controlled pilot study (BEDIP study).

Science.gov (United States)

Haupt, E; Ledermann, H; Köpcke, W

2005-02-01

The aim of the study was to evaluate the efficacy of benfotiamine administered over three weeks (allithiamine; a lipid-soluble vitamin B1 prodrug with high bioavailability) to patients with diabetic polyneuropathy in a randomized, placebo-controlled, double-blind, two-center pilot study. Forty inpatients (23 male, 18 female, age range 18 - 70 years) with a history of type 1 or 2 diabetes and polyneuropathy of not longer than two years, were included in the study. Twenty Patients received two 50 mg benfotiamine tablets four times daily and 20 patients received placebo over the three-week study period. Two clinical units were involved with 10 patients receiving placebo and 10 patients benfotiamine in each. The neuropathy score according to Katzenwadel et al. [1987] was used to evaluate symptoms of polyneuropathy, vibration perception threshold and both the physician's and the patient's own assessment were documented. A statistically significant (p = 0.0287) improvement in the neuropathy score was observed in the group given active drug when compared to the placebo-treated controls. There was no statistically significant change observed in the tuning fork test. The most pronounced effect on complaints was a decrease in pain (p = 0.0414). More patients in the benfotiamine-treated group than in the placebo group considered their clinical condition to have improved (p = 0.052). No side effects attributable to benfotiamine were observed. The differences between the groups cannot be attributed to a change in metabolic parameters since there were no significant alterations in the HbA1 levels and blood sugar profiles. The body mass index of the two groups did not differ. This pilot investigation (BEDIP Study) has confirmed the results of two earlier randomized controlled trials and has provided further evidence for the beneficial effects of benfotiamine in patients with diabetic neuropathy.

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study.

Science.gov (United States)

Wirz, Stefan; Conrad, Stefan; Shtrichman, Ronit; Schimo, Kai; Hoffmann, Eva

2017-01-01

Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group ( n = 43), opioids dispensed by nurses, and a test group ( n = 27), opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group ( P value PCoA Acute users were satisfied with its use. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

Design and Methods for a Pilot Study of a Phone-Delivered, Mindfulness-Based Intervention in Patients with Implantable Cardioverter Defibrillators

Directory of Open Access Journals (Sweden)

Elena Salmoirago-Blotcher

2012-01-01

Full Text Available Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs. Design and Methods. Consecutive, clinically stable outpatients (n=52 will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization. The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period. Conclusions. If proven feasible and effective, phone-delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.

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

Science.gov (United States)

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

2018-03-01

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

Patients' Priorities Regarding Female-to-Male Gender Affirmation Surgery of the Genitalia-A Pilot Study of 47 Patients in Sweden.

Science.gov (United States)

Jacobsson, Josephine; Andréasson, My; Kölby, Lars; Elander, Anna; Selvaggi, Gennaro

2017-06-01

their specific benefits and limitations to make an informed choice. Jacobsson J, Andréasson M, Kölby L, et al. Patients' Priorities Regarding Female-to-Male Gender Affirmation Surgery of the Genitalia-A Pilot Study of 47 Patients in Sweden. J Sex Med 2017;14:857-864. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Establishment of an Italian chronic migraine database: a multicenter pilot study.

Science.gov (United States)

Barbanti, Piero; Fofi, L; Cevoli, S; Torelli, P; Aurilia, C; Egeo, G; Grazzi, L; D'Amico, D; Manzoni, G C; Cortelli, P; Infarinato, F; Vanacore, N

2018-05-01

To optimize chronic migraine (CM) ascertainment and phenotype definition, provide adequate clinical management and health care procedures, and rationalize economic resources allocation, we performed an exploratory multicenter pilot study aimed at establishing a CM database, the first step for developing a future Italian CM registry. We enrolled 63 consecutive CM patients in four tertiary headache centers screened with face-to-face interviews using an ad hoc dedicated semi-structured questionnaire gathering detailed information on life-style, behavioral and socio-demographic factors, comorbidities, and migraine features before and after chronicization and healthcare resource use. Our pilot study provided useful insights revealing that CM patients (1) presented in most cases symptoms of peripheral trigeminal sensitization, a relatively unexpected feature which could be useful to unravel different CM endophenotypes and to predict trigeminal-targeted treatments' responsiveness; (2) had been frequently admitted to emergency departments; (3) had undergone, sometime repeatedly, unnecessary or inappropriate investigations; (4) got rarely illness benefit exemption or disability allowance only. We deem that the expansion of the database-shortly including many other Italian headache centers-will contribute to more precisely outline CM endophenotypes, hence improving management, treatment, and economic resource allocation, ultimately reducing CM burden on both patients and health system.

APMP Pilot Study on Transmittance Haze

Science.gov (United States)

Liu, Wen-Chun; Hwang, Jisoo; Koo, Annette; Wu, Houping; Leecharoen, Rojana; Yu, Hsueh-Ling

2018-02-01

Five NMIs within APMP, including CMS/ITRI, MSL, NIM, NIMT and KRISS from TCPR applied to the APMP technical committee initiative project for funding to carry out a pilot comparison of transmittance haze in 2012. The project started in 2014 and the final report was completed at the end of 2016. In this pilot comparison, three different haze standards were adopted, and transmittance haze for each standard was measured according to ASTM D1003 or ISO 14782. This paper presents the first results of an APMP pilot study of transmittance haze and the analysis of the variation among different haze measurement systems which are commonly used. The study shows that the variables such as sphere multiplier, transmittance distribution, fluorescence of samples and optical path of the incident beam cause discrepancies among NMIs and highlight deficiencies in current documentary standards.

Micronuclear and sister chromatid exchange analyses in peripheral lymphocytes of patients with oral lichen planus--a pilot study.

Science.gov (United States)

Ergun, S; Warnakulasuriya, S; Duman, N; Saruhanoğlu, A; Sevinç, B; Oztürk, S; Ozel, S; Cefle, K; Palanduz, S; Tanyeri, H

2009-10-01

The purpose of this study was to determine the genetic instability of peripheral blood lymphocytes from patients diagnosed with oral lichen planus (OLP) by investigation of frequencies of micronuclei (MN) and sister chromatid exchange (SCE). A total of 22 newly diagnosed and untreated patients with OLP of same severity scores and twenty healthy controls participated in this study. They were all non-smokers with no previous history or family history of cancer. The periodontal status, flow rate and buffering capacity of whole mouth saliva were recorded. SCE and MN analyses were performed on peripheral blood lymphocytes of OLP patients and healthy controls. The frequencies of MN (50.00 +/- 22.36) and SCE (6.89 +/- 1.48) in OLP patients were found to be significantly elevated compared with that in normal individuals (25.20 +/- 9.52 and 5.93 +/- 1.31; z = 3.946, P = 0.0001; z = 2.346, P = 0.019). There were no significant differences in the MN frequency and SCE between the two subgroups with reticular or erosive types of OLP. These pilot data indicate an increased genomic instability in peripheral blood lymphocytes of a cohort of Turkish patients diagnosed with oral lichen planus as compared with that of healthy individuals. As patients with OLP may have an increased or potential risk for oral malignancy, these assays could be used in translational research to monitor beneficial effects of interventions and long-term prognosis.

Concurrent chemoradiotherapy for advanced cervical cancer. A pilot study

International Nuclear Information System (INIS)

Kodama, Junichi; Hashimoto, Ichiro; Seki, Noriko; Hongo, Atsushi; Mizutani, Yasushi; Miyagi, Yasunari; Yoshinouchi, Mitsuo; Kudo, Takafumi

2001-01-01

Recently, attempts have made to use radiotherapy in combination with chemotherapy in various solid tumors including cervical cancer. Twenty-four patients with locally advanced cervical cancer were treated with concurrent Carboplatin (16-24 mg/m 2 /day) or Nedaplatin (20 mg/m 2 /week) and conventional radiotherapy. Of 13 evaluable patients, there were nine complete responders and four partial responders. There was no renal damage or grade 4 hematological toxicity. Gastrointestinal adverse reactions were mild. One patient had grade 3 dermatologic toxicity after delayed radiation therapy. This pilot study suggests that daily Carboplatin or weekly Nedaplatin administered with standard radiation therapy is safe, well-tolerated, and thus may be useful as a radiation sensitizer in the treatment of locally advanced cervical cancer. (author)

Corneal backscatter in insulin-dependent and non-insulin-dependent diabetes mellitus patients: a pilot study

Directory of Open Access Journals (Sweden)

Ana M Calvo-Maroto

Full Text Available ABSTRACT Purpose: To compare central corneal backscatter obtained from Scheimpflug images between patients with insulin-dependent and non-insulin-dependent diabetes mellitus (IDDM and NIDDM, respectively and healthy controls. Methods: Seven patients with IDDM (7 eyes, eleven patients with NIDDM (11 eyes, and sixteen healthy subjects (16 eyes were included in this pilot study. Scheimpflug imaging system (Pentacam, Oculus Inc., Germany was used to obtain optical sections of the cornea. Seven meridians were analyzed for each eye, oriented from 70° to 110°. Optical density values for the central 3-mm and 5-mm zones of the cornea were obtained by image analysis using external software. Results: Corneal backscatter was significantly higher in the diabetic patients than in the controls for the central 3-mm (p=0.016 and 5-mm (p=0.014 zones. No significant differences in corneal backscatter were found between the IDDM and NIDDM groups for either zone (both p>0.05. In the NIDDM group, significant correlations were observed for both central zones between corneal backscatter and age (3 mm: r=0.604, p=0.025; 5 mm: r=0.614, p=0.022 and central corneal thickness (3 mm: r=0.641, p=0.017; 5 mm: r=0.671, p=0.012; this was not found in the IDDM group (p>0.05. The presence of diabetes showed a significant effect on central corneal backscatter (Kruskal-Wallis test, p<0.001. Conclusions: Diabetic patients showed higher values of corneal light backscatter than healthy subjects. Corneal optical density analysis may be a useful tool for monitoring and assessing the ocular changes caused by diabetes.

Benefit of social media on patient engagement and satisfaction: Results of a 9-month, qualitative pilot study using Facebook.

Science.gov (United States)

Dhar, Vikrom K; Kim, Young; Graff, Justin T; Jung, Andrew D; Garrett, Jennifer; Dick, Lauren E; Harris, Jenifer; Shah, Shimul A

2018-03-01

Despite the potential benefits of social media, health care providers are often hesitant to engage patients through these sites. Our aim was to explore how implementation of social media may affect patient engagement and satisfaction. In September 2016 a Facebook support group was created for liver transplant patients to use as a virtual community forum. Data including user demographics and group activity were reviewed. A survey was conducted evaluating users' perceptions regarding participation in the group. Over 9 months, 350 unique users (50% liver transplant patients, 36% caregivers/friends, 14% health care providers) contributed 339 posts, 2,338 comments, and 6,274 reactions to the group; 98% of posts were reacted to or commented on by other group members. Patients were the most active users compared with health care providers and caregivers. A total of 95% of survey respondents reported that joining the group had a positive impact on their care; and 97% reported that their main motivation for joining was to provide or receive support from other patients. This pilot study indicates that the integration of social media into clinical practice can empower surgeons to synthesize effectively a patient support community that augments patient engagement and satisfaction. Copyright © 2017 Elsevier Inc. All rights reserved.

EFFECT OF DANCE EXERCISE ON COGNITIVE FUNCTION IN ELDERLY PATIENTS WITH METABOLIC SYNDROME: A PILOT STUDY

Directory of Open Access Journals (Sweden)

Sang-Wook Song

2011-12-01

Full Text Available Metabolic syndrome is associated with an increased risk of cognitive impairment. The purpose of this prospective pilot study was to examine the effects of dance exercise on cognitive function in elderly patients with metabolic syndrome. The participants included 38 elderly metabolic syndrome patients with normal cognitive function (26 exercise group and 12 control group. The exercise group performed dance exercise twice a week for 6 months. Cognitive function was assessed in all participants using the Korean version of the Consortium to Establish a Registry for Alzheimer's disease (CERAD-K. Repeated-measures ANCOVA was used to assess the effect of dance exercise on cognitive function and cardiometabolic risk factors. Compared with the control group, the exercise group significantly improved in verbal fluency (p = 0.048, word list delayed recall (p = 0.038, word list recognition (p = 0.007, and total CERAD-K score (p = 0.037. However, no significance difference was found in body mass index, blood pressure, waist circumference, fasting plasma glucose, triglyceride, and HDL cholesterol between groups over the 6-month period. In the present study, six months of dance exercise improved cognitive function in older adults with metabolic syndrome. Thus, dance exercise may reduce the risk for cognitive disorders in elderly people with metabolic syndrome.

Application of a ketogenic diet in children with autistic behavior: pilot study.

NARCIS (Netherlands)

Evangeliou, A.; Vlachonikolis, I.; Mihailidou, H.; Spilioti, M.; Skarpalezou, A.; Makaronas, N.; Prokopiou, A.; Christodoulou, P.; Liapi-Adamidou, G.; Helidonis, E.; Sbyrakis, S.; Smeitink, J.A.M.

2003-01-01

A pilot prospective follow-up study of the role of the ketogenic diet was carried out on 30 children, aged between 4 and 10 years, with autistic behavior. The diet was applied for 6 months, with continuous administration for 4 weeks, interrupted by 2-week diet-free intervals. Seven patients could

Decreasing Hospital Readmission in Ileostomy Patients: Results of Novel Pilot Program.

Science.gov (United States)

Shaffer, Virginia O; Owi, Tari; Kumarusamy, Mathu A; Sullivan, Patrick S; Srinivasan, Jahnavi K; Maithel, Shishir K; Staley, Charles A; Sweeney, John F; Esper, Greg

2017-04-01

Nearly 30% of patients with newly formed ileostomies require hospital readmission from severe dehydration or associated complications. This contributes to significant morbidity and rising healthcare costs associated with this procedure. Our aim was to design and pilot a novel program to decrease readmissions in this patient population. An agreement was established with Visiting Nurse Health System (VNHS) in March 2015 that incorporated regular home visits with clinical triggers to institute surgeon-supervised corrective measures aimed at preventing patient decompensation associated with hospital readmissions. Thirty-day readmission data for patients managed with and without VNHS support for 10.5 months before and after implementation of this new program were collected. Of 833 patients with small bowel procedures, 162 were ileostomies with 47 in the VNHS and 115 in the non-VNHS group. Before program implementation, VNHS (n = 24) and non-VNHS patients (n = 54) had similar readmission rates (20.8% vs 16.7%). After implementation, VNHS patients (n = 23) had a 58% reduction in hospital readmission (8.7%) and non-VNHS patient hospital readmissions (n = 61) increased slightly (24.5%). Total cost of readmissions per patient in the cohort decreased by >80% in the pilot VNHS group. Implementation of a novel program reduced the 30-day readmission rate by 58% and cost of readmissions per patient by >80% in a high risk for readmission patient population with newly created ileostomies. Future efforts will expand this program to a greater number of patients, both institutionally and systemically, to reduce the readmission-rate and healthcare costs for this high-risk patient population. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Tandem autotransplant as first-line consolidative treatment in poor-risk aggressive lymphoma: a pilot study of 36 patients.

Science.gov (United States)

Haioun, C; Mounier, N; Quesnel, B; Morel, P; Rieux, C; Beaujean, F; Marolleau, J P; Belhadj, K; Simon, D; Gaulard, P H; Lepage, E; Gisselbrecht, C H; Reyes, F

2001-12-01

In the previous LNH87-2 study, consolidative high-dose therapy followed by stem cell transplantation (HDT) improved disease-free survival, as well as survival for patients (pts) presenting with two or three factors of the age-adjusted international prognostic index (Aa-IPI) in first complete remission (CR). In order to improve further the outcome of such patients, we conducted a pilot study of consolidative tandem autotranplant. Thirty-six patients (pts) under 60 years of age with two or three factors of the Aa-IPI were enrolled. Their main characteristics were: diffuse large B-cell lymphoma (83%), Aa-IPI three factors (50%), and marrow involved (36)%. The procedure consisted of 1) induction with four cycles of ACVBP (doxorubicin, cyclophosphamide, vindesine, bleomycin, prednisone) 2) in responding pts, peripheral blood stem cell (PBSC) collection after the fourth cycle of ACVBP (11 pts) or after an additional mobilization regimen (Cyclophosphamide-VP16) (17 pts) 3) a first HDT (mitoxantrone, cyclophosphamide, VP16 and carmustine) followed by PBSC infusion 4) a second HDT (busulfan, carboplatin and melphalan) followed by PBSC infusion. Among the 29 patients responding to induction, 28 received the first HDTand 24 the second. The rates of three-year-event free survival and survival are 47% (95% confidence interval (95% CI: 31%-63%) and 50% (95% CI: 37%-69%), respectively. Eighteen patients remained free of evolutive disease and 18 patients have died, 15 from disease progression and three from treatment-related toxicity after tandem transplant (two veno-occlusive disease and one cerebral toxoplasmosis). We conclude that tandem transplant did not improve the results of the LNH87-2 study in which patients received a single consolidative HDT.

Direct experience and the course of eating disorders in patients on partial hospitalization: a pilot study.

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Soler, Joaquim; Soriano, José; Ferraz, Liliana; Grasa, Eva; Carmona, Cristina; Portella, Maria J; Seto, Victoria; Alvarez, Enric; Pérez, Víctor

2013-09-01

Awareness of sensory experience in the present moment is central to mindfulness practice. This type of information processing, in contrast to an analytical evaluative style of processing, could be more beneficial for the course of those psychiatric disorders characterized by ruminative and content-centred processing, such as eating disorders (EDs). We performed a pilot study to assess the relation between patients' approach to information processing and the duration and severity of EDs. Fifty-seven patients with a diagnosed ED were included in the study and participated in a self-guided eating activity to asses the primary information processing mode based on mindfulness concepts of 'Direct Experience' and 'Thinking About'. Additionally, dispositional mindfulness was assessed by the Five Factors Mindfulness Questionnaire, and anxiety during the experiment was determined by means of a 10-point visual analogue scale. We found that a higher level of self-reported Direct Experience was inversely associated with several severity variables and with anxiety levels. Direct Experience was predicted by a low anxiety level, less severe illness, and higher scores on one mindfulness facet (Observing). Our results suggest that a Direct Experience processing approach is associated with better ED outcomes. Future studies should be carried out to clarify the repercussion of mindfulness training on EDs. Copyright © 2013 John Wiley & Sons, Ltd and Eating Disorders Association.

Human leukocyte antigen genotypes and trial of desensitization in patients with oxcarbazepine-induced skin rash: a pilot study.

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Lee, Bolyun; Yu, Hee Joon; Kang, Eun-Suk; Lee, Munhyang; Lee, Jeehun

2014-08-01

Skin rash associated with specific antiepileptic drugs occurs not infrequently and it usually necessitates discontinuation of the causative drugs. An alternative strategy is to desensitize the individual to the offending drug. We checked the human leukocyte antigen genotypes and conducted a pilot study to investigate the usefulness and safety of desensitization in pediatric patients with skin rash associated with oxcarbazepine. We enrolled 19 patients with epilepsy who had discontinued oxcarbazepine because of skin rash despite an initial good response and then became refractory to other antiepileptic drugs along with an individual with paroxysmal kinesigenic dyskinesia with a similar situation. High-resolution HLA-A and -B genotyping was performed to investigate the genetic risk. The desensitization began with 0.1 mg daily reaching 120 mg on the thirty-first day. Thereafter, the dose was increased at a rate of 12 mg/day. Nineteen patients completed the desensitization protocol to a target dosage over 2-5 months. Five patients developed itching and erythema during desensitization, but the symptoms disappeared after withholding a dose increment transiently. There were no human leukocyte antigen genotypes relevant to aromatic antiepileptic drug-induced severe hypersensitivity reactions. The seizure frequency was reduced to less than at baseline in 18 individuals. This study demonstrated 95% efficacy, including 42% seizure-free patients and the favorable tolerability of desensitization to oxcarbazepine in patients with intractable epilepsy and one patient with paroxysmal kinesigenic dyskinesia. Screening for sensitive human leukocyte antigen types and exclusion of severe hypersensitivity reactions should precede desensitization. Copyright © 2014 Elsevier Inc. All rights reserved.

Including health economic analysis in pilot studies: lessons learned from a cost-utility analysis within the PROSPECTIV pilot study

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Richéal M. Burns

2017-07-01

Full Text Available PurposeTo assess feasibility and health economic benefits and costs as part of a pilot study for a nurse-led, psychoeducational intervention (NPLI for prostate cancer in order to understand the potential for cost effectiveness as well as contribute to the design of a larger scale trial.MethodsMen with stable prostate cancer post-treatment were recruited from two cancer centres in the UK. Eighty-three men were randomised to the NLPI plus usual care or usual care alone (UCA (42 NLPI and 41 UCA; the NLPI plus usual care was delivered in the primary-care setting (the intervention and included an initial face-to-face consultation with a trained nurse, with follow-up tailored to individual needs. The study afforded the opportunity to undertake a short-term within pilot analysis. The primary outcome measure for the economic evaluation was quality of life, as measured by the EuroQol five dimensions questionnaire (EQ-5D (EQ-5D-5L instrument. Costs (£2014 assessed included health-service resource use, out-of-pocket expenses and losses from inability to undertake usual activities.ResultsTotal and incremental costs varied across the different scenarios assessed, with mean cost differences ranging from £173 to £346; incremental effect, as measured by the change in utility scores over the duration of follow-up, exhibited wide confidence intervals highlighting inconclusive effectiveness (95% CI: -0.0226; 0.0438. The cost per patient of delivery of the intervention would be reduced if rolled out to a larger patient cohort.ConclusionsThe NLPI is potentially cost saving depending on the scale of delivery; however, the results presented are not considered generalisable.

Analgesic efficacy and safety of epidural oxycodone in patients undergoing total hip arthroplasty: a pilot study

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Olczak B

2017-09-01

Full Text Available Bogumił Olczak,1 Grzegorz Kowalski,1,2 Wojciech Leppert,2 Agnieszka Bienert,3 Artur Teżyk,4 Michał Adamski,1 Stanisław Rzymski,1 Katarzyna Wieczorowska-Tobis2 1Department of Anaesthesiology, Józef Struś Multiprofile Municipal Hospital, Poznań, 2Department of Palliative Medicine, 3Department of Clinical Pharmacy and Biopharmacy, 4Department of Forensic Medicine, Poznan University of Medical Sciences, Poznań, Poland Background and objectives: Oxycodone is poorly studied as an adjuvant to central blockades. The aim of this pilot study was to assess the efficacy and safety of oxycodone hydrochloride in epidural blockade among patients undergoing total hip arthroplasty (THA.Patients and methods: In 11 patients (American Society of Anesthesiologists physical status classification system II/III, age range: 59–82 years, THA was conducted with an epidural blockade using 15 mL 0.25% bupivacaine (37.5 mg with 5 mg oxycodone hydrochloride and sedation with propofol infusion at a dose of 3–5 mg/kg/h. After the surgery, patients received ketoprofen at a dose of 100 mg twice daily. In the first 24 hours postoperative period, pain was assessed by numerical rating scale at rest and on movement; adverse effects (AEs were recorded; and plasma concentrations of oxycodone, noroxycodone, and bupivacaine were measured.Results: The administration of epidural oxycodone at a dose of 5 mg in patients undergoing THA provided analgesia for a mean time of 10.3±4.89 h. In one patient, mild pruritus was observed. Oxycodone did not evoke other AEs. Plasma concentrations of oxycodone while preserving analgesia were >2.9 ng/mL. Noroxycodone concentrations in plasma did not guarantee analgesic effect.Conclusion: The administration of epidural oxycodone at a dose of 5 mg prolongs the analgesia period to ~10 hours in patients after THA. Oxycodone may evoke pruritus. A 5 mg dose of oxycodone hydrochloride used in an epidural blockade seems to be a safe drug in patients

The herbal medicine daikenchuto ameliorates an impaired anorectal motor activity in postoperative pediatric patients with an anorectal malformation--a pilot study.

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Takagi, Akiko; Yagi, Minoru; Tanaka, Yoshiaki; Asagiri, Kimio; Asakawa, Takahiro; Tanaka, Hiroaki; Ishii, Shinji; Egami, Hideaki; Akaiwa, Masao; Tsuru, Tomomitsu

2010-01-01

Fecoflowmetry (FFM) has been introduced to simulate natural anorectal evacuation. So far, few reports have described the effect of the herbal medicine Daikenchuto (DKT) on impaired anorectal motor function. The aim of this pilot study was to assess anorectal motor function by FFM in postoperatively impaired patients with an anorectal malformation (ARM) before and after administration of DKT. Six postoperative patients with ARM (mean age, 7.8 years) who complained of intractable constipation with soiling in spite of administration of magnesia as a laxative were assessed over an extended period. These patients received 0.3 g/kg/d of DKT for an average of 128 days. Evacuative rate and maximum fecal stream flow were seen to increase significantly after administration of DKT when compared with values before administration of DKT. In conclusion, DKT had a favorable clinical effect on anorectal motor function in postoperative patients with ARM.

Epilepsy health consumer groups and charities; how representative of patients are they? The results of a pilot study.

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Grinton, M; Leavy, Y; Ahern, D; Hughes, F; Duncan, S

2013-07-01

In the United Kingdom all health care providers are encouraged to consult with user groups. The submissions of charities and patient advocacy groups to NICE and SIGN are considered reflective of the patient groups they purport to represent, yet little is known about how representative they are. This pilot study was designed to ascertain how many patients attending a hospital based epilepsy clinic were members of such advocacy groups. Patients were asked to complete a brief 9-question questionnaire before they left the clinic. One hundred and twenty-five questionnaires were distributed, of which 101 were returned. Seventeen percent of patients were members of advocacy groups, with several being members of more than one charity/group. Only seven percent of the respondents had ever been contacted by an advocacy group to canvass their opinions. Seventy percent of patients questioned stated they thought a frank discussion with their physician, or specialist nurse was more likely to influence patient services. Patients with long duration of disease and taking multiple anti-epileptic drugs were more likely to be members of charity/advocacy groups. As patient charities in the U.K. are often in receipt of public funds, and actively seek to influence public policy this raises the question of whether they should be required to consult more widely with the people they claim to represent. Copyright © 2012 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

The association of patients' oral health literacy and dental school communication tools: a pilot study.

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Tam, Amy; Yue, Olivia; Atchison, Kathryn A; Richards, Jessica K; Holtzman, Jennifer S

2015-05-01

The aim of this pilot study was to assess adult patients' ability to read and understand two communication tools at the University of California, Los Angeles, School of Dentistry: the dental school clinic website and a patient education brochure pertaining to sedation in children that was written by dental school personnel. A convenience sample of 100 adults seeking treatment at the school's general dental clinic during 2012-13 completed a health literacy screening instrument. They were then asked to read clinic educational and informational materials and complete a survey. Analyses were conducted to determine the association between the subjects' oral health literacy and sociodemographics and their ability to locate and interpret information in written oral health information materials. SMOG and Flesch-Kincade formulas were used to assess the readability level of the electronic and written communication tools. The results demonstrated an association between these adults' oral health literacy and their dental knowledge and ability to navigate health information website resources and understand health education materials. Health literacy was not associated with age or gender, but was associated with education and race/ethnicity. The SMOG Readability Index determined that the website and the sedation form were written at a ninth grade reading level. These results suggest that dental schools and other health care organizations should incorporate a health-literate approach for their digital and written materials to enhance patients' ability to navigate and understand health information, regardless of their health literacy.

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

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

2014-03-01

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

Patient safety improvement programmes for primary care. Review of a Delphi procedure and pilot studies by the LINNEAUS collaboration on patient safety in primary care

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Verstappen, Wim; Gaal, Sander; Esmail, Aneez; Wensing, Michel

2015-01-01

ABSTRACT Background: To improve patient safety it is necessary to identify the causes of patient safety incidents, devise solutions and measure the (cost-) effectiveness of improvement efforts. Objective: This paper provides a broad overview with practical guidance on how to improve patient safety. Methods: We used modified online Delphi procedures to reach consensus on methods to improve patient safety and to identify important features of patient safety management in primary care. Two pilot studies were carried out to assess the value of prospective risk analysis (PRA), as a means of identifying the causes of a patient safety incident. Results: A range of different methods can be used to improve patient safety but they have to be contextually specific. Practice organization, culture, diagnostic errors and medication safety were found to be important domains for further improvement. Improvement strategies for patient safety could benefit from insights gained from research on implementation of evidence-based practice. Patient involvement and prospective risk analysis are two promising and innovative strategies for improving patient safety in primary care. Conclusion: A range of methods is available to improve patient safety, but there is no ‘magic bullet.’ Besides better use of the available methods, it is important to use new and potentially more effective strategies, such as prospective risk analysis. PMID:26339837

DNA damage in blood cells in relation to chemotherapy and nutritional status in colorectal cancer patients-A pilot study.

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Kværner, Ane Sørlie; Minaguchi, Jun; Yamani, Naouale El; Henriksen, Christine; Ræder, Hanna; Paur, Ingvild; Henriksen, Hege Berg; Wiedswang, Gro; Smeland, Sigbjørn; Blomhoff, Rune; Collins, Andrew Richard; Bøhn, Siv Kjølsrud

2018-03-01

DNA damage can be considered as a biomarker for toxicity and response to chemotherapy. It is not known whether the chemotherapy-induced genotoxicity is associated with malnutrition. In this pilot study, we assess genotoxicity by means of DNA damage in patients with lymph-node positive colorectal cancer (CRC) and explore associations with chemotherapy treatment and nutritional status. DNA damage was compared between patients receiving chemotherapy (n = 24) and those not receiving chemotherapy (n = 20). DNA damage was measured in frozen whole blood by the comet assay. Associations between DNA damage and various indicators of malnutrition were also explored, including Patient-Generated Subjective Global Assessment (PG-SGA), bioelectrical impedance analysis (BIA) and anthropometric measurements, using multiple linear regression models. Patients on chemotherapy have higher levels of DNA damage in blood cells than patients not receiving chemotherapy (median of 16.9 and 7.9% tail DNA respectively, p = 0.001). The moderately malnourished patients (PG-SGA category B), representing 41% of the patients, have higher levels of cellular DNA damage than patients with good nutritional status (mean difference of 7.5% tail DNA, p = 0.033). In conclusion, adjuvant chemotherapy and malnutrition are both associated with increased levels of DNA damage in blood cells of CRC patients. Carefully controlled longitudinal studies or randomized controlled trials should be performed to determine whether good nutritional status may protect against chemotherapy-induced genotoxicity and enhance compliance to therapy in CRC patients. Copyright © 2018 Elsevier B.V. All rights reserved.

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

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McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for

Quality of life and side effects in patients with actinic keratosis treated with ingenol mebutate: a pilot study.

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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.

Developing and piloting an instrument to prioritize the worries of patients with acute myeloid leukemia

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Bridges JFP

2018-04-01

Full Text Available John FP Bridges,1 Allison H Oakes,1 Crystal A Reinhart,2 Ernest Voyard,3 Bernadette O’Donoghue3 1Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; 2Center for Prevention Research and Development, University of Illinois at Urbana-Champaign, Champaign, IL, USA; 3The Leukemia & Lymphoma Society, Rye Brook, NY, USA Background: Acute myeloid leukemia (AML is a rapidly progressing blood cancer for which new treatments are needed. We sought to promote patient-focused drug development (PFDD for AML by developing and piloting an instrument to prioritize the worries of patients with AML.Patients and methods: An innovative community-centered approach was used to engage expert and community stakeholders in the development, pretesting, pilot testing, and dissemination of a novel best–worst scaling instrument. Patient worries were identified through individual interviews (n=15 and group calls. The instrument was developed through rigorous pretesting (n=13 and then piloted among patients and caregivers engaged in this study (n=25. Priorities were assessed using best–worst scores (spanning from +1 to -1 representing the relative number of times that items were endorsed as the most and the least worrying. All findings were presented at a PFDD meeting at the US Food and Drug Administration (FDA that was attended by >80 stakeholders. Results: The final instrument included 13 worries spanning issues such as decision making, treatment delivery, physical impacts, and psychosocial effects. Patients and caregivers most prioritized worries about dying from their disease (best minus worst [BW] score=0.73, long-term side effects (BW=0.28, and time in hospital (BW=0.25.Conclusion: Community-centered approaches are valuable in designing and executing PFDD meetings and associated quantitative surveys to document the experience of patients. Expert and community stakeholders welcomed the opportunity to share

Centrifuge Study of Pilot Tolerance to Acceleration and the Effects of Acceleration on Pilot Performance

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Creer, Brent Y.; Smedal, Harald A.; Wingrove, Rodney C.

1960-01-01

A research program the general objective of which was to measure the effects of various sustained accelerations on the control performance of pilots, was carried out on the Aviation Medical Acceleration Laboratory centrifuge, U.S. Naval Air Development Center, Johnsville, PA. The experimental setup consisted of a flight simulator with the centrifuge in the control loop. The pilot performed his control tasks while being subjected to acceleration fields such as might be encountered by a forward-facing pilot flying an atmosphere entry vehicle. The study was divided into three phases. In one phase of the program, the pilots were subjected to a variety of sustained linear acceleration forces while controlling vehicles with several different sets of longitudinal dynamics. Here, a randomly moving target was displayed to the pilot on a cathode-ray tube. For each combination of acceleration field and vehicle dynamics, pilot tracking accuracy was measured and pilot opinion of the stability and control characteristics was recorded. Thus, information was obtained on the combined effects of complexity of control task and magnitude and direction of acceleration forces on pilot performance. These tests showed that the pilot's tracking performance deteriorated markedly at accelerations greater than about 4g when controlling a lightly damped vehicle. The tentative conclusion was also reached that regardless of the airframe dynamics involved, the pilot feels that in order to have the same level of control over the vehicle, an increase in the vehicle dynamic stability was required with increases in the magnitudes of the acceleration impressed upon the pilot. In another phase, boundaries of human tolerance of acceleration were established for acceleration fields such as might be encountered by a pilot flying an orbital vehicle. A special pilot restraint system was developed to increase human tolerance to longitudinal decelerations. The results of the tests showed that human tolerance

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

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Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

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

Clinical predictors of dengue fever co-infected with leptospirosis among patients admitted for dengue fever - a pilot study.

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Suppiah, Jeyanthi; Chan, Shie-Yien; Ng, Min-Wern; Khaw, Yam-Sim; Ching, Siew-Mooi; Mat-Nor, Lailatul Akmar; Ahmad-Najimudin, Naematul Ain; Chee, Hui-Yee

2017-06-28

Dengue and leptospirosis infections are currently two major endemics in Malaysia. Owing to the overlapping clinical symptoms between both the diseases, frequent misdiagnosis and confusion of treatment occurs. As a solution, the present work initiated a pilot study to investigate the incidence related to co-infection of leptospirosis among dengue patients. This enables the identification of more parameters to predict the occurrence of co-infection. Two hundred sixty eight serum specimens collected from patients that were diagnosed for dengue fever were confirmed for dengue virus serotyping by real-time polymerase chain reaction. Clinical, laboratory and demographic data were extracted from the hospital database to identify patients with confirmed leptospirosis infection among the dengue patients. Thus, frequency of co-infection was calculated and association of the dataset with dengue-leptospirosis co-infection was statistically determined. The frequency of dengue co-infection with leptospirosis was 4.1%. Male has higher preponderance of developing the co-infection and end result of shock as clinical symptom is more likely present among co-infected cases. It is also noteworthy that, DENV 1 is the common dengue serotype among all cases identified as dengue-leptospirosis co-infection in this study. The increasing incidence of leptospirosis among dengue infected patients has posed the need to precisely identify the presence of co-infection for the betterment of treatment without mistakenly ruling out either one of them. Thus, anticipating the possible clinical symptoms and laboratory results of dengue-leptospirosis co-infection is essential.

Short-term cognitive behavioral partial hospital treatment: a pilot study.

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Neuhaus, Edmund C; Christopher, Michael; Jacob, Karen; Guillaumot, Julien; Burns, James P

2007-09-01

Brief, cost-contained, and effective psychiatric treatments benefit patients and public health. This naturalistic pilot study examined the effectiveness of a 2-week, cognitive-behavioral therapy (CBT) oriented partial hospital program. Study participants were 57 patients with mood, anxiety, and/or personality disorders receiving treatment in a private psychiatric partial hospital (PH) setting. A flexible treatment model was used that adapts evidence-based CBT treatment interventions to the PH context with emphases on psychoeducation and skills training. Participants completed self-report measures at admission and after 1 and 2 weeks, to assess stabilization and functional improvements, with added attention to the acquisition of cognitive and behavioral skills. The data were analyzed using repeated measures analyses of variance and correlation. Participants reported a decrease in symptoms and negative thought patterns, improved satisfaction with life, and acquisition and use of cognitive and behavioral skills. Skill acquisition was correlated with symptom reduction, reduced negative thought patterns, and improved satisfaction with life. Results of this pilot study suggest that a 2-week PH program can be effective for a heterogeneous patient population with mood, anxiety, and/or personality disorders. These findings are promising given the prevalence of treatments of such brief duration in private sector PH programs subject to the managed care marketplace. Future studies are planned to test this flexible PH treatment model, with particular attention to the effectiveness of the CBT approach for the treatment of different disorders and to whether effectiveness is sustained at follow-up. Further study should also examine whether skill acquisition is a mechanism of change for symptom reduction and functional improvements.

Using tablet-based technology in patient education about systemic therapy options for early-stage breast cancer: a pilot study.

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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.

Recall of intensive care unit stay in patients managed with a sedation protocol or a sedation protocol with daily sedative interruption: a pilot study.

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Ethier, Cheryl; Burry, Lisa; Martinez-Motta, Carlos; Tirgari, Sam; Jiang, Depeng; McDonald, Ellen; Granton, John; Cook, Deborah; Mehta, Sangeeta

2011-04-01

Analgesics and sedatives are integral for the relief of pain and anxiety in critically ill patients. However, these agents may contribute to amnesia for intensive care unit (ICU) events; which has been associated with development of posttraumatic stress disorder. Drug administration strategies that minimize sedative use have been associated with less amnesia. The objective of this pilot study was to evaluate recall of ICU stay in patients managed with 2 sedation strategies: a sedation protocol or a combination of sedation protocol and daily sedative/analgesic interruption. A questionnaire was administered on day 3 following ICU discharge to evaluate patients' recollections of pain, anxiety, fear, and sleep, as well as memories for specific ICU procedures. Participants were ICU survivors who had been enrolled in SLEAP - a randomized pilot trial comparing two sedation strategies, at 3 university-affiliated medical/surgical ICUs. Twenty-one patients who regained orientation within 72 hours of ICU discharge completed the questionnaire. More than 50% of patients recalled experiencing pain, anxiety, and fear to a moderate or extreme extent; and 57% reported inadequate sleep while in the ICU. Of the 21 patients, 48%, 33%, and 29% had no memories of endotracheal tube suctioning, being on a "breathing machine," and being bathed, respectively. A notable percentage of patients discharged from the ICU report moderate to extreme pain, anxiety, and fear, and inability to sleep during their ICU stay; and 29% to 48% have no recall of specific ICU events. Copyright © 2011 Elsevier Inc. All rights reserved.

Adjuvant interferon gamma in patients with drug – resistant pulmonary tuberculosis: a pilot study

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Carbonell Dalia

2004-10-01

Full Text Available Abstract Background Tuberculosis (TB is increasing in the world and drug-resistant (DR disease beckons new treatments. Methods To evaluate the action of interferon (IFN gamma as immunoadjuvant to chemotherapy on pulmonary DR-TB patients, a pilot, open label clinical trial was carried out in the Cuban reference ward for the management of this disease. The eight subjects existing in the country at the moment received, as in-patients, 1 × 106 IU of recombinant human IFN gamma intramuscularly, daily for one month and then three times per week up to 6 months as adjuvant to the indicated chemotherapy, according to their antibiograms and WHO guidelines. Sputum samples collection for direct smear observation and culture as well as routine clinical and thorax radiography assessments were done monthly. Results Sputum smears and cultures became negative for acid-fast-bacilli before three months of treatment in all patients. Lesion size was reduced at the end of 6 months treatment; the lesions disappeared in one case. Clinical improvement was also evident; body mass index increased in general. Interferon gamma was well tolerated. Few adverse events were registered, mostly mild; fever and arthralgias prevailed. Conclusions These data suggest that IFN gamma is useful and well tolerated as adjunctive therapy in patients with DR-TB. Further controlled clinical trials are encouraged.

Quality of Life and Neutropenia in Patients with Early Stage Breast Cancer: A Randomized Pilot Study Comparing Additional Treatment with Mistletoe Extract to Chemotherapy Alone

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Wilfried Tröger

2009-01-01

Full Text Available Background: Chemotherapy for breast cancer often deteriorates quality of life, augments fatigue, and induces neutropenia. Mistletoe preparations are frequently used by cancer patients in Central Europe. Physicians have reported better quality of life in breast cancer patients additionally treated with mistletoe preparations during chemotherapy. Mistletoe preparations also have immunostimulant properties and might therefore have protective effects against chemotherapy-induced neutropenia.Patients and Methods: We conducted a prospective randomized open label pilot study with 95 patients randomized into three groups. Two groups received Iscador® M special (IMS or a different mistletoe preparation, respectively, additionally to chemotherapy with six cycles of cyclophosphamide, adriamycin, and 5-fluoro-uracil (CAF. A control group received CAF with no additional therapy. Here we report the comparison IMS (n = 30 vs. control (n = 31. Quality of life including fatigue was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30. Neutropenia was defined as neutrophil counts <1,000/µl and assessed at baseline and one day before each CAF cycle.Results: In the descriptive analysis all 15 scores of the EORTC-QLQ-C30 showed better quality of life in the IMS group compared to the control group. In 12 scores the differences were significant (p < 0.02 and nine scores showed a clinically relevant and significant difference of at least 5 points. Neutropenia occurred in 3/30 IMS patients and in 8/31 control patients (p = 0.182.Conclusions: This pilot study showed an improvement of quality of life by treating breast cancer patients with IMS additionally to CAF. CAF-induced neutropenia showed a trend to lower frequency in the IMS group.

Plasma Metabolites Predict Severity of Depression and Suicidal Ideation in Psychiatric Patients-A Multicenter Pilot Analysis.

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Setoyama, Daiki; Kato, Takahiro A; Hashimoto, Ryota; Kunugi, Hiroshi; Hattori, Kotaro; Hayakawa, Kohei; Sato-Kasai, Mina; Shimokawa, Norihiro; Kaneko, Sachie; Yoshida, Sumiko; Goto, Yu-Ichi; Yasuda, Yuka; Yamamori, Hidenaga; Ohgidani, Masahiro; Sagata, Noriaki; Miura, Daisuke; Kang, Dongchon; Kanba, Shigenobu

2016-01-01

Evaluating the severity of depression (SOD), especially suicidal ideation (SI), is crucial in the treatment of not only patients with mood disorders but also psychiatric patients in general. SOD has been assessed on interviews such as the Hamilton Rating Scale for Depression (HAMD)-17, and/or self-administered questionnaires such as the Patient Health Questionnaire (PHQ)-9. However, these evaluation systems have relied on a person's subjective information, which sometimes lead to difficulties in clinical settings. To resolve this limitation, a more objective SOD evaluation system is needed. Herein, we collected clinical data including HAMD-17/PHQ-9 and blood plasma of psychiatric patients from three independent clinical centers. We performed metabolome analysis of blood plasma using liquid chromatography mass spectrometry (LC-MS), and 123 metabolites were detected. Interestingly, five plasma metabolites (3-hydroxybutyrate (3HB), betaine, citrate, creatinine, and gamma-aminobutyric acid (GABA)) are commonly associated with SOD in all three independent cohort sets regardless of the presence or absence of medication and diagnostic difference. In addition, we have shown several metabolites are independently associated with sub-symptoms of depression including SI. We successfully created a classification model to discriminate depressive patients with or without SI by machine learning technique. Finally, we produced a pilot algorithm to predict a grade of SI with citrate and kynurenine. The above metabolites may have strongly been associated with the underlying novel biological pathophysiology of SOD. We should explore the biological impact of these metabolites on depressive symptoms by utilizing a cross species study model with human and rodents. The present multicenter pilot study offers a potential utility for measuring blood metabolites as a novel objective tool for not only assessing SOD but also evaluating therapeutic efficacy in clinical practice. In addition

Plasma Metabolites Predict Severity of Depression and Suicidal Ideation in Psychiatric Patients-A Multicenter Pilot Analysis.

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Daiki Setoyama

Full Text Available Evaluating the severity of depression (SOD, especially suicidal ideation (SI, is crucial in the treatment of not only patients with mood disorders but also psychiatric patients in general. SOD has been assessed on interviews such as the Hamilton Rating Scale for Depression (HAMD-17, and/or self-administered questionnaires such as the Patient Health Questionnaire (PHQ-9. However, these evaluation systems have relied on a person's subjective information, which sometimes lead to difficulties in clinical settings. To resolve this limitation, a more objective SOD evaluation system is needed. Herein, we collected clinical data including HAMD-17/PHQ-9 and blood plasma of psychiatric patients from three independent clinical centers. We performed metabolome analysis of blood plasma using liquid chromatography mass spectrometry (LC-MS, and 123 metabolites were detected. Interestingly, five plasma metabolites (3-hydroxybutyrate (3HB, betaine, citrate, creatinine, and gamma-aminobutyric acid (GABA are commonly associated with SOD in all three independent cohort sets regardless of the presence or absence of medication and diagnostic difference. In addition, we have shown several metabolites are independently associated with sub-symptoms of depression including SI. We successfully created a classification model to discriminate depressive patients with or without SI by machine learning technique. Finally, we produced a pilot algorithm to predict a grade of SI with citrate and kynurenine. The above metabolites may have strongly been associated with the underlying novel biological pathophysiology of SOD. We should explore the biological impact of these metabolites on depressive symptoms by utilizing a cross species study model with human and rodents. The present multicenter pilot study offers a potential utility for measuring blood metabolites as a novel objective tool for not only assessing SOD but also evaluating therapeutic efficacy in clinical practice. In

Gas emission during laparoscopic colorectal surgery using a bipolar vessel sealing device: A pilot study on four patients

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Gianella Michele

2008-09-01

Full Text Available Abstract Background Dissection during laparoscopic surgery produces smoke containing potentially toxic substances. The aim of the present study was to analyze smoke samples produced during laparoscopic colon surgery using a bipolar vessel sealing device (LigaSure™. Methods Four consecutive patients undergoing left-sided colectomy were enrolled in this pilot study. Smoke was produced by the use of LigaSure™. Samples (5,5l were evacuated from the pneumoperitoneum in a closed system into a reservoir. Analysis was performed with CO2-laser-based photoacoustic spectroscopy and confirmed by a Fourier-transform infrared spectrum. The detected spectra were compared to the available spectra of known toxins. Results Samples from four laparoscopic sigmoid resections were analyzed. No relevant differences were noted regarding patient and operation characteristics. The gas samples were stable over time proven by congruent control measurements as late as 24 h after sampling. The absorption spectra differed considerably between the patients. One broad absorption line at 100 ppm indicating H2O and several unknown molecules were detected. With a sensitivity of alpha min ca 10-5 cm-1 no known toxic substances like phenol or indole were identified. Conclusion The use of a vessel sealing device during laparoscopic surgery does not produce known toxic substances in relevant quantity. Further studies are needed to identify unknown molecules and to analyze gas emission under various conditions.

A mixed method pilot study: the researchers' experiences.

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Secomb, Jacinta M; Smith, Colleen

2011-08-01

This paper reports on the outcomes of a small well designed pilot study. Pilot studies often disseminate limited or statistically meaningless results without adding to the body knowledge on the comparative research benefits. The design a pre-test post-test group parallel randomised control trial and inductive content analysis of focus group transcripts was tested specifically to increase outcomes in a proposed larger study. Strategies are now in place to overcome operational barriers and recruitment difficulties. Links between the qualitative and quantitative arms of the proposed larger study have been made; it is anticipated that this will add depth to the final report. More extensive reporting on the outcomes of pilot studies would assist researchers and increase the body of knowledge in this area.

Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study

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Stefan Wirz

2017-01-01

Full Text Available Background. Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. Methods. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group (n=43, opioids dispensed by nurses, and a test group (n=27, opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. Results. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group (P value < 0.05. The test group took 67% more pills than the control group, indicating enhanced compliance. Pain scores were significantly lower for patients in the test group (P value < 0.05. Over 90% of PCoA Acute users were satisfied with its use. Conclusions. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

Adjustable recessions in horizontal comitant strabismus: A pilot study

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Siddharth Agrawal

2015-01-01

Full Text Available Aim: To compare the surgical outcome of adjustable with the conventional recession in patients with horizontal comitant strabismus. Patients and Methods: A prospective comparative nonrandomized interventional pilot study was performed on patients with horizontal comitant strabismus. Fifty-four patients (27 in each group were allocated into 2 groups to undergo either adjustable suture (AS recession or non-AS (NAS recession along with conventional resection. The patients were followed up for 6 months. A successful outcome was defined as deviation ±10 prism diopters at 6 months. The results were statistically analyzed by Chi-square test, Fisher′s exact test, and Student′s t-test. Results: A successful outcome was found in 24 (88.8% patients in AS and 17 (62.9% in NAS group (P = 0.02. The postoperative adjustment was done in 13 (48.1% patients in AS group. There was one complication (tenon′s cyst in AS group. Conclusion: AS recession may be considered in all cooperative patients undergoing strabismus surgery for comitant deviations.

High-risk human papillomavirus (HPV screening and detection in healthy patient saliva samples: a pilot study

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Wang Robert C

2011-10-01

Full Text Available Abstract Background The human papillomaviruses (HPV are a large family of non-enveloped DNA viruses, mainly associated with cervical cancers. Recent epidemiologic evidence has suggested that HPV may be an independent risk factor for oropharyngeal cancers. Evidence now suggests HPV may modulate the malignancy process in some tobacco- and alcohol-induced oropharynx tumors, but might also be the primary oncogenic factor for inducing carcinogenesis among some non-smokers. More evidence, however, is needed regarding oral HPV prevalence among healthy adults to estimate risk. The goal of this study was to perform an HPV screening of normal healthy adults to assess oral HPV prevalence. Methods Healthy adult patients at a US dental school were selected to participate in this pilot study. DNA was isolated from saliva samples and screened for high-risk HPV strains HPV16 and HPV18 and further processed using qPCR for quantification and to confirm analytical sensitivity and specificity. Results Chi-square analysis revealed the patient sample was representative of the general clinic population with respect to gender, race and age (p Conclusions The successful recruitment and screening of healthy adult patients revealed HPV16, but not HPV18, was present in a small subset. These results provide new information about oral HPV status, which may help to contextualize results from other studies that demonstrate oral cancer rates have risen in the US among both females and minorities and in some geographic areas that are not solely explained by rates of tobacco and alcohol use. The results of this study may be of significant value to further our understanding of oral health and disease risk, as well as to help design future studies exploring the role of other factors that influence oral HPV exposure, as well as the short- and long-term consequences of oral HPV infection.

Osteopathic manipulative treatment results in sustained relief from spinal pain in older patients: A pilot crossover study

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Pannunzio A

2016-01-01

Full Text Available Osteopathic Manipulative Treatment is commonly used to complement conventional treatment of back pain. The present study verified whether OMT, associated with training program, reduces spinal pain in older. A pilot randomized, double-blind crossover study was conducted at Sport Association of Milan, Italy. We recruited 19 subjects above 60 years old, with presence of SP for more than 3 weeks and with intensity score higher than 3 (NRS score. All patients underwent a multi-component group exercise program for older adults and were randomized in two groups: in the study group (SG OMT was added, while the control group (CG continued with the exercise only. After 6 weeks a crossover was applied to the 2 groups and OMT was added to CG, while SG continued with the exercise only. Self-reported measures: the Numeric Rating Scale (NRS was used at each time to evaluate treatment outcomes. At pre-crossover, SG had a significant improvement in pain perception (p<0.05, while CG had a not significate improvement in pain perception (p=0.33.At post-crossover, the SG remains relatively stable (p=0.37, while CG after OMT addition have a significant benefit on pain perception (p=0.001. At follow-up, pain improvement is sustained (p=0.32. OMT associated to exercise reduce spinal pain in older patients. Our study suggests that OMT associated to exercise leads to significant improvement on pain relief in patients with chronic SP in a short term and the exercise allows to maintain these improvements for several months

The Efficacy of Functional Electrical Stimulation of the Abdominal Muscles in the Treatment of Chronic Constipation in Patients with Multiple Sclerosis: A Pilot Study

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Christine Singleton

2016-01-01

Full Text Available Chronic constipation in patients with multiple sclerosis (MS is common and the current methods of treatment are ineffective in some patients. Anecdotal observations suggest that functional electrical stimulation (FES of the abdominal muscles may be effective in the management of constipation in these patients. Patients and Methods. In this exploratory investigation we studied the effects of FES on the whole gut transit time (WGTT and the colonic transit time (CTT. In addition, we evaluated the treatment effect on the patients’ constipation-related quality of life and on the use of laxatives and the use of manual bowel evacuation. FES was given for 30 minutes twice a day for a period of six weeks. Four female patients were studied. Results. The WGTT and CTT and constipation-related quality of life improved in all patients. The patients’ use of laxatives was reduced. No adverse effects of FES treatment were reported. Conclusion. The findings of this pilot study suggest that FES applied to the abdominal muscles may be an effective treatment modality for severe chronic constipation in patients with MS.

Dietary Interventions in Multiple Sclerosis: Development and Pilot-Testing of an Evidence Based Patient Education Program.

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Riemann-Lorenz, Karin; Eilers, Marlene; von Geldern, Gloria; Schulz, Karl-Heinz; Köpke, Sascha; Heesen, Christoph

2016-01-01

Dietary factors have been discussed to influence risk or disease course of multiple sclerosis (MS). Specific diets are widely used among patients with MS. To design and pilot-test an evidence based patient education program on dietary factors in MS. We performed a systematic literature search on the effectiveness of dietary interventions in MS. A web-based survey among 337 patients with MS and 136 healthy controls assessed knowledge, dietary habits and information needs. An interactive group education program was developed and pilot-tested. Fifteen randomised-controlled trials (RCTs) were included in the systematic review. Quality of evidence was low and no clear benefit could be seen. Patients with MS significantly more often adhered to a `Mediterranean Diet`(29.7% versus 14.0%, ppilot test of our newly developed patient education program with 13 participants showed excellent comprehensibility and the MS-specific content was judged as very important. However, the poor evidence base for dietary approaches in MS was perceived disappointing. Development and pilot-testing of an evidence-based patient education program on nutrition and MS is feasible. Patient satisfaction with the program suffers from the lack of evidence. Further research should focus on generating evidence for the potential influence of lifestyle habits (diet, physical activity) on MS disease course thus meeting the needs of patients with MS.

SUPERFUND TREATABILITY CLEARINGHOUSE: SOIL STABILIZATION PILOT STUDY, UNITED CHROME NPL SITE PILOT STUDY AND HEALTH AND SAFETY PROGRAM, UNITED CHROME NPL SITE PILOT STUDY

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This document is a project plan for a pilot study at the United Chrome NPL site, Corvallis, Oregon and includes the health and safety and quality assurance/quality control plans. The plan reports results of a bench-scale study of the treatment process as iieasured by the ...

Barriers to physical activity in chronic hemodialysis patients: a single-center pilot study in an Italian dialysis facility.

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Fiaccadori, Enrico; Sabatino, Alice; Schito, Franco; Angella, Francesca; Malagoli, Martina; Tucci, Marco; Cupisti, Adamasco; Capitanini, Alessandro; Regolisti, Giuseppe

2014-01-01

In patients on chronic dialysis a sedentary lifestyle is a strong, yet potentially modifiable, predictor of mortality. The present single-center pilot study evaluated social, psychological and clinical barriers that may hinder physical activity in this population. We explored the association between barriers to physical activity and sedentarism in adult patients at a chronic dialysis facility in Parma, Italy. We used different questionnaries exploring participation in physical activity, physical functioning, patient attitudes and preferences, and barriers to physical activity perceived by either patients or dialysis doctors and nurses. We enrolled 104 patients, (67 males, 65%), mean age 69 years (79% of patients older than 60 years); median dialysis vintage 60 months (range 8-440); mean Charlson score 5.55, ADL (Activities of Daily Living) score 5.5. Ninety-two participants (88.5%) reported at least one barrier to physical activity. At multivariable analysis, after adjusting for age and sex, feeling to have too many medical problems (OR 2.99, 95% CI 1.27 to 7.07; P=0.012), chest pain (OR 10.78, 95% CI 1.28 to 90.28; P=0.029) and sadness (OR 2.59, 95% CI 1.10 to 6.09; P=0.030) were independently associated with physical inactivity. Lack of time for exercise counseling and the firm belief about low compliance/interest by the patients toward exercise were the most frequent barriers reported by doctors and nurses. We identified a number of patient-related and health personnel-related barriers to physical activity in patients on chronic dialysis. Solutions for these barriers should be addressed in future studies aimed at increasing the level of physical activity in this population. © 2014 S. Karger AG, Basel.

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

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Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned.

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Forsythe, Laura P; Ellis, Lauren E; Edmundson, Lauren; Sabharwal, Raj; Rein, Alison; Konopka, Kristen; Frank, Lori

2016-01-01

Patients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact. We aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned. A self-report instrument was completed by researchers between 6 and 12 months following project initiation. Forty-seven principal investigators or their designees (94 % response rate) participated in the study. MAIN MEASURES Self-report of types of stakeholders engaged, stages and levels of engagement, facilitators and barriers to engagement, lessons learned, and contributions from engagement were measured. Most (83 %) reported engaging more than one stakeholder in their project. Among those, the most commonly reported groups were patients (90 %), clinicians (87 %), health system representatives (44 %), caregivers (41 %), and advocacy organizations (41 %). Stakeholders were commonly involved in topic solicitation, question development, study design, and data collection. Many projects engaged stakeholders in data analysis, results interpretation, and dissemination. Commonly reported contributions included changes to project methods, outcomes or goals; improvement of measurement tools; and interpretation of qualitative data. Investigators often identified communication and shared leadership strategies as "critically important" facilitators (53 and 44 % respectively); lack of stakeholder time was the most commonly reported challenge (46 %). Most challenges were only partially resolved. Early lessons learned included the importance of continuous and genuine partnerships, strategic selection of stakeholders, and accommodation of stakeholders' practical needs. PCORI Pilot Projects investigators report engaging a variety of stakeholders across many stages of research, with specific

Rural patients' access to mobile phones and willingness to receive mobile phone-based pharmacy and other health technology services: a pilot study.

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Sankaranarayanan, Jayashri; Sallach, Rory E

2014-02-01

This pilot study explores the patient-centered demand for mobile phone-based health (mobile health [m-health]) services in the rural United States by documenting rural patients' access to mobile phones and patients' willingness to receive m-health services. An anonymous institutional review board-approved survey was completed by patients visiting two rural pharmacies in Nebraska from August to October 2011. Patients who volunteered to complete the survey provided their demographic data, disease state information, health status, mobile phone access, and willingness to receive (in terms of using and giving time to) m-health services. The majority of the 24 survey respondents were 19-40 years old (52%), female (88%), married (63%), with excellent to very good health status (63%), with no comorbidities (83%), with ≤$100 monthly medication expenses (80%), with private insurance (78%), living within 5 miles of their pharmacy (71%), and reporting that m-health services are important to them (75%; 12/16). Approximately 95%, 81%, 73%, and 55% of respondents reported access to a mobile phone, voice mails, text messaging, and mobile phone applications, respectively. Of the respondents, 65%, 57%, 52%, and 48% were willing to receive prerecorded messages for appointment reminders from the doctor, disease information, medication use/self-care information, and symptom monitoring information, respectively. In total, 70%, 63%, 61%, 54%, and 50% were willing to receive prerecorded messages from the pharmacist containing contact requests, new/refill prescription reminders, information on medication problems, reviewing/monitoring of medication use, and medication self-management/preventive screenings/immunizations, respectively. Of 44% (7/16) respondents willing to give time for m-health services, 83% were willing to give 15 min, and 17% were willing to give 30 min every month. By demonstrating rural patients' demand for m-health (including pharmacy) services, this is one of the

Perceived outcomes of music therapy with Body Tambura in end of life care - a qualitative pilot study.

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Teut, Michael; Dietrich, Cordula; Deutz, Bernhard; Mittring, Nadine; Witt, Claudia M

2014-04-07

In recent years, music therapy is increasingly used in palliative care. The aim of this pilot study was to record and describe the subjective experiences of patients and their relatives undergoing music therapy with a Body Tambura in a German hospice and to develop hypotheses for future studies. In a qualitative interview pilot study, data collection and analyses were performed according to the methodological framework of grounded theory. We included German-speaking patients, or relatives of patients, receiving end of life care in an inpatient hospice setting. 11 persons consisting of 8 patients (age range 51-82 years, 4 male and 4 female) and 3 relatives were treated and interviewed. All patients suffered from cancer in an advanced stage. The most often described subjective experiences were a relaxing and calming effect, sensations that the body feels lighter, and the generation of relaxing images and visualizations. Family members enjoyed listening to the music and felt more connected with the sick family member. Patient reported beneficial aspects. The small sample size could be seen as a limitation. Assessment instruments measuring relaxation, stress, quality of life and should be included in future quantitative studies.

Validity of a simple Internet-based outcome-prediction tool in patients with total hip replacement: a pilot study.

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Stöckli, Cornel; Theiler, Robert; Sidelnikov, Eduard; Balsiger, Maria; Ferrari, Stephen M; Buchzig, Beatus; Uehlinger, Kurt; Riniker, Christoph; Bischoff-Ferrari, Heike A

2014-04-01

We developed a user-friendly Internet-based tool for patients undergoing total hip replacement (THR) due to osteoarthritis to predict their pain and function after surgery. In the first step, the key questions were identified by statistical modelling in a data set of 375 patients undergoing THR. Based on multiple regression, we identified the two most predictive WOMAC questions for pain and the three most predictive WOMAC questions for functional outcome, while controlling for comorbidity, body mass index, age, gender and specific comorbidities relevant to the outcome. In the second step, a pilot study was performed to validate the resulting tool against the full WOMAC questionnaire among 108 patients undergoing THR. The mean difference between observed (WOMAC) and model-predicted value was -1.1 points (95% confidence interval, CI -3.8, 1.5) for pain and -2.5 points (95% CI -5.3, 0.3) for function. The model-predicted value was within 20% of the observed value in 48% of cases for pain and in 57% of cases for function. The tool demonstrated moderate validity, but performed weakly for patients with extreme levels of pain and extreme functional limitations at 3 months post surgery. This may have been partly due to early complications after surgery. However, the outcome-prediction tool may be useful in helping patients to become better informed about the realistic outcome of their THR.

Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study.

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Holthoff, Vjera A; Marschner, Kira; Scharf, Maria; Steding, Julius; Meyer, Shirin; Koch, Rainer; Donix, Markus

2015-01-01

There is evidence that physical activity (PA) is of cognitive benefit to the ageing brain, but little is known on the effect in patients with Alzheimer's disease (AD). The present pilot study assessed the effect of a home-based PA training on clinical symptoms, functional abilities, and caregiver burden after 12 and 24 weeks. In an RCT thirty patients (aged 72.4±4.3 years) with AD (MMSE: 20.6±6.5 points) and their family caregivers were allocated to a home-based 12-week PA intervention program or the usual care group. The program changed between passive, motor-assisted or active resistive leg training and changes in direction on a movement trainer in order to combine physical and cognitive stimuli. Analysis of activities of daily living in the patients (ADCS ADL total score) revealed a significant group × time interaction effect (95% CI of the difference between both groups at T2: 5.01-10.51). The control group experienced decreases in ADL performance at week 12 and 24 whereas patients in the intervention group remained stable. Analyses of executive function and language ability revealed considerable effects for semantic word fluency with a group × time interaction (95% CI of the difference between both groups at T2: 0.18-4.02). Patients in the intervention group improved during the intervention and returned to initial performance at week 12 whereas the controls revealed continuous worsening. Analyses of reaction time, hand-eye quickness and attention revealed improvement only in the intervention group. Caregiver burden remained stable in the intervention group but worsened in the control group. This study suggests that PA in a home-based setting might be an effective and intrinsically attractive way to promote PA training in AD and modulate caregiver burden. The results demonstrate transfer benefits to ADL, cognitive and physical skill in patients with AD. ClinicalTrials.gov NCT02196545.

Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study.

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Vjera A Holthoff

Full Text Available There is evidence that physical activity (PA is of cognitive benefit to the ageing brain, but little is known on the effect in patients with Alzheimer's disease (AD. The present pilot study assessed the effect of a home-based PA training on clinical symptoms, functional abilities, and caregiver burden after 12 and 24 weeks.In an RCT thirty patients (aged 72.4±4.3 years with AD (MMSE: 20.6±6.5 points and their family caregivers were allocated to a home-based 12-week PA intervention program or the usual care group. The program changed between passive, motor-assisted or active resistive leg training and changes in direction on a movement trainer in order to combine physical and cognitive stimuli.Analysis of activities of daily living in the patients (ADCS ADL total score revealed a significant group × time interaction effect (95% CI of the difference between both groups at T2: 5.01-10.51. The control group experienced decreases in ADL performance at week 12 and 24 whereas patients in the intervention group remained stable. Analyses of executive function and language ability revealed considerable effects for semantic word fluency with a group × time interaction (95% CI of the difference between both groups at T2: 0.18-4.02. Patients in the intervention group improved during the intervention and returned to initial performance at week 12 whereas the controls revealed continuous worsening. Analyses of reaction time, hand-eye quickness and attention revealed improvement only in the intervention group. Caregiver burden remained stable in the intervention group but worsened in the control group.This study suggests that PA in a home-based setting might be an effective and intrinsically attractive way to promote PA training in AD and modulate caregiver burden. The results demonstrate transfer benefits to ADL, cognitive and physical skill in patients with AD.ClinicalTrials.gov NCT02196545.

Little effect of praziquantel or artemisinin on clonorchiasis in Northern Vietnam. A pilot study

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Tinga, N.; de, N.; Vien, H. V.; Chau, L.; Toan, N. D.; Kager, P. A.; Vries, P. J.

1999-01-01

The first choice for treatment of Clonorchis sinensis infections is praziquantel. Experimental data suggest that artemisinin derivatives are active against C. sinensis. The efficacy of both drugs against clonorchiasis was evaluated in a pilot study in clonorchiasis patients in an endemic area in the

How to Train an Injured Brain? A Pilot Feasibility Study of Home-Based Computerized Cognitive Training.

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Verhelst, Helena; Vander Linden, Catharine; Vingerhoets, Guy; Caeyenberghs, Karen

2017-02-01

Computerized cognitive training programs have previously shown to be effective in improving cognitive abilities in patients suffering from traumatic brain injury (TBI). These studies often focused on a single cognitive function or required expensive hardware, making it difficult to be used in a home-based environment. This pilot feasibility study aimed to evaluate the feasibility of a newly developed, home-based, computerized cognitive training program for adolescents who suffered from TBI. Additionally, feasibility of study design, procedures, and measurements were examined. Case series, longitudinal, pilot, feasibility intervention study with one baseline and two follow-up assessments. Nine feasibility outcome measures and criteria for success were defined, including accessibility, training motivation/user experience, technical smoothness, training compliance, participation willingness, participation rates, loss to follow-up, assessment timescale, and assessment procedures. Five adolescent patients (four boys, mean age = 16 years 7 months, standard deviation = 9 months) with moderate to severe TBI in the chronic stage were recruited and received 8 weeks of cognitive training with BrainGames. Effect sizes (Cohen's d) were calculated to determine possible training-related effects. The new cognitive training intervention, BrainGames, and study design and procedures proved to be feasible; all nine feasibility outcome criteria were met during this pilot feasibility study. Estimates of effect sizes showed small to very large effects on cognitive measures and questionnaires, which were retained after 6 months. Our pilot study shows that a longitudinal intervention study comprising our novel, computerized cognitive training program and two follow-up assessments is feasible in adolescents suffering from TBI in the chronic stage. Future studies with larger sample sizes will evaluate training-related effects on cognitive functions and underlying brain structures.

Cognitive rehabilitation training in patients with brain tumor-related epilepsy and cognitive deficits: a pilot study.

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Maschio, Marta; Dinapoli, Loredana; Fabi, Alessandra; Giannarelli, Diana; Cantelmi, Tonino

2015-11-01

The aim of this pilot observational study was to evaluate effect of cognitive rehabilitation training (RehabTr) on cognitive performances in patients with brain tumor-related epilepsy (BTRE) and cognitive disturbances. Medical inclusion criteria: patients (M/F) ≥ 18 years ≤ 75 with symptomatic seizures due to primary brain tumors or brain metastases in stable treatment with antiepileptic drugs; previous surgical resection or biopsy; >70 Karnofsky Performance Status; stable oncological disease. Eligible patients recruited from 100 consecutive patients with BTRE at first visit to our Center from 2011 to 2012. All recruited patients were administered battery of neuropsychological tests exploring various cognitive domains. Patients considered to have a neuropsychological deficit were those with at least one test score for a given domain indicative of impairment. Thirty patients out of 100 showed cognitive deficits, and were offered participation in RehabTr, of which 16 accepted (5 low grade glioma, 4 high grade glioma, 2 glioblastoma, 2 meningioma and 3 metastases) and 14 declined for various reasons. The RehabTr consisted of one weekly individual session of 1 h, for a total of 10 weeks, carried out by a trained psychologist. The functions trained were: memory, attention, visuo-spatial functions, language and reasoning by means of Training NeuroPsicologico (TNP(®)) software. To evaluate the effect of the RehabTr, the same battery of tests was administered directly after cognitive rehabilitation (T1), and at six-month follow-up (T2). Statistical analysis with Student T test for paired data showed that short-term verbal memory, episodic memory, fluency and long term visuo-spatial memory improved immediately after the T1 and remained stable at T2. At final follow-up all patients showed an improvement in at least one domain that had been lower than normal at baseline. Our results demonstrated a positive effect of rehabilitative training at different times, and, for

Does hyperbaric oxygen treatment have the potential to increase salivary flow rate and reduce xerostomia in previously irradiated head and neck cancer patients? A pilot study

DEFF Research Database (Denmark)

Forner, Lone; Hansen, Ole Hyldegaard; von Brockdorff, Annet Schack

2011-01-01

in irradiated head and neck cancer patients. Eighty patients eligible for HBO treatment on the indication of prevention/treatment of osteoradionecrosis or soft tissue radiation injury were consecutively sampled, of whom 45 had hyposalivation (i.e. unstimulated whole saliva (UWS) flow rate......Irradiated head and neck cancer survivors treated in the Hyperbaric Oxygen (HBO) Unit, Copenhagen University Hospital, spontaneously reported improvement of radiation-induced dry mouth feeling. The aim of this pilot study was to evaluate salivary flow rate and xerostomia before and after HBO...

The incidence of venous thromboembolism in commercial airline pilots: a cohort study of 2630 pilots.

Science.gov (United States)

Kuipers, S; Venemans-Jellema, A; Cannegieter, S C; van Haften, M; Middeldorp, S; Büller, H R; Rosendaal, F R

2014-08-01

Airline pilots may be at increased risk of venous thromboembolism (VTE) because air travel has recently been established as a risk factor for VTE. The aim of this study was to assess the risk of VTE in a cohort of Dutch airline pilots. Airline pilots who had been active members of the Dutch aviation society (VNV) were questioned for the occurrence of VTE, presence of risk factors for VTE and number of flight hours per year and rank. Incidence rates among pilots were compared with those of the general Dutch population and with a population of frequently flying employees of multinational organizations. A total of 2630 male pilots were followed-up for a total of 20420 person-years (py). Six venous thromboses were reported, yielding an incidence rate of 0.3 per 1000 py. The standardized morbidity ratio, comparing these pilots with the general Dutch population adjusted for age, was 0.8. Compared with the international employee cohort, the standardized morbidity ratio was 0.7 when all employees were included and 0.6 when only the frequently travelling employees were included. The incidence rate did not increase with number of flight hours per year and did not clearly vary by rank. We conclude that the risk of VTE is not increased amongst airline pilots. © 2014 International Society on Thrombosis and Haemostasis.

Predictors of Home Care Expenditures and Death at Home for Cancer Patients in an Integrated Comprehensive Palliative Home Care Pilot Program

Science.gov (United States)

Howell, Doris M.; Abernathy, Tom; Cockerill, Rhonda; Brazil, Kevin; Wagner, Frank; Librach, Larry

2011-01-01

Purpose: Empirical understanding of predictors for home care service use and death at home is important for healthcare planning. Few studies have examined these predictors in the context of the publicly funded Canadian home care system. This study examined predictors for home care use and home death in the context of a “gold standard” comprehensive palliative home care program pilot in Ontario where patients had equal access to home care services. Methods: Secondary clinical and administrative data sources were linked using a unique identifier to examine multivariate factors (predisposing, enabling, need) on total home care expenditures and home death for a cohort of cancer patients enrolled in the HPCNet pilot. Results: Subjects with gastrointestinal symptoms (OR: 1.64; p=0.03) and those with higher income had increased odds of dying at home (OR: 1.14; phome care expenditures. Conclusions: Predictors of home death found in earlier studies appeared less important in this comprehensive palliative home care pilot. An income effect for home death observed in this study requires examination in future controlled studies. Relevance: Access to palliative home care that is adequately resourced and organized to address the multiple domains of issues that patients/families experience at the end of life has the potential to enable home death and shift care appropriately from limited acute care resources. PMID:22294993

A multifaceted intervention to reduce inappropriate polypharmacy in primary care: research co-creation opportunities in a pilot study.

Science.gov (United States)

Anderson, Kristen; Foster, Michele M; Freeman, Christopher R; Scott, Ian A

2016-04-18

Co-creation (or co-design) represents the highest form of stakeholder engagement, but it can be infeasible to co-create with all stakeholders through all stages of a research project. The choice of stakeholders for co-design will depend on the study purpose and context of change. For this deprescribing pilot study, general practitioners were recognised as a critical gateway for co-creation, with patients' perspectives of the deprescribing process to be assessed in the evaluation of the pilot.

cDNA microarray analysis of human keratinocytes cells of patients submitted to chemoradiotherapy and oral photobiomodulation therapy: pilot study.

Science.gov (United States)

Antunes, Heliton S; Wajnberg, Gabriel; Pinho, Marcos B; Jorge, Natasha Andressa Nogueira; de Moraes, Joyce Luana Melo; Stefanoff, Claudio Gustavo; Herchenhorn, Daniel; Araújo, Carlos M M; Viégas, Celia Maria Pais; Rampini, Mariana P; Dias, Fernando L; de Araujo-Souza, Patricia Savio; Passetti, Fabio; Ferreira, Carlos G

2018-01-01

Oral mucositis is an acute toxicity that occurs in patients submitted to chemoradiotherapy to treat head and neck squamous cell carcinoma. In this study, we evaluated differences in gene expression in the keratinocytes of the oral mucosa of patients treated with photobiomodulation therapy and tried to associate the molecular mechanisms with clinical findings. From June 2009 to December 2010, 27 patients were included in a randomized double-blind pilot study. Buccal smears from 13 patients were obtained at days 1 and 10 of chemoradiotherapy, and overall gene expression of samples from both dates were analyzed by complementary DNA (cDNA) microarray. In addition, samples from other 14 patients were also collected at D1 and D10 of chemoradiotherapy for subsequent validation of cDNA microarray findings by qPCR. The expression array analysis identified 105 upregulated and 60 downregulated genes in our post-treatment samples when compared with controls. Among the upregulated genes with the highest fold change, it was interesting to observe the presence of genes related to keratinocyte differentiation. Among downregulated genes were observed genes related to cytotoxicity and immune response. The results indicate that genes known to be induced during differentiation of human epidermal keratinocytes were upregulated while genes associated with cytotoxicity and immune response were downregulated in the laser group. These results support previous clinical findings indicating that the lower incidence of oral mucositis associated with photobiomodulation therapy might be correlated to the activation of genes involved in keratinocyte differentiation.

A Pilot Study of Cultural/Racial Differences in Patient Perspectives on Long-Acting Injectable Antipsychotics for the Treatment of Schizophrenia.

Science.gov (United States)

Potkin, Steven G; Bera, Rimal; Eramo, Anna; Lau, Gina

Long-acting injectable (LAI) antipsychotics improve treatment outcomes in patients with schizophrenia but are often reserved for only the most severely affected or nonadherent. Studies show cultural/racial differences in prescribing. This pilot study examined prescriber-patient interactions and cultural/racial differences in perceptions of LAIs among patients. A linguist analyzed 120 prescriber-patient conversations representing selected patient cultural/racial subgroups (European American, African American, Latino American; n=40 each) to identify similarities and differences in conceptualization and attitudes toward LAIs. Of 35 LAI-naive patients offered LAIs, 9% (3/35) responded favorably, 46% (16/35) were neutral/passive, and 46% (16/35) had concerns or viewed LAIs as unfavorable. Among LAI-naive patients, favorable or neutral/passive responses were reported for 50% (7/14) of European Americans, 63% (10/16) of African Americans, and 40% (2/5) of Latino Americans. The majority of LAI-naive patients (57% [20/35]) accepted LAI prescriptions, including 53% (17/32) of those who initially were neutral/passive or refused treatment (European American, 42% [5/12]; African American, 53% [8/15]; Latino American, 80% [4/5]). Fifty-seven percent (68/120) of patients expressed treatment goals. Goals of positive/negative symptom control were associated with positive attitudes toward LAIs while patients with goals focused on control of anxiety and insomnia tended to have negative attitudes toward LAIs. Latino-American patients who expressed treatment goals seemed more focused on discomfort control (67% [12/18]); goals of European Americans and African Americans were more equally distributed. Equal numbers of LAI-naive patients had unfavorable/concerned or neutral/passive attitudes toward treatment; relatively few patients responded favorably. The limited sample size precludes cultural/racial-specific conclusions.

Correlation Between Metabolic Syndrome, Periodontitis and Reactive Oxygen Species Production. A Pilot Study

OpenAIRE

Patini, Romeo; Gallenzi, Patrizia; Spagnuolo, Gianrico; Cordaro, Massimo; Cantiani, Monica; Amalfitano, Adriana; Arcovito, Alessandro; Callà, Cinzia; Mingrone, Gertrude; Nocca, Giuseppina

2017-01-01

Background and Objective: Metabolic syndrome (MetS) is associated with an increased risk of periodontitis even if the mechanism is unknown. Since both MetS and periodontitis are characterized by an alteration of inflammation status, the aim of this pilot study was to determine if differences in ROS metabolism of phagocytes isolated from (A) patients with MetS, (B) patients with both MetS and mild periodontitis, (C) healthy subjects and (D) normal weight subjects with mild periodontitis, were ...

The effect of self-monitoring on Wisconsin Card Sorting Test performance in euthymic patients with bipolar disorder: a pilot study.

Science.gov (United States)

Robinson, Lucy J; Gray, John M; Ferrier, I Nicol; Gallagher, Peter

2016-05-01

Euthymic patients with bipolar disorder (BD) show executive impairment. Assisting cognitive function with non-pharmacological strategies has not been widely explored in BD. In schizophrenia, concomitant verbalisation (self-monitoring) during executive tests improved performance. The present pilot study assesses the effects of self-monitoring whilst completing the Wisconsin Card Sorting Test (WCST) in BD patients. Thirty-six euthymic BD patients and 42 healthy controls participated. Twenty patients with BD and 20 controls received standard administration and 16 patients and 22 controls used self-monitoring during the test. ANCOVA revealed a significant "group by administration" interaction. Patients who received the standard administration were significantly worse than healthy controls (trials administered: p = .012, η p (2) = 0.17; trials to first category: p = .046, η p (2) = 0.11; failure to maintain set: p = .003, η p (2) = 0.23). BD patients who self-monitored performed significantly better than patients receiving the standard administration (trials to first category: p = .020, η p (2) = 0.17) and showed no significant differences in performance compared to controls. Self-monitoring deserves further investigation as a tool that may be helpful for patients with BD. Further exploration of the utility, generalisability, and stability of the effects of self-monitoring is needed.

Costs and difficulties of recruiting patients to provide e-health support: pilot study in one primary care trust.

Science.gov (United States)

Jones, Ray B; O'Connor, Anita; Brelsford, Jade; Parsons, Neil; Skirton, Heather

2012-03-29

Better use of e-health services by patients could improve outcomes and reduce costs but there are concerns about inequalities of access. Previous research in outpatients suggested that anonymous personal email support may help patients with long term conditions to use e-health, but recruiting earlier in their 'journey' may benefit patients more. This pilot study explored the feasibility and cost of recruiting patients for an e-health intervention in one primary care trust. The sample comprised 46 practices with total patient population of 250,000. We approached all practices using various methods, seeking collaboration to recruit patients via methods agreed with each practice. A detailed research diary was kept of time spent recruiting practices and patients. Researcher time was used to estimate costs. Patients who consented to participate were offered email support for their use of the Internet for health. Eighteen practices agreed to take part; we recruited 27 patients, most (23/27) from five practices. Practices agreed to recruit patients for an e-health intervention via waiting room leaflets (16), posters (16), practice nurses (15), doctors giving patients leaflets (5), a study website link (7), inclusion in planned mailshots (2), and a special mailshot to patients selected from practice computers (1). After low recruitment response we also recruited directly in five practices through research assistants giving leaflets to patients in waiting rooms. Ten practices recruited no patients. Those practices that were more difficult to recruit were less likely to recruit patients. Leaving leaflets for practice staff to distribute and placing posters in the practice were not effective in recruiting patients. Leaflets handed out by practice nurses and website links were more successful. The practice with lowest costs per patient recruited (£70) used a special mailshot to selected patients. Recruitment via general practice was not successful and was therefore expensive

A pilot study of daunorubicin-augmented hyper-CVAD induction chemotherapy for adults with acute lymphoblastic leukemia.

Science.gov (United States)

Kim, Sung-Yong; Park, Ji Hyun; Yoon, So Young; Cho, Yo-Han; Lee, Mark Hong

2018-02-01

Induction of complete remission (CR) is imperative for long-term survival in adult acute lymphoblastic leukemia (ALL) patients regardless of transplantation eligibility. Hyper-CVAD chemotherapy is a widely-used frontline remission induction regimen for these patients. We conducted a pilot trial of frontline remission induction using daunorubicin-augmented hyper-CVAD regimen (hyper-CVDD) in adult ALL patients (n = 15). The CR rate after this modified regimen was 100% (n = 15). Twelve patients were able to proceed to allogeneic hematopoietic cell transplantation, two patients died before transplantation due to infection, and the remaining one who was ineligible for transplant due to her age received an additional five courses of consolidation chemotherapy. Overall survival (OS) and event-free survival (EFS) of the study patients was 61.0 and 47.5% at 3 years. OS and relapse-free survival of transplanted patients was 66.8 and 55.0% at 3 years. This pilot trial demonstrates the favorable efficacy of the hyper-CVDD chemotherapy as a frontline remission induction regimen. Further clinical trials using this regimen are warranted.

Coping-Infused Dialogue through Patient-Preferred Live Music: A Medical Music Therapy Protocol and Randomized Pilot Study for Hospitalized Organ Transplant Patients.

Science.gov (United States)

Hogan, Tyler James; Silverman, Michael J

2015-01-01

Solid organ transplant patients often experience a variety of psychosocial stressors that can lead to distress and may hinder successful recovery. Using coping-infused dialogue (CID) through patient- preferred live music (PPLM) music therapy sessions may improve mood and decrease pain while also imparting psychoeducational knowledge concerning the identification of local and global problems and coping skills. The purpose of this pilot study was to develop a coping-based medical music therapy protocol that combines coping-infused dialogue (CID) with patient-preferred live music (PPLM) and measure the effects of the resulting CID-PPLM protocol on mood (positive and negative affect) and pain in hospitalized transplant patients. Our study used a pre-/posttest single-session wait-list control design. Participants (N=25) were randomly assigned to experimental (CID-PPLM) or control (usual care) conditions. Participants in the CID-PPLM condition received a single 30-minute session that integrated stressor identification and knowledge of coping skills (CID) with patient-preferred live music (PPLM). Results indicated no between-group differences at pretest and significant correlations between pre- and posttest measures. Concerning posttest ANCOVA analyses, there were significant between-group differences in positive affect, negative affect, and pain, with experimental participants having more favorable posttest scores than control participants. Effect sizes were in the medium-to-large range for positive affect (η2=.198), negative affect (η2=.422), and pain (η2=.303). CID through receptive PPLM may be an effective protocol for improving mood and decreasing pain in organ transplant recipients. MT interventions can be an important tool to develop rapport and enhance outcomes with patients. As greater engagement during interventions may have stronger treatment effects, we recommend future research examining patient engagement as a potential mediator of intervention effects

What Impact Do Chaplains Have? A Pilot Study of Spiritual AIM for Advanced Cancer Patients in Outpatient Palliative Care.

Science.gov (United States)

Kestenbaum, Allison; Shields, Michele; James, Jennifer; Hocker, Will; Morgan, Stefana; Karve, Shweta; Rabow, Michael W; Dunn, Laura B

2017-11-01

Spiritual care is integral to quality palliative care. Although chaplains are uniquely trained to provide spiritual care, studies evaluating chaplains' work in palliative care are scarce. The goals of this pre-post study, conducted among patients with advanced cancer receiving outpatient palliative care, were to evaluate the feasibility and acceptability of chaplain-delivered spiritual care, utilizing the Spiritual Assessment and Intervention Model ("Spiritual AIM"), and to gather pilot data on Spiritual AIM's effects on spiritual well-being, religious and cancer-specific coping, and physical and psychological symptoms. Patients with advanced cancer (N = 31) who were receiving outpatient palliative care were assigned based on chaplains' and patients' outpatient schedules, to one of three professional chaplains for three individual Spiritual AIM sessions, conducted over the course of approximately six to eight weeks. Patients completed the following measures at baseline and post-intervention: Edmonton Symptom Assessment Scale, Steinhauser Spirituality, Brief RCOPE, Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp-12), Mini-Mental Adjustment to Cancer (Mini-MAC), Patient Dignity Inventory, Center for Epidemiological Studies-Depression (10 items), and Spielberger State Anxiety Inventory. From baseline to post-Spiritual AIM, significant increases were found on the FACIT-Sp-12 Faith subscale, the Mini-MAC Fighting Spirit subscale, and Mini-MAC Adaptive Coping factor. Two trends were observed, i.e., an increase in Positive religious coping on the Brief RCOPE and an increase in Fatalism (a subscale of the Mini-MAC). Spiritual AIM, a brief chaplain-led intervention, holds potential to address spiritual needs and religious and general coping in patients with serious illnesses. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Salmeterol improves fluid clearance from alveolar-capillary membrane in COPD patients: a pilot study.

Science.gov (United States)

Di Marco, Fabiano; Guazzi, Marco; Sferrazza Papa, Giuseppe Francesco; Vicenzi, Marco; Santus, Pierachille; Busatto, Paolo; Piffer, Federico; Blasi, Francesco; Centanni, Stefano

2012-02-01

The cardiovascular component associated with chronic obstructive pulmonary disease (COPD) plays a major role in disease prognosis, accounting for 25% of the deaths. Experimental and initial clinical data suggest that beta-adrenergic agonists accelerate fluid clearance from the alveolar airspace, with potentially positive effects on cardiogenic and noncardiogenic pulmonary oedema. This pilot study investigated the acute effects of the long-acting beta-2 agonist, salmeterol, on alveolar fluid clearance after rapid saline intravenous infusion by evaluating diffusive and mechanical lung properties. Ten COPD and 10 healthy subjects were treated with salmeterol or placebo 4 h before the patient's mechanical and diffusive lung properties were measured during four non consecutive days, just before and after a rapid saline infusion, or during a similar period without an infusion. In both COPD and healthy subjects, rapid saline infusion with placebo or salmeterol premedication lead to a significant decrease in diffusion capacity for carbon monoxide (DLCO) and forced expiratory volume in 1 s (FEV1). Nonetheless, salmeterol pretreatment lead to a significantly reduced gas exchange impairment caused by saline infusion (-64% of DLCO reduction compared with placebo), whereas it did not affect changes in FEV1. In the control setting with no infusion, we found no significant change in either DLCO or mechanical properties of the lung. Salmeterol appears to provide a protective effect, not related to bronchodilation, against an acute alveolar fluid clearance challenge secondary to lung fluid overload in COPD patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.

Science.gov (United States)

Latkovskis, Gustavs; Saripo, Vita; Sokolova, Emma; Upite, Dana; Vanaga, Ilona; Kletnieks, Ugis; Erglis, Andrejs

2016-01-01

Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM. In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography. Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (PMuscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry. Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study.

Science.gov (United States)

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

2017-03-01

The purpose of the study was to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in sub-acute hemiplegic patients. Randomized controlled pilot study. Inpatient rehabilitation centers. Thirty hemiplegic stroke patients (Ashworth spasticity index hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the CG received the same amount of time in terms of conventional hand rehabilitation. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences, (Δ) mean(standard deviation), compared between groups. Results Twenty-seven patients concluded the program: 14 in the TG and 13 in the CG. None of the patients refused the device and only one adverse event of rheumatoid arthritis reactivation was reported. Baseline data did not differ significantly between the two groups. In TG, ΔMI 23(16.4), ΔNHPT 0.16(0.16), ΔGRIP 0.27(0.23) and ΔPINCH 0.07(0.07) were significantly greater than in CG, ΔMI 5.2(9.2), ΔNHPT 0.02(0.07), ΔGRIP 0.03(0.06) and ΔPINCH 0.02(0.03)] ( p=0.002, p=0.009, p=0.003 and p=0.038, respectively). Gloreha Professional is feasible and effective in recovering fine manual dexterity and strength and reducing arm disability in sub-acute hemiplegic patients.

A pilot pharmacokinetic study of tricyclic antidepressant ovine Fab for TCA poisoning in children.

Science.gov (United States)

Yalindağ-Oztürk, Nilüfer; Goto, Collin S; Shepherd, Greene; Torres, Olivia Nayeli; Giroir, Brett

2010-06-01

A pilot study of tricyclic antidepressant (TCA)-specific antibody fragments (TCA Fab) in TCA-intoxicated adults showed a marked increase in serum total TCA concentrations following TCA Fab infusion with no worsening signs of TCA toxicity. TCA Fab pharmacokinetics (PK) was not described in this adult study. The objective of this study was to evaluate the PK of TCA Fab in children with TCA poisoning. This was an open-label, single-center, dose escalation pilot trial of three patients. Inclusion criteria were documented TCA ingestion with at least one serious complication (QRS prolongation, dysrhythmia, hypotension, seizure, or coma). Patients were assigned to either a low-dose intravenous TCA Fab regimen (15, 30, and 60 mg/kg) or a high-dose regimen (30, 60, and 120 mg/kg) as needed to reverse TCA toxicity. Following the administration of TCA Fab, samples of blood and urine were obtained for PK evaluations. The outcomes of interest were serum and urine TCA concentrations (free and total), serum and urine Fab concentrations, improvement or worsening of TCA toxicity, and adverse effects. Three study patients were 11, 11, and 14 years of age. Two patients received 15 mg/kg of TCA Fab and one patient received a total of 90 mg/kg of TCA Fab (30 + 60 mg/kg). Serum-bound TCA increased significantly following TCA Fab administration with concomitant enhanced urinary elimination. Serum-free TCA concentrations were minimal to undetectable. Fab data were available for two patients. The serum TCA Fab area under the curve was 306.12 mg/L/h for the 15 mg/kg dose and 2,198.10 mg/L/h for the 90 mg/kg dose of TCA Fab. Maximum Fab concentrations correlated with maximum bound TCA in serum. The volume of distribution (V(D)) of TCA Fab was 0.2-0.3 L/kg. The clearance was 0.036-0.05 L/kg/h and the elimination half-life was 4 h. No adverse effects were observed. The limited PK data from this study are consistent with binding of TCA to TCA Fab and redistribution of TCA from the tissue to

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

Science.gov (United States)

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

2017-03-01

and McMaster Universities Osteoarthritis Index scale[WOMAC] and the Lequesne Index) as well as the timed up and go, sit to stand, preferred gait speed, and body composition. This pilot study appears to be the first study assessing the feasibility and safety of a home-based HIIT training program for middle-aged and older adults with knee OA. As HIIT has been demonstrated to be more effective than MICT for improving aspects of health status, body composition, and/or muscular function in other chronic disease groups, the current study has the potential to improve patient outcomes and inform the design of future randomized controlled trials.

A training program to improve gait while dual tasking in patients with Parkinson's disease: a pilot study.

Science.gov (United States)

Yogev-Seligmann, Galit; Giladi, Nir; Brozgol, Marina; Hausdorff, Jeffrey M

2012-01-01

Impairments in the ability to perform another task while walking (ie, dual tasking [DT]) are associated with an increased risk of falling. Here we describe a program we developed specifically to improve DT performance while walking based on motor learning principles and task-specific training. We examined feasibility, potential efficacy, retention, and transfer to the performance of untrained tasks in a pilot study among 7 patients with Parkinson's disease (PD). Seven patients (Hoehn and Yahr stage, 2.1±0.2) were evaluated before, after, and 1 month after 4 weeks of DT training. Gait speed and gait variability were measured during usual walking and during 4 DT conditions. The 4-week program of one-on-one training included walking while performing several distinct cognitive tasks. Gait speed and gait variability during DT significantly improved. Improvements were also seen in the DT conditions that were not specifically trained and were retained 1 month after training. These initial findings support the feasibility of applying a task-specific DT gait training program for patients with PD and suggest that it positively affects DT gait, even in untrained tasks. The present results are also consistent with the possibility that DT gait training enhances divided attention abilities during walking. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Cervicocephalic kinesthetic sensibility and postural balance in patients with nontraumatic chronic neck pain--a pilot study.

Science.gov (United States)

Palmgren, Per J; Andreasson, Daniel; Eriksson, Magnus; Hägglund, Andreas

2009-06-30

Although cervical pain is widespread, most victims are only mildly and occasionally affected. A minority, however, suffer chronic pain and/or functional impairments. Although there is abundant literature regarding nontraumatic neck pain, little focuses on diagnostic criteria. During the last decade, research on neck pain has been designed to evaluate underlying pathophysiological mechanisms, without noteworthy success. Independent researchers have investigated postural balance and cervicocephalic kinesthetic sensibility among patients with chronic neck pain, and have (in most cases) concluded the source of the problem is a reduced ability in the neck's proprioceptive system. Here, we investigated cervicocephalic kinesthetic sensibility and postural balance among patients with nontraumatic chronic neck pain. Ours was a two-group, observational pilot study of patients with complaints of continuous neck pain during the 3 months prior to recruitment. Thirteen patients with chronic neck pain of nontraumatic origin were recruited from an institutional outpatient clinic. Sixteen healthy persons were recruited as a control group. Cervicocephalic kinesthetic sensibility was assessed by exploring head repositioning accuracy and postural balance was measured with computerized static posturography. Parameters of cervicocephalic kinesthetic sensibility were not reduced. However, in one of six test movements (flexion), global repositioning errors were significantly larger in the experimental group than in the control group (p < .05). Measurements did not demonstrate any general impaired postural balance, and varied substantially among participants in both groups. In patients with nontraumatic chronic neck pain, we found statistically significant global repositioning errors in only one of six test movements. In this cohort, we found no evidence of impaired postural balance.Head repositioning accuracy and computerized static posturography are imperfect measures of functional

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

Science.gov (United States)

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

2017-12-01

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

Cardiovascular investigations of airline pilots with excessive cardiovascular risk.

Science.gov (United States)

Wirawan, I Made Ady; Aldington, Sarah; Griffiths, Robin F; Ellis, Chris J; Larsen, Peter D

2013-06-01

This study examined the prevalence of airline pilots who have an excessive cardiovascular disease (CVD) risk score according to the New Zealand Guideline Group (NZGG) Framingham-based Risk Chart and describes their cardiovascular risk assessment and investigations. A cross-sectional study was performed among 856 pilots employed in an Oceania based airline. Pilots with elevated CVD risk that had been previously evaluated at various times over the previous 19 yr were reviewed retrospectively from the airline's medical records, and the subsequent cardiovascular investigations were then described. There were 30 (3.5%) pilots who were found to have 5-yr CVD risk score of 10-15% or higher. Of the 29 pilots who had complete cardiac investigations data, 26 pilots underwent exercise electrocardiography (ECG), 2 pilots progressed directly to coronary angiograms and 1 pilot with abnormal echocardiogram was not examined further. Of the 26 pilots, 7 had positive or borderline exercise tests, all of whom subsequently had angiograms. One patient with a negative exercise test also had a coronary angiogram. Of the 9 patients who had coronary angiograms as a consequence of screening, 5 had significant disease that required treatment and 4 had either trivial disease or normal coronary arteries. The current approach to investigate excessive cardiovascular risk in pilots relies heavily on exercise electrocardiograms as a diagnostic test, and may not be optimal either to detect disease or to protect pilots from unnecessary invasive procedures. A more comprehensive and accurate cardiac investigation algorithm to assess excessive CVD risk in pilots is required.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment.

Science.gov (United States)

Hubbard, Gill; Campbell, Anna; Davies, Zoe; Munro, Julie; Ireland, Aileen V; Leslie, Stephen; Watson, Angus Jm; Treweek, Shaun

2015-01-01

Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used:Nurse assessed patients for eligibility.Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study.An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. There were variations in the time taken to award Research Management approval to run the study at the three sites (45-359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial's recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and

Managing ethical issues in sexual violence research using a pilot study

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S.E. Duma

2009-09-01

Full Text Available Conducting research in the area of sexual violence has complex ethical and practical challenges for the researcher. Managing ethical issues in sexual violence is important and can be achieved through the use of pilot studies. The primary purpose of the pilot study was to identify and manage potential ethical and practical problems that could jeopardise the main study or violate the ethical and human rights of participants in the main study on women’s journey of recovery from sexual assault. The secondary purpose was to collect preliminary data in order to determine the human, financial and time resources needed for a planned study. The methods and processes used in conducting the pilot study in the study on women’s journey of recovery are discussed according to each of the objectives of the pilot study, methods used to achieve the objective, observations or findings made during the pilot study, and implications for the main study. This article aims to demonstrate how a pilot study was used to manage identified potential ethical and practical research issues during the recruitment of participants and data collection for the research that was conducted by the first author to investigate women’s journey of recovery from sexual assault trauma within the first week following sexual assault.

Ultrasound assessment of lung consolidation and reaeration after pleural effusion drainage in patients with Acute Respiratory Distress Syndrome: a pilot study.

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Chinardet, B; Brisson, H; Arbelot, C; Langeron, O; Rouby, J J; Lu, Q

2016-01-01

The aim of the pilot study was to assess by ultrasound changes in dimensions of lung consolidation and reaeration after drainage of large pleural effusion in patients with acute respiratory distress syndrome (ARDS). Lung ultrasound and blood gas were performed before, 2 hours (H2) and 24 hours (H24) after drainage of pleural effusion. Lung ultrasound aeration score was calculated. Cephalocaudal dimension and diaphragmatic transversal area of lung consolidation were measured. Ten patients were studied. Median volume of drained effusion was 675 ml at H2 and 895 at H24. Two hours after drainage, dimension of cephalocaudal consolidation and diaphragmatic transversal area decreased significantly. Lung reaeration after drainage occurred mainly in latero-inferior and postero-superior regions. PaO2/FiO2 increased significantly at H24. Ultrasound is a useful method to assess lung consolidation after pleural effusion drainage. Drainage of pleural effusion may lead to a decrease of lung consolidation and improvement of lung reaeration.

Liverpool Telecare Pilot: case studies

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Nigel Barnes

2006-09-01

Full Text Available Telecare services use information and communications technology (ICT to support the provision of care to people in their own homes. This paper describes a pilot telecare service employed by Liverpool (UK City Council to support a sample of their frail and elderly social services users. The pilot has been running for over two years and has been deployed for 21 individuals in Liverpool. In this paper we present the pilot system and provide real example cases which help to illustrate the benefits of such a system.

Pilot study of a heptavalent vaccine-keyhole limpet hemocyanin conjugate plus QS21 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer

DEFF Research Database (Denmark)

Sabbatini, Paul J; Ragupathi, Govind; Hood, Chandra

2007-01-01

PURPOSE: To characterize the safety and immunogenicity of a heptavalent antigen-keyhole limpet hemocyanin (KLH) plus QS21 vaccine construct in patients with epithelial ovarian, fallopian tube, or peritoneal cancer in second or greater complete clinical remission. EXPERIMENTAL DESIGN: Eleven......). RESULTS: Eleven patients were included in the safety analysis; 9 of 11 patients remained on study for at least 2 weeks past fourth vaccination and were included in the immunologic analysis (two withdrew, disease progression). The vaccine was well tolerated. Self-limited and mild fatigue (maximum grade 2...... patients in this pilot trial received a heptavalent vaccine s.c. containing GM2 (10 microg), Globo-H (10 microg), Lewis Y (10 microg), Tn(c) (3 microg), STn(c) (3 microg), TF(c) (3 microg), and Tn-MUC1 (3 microg) individually conjugated to KLH and mixed with adjuvant QS21(100 microg). Vaccinations were...

F-18-FDG PET/CT in inflammation of unknown origin : a cost-effectiveness pilot-study

NARCIS (Netherlands)

Balink, H.; Tan, S. S.; Veeger, N. J. G. M.; Holleman, F.; van Eck-Smit, B. L. F.; Bennink, R. J.; Verberne, H. J.

Purpose Patients with increased inflammatory parameters, nonspecific signs and symptoms without fever and without a diagnosis after a variety of diagnostic procedures are a diagnostic dilemma and are referred to as having inflammation of unknown origin (IUO). The objective of this pilot study was to

A Pilot Study for Linking Adolescent Patients to an Interactive Tobacco Prevention Program

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Karen S. Calabro

2017-04-01

Full Text Available Context: The American Academy of Pediatrics and professional guidelines recommend intervening with adolescents about avoiding tobacco use in the health-care setting. Barriers in the clinical setting limit consistent provision of this critical service. Objectives: This pilot study compared 2 approaches for referring adolescents to an evidence-based tobacco prevention and cessation program in the outpatient setting. Secondary aims assessed tobacco use, knowledge, and program evaluation. Design, Setting, and Participants: The study setting was a medical and dental clinic. Participants aged 13 to 18 received tobacco advice and instructions to work through “A Smoking Prevention Interactive Experience.” The program addresses health concerns of adolescents about tobacco use and is founded on behavioral change theories. The link to access it is featured on the website of the National Cancer Institute’s Research-Tested Interventions. Participants (N = 197 were randomized to 1 of 2 approaches (ie, a program link via e-mail or referral by a printed card. Results: The program was accessed by 57% (112 of 197 of participants. Both referral approaches were equally effective. Non-Hispanics were twice as likely to access the program as Hispanics (adjusted odds ratio = 2.1, 95% confidence interval = 1.2-3.8, P < .05. Over 95% of participants identified themselves as nonusers of tobacco and evaluated the program as beneficial in increasing knowledge and motivation to remain tobacco-free. Conclusion: Linking adolescent patients to an evidence-based tobacco prevention/cessation program at a community health clinic was highly promising and feasible. We present conclusions for future research.

Airplane pilot mental health and suicidal thoughts: a cross-sectional descriptive study via anonymous web-based survey.

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Wu, Alexander C; Donnelly-McLay, Deborah; Weisskopf, Marc G; McNeely, Eileen; Betancourt, Theresa S; Allen, Joseph G

2016-12-15

The Germanwings Flight 9525 crash has brought the sensitive subject of airline pilot mental health to the forefront in aviation. Globally, 350 million people suffer from depression-a common mental disorder. This study provides further information on this important topic regarding mental health especially among female airline pilots. This is the first study to describe airline pilot mental health-with a focus on depression and suicidal thoughts-outside of the information derived from aircraft accident investigations, regulated health examinations, or identifiable self-reports, which are records protected by civil aviation authorities and airline companies. This is a descriptive cross-sectional study via an anonymous web-based survey administered between April and December 2015. Pilots were recruited from unions, airline companies, and airports via convenience sampling. Data analysis included calculating absolute number and prevalence of health characteristics and depression scores. One thousand eight hundred thirty seven (52.7%) of the 3485 surveyed pilots completed the survey, with 1866 (53.5%) completing at least half of the survey. 233 (12.6%) of 1848 airline pilots responding to the Patient Health Questionnaire 9 (PHQ-9), and 193 (13.5%) of 1430 pilots who reported working as an airline pilot in the last seven days at time of survey, met depression threshold-PHQ-9 total score ≥ 10. Seventy-five participants (4.1%) reported having suicidal thoughts within the past two weeks. We found a significant trend in proportions of depression at higher levels of use of sleep-aid medication (trend test z = 6.74, p sexual harassment (z = 3.18, p = 0.001) or verbal harassment (z = 6.13, p < 0.001). Hundreds of pilots currently flying are managing depressive symptoms perhaps without the possibility of treatment due to the fear of negative career impacts. This study found 233 (12.6%) airline pilots meeting depression threshold and 75 (4.1%) pilots

Usability Test of Exercise Games Designed for Rehabilitation of Elderly Patients After Hip Replacement Surgery: Pilot Study

Science.gov (United States)

Ter Meer, Louis P; Yumak, Zerrin; Veltkamp, Remco C

2017-01-01

Background Patients who receive rehabilitation after hip replacement surgery are shown to have increased muscle strength and better functional performance. However, traditional physiotherapy is often tedious and leads to poor adherence. Exercise games, provide ways for increasing the engagement of elderly patients and increase the uptake of rehabilitation exercises. Objective The objective of this study was to evaluate Fietsgame (Dutch for cycling game), which translates existing rehabilitation exercises into fun exercise games. The system connects exercise games with a patient’s personal record and a therapist interface by an Internet of Things server. Thus, both the patient and physiotherapist can monitor the patient’s medical status. Methods This paper describes a pilot study that evaluates the usability of the Fietsgame. The study was conducted in a rehabilitation center with 9 participants, including 2 physiotherapists and 7 patients. The patients were asked to play 6 exercise games, each lasting about 5 min, under the guidance of a physiotherapist. The mean age of the patients was 74.57 years (standard deviation [SD] 8.28); all the patients were in the recovery process after hip surgery. Surveys were developed to quantitatively measure the usability factors, including presence, enjoyment, pain, exertion, and technology acceptance. Comments on advantages and suggested improvements of our game system provided by the physiotherapists and patients were summarized and their implications were discussed. Results The results showed that after successfully playing the games, 75% to 100% of the patients experienced high levels of enjoyment in all the games except the squats game. Patients reported the highest level of exertion in squats when compared with other exercise games. Lunges resulted in the highest dropout rate (43%) due to interference with the Kinect v2 from support chairs. All the patients (100%) found the game system useful and easy to use, felt that

Spasmodic Dysphonia in Multiple Sclerosis Treatment With Botulin Toxin A: A Pilot Study.

Science.gov (United States)

Di Stadio, Arianna; Bernitsas, Evanthia; Restivo, Domenico Antonio; Alfonsi, Enrico; Marchese-Ragona, Rosario

2018-04-09

This study aims to evaluate the effect of botulin toxin A in patients with multiple sclerosis (MS) affected by spasmodic dysphonia (SD) and to show the safety and effectiveness of this treatment in long-term observation. This is a pilot study on three relapsing-remitting MS patients with SD and their response to botulin toxin A. None of the patients reported dysphagia or other adverse events. Significant improvement was observed in terms of both voice quality and laryngostroboscopy results. The treatment effect was durable for 6-8 months. Botulin toxin A is a safe treatment that can be successfully used to treat SD in patients with MS. Larger studies are necessary to confirm our results. Copyright © 2018 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Tailor-made rehabilitation approach using multiple types of hybrid assistive limb robots for acute stroke patients: A pilot study.

Science.gov (United States)

Fukuda, Hiroyuki; Morishita, Takashi; Ogata, Toshiyasu; Saita, Kazuya; Hyakutake, Koichi; Watanabe, Junko; Shiota, Etsuji; Inoue, Tooru

2016-01-01

This article investigated the feasibility of a tailor-made neurorehabilitation approach using multiple types of hybrid assistive limb (HAL) robots for acute stroke patients. We investigated the clinical outcomes of patients who underwent rehabilitation using the HAL robots. The Brunnstrom stage, Barthel index (BI), and functional independence measure (FIM) were evaluated at baseline and when patients were transferred to a rehabilitation facility. Scores were compared between the multiple-robot rehabilitation and single-robot rehabilitation groups. Nine hemiplegic acute stroke patients (five men and four women; mean age 59.4 ± 12.5 years; four hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using multiple types of HAL robots for 19.4 ± 12.5 days, and 14 patients (six men and eight women; mean age 63.2 ± 13.9 years; nine hemorrhagic stroke and five ischemic stroke) underwent rehabilitation using a single type of HAL robot for 14.9 ± 8.9 days. The multiple-robot rehabilitation group showed significantly better outcomes in the Brunnstrom stage of the upper extremity, BI, and FIM scores. To the best of the authors' knowledge, this is the first pilot study demonstrating the feasibility of rehabilitation using multiple exoskeleton robots. The tailor-made rehabilitation approach may be useful for the treatment of acute stroke.

Synthesis of qualitative linguistic research--a pilot review integrating and generalizing findings on doctor-patient interaction.

Science.gov (United States)

Nowak, Peter

2011-03-01

There is a broad range qualitative linguistic research (sequential analysis) on doctor-patient interaction that had only a marginal impact on clinical research and practice. At least in parts this is due to the lack of qualitative research synthesis in the field. Available research summaries are not systematic in their methodology. This paper proposes a synthesis methodology for qualitative, sequential analytic research on doctor-patient interaction. The presented methodology is not new but specifies standard methodology of qualitative research synthesis for sequential analytic research. This pilot review synthesizes twelve studies on German-speaking doctor-patient interactions, identifies 45 verbal actions of doctors and structures them in a systematics of eight interaction components. Three interaction components ("Listening", "Asking for information", and "Giving information") seem to be central and cover two thirds of the identified action types. This pilot review demonstrates that sequential analytic research can be synthesized in a consistent and meaningful way, thus providing a more comprehensive and unbiased integration of research. Future synthesis of qualitative research in the area of health communication research is very much needed. Qualitative research synthesis can support the development of quantitative research and of educational materials in medical training and patient training. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

A pilot study of bendamustine in advanced bile duct cancer.

Science.gov (United States)

Schoppmeyer, Konrad; Kreth, Florian; Wiedmann, Marcus; Mössner, Joachim; Preiss, Rainer; Caca, Karel

2007-07-01

We performed a pilot study to evaluate the safety and tolerability of bendamustine in patients with advanced hilar bile duct cancer and impaired liver function. Six patients with histologically proven, unresectable adenocarcinoma of the hilar bile duct were treated with bendamustine 140 mg/m intravenously on day 1 of the first cycle and with bendamustine 100 mg/m on days 1 and 2 of the second to fourth cycle. Treatment cycles were repeated every 21 days. Primary endpoint was the safety and tolerability of the treatment; secondary endpoints were response rate, time to progression and overall survival. Transient lymphopenia grade 3 occurred in all six patients. No other grade 3 or 4 toxicities were present. The most common nonhematologic toxicity was mouth dryness grade 2 in six patients. Three patients had stable disease. No partial or complete responses were observed. Median time to progression was 3.3 months; median overall survival was 6 months. Our study demonstrates that bendamustine can be safely administered in patients with hilar bile duct cancer and impaired liver function. A potential role of bendamustine in combination therapies for bile duct cancer will be a subject of further trials.

Intranasal insulin influences the olfactory performance of patients with smell loss, dependent on the body mass index: A pilot study.

Science.gov (United States)

Schöpf, V; Kollndorfer, K; Pollak, M; Mueller, C A; Freiherr, J

2015-12-01

The application of intranasal insulin in healthy humans has been linked to improved memory function, reduced food intake, and increased olfactory thresholds. There has also been some correlation between the morbidities associated with central nervous system (CNS) insulin resistance, such as type II diabetes mellitus, Alzheimer's disease, obesity, and impaired odour recognition. Given that impaired odour recognition is an important component of olfactory performance, mechanisms that govern these effects may account for impaired olfactory functions in anosmic patients. Ten patients with post-infectious olfactory loss received intranasal administration of 40 IU insulin or a placebo solution, as well as olfactory performance tests before and after administration. When administered insulin, patients exhibited an immediate performance improvement with regard to olfactory sensitivity and olfactory intensity ratings. In addition, more odours were correctly identified. Furthermore, an improvement in the odour identification task was detected in patients with higher body mass index. Results of this pilot study shed light on the link between cerebral insulin level and an impaired sense of smell. This research line might provide a better understanding of olfactory loss in relation to eating and dietary behavior, and could offer opportunities to develop faster therapeutic intervention for patients with olfactory dysfunction.

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

Science.gov (United States)

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.

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

Science.gov (United States)

Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

2017-11-13

Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger

A linguistic study of patient-centered interviewing: emergent interactional effects.

Science.gov (United States)

Hesson, Ashley M; Sarinopoulos, Issidoros; Frankel, Richard M; Smith, Robert C

2012-09-01

To evaluate interactional effects of patient-centered interviewing (PCI) compared to isolated clinician-centered interviewing (CCI). We conducted a pilot study comparing PCI (N=4) to CCI (N=4) for simulated new-patient visits. We rated interviews independently and measured patient satisfaction with the interaction via a validated questionnaire. We conducted interactional sociolinguistic analysis on the interviews and compared across three levels of analysis: turn, topic, and interaction. We found significant differences between PCI and CCI in physician responses to patients' psychosocial cues and concerns. The number and type of physician questions also differed significantly across PCI and CCI sets. Qualitatively, we noted several indicators of physician-patient attunement in the PCI interviews that were not present in the CCI interviews. They spanned diverse aspects of physician and patient speech, suggesting interactional accommodation on the part of both participants. This small pilot study highlights a variety of interactional variables that may underlie the effects associated with patient-centered interviewing (e.g., positive relationships, health outcomes). Question form, phonological accommodation processes, and use of stylistic markers are relatively unexplored in controlled studies of physician-patient interaction. This study characterizes several interactional variables for larger scale studies and contributes to models of patient-centeredness in practice. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Effect of early use of AbobotulinumtoxinA after stroke on spasticity progression: Protocol for a randomised controlled pilot study in adult subjects with moderate to severe upper limb spasticity (ONTIME pilot

Directory of Open Access Journals (Sweden)

Keng He Kong

2017-06-01

Discussion: This pilot study will facilitate the design and sample size calculation of further confirmatory studies, and is expected to provide insights into the optimal management of post-stroke patients, including timing of BoNT-A therapy and follow-up duration.

The quality of medical services in a subjective assessment of hospitalized patients using the SERVQUAL method – a pilot study

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Paweł Węgłowski

2016-09-01

Full Text Available Background . The provision of medical services to patients according to their expectations and needs is necessary for the comfort and quality of life of patients, as well as for the standardization of hospital procedures. In recognizing these needs and expectations, an important step is the verification of provided services in order to improve their quality. The present study was designed to determine differences in service quality, as evaluated by hospitalized patients. Objectives . The analysis of the subjective feelings of hospitalized patients concerning service quality in the context of the application of the SER VQUAL method – a pilot study. Material and methods. The study was conducted in a Lower Silesian hospital in a group of 29 young patients (women: 16, men: 13, average age: 16 diagnosed with kidney disease. In the study a standard sheet of 22 SER VQUAL statements was used, and an analysis of the validity of 5 quality areas important for the patient was conducted. Results. According to the respondents, the most important of all 5 features directly affecting the quality of life during treatment is the ability and skill of the ward staff to provide medical services, so-called reliability – 24.48%. In turn, the least important of all the study characteristics was the aesthetics and ergonomics of rooms, the presence of appropriate equipment, the so-called material dimension – 15.31%. Furthermore, service quality gaps were visible in all five service quality dimensions. Conclusions . 1. The SER VQUAL method helps to identify discrepancies between the perceptions of patients’ expectations in all dimensions of the quality of provided medical services. 2. For the patients the least important is the material dimension, and the most affecting is the dimension associated with the reliability of the medical services. 3. Improvement of the level of satisfaction with the quality of medical services requires proper planning and effective

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

Science.gov (United States)

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Usability Test of Exercise Games Designed for Rehabilitation of Elderly Patients After Hip Replacement Surgery: Pilot Study.

Science.gov (United States)

Ling, Yun; Ter Meer, Louis P; Yumak, Zerrin; Veltkamp, Remco C

2017-10-12

Patients who receive rehabilitation after hip replacement surgery are shown to have increased muscle strength and better functional performance. However, traditional physiotherapy is often tedious and leads to poor adherence. Exercise games, provide ways for increasing the engagement of elderly patients and increase the uptake of rehabilitation exercises. The objective of this study was to evaluate Fietsgame (Dutch for cycling game), which translates existing rehabilitation exercises into fun exercise games. The system connects exercise games with a patient's personal record and a therapist interface by an Internet of Things server. Thus, both the patient and physiotherapist can monitor the patient's medical status. This paper describes a pilot study that evaluates the usability of the Fietsgame. The study was conducted in a rehabilitation center with 9 participants, including 2 physiotherapists and 7 patients. The patients were asked to play 6 exercise games, each lasting about 5 min, under the guidance of a physiotherapist. The mean age of the patients was 74.57 years (standard deviation [SD] 8.28); all the patients were in the recovery process after hip surgery. Surveys were developed to quantitatively measure the usability factors, including presence, enjoyment, pain, exertion, and technology acceptance. Comments on advantages and suggested improvements of our game system provided by the physiotherapists and patients were summarized and their implications were discussed. The results showed that after successfully playing the games, 75% to 100% of the patients experienced high levels of enjoyment in all the games except the squats game. Patients reported the highest level of exertion in squats when compared with other exercise games. Lunges resulted in the highest dropout rate (43%) due to interference with the Kinect v2 from support chairs. All the patients (100%) found the game system useful and easy to use, felt that it would be a useful tool in their further

Regional ventricular performance and exercise training in children and young adults after repair of tetralogy of Fallot: randomized controlled pilot study.

Science.gov (United States)

Duppen, Nienke; Geerdink, Lianne M; Kuipers, Irene M; Bossers, Sjoerd S M; Koopman, Laurens P; van Dijk, Arie P J; Roos-Hesselink, Jolien W; De Korte, Chris L; Helbing, Willem A; Kapusta, Livia

2015-04-01

Public-health guidelines recommend patients with congenital heart disease to exercise. Studies have shown that patients with congenital heart disease can improve physical exercise capacity. The effect of training on regional ventricular performance has hardly been studied. We performed a pilot study to assess whether an exercise training program would result in adverse changes of regional ventricular performance in patients with corrected tetralogy of Fallot. Multicenter prospective randomized controlled pilot study in patients with tetralogy of Fallot aged 10 to 25 years. A 12-week standardized aerobic dynamic exercise training program (3 one-hour sessions per week) was used. Pre- and post-training cardiopulmonary exercise tests, MRI, and echocardiography, including tissue-Doppler imaging, were performed. Patients were randomized to the exercise group (n=28) or control group (n=20). One patient in the exercise group dropped out. Change in tissue-Doppler imaging parameters was similar in the exercise group and control group (change in right ventricle free wall peak velocity E' exercise group, 0.8±2.6 cm/s; control group, 0.9±4.1; peak velocity A' exercise group, 0.4±2.4 m/s; control group 4.6±18.1 cm/s). This randomized controlled pilot study provides preliminary data suggesting that regional ventricular performance is well maintained during 3-month aerobic dynamic exercise training in children and young adults with repaired tetralogy of Fallot. This information might help patients adhere to current public-health guidelines. URL: http//:www.trialregister.nl. Unique identifier: NTR2731. © 2015 American Heart Association, Inc.

Awareness during anaesthesia for surgery requiring evoked potential monitoring: A pilot study

Directory of Open Access Journals (Sweden)

Pritish J Korula

2017-01-01

Full Text Available Background: Evoked potential monitoring such as somatosensory-evoked potential (SSEP or motor-evoked potential (MEP monitoring during surgical procedures in proximity to the spinal cord requires minimising the minimum alveolar concentrations (MACs below the anaesthetic concentrations normally required (1 MAC to prevent interference in amplitude and latency of evoked potentials. This could result in awareness. Our primary objective was to determine the incidence of awareness while administering low MAC inhalational anaesthetics for these unique procedures. The secondary objective was to assess the adequacy of our anaesthetic technique from neurophysiologist′s perspective. Methods: In this prospective observational pilot study, 61 American Society of Anesthesiologists 1 and 2 patients undergoing spinal surgery for whom intraoperative evoked potential monitoring was performed were included; during the maintenance phase, 0.7-0.8 MAC of isoflurane was targeted. We evaluated the intraoperative depth of anaesthesia using a bispectral (BIS index monitor as well as the patients response to surgical stimulus (PRST scoring system. Post-operatively, a modified Bruce questionnaire was used to verify awareness. The adequacy of evoked potential readings was also assessed. Results: Of the 61 patients, no patient had explicit awareness. Intraoperatively, 19 of 61 patients had a BIS value of above sixty at least once, during surgery. There was no correlation with PRST scoring and BIS during surgery. Fifty-four out of 61 patient′s evoked potential readings were deemed ′good′ or ′fair′ for the conduct of electrophysiological monitoring. Conclusions: This pilot study demonstrates that administering low MAC inhalational anaesthetics to facilitate evoked potential monitoring does not result in explicit awareness. However, larger studies are needed to verify this. The conduct of SSEP electrophysiological monitoring was satisfactory with the use of this

Surveillance of acute respiratory infections among outpatients: A pilot study in Isfahan city

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Abbasali Javadi

2015-01-01

Full Text Available Background: Considering that there was not any regional survey in Isfahan, Iran regarding the epidemiology of acute respiratory tract infections (ARTI in different age groups of general population, the aim of this study was to determine the epidemiologic feature of ARTIs in Isfahan using multiplex polymerase chain reaction (PCR method. Materials and Methods: In this cross-sectional study, patients aged 15 years old. Rhinovirus was the most common cause of ARTI in patients aged 50 years. Influenza virus B was the most common cause of ARTI in patients aged 5-50 years. Conclusion: Our study provides baseline information on the epidemiologic and clinical feature of outpatients with ARTIs in Isfahan city. Though our findings in this pilot study could be helpful in diagnosis, treatment, and prevention of ARTI, planning preventive interventional.

Superior Predictive Value for NTproBNP Compared with High Sensitivity cTnT in Dialysis Patients: A Pilot Prospective Observational Study

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Luminita Voroneanu

2014-12-01

Full Text Available Background/Aims: The clinical utility of the new biomarker, high sensitivity cardiac T troponin (hs-cTnT is still unclear in dialysis patients. Furthermore, the prognostic value of combining N-terminal pro-B-type natriuretic peptide (NT-pro-BNP and hs-cTnT has not been explored so far. The objective of this pilot study was to determine the utility of hs-cTnT alone versus hs-cTnT in combination with NT-proBNP for predicting death in a stable hemodialysis cohort. Methods: A prospective observational pilot study including 98 chronic asymptomatic hemodialysis patients with a follow up period of 24 months was designed. The cut-off values for NT-proBNP and hs-cTnT were calculated using receiver operating characteristic (ROC analysis, using mortality as an end-point. Based on the cut-off values, the cohort was divided into four groups. Group 1 - NT-proBNP 69.48 ng/l; group 3 - NT-proBNP > 14275 pg/ml and hs-cTnT 14275 pg/ml and hs-cTnT > 69.48 ng/l. Survival for each group was determined using the Kaplan-Meier method and Cox regression analysis. Results: During the follow-up period 16 patients died. According to the ROC curves analysis, the cut-off point for hs-cTnT and for NT-proBNP were 69.43 ng/l (AUC = 0.618; p = 0.04 and 14275 pg/ml (AUC = 0.722; p = 0.003, respectively. In univariate Cox analysis, both hs-cTnT (HR = 3.34; p = 0.016 and NT-proBNP (HR = 5.94; p = 0.01 were predictors of death. In the multivariable Cox proportional hazards model, only NT-pro-BNP levels above the cut-off value remained an independent predictor of all-cause mortality. The combined elevation of both biomarkers did not improve significantly the prognostic value compared with NT-proBNP alone (HR = 6.15 versus HR =4 .78; p = 0.338. Conclusion: NT-pro-BNP is a strong predictor of overall mortality in asymptomatic hemodialysis patients. The addition of hs-cTnT did not improve the prognostic accuracy compared with NT proBNP alone.

A pilot study to evaluate effectiveness of botulinum toxin in treatment of androgenetic alopecia in males

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Sehdev Singh

2017-01-01

Full Text Available Introduction: Androgenetic alopecia is a common form of alopecia with multifactorial etiology. Finasteride and minoxidil are approved by the FDA for the treatment of androgenetic alopecia. Balding scalp is believed to have relative microvascular insufficiency. Blood vessels in the scalp travel through the intramuscular plane. Intramuscular injection of botulinum toxin relaxes muscles and thereby increases blood flow in balding scalp. We conducted a pilot study to evaluate the efficacy of botulinum toxin in androgenetic alopecia management. Material and Methods: The study was conducted in a tertiary care center. A total of 10 male patients with androgenetic alopecia meeting inclusion criteria of the study were included. In the scalp, 30 sites were injected with 5 U of botulinum toxin in each site. Preprocedure photograph taken and evaluation was done, which was repeated after 24 weeks. Efficacy was assessed by photography and self-assessment scoring was done by patients. Results: Of 10 patients, 8 had good to excellent response on photographic assessment. At the end of 24 weeks, 1 patient showed poor and 1 showed fair response to treatment. As per self-assessment, 7of 10 patients showed good to excellent response. Two patients had fair response and 1 patient showed poor response to treatment. Conclusion: Botulinum toxin was found to be safe and effective therapy for the management of androgenetic alopecia in this pilot study. Studies with larger sample size and randomized controlled trials are required to establish the role of botulinum toxin in the management of androgenetic alopecia.

Combined curative radiation therapy alone in (T1) T2-3 rectal adenocarcinoma: a pilot study of 29 patients

International Nuclear Information System (INIS)

Gerard, J.P.; Roy, P.; Coquard, R.; Barbet, N.; Romestaing, P.; Ayzac, L.; Ardiet, J.M.; Thalabard, J.C.

1996-01-01

Aim: Analysis of a pilot study including 29 consecutive patients with high surgical risk or refusal of colostomy treated with radiation therapy alone with curative intent. Patients: Between 1986 and 1992, 29 patients were treated for infiltrating adenocarcinoma of the rectum. Median age was 72 years. Transrectal ultrasound staging was used in 24 patients (T1, 2; T2, 14; T3, 13; N0, 23; N1, 6). In 20 patients the lower border of the tumor was at 5 cm or less from the anal verge and in 19 patients the diameter exceeded 3 cm. CEA was elevated in seven cases. Treatment: Contact X-ray (50 kV) was given first (70 Gy/3 fractions). External beam radiation therapy used a three-field technique in the prone position. Accelerated schedule (39 Gy/13 fractions/17 days) with a concomitant boost 'field within the field' (4 Gy/4 fractions). Six weeks later an iridium-192 implant was performed in 21 (20 Gy/22 h). Results: Median follow-up time was 46 months. Overall and specific survival at 5 years was 68% (SE = 0.09) and 76% (SE = 0.08). Local control was obtained in (21(29)) patients (72%). There was one grade 2 rectal bleeding and five grade 2 rectal necroses. The overall tolerance was good in these frail patients. Discussion: For T2. T3 or T1 > 3 cm diameter rectal adenocarcinoma, where contact X-ray alone is not recommended, a combined treatment with radiation therapy alone is able to give good local control with acceptable toxicity. This treatment should be restricted to inoperable patients

Polyethylene glycol intestinal lavage in addition to usual antibiotic treatment for severe Clostridium difficile colitis: a randomised controlled pilot study.

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McCreery, Greig; Jones, Philip M; Kidane, Biniam; DeMelo, Vanessa; Mele, Tina

2017-07-31

Clostridium difficile infections (CDI) are common, costly and potentially life threatening. Most CDI will respond to antibiotic therapy, but 3%-10% of all patients with CDI will progress to a severe, life-threatening course. Complete removal of the large bowel is indicated for severe CDI. However, the 30-day mortality following surgical intervention for severe CDI ranges from 20% to 70%. A less invasive approach using surgical faecal diversion and direct colonic lavage with polyethylene glycol (PEG) and vancomycin has demonstrated a relative mortality reduction of approximately 50%. As an alternative to these operative approaches, we propose to treat patients with bedside intestinal lavage with PEG and vancomycin instillation via nasojejunal tube, in addition to usual antibiotic management. Preliminary data collected by our research group are encouraging. We will conduct a 1-year, single-centre, pilot randomised controlled trial to study this new treatment strategy for patients with severe CDI and additional risk factors for fulminant or complicated infection. After informed consent, patients with severe-complicated CDI without immediate indication for surgery will be randomised to either usual antibiotic treatment or usual antibiotic treatment with the addition of 8 L of PEG lavage via nasojejunal tube. This pilot trial will evaluate our eligibility and enrolment rate, protocol compliance and adverse event rates and provide further data to inform a more robust sample size calculation and protocol modifications for a definitive multicentre trial design. Based on historical data, we anticipate enrolling approximately 24 patients during the 1-year pilot study period.As a pilot study, data will be reported in aggregate. Between-group differences will be assessed in a blinded fashion for evidence of harm, and to further refine our sample size calculation. This study protocol has been reviewed and approved by our local institutional review board. Results of the pilot

Seaside, Oregon, Tsunami Vulnerability Assessment Pilot Study

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Dunbar, P. K.; Dominey-Howes, D.; Varner, J.

2006-12-01

The results of a pilot study to assess the risk from tsunamis for the Seaside-Gearhart, Oregon region will be presented. To determine the risk from tsunamis, it is first necessary to establish the hazard or probability that a tsunami of a particular magnitude will occur within a certain period of time. Tsunami inundation maps that provide 100-year and 500-year probabilistic tsunami wave height contours for the Seaside-Gearhart, Oregon, region were developed as part of an interagency Tsunami Pilot Study(1). These maps provided the probability of the tsunami hazard. The next step in determining risk is to determine the vulnerability or degree of loss resulting from the occurrence of tsunamis due to exposure and fragility. The tsunami vulnerability assessment methodology used in this study was developed by M. Papathoma and others(2). This model incorporates multiple factors (e.g. parameters related to the natural and built environments and socio-demographics) that contribute to tsunami vulnerability. Data provided with FEMA's HAZUS loss estimation software and Clatsop County, Oregon, tax assessment data were used as input to the model. The results, presented within a geographic information system, reveal the percentage of buildings in need of reinforcement and the population density in different inundation depth zones. These results can be used for tsunami mitigation, local planning, and for determining post-tsunami disaster response by emergency services. (1)Tsunami Pilot Study Working Group, Seaside, Oregon Tsunami Pilot Study--Modernization of FEMA Flood Hazard Maps, Joint NOAA/USGS/FEMA Special Report, U.S. National Oceanic and Atmospheric Administration, U.S. Geological Survey, U.S. Federal Emergency Management Agency, 2006, Final Draft. (2)Papathoma, M., D. Dominey-Howes, D.,Y. Zong, D. Smith, Assessing Tsunami Vulnerability, an example from Herakleio, Crete, Natural Hazards and Earth System Sciences, Vol. 3, 2003, p. 377-389.

Glycemic variability and insulin needs in patients with type 1 diabetes mellitus supplemented with vitamin D: a pilot study using continuous glucose monitoring system.

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Felício, Karem Miléo; de Souza, Ana Carolina Contente Braga; Neto, João Felício Abrahão; de Melo, Franciane Trindade Cunha; Carvalho, Carolina Tavares; Arbage, Thaís Pontes; de Rider Brito, Hana Andrade; Peixoto, Amanda Soares; de Oliveira, Alana Ferreira; de Souza Resende, Fabricio; Reis, Scarlatt Sousa; Motta, Ana Regina; da Costa Miranda, Henrique; Janaú, Luísa Corrêa; Yamada, Elizabeth Sumi; Felício, João Soares

2017-06-15

Recent studies suggest that glycemic variability could influence the risk of complications in type 1 diabetes mellitus (T1DM). There are no data about the action of vitamin D (VD) on glycemic variability. Our pilot study aims to evaluate glycemic variability and insulin needs in patients with T1DM supplemented with VD. 22 patients received doses of 4000 and 10000 IU/day of cholecalciferol for 12 weeks, according to the patient's baseline VD levels and underwent continuous glucose monitoring system. Correlations were found between percentage variation (∆) of glycemia standard deviation (∆SDG), calculated using continuous glucose monitoring, with ∆ of basal (r= 0.6; p needed by patients is lower when VD status is better. We divided patients in two subgroups: SDG improved (subgroup 1; n =12 (55%)) and SDG worsened (subgroup 2; n =10 (45%)). Group 1, compared to subgroup 2, required a lower insulin dose (∆basal insulin dose = -8.0 vs 6.3%; p needs and lower frequency of hypoglycemia in patients with T1DM. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study.

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Benhamou, Pierre Yves; Huneker, Erik; Franc, Sylvia; Doron, Maeva; Charpentier, Guillaume

2018-06-01

Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach. A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters. Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70-180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses. This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety. This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.

Acceptability and preliminary feasibility of an internet/CD-ROM-based education and decision program for early-stage prostate cancer patients: randomized pilot study.

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Diefenbach, Michael A; Mohamed, Nihal E; Butz, Brian P; Bar-Chama, Natan; Stock, Richard; Cesaretti, Jamie; Hassan, Waleed; Samadi, David; Hall, Simon J

2012-01-13

Prostate cancer is the most common cancer affecting men in the United States. Management options for localized disease exist, yet an evidence-based criterion standard for treatment still has to emerge. Although 5-year survival rates approach 98%, all treatment options carry the possibility for significant side effects, such as erectile dysfunction and urinary incontinence. It is therefore recommended that patients be actively involved in the treatment decision process. We have developed an Internet/CD-ROM-based multimedia Prostate Interactive Educational System (PIES) to enhance patients' treatment decision making. PIES virtually mirrors a health center to provide patients with information about prostate cancer and its treatment through an intuitive interface, using videos, animations, graphics, and texts. (1) To examine the acceptability and feasibility of the PIES intervention and to report preliminary outcomes of the program in a pilot trial among patients with a new prostate cancer diagnosis, and (2) to explore the potential impact of tailoring PIES treatment information to participants' information-seeking styles on study outcomes. Participants (n = 72) were patients with newly diagnosed localized prostate cancer who had not made a treatment decision. Patients were randomly assigned to 3 experimental conditions: (1) control condition (providing information through standard National Cancer Institute brochures; 26%), and PIES (2) with tailoring (43%) and (3) without tailoring to a patient's information-seeking style (31%). Questionnaires were administrated before (t1) and immediately after the intervention (t2). Measurements include evaluation and acceptability of the PIES intervention, monitoring/blunting information-seeking style, psychological distress, and decision-related variables (eg, decisional confidence, feeling informed about prostate cancer and treatment, and treatment preference). The PIES program was well accepted by patients and did not interfere

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: a randomized controlled pilot study.

NARCIS (Netherlands)

Kessels, R.P.C.; Hensken, L.M.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

Effects of errorless skill learning in people with mild-to-moderate or severe dementia: A randomized controlled pilot study

NARCIS (Netherlands)

Kessels, R.P.C.; Olde Hensken, L.M.G.

2009-01-01

This pilot study examines whether learning without errors is advantageous compared to trial-and-error learning in people with dementia using a procedural task and a randomized case-control design. A sample of 60 people was recruited, consisting of 20 patients with severe dementia, 20 patients with

A pilot study of minocycline for the prevention of paclitaxel-associated neuropathy: ACCRU study RU221408I.

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Pachman, Deirdre R; Dockter, Travis; Zekan, Patricia J; Fruth, Briant; Ruddy, Kathryn J; Ta, Lauren E; Lafky, Jacqueline M; Dentchev, Todor; Le-Lindqwister, Nguyet Anh; Sikov, William M; Staff, Nathan; Beutler, Andreas S; Loprinzi, Charles L

2017-11-01

Paclitaxel is associated with both an acute pain syndrome (P-APS) and chronic chemotherapy-induced peripheral neuropathy (CIPN). Given that extensive animal data suggest that minocycline may prevent chemotherapy-induced neurotoxicity, the purpose of this pilot study was to investigate the efficacy of minocycline for the prevention of CIPN and the P-APS. Patients with breast cancer were enrolled prior to initiating neoadjuvant or adjuvant weekly paclitaxel for 12 weeks and were randomized to receive minocycline 200 mg on day 1 followed by 100 mg twice daily or a matching placebo. Patients completed (1) an acute pain syndrome questionnaire daily during chemotherapy to measure P-APS and (2) the EORTC QLQ-CIPN20 questionnaire at baseline, prior to each dose of paclitaxel, and monthly for 6 months post treatment, to measure CIPN. Forty-seven patients were randomized. There were no remarkable differences noted between the minocycline and placebo groups for the overall sensory neuropathy score of the EORTC QLQ-CIPN20 or its individual components, which evaluate tingling, numbness and shooting/burning pain in hands and feet. However, patients taking minocycline had a significant reduction in the daily average pain score attributed to P-APS (p = 0.02). Not only were no increased toxicities reported with minocycline, but there was a significant reduction in fatigue (p = 0.02). Results of this pilot study do not support the use of minocycline to prevent CIPN, but suggest that it may reduce P-APS and decrease fatigue; further study of the impact of this agent on those endpoints may be warranted.

Quantum Physics Principles and Communication in the Acute Healthcare Setting: A Pilot Study.

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Helgeson, Heidi L; Peyerl, Colleen Kraft; Solheim-Witt, Marit

This pilot study explores whether clinician awareness of quantum physics principles could facilitate open communication between patients and providers. In the spirit of action research, this study was conceptualized with a holistic view of human health, using a mixed method design of grounded theory as an emergent method. Instrumentation includes surveys and a focus group discussion with twelve registered nurses working in an acute care hospital setting. Findings document that the preliminary core phenomenon, energy as information, influences communication in the healthcare environment. Key emergent themes include awareness, language, validation, open communication, strategies, coherence, incoherence and power. Research participants indicate that quantum physics principles provide a language and conceptual framework for improving their awareness of communication and interactions in the healthcare environment. Implications of this pilot study support the feasibility of future research and education on awareness of quantum physics principles in other clinical settings. Copyright © 2016 Elsevier Inc. All rights reserved.

The Detection of Patients at Risk of Gastrointestinal Toxicity during Pelvic Radiotherapy by Electronic Nose and FAIMS: A Pilot Study

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Covington, James A.; Wedlake, Linda; Andreyev, Jervoise; Ouaret, Nathalie; Thomas, Matthew G.; Nwokolo, Chuka U.; Bardhan, Karna D.; Arasaradnam, Ramesh P.

2012-01-01

It is well known that the electronic nose can be used to identify differences between human health and disease for a range of disorders. We present a pilot study to investigate if the electronic nose and a newer technology, FAIMS (Field Asymmetric Ion Mobility Spectrometry), can be used to identify and help inform the treatment pathway for patients receiving pelvic radiotherapy, which frequently causes gastrointestinal side-effects, severe in some. From a larger group, 23 radiotherapy patients were selected where half had the highest levels of toxicity and the others the lowest. Stool samples were obtained before and four weeks after radiotherapy and the volatiles and gases emitted analysed by both methods; these chemicals are products of fermentation caused by gut microflora. Principal component analysis of the electronic nose data and wavelet transform followed by Fisher discriminant analysis of FAIMS data indicated that it was possible to separate patients after treatment by their toxicity levels. More interestingly, differences were also identified in their pre-treatment samples. We believe these patterns arise from differences in gut microflora where some combinations of bacteria result to give this olfactory signature. In the future our approach may result in a technique that will help identify patients at “high risk” even before radiation treatment is started. PMID:23201982

The Detection of Patients at Risk of Gastrointestinal Toxicity during Pelvic Radiotherapy by Electronic Nose and FAIMS: A Pilot Study

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Ramesh P. Arasaradnam

2012-09-01

Full Text Available It is well known that the electronic nose can be used to identify differences between human health and disease for a range of disorders. We present a pilot study to investigate if the electronic nose and a newer technology, FAIMS (Field Asymmetric Ion Mobility Spectrometry, can be used to identify and help inform the treatment pathway for patients receiving pelvic radiotherapy, which frequently causes gastrointestinal side-effects, severe in some. From a larger group, 23 radiotherapy patients were selected where half had the highest levels of toxicity and the others the lowest. Stool samples were obtained before and four weeks after radiotherapy and the volatiles and gases emitted analysed by both methods; these chemicals are products of fermentation caused by gut microflora. Principal component analysis of the electronic nose data and wavelet transform followed by Fisher discriminant analysis of FAIMS data indicated that it was possible to separate patients after treatment by their toxicity levels. More interestingly, differences were also identified in their pre-treatment samples. We believe these patterns arise from differences in gut microflora where some combinations of bacteria result to give this olfactory signature. In the future our approach may result in a technique that will help identify patients at “high risk” even before radiation treatment is started.

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

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

2017-07-01

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

Reflexology treatment for patients with lower limb amputations and phantom limb pain--an exploratory pilot study.

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Brown, Christine Ann; Lido, Catherine

2008-05-01

The objectives of the study were to evaluate the possibility of reflexology being used as a non-invasive form of phantom limb pain relief and of empowering patients to maintain any positive results with self-treatment. Prosthetic Services Centre, Herbert Street, Wolverhampton, West Midlands, England. A same-subject, experimental pilot study, recording the intensity of phantom limb pain in weekly pain diaries over a 30-week period, which was divided into five phases: phase 1 gave a baseline of pain, whilst phase 3 was a resting phase. Phases 2, 4 and 5 provided the reflexology interventions. Ten participants with unilateral lower limb amputations and phantom limb pain were selected from the database at the Prosthetic Centre. REFLEXOLOGY INTERVENTIONS: In phase 2, six weekly reflexology treatments were given, which consisted of: full foot reflexology to the remaining foot and full hand reflexology to the hand of the amputated side of the body. In phase 4, six weekly hand reflexology teaching sessions were carried out; patients copied on their own hands what the therapist did on hers. A hand reflexology booklet gave the sequence of the treatment and was used as a reference. In phase 5, the patients self-treated for 6 weeks at home, using the reference material. Over the 30-week period, there was an improvement in the perception of the presence and the intensity of the phantom limb pain, with a corresponding improvement in the duration of the pain and the affect on the person's lifestyle. The improvement was maintained when the clients self-treated. FOLLOW-UP QUESTIONNAIRE: A follow-up questionnaire was carried out in 2007--12 months after the project had ended--to elicit whether the patients had suffered from phantom pain over the previous 12 months, whether they still had relief from phantom limb pain and whether they still self-treated. The project indicated that reflexology treatment, teaching and self-treatment were effective in eradicating or reducing the

Cervicocephalic kinesthetic sensibility and postural balance in patients with nontraumatic chronic neck pain – a pilot study

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Palmgren, Per J; Andreasson, Daniel; Eriksson, Magnus; Hägglund, Andreas

2009-01-01

Background Although cervical pain is widespread, most victims are only mildly and occasionally affected. A minority, however, suffer chronic pain and/or functional impairments. Although there is abundant literature regarding nontraumatic neck pain, little focuses on diagnostic criteria. During the last decade, research on neck pain has been designed to evaluate underlying pathophysiological mechanisms, without noteworthy success. Independent researchers have investigated postural balance and cervicocephalic kinesthetic sensibility among patients with chronic neck pain, and have (in most cases) concluded the source of the problem is a reduced ability in the neck's proprioceptive system. Here, we investigated cervicocephalic kinesthetic sensibility and postural balance among patients with nontraumatic chronic neck pain. Methods Ours was a two-group, observational pilot study of patients with complaints of continuous neck pain during the 3 months prior to recruitment. Thirteen patients with chronic neck pain of nontraumatic origin were recruited from an institutional outpatient clinic. Sixteen healthy persons were recruited as a control group. Cervicocephalic kinesthetic sensibility was assessed by exploring head repositioning accuracy and postural balance was measured with computerized static posturography. Results Parameters of cervicocephalic kinesthetic sensibility were not reduced. However, in one of six test movements (flexion), global repositioning errors were significantly larger in the experimental group than in the control group (p < .05). Measurements did not demonstrate any general impaired postural balance, and varied substantially among participants in both groups. Conclusion In patients with nontraumatic chronic neck pain, we found statistically significant global repositioning errors in only one of six test movements. In this cohort, we found no evidence of impaired postural balance. Head repositioning accuracy and computerized static posturography are

A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study.

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Balachandran, Jay S; Yu, Xiaohong; Wroblewski, Kristen; Mokhlesi, Babak

2013-03-15

CPAP adherence patterns are often established very early in the course of therapy. Our objective was to quantify patients' perception of CPAP therapy using a 6-item questionnaire administered in the morning following CPAP titration. We hypothesized that questionnaire responses would independently predict CPAP adherence during the first 30 days of therapy. We retrospectively reviewed the CPAP perception questionnaires of 403 CPAP-naïve adults who underwent in-laboratory titration and who had daily CPAP adherence data available for the first 30 days of therapy. Responses to the CPAP perception questionnaire were analyzed for their association with mean CPAP adherence and with changes in daily CPAP adherence over 30 days. Patients were aged 52 ± 14 years, 53% were women, 54% were African American, the mean body mass index (BMI) was 36.3 ± 9.1 kg/m(2), and most patients had moderate-severe OSA. Four of 6 items from the CPAP perception questionnaire- regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit-were significantly correlated with mean 30-day CPAP adherence, and a composite score from these 4 questions was found to be internally consistent. Stepwise linear regression modeling demonstrated that 3 variables were significant and independent predictors of reduced mean CPAP adherence: worse score on the 4-item questionnaire, African American race, and non-sleep specialist ordering polysomnogram and CPAP therapy. Furthermore, a worse score on the 4-item CPAP perception questionnaire was consistently associated with decreased mean daily CPAP adherence over the first 30 days of therapy. In this pilot study, responses to a 4-item CPAP perception questionnaire administered to patients immediately following CPAP titration independently predicted mean CPAP adherence during the first 30 days. Further prospective validation of this questionnaire in different patient populations is warranted.

Prevalence of xerostomia and hyposalivation and their association with quality of life in elderly patients in dependence on dental status and prosthetic rehabilitation: a pilot study.

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Hahnel, Sebastian; Schwarz, Simone; Zeman, Florian; Schäfer, Lina; Behr, Michael

2014-06-01

The aims of this pilot study were to investigate the prevalence of xerostomia and hyposalivation and their impact on quality of life in a cohort of elderly patients including dental status and the character of potential prosthetic restorations as independent variables. Patients aged 60 years or older without any objective or subjective need for prosthodontic treatment taking part in a regular recall programme were included in the trial. Quality of life was assessed using the German version of the GOHAI; prevalence and severity of xerostomia was investigated using the shortened version of the Xerostomia Inventory (XI). Stimulated salivary flow rate was determined using a sialometric approach. Dental status and the character of prosthetic restorations (no/fixed restorations and removable but tooth-supported dentures vs. gum-supported dentures) were assessed in a clinical examination by experienced dentists specialized in prosthodontic treatment. A total of 68 patients were included in the trial; a prevalence of xerostomia of 16% and a prevalence of hyposalivation of 31% were identified. The quality of life in the study cohort decreased significantly as a function of xerostomia severity but not salivary flow; moreover, a significant impact of the number of teeth/implants in the upper jaw and the presence of gum-supported dentures in both jaws on GOHAI scores could be identified. Within the limitations of a pilot study, the results support the assumption that the quality of life in elderly patients is particularly related to their subjective perception of xerostomia. A decline in salivary flow, the dental status and the character of prosthetic restorations appear to play a subordinate role for the quality of life in elderly patients. The quality of life in elderly patients may be severely diminished due to an increased subjective perception of dry mouth. Dental treatment should focus on alleviating xerostomia, whereas the impact of dental status and prosthetic

Gut microbiome composition in lean patients with NASH is associated with liver damage independent of caloric intake: A prospective pilot study.

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Duarte, S M B; Stefano, J T; Miele, L; Ponziani, F R; Souza-Basqueira, M; Okada, L S R R; de Barros Costa, F G; Toda, K; Mazo, D F C; Sabino, E C; Carrilho, F J; Gasbarrini, A; Oliveira, C P

2018-04-01

The aim of the study was to compare the gut microbiomes from obese and lean patients with or without NASH to outline phenotypic differences. We performed a cross-sectional pilot study comprising biopsy-proven NASH patients grouped according to BMI. Microbiome DNA was extracted from stool samples, and PCR amplification was performed using primers for the V4 region of the 16S rRNA gene. The amplicons were sequenced using the Ion PGM Torrent platform, and data were analyzed using QIIME software. Macronutrient consumption was analyzed by a 7-day food record. Liver fibrosis ≥ F2 was associated with increased abundance of Lactobacilli (p = 0.0007). NASH patients showed differences in Faecalibacterium, Ruminococcus, Lactobacillus and Bifidobacterium abundance compared with the control group. Lean NASH patients had a 3-fold lower abundance of Faecalibacterium and Ruminococcus (p = 0.004), obese NASH patients were enriched in Lactobacilli (p = 0.002), and overweight NASH patients had reduced Bifidobacterium (p = 0.018). Moreover, lean NASH patients showed a deficiency in Lactobacillus compared with overweight and obese NASH patients. This group also appeared similar to the control group with regard to gut microbiome alpha diversity. Although there were qualitative differences between lean NASH and overweight/obese NASH, they were not statistically significant (p = 0.618). The study limitations included a small sample size, a food questionnaire that collected only qualitative and semi-quantitative data, and variations in group gender composition that may influence differences in FXR signaling, bile acids metabolism and the composition of gut microbiota. Our preliminary finding of a different pathogenetic process in lean NASH patients needs to be confirmed by larger studies, including those with patient populations stratified by sex and dietary habits. Copyright © 2017 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the

Evaluation of the Appropriate Washout Period Following Fan Therapy for Dyspnea in Patients With Advanced Cancer: A Pilot Study.

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Kako, Jun; Morita, Tatsuya; Yamaguchi, Takuhiro; Sekimoto, Asuko; Kobayashi, Masamitsu; Kinoshita, Hiroya; Ogawa, Asao; Zenda, Sadamoto; Uchitomi, Yosuke; Inoguchi, Hironobu; Matsushima, Eisuke

2018-02-01

To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients' face surface temperature after fan therapy. In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants' (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.

What is a pilot or feasibility study? A review of current practice and editorial policy

Directory of Open Access Journals (Sweden)

Cooper Cindy L

2010-07-01

Full Text Available Abstract Background In 2004, a review of pilot studies published in seven major medical journals during 2000-01 recommended that the statistical analysis of such studies should be either mainly descriptive or focus on sample size estimation, while results from hypothesis testing must be interpreted with caution. We revisited these journals to see whether the subsequent recommendations have changed the practice of reporting pilot studies. We also conducted a survey to identify the methodological components in registered research studies which are described as 'pilot' or 'feasibility' studies. We extended this survey to grant-awarding bodies and editors of medical journals to discover their policies regarding the function and reporting of pilot studies. Methods Papers from 2007-08 in seven medical journals were screened to retrieve published pilot studies. Reports of registered and completed studies on the UK Clinical Research Network (UKCRN Portfolio database were retrieved and scrutinized. Guidance on the conduct and reporting of pilot studies was retrieved from the websites of three grant giving bodies and seven journal editors were canvassed. Results 54 pilot or feasibility studies published in 2007-8 were found, of which 26 (48% were pilot studies of interventions and the remainder feasibility studies. The majority incorporated hypothesis-testing (81%, a control arm (69% and a randomization procedure (62%. Most (81% pointed towards the need for further research. Only 8 out of 90 pilot studies identified by the earlier review led to subsequent main studies. Twelve studies which were interventional pilot/feasibility studies and which included testing of some component of the research process were identified through the UKCRN Portfolio database. There was no clear distinction in use of the terms 'pilot' and 'feasibility'. Five journal editors replied to our entreaty. In general they were loathe to publish studies described as 'pilot'. Conclusion

Exploring the use of tablet computer-based electronic data capture system to assess patient reported measures among patients with chronic kidney disease: a pilot study.

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Wong, Dorothy; Cao, Shen; Ford, Heather; Richardson, Candice; Belenko, Dmitri; Tang, Evan; Ugenti, Luca; Warsmann, Eleanor; Sissons, Amanda; Kulandaivelu, Yalinie; Edwards, Nathaniel; Novak, Marta; Li, Madeline; Mucsi, Istvan

2017-12-06

Collecting patient reported outcome measures (PROMs) via computer-based electronic data capture system may improve feasibility and facilitate implementation in clinical care. We report our initial experience about the acceptability of touch-screen tablet computer-based, self-administered questionnaires among patients with chronic kidney disease (CKD), including stage 5 CKD treated with renal replacement therapies (RRT) (either dialysis or transplant). We enrolled a convenience sample of patients with stage 4 and 5 CKD (including patients on dialysis or after kidney transplant) in a single-centre, cross-sectional pilot study. Participants completed validated questionnaires programmed on an electronic data capture system (DADOS, Techna Inc., Toronto) on tablet computers. The primary objective was to evaluate the acceptability and feasibility of using tablet-based electronic data capture in patients with CKD. Descriptive statistics, Fischer's exact test and multivariable logistic regression models were used for data analysis. One hundred and twenty one patients (55% male, mean age (± SD) of 58 (±14) years, 49% Caucasian) participated in the study. Ninety-two percent of the respondents indicated that the computer tablet was acceptable and 79% of the participants required no or minimal help for completing the questionnaires. Acceptance of tablets was lower among patients 70 years or older (75% vs. 95%; p = 0.011) and with little previous computer experience (81% vs. 96%; p = 0.05). Furthermore, a greater level of assistance was more frequently required by patients who were older (45% vs. 15%; p = 0.009), had lower level of education (33% vs. 14%; p = 0.027), low health literacy (79% vs. 12%; p = 0.027), and little previous experience with computers (52% vs. 10%; p = 0.027). Tablet computer-based electronic data capture to administer PROMs was acceptable and feasible for most respondents and could therefore be used to systematically assess PROMs

Medical Student and Tutor Perceptions of Video Versus Text in an Interactive Online Virtual Patient for Problem-Based Learning: A Pilot Study

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Ellaway, Rachel H; Round, Jonathan; Vaughan, Sophie; Poulton, Terry; Zary, Nabil

2015-01-01

Background The impact of the use of video resources in primarily paper-based problem-based learning (PBL) settings has been widely explored. Although it can provide many benefits, the use of video can also hamper the critical thinking of learners in contexts where learners are developing clinical reasoning. However, the use of video has not been explored in the context of interactive virtual patients for PBL. Objective A pilot study was conducted to explore how undergraduate medical students interpreted and evaluated information from video- and text-based materials presented in the context of a branched interactive online virtual patient designed for PBL. The goal was to inform the development and use of virtual patients for PBL and to inform future research in this area. Methods An existing virtual patient for PBL was adapted for use in video and provided as an intervention to students in the transition year of the undergraduate medicine course at St George’s, University of London. Survey instruments were used to capture student and PBL tutor experiences and perceptions of the intervention, and a formative review meeting was run with PBL tutors. Descriptive statistics were generated for the structured responses and a thematic analysis was used to identify emergent themes in the unstructured responses. Results Analysis of student responses (n=119) and tutor comments (n=18) yielded 8 distinct themes relating to the perceived educational efficacy of information presented in video and text formats in a PBL context. Although some students found some characteristics of the videos beneficial, when asked to express a preference for video or text the majority of those that responded to the question (65%, 65/100) expressed a preference for text. Student responses indicated that the use of video slowed the pace of PBL and impeded students’ ability to review and critically appraise the presented information. Conclusions Our findings suggest that text was perceived to be a

Medical Student and Tutor Perceptions of Video Versus Text in an Interactive Online Virtual Patient for Problem-Based Learning: A Pilot Study.

Science.gov (United States)

Woodham, Luke A; Ellaway, Rachel H; Round, Jonathan; Vaughan, Sophie; Poulton, Terry; Zary, Nabil

2015-06-18

The impact of the use of video resources in primarily paper-based problem-based learning (PBL) settings has been widely explored. Although it can provide many benefits, the use of video can also hamper the critical thinking of learners in contexts where learners are developing clinical reasoning. However, the use of video has not been explored in the context of interactive virtual patients for PBL. A pilot study was conducted to explore how undergraduate medical students interpreted and evaluated information from video- and text-based materials presented in the context of a branched interactive online virtual patient designed for PBL. The goal was to inform the development and use of virtual patients for PBL and to inform future research in this area. An existing virtual patient for PBL was adapted for use in video and provided as an intervention to students in the transition year of the undergraduate medicine course at St George's, University of London. Survey instruments were used to capture student and PBL tutor experiences and perceptions of the intervention, and a formative review meeting was run with PBL tutors. Descriptive statistics were generated for the structured responses and a thematic analysis was used to identify emergent themes in the unstructured responses. Analysis of student responses (n=119) and tutor comments (n=18) yielded 8 distinct themes relating to the perceived educational efficacy of information presented in video and text formats in a PBL context. Although some students found some characteristics of the videos beneficial, when asked to express a preference for video or text the majority of those that responded to the question (65%, 65/100) expressed a preference for text. Student responses indicated that the use of video slowed the pace of PBL and impeded students' ability to review and critically appraise the presented information. Our findings suggest that text was perceived to be a better source of information than video in virtual

Gaming and conventional exercises for improvement of arm function after stroke: a randomised controlled pilot study

NARCIS (Netherlands)