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Sample records for qol prospective pilot

  1. Effects of radiotherapy for brain metastases on quality of life (QoL). Prospective pilot study of the DEGRO QoL working party

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    Steinmann, Diana; Bruns, Frank [Medical School, Hannover (Germany). Radiation Oncology; Schaefer, Christof; Hipp, Matthias [Regensburg Univ. (Germany). Radiation Oncology; Oorschot, Birgitt van [Wuerzburg Univ. (Germany). Radiation Oncology; Wypior, Hans-Joachim [Hospital Landshut (Germany). Radiation Oncology; Boelling, Tobias [Muenster Univ. (Germany). Radiation Oncology; Sehlen, Susanne [Ludwig Maximilians Univ., Muenchen (Germany). Radiation Oncology; Hagg, Juliane [Ulm Univ. (Germany). Radiation Oncology; Bayerl, Anja [Hospital Krems (Austria). Radiation Oncology; Geinitz, Hans [Technical Univ. Muenchen (Germany). Radiation Oncology; Vordermark, Dirk [Halle-Wittenberg Univ., Halle (Germany). Radiation Oncology

    2009-03-15

    Background: Prospective data on quality-of-life (QoL) effects of radiotherapy for brain metastases are currently lacking, but would be of great interest to guide therapeutic decisions. Patients and Methods: From 01/2007 to 08/2007, 46 patients with previously untreated brain metastases were recruited at eight centers. QoL was measured at start of treatment (T{sub 0}) and at 3 months ({sub T3mo}). In the pilot study, two combinations of QoL instruments could be used at the discretion of the centers (A: EORTC QLQ-C30 and B: EORTC QLQ-C15-PAL both with brain module BN20, assessment by proxies with A: Palliative Care Outcome Scale, B: self-constructed brain-specific instrument). Results: All patients received whole-brain radiotherapy, four with an additional boost irradiation. At T{sub 3mo}, 26/46 patients (56.5%) had died. 17/20 survivors (85%) completed the questionnaires. In 3-month survivors, QoL deteriorated in most domains, significant in drowsiness, hair loss and weakness of legs. The scores for headaches and seizures were slightly better after 3 months. Assessment by proxies also suggested worsening of QoL. Initial QoL at T{sub 0} was better in those alive than in those deceased at T{sub 3mo}, significant for physical function and for the symptom scales of fatigue and pain, motor dysfunction, communication deficit and weakness of legs. Conclusion: Practicability and compliance appeared better with the (shorter) version B. This version is now used in the ongoing main phase of the study with additional centers. First results indicate a moderate worsening of QoL during the first 3 months after start of palliative radiotherapy for brain metastases. QoL at initiation of radiotherapy may be prognostic for survival. (orig.)

  2. Neuro-QOL

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    Lai, J.-S.; Nowinski, C.J.; Victorson, D.; Peterman, A.; Miller, D.; Bethoux, F.; Heinemann, A.; Rubin, S.; Cavazos, J.E.; Reder, A.T.; Sufit, R.; Simuni, T.; Holmes, G.L.; Siderowf, A.; Wojna, V.; Bode, R.; McKinney, N.; Podrabsky, T.; Wortman, K.; Choi, S.; Gershon, R.; Rothrock, N.; Moy, C.

    2012-01-01

    Objective: To address the need for brief, reliable, valid, and standardized quality of life (QOL) assessment applicable across neurologic conditions. Methods: Drawing from larger calibrated item banks, we developed short measures (8–9 items each) of 13 different QOL domains across physical, mental, and social health and evaluated their validity and reliability. Three samples were utilized during short form development: general population (Internet-based, n = 2,113); clinical panel (Internet-based, n = 553); and clinical outpatient (clinic-based, n = 581). All short forms are expressed as T scores with a mean of 50 and SD of 10. Results: Internal consistency (Cronbach α) of the 13 short forms ranged from 0.85 to 0.97. Correlations between short form and full-length item bank scores ranged from 0.88 to 0.99 (0.82–0.96 after removing common items from banks). Online respondents were asked whether they had any of 19 different chronic health conditions, and whether or not those reported conditions interfered with ability to function normally. All short forms, across physical, mental, and social health, were able to separate people who reported no health condition from those who reported 1–2 or 3 or more. In addition, scores on all 13 domains were worse for people who acknowledged being limited by the health conditions they reported, compared to those who reported conditions but were not limited by them. Conclusion: These 13 brief measures of self-reported QOL are reliable and show preliminary evidence of concurrent validity inasmuch as they differentiate people based upon number of reported health conditions and whether those reported conditions impede normal function. PMID:22573626

  3. Wood torrefaction. Pilot tests and utilisation prospects

    Energy Technology Data Exchange (ETDEWEB)

    Wilen, C.; Jukola, P.; Jarvinen, T.; Sipila, K. [VTT Technical Reseach Centre of Finland, Espoo (Finland); Verhoeff, F.; Kiel, J. [Energy research Centre of the Netherlands, LE Petten (Netherlands)

    2013-09-15

    The research project 'Torrefaction of woody biomasses as energy carriers for the European markets' was carried out within the Tekes BioRefine programme in 2010-2012 and was coordinated by VTT. The main objective of the project was to create a discussion platform and collate basic information for the Finnish industrial stakeholders involved in developing torrefaction technology or planning to include torrefied biomass in their fuel supply for energy production. Given the availability of torrefaction pilot facilities in Europe, it was decided at an early phase of the national torrefaction research project not to build and operate separate pilot equipment, and thus save time and money. Experimental research was conducted in cooperation with ECN, The Netherlands. Finnish wood chips and crushed forest residue were tested at different torrefaction temperatures in the PATRIG torrefaction test rig with great success, and large quantities of torrefied wood chips and pellets were produced. CFD simulation work was carried out at VTT to investigate the feasibility of torrefied fuels to replace part of the coal. From the combustion point of view it seems feasible to replace coal by torrefied wood biomass with shares up to 50% by weight. Basic, small-scale experiments were carried out to compare torrefied wood pellets with conventional wood and straw pellets with regard to their handling and storage properties. The experiments showed that the torrefied pellets are clearly more hydrophobic than wood and straw pellets and do not disintegrate completely on exposure to water. A study on dust explosion and self-ignition characteristics indicated that the torrefied dust does not differ significantly from the normal biomass dust, but is clearly more reactive than coal dust. Commercial development of torrefaction is currently in its early phase. The current general view is that most of the demonstration plants have technical problems, which have delayed their commercial

  4. Complex tibial fractures are associated with lower social classes and predict early exit from employment and worse patient-reported QOL: a prospective observational study of 46 complex tibial fractures treated with a ring fixator.

    Science.gov (United States)

    Elsoe, Rasmus; Larsen, Peter; Petruskevicius, Juozas; Kold, Søren

    2018-04-01

    The long-term outcomes following complex fractures of the tibia are reported to carry a risk of knee pain, malalignment, articular injury and post-traumatic osteoarthritis. The main objective of this study was to account for the patient-reported quality of life (QOL) 12 months after ring fixator removal in patients with a complex tibial fracture. Secondary objectives included a review of the socio-economic characteristics of the patient group and the rate of return to work in the study period. A prospective follow-up study was conducted of 60 patients with complex fractures of the tibia treated with ring external fixation. Patient-reported outcomes, radiological outcomes and socio-economic status including employment status of the patients were obtained 12 months after frame removal. Forty-six patients completed the assessment 12 months after frame removal (77%). The mean age of the patient at the time of fracture was 54.6 years (range 31-86). There were 19 males and 27 females. At 12 months after frame removal, the mean EQ5D-5L index was 0.66 (CI 0.60-0.72). The mean EQ5D-5L VAS was 69 (CI 61-76). When this was compared to the established reference population from Denmark, the study population showed a significantly worse EQ5D-5L index. The majority of patients (87%) were in the lower social classes suggesting a higher degree of social deprivation in the study population. Twenty-seven per cent of patients who were employed prior to injury had returned to employment at approximately 19 months following fracture. The onset of post-traumatic osteoarthritis was present in the knee joint in 29% of patients following a proximal intra-articular fracture, whereas osteoarthritis was present at the ankle joint in 35% of patients following a distal intra-articular fracture 12 months after frame removal. This study indicates that at 12 months after frame removal there are poorer patient-reported QOL as when compared to reference populations. Furthermore, this study

  5. Impact of chemotherapy-induced neutropenia on quality of life: a prospective pilot investigation.

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    Fortner, Barry V; Schwartzberg, Lee; Tauer, Kurt; Houts, Arthur C; Hackett, James; Stolshek, Brad S

    2005-07-01

    In this exploratory, prospective study evaluated quality of life (QoL) changes in patients with diverse cancers during the first cycle of myelosuppressive chemotherapy. Of 80 patients enrolled, 71 were observed during one of five chemotherapy regimens: docetaxel; CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone); carboplatin-paclitaxel; carboplatin-docetaxel; and carboplatin-gemcitabine. Complete blood counts were taken weekly. QoL and symptom burden measures were administered at baseline and throughout the cycle, and included SF-36, Cancer Care Monitor (CCM), Hospital Anxiety and Depression Scale (HADS), and Psychosocial Adjustment to Illness Scale (PAIS). Using generalized estimating equations, we modeled the change in each measure from baseline to the end of each week using the following covariates: baseline QoL measure, baseline SF-36 Physical and Mental Health Summary scores, sex, age, cycle week, grade 4 neutropenia any time in the past 7 days (yes/no), and the interaction of the latter two covariates. Of the 71 patients observed, 33 developed grade 4 neutropenia during the first 2 weeks. Changes from baseline in SF-36 Bodily Pain, HADS Anxiety, and PAIS Social Environment scores were significantly less favorable (P<0.05) when patients experienced grade 4 neutropenia any time in the past 7 days compared to when they did not (grade 0-3). A similar, but non-significant, trend was also observed for 12 other QoL measures. QoL may be adversely affected up to 7 days after patients experience grade 4 (versus grade 0-3) neutropenia. Such findings need to be examined further in studies with adequate statistical power to test a priori hypotheses regarding specific QoL measures.

  6. Pilot study on microvascular anastomosis: performance and future educational prospects.

    Science.gov (United States)

    Berretti, G; Colletti, G; Parrinello, G; Iavarone, A; Vannucchi, P; Deganello, A

    2017-11-30

    The introduction of microvascular free flaps has revolutionised modern reconstructive surgery. Unfortunately, access to training opportunities at standardised training courses is limited and expensive. We designed a pilot study on microvascular anastomoses with the aim of verifying if a short course, easily reproducible, could transmit microvascular skills to participants; if the chosen pre-test was predictive of final performance; and if age could influence the outcome. A total of 30 participants (10 students, 10 residents and 10 surgeons) without any previous microvascular experience were instructed and tested during a single 3 to 5 hour course. The two microanastomoses evaluated were the first ever performed by each participant. More than the half of the cohort was able to produce both patent microanastomoses in less than 2 hours; two-thirds of the attempted microanastomoses were patent. The pretest predicted decent scores from poor performances with a sensitivity of 61.5%, specificity of 100%, positive predictive value of 100% and negative predictive value of 40%. Students and residents obtained significantly higher scores than surgeons. Since our course model is short, cost-effective and highly reproducible, it could be introduced and implemented anywhere as an educational prospect for preselecting young residents showing talent and natural predisposition and having ambitions towards microvascular reconstructive surgery. © Copyright by Società Italiana di Otorinolaringologia e Chirurgia Cervico-Facciale.

  7. Can Subclinical Rickets Cause SCFE? A Prospective, Pilot Study.

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    Arkader, Alexandre; Woon, Regina P; Gilsanz, Vicente

    2015-01-01

    Slipped capital femoral epiphysis (SCFE) is a common disorder of the growing hip; however, its etiology remains unknown. Vitamin D (25-OH) is a major regulator of bone homeostasis and calcium metabolism. Vitamin D deficiency is one of the major causes of rickets, and rickets has been associated with SCFE. Increased body mass index (BMI) has been linked to SCFE and obese children are known to have lower vitamin D levels. Therefore, we hypothesize that children who develop SCFE may have subclinical rickets predisposing them to the development of physeal disease. This was a pilot, prospective study designed to determine the relationship between vitamin D, bone, muscle, and fat in patients with SCFE. We enrolled 20 consecutive patients with idiopathic SCFE aged 9 to 14 years. Upon diagnosis, vitamin D, PTH, T4, and thyroid-stimulating hormone blood levels were obtained. A single-slice computed tomography was used to measure cortical bone density (CBD) of the femur. Demographics, BMI, and the results obtained were compared to generate a relationship between vitamin D levels and SCFE. Twenty patients were enrolled, 13 males and 7 females, at an average age of 12 years (range, 9 to 14 y), and mean BMI% was 93.9 (range, 81.3 to 99.5). There were 15 stable and 5 unstable SCFE. Overall, mean and SD values for vitamin D, 25-OH were within the normal range (43.9 ± 13.5). We found no difference in values in vitamin D between nonobese (BMI < 95%) and obese (BMI ≥ 95%) subjects (34.8 ± 16.8 vs. 51.6 ± 22.4, P = 0.144). Moreover, we found no difference in CBD between these 2 groups (1126 ± 33.1 vs. 1147 ± 41.2, P = 0.333). There was no relation between blood values of vitamin D and measures of CBD. Although obese children are known to have lower levels of vitamin D and a higher prevalence of SCFE, we found no correlation between low vitamin D and the development of SCFE in this subset of patients.

  8. Quality of life in patients with Irritable Bowel Syndrome (IBS), assessed using the IBS-Quality of Life (IBS-QOL) measure after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide: results of an international prospective observational cohort study in Poland, Egypt, Mexico and China.

    Science.gov (United States)

    Hou, Xiaohua; Chen, Shengliang; Zhang, Yali; Sha, Weihong; Yu, Xiaofeng; Elsawah, Hesham; Afifi, Afifi Fahmy; El-Khayat, Hisham Raafat; Nouh, Alaa; Hassan, Mohamed Fathalla; Fatah, Ayman Abdel; Rucker Joerg, Isabel; Sánchez Núñez, Juan Manuel; Osthoff Rueda, Rodolfo; Jurkowska, Grazyna; Walczak, Michal; Malecka-Panas, Ewa; Linke, Krzysztof; Hartleb, Marek; Janssen-van Solingen, Gwendolyn

    2014-11-01

    Irritable Bowel Syndrome (IBS) has a substantial impact on health-related quality of life (HR-QoL) but high-quality data pre- and post-treatment using the IBS-Quality of Life (IBS-QOL) measure are limited. The objective of this study was to evaluate the changes from baseline of the IBS-QOL scores, symptom scores and health economic data in IBS patients, after 4 and 8 weeks of treatment with mebeverine hydrochloride or pinaverium bromide. This was a prospective observational cohort study in patients with IBS, diagnosed using the Rome III criteria in four countries (Poland, Egypt, Mexico and China). A total of 607 patients were enrolled. At baseline, the IBS-QOL total scores were 52.0 in Poland, 48.9 in Egypt, 51.9 in Mexico, 76.4 in China and 56.4 overall. Increases in IBS-QOL total score were statistically significant at Weeks 4 and 8 overall and in each country (overall: 11.8 at Week 4, 24.3 at Week 8; p < 0.001). Improvements were shown in all IBS-QOL subscales and scores. Symptoms and health economic outcomes were improved. Furthermore, the favourable safety profile of these treatments was confirmed in this study. This study demonstrated that IBS patients have a substantially reduced HR-QoL and that treatment with mebeverine hydrochloride or pinaverium bromide improved HR-QoL.

  9. Evaluation of thyroid eye disease: quality-of-life questionnaire (TED-QOL) in Korean patients.

    Science.gov (United States)

    Son, Byeong Jae; Lee, Sang Yeul; Yoon, Jin Sook

    2014-04-01

    To assess impaired quality of life (QOL) of Korean patients with thyroid eye disease (TED) using the TED-QOL questionnaire, to evaluate the adaptability of the questionnaire, and to assess the correlation between TED-QOL and scales of disease severity. Prospective, cross-sectional study. Total of 90 consecutive adult patients with TED and Graves' disease were included in this study. TED-QOL was translated into Korean and administered to the patients. The results were compared with clinical severity scores (clinical activity score, VISA (vision loss (optic neuropathy); inflammation; strabismus/motility; appearance/exposure) classification, modified NOSPECS (no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss) score, Gorman diplopia scale, and European Group of Graves' Orbitopathy Classification). Clinical scores indicating inflammation and strabismus in patients with TED were positively correlated with overall and visual function-related QOL (Spearman coefficient 0.21-0.38, p < 0.05). Clinical scores associated with appearance were positively correlated with appearance-related QOL (Spearman coefficient 0.26-0.27, p < 0.05). In multivariate analysis, age, soft-tissue inflammation, motility disorder of modified NOSPECS, and motility disorder of VISA classification had positive correlation with overall and function-related QOL. Sex, soft-tissue inflammation, proptosis of modified NOSPECS, and appearance of VISA classification had correlation with appearance-related QOL. In addition, validity of TED-QOL was proved sufficient based on the outcomes of patient interviews and correlation between the subscales of TED-QOL. TED-QOL showed significant correlations with various objective clinical parameters of TED. TED-QOL was a simple and useful tool for rapid evaluation of QOL in daily outpatient clinics, which could be readily translated into different languages to be widely applicable to various populations. Copyright © 2014

  10. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    Science.gov (United States)

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  11. Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study.

    Science.gov (United States)

    Morrissey, Darlene; El-Khawand, Dominique; Ginzburg, Natasha; Wehbe, Salim; O'Hare, Peter; Whitmore, Kristene

    2015-01-01

    High-tone pelvic floor dysfunction (HTPFD) is a debilitating chronic pain disorder for many women with significant impact on their quality of life (QoL). Our objective was to determine the efficacy of electromyography-guided onabotulinumtoxinA (Botox; Allergan, Irvine, Calif) injections in treating patient's perception of pelvic pain and improving QoL measurement scores. This is a prospective pilot open-label study of women with chronic pelvic pain and HTPFD who have failed conventional therapy between January 2011 and August 2013. Botox injections (up to 300 U) were done using needle electromyography guidance, from a transperineal approach, to localize spastic pelvic floor muscles (PFMs). Data were collected at baseline, 4, 8, 12, and 24 weeks after injections. This included demographics; Visual Analog Scale (VAS) scores for pain and dyspareunia; validated questionnaires for symptoms, QoL, and sexual function; Global Response Assessment scale for pelvic pain; digital examination of PFM for tone and tenderness; and vaginal manometry. Side effects were also recorded. Out of 28 women who enrolled in the study, 21 completed the 6-month follow-up and qualified for analysis. The mean (SD) age was 35.1 (9.4) years (range, 22-50 years), and the mean (SD) body mass index was 25 (4.4). Comorbidities included interstitial cystitis/bladder pain syndrome (42.9%) and vulvodynia (66.7%). Overall, 61.9% of subjects reported improvement on Global Response Assessment at 4 weeks and 80.9% at 8, 12, and 24 weeks post injection, compared with baseline. Of the subjects who were sexually active at baseline, 58.8% (10/17), 68.8% (11/16), 80% (12/15), and 83.3% (15/18) reported less dyspareunia at 4, 8, 12, and 24 weeks, respectively. Dyspareunia Visual Analog Scale score significantly improved at weeks 12 (5.6, P = 0.011) and 24 (5.4, P = 0.004) compared with baseline (7.8). Two of the 4 patients who avoided sexual activity at baseline secondary to dyspareunia resumed and tolerated

  12. Spinal Orthoses: The Crucial Role of Comfort on Compliance of Wearing - Monocentric Prospective Pilot Study of Randomized Cross-Over Design.

    Science.gov (United States)

    Herget, G W; Patermann, S; Strohm, P C; Zwingmann, J; Eichelberger, P; Südkamp, N P; Hirschmüller, A

    2017-01-01

    PURPOSE OF THE STUDY Various spine disorders are regularly treated by orthoses, and success of treatment depends on wearing these devices. In this study we examined the compliance, wear comfort, subjective stabilization and side effects associated with spinal orthoses using an individualized questionnaire and the Compact Short Form-12 Health Survey (SF-12). MATERIAL AND METHODS In this prospective pilot study of randomized cross-over design, twelve healthy volunteers with a mean age of 31.2 years wore three different types of orthoses, each for one week: A hyperextension brace (HB), a custom-made semirigid orthosis (SO) and a custom-made rigid orthosis (RO). The daily duration of wearing the orthosis was defined as primary endpoint; contentment was measured using an individualized questionnaire and the standardized SF-12. RESULTS In the study population calculated probability of wearing the HB and RO was between 0.2 und 38.5% (95% confidence interval). No volunteer wore the SO orthosis for the predefined time. The SO and RO each displayed high subjective stabilization, while the RO was more often associated with side effects like skin pressure marks than the SO. The need for rework due to discomfort was mainly necessary with the RO. We observed no substantial differences in feeling compression and sweating. Noteworthy, eight of 12 subjects complained of uncomfortable sternal pressure due to the upper pad of the HB. The SF-12: scores ranged from 52.1 to 48.6 on the physical (PCS), and from 53.7 to 50.8 on the mental component score (MCS), demonstrating an influence on QoL. DISCUSSION AND CONCLUSIONS The design as well as the orthosis itself influence the compliance of wearing and exert a moderate negative, but acceptable impact on QoL. The SO appeared to correlate with the best overall compromise between comfort and subjective stabilization. Further investigations are necessary in patients with spinal diseases, for whom the effect of orthosis wearing may surpass the

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

    Science.gov (United States)

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

    2015-10-13

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

  14. Evaluation of QOL in cancer patients treated with radiation therapy

    International Nuclear Information System (INIS)

    Takahashi, Takeo; Machida, Kikuo; Honda, Norinari; Hosono, Makoto; Murata, Osamu; Osada, Hisato; Omichi, Masahide

    2002-01-01

    Evaluation of quality of life (QOL) in cancer patients is an important theme. However, we do not have an established method to assess QOL in cancer patients during radiotherapy in Japan. We evaluated both the changes of QOL and the factors affecting QOL in radiotherapy patients. Three hundred fifty-five cancer patients, who filled in a questionnaire at the beginning, middle, and end of radiotherapy between 1998 and 2001, were studied. We used The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs (QOL-ACD)'' devised by Kurihara et al, the Ministry of Health and Welfare. The QOL Questionnaire had five categories: physical activity, physical condition, mental state, social interaction, and face scale. The total score, sum of the score of five categories, were established synthetically (maximum score is 110). The mean of total QOL scores were 75.8, 77.6, and 78.2 at the beginning, middle, and end of radiotherapy respectively. Patients with symptoms related to cancer had apparent improvement of QOL score. Patients receiving chemotherapy had a decreased QOL score at the end of radiotherapy. The score of physical condition was reduced improvement. It was suggested that radiotherapy could be performed without losing QOL of cancer patients, including older patients. However, patients receiving chemotherapy and those with head and neck cancer may lose their QOL, therefore, we should treat such patients carefully. (author)

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

    Science.gov (United States)

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

    2017-02-01

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

  16. Activation of Coagulation and Fibrinolysis in Acute Respiratory Distress Syndrome: a Prospective Pilot Study

    Directory of Open Access Journals (Sweden)

    Agnese Ozolina

    2016-11-01

    Full Text Available Introduction: Coagulation and fibrinolysis remain sparsely addressed with regards to acute respiratory distress syndrome (ARDS. We hypothesized that ARDS development might be associated with changes in plasma coagulation and fibrinolysis. Our aim was to investigate the relationships between ARDS diagnosis and plasma concentrations of tissue factor (TF, tissue plasminogen activator (t-PA and plasminogen activator inhibitor-1 (PAI-1 in mechanically ventilated patients at increased risk of developing ARDS. Materials and Methods: We performed an ethically approved prospective observational pilot study. Inclusion criteria: patients with PaO2/FiO2 < 300 mmHg admitted to the intensive care unit (ICU for mechanical ventilation for 24 hours, or more, because of one or more disease conditions associated with increased risk of developing ARDS. Exclusion criteria: age below 18 years; cardiac disease. We sampled plasma prospectively and compared patients who developed ARDS with those who did not using descriptive statistics and chi-square analysis of baseline demographical and clinical data. We also analyzed plasma concentrations of TF, t-PA and PAI-1 at inclusion (T0 and on third (T3 and seventh day (T7 of the ICU stay with non-parametric statistics inclusive their sensitivity and specificity associated with the development of ARDS using receiver operating characteristic (ROC curve analysis. Statistical significance: p < 0.05.Results: Of 24 patients at risk, six developed mild ARDS and four of each moderate or severe ARDS, respectively, 3 ± 2 (Mean ± SD days after inclusion. Median plasma concentrations of TF and PAI-1 were significantly higher at T7 in patients with ARDS, as compared to non-ARDS. Simultaneously, we found moderate correlations between plasma concentrations of TF and PAI-1, TF and PaO2/FiO2 and PEEP and TF. TF plasma concentration was associated with ARDS with 71% sensitivity and 100% specificity, a cut off level of 145 pg/ml and AUC 0

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

    Science.gov (United States)

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

    2016-08-02

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

  18. Utility analysis and calibration of QOL assessment in disease management.

    Science.gov (United States)

    Liu, Mo

    2018-05-02

    In clinical trials, the assessment of health-related quality of life (QOL) (or patient-reported outcome [PRO] measure) has become very popular especially for clinical studies conducted for evaluating clinical benefits of patients with chronic, severe, and/or life threatening diseases. Health-related QOL information and PRO measures are useful for disease management for achieving best clinical practice. In this article, we will focus on health-related QOL assessment. The concept, design, and analysis of health-related QOL in clinical trials are reviewed. Validation of the use of health-related QOL instrument in terms of some key performance characteristics such as accuracy, reliability, sensitivity, and responsibility for assuring quality, integrity, and validity of collected QOL data are discussed. The concept of utility analysis and calibration (e.g., with respect to life events) for achieving the optimization of disease management are proposed. The change of the QOL could be translated into different life events for effective disease management. These translations could evaluate the treatment effect by more directly displaying the change of the QOL.

  19. The Quality of Life Scale (QOLS: Reliability, Validity, and Utilization

    Directory of Open Access Journals (Sweden)

    Anderson Kathryn L

    2003-10-01

    Full Text Available Abstract The Quality of Life Scale (QOLS, created originally by American psychologist John Flanagan in the 1970's, has been adapted for use in chronic illness groups. This paper reviews the development and psychometric testing of the QOLS. A descriptive review of the published literature was undertaken and findings summarized in the frequently asked questions format. Reliability, content and construct validity testing has been performed on the QOLS and a number of translations have been made. The QOLS has low to moderate correlations with physical health status and disease measures. However, content validity analysis indicates that the instrument measures domains that diverse patient groups with chronic illness define as quality of life. The QOLS is a valid instrument for measuring quality of life across patient groups and cultures and is conceptually distinct from health status or other causal indicators of quality of life.

  20. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    Directory of Open Access Journals (Sweden)

    Akhil Kapoor

    2016-01-01

    Full Text Available Introduction: Acute myeloid leukemia (AML in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m 2 . The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS was calculated using Kaplan-Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61-86 years with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4-7.6. Males had median OS of 7 months (95% CI: 5.4-8.6 versus females with OS of 3 months (95% CI: 1.5-4.4; P = 0.008. There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities.

  1. A Prospective Trial of Ayurveda for Coronary Heart Disease: A Pilot Study.

    Science.gov (United States)

    DuBroff, Robert; Lad, Vasant; Murray-Krezan, Cristina

    2015-01-01

    Coronary heart disease is the leading cause of death worldwide, and its incidence is rapidly accelerating in developing nations. Patients often search for therapies that are alternatives to traditional treatments, such as heart medicines, coronary bypass surgery, or coronary stenting. Ayurveda is an ancient, East Indian, holistic approach to health care, and its use has never been formally evaluated for patients with coronary heart disease. The study intended to examine the feasibility and effectiveness of comprehensive ayurvedic therapy-incorporating diet, meditation, breathing exercises, yoga, and herbs-for patients with established coronary heart disease. The study was a prospective, single-group, pilot study. The study took place at the University of New Mexico Cardiology Clinic and at the Ayurvedic Institute in Albuquerque, NM, USA. The participants were adults with a history of a prior heart attack, coronary bypass surgery, or a coronary intervention (ie, a coronary angioplasty and/or stent). All enrolled patients were evaluated by a single ayurvedic physician with >40 y of experience, and each received therapy consisting of a calorically unrestricted ayurvedic diet; instruction in yoga, meditation, and breathing; and use of ayurvedic herbs. The primary endpoint was arterial pulse wave velocity, a marker of arterial function and vascular health. Secondary endpoints included the following measurements: (1) body mass index (BMI); (2) blood pressure (BP) and amount of reduction in BP medications; and (3) levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. All parameters were measured at baseline and after 90 d of therapy. Twenty-two patients were enrolled in the study, and 19 patients completed it. The research team observed significant improvements in arterial pulse wave velocity (P = .015), and favorable reductions in BMI (P ayurveda on arterial function and multiple risk

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

    Science.gov (United States)

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

    2018-05-01

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

  3. Hyperfractionated external radiation therapy in stage IIIB carcinoma of uterine cervix: a prospective pilot study

    International Nuclear Information System (INIS)

    Faria, Sergio L.; Ferrigno, Robson

    1997-01-01

    Purpose: Brazil has one of the highest incidence of carcinoma of the cervix in the world. Half of the patients have advanced stages at the diagnosis. Due to this large number of patients we decided to conduct a prospective pilot study to investigate the tolerance to and survival rate with hyperfractionated external radiotherapy only in patients with Stage IIIB carcinoma of the uterine cervix. Methods and Materials: Between January 1991 and December 1993, 23 patients underwent hyperfractionated external beam radiotherapy without brachytherapy. All cases were biopsy proven squamous cell carcinoma of cervix clinically Staged as IIIB (FIGO). Hyperfractionation (HFX) was given with 1.2 Gy doses, twice daily at 6-h interval, 5 days/week, to the whole pelvis up to 72 Gy within 30 working days. Complications were evaluated by an adaptation of the RTOG Radiation Morbidity Scoring Table graded as 1 = none/mild; 2 = moderate, and 3 = severe. Results: Follow-up ranged from 27 to 50 months (median 40 months) on the 9 to 23 living patients at the time of the analysis in December 1995. There was no severe acute toxicity, but moderate acute reaction was high: 74%. The commonest site of complication was the intestine where severe late toxicity occurred in 2 of 23 (9%). Overall survival rate at 27 months was 48% and at 40 months was 43%. Discussion: There is little information in literature about HFX in carcinoma of the cervix. This is the third published study about it and the one that gave the highest total dose with external HFX of 60 x 1.2 Gy = 72 Gy. Theoretically, through the linear quadratic formula this schedule of HFX would be equivalent to 30 x 2 Gy = 60 Gy of standard fractionation, both treatments given in 30 working days. HFX schedules must be tested to establish their safety. Present results suggest being possible to further increase the total dose in the pelvis with hyperfractionated irradiation

  4. Physical and Mental Quality of Life (QOL) in Chronic Pancreatitis(CP): A Case-Control Study from the NAPS2 cohort

    Science.gov (United States)

    Amann, Stephen T.; Yadav, Dhiraj; Barmada, M. Micheal; O’Connell, Michael; Kennard, Elizabeth D.; Anderson, Michelle; Baillie, John; Sherman, Stuart; Romagnuolo, Joseph; Hawes, Robert H.; AlKaade, Samer; Brand, Randall E.; Lewis, Michele D.; Gardner, Timothy B.; Gelrud, Andres; Money, Mary E.; Banks, Peter A.; Slivka, Adam; Whitcomb, David C

    2012-01-01

    Objectives Define the Quality of Life (QOL) in chronic pancreatitis (CP) subjects Methods We studied 443 well phenotyped CP subjects and 611 controls prospectively enrolled from 20 US centers between 2000–2006 in the North American Pancreatitis Study 2 (NAPS2). Responses to the SF-12 questionnaire were used to calculate the Mental (MCS) and Physical component summary scores (PCS) with norm based scoring (normal ≥50). QOL in CP subjects was compared with controls after controlling for demographic factors, drinking history, smoking and medical conditions. QOL in CP was also compared with known scores for several chronic conditions. Results Both PCS (38±11.5 vs. 52±9.4) and MCS (44±11.5 vs. 51±9.2) were significantly lower in CP compared with controls (p<0.001). On multivariable analyses, compared to controls, a profound decrease in physical QOL (PCS 12.02 points lower) and a clinically significant decrease in mental QOL (MCS 4.24 points lower) was seen due to CP. QOL in CP was similar to (heart, kidney, liver, lung disease) or worse than (non-skin cancers, diabetes mellitus, hypertension, rheumatoid arthritis) other chronic conditions. Conclusions The impact of CP on QOL appears substantial. The QOL in CP subjects appears to be worse or similar to the QOL of many other chronic conditions. PMID:23357924

  5. Validation of the quality of life-radiation therapy instrument (QOL-RTI) in patients receiving definitive radiation therapy for locally advanced prostate cancer

    International Nuclear Information System (INIS)

    Gwede, Clement; Friedland, Jay L.; Johnson, Darlene J.; Casey, Linda; Cantor, Alan; Sauder, Bonnie; Beres, Kathleen L.

    1996-01-01

    Purpose/Objective: The incidence of prostate cancer has tripled over the last 10 years, doubled over the last four years and continues to increase. A common method of treating prostate cancer is with external beam radiotherapy with or without hormones. Accurate and comprehensive documentation through prospective studies with long term follow-up is necessary to reduce the negative impact of treatment on a patient's quality of life. While it is increasingly recognized that radiation therapy treatment for prostate cancer may result in permanent alteration of the patient's quality of life, the extent and timing of this change in quality of life has not been adequately investigated in a comprehensive and prospective manner. Furthermore, there are limited instruments developed for use with patients undergoing definitive radiotherapy. The purpose of this paper is to report on the validation of the Quality of Life Radiation Therapy Instrument (QOL-RTI), a 24-item visual analogue general quality of life tool developed for use with patients receiving radiotherapy. Materials and Methods: Health related quality of life was assessed in a prospective study of 62 patients treated with either combined hormonal therapy (HT) plus external beam radiotherapy (EBRT) or EBRT alone for locally advanced prostate cancer. Quality life was measured prospectively before, during, and after radiation therapy. Results: The estimated reliability of the subscales was assessed with coefficient alpha which ranged from 0.57 to 0.68. Internal consistency was calculated using initial questionnaires for the entire sample, yielding a Cronbach's alpha of 0.82. Test-retest produced a correlation coefficient of 0.75 (p<0.0001) [n=60]. Construct validity was assessed by a repeated measures design to look for time effect, group effect, group and time interaction effect. We examined quality of life total scores, subscale total scores and performance status scores for patients who were treated with HT+ EBRT and

  6. Liquid-type Botulinum Toxin Type A in Adductor Spasmodic Dysphonia: A Prospective Pilot Study.

    Science.gov (United States)

    Cha, Wonjae; Jang, Jeon Yeob; Wang, Soo-Geun; Kang, Ji-Heon; Jo, Min-Gyu

    2017-05-01

    Botulinum toxin (BTX) has been widely used to treat adductor spasmodic dysphonia (ADSD). Most commercially available forms of BTX require reconstitution before use, which may increase the risk of contamination and requires careful titration. Recently, a liquid-type BTX type A (BTX-A) has been developed, which should simplify the procedure and enhance its efficacy. Herein, we present a prospective pilot study to investigate the efficacy and safety of liquid-type BTX-A in the treatment of ADSD. Twenty-six consecutive liquid-type BTX-A injections were performed in 12 patients with ADSD. We included as a control group 34 consecutive patients with ADSD who had previously undergone 52 vocal fold injection procedures with freeze-dried-type BTX-A. All patients in both groups had improvement of symptoms related to ADSD and period of normal voice. Most patients experienced breathiness, and the onset time, the peak response time, and the duration of breathiness were similar in both groups. The duration of effect (days) was 96.96 ± 18.91 and 77.38 ± 18.97 in the freeze-dried-type and the liquid-type groups, and the duration of benefit (days) was 80.02 ± 18.24 and 62.69 ± 19.73 in the freeze-dried-type and the liquid-type groups. To compare the efficacy between the freeze-dried-type and the liquid-type BTX-A, the sessions of the unilateral vocal fold injection were included and were categorized as group A (1 ~ 2 units BTX-A) and group B (2 ~ 3 units BTX-A), according to the dose per vocal fold. There was no significant difference of effect time between freeze-dried-type and liquid-type BTX-A groups. No adverse events related to BTX or vocal fold injection were reported. Liquid-type BTX-A is safe and effective for the treatment of spasmodic dysphonia. With the advantages of simple preparation, storage, and reuse and animal protein-free constituents, liquid-type BTX-A may be a good option in the treatment of spasmodic dysphonia. Copyright © 2017 The

  7. Intraoperative Cochlear Implant Device Testing Utilizing an Automated Remote System: A Prospective Pilot Study.

    Science.gov (United States)

    Lohmann, Amanda R; Carlson, Matthew L; Sladen, Douglas P

    2018-03-01

    Intraoperative cochlear implant device testing provides valuable information regarding device integrity, electrode position, and may assist with determining initial stimulation settings. Manual intraoperative device testing during cochlear implantation requires the time and expertise of a trained audiologist. The purpose of the current study is to investigate the feasibility of using automated remote intraoperative cochlear implant reverse telemetry testing as an alternative to standard testing. Prospective pilot study evaluating intraoperative remote automated impedance and Automatic Neural Response Telemetry (AutoNRT) testing in 34 consecutive cochlear implant surgeries using the Intraoperative Remote Assistant (Cochlear Nucleus CR120). In all cases, remote intraoperative device testing was performed by trained operating room staff. A comparison was made to the "gold standard" of manual testing by an experienced cochlear implant audiologist. Electrode position and absence of tip fold-over was confirmed using plain film x-ray. Automated remote reverse telemetry testing was successfully completed in all patients. Intraoperative x-ray demonstrated normal electrode position without tip fold-over. Average impedance values were significantly higher using standard testing versus CR120 remote testing (standard mean 10.7 kΩ, SD 1.2 vs. CR120 mean 7.5 kΩ, SD 0.7, p automated testing with regard to the presence of open or short circuits along the array. There were, however, two cases in which standard testing identified an open circuit, when CR120 testing showed the circuit to be closed. Neural responses were successfully obtained in all patients using both systems. There was no difference in basal electrode responses (standard mean 195.0 μV, SD 14.10 vs. CR120 194.5 μV, SD 14.23; p = 0.7814); however, more favorable (lower μV amplitude) results were obtained with the remote automated system in the apical 10 electrodes (standard 185.4 μV, SD 11.69 vs. CR

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

    Science.gov (United States)

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

    2018-01-05

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

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

    Science.gov (United States)

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

    2015-01-01

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

  10. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

    International Nuclear Information System (INIS)

    Menard, J.E.; Bromberg, L.; Brown, T.; Burgess, Thomas W.; Dix, D.; Gerrity, T.; Goldston, R.J.; Hawryluk, R.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G.H.; Neumeyer, C.L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.G.; Zarnstorff, M.C.

    2011-01-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  11. Clinical Utility and Psychometric Properties of the Traumatic Brain Injury Quality of Life Scale (TBI-QOL) in US Military Service Members.

    Science.gov (United States)

    Lange, Rael T; Brickell, Tracey A; Bailie, Jason M; Tulsky, David S; French, Louis M

    2016-01-01

    To examine the clinical utility and psychometric properties of the Traumatic Brain Injury Quality of Life (TBI-QOL) scale in a US military population. One hundred fifty-two US military service members (age: M = 34.3, SD = 9.4; 89.5% men) prospectively enrolled from the Walter Reed National Military Medical Center and other nationwide community outreach initiatives. Participants included 99 service members who had sustained a mild traumatic brain injury (TBI) and 53 injured or noninjured controls without TBI (n = 29 and n = 24, respectively). Participants completed the TBI-QOL scale and 5 other behavioral measures, on average, 33.8 months postinjury (SD = 37.9). Fourteen TBI-QOL subscales; Neurobehavioral Symptom Inventory; Posttraumatic Stress Disorder Checklist-Civilian version; Alcohol Use Disorders Identification Test; Combat Exposure Scale. The internal consistency reliability of the TBI-QOL scales ranged from α = .91 to α = .98. The convergent and discriminant validity of the 14 TBI-QOL subscales was high. The mild TBI group had significantly worse scores on 10 of the 14 TBI-QOL subscales than the control group (range, P quality of life in a mild TBI military sample. Additional research is recommended to further evaluate the clinical utility of the TBI-QOL scale in both military and civilian settings.

  12. Laparo-Endoscopic Single-Site Surgery for Radical and Cytoreductive Nephrectomy, Renal Vein Thrombectomy, and Partial Nephrectomy: A Prospective Pilot Evaluation

    Directory of Open Access Journals (Sweden)

    Ithaar H. Derweesh

    2010-01-01

    Full Text Available Introduction. Laparo-endoscopic single-site surgery (LESS may diminish morbidity of laparoscopic surgery. We prospectively evaluated feasibility and outcomes of LESS-Radical Nephrectomy (LESS-RN and Partial Nephrectomy (LESS-PN. Methods. 10 patients underwent LESS-RN (6 and LESS-PN (4 between 2/2009-5/2009. LESS-RN included 2 with renal vein thrombectomy, one of which was also cytoreductive. Transperitoneal LESS access was obtained by periumbilical incision. Patient/tumor characteristics, oncologic, and quality of life (QoL outcomes were analyzed. Results. 3 Men/7 Women (mean age 58.7 years, median follow-up 9.8 months underwent LESS. 9/10 cases were completed successfully. All had negative margins. Mean operative time was 161 minutes, estimated blood loss was 125 mL, and incision size was 4.4 cm. Median tumor size for LESS-RN and -PN was 5.0 and 1.7 cm (=.045. Median LESS-PN ischemia time was 24 minutes; mean preoperative/postoperative creatinine were 0.7/0.8 mg/dL (=.19. Mean pain score at discharge was 1.3. Mean preoperative, 3-, and 6-month postoperative SF-36 QoL Score was 73.8, 74.4 and 77.1 (=.222. All patients are currently alive. Conclusions. LESS-RN, renal vein thrombectomy, and PN are technically feasible and safe while maintaining adherence to oncologic principles, with excellent QoL preservation and low discharge pain scores. Further study is requisite.

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

    Science.gov (United States)

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

    2014-06-11

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

  14. Quality of life (QOL) among community dwelling older people in Taiwan measured by the CASP-19, an index to capture QOL in old age.

    Science.gov (United States)

    Wu, Tai-Yin; Chie, Wei-Chu; Kuo, Kuan-Liang; Wong, Wai-Kuen; Liu, Jen-Pei; Chiu, Shih-Ting; Cheng, Yeung-Hung; Netuveli, Gopal; Blane, David

    2013-01-01

    There was no existing scale in Mandarin Chinese to specifically measure QOL in old age. We aimed to validate a Chinese Taiwan version of the CASP-19 (control, autonomy, self-realization, pleasure), a QOL questionnaire, in Taiwan. The existing CASP-19 Cantonese version was modified into Chinese Taiwan version and pilot tested. Data were then gathered from 699 older people. Score distribution, exploratory and confirmatory factor structure, reliability and clinical validity of the CASP-19 and its shortened version, the CASP-12, were examined. The mean age of the participants was 75.5 (standard deviation (SD) 6.5), and half (49.5%) were female. The mean CASP-19 score was 38.2 (range 11-56; SD 7.1), lower than that of Western countries. Exploratory factor analysis revealed an additional factor, 'participation' (CASPP-19). There was satisfactory internal consistency (Cronbach's α 0.63-0.85) for the subscales, except for the control domain. For the 19-item scale, the first order five-domain model (CASPP-19) yielded the best fit. For the CASP-12, first and second order original CASP-12 models performed equally well. There was an inverse relationship between the CASP total scores and frailty, chronic diseases, depressive disorders, living alone and fall events in the past 12months, supporting good clinical validity for all versions of the CASP scale (CASP-19, CASPP-19, original and new CASP-12). The original CASP-12 may be presently the best choice for use in China, Taiwan or other Mandarin-speaking populations due to its conciseness and model parsimony. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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

    OpenAIRE

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

    2016-01-01

    Internet Gaming Disorder (IGD) is positioned in the appendix of the DSM-5 as a condition requiring further study. The IGD criteria refer to withdrawal symptoms, including irritability, anxiety, or sadness, that follow cessation of Internet gaming (APA, 2013). The aim of this study was to prospectively examine the nature of Internet gaming withdrawal symptoms, if they occur, under gaming abstinence conditions. This study employed a repeated-measures protocol to examine the cognitive-affective ...

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

  18. Pharmacists' interventions on prescription problems in one French community pharmacy: A prospective pilot study.

    Science.gov (United States)

    Castronovo, A; Gervais, F; Mongaret, C; Slimano, F

    2018-03-16

    While many international studies widely describe pharmacists' interventions (PIs) on drug-related problems (DRP) in community pharmacies, in France, these activities are underreported. The aim of this study is to describe the PI rate, given as the number of interventions in among all prescriptions reviewed during the study period. This study was conducted in one French rural community pharmacy during a 7-month period. Age, sex, type of prescriber, type of problems, intervention and the outcome were prospectively recorded. PIs were prospectively formalized and classified using the validated tool from the French Society of Clinical Pharmacy. In addition, all interventions were reviewed by an independent pharmacist. Among the 20,238 prescriptions, n=211 pharmacists' interventions on 159 prescriptions (0.79%) were performed. Prescriptions were ordered by general practitioners in 78.6%. The most common DRP were the improper prescription (30.8%), a drug or medical device not received by the patient (21.8%, all linked to drug shortages) or a dosage problem (18.9%). Antibiotics were the most common drugs involved in DRP (13.3%). The main PI were the drug switch/establishment of a therapeutic alternative (38.4%), dose adjustment (25.6%) and optimization of the dispensing/administration modalities (25.1%). The overall acceptance rate of PIs was 93.4%. We found a PI rate, as well as acceptance rate by prescribers, in the same range than as reported in studies performed in other countries. A consequent large part percentage of PIs can be classified as "administrative". This first prospective French study needs to be further supported by multi-site studies. Copyright © 2018 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

  19. A prospective pilot study measuring muscle volumetric change in amyotrophic lateral sclerosis.

    Science.gov (United States)

    Jenkins, Thomas M; Burness, Christine; Connolly, Daniel J; Rao, D Ganesh; Hoggard, Nigel; Mawson, Susan; McDermott, Christopher J; Wilkinson, Iain D; Shaw, Pamela J

    2013-09-01

    Our objective was to investigate the potential of muscle volume, measured with magnetic resonance (MR), as a biomarker to quantify disease progression in patients with amyotrophic lateral sclerosis (ALS). In this longitudinal pilot study, we first sought to determine the stability of volumetric muscle MR measurements in 11 control subjects at two time-points. We assessed feasibility of detecting atrophy in four patients with ALS, followed at three-month intervals for 12 months. Muscle power and MR volume were measured in thenar eminence (TEm), first dorsal interosseous (1DIO), tibialis anterior (TA) and tongue. Changes over time were assessed using linear regression models and t-tests. Results demonstrated that, in controls, no volumetric MR changes were seen (mean volume variation in all muscles 0.1). In patients, between-subject heterogeneity was identified. Trends for volume loss were found in TEm (mean, - 26.84%, p = 0.056) and TA (- 8.29%, p = 0.077), but not in 1DIO (- 18.47%, p = 0.121) or tongue (< 5%, p = 0.367). In conclusion, volumetric muscle MR appears a stable measure in controls, and progressive volume loss was demonstrable in individuals with ALS in whom clinical weakness progressed. In this small study, subclinical atrophy was not demonstrable using muscle MR. Clinico-radiological discordance between muscle weakness and MR atrophy could reflect a contribution of upper motor neuron pathology.

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

    Directory of Open Access Journals (Sweden)

    Dean Kaptsis

    2016-12-01

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

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

    Science.gov (United States)

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

    2016-12-01

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

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

    Science.gov (United States)

    Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

    2018-02-01

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

  3. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Sabeti-Aschraf, M., E-mail: manuel.sabeti-aschraf@meduniwien.ac.a [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Ochsner, A. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schueller-Weidekamm, C. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Schmidt, M. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Funovics, Ph.T. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Skrbensky, G. von [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Goll, A. [Vienna Medical School, Core Unit for Medical Statistics and Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schatz, K.D. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria)

    2010-07-15

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  4. Natalizumab stabilizes physical, cognitive, MRI, and OCT markers of disease activity: A prospective, non-randomized pilot study.

    Directory of Open Access Journals (Sweden)

    Garrick D Talmage

    Full Text Available Natalizumab is an effective therapy for multiple sclerosis (MS. Its effectiveness has been demonstrated in several clinical and imaging studies. The objective of this study was to further demonstrate the efficacy of natalizumab using a comprehensive battery of clinical and imaging markers in the same cohort of patients followed longitudinally, hence capturing the multi-faceted nature of the MS disease process. A prospective, open-label, pilot study of 20 MS patients treated with natalizumab was conducted. High resolution MRI, Symbol-Digit Modalities Test (SDMT, and Optical Coherence Tomography (OCT scans were obtained at baseline, 48, and 96 weeks. 15 patients completed the study. Natalizumab treatment decreased Expanded Disability Status Scale score (EDSS and no change in SDMT, Brain Parenchymal Fraction (BPF, or any of the OCT markers of retinal degeneration was observed. Thalamic and whole brain volume as assessed by Percentage Brain Volume Change (PBVC showed continuous deterioration. Higher baseline T2 lesion load correlated with increased rate of PBVC at 96-weeks (r = 0.566, R2 = 0.320, p = 0.035 and thalamic volume loss (r = -0.586, R2 = 0.344, p = 0.027. Most patients, 93%, achieved no evidence of disease activity (NEDA at 2 years, likely due to early disease duration and lower initial baseline lesion load. This study further demonstrates stabilization of clinical and imaging markers of disease activity during natalizumab treatment.

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

    Science.gov (United States)

    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.

  6. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

    International Nuclear Information System (INIS)

    Sabeti-Aschraf, M.; Ochsner, A.; Schueller-Weidekamm, C.; Schmidt, M.; Funovics, Ph.T.; Skrbensky, G. von; Goll, A.; Schatz, K.D.

    2010-01-01

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2016-02-01

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

  9. Nefazodone treatment of dysthymic disorder an open, long-term, prospective pilot study.

    Science.gov (United States)

    Dursun, Serdar M; Bird, Diane; Ronson, Karen E

    2002-05-01

    Dysthymic disorder, described by the Diagnostic and Statistical Manual of Mental Disorders--4th edition (DSM-IV) criteria as a chronically depressed mood that occurs most of the day more days than not for at least 2 years and has a lifetime prevalence rate of approximately 3.3% [Gwirtsman, 1994. Psychopharmacol. Bull. 30 (1994) 45.]. This disorder, which is disabling, often goes unrecognized and its sufferers are often undertreated, but recent evidence has suggested that people with dysthymia may respond to antidepressant treatment. Based on effective outcomes in previous studies using fluoxetine (a 5-HT reuptake inhibitor) and ritanserin (a 5-HT2A antagonist), it was hypothesized that nefazodone, which is both a serotonin (5-HT) reuptake inhibitor (rather weak) and a 5-HT2A receptor antagonist, may provide an effective treatment for patients with dysthymic disorder. Six participants completed this 24-week pilot trial. A decrease in the Hamilton Rating Scale for Depression (HAM-D) scores was observed from baseline to Week 24, although most changes occurred in the first 4 weeks of participation. There was an improvement in anxiety symptomatology, both physiological and psychological. General functioning did not improve as observed by Global Assessment of Functioning Scale (GAF) scores. There may be some benefit to nefazodone for treatment of dysthymia, as indicated by positive results on HAM-D, Hamilton Anxiety Scale (HAM-AD), and Hopkins Symptom Checklist (HCL) scores within the first 4 weeks; however, it is possible that such dramatic results may be due to entry into the study alone, and not to medication.

  10. 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.

  11. Transcultural adaptation and validation of the Celiac Disease Quality of Life (CD-QOL survey, a specific questionnaire to measure quality of life in patients with celiac disease

    Directory of Open Access Journals (Sweden)

    Francesc Casellas

    2013-12-01

    Full Text Available Introduction: celiac disease is a chronic condition that requires continued treatment, with the resultant impact on health-related quality of life (HRQOL of people who suffer it. Most studies in this field have used generic questionnaires to measure HRQOL in celiac patients. It was therefore decided to conduct a study to translate into Spanish and validate a specific questionnaire for celiac disease, the Celiac Disease Quality Of Life Survey (CD-QOL. Objectives: to translate and validate in Spanish the specific celiac disease questionnaire CD-QOL. Methods: a multicenter, prospective, observational study was designed consisting of two phases: In the first phase, the questionnaire was translated and adapted into Spanish using the translation/back translation procedure and an understandability study. In the second phase, internal consistency of the translated questionnaire was analyzed. For this, results of the CD-QOL were compared to those of EuroQol and the Daily Fatigue Impact Scale (D-FIS. Understandability of the translated and adapted questionnaire was tested in six patients, and the validation study was done in 298 celiac patients (201 treated with a gluten-free diet and 97 at diagnosis. Results: in both celiac groups, Cronbach's alpha coefficient was high (0.90, feasibility was excellent (99.2 % of patients completed all questions, and there were no ceiling and floor effects. Spearman correlation to EuroQol and D-FIS was statistically significant (p < 0.05. CD-QOL score was different depending on whether state of health was good, fair, or poor based on the EuroQol score. Conclusion: the Spanish version of the CD-QOL is a valid tool for measuring HRQOL in celiac patients.

  12. Psychological predictors of outcome in vertical banded gastroplasty: a 6 months prospective pilot study.

    Science.gov (United States)

    Leombruni, Paolo; Pierò, Andrea; Dosio, Davide; Novelli, Alessia; Abbate-Daga, Giovanni; Morino, Mario; Toppino, Mauro; Fassino, Secondo

    2007-07-01

    At present, bariatric surgery is the most effective treatment for morbid obesity. Several factors appear to influence the patient's ability to adjust to the postoperative condition, but reliable predictors are lacking. The aim of this study was to assess whether psychological presurgical variables can predict outcome of vertical banded gastroplasty (VBG) in the short term. 38 severely obese patients (6 men and 32 women) underwent laparoscopic VBG. All were assessed prospectively at TO (before surgery) and at T6 (6 months after surgery) with a semi-structured interview and a battery of psychological tests: State Trait Anger Expression Inventory (STAXI), Eating Disorder Inventory (EDI-2), Symptom Checklist 90 (SCL-90), Beck Depression Inventory (BDI), Binge Eating Scale (BES), Body Shape Questionnaire (BSQ), and (only at TO) the Temperament and Character Inventory (TCI). The comparison between TO and T6 found a significant weight loss and an improvement in several dimensions of EDI-2, BDI, and BSQ, together with an increase in the frequency of vomiting. Self-directedness (TCI) and Body Dissatisfaction (EDI-2) appear to be predictors of short-term outcome regarding weight loss. Self-transcendence (TCI) is associated with emerging side-effects. Although larger and longer studies are necessary to confirm these data, Self directedness and Self trascendence emerge as predictors of 6 months clinical and psychological outcome of VBG.

  13. The association between maternal hydronephrosis and acute flank pain during pregnancy: a prospective pilot-study.

    Science.gov (United States)

    Farr, Alex; Ott, Johannes; Kueronya, Verena; Margreiter, Markus; Javadli, Elchin; Einig, Sabrina; Husslein, Peter W; Bancher-Todesca, Dagmar

    2017-10-01

    Maternal hydronephrosis may cause flank pain during pregnancy. We aimed to investigate the association between maternal hydronephrosis and flank pain intensity. From 2014 to 2015, all consecutive women with singleton pregnancies, who presented at our tertiary center due to acute flank pain, were prospectively evaluated by renal ultrasonography and pain questionnaires. A visual analogue scale was used to assess pain intensity. The study had 90% power to detect a significant correlation between hydronephrosis and flank pain (Spearman's test). A total of 51 consecutive women with left-sided (13.7%), right-sided (64.7%) or bilateral (21.6%) pain were enrolled. The mean gestational age of these women, who presented due to their pain, was 27.5 ± 6.8 weeks at the time of consultation. The mean VAS score was 7.6 ± 2.2. In 43/51 (84.3%) women, hydronephrosis was found on renal sonograms. No correlation was found between the grade of hydronephrosis and pain intensity (p = 0.466; r= -0.28). Women delivered at a mean gestational age of 38.1 ± 2.4 weeks and their infants had a mean birthweight of 3138 ± 677 g. Hydronephrosis is a common finding among pregnant women with acute flank pain. The grade of hydronephrosis does not affect pain intensity. This study suggests normal pregnancy outcomes in these women.

  14. Response of Treatment in Patients with Primary Headaches and Hypertension: A Prospective Observational Pilot Study

    Directory of Open Access Journals (Sweden)

    Abdullah Cüneyt Hocagil

    2018-03-01

    Full Text Available Objective: To determine the priority in the treatment of patients with primary headaches accompanied by high blood pressure. In our study, we investigated whether there was a relationship between the decline in headache after treatment and the change in the average arterial pressure. Materials and Methods: This prospective observational study was performed with 101 patients who were admitted to the hospital emergency department with primary headache accompanied by high blood pressure. After treatment, the decrease in the severity of headaches, mean arterial pressure, and percentage value for the drop of mean arterial pressure were calculated for all patients. Results: In the study, 25 (24.8% patients’ headache decreased 3 levels, 43 (42.6% patients’ headache decreased 2 levels, and 23 (22.8% patients’ headache decreased one level. The mean arterial pressure value at admission was 118.58±12.65 mmHg, and after treatment at the 30th minute decreased to 98.41±13.43 mmHg. Although there was a statistically significant (p0.05 drop in the mean arterial pressure value of the patients with one level decrease in headache severity after treatment. Conclusion: This study showed that when a primary headache, which is often associated with high blood pressure, was treated instead of treating high blood pressure as a secondary cause of headache, blood pressure decreased spontaneously

  15. Anterograde Amnesia during Electroconvulsive Therapy: A Prospective Pilot-Study in Patients with Major Depressive Disorder.

    Directory of Open Access Journals (Sweden)

    Elvira Boere

    Full Text Available Electroconvulsive therapy (ECT is considered an effective treatment for major depression with melancholic features. However, neurocognitive side-effects such as anterograde amnesia still regularly occur. The present study aims to evaluate the severity and course of anterograde amnesia in severely depressed patients undergoing ECT. In a prospective naturalistic study, anterograde memory function was assessed among inpatients who underwent ECT (n = 11. Subjects met DSM-IV criteria for major depressive disorder. Recruitment took place between March 2010-March 2011 and March 2012-March 2013. Controls treated with antidepressants (n = 9 were matched for age, gender and depression severity. Primary outcome measure was immediate recall; secondary outcome measures were delayed recall, recognition, and visual association. Differences were tested using repeated measures ANOVA and paired t-tests. Correlations with hypothesized covariates were calculated. In patients with major depressive disorder, ECT had a significant effect on delayed memory function (p<0.01 with large effect sizes. Findings on immediate recall were less consistent. Four weeks after treatment discontinuation, these memory functions had recovered. Age was identified as a very important covariate. The main limitations of our study are its naturalistic design, possibly compromising internal validity, and its small sample size. However, if these findings can be reproduced in a more comprehensive study group, then the possible induction of anterograde amnesia is not a justifiable reason for clinicians to disregard ECT as a treatment option.

  16. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium.

    Science.gov (United States)

    Evans, Joanna L; Nadler, Jacob W; Preud'homme, Xavier A; Fang, Eric; Daughtry, Rommie L; Chapman, Joseph B; Attarian, David; Wellman, Samuel; Krystal, Andrew D

    2017-08-01

    Delirium is a common post-operative complication associated with significant costs, morbidity, and mortality. We sought sleep/EEG predictors of delirium present prior to delirium symptoms to facilitate developing and targeting therapies. Continuous EEG data were obtained in 12 patients post-orthopedic surgery from the day of surgery until delirium assessment on post-operative day 2 (POD2). Diminished total sleep time (r=-0.68; pdelirium severity. Patients experiencing delirium slept 2.4h less and took 2h longer to fall asleep. Greater waking EEG delta power (r=0.84; pdelirium severity. Loss of sleep on night1 post-surgery is an early predictor of subsequent delirium. EEG Delta Power alterations in waking and sleep appear to be later indicators of impending delirium. Further work is needed to evaluate reproducibility/generalizability and assess whether sleep loss contributes to causing delirium. This first study to prospectively collect continuous EEG data for an extended period prior to delirium onset identified EEG-derived indices that predict subsequent delirium that could aid in developing and targeting therapies. Copyright © 2017. Published by Elsevier B.V.

  17. Prospective pilot study of a tablet computer in an Emergency Department.

    Science.gov (United States)

    Horng, Steven; Goss, Foster R; Chen, Richard S; Nathanson, Larry A

    2012-05-01

    The recent availability of low-cost tablet computers can facilitate bedside information retrieval by clinicians. To evaluate the effect of physician tablet use in the Emergency Department. Prospective cohort study comparing physician workstation usage with and without a tablet. 55,000 visits/year Level 1 Emergency Department at a tertiary academic teaching hospital. 13 emergency physicians (7 Attendings, 4 EM3s, and 2 EM1s) worked a total of 168 scheduled shifts (130 without and 38 with tablets) during the study period. Physician use of a tablet computer while delivering direct patient care in the Emergency Department. The primary outcome measure was the time spent using the Emergency Department Information System (EDIS) at a computer workstation per shift. The secondary outcome measure was the number of EDIS logins at a computer workstation per shift. Clinician use of a tablet was associated with a 38min (17-59) decrease in time spent per shift using the EDIS at a computer workstation (pcomputer was associated with a reduction in the number of times physicians logged into a computer workstation and a reduction in the amount of time they spent there using the EDIS. The presumed benefit is that decreasing time at a computer workstation increases physician availability at the bedside. However, this association will require further investigation. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  18. Decreased QOL and muscle strength are persistent 1 year after intramedullary nailing of a tibial shaft fracture

    DEFF Research Database (Denmark)

    Larsen, Peter; Elsoe, Rasmus; Laessoe, Uffe

    2016-01-01

    was measured with the questionnaire Eq5D-5L and compared to norm data from a reference population. Recordings of pain and contralateral muscle strength (isometric maximal voluntary contraction (MVC) for knee flexion and extension were collected at 6 weeks, 3, 6, and 12 months postoperatively. Ipsilateral MVCs......INTRODUCTION:To evaluate the development in patient-reported quality of life (QOL) and muscle strength in the period from surgery to 12 months postoperatively after intramedullary nailing of a tibial shaft fracture. MATERIALS AND METHODS:The design was a prospective, follow-up cohort study. QOL...... compared to the reference population. Six and 12 months after surgery patients demonstrated decreased muscle strength in the injured leg compared to the non-injured leg for knee extension and flexion (P strength during knee...

  19. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial

    Science.gov (United States)

    Rushton, Alison; Goodwin, Peter C.

    2015-01-01

    Objectives To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. Design and Setting A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. Participants Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. Interventions Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. Main Outcome Measures Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. Results At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. Conclusions Both interventions were acceptable, and it is promising that they both

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

    Science.gov (United States)

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

    2017-11-01

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

  1. Prospective pilot study of CT-guided microwave ablation in the treatment of osteoid osteomas

    International Nuclear Information System (INIS)

    Prud'homme, Clara; Nueffer, Jean-Philippe; Runge, Michel; Dubut, Jonathan; Kastler, Bruno; Aubry, Sebastien

    2017-01-01

    The aims of this work were to assess the feasibility and efficacy of CT-guided microwave ablation (MWA) in the treatment of osteoid osteomas (OOs). Thirteen consecutive patients (range 11-31 years old) presenting with OO were prospectively included and treated by CT-guided MWA. Power and duration of MWA were both recorded. The patient's pain was assessed using a numeric pain rating scale (NRS), and side effects were recorded during procedures, after 1 day, 7 days and 1 month. The nidus vascularization and the volume of necrosis induced by MWA were assessed using contrast-enhanced MRI. Success was defined as the complete relief of the patient's pain 1 month after the first procedure, associated with necrosis of the nidus on follow-up MRI. The success rate was up to 92.3% (12/13). At 1 day, 7 days and 1 month, the median NRSs were respectively 5 [interquartile range (IQR) 2-5], 0 (IQR 0-1) and 0 (IQR 0-0). Side effects observed were one partial and self-resolving lesion of a sensory branch of the radial nerve and two skin burns. The median power of the MWA used was 60 W (IQR 50-60) with a 1.5-min duration (IQR 1-2), leading to MWA-induced necrosis measuring on average 23 x 15 x 16 mm. CT-guided MWA of OO has a success rate that appears to be almost similar to that of laser or radiofrequency ablation, but care must be taken to prevent nerve or skin lesions. (orig.)

  2. Prospective pilot study of CT-guided microwave ablation in the treatment of osteoid osteomas

    Energy Technology Data Exchange (ETDEWEB)

    Prud' homme, Clara; Nueffer, Jean-Philippe; Runge, Michel; Dubut, Jonathan [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Kastler, Bruno [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); I4S Laboratory, INSERM EA4268, University of Franche-Comte, Besancon (France); Aubry, Sebastien [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Nanomedecine Laboratory, INSERM EA4662, University of Franche-Comte, Besancon (France)

    2017-03-15

    The aims of this work were to assess the feasibility and efficacy of CT-guided microwave ablation (MWA) in the treatment of osteoid osteomas (OOs). Thirteen consecutive patients (range 11-31 years old) presenting with OO were prospectively included and treated by CT-guided MWA. Power and duration of MWA were both recorded. The patient's pain was assessed using a numeric pain rating scale (NRS), and side effects were recorded during procedures, after 1 day, 7 days and 1 month. The nidus vascularization and the volume of necrosis induced by MWA were assessed using contrast-enhanced MRI. Success was defined as the complete relief of the patient's pain 1 month after the first procedure, associated with necrosis of the nidus on follow-up MRI. The success rate was up to 92.3% (12/13). At 1 day, 7 days and 1 month, the median NRSs were respectively 5 [interquartile range (IQR) 2-5], 0 (IQR 0-1) and 0 (IQR 0-0). Side effects observed were one partial and self-resolving lesion of a sensory branch of the radial nerve and two skin burns. The median power of the MWA used was 60 W (IQR 50-60) with a 1.5-min duration (IQR 1-2), leading to MWA-induced necrosis measuring on average 23 x 15 x 16 mm. CT-guided MWA of OO has a success rate that appears to be almost similar to that of laser or radiofrequency ablation, but care must be taken to prevent nerve or skin lesions. (orig.)

  3. Efficacy of Mesoglycan in Pain Control after Excisional Hemorrhoidectomy: A Pilot Comparative Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Gaetano Gallo

    2018-01-01

    Full Text Available Introduction. Various pain management strategies for patients undergoing open excisional hemorrhoidectomy have been proposed, yet postoperative pain remains a frequent complaint. Objective. To determine whether mesoglycan (30 mg two vials i.m. once/day for the first 5 days postoperative, followed by 50 mg 1 oral tablet twice/day for 30 days would reduce the edema of the mucocutaneous bridges and thus improve postoperative pain symptoms. Patients and Methods. For this prospective observational multicenter study, 101 patients undergoing excisional diathermy hemorrhoidectomy for III-IV degree hemorrhoidal disease were enrolled at 5 colorectal referral centers. Patients were assigned to receive either mesoglycan (study group SG or a recommended oral dose of ketorolac tromethamine of 10 mg every 4–6 hours, not exceeding 40 mg per day and not exceeding 5 postoperative days according to the indications for short-term management of moderate/severe acute postoperative pain, plus stool softeners (control group CG. Results. Postoperative thrombosis (SG 1/48 versus CG 5/45 (p<0.001 and pain after rectal examination (p<0.001 were significantly reduced at 7–10 days after surgery in the mesoglycan-treated group, permitting a faster return to work (p<0.001; however, in the same group, the incidence of postoperative bleeding, considered relevant when needing a readmission or an unexpected outpatient visit, was higher, possibly owing to the drug’s antithrombotic properties. Conclusions. The administration of mesoglycan after an open diathermy excisional hemorrhoidectomy can reduce postoperative thrombosis and pain at 7–10 days after surgery, permitting a faster return to normal activities.

  4. Validation of the prolapse quality-of-life questionnaire (P-QOL): An ...

    African Journals Online (AJOL)

    Background. The prolapse quality-of-life questionnaire (P-QOL) has been validated and translated into eight languages. The lack of an Afrikaans version of the P-QOL limits studies in Afrikaans-speaking patients with pelvic organ prolapse (POP). Objective. To validate an Afrikaans version of the P-QOL in a South African ...

  5. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    International Nuclear Information System (INIS)

    Antunes, Alberto A.; Carnevale, Francisco C.; Motta Leal Filho, Joaquim M. da; Yoshinaga, Eduardo M.; Cerri, Luciana M. O.; Baroni, Ronaldo H.; Marcelino, Antonio S. Z.; Cerri, Giovanni G.; Srougi, Miguel

    2013-01-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12–41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H 2 O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies

  6. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Antunes, Alberto A. [University of Sao Paulo Medical School, Division of Urology (Brazil); Carnevale, Francisco C., E-mail: fcarnevale@uol.com.br; Motta Leal Filho, Joaquim M. da [University of Sao Paulo Medical School, Interventional Radiology Unit (Brazil); Yoshinaga, Eduardo M. [University of Sao Paulo Medical School, Division of Urology (Brazil); Cerri, Luciana M. O. [University of Sao Paulo Medical School, Ultrasound Unit (Brazil); Baroni, Ronaldo H. [University of Sao Paulo Medical School, Magnetic Resonance Unit (Brazil); Marcelino, Antonio S. Z. [University of Sao Paulo Medical School, Ultrasound Unit (Brazil); Cerri, Giovanni G. [University of Sao Paulo Medical School, Radiology Department (Brazil); Srougi, Miguel [University of Sao Paulo Medical School, Division of Urology (Brazil)

    2013-08-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12-41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H{sub 2}O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies.

  7. SUPRAPATELLAR VERSUS INFRAPATELLAR TIBIAL NAIL INSERTION- A PROSPECTIVE, RANDOMISED CONTROL PILOT STUDY

    Directory of Open Access Journals (Sweden)

    Sreekumar K

    2017-06-01

    Full Text Available BACKGROUND The standard for treating tibial shaft fractures are by intramedullary nails currently. After the procedure, one of the most frequent complication is knee pain, after consolidation even more chronically. Chronic knee pain can affect more than 50% of the cases, which was said by most authors. Alternative routes of inserting the nail is used, which includes by means of lateral patellar paratendon, medial patellar paratendon or transtendon to avoid the symptom. The aim of the study is to study the clinical and functional outcomes of suprapatellar versus infrapatellar tibial nail insertion. MATERIALS AND METHODS This is a prospective study, which was done from January 2014 to February 2015 and 50 patients who were skeletally mature were selected and randomised into IP and SP nail insertion groups. They were also given informed consent and only after they agreed, they were taken into the study. The technique of nail insertion was revealed to both the surgeon and the patient at that time. Exclusion Criteria- Pregnant women, patients with intra-articular involvement, periprosthetic fractures, nonunions, ipsilateral injuries, previous knee injuries, history of gout, rheumatoid, osteoarthritis, spinal injury and incarceration. SP insertion was performed percutaneously with the help of a special cannula system. RESULTS A total of 50 patients were selected in this study. 31 SP and 19 IP. 10 SP and 2 IP did not show up for follow up examinations, so only 38 patients were present for 12 months. At last, there were 21 SP and 17 IP patients. The time from when the index procedure was done to follow up was 14.6 months, i.e. it ranged from 12-28 months. 12 were males and 9 were females with suprapatellar, 9 were males and 8 were females in infrapatellar. Average age of suprapatellar was 42 and that of infrapatellar was 44. Open fractures were 5 and closed fractures were 33. VAS score was 0.78 in suprapatellar and 1.87 in infrapatellar. Data analysis

  8. Re: Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder

    Directory of Open Access Journals (Sweden)

    Sinharib Çitgez

    2016-12-01

    Full Text Available EDITORIAL COMMENT Overactive bladder (OAB is a highly prevalent disorder in the pediatric population. This event negatively affects and impairs children’s development. Antimuscarinics are the mainstay pharmacological management of OAB, but their side effects profile limits their use. Mirabegron, a new molecule with a distinct mechanism of action (b3-adrenoreceptor agonist, was recently approved as monotherapy for idiopathic OAB in adults but has not been studied in the pediatric population. Blais et al. have evaluated the efficacy and safety of mirabegron in the treatment of urinary incontinence in children with idiopathic OAB who were refractory to and/or intolerant of antimuscarinics. This prospective off-label study, using an adjusted-dose regimen of mirabegron (25-50 mg, included pediatric patients with refractory urinary incontinence due to OAB. Patients without symptom improvement or with partial response under intensive behavioral protocol and medical therapy (at least two different antimuscarinic agents were included in the study. Their primary outcome was better reported efficacy than with the use of prior anticholinergic medication. Secondary end points were tolerability and safety. Families were questioned for continence, side effects, compliance, and Patient Perception of Bladder Condition (PPBC questionnaire. A total of 58 patients (14 girls, 44 boys were enrolled in a mirabegron open-label trial. The median age at initiation of mirabegron was 10.1 years [interquartile range (IQR: 8.8-13.5]. The median duration of treatment was 11.5 months (IQR: 6.0-15.0. The median bladder capacity improved from 150 ml to 200 ml (p<0.001. Continence improved in 52 of 58, with 13 being completely dry. The median PPBC score improved from 4.0 to 2.0 (p<0.001. The authors also assessed the safety of mirabegron. All electrocardiogram and blood tests remained normal. No significant change in blood pressure (<5 mmHg and heart rate (fewer than five beats

  9. [Relationship between Quality of Life (QOL) and cognitive function among community-dwelling elderly].

    Science.gov (United States)

    Konagaya, Yoko; Watanabe, Tomoyuki; Ohta, Toshiki; Takata, Kazuko

    2009-03-01

    It has become important for elderly to live better rather than to live longer. There have been many reports about quality of life (QOL) of the elderly, but we have no knowledge about the relation between the QOL and the cognitive function. We investigated the relationship between the QOL and the cognitive function among community-dwelling elderly. A total of 12,059 community-dwelling elderly were invited to join a cognitive screening study by telephone (TICS-J) combined with a mailed QOL questionnaire. Among them, 1,920 subjects (age 71.87+/-5.50 (mean+/-SD) years old, duration of education 11.08+/-2.61 years) who completed both TICS-J and QOL questionnaire were actually measured. TICS-J was administered by the previously reported method, and the QOL questionnaire was developed based on the component of QOL proposed by Lawton, and consisted of 6 subscales (daily activity, satisfaction with health, satisfaction with human support, satisfaction with economic state, symptoms of depression, and positive mental attitude). Correlations were analyzed among the scores of TICS-J, age, duration of education, and scores on each QOL subscale. Multiple linear regression analysis was conducted after QOL subscale scores, adjusting for gender, age, and duration of education, were entered as dependent variables. Four out of 6 subscales scores of QOL showed significant differences between men and women. All QOL subscale scores showed significant differences between the two groups in the TICS-J scores. Partial correlations were seen among TICS-J scores and each QOL subscale score. Multiple linear regression analysis revealed significant influence of cognitive function by TICS-J on QOL subscales scores. Cognitive function was considered to have more influence on QOL scores than gender or age. TICS-J and the QOL questionnaire in this study were useful to evaluate the outcome of welfare in community-dwelling elderly.

  10. Supporting parents in taking care of their infants admitted to a neonatal intensive care unit: a prospective cohort pilot study.

    Science.gov (United States)

    De Bernardo, Giuseppe; Svelto, Maria; Giordano, Maurizio; Sordino, Desiree; Riccitelli, Marina

    2017-04-17

    Family-Centred Care (FCC) is recognized as an important component of all paediatric care, including neonatal care, although practical clinical guidelines to support this care model are still needed in Italy. The characteristics and services for families in Italian NICUs show a lack of organization and participation. The first aim was to compare satisfaction and stress levels in two groups of parents: an FCC group and a non-FCC group (NFCC). The second aim was to evaluate body weight gain in the newborns enrolled. This non-randomized, prospective cohort pilot study was conducted in a single level III NICU at a hospital in Naples, Italy. A cohort of newborns in the NICU, with their parents were enrolled between March 2014 and April 2015 and they were divided into two groups: the FCC group (enrolled between October 2014 and April 2015) remained in the NICU for 8 h a day with FCC model; the NFCC group (enrolled between March 2014 and September 2014) was granted access to the NICU for only 1 hour per day. At discharge, both parent groups completed the Parental Stressor Scale (PSS)-NICU and a questionnaire to assess their satisfaction. In addition, we compared scores from the mothers and fathers within and between groups and the body weights of the newborns in the two groups at 60 days. Parents participating in the FCC group were more satisfied and less stressed than those in the NFCC group. Infants in the FCC group also showed increased body weight after 60 days of hospital stay. Despite our small population, we confirm that routine adoption of a procedure designed to apply a FCC model can contribute to improving satisfaction and distress among preterm infants' parents. Future multi-centre, randomized, controlled trials are needed to confirm these findings.

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

    Science.gov (United States)

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

    2018-04-10

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

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

    Science.gov (United States)

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

    2017-02-01

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

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

    Science.gov (United States)

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

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

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

    Science.gov (United States)

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

    2015-07-01

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

  15. Neuro-QOL and the NIH Toolbox: implications for epilepsy

    Science.gov (United States)

    Nowinski, Cindy J; Victorson, David; Cavazos, Jose E; Gershon, Richard; Cella, David

    2011-01-01

    The impact of neurological disorders on the lives of patients is often far more complex than what is measured in routine examination. Measurement of this impact can be challenging owing to a lack of brief, psychometrically sound and generally accepted instruments. Two NIH-funded initiatives are developing assessment tools, in English and Spanish, which address these issues, and should prove useful to the study and treatment of epilepsy and other neurological conditions. The first, Neuro-QOL, has created a set of health-related quality of life measures that are applicable for people with common neurological disorders. The second, the NIH Toolbox for the Assessment of Neurological and Behavioral Function, is assembling measures of cognitive, emotional, motor and sensory health and function that can be used across all ages, from 3 to 85 years. This article describes both the projects and their potential value to epilepsy treatment and research. PMID:21552344

  16. Neuropsychological outcomes after Gamma Knife radiosurgery for mesial temporal lobe epilepsy: a prospective multicenter study.

    Science.gov (United States)

    Quigg, Mark; Broshek, Donna K; Barbaro, Nicholas M; Ward, Mariann M; Laxer, Kenneth D; Yan, Guofen; Lamborn, Kathleen

    2011-05-01

    To assess outcomes of language, verbal memory, cognitive efficiency and mental flexibility, mood, and quality of life (QOL) in a prospective, multicenter pilot study of Gamma Knife radiosurgery (RS) for mesial temporal lobe epilepsy (MTLE). RS, randomized to 20 Gy or 24 Gy comprising 5.5-7.5 ml at the 50% isodose volume, was performed on mesial temporal structures of patients with unilateral MTLE. Neuropsychological evaluations were performed at preoperative baseline, and mean change scores were described at 12 and 24 months postoperatively. QOL data were also available at 36 months. Thirty patients were treated and 26 were available for the final 24-month neuropsychological evaluation. Language (Boston Naming Test), verbal memory (California Verbal Learning Test and Logical Memory subtest of the Wechsler Memory Scale-Revised), cognitive efficiency and mental flexibility (Trail Making Test), and mood (Beck Depression Inventory) did not differ from baseline. QOL scores improved at 24 and 36 months, with those patients attaining seizure remission by month 24s accounting for the majority of the improvement. The serial changes in cognitive outcomes, mood, and QOL are unremarkable following RS for MTLE. RS may provide an alternative to open surgery, especially in those patients at risk of cognitive impairment or who desire a noninvasive alternative to open surgery. Wiley Periodicals, Inc. © 2011 International League Against Epilepsy.

  17. The impact of dysphagia on quality of life in ageing and Parkinson's disease as measured by the swallowing quality of life (SWAL-QOL) questionnaire.

    Science.gov (United States)

    Leow, Li Pyn; Huckabee, Maggie-Lee; Anderson, Tim; Beckert, Lutz

    2010-09-01

    This prospective, cross-sectional study evaluated the impact of dysphagia on quality of life in healthy ageing and in subjects with Parkinson's disease (PD) using the Swallowing Quality of Life (SWAL-QOL) questionnaire. Sixteen healthy young adults (8 males, mean age = 25.1 years) and 16 healthy elders (8 males, mean age = 72.8 years) were recruited. Thirty-two subjects with idiopathic PD (mean age = 68.5 years) were recruited from a movement disorders clinic. The severity of PD was staged using the Hoehn and Yahr scale. Results revealed that elders experienced symptoms of dysphagia more frequently than young adults but the overall SWAL-QOL scores were not significantly different. Subjects with PD who experienced dysphagia reported greatly reduced QOL, and significant differences were found in all but one subsection of the SWAL-QOL. Disease progression detrimentally impacts QOL, with subjects in later-stage PD experiencing further reduction in the desire to eat, difficulty with food selection, and prolonged eating duration. These features, which increase with disease severity, are likely to impact negatively upon nutritional status, which is already under threat from PD-related dysphagia.

  18. Implication for QOL after I-125 brachytherapy for prostate cancer

    International Nuclear Information System (INIS)

    Teishima, Jun; Yasumoto, Hiroaki; Inoue, Syogo; Masumoto, Hiroshi; Hasegawa, Yasuhisa; Matsubara, Akio

    2009-01-01

    The aim of this study is to evaluate the quality of life (QOL) of patients following prostate brachytherapy. Between July 2004 and May 2008, 139 patients underwent I-125 permanent brachytherapy. Among those patients, 69 who were followed up for more than one year using the Expanded Prostate Index Composite (EPIC), Japanese version v1 TM , were enrolled in this study. Urinary summary scores became worse temporarily at 1 month after the end of treatment, but then recovered gradually to the level before treatment. Sexual summary scores before treatment were 42.2±16.3. They became worse temporarily at 1 month after treatment but then recovered gradually in patients whose sexual summary scores were more than 40. Urinary morbidity scores after prostate brachytherapy were not so severe and recovered within a short period. Further long-term observation is thought to be required in the future. Sexual function scores of patients before treatment in the present study were lower compared with those recorded in previous studies. (author)

  19. Factors that influence the QOL of cancer patients who have undergone radiotherapy as outpatients

    International Nuclear Information System (INIS)

    Senuma, Maiko; Shinoda, Shizuyo; Kitada, Yoko; Takei, Akemi; Kanda, Kiyoko; Seyama, Ruka; Igarashi, Reiko

    2011-01-01

    The purpose of this study was to elucidate the factors that influence the QOL of cancer patients who have undergone radiotherapy in the outpatient setting. The patient's quality of life (QOL) was investigated by using the QOL evaluation standard functional assessment of cancer therapy-general (FACT-G) in 73 cancer patients (mean age 64.2±12.2 yrs standard deviation (SD)) who had undergone radiotherapy as outpatients. The mean QOL score was 74.8±17.1 pointy, and a significant difference was seen in about 25 items as a result of examining the factors that influenced the patient's QOL. In addition, a stepwise multiple regression analysis revealed that the factors which influenced the QOL were the operation due to the original disease, social support (excluding the family), tiredness, relapse and the metastasis, performance status (PS), uneasiness of presence in descending order of influence. The results revealed the strong influence of psychological, mental and social factors on the QOL score. From the patient of view of nursing support for cancer patients, screening for these factors may allow earlier detection of any decrease in the QOL, or identify when the QOL has already decreased. Furthermore, support should be initiated at as early a stage as possible. (author)

  20. 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.

  1. The Cerebral Palsy Quality of Life for Children (CP QOL-Child): Evidence of Construct Validity

    Science.gov (United States)

    Chen, Kuan-Lin; Wang, Hui-Yi; Tseng, Mei-Hui; Shieh, Jeng-Yi; Lu, Lu; Yao, Kai-Ping Grace; Huang, Chien-Yu

    2013-01-01

    The Cerebral Palsy Quality of Life for Children (CP QOL-Child) is the first health condition-specific questionnaire designed for measuring QOL in children with cerebral palsy (CP). However, its construct validity has not yet been confirmed by confirmatory factor analysis (CFA). Hence, this study assessed the construct validity of the caregiver…

  2. Quality of life (QoL) and neurotoxicity in germ-cell cancer survivors (GCCS)

    DEFF Research Database (Denmark)

    Lauritsen, J.; Bandak, Mikkel; Mortensen, M. S.

    2016-01-01

    Background: The majority of patients with testicular cancer become long-term survivors. However, treatment is associated with late effects which may hamper QoL. The aims of the present study were to assess the impact of treatment on long-term QoL and evaluate the influence of neurotoxicity on Qo...

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

    Science.gov (United States)

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

    2013-01-01

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

  4. A Prospective Pilot Study to Validate the Management Protocol for Patients Presenting with Acute Urinary Retention: A Community-Based, Nonhospitalised Protocol

    Directory of Open Access Journals (Sweden)

    Shyamala S. Gopi

    2006-01-01

    Full Text Available Acute urinary retention (AUR in males is managed conventionally by hospital admission, alpha-adrenergic therapy, and trial without catheter. To reduce inpatient bed pressures, we set up a protocol to manage such patients in the community. We review our results in this paper. We performed a prospective study of male patients presenting to our acute admissions ward and Accident and Emergency department over 6 months. Patients with chronic urinary retention, macroscopic haematuria, sepsis, urinary tract infection, and/or serum creatinine >130 mmol/l were excluded from the study. Those enrolled were catheterised, commenced on alfuzosin (10 mg nocte, and discharged to the community. A trial without catheter (TWOC was performed 5—7 days later. QoL/IPSS, peak flow rate, and residual volume assessment were performed following successful TWOC 3 months later.Thirty-one male patients with a median age of 69 years were studied and the median residual volume following catheterisation was 900 ml. The aetiology of AUR was benign prostatic hyperplasia (BPH in 29 patients and constipation in the remaining 2 patients. TWOC was successful in 19 patients (61.3% following first TWOC, 26 (83.9% following second trial of voiding. The mean peak flow rate was 6.5 ml/sec and postvoid scan 165 ml, following an immediate TWOC. At 3 months follow-up, mean peak flow rate was 13.2 ml/sec, postvoid scan 26.5 ml, IPSS 4.5, and QoL score was 2. This study has shown that AUR can be managed safely and effectively in the community. Effective communication with the nurse urology specialist, general practitioner, and emergency department are crucial for the successful implementation of the protocol.

  5. 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...

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

    Science.gov (United States)

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

    2018-06-01

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

  7. 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.

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

    Science.gov (United States)

    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.

  9. The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study

    Directory of Open Access Journals (Sweden)

    Matej Samoš

    2016-01-01

    Full Text Available Background. The aim of this study was to validate the impact of type 2 diabetes (T2D on the platelet reactivity in patients with acute ST elevation myocardial infarction (STEMI treated with adenosine diphosphate (ADP receptor blockers. Methods. A pilot prospective study was performed. Totally 67 patients were enrolled. 21 patients had T2D. Among all study population, 33 patients received clopidogrel and 34 patients received prasugrel. The efficacy of ADP receptor blocker therapy had been tested in two time intervals using light transmission aggregometry with specific inducer and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P flow cytometry assay. Results. There were no significant differences in platelet aggregability among T2D and nondiabetic (ND group. The platelet reactivity index of VASP-P did not differ significantly between T2D and ND group (59.4±30.9% versus 60.0±25.2% and 33.9±25.3% versus 38.6±29.3% in second testing. The number of ADP receptor blocker nonresponders did not differ significantly between T2D and ND patients. The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations. Conclusion. This prospective study did not confirm the higher platelet reactivity and higher prevalence of ADP receptor blocker nonresponders in T2D acute STEMI patients.

  10. Development of a head and neck companion module for the quality of life - radiation therapy instrument (QOL-RTI)

    International Nuclear Information System (INIS)

    Trotti, Andy; Johnson, Darlene J.; Gwede, Clement; Casey, Linda; Cantor, Alan

    1997-01-01

    Purpose/Objective: The purpose of this study is to develop a Likert version, disease specific module for the Quality of Life - Radiation Therapy Instrument (QOL-RTI) for head and neck patients. This module combined with the QOL-RTI may help us to determine what changes, if any, occur in the quality of life of patients receiving primary radiation therapy for head and neck cancer. A compelling reason to study head and neck patients is because of the extensive difficulties these patients experience while undergoing radiotherapy. Their psychological and emotional well-being may also have an adverse affect on their quality of life as they strive to cope with both a life-threatening disease and with the prospect of disfigurement or dysfunction that cannot be hidden from view. Many tools have been developed to measure quality of life, however, previously published literature has focused on quantifying functional status and toxicity assessment rather than the alteration of quality of life as perceived by the patient. This study, limited to patients receiving primary radiation, is expected to yield a tool that is applicable to the patient receiving multi-modality treatment for head and neck cancer and will be useful to the physician/nurse in determining interventions for these patients. Materials and Methods: This study is an uncontrolled, non-randomized exploratory study, including fifty (50) consecutive eligible patients undergoing definitive primary radiotherapy. The questionnaires were given to all eligible patients being treated with radiotherapy for head and neck cancer who are not already registered on another research study assessing Quality of Life (i.e. RTOG). During the 5-8 week treatment period, the QOL-RTI/H and N instrument is administered as follows: at baseline evaluation (immediately prior to the beginning of radiotherapy), at week four (4) two days in a row (for test-retest) and at the end of the treatment period. For validation purposes the QOL-RTI/H and

  11. Skill learning in patients with moderate Alzheimer's disease: a prospective pilot-study of waltz-lessons.

    Science.gov (United States)

    Rösler, Alexander; Seifritz, Erich; Kräuchi, Kurt; Spoerl, David; Brokuslaus, Ilona; Proserpi, Sara-Maria; Gendre, Annekäthi; Savaskan, Egemen; Hofmann, Marc

    2002-12-01

    The authors report the effect of a 12-day prospective, blinded dance-learning trial in 5 patients with moderate Alzheimer's disease (AD) and 5 age-matched depressed patients. Patients with AD showed a significant effect in procedural learning whereas depressed patients did not. These findings suggest potential implications for therapeutic interventions in patients with moderate AD. Copyright 2002 John Wiley & Sons, Ltd.

  12. Validation of the prolapse quality-of-life questionnaire (P-QOL): An ...

    African Journals Online (AJOL)

    Afrikaans version of the P-QOL limits studies in Afrikaans-speaking patients with pelvic organ prolapse (POP). Objective. ... The Cronbach alpha was used to determine internal consistency and ... German,[11] ..... quality of life, and risk factors.

  13. A new questionnaire for measuring quality of life - the Stark QoL.

    Science.gov (United States)

    Hardt, Jochen

    2015-10-26

    The Stark questionnaire measures health-related quality of life (QoL) using pictures almost exclusively. It is supplemented by a minimum of words. It comprises a mental and a physical health component. A German sample of n = 500 subjects, age and gender stratified, filled out the Stark Qol questionnaire along with various other questionnaires via internet. The physical component shows good reliability (Cronbach's alpha = McDonalds Omega = greatest lower bound = .93), the mental component can be improved (Cronbach's alpha = .63, McDonalds Omega = .72, greatest lower bound = .77). Confirmatory factor analysis shows a good fit (Bentlers CFI = .97). Construct validity was proven. The Stark QoL is a promising new development in measuring QoL, it is a short and easy to apply questionnaire. Additionally, it is particularly promising for international research.

  14. Overview of the Spinal Cord Injury--Quality of Life (SCI-QOL) measurement system.

    Science.gov (United States)

    Tulsky, David S; Kisala, Pamela A; Victorson, David; Tate, Denise G; Heinemann, Allen W; Charlifue, Susan; Kirshblum, Steve C; Fyffe, Denise; Gershon, Richard; Spungen, Ann M; Bombardier, Charles H; Dyson-Hudson, Trevor A; Amtmann, Dagmar; Kalpakjian, Claire Z; Choi, Seung W; Jette, Alan M; Forchheimer, Martin; Cella, David

    2015-05-01

    The Spinal Cord Injury--Quality of Life (SCI-QOL) measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome (PRO) measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. Using a computer adaptive testing (CAT) approach, the SCI-QOL builds on the Patient Reported Outcomes Measurement Information System (PROMIS) and the Quality of Life in Neurological Disorders (Neuro-QOL) initiative. This initial manuscript introduces the background and development of the SCI-QOL measurement system. Greater detail is presented in the additional manuscripts of this special issue. Classical and contemporary test development methodologies were employed. Qualitative input was obtained from individuals with SCI and clinicians through interviews, focus groups, and cognitive debriefing. Item pools were field tested in a multi-site sample (n=877) and calibrated using item response theory methods. Initial reliability and validity testing was performed in a new sample of individuals with traumatic SCI (n=245). Five Model SCI System centers and one Department of Veterans Affairs Medical Center across the United States. Adults with traumatic SCI. n/a n/a The SCI-QOL consists of 19 item banks, including the SCI-Functional Index banks, and 3 fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL). The SCI-QOL measurement system consists of psychometrically sound measures for individuals with SCI. The manuscripts in this special issue provide evidence of the reliability and initial validity of this measurement system. The SCI-QOL also links to other measures designed for a general medical population.

  15. Overview of the Spinal Cord Injury – Quality of Life (SCI-QOL) measurement system

    Science.gov (United States)

    Tulsky, David S.; Kisala, Pamela A.; Victorson, David; Tate, Denise G.; Heinemann, Allen W.; Charlifue, Susan; Kirshblum, Steve C.; Fyffe, Denise; Gershon, Richard; Spungen, Ann M.; Bombardier, Charles H.; Dyson-Hudson, Trevor A.; Amtmann, Dagmar; Z. Kalpakjian, Claire; W. Choi, Seung; Jette, Alan M.; Forchheimer, Martin; Cella, David

    2015-01-01

    Context/Objective The Spinal Cord Injury – Quality of Life (SCI-QOL) measurement system was developed to address the shortage of relevant and psychometrically sound patient reported outcome (PRO) measures available for clinical care and research in spinal cord injury (SCI) rehabilitation. Using a computer adaptive testing (CAT) approach, the SCI-QOL builds on the Patient Reported Outcomes Measurement Information System (PROMIS) and the Quality of Life in Neurological Disorders (Neuro-QOL) initiative. This initial manuscript introduces the background and development of the SCI-QOL measurement system. Greater detail is presented in the additional manuscripts of this special issue. Design Classical and contemporary test development methodologies were employed. Qualitative input was obtained from individuals with SCI and clinicians through interviews, focus groups, and cognitive debriefing. Item pools were field tested in a multi-site sample (n = 877) and calibrated using item response theory methods. Initial reliability and validity testing was performed in a new sample of individuals with traumatic SCI (n = 245). Setting Five Model SCI System centers and one Department of Veterans Affairs Medical Center across the United States. Participants Adults with traumatic SCI. Interventions n/a Outcome Measures n/a Results The SCI-QOL consists of 19 item banks, including the SCI-Functional Index banks, and 3 fixed-length scales measuring physical, emotional, and social aspects of health-related QOL (HRQOL). Conclusion The SCI-QOL measurement system consists of psychometrically sound measures for individuals with SCI. The manuscripts in this special issue provide evidence of the reliability and initial validity of this measurement system. The SCI-QOL also links to other measures designed for a general medical population. PMID:26010962

  16. Comparison of QOL between patients with different degenerative dementias, focusing especially on positive and negative affect.

    Science.gov (United States)

    Kurisu, Kairi; Terada, Seishi; Oshima, Etsuko; Horiuchi, Makiko; Imai, Nao; Yabe, Mayumi; Yokota, Osamu; Ishihara, Takeshi; Yamada, Norihito

    2016-08-01

    Quality of life (QOL) has become an important outcome measure in the care of dementia patients. However, there have been few studies focusing on the difference in QOL between different dementias. Two-hundred seventy-nine consecutive outpatients with Alzheimer's disease (AD), dementia with Lewy bodies (DLB) or frontotemporal dementia (FTD) were recruited. The QOL was evaluated objectively using the QOL Questionnaire for Dementia (QOL-D).The QOL-D comprises six domains: positive affect, negative affect and actions, communication, restlessness, attachment to others, and spontaneity. General cognition, daily activities, and behavioral and psychological symptoms of dementia were also evaluated. The scores of positive affect of QOL-D of AD patients were significantly higher than those of patients with DLB or FTD (AD 3.1 ± 0.8, DLB 2.6 ± 0.9, FTD 2.6 ± 0.7). The scores of negative affect and action of QOL-D of FTD patients were significantly higher than those of patients with AD or DLB (FTD 2.0 ± 0.8, AD 1.4 ± 0.5, DLB 1.5 ± 0.6). The apathy scores of FTD and DLB patients were significantly higher than those of patients with AD. The disinhibition scores of FTD patients were significantly higher than those of patients with AD or DLB. The apathy of FTD and DLB patients and depression of DLB patients might affect the lower positive affect of FTD and DLB patients compared to AD patients. The disinhibition of FTD patients might affect the abundance of negative affect & actions in FTD patients compared to AD and DLB patients.

  17. Validation of the Stroke Specific Quality of Life Scale (SS-QOL): test of reliability and validity of the Danish version (SS-QOL-DK).

    Science.gov (United States)

    Muus, Ingrid; Williams, Linda S; Ringsberg, Karin C

    2007-07-01

    To test the reliability and validity of the Danish version of the Stroke Specific Quality of Life Scale version 2.0 (SS-QOL-DK), an instrument for evaluation of health-related quality of life. A correlational study. A stroke unit that provides acute care and rehabilitation for stroke patients in Frederiksborg County, Denmark. One hundred and fifty-two stroke survivors participated; 24 of these performed test-retest. Questionnaires were sent out and returned by mail. A subsequent telephone interview assessed functional level and missing items. Test-retest was measured using Spearman's r, internal consistency was estimated using Cronbach's alpha, and evaluation of floor and ceiling values in proportion of minimum and maximum scores. Construct validity was assessed by comparing patients' scores on the SS-QOL-DK with those obtained by other test methods: Beck's Depression Index, the General Health Survey Short Form 36 (SF-36), the Barthel Index and the National Institutes of Health Stroke Scale, evaluating shared variance using coefficient of determination, r2. Comparing groups with known scores assessed known-group validity. Convergent and discriminant validity were assessed. Test-retest of SS-QOL-DK showed excellent stability, Spearman's r = 0.65-0.99. Internal consistency for all domains showed Cronbach's alpha = 0.81-0.94. Missing items rate was 1.0%. Most SS-QOL-DK domains showed moderately shared variance with similar domains of other test methods, r2 = 0.03-0.62. Groups with known differences showed statistically significant difference in scores. Item-to-scale correlation coefficients of 0.37-0.88 supported convergent validity. SS-QOL-DK is a reliable and valid instrument for measuring self-reported health-related quality of life on group level among people with mild to moderate stroke.

  18. ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.

    Science.gov (United States)

    Kim, Min Jeong; Tsinalis, Dimitrios; Franz, Stefan; Binet, Isabelle; Gürke, Lorenz; Mihatsch, Michael J; Steiger, Jürg; Thiel, Gilbert; Dickenmann, Michael

    2008-01-01

    Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible. Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group. The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient. In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.

  19. The administration of intermittent parathyroid hormone affects functional recovery from trochanteric fractured neck of femur: a randomised prospective mixed method pilot study.

    Science.gov (United States)

    Chesser, T J S; Fox, R; Harding, K; Halliday, R; Barnfield, S; Willett, K; Lamb, S; Yau, C; Javaid, M K; Gray, A C; Young, J; Taylor, H; Shah, K; Greenwood, R

    2016-06-01

    We wished to assess the feasibility of a future randomised controlled trial of parathyroid hormone (PTH) supplements to aid healing of trochanteric fractures of the hip, by an open label prospective feasibility and pilot study with a nested qualitative sub study. This aimed to inform the design of a future powered study comparing the functional recovery after trochanteric hip fracture in patients undergoing standard care, versus those who undergo administration of subcutaneous injection of PTH for six weeks. We undertook a pilot study comparing the functional recovery after trochanteric hip fracture in patients 60 years or older, admitted with a trochanteric hip fracture, and potentially eligible to be randomised to either standard care or the administration of subcutaneous PTH for six weeks. Our desired outcomes were functional testing and measures to assess the feasibility and acceptability of the study. A total of 724 patients were screened, of whom 143 (20%) were eligible for recruitment. Of these, 123 were approached and 29 (4%) elected to take part. However, seven patients did not complete the study. Compliance with the injections was 11 out of 15 (73%) showing the intervention to be acceptable and feasible in this patient population. Only 4% of patients who met the inclusion criteria were both eligible and willing to consent to a study involving injections of PTH, so delivering this study on a large scale would carry challenges in recruitment and retention. Methodological and sample size planning would have to take this into account. PTH administration to patients to enhance fracture healing should still be considered experimental. Cite this article: Bone Joint J 2016;98-B:840-5. ©2016 Chesser et al.

  20. Quality of life assessment in cosmetics: specificity and interest of the international BeautyQol instrument.

    Science.gov (United States)

    Beresniak, Ariel; Auray, Jean-Paul; Duru, Gérard; Aractingi, Selim; Krueger, Gerald G; Talarico, Sergio; Tsutani, Kiichiro; Dupont, Danielle; de Linares, Yolaine

    2015-09-01

    The wide use of cosmetics and their perceived benefits upon well-being imply objective descriptions of their effects upon the different dimensions contributing to the quality of life (QoL). Such a goal pleas for using relevant and validated scientific instruments with robust measurement methods. This paper discusses the interest of the new validated questionnaire BeautyQoL specifically designed to assess the effect of cosmetic products on physical appearance and QoL. After conducting a review of skin appearance and QoL, three phases of the international codevelopment have been carried out in the following sequence: semi-directed interviews (Phase 1), acceptability study (Phase 2), and validation study (Phase 3). Data collection and validation process have been carried out in 16 languages. This review confirms that QoL instruments developed in dermatology are not suitable to assess cosmetic products, mainly because of their lack of sensitivity. General acceptability of BeautyQol was very good. Forty-two questions have been structured in five dimensions that explained 76.7% of the total variance: Social Life, Self-confidence, Mood, Vitality, and Attractiveness. Cronbach's alpha coefficients are between 0.932 and 0.978, confirming the good internal consistency of the results. The BeautyQol questionnaire is the first international instrument specific to cosmetic products and physical appearance that has been validated in 16 languages and could be used in a number of clinical trials and descriptive studies to demonstrate the added value of these products on the QoL. © 2015 Wiley Periodicals, Inc.

  1. Quality of life outcome measures following partial glossectomy: Assessment using the UW-QOL scale

    Directory of Open Access Journals (Sweden)

    Kazi R

    2008-01-01

    Full Text Available Background: The consequences of a diagnosis of head and neck cancer and the impact of treatment have a clear and direct influence on well-being and associated quality of life (QOL in these patients. Aims: To determine the QOL in head and neck cancer patients following a partial glossectomy operation. Design and Setting: Cross-sectional cohort study; Head and Neck Oncology Unit, tertiary referral center. Materials and Methods: 38 patients with partial glossectomy were assessed with the University of Washington head and neck quality of life (UW-QOL scale, version 4. Statistical Analysis: Statistical analysis was performed using the Statistical Package for Social Sciences 10.0 (SPSS Inc, Chicago version III. Information from the scale was correlated using the Mann Whitney test. A P value less than/equal to 0.05 was considered as significant. Results: The mean (sd composite score of the QOL in our series was 73.6 (16.1. The majority (71.8% quoted their QOL as good or very good. Swallowing (n = 16, 47.1%, speech (n = 15, 44.1% and saliva (n = 15, 44.1% were most commonly cited issues over the last 7 days. On the other hand, the groups with reconstruction, neck dissection, complications and radiotherapy demonstrated a significant reduction of quality of life scores (Mann Whitney test, P < 0.05. Conclusion: The composite score and overall QOL as assessed using the UW-QOL scale (version 4 were modestly high in our series of partial glossectomy patients. Swallowing, speech, and saliva are regarded as the most important issues. Stage of the disease, neck dissection, reconstruction, complications, radiotherapy and time since operation were seen to significantly affect domain scores.

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

    Science.gov (United States)

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

    2011-01-01

    The diagnosis of perilymphatic fluid (PLF) fistula is still challenging. Perilymphatic fluid fistula is one possible complication after stapedotomy or cochlear implant surgery. We have performed a prospective diagnostic pilot study to further investigate β-trace protein (β-TP) as a marker for PLF fistula. In this pilot study, we tested the sensitivity of the β-TP marker using a simple method for sample collection from the tympanic cavity. Prospective controlled diagnostic study. Two-center tertiary referral hospitals. A total of 35 adult patients undergoing ear surgery were included. Subjects were divided into 2 groups: 1) 19 patients undergoing stapedotomy were investigated for PLF fistula in samples obtained from the tympanic cavity and 2) 16 patients undergoing myringoplasty were investigated for PLF fistula in samples from the tympanic cavity. This group served as the control. Mean age +/- SD at surgery was 49.9 +/- 8.0 years in the study group and 39.69 +/- 15.47 years in the control group. β-Trace protein (prostaglandin D synthase) in tympanic cavity samples and serum samples was analyzed. The samples were collected by gradually filling the tympanic cavity with 100 to 200 μl sodium chloride and by immediately collecting a volume of 60 to 100 μl in a mucus specimen set container. The concentration of β-TP was quantified using laser nephelometry. The median β-TP in the study group was 0.8 mg/L (range, 0.05-4.5 mg/L). In the control group, the median β-TP value was 0.16 mg/L (range, 0.01-0.36 mg/L). Thirty-five percent of the values in the study group were below the highest value in the negative control group. The β-TP values of the tympanic cavity samples were significantly higher in the study group than in controls (p = 0.0001). The serum values were 0.55 +/- 0.18 and 0.53 +/- 0.11 mg/L, respectively. It may be feasible to test for PLF fistula using β-TP in samples from the tympanic cavity. Our results, however, suggest a relative low diagnostic

  3. Establishment of a metallogenetic prospecting model of a pilot area in the Resende Basin - RJ, Brazil, within it's geomorphic aspects

    International Nuclear Information System (INIS)

    Bidone, E.D.; Perrin, P.; Rocha, J.A. da

    1984-01-01

    The Resende Basin lies between the Mantiqueira Mountain range which rises up to 2800m in the alcaline massif of Itatiaia - Passa Quatro in the North, and the Serra do Mar Mountain range in the South. The basin is the most casterly of a series of elongate Tertiary sedimentary basins that stretch SW to NE between Sao Paulo and Barra Mansa in the state of Rio de Janeiro, Brazil (44 0 to 47 0 West). Considering: -The economic potential represented by source rocks for the basin sediments; -the known capacity of sediments to concentrate metals when weathering, transport and deposition conditions are favorable, a geochemical analysis was done to determine; -favorable sites of uranium and thorium concentrations; -the evolution of depositional environments through integration of sedimentalogical, mineralogical, and geochemical data in order that the metallogenetic analysis promotes more efficient prospecting. The results permit a better understanding of the sedimentological and geochemical setting of Tertiary sediments in the region, as well as establish a method of rapid, inexpensive and efficient prospection that can be used in other basins of this type. (Author) [pt

  4. Development and evaluation of oral Cancer quality-of-life questionnaire (QOL-OC).

    Science.gov (United States)

    Nie, Min; Liu, Chang; Pan, Yi-Chen; Jiang, Chen-Xi; Li, Bao-Ru; Yu, Xi-Jie; Wu, Xin-Yu; Zheng, Shu-Ning

    2018-05-03

    In this study scales and items for the Oral Cancer Quality-of-life Questionnaire (QOL-OC) were designed and the instrument was evaluated. The QOL-OC was developed and modified using the international definition of quality of life (QOL) promulgated by the European Organization for Research and Treatment of Cancer (EORTC) and analysis of the precedent measuring instruments. The contents of each item were determined in the context of the specific characteristics of oral cancer. Two hundred thirteen oral cancer patients were asked to complete both the EORTC core quality of life questionnaire (EORTC QLC-C30) and the QOL-OC. Data collected was used to conduct factor analysis, test-retest reliability, internal consistency, and construct validity. Questionnaire compliance was relatively high. Fourteen of the 213 subjects accepted the same tests after 24 to 48 h demonstrating a high test-retest reliability for all five scales. Overall internal consistency surpasses 0.8. The outcome of the factor analysis coincides substantially with our theoretical conception. Each item shows a higher correlation coefficient within its own scale than the others which indicates high construct validity. QOL-OC demonstrates fairly good statistical reliability, validity, and feasibility. However, further tests and modification are needed to ensure its applicability to the quality-of-life assessment of Chinese oral cancer patients.

  5. Influence of preoperative life satisfaction on recovery and outcomes after colorectal cancer surgery - a prospective pilot study.

    Science.gov (United States)

    Romain, B; Rohmer, O; Schimchowitsch, S; Hübner, M; Delhorme, J B; Brigand, C; Rohr, S; Guenot, D

    2018-01-17

    Colorectal surgery has an important impact on a patient's quality of life, and postoperative rehabilitation shows large variations. To enhance the understanding of recovery after colorectal cancer, health-related quality of life has become a standard outcome measurement for clinical care and research. Therefore, we aimed to correlate the influence of preoperative global life satisfaction on subjective feelings of well-being with clinical outcomes after colorectal surgery. In this pilot study of consecutive colorectal surgery patients, various dimensions of feelings of preoperative life satisfaction were assessed using a self-rated scale, which was validated in French. Both objective (length of stay and complications) and subjective (pain, subjective well-being and quality of sleep) indicators of recovery were evaluated daily during each patient's hospital stay. A total of 112 patients were included. The results showed a negative relationship between life satisfaction and postoperative complications and a significant negative correlation with the length of stay. Moreover, a significant positive correlation between life satisfaction and the combined subjective indicators of recovery was observed. We have shown the importance of positive preoperative mental states and global life satisfaction as characteristics that are associated with an improved recovery after colorectal surgery. Therefore, patients with a good level of life satisfaction may be better able to face the consequences of colorectal surgery, which is a relevant parameter in supportive cancer care.

  6. Serum lipid profile changes after successful treatment with electroconvulsive therapy in major depression: A prospective pilot trial.

    Science.gov (United States)

    Aksay, Suna Su; Bumb, Jan Malte; Janke, Christoph; Biemann, Ronald; Borucki, Katrin; Lederbogen, Florian; Deuschle, Michael; Sartorius, Alexander; Kranaster, Laura

    2016-01-01

    Cholesterol is reduced in depressed patients, however, these patients have a higher risk for cardiovascular diseases. Electroconvulsive therapy (ECT) is a highly effective treatment option for specific forms of depression. Like for other non-pharmacological therapies targeting depression such as psychotherapy or sleep deprivation, there is a lack of evidence about the effects on peripheral lipid parameters. Our objective was to study the impact of ECT as a non-pharmacological treatment on the peripheral lipid pattern in depressive patients. Peripheral lipid profile composition before and after a course of ECT was analysed in 27 non-fasting inpatients at a university psychiatric hospital with DSM-IV major depressive episode. For the impact of ECT treatment on each lipid parameter a multivariate repeated measurement regression analysis was performed and computed separately for every dependent variable. Total Cholesterol and the cholesterol subtypes HDL and LDL were increased after the treatment compared to baseline. Apolipoprotein A1 was also increased after ECT, whereas apolipoprotein B was not. Indices for the prediction of cardiovascular diseases were unchanged after successful treatment by ECT. The reduction of depressive psychopathology negatively correlated with increases of HDL cholesterol and apolipoprotein A1. Subjects received several antidepressants and other psychotropic medication before and during the ECT. In our preliminary pilot study ECT as a non-pharmacological, effective treatment of depression led to distinct effects on the peripheral lipid pattern. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Preliminary Experience with Instillation of Triamcinolone Acetonide into the Urethra for Idiopathic Urethritis: A Prospective Pilot Study.

    Science.gov (United States)

    Ashraf, Junaid; Radford, Anna R; Turner, Alexander; Subramaniam, Ramnath

    2017-11-01

    Idiopathic bulbar urethritis (IBU) is characterized by hematuria ± dysuria without infection. Symptoms result from inflammation of the bulbar urethra, distal to external sphincter. IBU is difficult to manage and there is no recommended therapy. To determine whether instillation of triamcinolone acetonide is a useful treatment of IBU and its associated complications. Data were prospectively collected, for 22 months, on 14 consecutive patients presenting with terminal hematuria or blood spotting ± dysuria to a pediatric urology unit. Median age was 12 years (range: 10-15). Mean symptom duration was 13 months (range: 8-24). Normal baseline laboratory blood tests, urine cultures, and ultrasound assessments were seen in all; therefore, none were excluded on the basis of a known pathology. Follow-up telephone interviews, to assess symptom persistence and side effects, were performed at 6 weeks postintervention. The mean follow-up period was 15 months (range: 4-20). Visual confirmation of IBU was obtained cystoscopically and 40 mg of triamcinolone was instilled to the inflamed area under direct vision using an open-ended ureteral catheter. Symptoms resolution was the primary outcome. Repeat cystoscopic assessment ± triamcinolone instillation was recorded, as was the occurrence of complications. Seven patients (50%) required at least one further treatment. Overall complete or partial resolution was reported in 12/14 patients (85.7%). No side effects were reported. This small prospective series demonstrates that intraurethral instillation of triamcinolone seems to be a promising treatment option to alleviate inflammatory symptoms in majority of cases of idiopathic urethritis. Patient Summary: Fourteen boys with inflammation of the urethra, with no identifiable cause, were treated by topically triamcinolone, directly to the inflamed area. We demonstrate an 85.7% complete/partial resolution of symptoms with no side effects seen.

  8. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  9. Quality of Life Assessment Using EuroQOL EQ-5D Questionnaire in Patients with Deep Infiltrating Endometriosis: The Relation with Symptoms and Locations

    Science.gov (United States)

    Touboul, C.; Amate, P.; Ballester, M.; Bazot, M.; Fauconnier, A.; Daraï, E.

    2013-01-01

    The objective of this study was to evaluate the quality of life (QOL) of patients with deep infiltrating endometriosis (DIE) using EuroQOL (EQ-5D) and its correlation with symptoms and locations of endometriotic lesions. One hundred and fifty-nine patients referred for DIE from January 2011 to April 2011 were prospectively invited to complete questionnaires evaluating symptoms associated with endometriosis as well as the EQ-5D questionnaire and health state. Patients also had locations of DIE evaluated by clinical examination and magnetic resonance imaging (MRI). All 159 patients completed the questionnaires. Item response rate was 91.1%. The most intense symptoms were dysmenorrhea (7.1/10), painful defecation (6.3/10), and fatigue (6.0/10). Mean (SD) scores were 77 (14) for the EQ-5D questionnaire and 63.4 (21) for the health state. A relation was observed between the EQ-5D questionnaire and the presence of dysmenorrhea, dyspareunia, cyclic pelvic pain, painful defecation, and diarrhea or constipation. Vaginal and rectal infiltrations were significantly associated with altered EQ-5D and health state scores. The EQ-5D questionnaire is easy to complete and well related to symptoms of DIE. Rectal and vaginal infiltrations were found to be determinant factors of altered QOL by the EQ-5D questionnaire and health state. PMID:26464845

  10. A randomized assessment of three quality of life (QOL) questionnaires for prostate cancer patients undergoing different radiation treatment modalities

    International Nuclear Information System (INIS)

    Senter, K.K.; Hardy, M.; Flynn, C.; Lewis, L.; Wallace, M.; Boyea, G.; Mitchell, C.; Fluellen, L.; Henry, C.St.; Martinez, A.

    2001-01-01

    Purpose: The goal of this prospective, randomized study was to assess and compare compliance of patients diagnosed with prostate cancer to completing three different validated QOL instruments pre-treatment and six months later. Materials and Methods: Between April 2000 and April 2001, 124 patients were asked to fill out only one of three randomly selected QOL questionnaires (version A, B, C). Each addressed urinary and sexual function. One also addressed patients' physical, social, family, emotional, and functional well being. Study patients received External Beam Radiation Therapy (EBRT) or Brachytherapy (BRACHY), according to departmental policy. Exclusion criteria included current/previous hormone therapy and prostatectomy. Patients were asked to return the questionnaire at their first treatment visit. The three tools were: A The Functional Assessment of Cancer Therapy for Prostate Patients (FACT-P), The Sexual Adjustments Questionnaire (SAQ), and The American Urological Association (AUA) Questionnaire. The Fact-P questionnaire elicits information about physical, social, family, emotional, and functional well being as they relate to prostate cancer. SAQ focuses on sexual function; the AUA on urinary symptoms. B SAQ and AUA only; identical to Version A, but does not address physical, social, family, emotional, and functional well-being. C The International Prostate Symptom Score (I-PSS) Questionnaire, which addresses urinary symptoms and Patient Sexual Function Questionnaire, which focuses on erectile function. Additionally, patients were asked to respond yes/no to four variables designed to evaluate these questionnaires: 1) ease of understanding, 2) too personal, 3)addresses concerns regarding urinary function and sexual potency and 4) willingness to complete questionnaire in six months. These variables were examined for any trends that may exist between the different questionnaires. Results: Fifteen (12%) of the 124 patients returned incomplete questionnaires

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

    Heinävaara, Sirpa; Tokola, Kari; Kurttio, Päivi; Auvinen, Anssi

    2011-03-08

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

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

    Science.gov (United States)

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

    2015-07-01

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

  14. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    Directory of Open Access Journals (Sweden)

    Fölster-Holst R

    2015-10-01

    Full Text Available Regina Fölster-Holst,1 Jagoda Galecka,1 Sigo Weißmantel,1 Ute Dickschat,2 Frank Rippke,3 Kerstin Bohnsack,3 Thomas Werfel,4 Katja Wichmann,4 Matthias Buchner,1 Thomas Schwarz,1 Annika Vogt,5 Jürgen Lademann,5 Martina C Meinke5 1Department of Dermatology, Venerology and Allergy, University of Kiel, 2Wörth, 3Beiersdorf AG, Hamburg, 4Department of Dermatology, Venerology and Allergy, Division of Immunodermatology and Allergy Research, Hannover Medical School, Hannover, 5Department of Dermatology, Venerology and Allergology, Charité – Universitätsmedizin Berlin, Berlin, Germany Abstract: There is little clinical evidence for a correlation between the severity of atopic eczema (AE and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. Keywords: aeroallergens, atopic eczema, seasonality, skin antigen-presenting cells, skin barrier penetration

  15. Training opioid addiction treatment providers to adopt contingency management: A prospective pilot trial of a comprehensive implementation science approach.

    Science.gov (United States)

    Becker, Sara J; Squires, Daniel D; Strong, David R; Barnett, Nancy P; Monti, Peter M; Petry, Nancy M

    2016-01-01

    Few prospective studies have evaluated theory-driven approaches to the implementation of evidence-based opioid treatment. This study compared the effectiveness of an implementation model (Science to Service Laboratory; SSL) to training as usual (TAU) in promoting the adoption of contingency management across a multisite opioid addiction treatment program. We also examined whether the SSL affected putative mediators of contingency management adoption (perceived innovation characteristics and organizational readiness to change). Sixty treatment providers (39 SSL, 21 TAU) from 15 geographically diverse satellite clinics (7 SSL, 8 TAU) participated in the 12-month study. Both conditions received didactic contingency management training and those in the predetermined experimental region received 9 months of SSL-enhanced training. Contingency management adoption was monitored biweekly, whereas putative mediators were measured at baseline, 3 months, and 12 months. Relative to providers in the TAU region, treatment providers in the SSL region had comparable likelihood of contingency management adoption in the first 20 weeks of the study, and then significantly higher likelihood of adoption (odds ratios = 2.4-13.5) for the remainder of the study. SSL providers also reported higher levels of one perceived innovation characteristic (Observability) and one aspect of organizational readiness to change (Adequacy of Training Resources), although there was no evidence that the SSL affected these putative mediators over time. Results of this study indicate that a fully powered randomized trial of the SSL is warranted. Considerations for a future evaluation are discussed.

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

    Science.gov (United States)

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

    2014-01-01

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

  17. A pilot muon radiography to image the shallow conduit of the Stromboli volcano: results and future prospects

    Science.gov (United States)

    Miyamoto, Seigo; Tioukov, Valeri; Sirignano, Chiara; Bozza, Cristiano; Morishima, Kunihiro

    2017-04-01

    The test result of imaging the shallow part of the Stromboli crater zone by using cosmic-ray muons in 2012 and possible performance of the future muon observation will be presented. It is well known that the behavior of volcanic eruptions strongly depends on the shape of the conduit. Stromboli is one of the most known and studied active volcanoes in the world, nevertheless the details of its internal structure are not well defined yet. Geophysical exploration method which use high energy cosmic-ray muons and makes the density image of the object like X-ray radiography for the human body is called "muon radiography " or "muography". A pilot muography was done for the shallow part of Stromboli in 2012. We succeeded to clarify that there is a less density part at the North-East cone in the crater zone. It is considered that the stack of volcanic ashes. On the other hand, we also confirmed that the contamination of the physical background particles and they makes the noisy density image especially about 50 meter below from the top of the crater. In another observation, Nishiyama et al (2014) revealed the contents of background particles and the way to remove them were presented. They showed that the main contents of the background particles is low kinetic energy charged particles and also showed that it is possible to remove them by using multi-layerd muon film detector. We can plan the future muography observation to see the deeper part of the conduit( at least until 100 meter from the top of crater) by their backgroundless method. Therefore we estimated possible performance of the future observation by multi-layer muon films. The result suggests that we might get the image of shallow conduit from the surface to the depth of e.g. 55 meter with 20 meter spatial resolution or 100 meter with 27 meter resolution in case the density in the conduit is 0.0 g/cm3 and with 71 percent statistical confidence level.

  18. EUS-guided rendezvous for difficult biliary cannulation using a standardized algorithm: a multicenter prospective pilot study (with videos).

    Science.gov (United States)

    Iwashita, Takuji; Yasuda, Ichiro; Mukai, Tsuyoshi; Iwata, Keisuke; Ando, Nobuhiro; Doi, Shinpei; Nakashima, Masanori; Uemura, Shinya; Mabuchi, Masatoshi; Shimizu, Masahito

    2016-02-01

    Biliary cannulation is necessary in therapeutic ERCP for biliary disorders. EUS-guided rendezvous (EUS-RV) can salvage failed cannulation. Our aim was to determine the safety and efficacy of EUS-RV by using a standardized algorithm with regard to the endoscope position in a prospective study. EUS-RV was attempted after failed cannulation in 20 patients. In a standardized approach, extrahepatic bile duct (EHBD) cannulation was preferentially attempted from the second portion of the duodenum (D2) followed by additional approaches to the EHBD from the duodenal bulb (D1) or to the intrahepatic bile duct from the stomach, if necessary. A guidewire was placed in an antegrade fashion into the duodenum. After the guidewire was placed, the endoscope was exchanged for a duodenoscope to complete the cannulation. The bile duct was accessed from the D2 in 10 patients, but from the D1 in 5 patients and the stomach in 4 patients because of no dilation or tumor invasion at the distal EHBD. In the remaining patient, biliary puncture was not attempted due to the presence of collateral vessels. The guidewire was successfully manipulated in 80% of patients: 100% (10/10) with the D2 approach and 66.7% (6/9) with other approaches. The overall success rate was 80% (16/20). Failed EUS-RV was salvaged with a percutaneous approach in 2 patients, repeat ERCP in 1 patient, and conservative management in 1 patient. Minor adverse events occurred in 15% of patients (3/20). EUS-RV is a safe and effective salvage method. Using EUS-RV to approach the EHBD from the D2 may improve success rates. Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  19. Serial plasma choline measurements after cardiac arrest in patients undergoing mild therapeutic hypothermia: a prospective observational pilot trial.

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    Christian Storm

    Full Text Available OBJECTIVE: Choline is related to phospholipid metabolism and is a marker for global ischaemia with a small reference range in healthy volunteers. The aim of our study was to characterize the early kinetics of plasma free choline in patients after cardiac arrest. Additionally, we investigated the potential of plasma free choline to predict neurological outcome. METHODS: Twenty patients admitted to our medical intensive care unit were included in this prospective, observational trial. All patients were enrolled between May 2010 and May 2011. They received post cardiac arrest treatment including mild therapeutic hypothermia which was initiated with a combination of cold fluid and a feedback surface cooling device according to current guidelines. Sixteen blood samples per patient were analysed for plasma free choline levels within the first week after resuscitation. Choline was detected by liquid chromatography-tandem mass spectrometry. RESULTS: Most patients showed elevated choline levels on admission (median 14.8 µmol/L; interquartile range; IQR 9.9-20.1 which subsequently decreased. 48 hours after cardiac arrest choline levels in all patients reached subnormal levels at a median of 4.0 µmol/L (IQR 3-4.9; p = 0.001. Subsequently, choline levels normalized within seven days. There was no significant difference in choline levels when groups were analyzed in relation to neurological outcome. CONCLUSIONS: Our data indicate a choline deficiency in the early postresucitation phase. This could potentially result in impaired cell membrane recovery. The detailed characterization of the early choline time course may aid in planning of choline supplementation trials. In a limited number of patients, choline was not promising as a biomarker for outcome prediction.

  20. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    Directory of Open Access Journals (Sweden)

    I. L. Toscano Jr.

    Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

  1. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

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

    Science.gov (United States)

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

    2017-01-01

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

  3. Effectiveness of ambulatory tru-close thoracic vent for the outpatient management of pneumothorax: A prospective pilot study

    International Nuclear Information System (INIS)

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

    2017-01-01

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

  4. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

    Science.gov (United States)

    Kong, Moonkyoo; Shin, Sung Hee; Lee, Eunmi; Yun, Eun Kyoung

    2014-01-01

    Background There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT). We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients’ evaluation of pain within the RT field was also assessed. Results In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%), five (33.3%), and five patients (33.3%), respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%), nine (47.4%), two (10.5%), and one patient (5.3%), respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%). The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not statistically significant. Conclusion The results of this study show that laughter therapy can have a beneficial role in preventing radiation dermatitis in patients with breast cancer. To confirm the results of our study, well-designed randomized studies with large sample sizes are required. PMID:25395864

  5. High-pressure balloon valvuloplasty for severe pulmonary valve stenosis: a prospective observational pilot study in 25 dogs.

    Science.gov (United States)

    Belanger, Catherine; Gunther-Harrington, Catherine T; Nishimura, Satoko; Oldach, Maureen S; Fousse, Samantha L; Visser, Lance C; Stern, Joshua A

    2018-04-01

    We aimed to evaluate safety and efficacy of high-pressure balloon valvuloplasty (HPBVP) for treatment of canine severe pulmonary valve stenosis (PS). A secondary aim was to provide pre-procedure predictors of success. Twenty-five dogs. Prospective observational study. Dogs with severe PS (echocardiographically derived trans-pulmonary peak/maximum pressure gradient (EDPG) ≥80 mmHg) were recruited. All dogs underwent echocardiography before and 20-24hrs after HPBVP using a high-pressure balloon with rated burst pressures ranging from 12 to 18 ATM. Procedural success was defined as a post-HPBVP EDPG reduction of ≥50% or reduction into at least the moderate category of PS (50-79 mmHg). Optimal result was defined as a post-procedural EDPG ≤30 mmHg. Initial median (IQR) EDPG for all dogs was 96 (88, 127) mmHg with a post-operative median of 48 (36, 65) mmHg. The median EDPG reduction provided by HPBVP was 63% (39, 68); procedural success rate was 92% (23 dogs). Optimal results were achieved in 56% (14 dogs). There were no significant correlations between EDPG reduction and valve morphology (Type A and Type B) or severity of right ventricular hypertrophy. Pulmonary valve annulus diameter was the only echocardiographic variable that was significantly correlated to EDPG reduction (p = 0.02; r = -0.46). No dog experienced any anesthetic or surgical complications, and all patients survived the procedure. In this cohort of 25 dogs with severe PS, HPBVP was safe and effective. The procedural success rate and high number of optimal results achieved with HPBVP suggest future randomized controlled trials comparing HPBVP to conventional valvuloplasty are warranted. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. Multimodal navigated skull base tumor resection using image-based vascular and cranial nerve segmentation: A prospective pilot study.

    Science.gov (United States)

    Dolati, Parviz; Gokoglu, Abdulkerim; Eichberg, Daniel; Zamani, Amir; Golby, Alexandra; Al-Mefty, Ossama

    2015-01-01

    Skull base tumors frequently encase or invade adjacent normal neurovascular structures. For this reason, optimal tumor resection with incomplete knowledge of patient anatomy remains a challenge. To determine the accuracy and utility of image-based preoperative segmentation in skull base tumor resections, we performed a prospective study. Ten patients with skull base tumors underwent preoperative 3T magnetic resonance imaging, which included thin section three-dimensional (3D) space T2, 3D time of flight, and magnetization-prepared rapid acquisition gradient echo sequences. Imaging sequences were loaded in the neuronavigation system for segmentation and preoperative planning. Five different neurovascular landmarks were identified in each case and measured for accuracy using the neuronavigation system. Each segmented neurovascular element was validated by manual placement of the navigation probe, and errors of localization were measured. Strong correspondence between image-based segmentation and microscopic view was found at the surface of the tumor and tumor-normal brain interfaces in all cases. The accuracy of the measurements was 0.45 ± 0.21 mm (mean ± standard deviation). This information reassured the surgeon and prevented vascular injury intraoperatively. Preoperative segmentation of the related cranial nerves was possible in 80% of cases and helped the surgeon localize involved cranial nerves in all cases. Image-based preoperative vascular and neural element segmentation with 3D reconstruction is highly informative preoperatively and could increase the vigilance of neurosurgeons for preventing neurovascular injury during skull base surgeries. Additionally, the accuracy found in this study is superior to previously reported measurements. This novel preliminary study is encouraging for future validation with larger numbers of patients.

  7. Effectiveness of ambulatory tru-close thoracic vent for the outpatient management of pneumothorax: A prospective pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Yong Pyo; Lee, Sung Soo; Lee, Geun Dong; Joo, Seung Moon; Yum, Tae Jun; Lee, Kwang Hun [Gangnam Severance Hospital, Yonsei University Health System, Seoul (Korea, Republic of); Haam, Seok Jin [Dept. of Cardiothoracic Surgery, Ajou University Hospital, Suwon (Korea, Republic of)

    2017-06-15

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

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

    Directory of Open Access Journals (Sweden)

    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.

  9. Romanian Translation and Cross-Cultural Adaptation of the SarQol Questionnaire

    Directory of Open Access Journals (Sweden)

    Ildiko Gasparik Andrea

    2016-09-01

    Full Text Available Sarcopenia, or age-related muscle loss is emerging as a major public health concern. A reduced quality of life (QoL due to impaired physical performance associated with this disease has been evidenced in these individuals. Generic instruments, such as Short Form 36 questionnaire (SF-36, do not accurately assess the impact of sarcopenia on QoL. SarQol (Sarcopenia Quality of Life questionnaire, was the first disease-specific questionnaire addressing quality of life in patients with sarcopenia and has been recently designed for providing a global picture on quality of life in community-dwelling elderly subjects aged 65 years and older. Our aim was the translation and cultural adaptation of the original SarQol, to finally obtain a highly reliable instrument for the assessment of the quality of life of Romanian patients, affected by sarcopenia. We followed the recommended process, the international protocol of translation. The pretest process involved 20 subjects (10 sarcopenic and 10 non sarcopenic with different educational and socioeconomic backgrounds who were asked to complete the questionnaire. Feedbacks were requested from all subjects regarding the clearness of questions, difficulties in completing the test or understanding the meaning of questions. Using the recommended best practice protocol for translation, the pre-final version is comparable with the original instrument in terms of content and accuracy. After the validation of psychometric properties, it should be a useful tool to assess Quality of Life and sarcopenia among elderly romanian patients.

  10. The QOL-DASS Model to Estimate Overall Quality of Life and General Subjective Health.

    Science.gov (United States)

    Mazaheri, Mehrdad

    2011-01-01

    In Order to find how rating the WHOQOL-BREF and DASS scales are combined to produce an overall measure of quality of life and satisfaction with health rating, a QOL-DASS model was designed; and the strength of this hypothesized model was examined using the structural equation modeling. Participants included a sample of 103 voluntary males who were divided into two groups of unhealthy (N=55) and healthy (N=48). To assess satisfaction and negative emotions of depression, anxiety and stress among the participants, they were asked to fill out the WHOQOL-BREF and The Depression Anxiety Stress Scale (DASS-42). Our findings on running the hypothesized model of QOL-DASS indicated that the proposed model of QOL-DASS fitted the data well for the both healthy and unhealthy groups. Our findings with CFA to evaluate the hypothesized model of QOL-DASS indicated that the different satisfaction domain ratings and the negative emotions of depression, anxiety and stress as the observed variables can represent the underlying constructs of general health and quality of life on both healthy and unhealthy groups.

  11. Serum magnesium and not vitamin D is associated with better QoL in COPD

    DEFF Research Database (Denmark)

    Hashim Ali Hussein, Sarah; Nielsen, Lars Peter; Dolberg, Mette K.Bøgebjerg

    2015-01-01

    BACKGROUND: Deficiency of serum levels of vitamin D3 (se vitD), magnesium (se Mg) and calcium (se Ca) may be associated with increased exacerbation risk in chronic obstructive pulmonary disease (COPD). However, associations with other aspects of COPD, e.g. lung function and quality of life (QoL),...

  12. Quality of life (QOL) assessment in patients received carbon ion radiotherapy

    International Nuclear Information System (INIS)

    Imai, Reiko; Kamada, Tadashi; Tsujii, Hirohiko

    2004-01-01

    The purpose of this study was to investigate changes in quality of life (QoL) of medically inoperable bone and soft tissue sarcoma treated carbon ion radiotherapy (CIRT). Fifty-eight patients followed over 1 year were reviewed in this report. The questionnaire, European Organaization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ-C30) was assessed before the start of CIRT, and subsequently at the end of CIRT, 3, 6, 12, 24 months after CIRT. During follow-up, it was send to the patients by mail. The compliance was 98% for all follow-up period in this study. The scores about QoL and functioning did not significantly change for 1 year. QoL scores tended to decrease in large clinical target volume (CTV) (>600 cc) group compared to small CTV group. CIRT could keep QoL levels of patients with medically inoperable bone and soft tissue tumors. (author)

  13. The QOL-DASS Model to Estimate Overall Quality of Life and General Health

    Directory of Open Access Journals (Sweden)

    Mehrdad Mazaheri

    2011-01-01

    Full Text Available "n Objective: In order to find how rating the WHOQOL-BREF and DASS scales are combined to produce an overall measure of quality of life and satisfaction with health rating, a QOL-DASS model was designed ; and the strength of this hypothesized model was examined using the structural equation modeling "n "nMethod: Participants included a sample of 103 voluntary males who were divided into two groups of unhealthy (N=55 and healthy (N=48. To assess satisfaction and negative  emotions of depression, anxiety and stress among the participants, they were asked to fill out the WHOQOLBREF and The Depression Anxiety Stress Scale (DASS-42. "nResults: Our findings on running the hypothesized model of QOL-DASS indicated that the proposed model of QOL-DASS fitted the data well for the both healthy and unhealthy groups "nConclusion: Our findings with CFA to evaluate the hypothesized model of QOL-DASS indicated that the different satisfaction domain ratings and the negative emotions of depression, anxiety and stress as the observed variables can represent the underlying constructs of general health and quality of life on both healthy and unhealthy groups.

  14. Exploring the quality of life (QOL) in the Indian software industry: a public health viewpoint.

    Science.gov (United States)

    Jha, Ayan; Sadhukhan, Sanjoy Kumar; Velusamy, Saravanan; Banerjee, Gargi; Banerjee, Arpita; Saha, Amitava; Talukdar, Sumit

    2012-04-01

    Our objectives were to describe the QOL and its determinants among software professionals of Kolkata, and to compare the same according to information technology (IT) and IT-enabled services (ITeS) sub-sectors. An institution-based cross-sectional study was conducted among software professionals of Kolkata applying a two-stage stratified random sampling technique. The WHO QOL BREF questionnaire was administered along with a list of pertinent variables. Overall, the analysis for 338 software professionals (177 IT and 161 ITeS) clearly demonstrated significant differences between mean scores of these two sectors for each of the six outcome domains of WHO QOL BREF. Multilevel multivariate analysis outlined 13 significant predictors of QOL-four positive (age, regular fitness regimes, foreign placements and changing companies frequently) and the rest of the nine, negative (multiple sex partners, multiple addictions, extended working hours, night-shift duties, income, expenditure, carrying office work home, current illness and ITeS company type). Our study helps in obtaining a clear understanding of the multifaceted risk factors prevailing in this sector, the majority of which can be effectively addressed by specific health promotional interventions. A dedicated health policy is mandated at both government and company levels.

  15. The effect of laughter therapy on radiation dermatitis in patients with breast cancer: a single-blind prospective pilot study

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    Kong M

    2014-11-01

    Full Text Available Moonkyoo Kong,1 Sung Hee Shin,2 Eunmi Lee,3 Eun Kyoung Yun2 1Department of Radiation Oncology, Kyung Hee University Medical Center, Kyung Hee University School of Medicine, 2College of Nursing Science, Kyung Hee University, 3Department of Quality Improvement, Kyung Hee University Medical Center, Seoul, Republic of Korea Background: There have not yet been any published studies on the effects of laughter therapy on radiation-induced dermatitis in breast cancer patients treated with radiotherapy (RT. We assessed the effectiveness of laughter therapy in preventing radiation dermatitis in patients with breast cancer. Methods: Thirty-seven patients were prospectively enrolled in this study. Eighteen patients were assigned to the experimental group and the other 19 patients were assigned to the control group. The patients who were assigned to the experimental group received laughter therapy during RT. Laughter therapy was started at the onset of RT and was provided twice a week until completion of RT. The patients who were assigned to the control group only received RT without laughter therapy. The grade of radiation dermatitis was scored by a radiation oncologist who was blinded to subject assignment. The patients' evaluation of pain within the RT field was also assessed. Results: In the experimental group, radiation dermatitis of grade 3, 2, and 1 developed in five (33.3%, five (33.3%, and five patients (33.3%, respectively. In comparison, in the control group, radiation dermatitis of grade 3, 2, 1, and 0 developed in seven (36.8%, nine (47.4%, two (10.5%, and one patient (5.3%, respectively. The experimental group exhibited a lower incidence of grade 2 or worse radiation dermatitis than the control group (33.3% versus 47.4%. The mean maximal pain scores in the experimental and control group were 2.53 and 3.95, respectively. The experimental group complained of less severe pain than the control group during RT. However, these differences were not

  16. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

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

    Science.gov (United States)

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

    2012-11-01

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

  18. Sensitivity and responsiveness of the patient-reported TED-QOL to rehabilitative surgery in thyroid eye disease.

    Science.gov (United States)

    Fayers, Tessa; Fayers, Peter M; Dolman, Peter J

    2016-12-01

    We tested the sensitivity and responsiveness of the TED-QOL to rehabilitative surgery in thyroid eye disease (TED). The 3-item TED-QOL and 16-item GO-QOL, which assess quality of life (QoL) in TED, were administered to consecutive patients undergoing rehabilitative surgery. The questionnaires were completed pre-and post-operatively to assess sensitivity (ability to discriminate between different surgical groups) and responsiveness (ability to detect within patient changes over time).56 patients underwent 69 procedures for TED (29 orbital decompressions, 15 strabismus operations, 25 eyelid procedures). The differences in scores between the three types of surgery (a measure of sensitivity) were statistically significant at the 5% level pre-operatively and post-operatively for all 3 TED-QOL scales and for both GO-QOL scales, but much more so for the TED-QOL scales in each case. The within-patient changes between the pre- and post-operative scores for the same subjects (a measure of responsiveness) were statistically very highly significant for the TED-QOL overall and appearance scales for each of the surgeries. The pre- and post-operative difference for the TED-QOL functioning scale was highly statistically significant for strabismus surgery but not for decompression or lid surgery. The change between the pre- and post-operative scores for the GO-QOL was significant for the functioning scale with strabismus and lid surgery, and was highly significant for the appearance scale with lid surgery but not for strabismus surgery or decompression. The 3-item TED-QOL is sensitive and responsive to rehabilitative surgery in TED and compares favorably with the lengthier GO-QOL for these parameters.

  19. Methodology for the development and calibration of the SCI-QOL item banks.

    Science.gov (United States)

    Tulsky, David S; Kisala, Pamela A; Victorson, David; Choi, Seung W; Gershon, Richard; Heinemann, Allen W; Cella, David

    2015-05-01

    To develop a comprehensive, psychometrically sound, and conceptually grounded patient reported outcomes (PRO) measurement system for individuals with spinal cord injury (SCI). Individual interviews (n=44) and focus groups (n=65 individuals with SCI and n=42 SCI clinicians) were used to select key domains for inclusion and to develop PRO items. Verbatim items from other cutting-edge measurement systems (i.e. PROMIS, Neuro-QOL) were included to facilitate linkage and cross-population comparison. Items were field tested in a large sample of individuals with traumatic SCI (n=877). Dimensionality was assessed with confirmatory factor analysis. Local item dependence and differential item functioning were assessed, and items were calibrated using the item response theory (IRT) graded response model. Finally, computer adaptive tests (CATs) and short forms were administered in a new sample (n=245) to assess test-retest reliability and stability. A calibration sample of 877 individuals with traumatic SCI across five SCI Model Systems sites and one Department of Veterans Affairs medical center completed SCI-QOL items in interview format. We developed 14 unidimensional calibrated item banks and 3 calibrated scales across physical, emotional, and social health domains. When combined with the five Spinal Cord Injury--Functional Index physical function banks, the final SCI-QOL system consists of 22 IRT-calibrated item banks/scales. Item banks may be administered as CATs or short forms. Scales may be administered in a fixed-length format only. The SCI-QOL measurement system provides SCI researchers and clinicians with a comprehensive, relevant and psychometrically robust system for measurement of physical-medical, physical-functional, emotional, and social outcomes. All SCI-QOL instruments are freely available on Assessment CenterSM.

  20. Self-initiated coping with Tourette's syndrome: Effect of tic suppression on QOL.

    Science.gov (United States)

    Matsuda, Natsumi; Kono, Toshiaki; Nonaka, Maiko; Fujio, Miyuki; Kano, Yukiko

    2016-02-01

    Because of the semi-voluntary nature of tics, patients with Tourette' syndrome (TS) often report self-initiated coping with tics. Our goals were to understand the experiences of self-initiated coping with tics by individuals with TS (e.g., suppression frequency, suppression ability, and side effects of tic suppression), and investigate the effects of tic control on quality of life (QOL). One hundred participants with TS (38 children and 62 adults) answered a questionnaire concerning tic control, QOL, and other clinical characteristics. Fifty-eight percent of the participants always or frequently tried to suppress tics daily. In contrast, over 90% felt uncomfortable or incomplete when they suppressed tics and needed concentration or extra effort to suppress them. Thirty-four percent could suppress tics for less than one minute and 65% could suppress tics for less than 10min. Higher subjective satisfaction with tic control was positively correlated with life satisfaction and QOL. Individuals with TS often attempt self-initiated coping in their daily lives, especially through tic suppression, despite experiencing subjective discomfort and being aware that the duration of tic suppression is often limited. Moreover, it was found that their subjective satisfaction with tic control and effective tic suppression might have a positive influence on their life satisfaction and QOL. Thus, self-initiated coping with tics is vital for improving the QOL of individuals with TS and intervention aimed at enhancing subjective satisfaction with tic control could help manage TS. Copyright © 2015 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

  1. The measurement of health-related quality of life (QOL in paediatric clinical trials: a systematic review

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    Eiser Christine

    2004-11-01

    Full Text Available Abstract Background The goal of much care in chronic childhood illness is to improve quality of life (QOL. However, surveys suggest QOL measures are not routinely included. In addition, there is little consensus about the quality of many QOL measures. Objectives To determine the extent to which quality of life (QOL measures are used in paediatric clinical trials and evaluate the quality of measures used. Design Systematic literature review. Review Methods Included paediatric trials published in English between 1994 and 2003 involving children and adolescents up to the age of 20 years, and use of a standardised QOL measure. Data Sources included MEDLINE, CINAHL, EMB Reviews, AMED, BNI, PSYCHINFO, the Cochrane library, Internet, and reference lists from review articles. Results We identified 18 trials including assessment of QOL (4 Asthma, 4 Rhinitis, 2 Dermatitis, and single studies of Eczema, Cystic fibrosis, Otis media, Amblyopia, Diabetes, Obesity associated with a brain tumour, Idiopathic short stature, and Congenital agranulocytosis. In three trials, parents rated their own QOL but not their child's. Fourteen different QOL measures were used but only two fulfilled our minimal defined criteria for quality. Conclusions This review confirms previous reports of limited use of QOL measures in paediatric clinical trials. Our review provides information about availability and quality of measures which will be of especial value to trial developers.

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

    Directory of Open Access Journals (Sweden)

    Francesca Lombardi

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

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

    Science.gov (United States)

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

    2018-06-01

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

  4. The use of school teachers to promote oral hygiene in some secondary school students at Hyderabad, Andhra Pradesh, India: A short term prospective pilot study

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    Byalakere R Chandrashekar

    2012-01-01

    Full Text Available Study design : It was a short term prospective pilot study on a group of 116 secondary school students. Objectives: To assess the feasibility of using the services of school teachers to promote oral hygiene in secondary school students and compare the effectiveness of dental health education (DHE offered by school teachers on a fortnightly basis with what is offered by dental professionals at three- monthly intervals. Materials and Methods: Six secondary schools were randomly selected. The base-line Oral Hygiene Index simplified (OHI-S and Plaque index (PI scores for all the students were recorded. The teachers were trained on dental health facts. The six schools were divided into three groups of two schools with different intervention techniques: Group 1- Schools given no health education, Group 2 - Schools given health education by their school teachers on a fortnightly basis together with simple screening for deposits of gross calculus , Group 3 - Schools which were given health education by dental professionals at intervals of three months without any screening. Grade nine students were selected for pre and post intervention evaluation. The second examination was done six months following the intervention to find out the OHI-S and Plaque index scores. The examination was done by three trained and calibrated dentists. Data analysis was done with SPSS 16 with relevant statistical tests. Results: The mean OHI-S and PI scores were significantly less in group 2 and there was a statistically significant difference between the baseline OHI - S, PI score and the scores after six months in all the three groups. Conclusion: The concept of utilizing the teachers for frequent DHE and screening for any gross deposits of food debris and calculus is feasible. Also frequent DHE by teachers was more effective than the infrequent DHE by the professionals.

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

    Science.gov (United States)

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

    2013-04-01

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

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

    Science.gov (United States)

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

    2017-12-21

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

  7. Description and Psychometric Properties of the CP QOL-Teen: A Quality of Life Questionnaire for Adolescents with Cerebral Palsy

    Science.gov (United States)

    Davis, Elise; Mackinnon, Andrew; Davern, Melanie; Boyd, Roslyn; Bohanna, India; Waters, Elizabeth; Graham, H. Kerr; Reid, Susan; Reddihough, Dinah

    2013-01-01

    To assess the measurement properties of a new QOL instrument, the Cerebral Palsy Quality of Life Questionnaire-Teen (CP QOL-Teen), in adolescents with cerebral palsy (CP) aged 13-18 years, examining domain structure, reliability, validity and adolescent-caregiver concordance. Based on age, 695 eligible families were invited to participate by mail.…

  8. Relationship Between Student QoL With Irritable Bowel Syndrome and Related Factors at Ahvaz Jundishapur University of Medical Sciences

    Directory of Open Access Journals (Sweden)

    Asadi

    2015-01-01

    Full Text Available Background Irritable bowel syndrome (IBS is one of the most common functional disorders of the lower gastrointestinal tract characterized by abdominal pain and changes in bowel habits. This disorder changes the QoL (QoL for patients. Objectives This study examines the relationship between QoL for nursing students with other associated factors. Patients and Methods These descriptive-analytic studies indicate a census for 57 senior nursing students of the School of Nursing-Midwifery, Ahvaz in 2013–2014. The data from the demographic questionnaire and QoL questionnaire (QOL-34 was collected. Data using ANOVA and t-tests with significance level of P 0.05.While for QoL and academic Grade Point Average (P = 0.048, ethnicity (P = 0.006, disease duration (P = 0.049, and disease severity (P = 0.030 were significantly related . Conclusions It seems important to pay attention to health problems and to apply interventions that will influence QoL. Lifestyle changes and staying away from activities that are associated with tension stress can help to eliminate the symptoms and disease severity and improve the QoL for student.

  9. Validity and QOL of neck dissection preceding radiation therapy for hypopharyngeal cancer

    International Nuclear Information System (INIS)

    Uemura, Hirokazu; Yoshino, Kunitoshi; Fujii, Takashi; Suzuki, Motoyuki

    2009-01-01

    Thirty-one cases of hypopharyngeal cancer with neck dissection preceding radiation and 16 cases of hypopharyngeal cancer with neck dissection for locoregional recurrences after radiation were reviewed in order to make comparative evaluations of difficulty in surgical operation, postoperative complications, laryngeal preservation rate, and cause specific 5-year survival rate retrospectively. And quality of life (QOL) after neck dissection was additionally evaluated through the questionnaire. Since neck dissection preceding radiation for hypopharyngeal cancer may be superior to neck dissection for radiation failure, with easy surgical approach an non-lymphoid tissue preservation, that modality can be a reasonable choice of treatment for patients with nodal lesions, which are probably difficult to treat with radiation alone. Even though further investigation on QOL questionnaire is necessary, this modality can make a contribution to the neck and shoulder condition after neck dissection. (author)

  10. The QOL-DASS Model to Estimate Overall Quality of Life and General Subjective Health

    OpenAIRE

    Mazaheri, Mehrdad

    2011-01-01

    Objective In Order to find how rating the WHOQOL-BREF and DASS scales are combined to produce an overall measure of quality of life and satisfaction with health rating, a QOL-DASS model was designed; and the strength of this hypothesized model was examined using the structural equation modeling. Method Participants included a sample of 103 voluntary males who were divided into two groups of unhealthy (N=55) and healthy (N=48). To assess satisfaction and negative emotions of depression, anxiet...

  11. Assessment of Quality of Life (QOL) in Obsessive Compulsive Disorder (OCD) and Dysthymic Disorder (DD): A Comparative Study.

    Science.gov (United States)

    Vasudev, Roopesh Gopal Nariyandada; Yallappa, Sudarshan Chikkanayakanahalli; Saya, Ganesh Kumar

    2015-05-01

    There is paucity of data on Quality of Life (QOL) in non-psychotic mental disorders. To assess the Quality of Life (QOL) in Obsessive Compulsive Disorder (OCD) and compare it with Dysthymic Disorder (DD). This hospital based cross-sectional study was conducted in 30 patients each diagnosed to have OCD and DD during October 2009 to September 2011 in a medical institution in Davanagere, Karnataka, India. DSM-IV-TR (Diagnostic statistical manual-IV-Text Revised) criteria was used for diagnosis of OCD and DD. Yale Brown Obsessive Compulsive Scale (Y-BOCS) and WHO QOL BREF (brief form) scales were used. Data was analysed by independent sample t-test. Overall QOL score was 51.07(SD=11.47) and 50.91(SD=7.41) in OCD and DD groups respectively. QOL score was comparatively low in psychological domain with score of 44.12(SD=14.14) and 45.10(12.35) in OCD and DD respectively. There was no significant difference in the QOL score of the two groups with respect to socio demographic variables in OCD group, but it was different with respect to place of residence in DD group (p0.05). Overall QOL score was average and there was no significant difference of QOL score between the OCD and DD groups implying that both these non-psychotic mental disorders may have same influence or effect on QOL of the subjects. Further analytical studies will explore the associated factors of QOL in OCD and DD.

  12. A Single-Center Pilot Prospective Study of Topical Application of Platelet-Derived Eye Drops for Patients with Ocular Chronic Graft-versus-Host Disease.

    Science.gov (United States)

    Zallio, Francesco; Mazzucco, Laura; Monaco, Federico; Astori, Maria Rosa; Passera, Roberto; Drago, Giovanna; Tamiazzo, Stefania; Rapetti, Manuela; Dolcino, Daniela; Guaschino, Roberto; Pini, Massimo; Ladetto, Marco

    2016-09-01

    Ocular involvement of chronic graft-versus-host disease (cGVHD) is a complication that occurs in up to 60% of patients after allogeneic hematopoietic stem cell transplantation. Conventional therapeutic options include medical and surgical procedures that are administered depending on the severity of the condition, but most of them have provided unsatisfactory results and, to date, there is no consensus about treatment. We considered that topical application of a platelet lysate, administered as eye drops, might be considered an alternative worthwhile of investigation to treat ocular surface disorders in patients suffering from cGVHD. Therefore, we conducted a single-center prospective pilot study to assess the efficacy and safety of using eye drops made from reconstituted lysed platelet concentrate. Twenty-six patients with ocular cGVHD were eligible for the study; all but 2 completed their scheduled 1-year treatment and complied with the hematologic and ophthalmic regimen. At their first assessment interviews, after 30 days of treatment, 91% of patients reported an improvement in their symptoms and for 32%, substantive objective differences were measured. Remission of corneal damage was seen for 86% of our cohort, and improved National Institutes of Health scores for 73%, of whom 8% achieved the best score of 0 (ie, non-dry eye). Similar results were seen at later time points. Comparing outcomes for our patient cohort to those determined retrospectively for patients in our institutional database revealed a 5-year overall survival (OS) of 65%. This OS is comparable to patients with limited cGVHD (75%) and is superior to that of patients with nonocular extensive cGVHD or without cGVHD (30% and 59%, respectively) (P = .013). Our results suggest that platelet-derived eye drops are a safe, practical, and well-tolerated therapeutic option that offers substantial benefits for most patients affected by ocular cGVHD at onset. The favorable OS of our patient cohort

  13. Simulation-based inter-professional education to improve attitudes towards collaborative practice: a prospective comparative pilot study in a Chinese medical centre.

    Science.gov (United States)

    Yang, Ling-Yu; Yang, Ying-Ying; Huang, Chia-Chang; Liang, Jen-Feng; Lee, Fa-Yauh; Cheng, Hao-Min; Huang, Chin-Chou; Kao, Shou-Yen

    2017-11-08

    Inter-professional education (IPE) builds inter-professional collaboration (IPC) attitude/skills of health professionals. This interventional IPE programme evaluates whether benchmarking sharing can successfully cultivate seed instructors responsible for improving their team members' IPC attitudes. Prospective, pre-post comparative cross-sectional pilot study. Thirty four physicians, 30 nurses and 24 pharmacists, who volunteered to be trained as seed instructors participated in 3.5-hour preparation and 3.5-hour simulation courses. Then, participants (n=88) drew lots to decide 44 presenters, half of each profession, who needed to prepare IPC benchmarking and formed Group 1. The remaining participants formed Group 2 (regular). Facilitators rated the Group 1 participants' degree of appropriate transfer and sustainable practice of the learnt IPC skills in the workplace according to successful IPC examples in their benchmarking sharing. For the three professions, improvement in IPC attitude was identified by sequential increase in the post-course (second month, T 2 ) and end-of-study (third month, T 3 ) Interdisciplinary Education Perception Scale (IEPS) and Attitudes Towards Healthcare Teams Scale (ATHCTS) scores, compared with pre-course (first month, T 1 ) scores. By IEPS and ATHCTS-based assessment, the degree of sequential improvements in IPC attitude was found to be higher among nurses and pharmacists than in physicians. In benchmarking sharing, the facilitators' agreement about the degree of participants'appropriate transfer and sustainable practice learnt 'communication and teamwork' skills in the workplace were significantly higher among pharmacists and nurses than among physicians. The post-intervention random sampling survey (sixth month, T post ) found that the IPC attitude of the three professions improved after on-site IPC skill promotion by new programme-trained seed instructors within teams. Addition of benchmark sharing to a diamond-based IPE simulation

  14. A cross-sectional study of QOL of diabetic patients at tertiary care hospitals in Delhi

    Directory of Open Access Journals (Sweden)

    Gautam Yogesh

    2009-01-01

    Full Text Available Background: According to WHO estimates India will be the global capital of diabetes by 2025, accounting for 57.2 million diabetics. Worsening the situation is the fact that diabetes affects the economically productive age-group (45-65 years in developing countries. Objective : To measure quality of life (QOL and study the clinical profiles and associated sociodemographic factors affecting diabetic patients aged 20 years and above. Materials and Methods: We conducted a hospital-based cross-sectional study using a generic instrument, Short-Form 36 (SF-36 of the Medical Outcome Study Group to measure QOL of diabetic subjects aged ≥20 years. Two hundred and sixty diabetics, including 91 males and 169 females, were selected from the clinics of SSK Hospital and Dr RML Hospital of New Delhi. Data was analysed using SPSS for Windows, version 12. Results: The mean age of the respondents was 49.7 years, with 80% of respondents being in the age-group of 40-69 years. The majority (52.1% of female respondents were illiterate and 91.1% were economically dependent. Of the male respondents, 65.9% were skilled workers. Substance abuse was present among 41.8% male subjects. Type 2 diabetes was the commonest, with 94.6% of the subjects having this form. The mean duration of diabetes was 6.96 ± 6.08 years. Oral hypoglycemic agents were being taken by 70.77% of the respondents. Among the diabetics the most common comorbidity was hypertension (30.8% and the commonest complication was neuropathy (26.2%. We calculated the body mass index (BMI of all subjects and found that, 46.2% of the male and 59.8% of the female respondents were either overweight or obese. As predicted by the waist/hip ratio (WHR, 53.8% of the male and 66.9% of the female respondents had high risk for CHD. Regular physical activity was undertaken by less than half of the subjects (46.5%. Out of eight domains of QOL in the SF-36, the two most affected were ′General Health′ and

  15. [The relationship of quality of life (QOL) with physical fitness, competence and stress response in elderly in Japan].

    Science.gov (United States)

    Uemura, Shinichi; Machida, Kazuhiki

    2003-09-01

    In order to evaluate the relationship of quality of life (QOL) with physical fitness, competence and stress response in the elderly population in Japan, a cross sectional field survey of elderly subjects was conducted. This survey was taken in Naguri village, Saitama. The data collected included physical fitness, competence, stress response and QOL in addition to demographic variables. As for physical fitness indexes, grip strength (GS), single leg balance with eyes closed (SLB), bar grip ping reaction time (RT), trunk flexion (RF), ten-meter walking time (WT) and vital capacity (VC) were measured. The SF-36 was used for QOL assessment. A total of 120 elderly subjected participated to the survey. There were 42 males (73.5 +/- 5.74 years) and 78 females (74.2 +/- 6.17 years). The associations between physical health parameters in SF-36 and WT were highly significant: physical functioning (beta = -2.96, p fit indexes of the structural equation model describing the relationships among physical fitness, competence, stress response and QOL indicated excellent fit to the data with GFI = 0.95 and AGFI = 0.88. Stress response showed relatively stronger influence on QOL than physical fitness or competence. Although there were slight differences in degree of influence, physical fitness, stress response and competence were found to be clearly related to QOL in elderly subjects. To keep good QOL status, it is important to maintain good physical fitness and level of competence and to reduce stress response.

  16. The Use of COVD-QOL Questionnaire in School Vision Screening

    Directory of Open Access Journals (Sweden)

    Nurul Farhana Abu Bakar

    2011-05-01

    Full Text Available Purpose: To evaluate the application of College of Optometrist in Vision Development (COVD Quality of Life (QOL questionnaire in vision screening for normal school children and children with learning disabilities (LD and to determine appropriate referral-score for different target population. Methods: A total of 90 children (Normal: 45, LD: 45 who attended government primary schools aged between 6 to 12 years old were recruited. An interview session with normal children and parents or teachers in children with LD was made to determine visual symptoms using shorter version of COVD-QOL questionnaire. A comprehensive eye examination was performed after completion of the questionnaire. The evaluation was made base on the sensitivity and specificity for detection of refractive error, amblyopia, strabismus, vergence and accommodative disorders. Results: The mean score for normal children and children with LD were 22.47±10.75 and 12.24±8.72 respectively. Rapidity of the test in normal children and children with LD were 177.27±9.52 seconds and 162.16±16.58 seconds respectively. In normal children referral score of =20 showed highest sensitivity (66.7% and specificity (95.8% for detection of amblyopia. Sensitivity and specificity for referral-score of =20, =10 and =4 for detection of overall vision problems in children with LD were (20.4%, 100.0%, (54.5%, 100.0% and (81.8%, 100.0% respectively. Conclusion: COVD-QOL questionnaire was recommended as an easy, rapid and cost-effective tool for school vision screening. Different referral-score was suggested for different target population.

  17. The QOL-DASS Model to Estimate Overall Quality of Life and General Health

    OpenAIRE

    Mehrdad Mazaheri

    2011-01-01

    "n Objective: In order to find how rating the WHOQOL-BREF and DASS scales are combined to produce an overall measure of quality of life and satisfaction with health rating, a QOL-DASS model was designed ; and the strength of this hypothesized model was examined using the structural equation modeling "n "nMethod: Participants included a sample of 103 voluntary males who were divided into two groups of unhealthy (N=55) and healthy (N=48). To assess satisfaction and negative  emotions of depress...

  18. Quality of life (QOL) assessment in patients received carbon ion radiotherapy

    International Nuclear Information System (INIS)

    Kamada, Tadashi; Mizoe, Jun-Etsu; Tsuji, Hiroshi; Yanagi, Tsuyoshi; Miyamoto, Tada-aki; Kato, Hirotoshi; Oono, Tatsuya; Yamada, Shigeru; Tsujii, Hirohiko

    2003-01-01

    Until February 2003, a total of 1,463 patients were enrolled in clinical trials of carbon ion radiotherapy. Most of the patients had locally advanced and/or medically inoperable tumors. The clinical trials revealed that carbon ion radiotherapy provided definite local control and offered a survival advantage without unacceptable morbidity in a variety of tumors that were hard to cure by other modalities. In this study, quality of life (QOL) outcomes of patients with unresectable bone and soft tissue sarcoma after carbon ion radiotherapy are investigated. (author)

  19. Physical and cognitive stimulation in Alzheimer Disease. the GAIA Project: a pilot study.

    Science.gov (United States)

    Maci, Tiziana; Pira, Francesco Le; Quattrocchi, Graziella; Nuovo, Santo Di; Perciavalle, Vincenzo; Zappia, Mario

    2012-03-01

    Several data suggest that physical activity and cognitive stimulation have a positive effect on the quality of life (QoL) of people with Alzheimer's disease (AD), slowing the decline due to the disease. A pilot project was undertaken to assess the effect of cognitive stimulation, physical activity, and socialization on patients with AD and their informal caregiver's QoL and mood. Fourteen patients with AD were randomly divided into active treatment group and control group. At the end of treatment, a significant improvement in apathy, anxiety, depression, and QoL in the active treatment group was found. Considering caregivers, those of the active treatment group exhibited a significant improvement in their mood and in their perception of patients' QoL. This study provides evidence that a combined approach based on cognitive stimulation, physical activity, and socialization is a feasible tool to improve mood and QoL in patients with AD and their caregivers.

  20. Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

    Science.gov (United States)

    Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

    2016-05-01

    Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

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

    Directory of Open Access Journals (Sweden)

    van Lint CL

    2015-12-01

    Full Text Available Céline L van Lint,1 Paul JM van der Boog,1 Wenxin Wang,2,3 Willem-Paul Brinkman,2 Ton JM Rövekamp,3 Mark A Neerincx,2 Ton J Rabelink,1 Sandra van Dijk1,4 1Department of Nephrology, Leiden University Medical Centre (LUMC, Leiden, 2Faculty of Electrical Engineering, Mathematics and Computer Science, Delft University of Technology, Delft, 3Department of Technology in Healthcare, Prevention and Health, Dutch Organization for Applied Scientific Research (TNO, Leiden, 4Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioural Sciences, Leiden University, Leiden, the Netherlands Background: 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.Materials and methods: 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.Results: 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 (P<0.01, level of self-efficacy (P<0.01, and amount of trust in the accuracy of the creatinine meter (P<0.01. The use of both the creatinine and blood pressure meter was considered pleasant and useful, despite the level of trust in the

  2. Validation of a health-related quality of life instrument for primary ciliary dyskinesia (QOL-PCD).

    Science.gov (United States)

    Behan, Laura; Leigh, Margaret W; Dell, Sharon D; Dunn Galvin, Audrey; Quittner, Alexandra L; Lucas, Jane S

    2017-09-01

    Quality of life (QOL)-primary ciliary dyskinesia (PCD) is the first disease-specific, health-related QOL instrument for PCD. Psychometric validation of QOL-PCD assesses the performance of this measure in adults, including its reliability, validity and responsiveness to change. Seventy-two adults (mean (range) age: 33 years (18-79 years); mean (range) FEV 1 % predicted: 68 (26-115)) with PCD completed the 49-item QOL-PCD and generic QOL measures: Short-Form 36 Health Survey, Sino-Nasal Outcome Test 20 (SNOT-20) and St George Respiratory Questionnaire (SGRQ)-C. Thirty-five participants repeated QOL-PCD 10-14 days later to measure stability or reproducibility of the measure. Multitrait analysis was used to evaluate how the items loaded on 10 hypothesised scales: physical, emotional, role and social functioning, treatment burden, vitality, health perceptions, upper respiratory symptoms, lower respiratory symptoms and ears and hearing symptoms. This analysis of item-to-total correlations led to 9 items being dropped; the validated measure now comprises 40 items. Each scale had excellent internal consistency (Cronbach's α: 0.74 to 0.94). Two-week test-retest demonstrated stability for all scales (intraclass coefficients 0.73 to 0.96). Significant correlations were obtained between QOL-PCD scores and age and FEV 1 . Strong relationships were also found between QOL-PCD scales and similar constructs on generic questionnaires, for example, lower respiratory symptoms and SGRQ-C (r=0.72, pmeasures of different constructs. QOL-PCD has demonstrated good internal consistency, test-retest reliability, convergent and divergent validity. QOL-PCD offers a promising tool for evaluating new therapies and for measuring symptoms, functioning and QOL during routine care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  3. Effects of interactive metronome training on upper extremity function, ADL and QOL in stroke patients.

    Science.gov (United States)

    Yu, Ga-Hui; Lee, Jae-Shin; Kim, Su-Kyoung; Cha, Tae-Hyun

    2017-01-01

    Rhythm and timing training is stimulation that substitutes for a damaged function controls muscular movement or temporal element, which has positive impacts on the neurological aspect and movement of the brain. This study is to assess the changes caused by rhythm and timing training using an interactive metronome (IM) on upper extremity function, ADL and QOL in stroke patients. In order to assess the effects of IM training, a group experiment was conducted on 30 stroke patients. Twelve sessions of IM training were provided for the experimental group three times a week for four weeks, while the control group was trained with a Bilateral arm Self-Exercise (BSE) for the same period. Both groups were evaluated by pre- and post-tests through MFT, MAL, K-MBI and SS-QOL. There were more statistically significant differences (<0.05) in the total score of MFT and the finger control item in the IM Group than in the BSE Group. With respect to ADL, there were more statistically significant differences (<0.05) in the total score of K-MBI and the dressing item in the IM Group than in the BSE Group. The study proposes that IM training can be applied as an occupational therapy program in patients with various diseases who need to adjust the time for performing movements as well as stroke patients.

  4. Surgery for two cases with markedly impaired QOL(Quality of Life) of radiation enterocolitis

    International Nuclear Information System (INIS)

    Shiba, Tadaaki; Tanishima, Satoru; Sato, Masahiko; Yanagisawa, Terumasa; Yoshino, Masaaki; Takatsuka, Jun

    1996-01-01

    Two cases of radiation enterocolitis with markedly impaired QOL for a long period were reported. Case 1: A 61 years old female. She received 60 Gy irradiation post hysterectomy and ovariectomy due to uterine cancer at the age of 39 y. She suffered from fecal incontinence and anal pain at 58 y, was diagnosed to have radiation colitis. She was hospitalized due to neurosis, anal pain and hypertension at 59 y. She received nephrostomy due to hydronephrosis and ureterostenosis at 60 y, and colostomy and ileal conduit formation due to anal pain and dyschezia. Case 2: A 70 years old female who received 60 Gy irradiation post surgery similar to case 1 at the age of 61 y. She suffered from ileus, intestinal retention and hydronephrosis thereafter. She was hospitalized due to metastasis of the cancer to sacred bone, and received further 40 Gy radiation therapy at the age of 65 y. Up to the present, she received several operations such as ileostomy, nephrostomy and hemorrhoids excision. It is important for surgeons to understand the actual QOL of patients with radiation enterocolitis. (K.H.)

  5. Surgery for two cases with markedly impaired QOL(Quality of Life) of radiation enterocolitis

    Energy Technology Data Exchange (ETDEWEB)

    Shiba, Tadaaki; Tanishima, Satoru; Sato, Masahiko; Yanagisawa, Terumasa; Yoshino, Masaaki; Takatsuka, Jun [Toho Univ., Tokyo (Japan). School of Medicine

    1996-10-01

    Two cases of radiation enterocolitis with markedly impaired QOL for a long period were reported. Case 1: A 61 years old female. She received 60 Gy irradiation post hysterectomy and ovariectomy due to uterine cancer at the age of 39 y. She suffered from fecal incontinence and anal pain at 58 y, was diagnosed to have radiation colitis. She was hospitalized due to neurosis, anal pain and hypertension at 59 y. She received nephrostomy due to hydronephrosis and ureterostenosis at 60 y, and colostomy and ileal conduit formation due to anal pain and dyschezia. Case 2: A 70 years old female who received 60 Gy irradiation post surgery similar to case 1 at the age of 61 y. She suffered from ileus, intestinal retention and hydronephrosis thereafter. She was hospitalized due to metastasis of the cancer to sacred bone, and received further 40 Gy radiation therapy at the age of 65 y. Up to the present, she received several operations such as ileostomy, nephrostomy and hemorrhoids excision. It is important for surgeons to understand the actual QOL of patients with radiation enterocolitis. (K.H.)

  6. Female sexual dysfunction (FSD): Prevalence and impact on quality of life (QoL).

    Science.gov (United States)

    Nappi, Rossella E; Cucinella, Laura; Martella, Silvia; Rossi, Margherita; Tiranini, Lara; Martini, Ellis

    2016-12-01

    Female sexual dysfunction (FSD) and quality of life (QOL) are both multidimensional and have a bidirectional relationship across the reproductive life span and beyond. Methodological difficulties exist in estimating the real prevalence of FSD because it is hard to determine the level of distress associated with sexual symptoms in a large-scale survey. Approximately 40-50% of all women report at least one sexual symptom, and some conditions associated with hormonal changes at menopause, such as vulvovaginal atrophy (VVA) and hypoactive sexual desire disorder (HSDD), have a significant impact on sexual function and QOL. Sexual distress peaks at midlife, declines with age and is strongly partner-related. Many postmenopausal women are still sexually active, especially if they are in a stable partnership. Even though sexual functioning is impaired, a variety of psychosocial factors may maintain sexual satisfaction. That being so, health care providers (HCPs) should proactively address sexual symptoms at midlife and in older women, from a balanced perspective. Adequate counselling should be offered. Women with distressing symptoms may benefit from tailored hormonal and non-hormonal therapies, whereas women without distress related to their sexual experiences should not receive any specific treatment. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. The Validity and Reliability Test of the Indonesian Version of Gastroesophageal Reflux Disease Quality of Life (GERD-QOL) Questionnaire.

    Science.gov (United States)

    Siahaan, Laura A; Syam, Ari F; Simadibrata, Marcellus; Setiati, Siti

    2017-01-01

    to obtain a valid and reliable GERD-QOL questionnaire for Indonesian application. at the initial stage, the GERD-QOL questionnaire was first translated into Indonesian language and the translated questionnaire was subsequently translated back into the original language (back-to-back translation). The results were evaluated by the researcher team and therefore, an Indonesian version of GERD-QOL questionnaire was developed. Ninety-one patients who had been clinically diagnosed with GERD based on the Montreal criteria were interviewed using the Indonesian version of GERD-QOL questionnaire and the SF 36 questionnaire. The validity was evaluated using a method of construct validity and external validity, and reliability can be tested by the method of internal consistency and test retest. the Indonesian version of GERD-QOL questionnaire had a good internal consistency reliability with a Cronbach Alpha of 0.687-0.842 and a good test retest reliability with an intra-class correlation coefficient of 0.756-0.936; pGERD-QOL questionnaire has been proven valid and reliable to evaluate the quality of life of GERD patients.

  8. Esophageal Motility and Rikkunshito Treatment for Proton Pump Inhibitor-Refractory Nonerosive Reflux Disease: A Prospective, Uncontrolled, Open-Label Pilot Study Trial

    Directory of Open Access Journals (Sweden)

    Takeo Odaka, MD, PhD

    2017-01-01

    Conclusions: In the pilot study, patients with PPI-refractory NERD had disorders of esophageal and lower esophageal sphincter motility that were improved by RKT. Further studies examining esophageal motor activity of RKT in PPI-refractory NERD are required. University hospital Medical Information Network (UMIN Clinical Trial Registry identifier: UMIN000003092.

  9. A prospective pilot study on the effect of sucralfate mouth-swishing in reducing stomatitis during radiotherapy of the oral cavity

    International Nuclear Information System (INIS)

    Pfeiffer, P.; Hansen, O.; Madsen, E.L.; May, O.

    1990-01-01

    Radiotherapy in sufficient dose involving the oral cavity always causes stomatitis, the severity of which is dependent on primary diagnosis, age, oral status and whether concomitant chemotherapy is given or not. The aim of the present pilot study was to assess whether mouth-swishing with sucralfate suspension might reduce oral radiation mucositis without disturbing side effects. (orig./MG)

  10. A prospective pilot study on the effect of sucralfate mouth-swishing in reducing stomatitis during radiotherapy of the oral cavity

    Energy Technology Data Exchange (ETDEWEB)

    Pfeiffer, P.; Hansen, O.; Madsen, E.L.; May, O. (Odense Univ. (Denmark). Dept. of Oncology)

    1990-01-01

    Radiotherapy in sufficient dose involving the oral cavity always causes stomatitis, the severity of which is dependent on primary diagnosis, age, oral status and whether concomitant chemotherapy is given or not. The aim of the present pilot study was to assess whether mouth-swishing with sucralfate suspension might reduce oral radiation mucositis without disturbing side effects. (orig./MG).

  11. Validation and psychometric properties of the Spanish version of the Quality of Life Scale (QOLS) in patients with fibromyalgia.

    Science.gov (United States)

    Latorre-Román, Pedro A; Martínez-Amat, Antonio; Martínez-López, Emilio; Moral, Angel; Santos, María A; Hita-Contreras, Fidel

    2014-04-01

    Fibromyalgia (FM) is a chronic disease associated with high disability levels, which in turn lead to low quality of life (QOL). The objectives of this study were to translate the Quality of Life Scale (QOLS) into Spanish and to assess its reliability and validity for its use in patients with FM. A total of 140 women are suffering from FM (52.87 ± 9.35 years old). All belonged to an association of FM patients (AFIXA, Jaén, Spain). The Spanish versions of the FM impact questionnaire (FIQ), the SF-36, and Beck's Depression Inventory were used to assess them. The construct's validity was checked by means of exploratory factorial analysis (varimax with Kaiser normalization). Test-retest reliability was assessed through intraclass correlation coefficient (ICC), and convergent validity through Spearman's correlation. Results show that Cronbach's alpha was 0.887, which revealed high internal consistency. The value of ICC for the QOLS total was 0.765 (95 % CI 0.649-0.843, p < 0.001). QOLS presented a significant Spearman's correlation (p < 0.01) with Beck's Inventory, with the physical and mental subtotals of SF-36 and with FIQ. The main component analysis and the varimax rotation revealed the convergence on three factors that account for 54.05 % of variance. Taking into account the severity of the disorder, significant differences (p < 0.05) appeared in QOLS, with moderately afflicted patients getting higher scores than the most severe cases. In conclusion, our study shows that the Spanish version of the QOLS is a reliable instrument, with a good convergent and discriminant construct validity, for measuring the QOL of Spanish FM patients.

  12. QOL in caregivers of Japanese patients with Prader-Willi syndrome with reference to age and genotype.

    Science.gov (United States)

    Ihara, Hiroshi; Ogata, Hiroyuki; Sayama, Masayuki; Kato, Aya; Gito, Masao; Murakami, Nobuyuki; Kido, Yasuhiro; Nagai, Toshiro

    2014-09-01

    This study aimed to measure quality of life (QOL) of the primary family caregivers for patients with Prader-Willi syndrome (PWS). Comparisons were made between caregivers' QOL in regard to their dependents' genotype and age group. The participants with PWS consisted of 22 children (aged from 6 to 12 years) and 23 adolescents (aged from 13 to 19 years), including 6 children and 7 adolescents with maternal uniparental disomy (mUPD) and 16 children and 16 adolescents with deletion (DEL). The QOL of the primary family caregiver for each patient was assessed using the Japanese version of the WHOQOL-BREF. To examine the effect that age (children vs. adolescents) and genotype (DEL vs. mUPD) have on the QOL of caregivers, a two-way ANOVA was conducted, followed by the Bonferroni procedure to test the simple main effects. The two age groups and the two genotypes of PWS were used as independent variables and the total QOL of caregivers as a dependent variable. The two-way ANOVA (F(1, 41) = 6.98, P caregivers of DEL adolescents showed little difference from that with DEL children, but the QOL of caregivers for mUPD adolescents was shown to be lower than that with mUPD children along with that of caregivers with DEL adolescents. There is hence a growing tendency for the deterioration in the QOL of caregivers to manifest itself later in the patients' adolescence, found mainly with mUPD patients. © 2014 The Authors. American Journal of Medical Genetics Part A Published by Wiley Periodicals, Inc.

  13. Pilot prospective evaluation of {sup 18}F-FPPRGD{sub 2} PET/CT in patients with cervical and ovarian cancer

    Energy Technology Data Exchange (ETDEWEB)

    Minamimoto, Ryogo; Jamali, Mehran; Gambhir, Sanjiv Sam [Stanford University, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford, CA (United States); Stanford University, Molecular Imaging Program at Stanford (MIPS), Department of Radiology, Stanford, CA (United States); Karam, Amer; Dorigo, Oliver [Stanford University, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Stanford, CA (United States); Barkhodari, Amir; Iagaru, Andrei [Stanford University, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford, CA (United States)

    2016-06-15

    We report the effect of antiangiogenic therapy on the biodistribution of {sup 18}F-FPPRGD{sub 2} (a surrogate biomarker of integrin α{sub v}β{sub 3} expression), and the potential of {sup 18}F-FPPRGD{sub 2} to predict the prognosis in patients with cervical cancer and ovarian cancer in this clinical scenario. Data from six women, age range 30 - 59 years (mean ± SD 44.0 ± 12.5 years), who had undergone a {sup 18}F-FPPRGD{sub 2} PET/CT scan and bevacizumab-containing therapy were prospectively collected and analyzed. We compared baseline {sup 18}F-FPPRGD{sub 2} and {sup 18}F-FDG uptake in the lesions and tumor-to-background (T/B) ratios. The maximum and mean {sup 18}F-FPPRGD{sub 2} standardized uptake values (SUV{sub max} and SUV{sub mean}) were recorded for 13 normal organs, as well as in all the identified malignant lesions on the pretreatment scan and the 1-week post-treatment scan. We also measured changes in {sup 18}F-FPPRGD{sub 2} uptake from before to 1 week after treatment{sub ,} and compared them to the changes in {sup 18}F-FDG uptake from before to 6 weeks after treatment. Treatment outcomes were correlated with these changes. The uptake in lesions and T/B ratio of {sup 18}F-FPPRGD{sub 2} were lower than those of {sup 18}F-FDG (SUV{sub max} 3.7 ± 1.3 vs. 6.0 ± 1.8, P < 0.001; SUV{sub mean} 2.6 ± 0.7 vs. 4.2 ± 1.3, P < 0.001; T/B ratio based on SUV{sub max} 2.4 ± 1.0 vs. 2.6 ± 1.0, P < 0.04; T/B ratio based on SUV{sub mean} 1.9 ± 0.6 vs. 2.4 ± 1.0, P < 0.003). One patient did not return for the follow-up scan and in another patient no lesions were identified on the pretreatment scan. {sup 18}F-FPPRGD{sub 2} uptake in lesions in the remaining four patients had significantly changed 1 week after treatment (SUV{sub mean} 3.3 ± 1.0 vs. 2.7 ± 1.0, P < 0.001), while uptake in all normal tissues analyzed was not affected by treatment. One patient with clinical disease progression had a decrease in lesional {sup 18}F-FPPRGD{sub 2} SUV{sub mean} of 1

  14. Dysphagia-related quality of life in oculopharyngeal muscular dystrophy: Psychometric properties of the SWAL-QOL instrument.

    Science.gov (United States)

    Youssof, Sarah; Romero-Clark, Carol; Warner, Teddy; Plowman, Emily

    2017-07-01

    The Swallowing Quality of Life instrument (SWAL-QOL) is a patient-reported outcome measure of swallowing-related quality of life (SR-QoL). Its psychometric properties in oculopharyngeal muscular dystrophy (OPMD) are not known. We administered the SWAL-QOL to U.S. OPMD Registry participants. We described SR-QoL profiles and assessed reliability and validity. The mean composite score in 113 individuals with OPMD was 54.4 ± 20.7, indicating moderate impairment. Severe impairments were observed in eating duration, burden, and fatigue scales. Internal consistency reliability of all scales was found to be satisfactory, and 9 of 10 scales demonstrated adequate test-retest reliability. Data confirmed 86% of hypotheses, supporting construct validity. The SWAL-QOL limitations in OPMD include: floor/ceiling effects in 7 of 10 scales and low specificity of sleep, fatigue, and communication scales for dysphagia. SR-QoL is reduced in OPMD. Given several limitations of the SWAL-QOL, development of an improved dysphagia-specific QoL instrument for OPMD is warranted. Muscle Nerve 56: 28-35, 2017. © 2016 Wiley Periodicals, Inc.

  15. Prediction of specific depressive symptom clusters in youth with epilepsy: The NDDI-E-Y versus Neuro-QOL SF.

    Science.gov (United States)

    Kellermann, Tanja S; Mueller, Martina; Carter, Emma G; Brooks, Byron; Smith, Gigi; Kopp, Olivia J; Wagner, Janelle L

    2017-08-01

    Proper assessment and early identification of depressive symptoms are essential to initiate treatment and minimize the risk for poor outcomes in youth with epilepsy (YWE). The current study examined the predictive utility of the Neurological Disorders Depression Inventory-Epilepsy for Youth (NDDI-E-Y) and the Neuro-QOL Depression Short Form (Neuro-QOL SF) in explaining variance in overall depressive symptoms and specific symptom clusters on the gold standard Children's Depression Inventory-2 (CDI-2). Cross-sectional study examining 99 YWE (female 68, mean age 14.7 years) during a routine epilepsy visit, who completed self-report measures of depressive symptoms, including the NDDI-E-Y, CDI-2, and the Neuro-QOL SF. Caregivers completed a measure of seizure severity. All sociodemographic and medical information was evaluated through electronic medical record review. After accounting for seizure and demographic variables, the NDDI-E-Y accounted for 45% of the variance in the CDI-2 Total score and the CDI-2 Ineffectiveness subscale. Furthermore, the NDDI-E-Y predicted CDI-2 Total scores and subscales similarly, with the exception of explaining significantly more variance in the CDI-2 Ineffectiveness subscale compared to the Negative Mood subscale. The NDDI-E-Y explained greater variance compared to Neuro-QOL SF across the Total (48% vs. 37%) and all CDI-2 subscale scores; however, the NDDI-E-Y emerged as a stronger predictor of only CDI-2 Ineffectiveness. Both the NDDI-E-Y and Neuro-QOL SF accounted for the lowest amount of variance in CDI-2 Negative Mood. Sensitivity was poor for the Neuro-QOL SF in predicting high versus low CDI-2 scores. The NDDI-E-Y has strong psychometrics and can be easily integrated into routine epilepsy care for quick, brief screening of depressive symptoms in YWE. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  16. Improvement of Quality of Life (QOL in Osteoporotic Patients by Elcatonin Treatment: A Trial Taking the Participants’ Preference into Account

    Directory of Open Access Journals (Sweden)

    K. Yoh

    2012-01-01

    Full Text Available Osteoporosis is associated with compromised quality of life (QOL, to which pain has the most important contribution. Elcatonin, a derivative of calcitonin, is widely used in the treatment of osteoporosis in two ways. One is as the inhibitor of osteoclastic bone resorption. The other is for osteoporosis-related pain based on the unique analgesic effects of elcatonin. Since pain is subjective in nature, and QOL is the only clinical outcome representing the patients’ subjective perception of health status, pain associated with osteoporosis would be best evaluated based on QOL assessment. Evidence based medicine gives the highest remarks to the double-blinded, randomized controlled trial, which, however, cannot be free from methodological problems on some occasions. For example, it is practically impossible to remain blinded in the trial of a potent analgesia, which in turn causes biases. Thus, the significance of taking the patients’ preference into account is increasingly acknowledged. In this study, 45 osteoporotic patients were given brochures describing the pros and cons on the three treatment choices; calcium and alfacalcidol, additional use of elcatonin, and additional use of bisphosphonate. Those who favored elcatonin were older, had more vertebral fractures, and lower QOL scores. QOL was evaluated before and three months after the treatment using SF-8; the most widely used generic questionnaire, and RDQ; a lumbago-specific measure. Elcatonin treatment improved physical function, general health, and vitality of SF-8, and RDQ score. Although this is a preliminary study, our results suggest that patients with vertebral fracture(s have impaired QOL and more likely to favor elcatonin treatment expecting analgesia.

  17. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate.

    Science.gov (United States)

    Boyer, Laurent; Dousset, Alix; Roussel, Philippe; Dossetto, Nathalie; Cammilleri, Serge; Piano, Virginie; Khalfa, Stéphanie; Mundler, Olivier; Donnet, Anne; Guedj, Eric

    2014-04-08

    This double-blind, randomized, placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation (rTMS) on quality of life (QoL) of patients with fibromyalgia, and its possible brain metabolic substrate. Thirty-eight patients were randomly assigned to receive high-frequency rTMS (n = 19) or sham stimulation (n = 19), applied to left primary motor cortex in 14 sessions over 10 weeks. Primary clinical outcomes were QoL changes at the end of week 11, measured using the Fibromyalgia Impact Questionnaire (FIQ). Secondary clinical outcomes were mental and physical QoL component measured using the 36-Item Short Form Health Survey (SF-36), but also pain, mood, and anxiety. Resting-state [(18)F]-fluorodeoxyglucose-PET metabolism was assessed at baseline, week 2, and week 11. Whole-brain voxel-based analysis was performed to study between-group metabolic changes over time. At week 11, patients of the active rTMS group had greater QoL improvement in the FIQ (p = 0.032) and in the mental component of the SF-36 (p = 0.019) than the sham stimulation group. No significant impact was found for other clinical outcomes. Compared with the sham stimulation group, patients of the active rTMS group presented an increase in right medial temporal metabolism between baseline and week 11 (p FIQ and mental component SF-36 concomitant changes (r = -0.38, p = 0.043; r = 0.51, p = 0.009, respectively). QoL improvement involved mainly affective, emotional, and social dimensions. Our study shows that rTMS improves QoL of patients with fibromyalgia. This improvement is associated with a concomitant increase in right limbic metabolism, arguing for a neural substrate to the impact of rTMS on emotional dimensions involved in QoL. This study provides Class II evidence that rTMS compared with sham rTMS improves QoL in patients with fibromyalgia.

  18. Translation and validation of a Japanese version of the irritable bowel syndrome-quality of life measure (IBS-QOL-J

    Directory of Open Access Journals (Sweden)

    Hongo Michio

    2007-03-01

    Full Text Available Abstract Aims To compare quality of life (QOL for patients with irritable bowel syndrome (IBS between the U.S. and Japan, it is indispensable to develop common instruments. The IBS-QOL, which is widely used in Western countries, was translated into Japanese as there has been a lack of Japanese disease-specific QOL measures for IBS. Methods The original 34 items of the IBS-QOL were translated from English into Japanese through two independent forward translations, resolution, back translation, and resolution of differences. Forty nine patients who had GI symptoms but did not have any organic diseases (including 30 IBS patients diagnosed by Rome II criteria were recruited from Tohoku University Hospital in Sendai, Japan and completed a Japanese version of the IBS-QOL (IBS-QOL-J concomitant with a Japanese version of the IBS severity index (IBSSI-J twice within 7–14 days. Results The IBS-QOL-J demonstrated high internal consistency (Cronbach's alpha; 0.96 and high reproducibility (intraclass correlation coefficient; 0.92, p Conclusion The IBS-QOL-J is a reliable instrument to assess the disease-specific QOL for IBS. Considering cross-cultural comparison, this measure is likely to be a valuable tool to investigate the QOL in Japanese patients with IBS.

  19. Work performance evaluation and QoL of adults with High Functioning Autism Spectrum Disorders (HFASD).

    Science.gov (United States)

    Katz, Noomi; Dejak, Ifat; Gal, Eynat

    2015-01-01

    Studies suggest that adults with High Functioning Autism Spectrum Disorders (HFASD) are reliant on others for support in functioning in everyday life and employment. This study followed a work placement program for people with HFASD over a nine months period. It aimed to measure the trajectory of their work performance and Quality of life on jobs in the open market. Twenty-six participants with HFASD ages 18-40 underwent extensive evaluation and based on it were placed in various jobs on the open market. Participants were followed for nine months at their work place at four different time points. QoL was self-assessed in addition to work performance (WPE) which was assessed both by first-hand and team member's accounts. Team members are health professional who accompany and support the participants in the transition to their jobs. All 26 participants were able to maintain their jobs during the nine months of follow-up. WPE was perceived as high to start with, and its scores slightly improved by both people with HFASD and team members. Self-report suggests a significant change in the quality of life of the participants, specifically in their evaluations of self-competency. This study enhances the importance of providing people with HFASD with work placing programs and following up during actual work performance.

  20. Enhancing the quality of life for palliative care cancer patients in Indonesia through family caregivers: a pilot study of basic skills training.

    Science.gov (United States)

    Kristanti, Martina Sinta; Setiyarini, Sri; Effendy, Christantie

    2017-01-17

    Palliative care in Indonesia is problematic because of cultural and socio-economic factors. Family in Indonesia is an integral part of caregiving process in inpatient and outpatient settings. However, most families are not adequately prepared to deliver basic care for their sick family member. This research is a pilot project aiming to evaluate how basic skills training (BST) given to family caregivers could enhance the quality of life (QoL) of palliative care cancer patients in Indonesia. The study is a prospective quantitative with pre and post-test design. Thirty family caregivers of cancer patients were trained in basic skills including showering, washing hair, assisting for fecal and urinary elimination and oral care, as well as feeding at bedside. Patients' QoL were measured at baseline and 4 weeks after training using EORTC QLQ C30. Hypothesis testing was done using related samples Wilcoxon Signed Rank. A paired t-test and one-way ANOVA were used to check in which subgroups was the intervention more significant. The intervention showed a significant change in patients' global health status/QoL, emotional and social functioning, pain, fatigue, dyspnea, insomnia, appetite loss, constipation and financial hardship of the patients. Male patient's had a significant effect on global health status (qol) (p = 0.030); female patients had a significant effect on dyspnea (p = 0.050) and constipation (p = 0.038). Younger patients had a significant effect in global health status/QoL (p = 0.002). Patients between 45 and 54 years old had significant effect on financial issue (p = 0.039). Caregivers between 45 and 54 years old had significant effect on patients' dyspnea (p = 0.031). Basic skills training for family caregivers provided some changes in some aspects of QoL of palliative cancer patients. The intervention showed promises in maintaining the QoL of cancer patients considering socio-economic and cultural challenges in the provision of

  1. Caring for a Child with Autism Spectrum Disorder and Parents' Quality of Life: Application of the CarerQol

    NARCIS (Netherlands)

    R.J. Hoefman (Renske); N. Payakachat (Nalin); N.J.A. van Exel (Job); K.A. Kuhlthau (Karen); E.M. Kovacs (Erica); J.M. Pyne (Jeffrey); J.M. Tilford (John Mick)

    2014-01-01

    textabstractThis study describes the impact of caregiving on parents of children with autism spectrum disorders (ASDs). Secondly, we investigate construct validation of the care-related quality of life instrument (CarerQol) measuring impact of caregiving. Primary caregivers of children with ASDs

  2. Factor Structure of the Schalock and Keith Quality of Life Questionnaire (QOL-Q): Validation on Mexican and Spanish Samples

    Science.gov (United States)

    Caballo, C.; Crespo, M.; Jenaro, C.; Verdugo, M. A.; Martinez, J. L.

    2005-01-01

    Background: The Quality of Life Questionnaire (QOL-Q) is used widely to evaluate the quality of life of persons with intellectual disability (ID). Its validity for use with Spanish-speaking cultures has been demonstrated for individuals with visual disabilities, but not for those with physical or intellectual disabilities. Such was the purpose of…

  3. Food allergy QoL questionnaire for children aged 0-12 years : content, construct, and cross-cultural validity

    NARCIS (Netherlands)

    DunnGalvin, A.; de BlokFlokstra, B. M. J.; Burks, A. W.; Dubois, A. E. J.; Hourihane, J. O'B.

    Background To date, there is no food allergy-specific questionnaire that allows parents to report children's health-related QoL (HRQL) from the child's perspective. Objective The aim of this study was to develop a sensitive, multi-dimensional measure to assess parental perception of HRQL in children

  4. Pre-diagnosis quality of life (QoL) in patients with hematuria : Comparison of bladder cancer with other causes

    NARCIS (Netherlands)

    Goossens-Laan, C.A.; Kil, P.J.M.; Bosch, J.L.; de Vries, J.

    2013-01-01

    Purpose To examine quality of life (QoL), health status, sexual function, and anxiety in patients with primary hematuria who later appear to have bladder cancer (BC) and patients with other diagnoses. Methods From July 2007 to July 2010, 598 patients with primary hematuria were enrolled in this

  5. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate

    NARCIS (Netherlands)

    Boyer, L.; Dousset, A.; Roussel, P.; Dossetto, N.; Cammilleri, S.; Piano, V.M.M.; Khalfa, S.; Mundler, O.; Donnet, A.; Guedj, E.

    2014-01-01

    OBJECTIVE: This double-blind, randomized, placebo-controlled study investigated the impact of repetitive transcranial magnetic stimulation (rTMS) on quality of life (QoL) of patients with fibromyalgia, and its possible brain metabolic substrate. METHODS: Thirty-eight patients were randomly assigned

  6. Pilot Implementations

    DEFF Research Database (Denmark)

    Manikas, Maria Ie

    by conducting a literature review. The concept of pilot implementation, although commonly used in practice, is rather disregarded in research. In the literature, pilot implementations are mainly treated as secondary to the learning outcomes and are presented as merely a means to acquire knowledge about a given...... objective. The prevalent understanding is that pilot implementations are an ISD technique that extends prototyping from the lab and into test during real use. Another perception is that pilot implementations are a project multiple of co-existing enactments of the pilot implementation. From this perspective......This PhD dissertation engages in the study of pilot (system) implementation. In the field of information systems, pilot implementations are commissioned as a way to learn from real use of a pilot system with real data, by real users during an information systems development (ISD) project and before...

  7. 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.

  8. 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.

  9. Anxiety, Depression, and Health-Related QOL in Patients Diagnosed with PAH or CTEPH.

    Science.gov (United States)

    Pfeuffer, Elena; Krannich, Holger; Halank, Michael; Wilkens, Heinrike; Kolb, Philipp; Jany, Berthold; Held, Matthias

    2017-12-01

    Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are life-threatening diseases with a high burden of symptoms. Although depression, anxiety, and reduced health related quality of life (HRQOL) have also been reported, a comparative analysis which explores these traits and their underlying factors was lacking. A retrospective analysis of depression, anxiety, and health related QOL was conducted using a Hospital anxiety and depression scale (HADS) as well as the SF-36 HRQOL questionnaire. Results from these tools were compared with haemodynamic and functional parameters in 70 PAH and 23 CTEPH outpatients from a German tertiary care center specializing in pulmonary hypertension. Although HRQOL was reduced in both cohorts of patients, individuals diagnosed with CTEPH scored lower in nearly all SF-36 parameters. Significance was noted in both "mental health" (p = 0.01) and "mental component summary score" (MCS) (p = 0.02). Depression was also more frequent in patients with CTEPH (56%) than in patients with PAH (30%), (p = 0.03). Overall, depression and anxiety correlated with most SF-36 scales in both PAH and CTEPH. In CTEPH, depression also correlated with the Borg Dyspnea Scale (r = 0.44, p = 0.01). These patients also had significantly lower pCO 2 levels than the PAH cohort reflecting more severe ventilation/perfusion mismatch. All other haemodynamic and functional parameters did not differ across the groups. While both cohorts of patients suffer from a reduced HRQOL as well as depression and anxiety, decreases in mental health parameters are more pronounced in the CTEPH cohort. This suggests a strong effort to improve early detection, especially in dyspneic patients with classical risk factors for CTEPH and PAH and argues for mental illness interventions alongside routine clinical care provided to patients diagnosed with PAH or CTEPH.

  10. Development of a head and neck companion module for the quality of life-radiation therapy instrument (QOL-RTI)

    International Nuclear Information System (INIS)

    Trotti, Andy; Johnson, Darlene J.; Gwede, Clement; Casey, Linda; Sauder, Bonnie; Cantor, Alan; Pearlman, James

    1998-01-01

    Purpose/Objective: A review of available head and neck quality of life (QOL) instruments reveals them to inadequately address important radiation related side effects, or to be too cumbersome for routine use. The purpose of this study was to develop a head and neck disease specific module as a companion to the previously developed quality of life - radiation therapy instrument (QOL-RTI). The goal was to create a more complete, yet concise, head and neck site-specific module geared toward patients receiving radiation therapy for head and neck cancer. Methods and Materials: This exploratory study included 34 consecutive patients undergoing definitive radiotherapy over a 6-7 week course (60-79.8 Gy). We developed and administered a 14-item questionnaire to all eligible patients treated with radiotherapy for head and neck cancer who were not already registered in another research study assessing quality of life (e.g., RTOG). During the treatment period, the QOL-RTI general tool and the head and neck (H and N) module were administered as follows: at baseline, at week four (for test-retest), and at the end of the treatment period. For validation purposes the QOL-RTI/H and N was compared to the functional assessment cancer tool head and neck (FACT-H and N) questionnaire. The FACT-H and N was administered one time at week 4, on the same day as the QOL-RTI/H and N. This report includes the treatment phase of the study (during the course of radiation). Results: Mean age was 62 years (range 40-75). Internal consistency of the module was satisfactory (Chronbach's α = 0.85). Test-retest yielded a correlation coefficient of 0.90 (p < 0.001). Concurrent validity, established by comparing the module to the FACT/H and N , yielded a correlation coefficient of 0.85. Significant changes in quality of life scores during a course of radiation was noted for both general quality of life tool and the site specific module. For the head and neck module, the difference in the mean baseline

  11. QOL models constructed for the community-dwelling elderly with ikigai (purpose in life) as a composition factor, and the effect of habitual exercise.

    Science.gov (United States)

    Demura, Shinichi; Kobayashi, Hidetsugu; Kitabayashi, Tamotsu

    2005-09-01

    The purpose of this study was to construct QOL models for the elderly that included ikigai as a composition factor and to clarify differences in two kinds of models, one constructed for the elderly with habitual exercise and the other for those without it. The subjects were 1,566 healthy community-dwelling independent people aged 60 years or more (752 males, 814 females). First, the ratio of subjects with ikigai was calculated. The ratios of subjects with different kinds of objects of ikigai were also calculated. Next, structural equation models (SEM) were constructed on the basis of social, physical, and mental QOL and ikigai. Fits of the models were evaluated. To examine whether the presence or absence of habitual exercise caused any difference in the QOL model, subjects were divided into 4 groups according to whether they were male or female and whether they had or did not have an exercise habit. Multi-population group simultaneous analysis was then performed among the four groups. More than 85% of the subjects had objects of ikigai. Ikigai is an important factor for comprehending the QOL of the elderly. It was possible to construct QOL models for the elderly with ikigai as a composition factor. The effect of physical QOL on mental QOL was negligible in females irrespective of whether they had an exercise habit. The effect of social QOL on mental QOL was profound in aged females with an exercise habit. The effect of the living situation on mental QOL was profound in aged females without an exercise habit. The effect of mental QOL on ikigai was more marked in subjects without an exercise habit than in those with an exercise habit.

  12. Validity and reliability of the TED-QOL: a new three-item questionnaire to assess quality of life in thyroid eye disease.

    Science.gov (United States)

    Fayers, Tessa; Dolman, Peter J

    2011-12-01

    To develop and test a user-friendly questionnaire for rapidly assessing quality of life (QOL) in thyroid eye disease (TED). A three-item questionnaire, the TED-QOL, was designed and compared to the 16-item Graves Ophthalmopathy (GO)-QOL and the nine-item GO-Quality of Life Scale (QLS). 100 patients with TED were administered all three questionnaires on two occasions. Results were compared to clinical severity scores (Vision, Inflammation, Strabismus, Appearance (VISA) classification). Main outcomes were construct and criterion validity, test-retest reliability, duration, comprehension and completion rates. TED-QOL correlated strongly with the other questionnaires for corresponding items (Pearson correlation: appearance 0.71, 0.62; functioning 0.69, 0.66; overall QOL 0.53). Test-retest analysis demonstrated good reliability for all three questionnaires (intraclass correlations: TED-QOL 0.81, 0.74, 0.87; GO-QOL 0.81, 0.82; GO-QLS 0.74, 0.86, 0.67). TED-QOL was significantly faster to complete (1.6 min vs GO-QOL 3.1 min, GO-QLS 2.7 min, p<0.0001) and had a higher completion rate (100% vs GO-QOL 78%, GO-QLS 94%). There was only moderate correlation between items on all three questionnaires and VISA scores. The TED-QOL is rapid and easy to complete and analyse and has similar validity and reliability to longer questionnaires. All questionnaires showed only moderate correlation with disease severity, emphasising the discrepancy between objective and subjective assessments and the importance of measuring both.

  13. Cytokines levels, Severity of acute mucositis and the need of PEG tube installation during chemo-radiation for head and neck cancer - a prospective pilot study

    International Nuclear Information System (INIS)

    Meirovitz, Amichay; Kuten, Michal; Billan, Salem; Abdah-Bortnyak, Roxolyana; Sharon, Anat; Peretz, Tamar; Sela, Mordechai; Schaffer, Moshe; Barak, Vivian

    2010-01-01

    The purpose of this pilot study was to detect a correlation between serum cytokine levels and severity of mucositis, necessitating installation of a percutaneous endoscopic gastrostomy tube (PEG) in head and neck (H&N) cancer patients receiving combined chemo-radiation therapy. Fifteen patients with H&N epithelial cancer were recruited to this study. All patients received radiotherapy to the H&N region, with doses ranging from 50-70 Gy. Chemotherapy with cisplatin, carboplatin, 5-fluorouracil and taxanes was given to high-risk patients, using standard chemotherapy protocols. Patients were evaluated for mucositis according to WHO common toxicity criteria, and blood samples were drawn for inflammatory (IL-1, IL-6, IL-8, TNF-α) and anti-inflammatory (IL-10) cytokine levels before and during treatment. A positive correlation was found between IL-6 serum levels and severity of mucositis and dysphagia; specifically, high IL-6 levels at week 2 were correlated with a need for PEG tube installation. A seemingly contradictory correlation was found between low IL-8 serum levels and a need for a PEG tube. These preliminary results, indicating a correlation between IL-6 and IL-8 serum levels and severity of mucositis and a need for a PEG tube installation, justify a large scale study

  14. INTRAVITREAL DEXAMETHASONE IMPLANT AS ADJUVANT TREATMENT FOR BEVACIZUMAB- AND RANIBIZUMAB-RESISTANT NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: A Prospective Pilot Study.

    Science.gov (United States)

    Barikian, Anita; Salti, Haytham; Safar, Ammar; Mahfoud, Ziyad R; Bashshur, Ziad F

    2017-07-01

    To study the benefit of intravitreal dexamethasone implant in the management of neovascular age-related macular degeneration resistant to bevacizumab and ranibizumab. Patients with persistent macular fluid on optical coherence tomography despite monthly treatment with at least three consecutive bevacizumab injections followed by at least three ranibizumab injections were prospectively enrolled. A single dexamethasone implant was administered followed by intravitreal ranibizumab 1 week later. Ranibizumab was continued afterward on an as-needed basis. Main outcomes were improvement in central retinal thickness and best-corrected visual acuity. Nineteen patients (19 eyes) were enrolled. There was no significant change in best-corrected visual acuity over 6 months. Greatest reduction in mean central retinal thickness, from 295.2 μm to 236.2 μm, occurred 1 month after dexamethasone implant (P macular intraretinal fluid in eyes with neovascular age-related macular degeneration resistant to bevacizumab and ranibizumab. However, this treatment had a limited duration.

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

    Science.gov (United States)

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

    2017-11-01

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

  16. Estimation of EuroQol 5-Dimensions health status utility values in hereditary angioedema.

    Science.gov (United States)

    Aygören-Pürsün, Emel; Bygum, Anette; Beusterien, Kathleen; Hautamaki, Emily; Sisic, Zlatko; Boysen, Henrik B; Caballero, Teresa

    2016-01-01

    To estimate health status utility (preference) weights for hereditary angioedema (HAE) during an attack and between attacks using data from the Hereditary Angioedema Burden of Illness Study in Europe (HAE-BOIS-Europe) survey. Utility measures quantitatively describe the net impact of a condition on a patient's life; a score of 0.0 reflects death and 1.0 reflects full health. The HAE-BOIS-Europe was a cross-sectional survey conducted in Spain, Germany, and Denmark to assess the real-world experience of HAE from the patient perspective. Survey items that overlapped conceptually with the EuroQol 5-Dimensions (EQ-5D) domains (pain/discomfort, mobility, self-care, usual activities, and anxiety/depression) were manually crosswalked to the corresponding UK population-based EQ-5D utility weights. EQ-5D utilities were computed for each respondent in the HAE-BOIS-Europe survey for acute attacks and between attacks. Overall, a total of 111 HAE-BOIS-Europe participants completed all selected survey items and thus allowed for computation of EQ-5D-based utilities. The mean utilities for an HAE attack and between attacks were 0.44 and 0.72, respectively. Utilities for an acute attack were dependent on the severity of pain of the last attack (0.61 for no pain or mild pain, 0.47 for moderate pain, and 0.08 for severe pain). There were no significant differences across countries. Mean utilities derived from the study approach compare sensibly with other disease states for both acute attacks and between attacks. The impacts of HAE translate into substantial health status disutilities associated with acute attacks as well as between attacks, documenting that the detrimental effects of HAE are meaningful from the patient perspective. Results were consistent across countries with regard to pain severity and in comparison to similar disease states. The results can be used to raise awareness of HAE as a serious disease with wide-ranging personal and social impacts.

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

    Science.gov (United States)

    2012-11-15

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

  18. Measuring the quality of life of people with dementia in nursing homes in Germany - the study protocol for the Qol-Dem Project.

    Science.gov (United States)

    Dichter, Martin Nikolaus; Halek, Margareta; Dortmann, Olga; Meyer, Gabriele; Bartholomeyczik, Sabine

    2013-01-01

    QUALIDEM is a standardized dementia-specific quality of life (Qol) measurement, which was developed and validated in the Netherlands. A German version has been available since 2008. This study protocol describes the design and methodology for the quality of life of people with dementia (Qol-Dem) project. This project aims to evaluate the reliability and validity of the German version of the QUALIDEM. Due to the lack of both a universal definition of Qol and of standards to verify the validity of Qol measurements, this study is divided into three phases. The aim of the first theoretical phase is the development of a dementia-specific Qol model as a result of a meta-synthesis of qualitative studies. The second empirical phase consists of the three following steps: (a) an investigation of the scalability and internal consistency of the measure, (b) an evaluation of the interrater and intrarater reliability, and (c) an extensive evaluation of the validity of the QUALIDEM. The resulting Qol model (phase 1) will be used for the selection of appropriate comparators for validity testing. In the third phase, the QUALIDEM will be adapted, if necessary, based on the knowledge generated in the first two phases. The findings of the Qol-Dem project should deliver an accurate assessment of the psychometric properties of the German version of the QUALIDEM. The results will contribute to the further development of the instrument. Furthermore, the results will contribute to the theoretical development of the concept of Qol among people with dementia.

  19. Comparison of Hemostasis Times With a Kaolin-Based Hemostatic Pad (QuikClot Radial) vs Mechanical Compression (TR Band) Following Transradial Access: A Pilot Prospective Study.

    Science.gov (United States)

    Roberts, Jonathan S; Niu, Jianli; Pastor-Cervantes, Juan A

    2017-10-01

    Hemostasis following transradial access (TRA) is usually achieved by mechanical compression. We investigated use of the QuikClot Radial hemostasis pad (Z-Medica) compared with the TR Band (Terumo Medical) to shorten hemostasis after TRA. Thirty patients undergoing TRA coronary angiography and/or percutaneous coronary intervention were randomized into three cohorts post TRA: 10 patients received mechanical compression with the TR Band, 10 patients received 30 min of compression with the QuikClot Radial pad, and 10 patients received 60 min of compression with the QuikClot Radial pad. Times to hemostasis and access-site complications were recorded. Radial artery patency was evaluated 1 hour after hemostasis by the reverse Barbeau's test. There were no differences in patient characteristics, mean dose of heparin (7117 ± 1054 IU), or mean activated clotting time value (210 ± 50 sec) at the end of procedure among the three groups. Successful hemostasis was achieved in 100% of patients with both the 30-min and 60-min compression groups using the QuikClot pad. Hemostasis failure occurred in 50% of patients when the TR Band was initially weaned at the protocol-driven time (40 min after sheath removal). Mean compression time for hemostasis with the TR Band was 149.4 min compared with 30.7 min and 60.9 min for the 30-min and 60-min QuikClot groups, respectively. No radial artery occlusion occurred in any subject at the end of the study. Use of the QuikClot Radial pad following TRA in this pilot trial significantly shortened hemostasis times when compared with the TR Band, with no increased complications noted.

  20. 'Out of hours' adult CT head interpretation by senior emergency department staff following an intensive teaching session: a prospective blinded pilot study of 405 patients.

    Science.gov (United States)

    Jamal, Karim; Mandel, Laura; Jamal, Leila; Gilani, Shamim

    2014-06-01

    Cranial CT is the gold standard for the investigation of intracranial emergencies. The aim of this pilot study was to audit whether senior emergency physicians were able to report CT head scans accurately and reliably having attended structured teaching. Senior emergency physicians attended a 3 h teaching session. Following this, they independently reported adult CT head scans between 22:00 and 08:00 using a pro forma. CT head examinations performed in this 'out of hours' period were formally reported by a consultant radiologist on the following morning. Data were collected in a blinded fashion over an 8-month period. 405 adult CT head examinations were performed. 360 pro formas were available for analysis, and the rest were excluded either because a consultant radiologist had been rung to discuss the results (five patients) or because the pro forma was not completed (40 patients). Concordance between consultant radiologists and emergency physicians was found in 339 (94%) of the cases (κ coefficient 0.78). None of the discordant cases was managed inappropriately or had an adverse clinical outcome. All cases of extradural, subdural and subarachnoid haemorrhage were detected by emergency physicians. In conclusion, we feel that this model can be employed as a safe and long-term alternative provided that the radiology department are committed to providing ongoing teaching and that a database is maintained to highlight problem areas. Emergency physicians need to remember that the clinical status of the patient must never be ignored, irrespective of their CT head findings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

    Science.gov (United States)

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

    2017-01-23

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

  2. Five-months-postoperative neuropsychological outcome from a pilot prospective randomized clinical trial of thalamic deep brain stimulation for Tourette syndrome.

    Science.gov (United States)

    Schoenberg, Mike R; Maddux, Brian N; Riley, David E; Whitney, Christina M; Ogrocki, Paula K; Gould, Deborah; Maciunas, Robert J

    2015-02-01

    Tourette syndrome (TS) is a neuropsychiatric disorder presenting with motor and/or sonic tics associated with frontostriatal dysfunction. This study provided pilot data of the neuropsychological safety of bilateral thalamic deep brain stimulation (DBS) to treat medication-refractory TS in adults. This study used a repeated-measures design with pretest and 3-month follow-up from start of continuous bilateral DBS. Five male patients underwent DBS surgery for medically refractory TS. Repeated-measures ANOVA was used to evaluate for any change in neuropsychological test scores, employing a false discovery rate. Outcome measures included 14 neuropsychological tests assessing psychomotor speed, attention, memory, language, visuoconstructional, and executive functions, as well as subjective mood ratings of depression and anxiety. Average age was 28.2 years (SD = 7.5) with 12-17 years of education. Participants were disabled by tics, with a tic frequency of 50-80 per minute before surgery. At baseline, subjects' cognitive function was generally average, although mild deficits in sequencing and verbal fluency were present, as were clinically mild obsessive-compulsive symptoms. At 3 months of continuous DBS (5 months after implantation), 3 of 5 participants had clinical reductions in motor and sonic tics. Cognitive scores generally remained stable, but declines of moderate to large effect size (Cohen's d > 0.6) in verbal fluency, visual immediate memory, and reaction time were observed. Fewer symptoms of depression and anxiety, as well as fewer obsessions and compulsions, were reported after 3 months of continuous high-frequency DBS. Bilateral centromedian-parafascicular thalamic DBS for medically refractory TS shows promise for treatment of medically refractory TS without marked neuropsychological morbidity. Symptoms of depression and anxiety improved. © 2014 International Neuromodulation Society.

  3. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Lindsay S Elliott

    Full Text Available In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110 were randomized to pharmacogenetic profiling (n = 57. The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53 received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR, 0.65; 95% confidence interval (CI, 0.32-1.28; P = 0.21 and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007. The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16 and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045. Differences in composite outcomes at 60 days (exploratory endpoints

  4. Effects of Aqua Exercises Towards Improving The Quality of Life (QoL) of Obese Women in Malaysia

    Science.gov (United States)

    Karim, Noor Liyana Binti; Jalil, Asma Diyana binti Abd; Hasri, Noor Haninah Binti; Rahman, Hezlin Aryani Binti Abd; Shari, Maisarah Binti; Idris, Nur Izzati Binti

    2018-05-01

    Aqua exercise is a form of water exercise, done in the water which is beneficial for weight loss as well as improving the quality of life. It is suitable for all age group and fitness levels whereby due to the water buoyancy makes it easier to perform exercises especially for obese and knee-injured people. However, there was not much study done to measure the effectiveness of the aqua exercises in improving the quality life. Thus, this study aims to investigate and compare the effectiveness of aqua exercises towards obese women within eight domains of the Quality of Life (QoL). This study uses the 36-Items Short Form Health Survey (SF-36) questionnaire and a purposive sample of 61 participants to measure the effectiveness of the aqua exercise before and after 36 days of aqua workout. As the nature of the data collected was not normally distributed, hence the Wilcoxon signed rank test was used as the statistical method of analysis. The findings of this study showed that there was a significant difference between the overall QoL pre and post since the p-value physical functioning, general health, social functioning, mental health, and health transition were the domains showing significant difference between the pre and post-test (p-value < 0.05), and where majority of the participants showed a significant improvement after the aqua workouts. Thus, it can be concluded that aqua exercises is effective in improving the general QoL of obese women.

  5. Long-term functional outcomes of PPPD in children--Nutritional status, pancreatic function, GI function and QOL.

    Science.gov (United States)

    Park, Hwon-Ham; Kim, Hyun-Young; Jung, Sung-Eun; Lee, Seong-Cheol; Park, Kwi-Won

    2016-03-01

    The purpose of this study was to analyze the long-term outcomes, such as nutritional status, pancreatic function, gastrointestinal (GI) function, and quality of life (QOL), in children who underwent pylorus-preserving pancreaticoduodenectomy (PPPD). Between 1992 and 2013, there were 15 children who underwent PPPD at Seoul National University Children's Hospital, and 10 of them participated in this study. A retrospective review of the patients' medical records and follow-up was done. Their nutritional statuses were estimated by height, body weight, weight for age Z-score, body mass index (BMI), and serum protein, albumin levels. The endocrine and exocrine functions of the pancreas were estimated by diabetes mellitus (DM), steatorrhea, and Bristol stool chart. The GI function and QOL were evaluated via questionnaires. The follow-up period ranged from 3 to 18years. There were no severe growth disturbances, 6 patients experienced mild steatorrhea and 3 showed above the category 6 in Bristol stool chart. All the patients experienced mild GI symptoms. As for the QOL, there were no significant negative answers, except for one patient with DM. Almost all the study subjects, who underwent PPPD in their childhood, did not present significant problems except for one patient with DM. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Prospective 1-year follow-up pilot study of CT-guided microwave ablation in the treatment of bone and soft-tissue malignant tumours

    Energy Technology Data Exchange (ETDEWEB)

    Aubry, Sebastien; Kastler, Bruno [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); University of Franche-Comte, I4S laboratory, INSERM EA4268, Besancon (France); Dubut, Jonathan; Nueffer, Jean-Philippe [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Chaigneau, Loic [University Hospital of Besancon, Department of Oncology, Besancon (France); Vidal, Chrystelle [University Hospital of Besancon, Clinical Investigation Center, INSERM CIT808, Besancon (France)

    2017-04-15

    The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation (MWA) in the treatment of malignant musculoskeletal tumours. Sixteen bone and soft-tissue malignant tumours were prospectively included and were treated by CT-guided MWA. The percentage and size of necrosis of the lesions were measured by contrast-enhanced MRI before the procedure and after 1, 3, 6 and 12 months. mRECIST criteria were used to assess tumour response. Procedural success was defined as ≥80 % necrosis. Patient pain (as assessed using a numeric visual scale (NVS)) and side effects were noted. Six osteolytic metastases, five osteoblastic metastases and five soft tissue sarcomas were treated. At 1 month, 40 % were treated completely, the percentage of necrosis was 85 ± 30.4 %, and the success rate was 80 %. At 3, 6 and 12 months the success rate was 80 %, 76.9 % and 63.6 %, respectively. At 12 months, four lesions (36.3 %) still had no recurrence. Mean NVS during the procedure was 3.5 ± 2.8. One patient had transitory sciatica without neurological deficit that was treated medically. CT-guided MWA of bone and soft-tissue malignant tumours is efficient, well tolerated and has good short-term anti-cancer effects. (orig.)

  7. Effect of an electronic nicotine delivery device (e-Cigarette on smoking reduction and cessation: a prospective 6-month pilot study

    Directory of Open Access Journals (Sweden)

    Papale Gabriella

    2011-10-01

    Full Text Available Abstract Background Cigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette, a battery-powered electronic nicotine delivery device (ENDD resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated. Methods In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5% participants; their median of 25 cigs/day decreasing to 6 cigs/day (p Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597.

  8. Emotional impact of severe post-partum haemorrhage on women and their partners: an observational, case-matched, prospective, single-centre pilot study.

    Science.gov (United States)

    Ricbourg, Aude; Gosme, Christelle; Gayat, Etienne; Ventre, Chloé; Barranger, Emmanuel; Mebazaa, Alexandre

    2015-10-01

    This observational, matched-control, prospective, single-centre study sought to estimate the emotional impact of post-partum haemorrhage (PPH) on women and their partners, including its influences on post-traumatic stress disorder (PTSD), postpartum depression and the mother/child relationship. All consecutive women who were admitted for PPH from December 2010 through December 2011 and their partners were screened for eligibility. Emotional impact was assessed using three self-reported questionnaires (Impact of Event Scale-Revised to assess PTSD, Edinburgh Post Natal Depression Scale to assess post-natal depression and Mother-Infant Bonding Scale to assess the relationship between mother and child). Each PPH patient was matched with a control woman for whom the delivery was not complicated by PPH. The results showed (a) that women with PPH and their partners were more likely to report symptoms related to PTSD compared with controls, (b) that women with PPH were less likely to suffer from postnatal depression and (c) that there was no difference in the mother/child relationship between women with PPH and controls. PPH is associated with a high incidence of PTSD-related symptoms in both women and their partners. PTSD in the context of PPH is likely an under-recognised phenomenon by health care professionals. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  9. Gut microbiome composition in lean patients with NASH is associated with liver damage independent of caloric intake: A prospective pilot study.

    Science.gov (United States)

    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

  10. Estimation of EuroQol 5-Dimensions health status utility values in hereditary angioedema

    Directory of Open Access Journals (Sweden)

    Aygören-Pürsün E

    2016-09-01

    Full Text Available Emel Aygören-Pürsün,1 Anette Bygum,2 Kathleen Beusterien,3 Emily Hautamaki,4 Zlatko Sisic,5 Henrik B Boysen,6 Teresa Caballero7 1Angioedema Centre, Department for Children and Adolescents, University Hospital Frankfurt, Goethe University, Frankfurt, Germany; 2Hereditary Angioedema Centre Denmark, Department of Dermatology and Allergy Centre, Odense University Hospital, Odense, Denmark; 3Outcomes Research Strategies in Health, Washington, DC, 4Patient Reported Outcomes, Oxford Outcomes Inc., an ICON plc company, Bethesda, MD, USA; 5ViroPharma Incorporated, Chatsworth House, Maidenhead, UK; 6HAEi – Hereditary Angioedema International Patient Organization for C1 Inhibitor Deficiencies, Skanderborg, Denmark; 7Allergy Department, Hospital La Paz Institute for Health Research (IdiPaz, Biomedical Research Network on Rare Diseases U754 (CIBERER, University Hospital La Paz, Madrid, Spain Objective: To estimate health status utility (preference weights for hereditary angioedema (HAE during an attack and between attacks using data from the Hereditary Angioedema Burden of Illness Study in Europe (HAE-BOIS-Europe survey. Utility measures quantitatively describe the net impact of a condition on a patient’s life; a score of 0.0 reflects death and 1.0 reflects full health.Study design and methods: The HAE-BOIS-Europe was a cross-sectional survey conducted in Spain, Germany, and Denmark to assess the real-world experience of HAE from the patient perspective. Survey items that overlapped conceptually with the EuroQol 5-Dimensions (EQ-5D domains (pain/discomfort, mobility, self-care, usual activities, and anxiety/depression were manually crosswalked to the corresponding UK population-based EQ-5D utility weights. EQ-5D utilities were computed for each respondent in the HAE-BOIS-Europe survey for acute attacks and between attacks.Results: Overall, a total of 111 HAE-BOIS-Europe participants completed all selected survey items and thus allowed for computation

  11. Prevalence of swallowing and speech problems in daily life after chemoradiation for head and neck cancer based on cut-off scores of the patient-reported outcome measures SWAL-QOL and SHI.

    Science.gov (United States)

    Rinkel, Rico N; Verdonck-de Leeuw, Irma M; Doornaert, Patricia; Buter, Jan; de Bree, Remco; Langendijk, Johannes A; Aaronson, Neil K; Leemans, C René

    2016-07-01

    The objective of this study is to assess swallowing and speech outcome after chemoradiation therapy for head and neck cancer, based on the patient-reported outcome measures Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI), both provided with cut-off scores. This is a cross-sectional study. Department of Otolaryngology/Head and Neck Surgery of a University Medical Center. Sixty patients, 6 months to 5 years after chemoradiation for head and neck squamous cell carcinoma. Swallowing Quality of Life Questionnaire (SWAL-QOL) and SHI, both validated in Dutch and provided with cut-off scores. Associations were tested between the outcome measures and independent variables (age, gender, tumor stage and site, and radiotherapy technique, time since treatment, comorbidity and food intake). Fifty-two patients returned the SWAL-QOL and 47 the SHI (response rate 87 and 78 %, respectively). Swallowing and speech problems were present in 79 and 55 %, respectively. Normal food intake was noticed in 45, 35 % had a soft diet and 20 % tube feeding. Patients with soft diet and tube feeding reported more swallowing problems compared to patients with normal oral intake. Tumor subsite was significantly associated with swallowing outcome (less problems in larynx/hypopharynx compared to oral/oropharynx). Radiation technique was significantly associated with psychosocial speech problems (less problems in patients treated with IMRT). Swallowing and (to a lesser extent) speech problems in daily life are frequently present after chemoradiation therapy for head and neck cancer. Future prospective studies will give more insight into the course of speech and swallowing problems after chemoradiation and into efficacy of new radiation techniques and swallowing and speech rehabilitation programs.

  12. Is there a role for hyperbaric oxygen as primary treatment for grade IV radiation-induced haemorrhagic cystitis? a prospective pilot-feasibility study and review of literature

    International Nuclear Information System (INIS)

    Dellis, Athanasios; Deliveliotis, Charalambos; Kalentzos, Vasileios; Vavasis, Pavlos; Skolarikos, Andreas

    2014-01-01

    Purpose: To examine the safety and efficacy of hyperbaric oxygen as the primary treatment for Grade IV radiation-induced haemorrhagic cystitis. Materials and Methods: Hyperbaric oxygen was prospectively applied as a primary treatment option in 11 patients with Grade IV radiation cystitis. Primary endpoint was the incidence of complete and partial response to treatment. Secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. Results: All patients completed therapy without complications for a mean follow-up of 17.82 months (range 3 to 34). Mean number of sessions needed was 32.8 (range 27 to 44). Complete and partial response rate was 81.8% and 18.2%, respectively. However, in three patients the first treatment session was not either sufficient or durable giving a 72.7% rate of durable effect. Interestingly, all 9 patients with complete response received therapy within 6 months of the haematuria onset compared to the two patients with partial response who received therapy at 8 and 10 months from the haematuria onset, respectively (p = 0.018). The need for blood transfusion (p = 0.491) and the total radiation dose (p = 0.259) were not correlated to success-rate. One patient needed cystectomy, while all patients were alive at the end of follow-up. Conclusions: Early primary use of hyperbaric oxygen to treat radiation-induced grade IV cystitis is an effective and safe treatment option. (author)

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

    Energy Technology Data Exchange (ETDEWEB)

    Veltri, Andrea, E-mail: andrea.veltri@unito.it; Busso, Marco; Sardo, Diego; Angelino, Valeria; Priola, Adriano M. [University of Torino, Department of Radiology, San Luigi Gonzaga Hospital (Italy); Novello, Silvia [University of Torino, Department of Oncology, San Luigi Gonzaga Hospital (Italy); Barba, Matteo [University of Torino, Department of Radiology, San Luigi Gonzaga Hospital (Italy); Gatti, Gaia; Righi, Luisella [University of Torino, Department of Pathology, San Luigi Gonzaga Hospital (Italy)

    2017-06-15

    PurposeTo prospectively evaluate feasibility and diagnostic performance of the 14-gauge helical-tip (Spirotome™, Cook{sup ®} Medical, Bloomington, USA) needle in transthoracic needle biopsy (TTNB) of lung lesions, compared to a conventional 18-gauge Tru-Cut needle.Materials and MethodsStudy was institutional review board approved, with informed consent obtained. Data from synchronous Spirotome and Tru-Cut image-guided TTNB of 20 consecutive patients with malignant peripheral lung tumors larger than 3 cm were enrolled for pathologic characterization and mutational analysis. Samples obtained with Spirotome and Tru-Cut needle were compared for fragmentation, length, weight, morphologic and immunohistochemistry typifying, tumor cellularity (TC) and DNA concentration.ResultsThe technical success rate for TTNB with Spirotome was 100%, and no major complications occurred. Less fragmentation (mean 2 vs. 3 fragments, P = .418), greater weight (mean 13 vs. 8.5 mg, P = .027) and lower length (mean 10.2 vs. 12.6 mm, P = .174) were observed with Spirotome compared to Tru-Cut needle. Accuracy of Spirotome and Tru-Cut needle in defining cancer histotype was similar (90%). Absolute and relative TC (mean 42 vs. 38, 124 vs. 108/10HPF), and DNA concentration (mean 49.6 vs. 39.0 ng/μl) were higher with Spirotome compared to Tru-Cut needle, with no statistical significance (P = .787 and P = .140, respectively).Conclusions Percutaneous 14-gauge Spirotome TTNB of selected lesions is feasible and accurate. It provides adequate samples for diagnosis, comparable to 18-gauge Tru-Cut needle, with a higher amount of tumor tissue (weight, TC, DNA concentration) even in shorter samples.

  14. A prospective pilot study of genome-wide exome and transcriptome profiling in patients with small cell lung cancer progressing after first-line therapy.

    Directory of Open Access Journals (Sweden)

    Glen J Weiss

    Full Text Available Small cell lung cancer (SCLC that has progressed after first-line therapy is an aggressive disease with few effective therapeutic strategies. In this prospective study, we employed next-generation sequencing (NGS to identify therapeutically actionable alterations to guide treatment for advanced SCLC patients.Twelve patients with SCLC were enrolled after failing platinum-based chemotherapy. Following informed consent, genome-wide exome and RNA-sequencing was performed in a CLIA-certified, CAP-accredited environment. Actionable targets were identified and therapeutic recommendations made from a pharmacopeia of FDA-approved drugs. Clinical response to genomically-guided treatment was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.The study completed its accrual goal of 12 evaluable patients. The minimum tumor content for successful NGS was 20%, with a median turnaround time from sample collection to genomics-based treatment recommendation of 27 days. At least two clinically actionable targets were identified in each patient, and six patients (50% received treatment identified by NGS. Two had partial responses by RECIST 1.1 on a clinical trial involving a PD-1 inhibitor + irinotecan (indicated by MLH1 alteration. The remaining patients had clinical deterioration before NGS recommended therapy could be initiated.Comprehensive genomic profiling using NGS identified clinically-actionable alterations in SCLC patients who progressed on initial therapy. Recommended PD-1 therapy generated partial responses in two patients. Earlier access to NGS guided therapy, along with improved understanding of those SCLC patients likely to respond to immune-based therapies, should help to extend survival in these cases with poor outcomes.

  15. A prospective pilot study of genome-wide exome and transcriptome profiling in patients with small cell lung cancer progressing after first-line therapy.

    Science.gov (United States)

    Weiss, Glen J; Byron, Sara A; Aldrich, Jessica; Sangal, Ashish; Barilla, Heather; Kiefer, Jeffrey A; Carpten, John D; Craig, David W; Whitsett, Timothy G

    2017-01-01

    Small cell lung cancer (SCLC) that has progressed after first-line therapy is an aggressive disease with few effective therapeutic strategies. In this prospective study, we employed next-generation sequencing (NGS) to identify therapeutically actionable alterations to guide treatment for advanced SCLC patients. Twelve patients with SCLC were enrolled after failing platinum-based chemotherapy. Following informed consent, genome-wide exome and RNA-sequencing was performed in a CLIA-certified, CAP-accredited environment. Actionable targets were identified and therapeutic recommendations made from a pharmacopeia of FDA-approved drugs. Clinical response to genomically-guided treatment was evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The study completed its accrual goal of 12 evaluable patients. The minimum tumor content for successful NGS was 20%, with a median turnaround time from sample collection to genomics-based treatment recommendation of 27 days. At least two clinically actionable targets were identified in each patient, and six patients (50%) received treatment identified by NGS. Two had partial responses by RECIST 1.1 on a clinical trial involving a PD-1 inhibitor + irinotecan (indicated by MLH1 alteration). The remaining patients had clinical deterioration before NGS recommended therapy could be initiated. Comprehensive genomic profiling using NGS identified clinically-actionable alterations in SCLC patients who progressed on initial therapy. Recommended PD-1 therapy generated partial responses in two patients. Earlier access to NGS guided therapy, along with improved understanding of those SCLC patients likely to respond to immune-based therapies, should help to extend survival in these cases with poor outcomes.

  16. The effect of increasing the dose of hydroxychloroquine (HCQ) in patients with refractory cutaneous lupus erythematosus (CLE): An open-label prospective pilot study.

    Science.gov (United States)

    Chasset, François; Arnaud, Laurent; Costedoat-Chalumeau, Nathalie; Zahr, Noel; Bessis, Didier; Francès, Camille

    2016-04-01

    Up to 30% of patients with cutaneous lupus erythematosus (CLE) fail to respond to hydroxychloroquine (HCQ). We sought to evaluate the efficacy of increased daily doses of HCQ on cutaneous response in refractory CLE. We conducted an open-label prospective study between 2010 and 2014. Patients with CLE and HCQ blood level less than or equal to 750 ng/mL were included. The daily dose of HCQ was increased to reach blood concentrations greater than 750 ng/mL. The primary end point was the number of responders defined by an improvement of CLE Disease Area and Severity Index score (4 points or 20% decrease) in patients with HCQ blood concentration greater than 750 ng/mL. We included 34 patients (26 women; median age 45 [range 28-72] years). Two nonadherent patients were excluded. The median CLE Disease Area and Severity Index score before treatment was significantly improved after treatment (8 [range 2-30] vs 1.5 [range 0-30]), P < .001). The primary response criterion was reached in 26 (81%) of the 32 patients analyzed. A decrease in HCQ doses without further CLE flare (median follow-up 15.8 [range 3.06-77.4] months) was achieved in 15 of the 26 responders. The main limitations of the study are its open-label design and the limited number of patients included. Increasing HCQ doses to reach blood concentrations greater than 750 ng/mL should be considered before addition of other treatments in refractory CLE. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  17. Is there a role for hyperbaric oxygen as primary treatment for grade IV radiation-induced haemorrhagic cystitis? a prospective pilot-feasibility study and review of literature

    Energy Technology Data Exchange (ETDEWEB)

    Dellis, Athanasios [Surgical Department, University of Athens, Aretaieion Hospital (Greece); Deliveliotis, Charalambos [Urologic Department, University of Athens, Sismanoglio General Hospital (Greece); Kalentzos, Vasileios; Vavasis, Pavlos; Skolarikos, Andreas [Diving and Hyperbaric Oxygen Department, Naval and Veterans Hospital, Athens (Greece)

    2014-05-15

    Purpose: To examine the safety and efficacy of hyperbaric oxygen as the primary treatment for Grade IV radiation-induced haemorrhagic cystitis. Materials and Methods: Hyperbaric oxygen was prospectively applied as a primary treatment option in 11 patients with Grade IV radiation cystitis. Primary endpoint was the incidence of complete and partial response to treatment. Secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. Results: All patients completed therapy without complications for a mean follow-up of 17.82 months (range 3 to 34). Mean number of sessions needed was 32.8 (range 27 to 44). Complete and partial response rate was 81.8% and 18.2%, respectively. However, in three patients the first treatment session was not either sufficient or durable giving a 72.7% rate of durable effect. Interestingly, all 9 patients with complete response received therapy within 6 months of the haematuria onset compared to the two patients with partial response who received therapy at 8 and 10 months from the haematuria onset, respectively (p = 0.018). The need for blood transfusion (p = 0.491) and the total radiation dose (p = 0.259) were not correlated to success-rate. One patient needed cystectomy, while all patients were alive at the end of follow-up. Conclusions: Early primary use of hyperbaric oxygen to treat radiation-induced grade IV cystitis is an effective and safe treatment option. (author)

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

    Science.gov (United States)

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

    2017-09-26

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

  19. A Prospective Open-label Pilot Study of Fluvastatin on Pro-inflammatory and Pro-thrombotic Biomarkers in Antiphospholipid Antibody Positive Patients

    Science.gov (United States)

    Erkan, Doruk; Willis, Rohan; Murthy, Vijaya L.; Basra, Gurjot; Vega, JoAnn; Ruiz Limón, Patricia; Carrera, Ana Laura; Papalardo, Elizabeth; Martínez-Martínez, Laura Aline; González, Emilio B.; Pierangeli, Silvia S.

    2014-01-01

    Objective: To determine if pro-inflammatory and pro-thrombotic biomarkers are differentially upregulated in persistently antiphospholipid antibody (aPL)-positive patients, and to examine the effects of fluvastatin on these biomarkers. Methods: Four groups of patients (age 18-65) were recruited: a) Primary Antiphospholipid Syndrome (PAPS); b) Systemic Lupus Erythematosus (SLE) with APS (SLE/APS); c) Persistent aPL positivity without SLE or APS (Primary aPL); and d) Persistent aPL positivity with SLE but no APS (SLE/aPL). The frequency-matched control group, used for baseline data comparison, was identified from a databank of healthy persons. Patients received fluvastatin 40 mg daily for three months. At three months, patients stopped the study medication and they were followed for another three months. Blood samples for 12 pro-inflammatory and pro-thrombotic biomarkers were collected monthly for six months. Results: Based on the comparison of the baseline samples of 41 aPL-positive patients with 30 healthy controls, 9/12 (75%) biomarkers (interleukin [IL]-6, IL1β, vascular endothelial growth factor [VEGF], tumor necrosis factor [TNF]-□α, interferon [IFN]-α, inducible protein-10 [IP10], soluble CD40 ligand [sCD40L], soluble tissue factor [sTF], and intracellular cellular adhesion molecule [ICAM]-1) were significantly elevated. Twenty-four patients completed the study; fluvastatin significantly and reversibly reduced the levels of 6/12 (50%) biomarkers (IL1β, VEGF, TNFα, IP10, sCD40L, and sTF). Conclusion: Our prospective mechanistic study demonstrates that pro-inflammatory and pro-thrombotic biomarkers, which are differentially upregulated in persistently aPL-positive patients, can be reversibly reduced by fluvastatin. Thus, statin-induced modulation of the aPL effects on target cells can be a valuable future approach in the management of aPL-positive patients. PMID:23933625

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

    Science.gov (United States)

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

    2017-01-01

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

  1. Prospective assessment of nocturnal awakenings in a case series of treatment-seeking chronic insomnia patients: a pilot study of subjective and objective causes.

    Science.gov (United States)

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

    2012-12-01

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

  2. Treatment of Spontaneous Subarachnoid Hemorrhage and Self-Reported Neuropsychological Performance at 6 Months - Results of a Prospective Clinical Pilot Study on Good-Grade Patients.

    Science.gov (United States)

    Bründl, Elisabeth; Schödel, Petra; Bele, Sylvia; Proescholdt, Martin; Scheitzach, Judith; Zeman, Florian; Brawanski, Alexander; Schebesch, Karl-Michael

    2018-01-01

    Limited focus has been placed on neuropsychological patient profiles after spontaneous subarachnoid hemorrhage (sSAH). We conducted a prospective controlled study in good-grade sSAH patients to evaluate the time course of treatment-specific differences in cognitive processing after sSAH. Twenty-six consecutive sSAH patients were enrolled (drop out n=5). Nine patients received endovascular aneurysm occlusion (EV), 6 patients were treated microsurgically (MS), and 6 patients with perimesencephalic SAH (pSAH) underwent standardized intensive medical care. No patient experienced serious vasospasm-related ischemic or hemorrhagic complications. All patients were subjected to neuropsychological self-report assessment (36-Item Short Form Health Survey and ICD-10-Symptom-Rating questionnaire) subacutely (day 11 - 35) after the onset of bleeding (t1) and at the 6-month follow-up (FU; t 2 ). From t1 to t 2 , MS and EV patients significantly improved in physical functioning (Pfi; p=.001 each) and the physical component summary (p=.010 vs. p=.015). Bodily pain (Pain; MS p=.034) and general health perceptions (EV p=.014) significantly improved, and nutrition disorder (EV p=.008) worsened. At FU, MS patients reported significantly better Pfi (vs. EV p=.046), less Pain (vs. EV p=.040), and more depression (vs. pSAH p=.035). Group-rate analyses of test differences showed a significant alleviation in nutrition disorder in MS (vs. EV p=.009). All sSAH groups reported a significant deterioration in health. Though both MS and EV patients, improved in several physical items over time, our data suggest a better short-term Pfi, less Pain and improved nutrition disorder in surgically treated patients. pSAH patients performed significantly better in various aspects of physical and psychological functioning than patients with aneurysmal SAH.

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

    Science.gov (United States)

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

    2010-11-01

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

  4. Value of 18F-3,4-dihydroxyphenylalanine PET/MR image fusion in pediatric supratentorial infiltrative astrocytomas: a prospective pilot study.

    Science.gov (United States)

    Morana, Giovanni; Piccardo, Arnoldo; Milanaccio, Claudia; Puntoni, Matteo; Nozza, Paolo; Cama, Armando; Zefiro, Daniele; Cabria, Massimo; Rossi, Andrea; Garrè, Maria Luisa

    2014-05-01

    Infiltrative astrocytomas (IAs) represent a group of astrocytic gliomas ranging from low-grade to highly malignant, characterized by diffuse invasion of the brain parenchyma. When compared with their adult counterpart, pediatric IAs may be considered biologically distinct entities; nevertheless, similarly to those in adults they represent a complex oncologic challenge. The aim of this study was to investigate the diagnostic role, clinical contribution, and prognostic value of fused (18)F-3,4-dihydroxyphenylalanine ((18)F-DOPA) PET/MR images in pediatric supratentorial IAs. Pediatric patients with supratentorial IAs involving at least 2 cerebral lobes, either newly diagnosed or with suspected disease progression, prospectively underwent (18)F-DOPA PET and conventional MR imaging, performed within 10 d of each other. (18)F-DOPA PET data were interpreted qualitatively and semiquantitatively, fusing images with MR images. PET scans were classified as positive if tumors identified on MR imaging exhibited tracer uptake above the level of the corresponding contralateral normal brain. Maximum standardized uptake values, tumor-to-normal contralateral tissue ratios, and tumor-to-normal striatum ratios were calculated for all tumors. Correlations between the degree and extent of (18)F-DOPA uptake, MR imaging tumor characteristics, and histologic results were investigated. The contribution of (18)F-DOPA PET/MR image fusion was considered relevant if it enabled one to select the most appropriate biopsy site, discriminate between disease progression and treatment-related changes, or influence treatment strategy. The patient's outcome was finally correlated with (18)F-DOPA uptake. Thirteen patients (8 boys and 5 girls) were included (5 diffuse astrocytomas, 2 anaplastic astrocytomas, 5 gliomatosis cerebri, and 1 glioblastoma multiforme). The (18)F-DOPA uptake pattern was heterogeneous in all positive scans (9/13), revealing metabolic heterogeneities within each tumor. Significant

  5. Demonstrating the effectiveness of body armour: a pilot prospective computerised surface wound mapping trial performed at the Role 3 hospital in Afghanistan.

    Science.gov (United States)

    Breeze, Johno; Allanson-Bailey, L S; Hepper, A E; Midwinter, M J

    2015-03-01

    Modern body armour clearly reduces injury incidence and severity, but evidence to actually objectively demonstrate this effect is scarce. Although the Joint Theatre Trauma Registry (JTTR) alone cannot relate injury pattern to body armour coverage, the addition of computerised Surface Wound Mapping (SWM) may enable this utility. Surface wound locations of all UK and NATO coalition soldiers, Afghan National Army and Police and local nationals injured by explosively propelled fragments and treated in the Role 3 UK-led Field Hospital in Camp Bastion, Afghanistan, between 8 July and 20 October 2012 were prospectively recorded. The Abbreviated Injury Scores (AIS) and relative risk of casualties sustaining injuries under a type of body armour were compared with those that did not wear that armour. Casualties wearing a combat helmet were 2.7 times less likely to sustain a fragmentation wound to the head than those that were unprotected (mean AIS of 2.9 compared with 4.1). Casualties wearing a body armour vest were 4.1 times less likely to sustain a fragmentation wound to the chest or abdomen than those that were unprotected (mean AIS of 2.9 compared with 3.9). Casualties wearing pelvic protection were 10 times less likely to sustain a fragmentation wound to the pelvis compared with those that were unprotected (mean AIS of 3.4 compared with 3.9). Computerised SWM has objectively demonstrated the ability of body armour worn on current operations in Afghanistan to reduce wound incidence and severity. We recognise this technique is limited in that it only records the surface wound location and may be specific to this conflict. However, gathering electronic SWM at the same time as recording injuries for the JTTR was simple, required little extra time and therefore we would recommend its collection during future conflicts. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  6. The accuracy of postoperative, non-invasive Air-Test to diagnose atelectasis in healthy patients after surgery: a prospective, diagnostic pilot study.

    Science.gov (United States)

    Ferrando, Carlos; Romero, Carolina; Tusman, Gerardo; Suarez-Sipmann, Fernando; Canet, Jaume; Dosdá, Rosa; Valls, Paola; Villena, Abigail; Serralta, Ferran; Jurado, Ana; Carrizo, Juan; Navarro, Jose; Parrilla, Cristina; Romero, Jose E; Pozo, Natividad; Soro, Marina; Villar, Jesús; Belda, Francisco Javier

    2017-05-29

    To assess the diagnostic accuracy of peripheral capillary oxygen saturation (SpO 2 ) while breathing room air for 5 min (the 'Air-Test') in detecting postoperative atelectasis. Prospective cohort study. Diagnostic accuracy was assessed by measuring the agreement between the index test and the reference standard CT scan images. Postanaesthetic care unit in a tertiary hospital in Spain. Three hundred and fifty patients from 12 January to 7 February 2015; 170 patients scheduled for surgery under general anaesthesia who were admitted into the postsurgical unit were included. The Air-Test was performed in conscious extubated patients after a 30 min stabilisation period during which they received supplemental oxygen therapy via a venturi mask. The Air-Test was defined as positive when SpO 2 was ≤96% and negative when SpO 2 was ≥97%. Arterial blood gases were measured in all patients at the end of the Air-Test. In the subsequent 25 min, the presence of atelectasis was evaluated by performing a CT scan in 59 randomly selected patients. The primary study outcome was assessment of the accuracy of the Air-Test for detecting postoperative atelectasis compared with the reference standard. The secondary outcome was the incidence of positive Air-Test results. The Air-Test diagnosed postoperative atelectasis with an area under the receiver operating characteristic curve of 0.90 (95% CI 0.82 to 0.98) with a sensitivity of 82.6% and a specificity of 87.8%. The presence of atelectasis was confirmed by CT scans in all patients (30/30) with positive and in 5 patients (17%) with negative Air-Test results. Based on the Air-Test, postoperative atelectasis was present in 36% of the patients (62 out of 170). The Air-Test may represent an accurate, simple, inexpensive and non-invasive method for diagnosing postoperative atelectasis. NCT02650037. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is

  7. Development and psychometric characteristics of the SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks and short forms and the SCI-QOL Bladder Complications scale.

    Science.gov (United States)

    Tulsky, David S; Kisala, Pamela A; Tate, Denise G; Spungen, Ann M; Kirshblum, Steven C

    2015-05-01

    To describe the development and psychometric properties of the Spinal Cord Injury--Quality of Life (SCI-QOL) Bladder Management Difficulties and Bowel Management Difficulties item banks and Bladder Complications scale. Using a mixed-methods design, a pool of items assessing bladder and bowel-related concerns were developed using focus groups with individuals with spinal cord injury (SCI) and SCI clinicians, cognitive interviews, and item response theory (IRT) analytic approaches, including tests of model fit and differential item functioning. Thirty-eight bladder items and 52 bowel items were tested at the University of Michigan, Kessler Foundation Research Center, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital, and the James J. Peters VA Medical Center, Bronx, NY. Seven hundred fifty-seven adults with traumatic SCI. The final item banks demonstrated unidimensionality (Bladder Management Difficulties CFI=0.965; RMSEA=0.093; Bowel Management Difficulties CFI=0.955; RMSEA=0.078) and acceptable fit to a graded response IRT model. The final calibrated Bladder Management Difficulties bank includes 15 items, and the final Bowel Management Difficulties item bank consists of 26 items. Additionally, 5 items related to urinary tract infections (UTI) did not fit with the larger Bladder Management Difficulties item bank but performed relatively well independently (CFI=0.992, RMSEA=0.050) and were thus retained as a separate scale. The SCI-QOL Bladder Management Difficulties and Bowel Management Difficulties item banks are psychometrically robust and are available as computer adaptive tests or short forms. The SCI-QOL Bladder Complications scale is a brief, fixed-length outcomes instrument for individuals with a UTI.

  8. Personal goals and factors related to QoL in Dutch homeless people: what is the role of goal-related self-efficacy?

    Science.gov (United States)

    van der Laan, Jorien; Boersma, Sandra N; van Straaten, Barbara; Rodenburg, Gerda; van de Mheen, Dike; Wolf, Judith R L M

    2017-05-01

    Very little is known about the personal goals of homeless people and how these relate to their quality of life (QoL). By using survey data on 407 homeless adults upon entry to the social relief system in 2011, we examined the personal goals of homeless adults and the association between their perceived goal-related self-efficacy and their QoL. A hierarchical regression analysis was used to analyse the association between QoL and goal-related self-efficacy, relative to factors contributing to QoL, such as demographic characteristics, socioeconomic resources, health and service use. Results indicate that the majority of homeless adults had at least one personal goal for the coming 6 months and that most goals concerned housing and daily life (94.3%) and finances (83.6%). The QoL of homeless adults appeared to be lower in comparison with general population samples. General goal-related self-efficacy was positively related to QoL (β = 0.09, P = 0.042), independent of socioeconomic resources (i.e. income and housing), health and service use. The strongest predictors of QoL were psychological distress (β = -0.45, P people as the starting point of integrated service programmes and to promote their goal-related self-efficacy by strength-based interventions. © 2017 John Wiley & Sons Ltd.

  9. Edentulism and dental prostheses in the elderly: impact on quality of life measured with EuroQol--visual analog scale (EQ-VAS).

    Science.gov (United States)

    Cano-Gutiérrez, Carlos; Borda, Miguel G; Arciniegas, Antonio J; Borda, Claudia X

    2015-01-01

    The objective of this study was to measure the impact of edentulism and dental prostheses on quality of life (QOL) in older adults in Bogota, Colombia. Edentulism is a frequent condition in older adults and has great impact on their QOL. No epidemiological data are currently available on edentulism among older adults in Colombia. Data were obtained from the SABE-Bogota study, a cross-sectional study conducted in 2012, and used to analyze the EQ-VAS (Visual Analog Scale) from the EuroQol instrument to measure the perception of quality of life (QOL) in relation to edentulism. The study included 2,000 individuals over 60 years old. The Spearman-Rho correlation was used to analyze the correlation between EQ-VAS and edentulism. Chi-Square, ANOVA and t-test were used to study the differences in EQ-VAS scores between edentulous and healthy subjects. Statistical significance was set at peducation were related to edentulism. Individuals with fewer teeth and dental prostheses had lower EQ-VAS scores (pmeasuring the perception of QOL in dental health scenarios. Edentulism significantly affects QOL in older adults and the use of dental prosthesis does not improve the perception of QOL.

  10. Validity, reliability, and factor analysis of Persian version of quality of life questionnaire for irritable bowel syndrome (IBS-QOL-34

    Directory of Open Access Journals (Sweden)

    Nasrine Masaeli

    2013-01-01

    Full Text Available Background: Quality of life (QOL improvement is the main objective of treating patients with irritable bowel syndrome (IBS. This study aimed to assess the validity, reliability, and factor analysis of IBS-QOL-34 questionnaire as a common transcultural instrument for Iranian IBS patients. Materials and Methods: Two hundred and forty patients with IBS (based on gastroenterologists′ diagnosis according to ROM III criteria were referred to Digestive Health Clinic in Psychosomatic Research Center have been selected in this study. Aside with IBS-QOL-34, MOS 36-item short-form health survey (SF-36 and IBS severity index (IBSSI questionnaires were completed by the cases for determination of correlation coefficients; the data were analyzed using descriptive statistics, factor analysis, Cronbach′s alpha, Pearson correlation coefficient by Statistical Package for Social Sciences (SPSS software, version 18. Results: Total reliability of the questionnaire was reported by using Cronbach′s alpha as 0.95, ranging from 0.65 to 0.90. Correlation coefficients of concurrent implementation of IBS-QOL with SF-36 and IBSSI resulted in −0.61 and 0.64, respectively. Exploratory factor analysis using varimax rotation identified eight principle components, which will determine QOL at 67% variance. Conclusion: According to the results, IBS-QOL-34 questionnaire has good psychometric properties in the research community and can be safely used as a valid tool to assess QOL of patients with IBS for healthcare and therapeutic purposes.

  11. Metastatic breast cancer: do current treatments improve quality of life? A prospective study

    Directory of Open Access Journals (Sweden)

    Fernanda Amado

    Full Text Available CONTEXT AND OBJECTIVE: In metastatic breast cancer cases, the currently available therapeutic approaches provide minimal improvement in survival. As such, quality of life (QOL becomes one of the main objectives of treatment. It is not known whether current treatments derived from trials improve QOL. The aim was to evaluate changes in QOL among metastatic breast cancer patients receiving treatment derived from trials. DESIGN AND SETTING: Prospective observational QOL survey in a tertiary cancer center. METHODS: To evaluate the influence of current treatments on patients' QOL, the Medical Outcomes Study Short Form-36 (SF-36 and the Beck Depression Inventory (BDI were applied on three occasions: before starting treatment and at the 6th and 12th weeks, to consecutive metastatic breast cancer patients over a one-year period. RESULTS: We found an improvement in QOL in the sample evaluated (n = 40, expressed by changes in the overall SF-36 score (p = 0.002 and the BDI (p = 0.004. Taken individually, the SF-36 components Pain, Social Functioning and Mental Health also improved significantly. Patients with worse initial performance status and secondary symptoms displayed greater improvement than those with better initial performance status and asymptomatic disease (p < 0.001. Patients who received more than one type of therapy showed larger gains than those given only one type (p = 0.038. CONCLUSIONS: In our environment, current metastatic breast cancer treatments can improve QOL, especially among symptomatic patients and those with low performance status.

  12. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a iveelement model of pilot...... implementation and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can be difficult...

  13. A newly designed radiation therapy protocol in combination with prednisolone as treatment for meningoencephalitis of unknown origin in dogs: a prospective pilot study introducing magnetic resonance spectroscopy as monitor tool.

    Science.gov (United States)

    Beckmann, Katrin; Carrera, Inés; Steffen, Frank; Golini, Lorenzo; Kircher, Patrick R; Schneider, Uwe; Bley, Carla Rohrer

    2015-01-31

    A plethora of treatment options have been described for canine meningoencephalitis of unknown origin (MUO), yet a gold standard has not been established. The aim of this prospective pilot study was to document the effect of a newly designed 30 Gray (Gy) radiation therapy (RT) protocol plus corticosteroids as treatment for focal and multifocal MUO, to monitor clinical and imaging changes during the course of the disease with conventional magnetic resonance imaging (MRI) and proton MR Spectroscopy (H-1 MRS) and to detect the occurrence of radiation related side effects. Six dogs (3 with focal and 3 with multifocal lesions) were included in the study. The RT protocol used consisted of 30 Gy in 10 fractions. The neurological status of all six dogs improved during RT, with 3 of 6 cases returning to a normal condition. One dog was euthanized early during follow-up (dog and improved in 3 dogs and H-1 MRS normalized in 4. In the dog without improvement of the MRI lesions, the N-acetyl aspartate continued to decrease, while choline and creatine concentrations remained stable during that time. This dog was euthanized 18 month after the end of RT due to relapse. One dog was lost to follow up 12 month after completion of RT. The other 3 dogs are still alive at the time of writing. RT with 30 Gy in 10 fractions can provide an additional option for anti-inflammatory treatment of focal and multifocal MUO. The protocol used for treatment monitoring was feasible while no side effects of RT could be observed during the follow up period. Moreover, H-1 MRS could represent a new and non-invasive tool to control the progression of the disease during the treatment course.

  14. Toxicities Affecting Quality of Life After Chemo-IMRT of Oropharyngeal Cancer: Prospective Study of Patient-Reported, Observer-Rated, and Objective Outcomes

    International Nuclear Information System (INIS)

    Hunter, Klaudia U.; Schipper, Matthew; Feng, Felix Y.; Lyden, Teresa; Haxer, Mark; Murdoch-Kinch, Carol-Anne; Cornwall, Benjamin; Lee, Connie S.Y.; Chepeha, Douglas B.; Eisbruch, Avraham

    2013-01-01

    Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) aiming to spare the salivary glands and swallowing structures would reduce or eliminate the effects of xerostomia and dysphagia on quality of life (QOL). Methods and Materials: In this prospective, longitudinal study, 72 patients with stage III-IV oropharyngeal cancer were treated uniformly with definitive chemo-IMRT sparing the salivary glands and swallowing structures. Overall QOL was assessed by summary scores of the Head Neck QOL (HNQOL) and University of Washington QOL (UWQOL) questionnaires, as well as the HNQOL “Overall Bother” question. Quality of life, observer-rated toxicities (Common Toxicity Criteria Adverse Effects scale, version 2), and objective evaluations (videofluoroscopy assessing dysphagia and saliva flow rates assessing xerostomia) were recorded from before therapy through 2 years after therapy. Correlations between toxicities/objective evaluations and overall QOL were assessed using longitudinal repeated measures of analysis and Pearson correlations. Results: All observer-rated toxicities and QOL scores worsened 1-3 months after therapy and improved through 12 months, with minor further improvements through 24 months. At 12 months, dysphagia grades 0-1, 2, and 3, were observed in 95%, 4%, and 1% of patients, respectively. Using all posttherapy observations, observer-rated dysphagia was highly correlated with all overall QOL measures (P<.0001), whereas xerostomia and mucosal and voice toxicities were significantly correlated with some, but not all, overall QOL measures, with lower correlation coefficients than dysphagia. Late overall QOL (≥6 or ≥12 months after therapy) was primarily associated with observer-rated dysphagia, and to a lesser extent with xerostomia. Videofluoroscopy scores, but not salivary flows, were significantly correlated with some of the overall QOL measures. Conclusion: After chemo-IMRT, although late dysphagia was on average mild

  15. Toxicities Affecting Quality of Life After Chemo-IMRT of Oropharyngeal Cancer: Prospective Study of Patient-Reported, Observer-Rated, and Objective Outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Hunter, Klaudia U. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Schipper, Matthew [Department of Biostatistics, University of Michigan, Ann Arbor, Michigan (United States); Feng, Felix Y. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Lyden, Teresa; Haxer, Mark [Department of Speech-Language Pathology, University of Michigan, Ann Arbor, Michigan (United States); Murdoch-Kinch, Carol-Anne; Cornwall, Benjamin [Department of Hospital Dentistry, University of Michigan, Ann Arbor, Michigan (United States); Lee, Connie S.Y. [Department of Biostatistics, University of Michigan, Ann Arbor, Michigan (United States); Chepeha, Douglas B. [Department of Otolaryngology-Head Neck Surgery, University of Michigan, Ann Arbor, Michigan (United States); Eisbruch, Avraham, E-mail: Eisbruch@umich.edu [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2013-03-15

    Purpose: To test the hypothesis that intensity modulated radiation therapy (IMRT) aiming to spare the salivary glands and swallowing structures would reduce or eliminate the effects of xerostomia and dysphagia on quality of life (QOL). Methods and Materials: In this prospective, longitudinal study, 72 patients with stage III-IV oropharyngeal cancer were treated uniformly with definitive chemo-IMRT sparing the salivary glands and swallowing structures. Overall QOL was assessed by summary scores of the Head Neck QOL (HNQOL) and University of Washington QOL (UWQOL) questionnaires, as well as the HNQOL “Overall Bother” question. Quality of life, observer-rated toxicities (Common Toxicity Criteria Adverse Effects scale, version 2), and objective evaluations (videofluoroscopy assessing dysphagia and saliva flow rates assessing xerostomia) were recorded from before therapy through 2 years after therapy. Correlations between toxicities/objective evaluations and overall QOL were assessed using longitudinal repeated measures of analysis and Pearson correlations. Results: All observer-rated toxicities and QOL scores worsened 1-3 months after therapy and improved through 12 months, with minor further improvements through 24 months. At 12 months, dysphagia grades 0-1, 2, and 3, were observed in 95%, 4%, and 1% of patients, respectively. Using all posttherapy observations, observer-rated dysphagia was highly correlated with all overall QOL measures (P<.0001), whereas xerostomia and mucosal and voice toxicities were significantly correlated with some, but not all, overall QOL measures, with lower correlation coefficients than dysphagia. Late overall QOL (≥6 or ≥12 months after therapy) was primarily associated with observer-rated dysphagia, and to a lesser extent with xerostomia. Videofluoroscopy scores, but not salivary flows, were significantly correlated with some of the overall QOL measures. Conclusion: After chemo-IMRT, although late dysphagia was on average mild

  16. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology.

    Science.gov (United States)

    Cella, D; Lai, J-S; Nowinski, C J; Victorson, D; Peterman, A; Miller, D; Bethoux, F; Heinemann, A; Rubin, S; Cavazos, J E; Reder, A T; Sufit, R; Simuni, T; Holmes, G L; Siderowf, A; Wojna, V; Bode, R; McKinney, N; Podrabsky, T; Wortman, K; Choi, S; Gershon, R; Rothrock, N; Moy, C

    2012-06-05

    To address the need for brief, reliable, valid, and standardized quality of life (QOL) assessment applicable across neurologic conditions. Drawing from larger calibrated item banks, we developed short measures (8-9 items each) of 13 different QOL domains across physical, mental, and social health and evaluated their validity and reliability. Three samples were utilized during short form development: general population (Internet-based, n = 2,113); clinical panel (Internet-based, n = 553); and clinical outpatient (clinic-based, n = 581). All short forms are expressed as T scores with a mean of 50 and SD of 10. Internal consistency (Cronbach α) of the 13 short forms ranged from 0.85 to 0.97. Correlations between short form and full-length item bank scores ranged from 0.88 to 0.99 (0.82-0.96 after removing common items from banks). Online respondents were asked whether they had any of 19 different chronic health conditions, and whether or not those reported conditions interfered with ability to function normally. All short forms, across physical, mental, and social health, were able to separate people who reported no health condition from those who reported 1-2 or 3 or more. In addition, scores on all 13 domains were worse for people who acknowledged being limited by the health conditions they reported, compared to those who reported conditions but were not limited by them. These 13 brief measures of self-reported QOL are reliable and show preliminary evidence of concurrent validity inasmuch as they differentiate people based upon number of reported health conditions and whether those reported conditions impede normal function.

  17. Anxiety, depression, perceived social support and quality of life in Malaysian breast cancer patients: a 1-year prospective study

    OpenAIRE

    Ng, Chong Guan; Mohamed, Salina; See, Mee Hoong; Harun, Faizah; Dahlui, Maznah; Sulaiman, Ahmad Hatim; Zainal, Nor Zuraida; Taib, Nur Aishah

    2015-01-01

    Background Depression and anxiety are common psychiatric morbidity among breast cancer patient. There is a lack of study examining the correlation between depression, anxiety and quality of life (QoL) with perceived social support (PSS) among breast cancer patients. This study aims to study the level of depression, anxiety, QoL and PSS among Malaysian breast cancer women over a period of 12?months and their associations at baseline, 6 and 12?months. Methods It is a 12?months prospective cohor...

  18. The impact of voice impairment after thyroidectomy on quality of life. A prospective cohort study

    DEFF Research Database (Denmark)

    Sørensen, Jesper Roed; Døssing, Helle; Bonnema, Steen Joop

    Introduction: To assess the impact of voice and vocal fold changes (VVFC) after thyroidectomy on disease specific quality of life (QoL). Methods: Prospective cohort study (inclusion period: 18 months, ending April-2016) with six months follow-up of patients with nodular goiter undergoing thyroide......Introduction: To assess the impact of voice and vocal fold changes (VVFC) after thyroidectomy on disease specific quality of life (QoL). Methods: Prospective cohort study (inclusion period: 18 months, ending April-2016) with six months follow-up of patients with nodular goiter undergoing...

  19. A pilot study on acupuncture for lower urinary tract symptoms related to chronic prostatitis/chronic pelvic pain

    Directory of Open Access Journals (Sweden)

    Stone Brian A

    2007-02-01

    Full Text Available Abstract Background The etiology and treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS remain poorly understood. Pain, lower urinary tract voiding symptoms and negative impact on quality of life (QOL are the most common complaints. Acupuncture, which has been widely used to treat painful and chronic conditions, may be a potential treatment to alleviate the constellation of symptoms experienced by men with CP/CPPS. The purpose of our study was to assess the impact of standardized full body and auricular acupuncture in men refractory to conventional therapies and collect pilot data to warrant further randomized trials. Methods Ten men diagnosed with category IIIA or IIIB CP/CPPS >6 months, refractory to at least 1 conventional therapy (antibiotics, anti-inflammatory agents, 5-α reductase inhibitors, α-1 blockers and scoring >4 on the pain subset of the NIH-CPSI were prospectively analyzed in an Institutional Review Board (IRB approved, single-center clinical trial (Columbia University Medical Center IRB#AAAA-7460. Standardized full body and auricular acupuncture treatment was given twice weekly for 6 weeks. The primary endpoints were total score of the NIH-CPSI and assessment of serious adverse events. The secondary endpoints were individual scores of the NIH-CPSI and QOL questionnaire scores of the short-form 36 (SF-36. Results The median age of the subjects was 36 years (range 29–63. Decreases in total NIH-CPSI scores (mean ± SD after 3 and 6 weeks from baseline (25.1 ± 6.6 were 17.6 ± 5.7 (P Conclusion The preliminary findings, although limited, suggest the potential therapeutic role of acupuncture in the treatment of CP/CPPS. Data from this and previous studies warrant randomized trials of acupuncture for CP/CPPS and particular attention towards acupuncture point selection, treatment intervention, and durability of acupuncture.

  20. Prospective assessment of disease-specific quality of life in adults with eosinophilic esophagitis.

    Science.gov (United States)

    Stern, E; Taft, T; Zalewski, A; Gonsalves, N; Hirano, I

    2017-10-27

    Eosinophilic esophagitis (EoE) is an important cause of upper gastrointestinal dysfunction in children and adults. The EoE-quality of life (QOL)-A was validated as a disease-specific measure of quality of life in EoE. This study characterized the extent of QOL concerns in a cohort of adult EoE patients and delineated the relationships between QOL and other disease activity measures. One hundred sixty-seven patients enrolled in this prospective cohort study. Patients with established and suspected EoE undergoing endoscopy at a single university-based medical center were recruited. EoE was diagnosed on the basis of the clinical criteria and histologic demonstration of ≥15 eos/hpf while on proton pump inhibition therapy. Sixty five patients undergoing repeat endoscopy during the enrollment period participated twice. Patients provided demographic information and completed symptom assessments and the EoE-QOL-A. Analyses included comparisons with overall QOL as well as QOL subscales. Outcome measures included endoscopic activity using a validated instrument, the EoE Endoscopic Reference Score, and histology. Overall QOL was significantly correlated with dysphagia frequency, intensity, and severity (P food impaction in the last 30 days had significantly worse overall QOL (P = 0.009). There was no correlation between overall QOL and years since diagnosis, symptom duration, endoscopic features, or histologic findings. Patient symptoms correlated with endoscopic features of edema, rings, and stricture severity. Histologic activity was highly correlated with severity of endoscopic features. Patients who underwent repeat endoscopy with histologic response demonstrated improved eating and social QOL; however, overall QOL was unchanged. In adults with EoE, patient reported QOL is associated with symptom severity but not endoscopic or histologic features. Disease-specific QOL may complement parameters of biologic activity in the assessment of overall disease burden in EoE.

  1. DASH (disabilities of the arm, shoulder, and hand) evaluation of QOL for carpal tunnel syndrome

    International Nuclear Information System (INIS)

    Morita, Akimasa; Kawamoto, Masataka; Fujisawa, Kouzou; Tsujii, Masaya; Hirata, Hitoshi

    2006-01-01

    The questionnaire on the disabilities of the arm, shoulder, and hand is a region-specific, self-administered outcome instrument that is developed as a measure of self-rate upper extremity disability and symptoms. Last year, the Japanese version of disabilities of the arm, shoulder and hand (DASH) was cross-culturally adapted. The main purpose of this study is to analyze the relationship between DASH and clinical assessment (findings of MRI and electrodiagnostic parameters). The subjects comprised 41 patients (6 males and 35 females) with carpal tunnel syndrome (CTS), except for cases with other upper extremity disorders. These subjects prospectively completed DASH 1 (disability module), DASH 2 (symptom module), and DASH (disability and symptom module) before the release of the open carpal tunnel. The patients were divided into 3 groups based on the symptom duration (A: shorter than 3 months, B: 4-11 months, C: longer than 12 months). All patients were preoperatively assessed with regard to sensory conduction velocity (SCV) and compound muscle action potential (CMAP). In addition, all patients underwent MRI in order to evaluate the flexor tenosynovial swelling represented by palmar bowing of the flexor retinaculum (PBFR). The relationships were estimated using the Spearman rank score, unpaired t tests, and Bonferroni tests. DASH 2 scores indicated greater responsiveness than DASH 1, which reflected the character of CTS. DASH 1 scores were higher in patients who were affected in their dominant hand than in those whose nondominant hand was affected. The DASH scores decreased significantly in groups A and B, with the exception of C. However, DASH did not show any correlation either with the parameters, age, or MRI assessment. DASH can be used for the research of preoperative outcomes related to CTS. It also has the advantage of being useful in assessing and comparing the outcome for various other hand disorders. (author)

  2. [Valuation and prospect of function preserving gastrectomy].

    Science.gov (United States)

    Wang, Shuchang; Yu, Site; Xu, Jia; Zhao, Gang

    2017-10-25

    Preserving gastric function and improving quality of life (QOL) is the tendency of surgery for early gastric cancer. Function preserving gastrectomy (FPG) is applied to modify the extent of surgery and to achieve better quality of life at the premise of radical resection. Pylorus-preserving gastrectomy is the most favorable approach of FPG with oncological safety, which can improve nutritional status and QOL via preserving pylorus and vagal nerve. Proximal gastrectomy is widely accepted as FPG for early upper 1/3 gastric cancer. However, the most optimal way of anastomosis is not yet solved. Sentinel node navigation is currently the most accurate approach for intraoperative diagnosis of lymph node metastasis, which stimulates the development of many kinds of FPG procedures for individual treatment. Nevertheless, more efforts should be made to reduce false negative rate of sentinel node biopsy. Herein we discuss the valuation and prospect of FPG.

  3. Quality of life in patients with fibromyalgia: validation and psychometric properties of the German Quality of Life Scale (QOLS-G).

    Science.gov (United States)

    Offenbächer, Martin; Sauer, Sebastian; Kohls, Niko; Waltz, Millard; Schoeps, Peter

    2012-10-01

    Our objectives were to translate the Quality of Life Scale (QOLS) into German and to evaluate its reliability and validity for the use in patients with fibromyalgia (FMS). Together with German versions of the Fibromyalgia Impact Questionnaire (FIQ), the SF-36, a tender point count (TPC) and other questionnaires, we administered the QOLS to 146 patients with FMS. Patients were asked about the severity of pain today (VAS) and the duration of symptoms. Test-retest reliability was assessed using Spearman's correlations. Internal consistency was evaluated with Cronbach's alpha. Construct validity of the QOLS was evaluated by correlating the QOLS with the FIQ, the SF-36, the Beck Depression Inventory (BDI), and the Symptom Checklist (SCL-90-R) as well as with the pain variables. An exploratory factor analysis (EFA) was also conducted. Mean age was 53.1 years. Means were for pain today 6.8 and for duration of symptoms 11.8 years. Test-retest reliability for the total QOLS was rho = .91. Internal consistency was α = .90. Low-to-moderate correlations were obtained between the QOLS and the total FIQ (rho = -.42), the SF-36 (e.g. physical functioning rho = .37; mental health rho = .56) as well as the pain variables (VAS rho = -.11 ns; TPC rho = -.20). Psychological variables were moderately to substantially correlated with the QOLS (e.g. BDI rho = -.61). An EFA suggested a three-factor solution. The QOLS-G is a reliable and valid instrument for measuring quality of life in German patients with FMS.

  4. Decreased physical activity, reduced QoL and presence of debilitating fatigue in patients with Addison's disease.

    Science.gov (United States)

    van der Valk, Eline S; Smans, Lisanne C C J; Hofstetter, Hedwig; Stubbe, Janine H; de Vries, Marieke; Backx, Frank J G; Hermus, Ad R M M; Zelissen, Pierre M J

    2016-09-01

    Health-related quality of life in patients with Addison's disease has been assessed in various European countries, indicating a reduced quality of life. However, no studies have addressed the impact of Addison's disease on physical activity. The aim of this study was to investigate the quality of life in Dutch patients with Addison's disease particularly regarding the presence of fatigue and the ability to be physically active. In this cross-sectional study, a postal survey was performed among Dutch patients with Addison's disease on stable glucocorticoid replacement therapy with hydrocortisone or cortisone acetate. For quality of life and physical activity assessment, patients completed general and health-related quality of life and physical activity questionnaires, and scores were compared to Dutch controls. A total of 328 patients with Addison's disease were studied. In patients with Addison's disease, only 45·7% met the standard of physical activity (Combinorm) compared to 67·8% of Dutch controls (P < 0·01). Forty-eight per cent of patients showed abnormal fatigue, while 61% had severe fatigue. The CIS fatigue scores were significantly higher compared to controls (P < 0·01). We found reduced general subjective health-related QoL scores in both male and female patients, especially in younger patients <65 years of age. Physical activity is decreased in patients with Addison's disease, combined with a reduced subjective health-related QoL and increased fatigue. © 2016 John Wiley & Sons Ltd.

  5. Home-based walking improves cardiopulmonary function and health-related QOL in community-dwelling adults.

    Science.gov (United States)

    Okamoto, N; Nakatani, T; Morita, N; Saeki, K; Kurumatani, N

    2007-12-01

    The objective of our study was to investigate the effects of a home-based walking program on physical fitness and QOL among community residents. Subjects (n = 200, mean age: 64.2 years, range: 42 - 75 years) who participated in the 32-week trial were randomly allocated to one of two groups: an exercise (E) group and a control (C) group. The E group was instructed to increase the number of steps a day that they walked and to perform aerobic walking at a target heart rate for 20 minutes or more daily, 2 or more days a week. The C group was told to continue their normal level of activity. Outcome measures were the 3-minute shuttle stamina walk test (SSWT), 30-second chair-stand test (CS-30), and SF-36. Increases in SSWT values were significantly greater in the E group than in the C group (men 24.1 m vs. 6.3 m; women 8.8 m vs. 2.4 m), as were increases in CS-30 values (men 5.9 vs. 2.6; women 4.5 vs. - 0.1). On the SF-36, the scores in the E group for vitality and mental health increased significantly. Home-based walking is considered to be an effective and feasible method to improve physical fitness and QOL among community residents.

  6. Metallic stents provide better QOL than plastic stents in patients with stricture of unresectable advanced esophageal cancer

    International Nuclear Information System (INIS)

    Ohta, Kazuki; Nagahara, Akihito; Iijima, Katsuyori

    2006-01-01

    The aim of this study was to elucidate the utility and safety of treatment with esophageal stents (plastic and metallic stents) for unresectable advanced esophageal cancer. Between 1992 and 2002, 14 cases of unresectable advanced esophageal cancer were treated with esophageal stents (the plastic stent group, 7 cases; and the metallic stent group, 7 cases). Of these, 10 cases had a history of chemotherapy and or radiotherapy. An improvement in oral intake and performance status (PS), survival time, periods at home, and adverse events were compared between the two groups. After stenting, oral intake and PS were significantly improved in the metallic stent group. Follow-up at home was possible in 71.4%. There was no significant difference in survival or duration of time at home between the two groups. All adverse events were controllable and there was no difference between the two groups. Stenting not only improved oral intake and PS but also allowed a stay at home, resulting in a marked improvement in patients' quality of life (QOL). Stenting was performed safely even in cases with a history of radiotherapy. There was no difference in survival, ratios of staying at home, and safety between the two groups, but QOL was significantly improved in the metallic stent group. These outcomes indicate that placement of metallic stents should be actively considered to treat stricture due to advanced esophageal cancer. (author)

  7. Multiattribute health utility scoring for the computerized adaptive measure CAT-5D-QOL was developed and validated.

    Science.gov (United States)

    Kopec, Jacek A; Sayre, Eric C; Rogers, Pamela; Davis, Aileen M; Badley, Elizabeth M; Anis, Aslam H; Abrahamowicz, Michal; Russell, Lara; Rahman, Md Mushfiqur; Esdaile, John M

    2015-10-01

    The CAT-5D-QOL is a previously reported item response theory (IRT)-based computerized adaptive tool to measure five domains (attributes) of health-related quality of life. The objective of this study was to develop and validate a multiattribute health utility (MAHU) scoring method for this instrument. The MAHU scoring system was developed in two stages. In phase I, we obtained standard gamble (SG) utilities for 75 hypothetical health states in which only one domain varied (15 states per domain). In phase II, we obtained SG utilities for 256 multiattribute states. We fit a multiplicative regression model to predict SG utilities from the five IRT domain scores. The prediction model was constrained using data from phase I. We validated MAHU scores by comparing them with the Health Utilities Index Mark 3 (HUI3) and directly measured utilities and by assessing between-group discrimination. MAHU scores have a theoretical range from -0.842 to 1. In the validation study, the scores were, on average, higher than HUI3 utilities and lower than directly measured SG utilities. MAHU scores correlated strongly with the HUI3 (Spearman ρ = 0.78) and discriminated well between groups expected to differ in health status. Results reported here provide initial evidence supporting the validity of the MAHU scoring system for the CAT-5D-QOL. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases

    International Nuclear Information System (INIS)

    Steinmann, Diana; Gerstein, Johanna; Gharbi, Nadine; Hagg, Juliane; Hipp, Matthias; Kleff, Irmgard; Müller, Axel; Schäfer, Christof; Schleicher, Ursula; Sehlen, Susanne; Theodorou, Marilena; Paelecke-Habermann, Yvonne; Wypior, Hans-Joachim; Zehentmayr, Franz; Oorschot, Birgitt van; Vordermark, Dirk; Geinitz, Hans; Aschoff, Raimund; Bayerl, Anja; Bölling, Tobias; Bosch, Elisabeth; Bruns, Frank; Eichenseder-Seiss, Ute

    2012-01-01

    Recently published results of quality of life (QoL) studies indicated different outcomes of palliative radiotherapy for brain metastases. This prospective multi-center QoL study of patients with brain metastases was designed to investigate which QoL domains improve or worsen after palliative radiotherapy and which might provide prognostic information. From 01/2007-01/2009, n=151 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. Most patients (82 %) received whole-brain radiotherapy. QoL was measured with the EORTC-QLQ-C15-PAL and brain module BN20 before the start of radiotherapy and after 3 months. At 3 months, 88/142 (62 %) survived. Nine patients were not able to be followed up. 62 patients (70.5 % of 3-month survivors) completed the second set of questionnaires. Three months after the start of radiotherapy QoL deteriorated significantly in the areas of global QoL, physical function, fatigue, nausea, pain, appetite loss, hair loss, drowsiness, motor dysfunction, communication deficit and weakness of legs. Although the use of corticosteroid at 3 months could be reduced compared to pre-treatment (63 % vs. 37 %), the score for headaches remained stable. Initial QoL at the start of treatment was better in those alive than in those deceased at 3 months, significantly for physical function, motor dysfunction and the symptom scales fatigue, pain, appetite loss and weakness of legs. In a multivariate model, lower Karnofsky performance score, higher age and higher pain ratings before radiotherapy were prognostic of 3-month survival. Moderate deterioration in several QoL domains was predominantly observed three months after start of palliative radiotherapy for brain metastases. Future studies will need to address the individual subjective benefit or burden from such treatment. Baseline QoL scores before palliative radiotherapy for brain metastases may contain prognostic information

  9. Translation and validation of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL questionnaire for the Brazilian Portuguese language

    Directory of Open Access Journals (Sweden)

    Luiz Gustavo Oliveira Brito

    2017-03-01

    Full Text Available ABSTRACT CONTEXT AND OBJECTIVE: Uterine fibroids (UF, also known as leiomyomas, are the most prevalent gynecological tumors. The Uterine Fibroid Symptoms and Quality of Life (UFS-QOL is the only specific questionnaire that assesses symptom intensity and quality-of-life issues for women with symptomatic UF; however, it only exists in the English language. Thus, we aimed to translate and culturally validate the UFS-QOL questionnaire for the Brazilian Portuguese language. DESIGN AND SETTING: Cross-sectional study, Department of Gynecology and Obstetrics, FMRP-USP. METHODS: 113 patients with UF (case group and 55 patients without UF (control group were interviewed using the UFS-QOL questionnaire after translation and cultural adaptation. The Short Form-36 questionnaire was used as a control. Demographic and psychometric variables were analyzed. RESULTS: Women with UF presented higher mean age, body mass index, weight, parity and comorbidities than the control group (P < 0.05. The most prevalent complaints were abnormal uterine bleeding (93.8%, pelvic pain (36.3% and extrinsic compression (10.6% and these presented adequate construct validity regarding UFS-QOL severity (P < 0.05. The UFS-QOL questionnaire presented good internal consistency regarding symptom severity and quality-of-life-related domains (intraclass correlation coefficient, ICC = 0.82/0.88. Structural validity presented correlation coefficients ranging from 0.59 to 0.91. Test-retest comparison did not show differences among the UFS-QOL subscales. After treatment, women with UF presented improvements on all subscales. CONCLUSION: The UFS-QOL questionnaire presented adequate translation to the Brazilian Portuguese language, with good internal consistency, discriminant validity, construct validity, structural validity and responsiveness, along with adequate test-retest results.

  10. Is the content of the Chinese Quality of Life Instrument (ChQOL) really valid in the context of traditional Chinese medicine in Hong Kong?

    Science.gov (United States)

    Wong, Wendy; Lam, Cindy L K; Leung, K F; Zhao, L

    2009-01-01

    Content validity is crucial in quality of life instrument development but there is very little literature on this in Chinese culture. The Chinese Quality of Life Instrument (ChQOL) was developed in Mainland China to capture the health-related quality of life (HRQOL) concepts specific to traditional Chinese medicine (TCM). The aim of this study was to evaluate the content validity of ChQOL in a Chinese population whose spoken dialect and health-care system are different from those of Mainland China to find out whether the instrument is generalizable. 8 TCM practitioners and 10 patients rated the clarity, relevance and appropriateness of each of the 50 items of the ChQOL (HK version), and completed qualitative cognitive debriefing interviews. The content of ChQOL was rated valid by TCM practitioners with CVIs on clarity, relevance and appropriateness ranging from 80 to 100%. 49 out of 50 items were well understood by patients, but 12 items had CVI on relevance and 5 items had CVI on appropriateness lower than 70% among patients. After reviewing the patients and TCM practitioners' opinions, revisions were made for three items (2, 8 and 29) to form the ChQOL (HK version)-2008. In general, the ChQOL was found to be too long which called for shorter version. The content of ChQOL was shown to be really valid in the context of Chinese Medicine for Cantonese speaking Chinese. There was some discrepancy between the judgments of TCM practitioners and patients indicating the importance of evaluation by both experts and lay persons.

  11. The effect of cognitive appraisal for stressors on the oral health-related QOL of dry mouth patients.

    Science.gov (United States)

    Matsuoka, Hirofumi; Chiba, Itsuo; Sakano, Yuji; Saito, Ichiro; Abiko, Yoshihiro

    2014-01-01

    Dry mouth is very common symptom, and psychological factors have an influence on this symptom. Although the influence of emotional factor related to patients with oral dryness has been examined in previous studies, the cognitive factors have not been examined thus far. The purpose of this study was to examine the influence of cognitive factors on patients with oral dryness. The participants were 106 patients complaining of oral dryness. They were required to complete a questionnaire measuring subjective oral dryness, oral-related QOL, cognition for stressors, and mood state. Correlational analyses revealed that OHIP-14 is significantly related to oral dryness, appraisal for effect, appraisal for threat, and commitment. These correlations were maintained even after controlling for the influence of depression and anxiety. Using oral dryness, appraisal for effect, appraisal for threat, and commitment, cluster analysis was done and three clusters (cluster-1, severe oral dryness; cluster-2, positive cognitive style: cluster-3, negative cognitive style) were extracted. The results of ANOVA showed that the group with severe oral dryness (cluster-1) had a significantly higher score on OHIP-14 than the other two groups. There was no significant difference between the groups with positive (cluster-2) and negative (cluster-3) cognitive style. Although the group of patients with positive cognitive style complained of more severe oral dryness than the group with negative cognitive style, no significant difference was observed between these two groups in OHIP-14. These results indicate that cognitive factors would be a useful therapeutic target for the improvement of the oral-related QOL of patients with oral dryness.

  12. Measuring anxiety after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Anxiety item bank and linkage with GAD-7.

    Science.gov (United States)

    Kisala, Pamela A; Tulsky, David S; Kalpakjian, Claire Z; Heinemann, Allen W; Pohlig, Ryan T; Carle, Adam; Choi, Seung W

    2015-05-01

    To develop a calibrated item bank and computer adaptive test to assess anxiety symptoms in individuals with spinal cord injury (SCI), transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a statistical linkage with the Generalized Anxiety Disorder (GAD)-7, a widely used anxiety measure. Grounded-theory based qualitative item development methods; large-scale item calibration field testing; confirmatory factor analysis; graded response model item response theory analyses; statistical linking techniques to transform scores to a PROMIS metric; and linkage with the GAD-7. Setting Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Participants Adults with traumatic SCI. Spinal Cord Injury-Quality of Life (SCI-QOL) Anxiety Item Bank Seven hundred sixteen individuals with traumatic SCI completed 38 items assessing anxiety, 17 of which were PROMIS items. After 13 items (including 2 PROMIS items) were removed, factor analyses confirmed unidimensionality. Item response theory analyses were used to estimate slopes and thresholds for the final 25 items (15 from PROMIS). The observed Pearson correlation between the SCI-QOL Anxiety and GAD-7 scores was 0.67. The SCI-QOL Anxiety item bank demonstrates excellent psychometric properties and is available as a computer adaptive test or short form for research and clinical applications. SCI-QOL Anxiety scores have been transformed to the PROMIS metric and we provide a method to link SCI-QOL Anxiety scores with those of the GAD-7.

  13. Objective and subjective outcomes of strabismus surgery in Graves' orbitopathy: a prospective multicentre study

    NARCIS (Netherlands)

    Jellema, Hinke Marijke; Saeed, Peerooz; Mombaerts, Ilse; Dolman, Peter J.; Garrity, Jim; Kazim, Mike; Dhrami-Gavazi, Elona; Lyons, Christopher; Nieuwkerk, Pythia; Mourits, Maarten P.

    2017-01-01

    To assess the change and interrelationship of the field of binocular single vision (BSV) and the quality of life (QoL), tested with two different tools, after one or two strabismus surgeries in patients with Graves' orbitopathy (GO). Prospectively, consecutive patients with GO who were scheduled for

  14. Pilot Greenhouse

    CERN Multimedia

    1983-01-01

    This pilot greenhouse was built in collaboration with the "Association des Maraichers" of Geneva in the frame of the study for making use of the heat rejected as warm water by CERN accelerators and experiments. Among other improvements, more automated and precise regulation systems for heating and ventilation were developed. See also 8305598X.

  15. Consequential late effects after radiotherapy for prostate cancer - a prospective longitudinal quality of life study

    Directory of Open Access Journals (Sweden)

    Schaar Sandra

    2010-04-01

    Full Text Available Abstract Background To answer the question if and to which extent acute symptoms at the end and/or several weeks after radiotherapy can predict adverse urinary and gastrointestinal long-term quality of life (QoL. Methods A group of 298 patients has been surveyed prospectively before (time A, at the last day (B, two months after (C and >one year after (D radiotherapy using a validated questionnaire (Expanded Prostate Cancer Index Composite. A subgroup of 10% with the greatest urinary/bowel bother score decrease at time D was defined as patients with adverse long-term QoL. Results Subgroup and correlation analyses could demonstrate a strong dependence of urinary/bowel QoL after radiotherapy on urinary/bowel QoL before radiotherapy. In contrast to absolute scores, QoL score changes (relative to baseline scores did not correlate with pretreatment scores. Long-term changes could be well predicted by acute changes. Patients reporting great/moderate bother with urinary/bowel problems at time C reported to have great/moderate bother at time D in ≥ 50%, respectively. In a multivariate analysis of factors for adverse long-term urinary and bowel QoL, score changes at time C were found to be independent predictors, respectively. Additionally, QoL changes at time B were independently predictive for adverse long-term bowel QoL. Conclusions Consequential late effects play a major role after radiotherapy for prostate cancer. Patients with greater and particularly longer non-healing acute toxicity are candidates for closer follow-up and possible prophylactic actions to reduce a high probability of long-term problems.

  16. Prospective longitudinal comparative study of health-related quality of life in patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer

    International Nuclear Information System (INIS)

    Kobuke, Makoto; Saika, Takashi; Nakanishi, Yoshiko

    2009-01-01

    To determine health-related quality of life (HRQOL) after radical retropubic prostatectomy (RRP) or permanent prostate brachytherapy (BT), third party-conducted QOL surveys were prospectively compared. Between 2004 and 2005, 37 patients underwent RRP and 36 were treated with BT. A QOL survey consisting of the Medical Outcomes Study 36-Item Short Form (SF-36), the University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) and the International Prostate Symptoms Score (IPSS) was completed prospectively by a research coordinator at baseline, and at 1, 3, 6 and 12 months after treatment. The RRP patients scored well in general QOL except at 1 month after surgery, with their mental health better than at baseline by 6 months after surgery. Disease-specific QOL in RRP patients received a low score at 1 month for both urinary and sexual function, though urinary function rapidly recovered to baseline levels. BT patient QOL was not affected by the therapy except in the IPSS score. However, general and mental health scores in BT patients were inferior to those in RRP patients. This prospective study revealed differences in QOL after RRP and BT. These results will be helpful in making treatment decisions. (author)

  17. Determinants of quality of life (QoL) and quality of university life (QuL) in Malaysian public university students

    Science.gov (United States)

    Haron, Halilah; Osman, Balkish Mohd; Maidinsah, Hamidah; Sari, Maznita Maksari @ Md; Zaki, Nurul Qusna Mohd

    2015-02-01

    Quality of life (QoL) refers to the degree of satisfaction, or the sense of well being, people experience in organizations including universities. The quality of life students experience in a university increases when they believe their needs are aligned with the goals of the university because they perceive that the university is responsive to their needs. Quality of University Life (QuL) refers to the students' ability to stabilize their life regarding social activities, academic performance, health and spiritual. A study was undertaken to investigate the accountability of Universiti Teknologi MARA (UiTM), Malaysia, in terms of teaching and learning. The objective of this paper is to identify and evaluate the determinants of QoL and QuL measurement models. Data from 788 students who responded to a set of questionnaire were collected from nine faculties. Factor analysis performed on the data resulted in six determinants for QuL; friendly, skills, satisfaction, interest, learning and feeling. Only two determinants, environment and quality represented QoL. Results indicated that the measures were highly reliable (in terms of internal consistency) based on Cronbach Alpha values ranging from 0.705 to 0.905 for QuL and 0.826 to 0.888 for QoL. Construct validity was supported by Average Variance Extraction values of more than 0.5 for QuL (0.481 - 0.724) and QoL. (0.503 and 0.519). The construct reliability (CR) values ranging between 0.623 to 0.882 for QuL and 0.731 to 0.815 for QoL suggested good reliability construct.

  18. Quality of Life in Children and Adolescents With Learning Problems: Development and Validation of the LD/QOL15 Scale.

    Science.gov (United States)

    Waber, Deborah P; Boiselle, Ellen C; Forbes, Peter W; Girard, Jonathan M; Sideridis, Georgios D

    2018-05-01

    Learning problems (LP) can have wider implications than the academic deficits per se. The goal of the present series of studies was to develop a reliable and valid quality-of-life measure targeted to children and adolescents with LP. In Study 1, using a 35-item questionnaire, we surveyed 151 parents/guardians of children referred for assessment of learning disorders. Exploratory factor analysis identified a three-factor model: Academic Performance, School Understanding, and Child/Family Psychological. These factors were validated against standardized measures of academic achievement and psychosocial functioning. The questionnaire was then reduced to 15 items-the LD/QOL15 -and administered to a community sample of 325 parents/guardians of children in Grades 1 to 8 (Study 2). The three-factor model was verified with confirmatory factor analysis. Comparison of general education ( n = 232) and LP ( n = 93) groups within the community sample documented substantial group differences ( p measure that is valid to assess quality of life and, potentially, outcomes in children and adolescents with LP.

  19. 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

  20. Change in quality of life and immune markers after a stay at a raw vegan institute: a pilot study.

    Science.gov (United States)

    Link, Lilli B; Hussaini, Najeeb S; Jacobson, Judith S

    2008-06-01

    The purpose of this study was to explore changes in quality of life (QOL), anxiety, stress, and immune markers after a stay at a raw vegan institute. Prospective observational study. English-speaking attendees at Hippocrates Health Institute (Florida, US), a raw vegan institute, were recruited on arrival and typically stayed 1-3 weeks. Participants completed questionnaires assessing overall QOL (SF-36), dietary QOL (QOL related to dietary change), perceived stress (Perceived Stress Scale), anxiety, and depression (Hospital Anxiety and Depression Scale) upon arrival and 12 weeks later. C-reactive protein (CRP), lymphocytes, T cells, CD4 cells, CD8 cells, B cells, and NK cells were measured at baseline and 12 weeks in participants living in North America. Of 107 attendees eligible for the questionnaire study and 82 for the blood marker substudy, 51 and 38 participants, respectively, provided complete follow-up data. Overall QOL improved 11.5% (p=0.001), driven mostly by the mental component. Anxiety decreased 18.6% (p=0.009) and perceived stress decreased 16.4% (pvegan institute was associated with improved mental and emotional QOL. Studies are needed to determine the feasibility of conducting a clinical trial of the raw vegan diet among healthy people, and subsequently among patients with specific diseases.

  1. Change in quality of life and immune markers after a stay at a raw vegan institute: a pilot study

    Science.gov (United States)

    Link, Lilli B.; Hussaini, Najeeb S.; Jacobson, Judith S.

    2008-01-01

    Objective The purpose of this study was to explore changes in quality of life (QOL), anxiety, stress, and immune markers after a stay at a raw vegan institute. Design Prospective observational study. Setting English-speaking attendees at Hippocrates Health Institute (Florida, US), a raw vegan institute, were recruited on arrival and typically stayed 1–3 weeks. Main outcome measures Participants completed questionnaires assessing overall QOL (SF-36), dietary QOL (QOL Related to Dietary Change), perceived stress (Perceived Stress Scale), anxiety, and depression (Hospital Anxiety and Depression Scale) upon arrival and 12 weeks later. C-reactive protein (CRP), lymphocytes, T cells, CD4 cells, CD8 cells, B cells, and NK cells were measured at baseline and 12 weeks in participants living in North America. Results Of 107 attendees eligible for the questionnaire study and 82 for the blood marker substudy, 51 and 38 participants, respectively, provided complete follow-up data. Overall QOL improved 11.5% (p=0.001), driven mostly by the mental component. Anxiety decreased 18.6% (p=0.009) and perceived stress decreased 16.4% (praw vegan institute was associated with improved mental and emotional QOL. Studies are needed to determine the feasibility of conducting a clinical trial of the raw vegan diet among healthy people, and subsequently among patients with specific diseases. PMID:18534324

  2. Correlation of physical aptitude; functional capacity, corporal balance and quality of life (QoL) among elderly women submitted to a post-menopausal physical activities program.

    Science.gov (United States)

    de Souza Santos, César Augusto; Dantas, Estélio Enrique Martin; Moreira, Maria Helena Rodrigues

    2011-01-01

    The objective of this study was to evaluate the effect of physical activity from the "Menopause in Form" program on physical aptitude, functional capacity, corporal balance and QoL among elderly women. In addition, correlations among these variables were examined. The present work was a longitudinal study that was quasi-experimental and correlational. A total of 323 elderly women (age: 69.0±5.53 years) participated in this study. Subjects were non-institutionalized, post-menopausal individuals residing at the Elderly Care Center in Belém Municipality (Pará, Brazil) and practiced one activity (i.e., dancing or walking) over a 10-month period. The assessment protocols used were the following: the Fullerton functional fitness test battery (physical aptitude); the activities of daily living (ADL) indices (functional capacity); the Tinetti-scale (corporal balance); and the WHOQOL-OLD questionnaire (QoL). The adopted significance level was p<0.05. Results from the Wilcoxon test demonstrated significant differences for the post-test assessment of functional capacity (Δ%=5.63%; p=0.0001) and general QoL (Δ%=9.19%; p=0.001). These results suggest that the physical activities employed during the "Menopause in Form" program resulted in significant improvements in the functional capacity and QoL of post-menopausal elderly women. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  3. Caring for a Child with Autism Spectrum Disorder and Parents' Quality of Life: Application of the CarerQol

    Science.gov (United States)

    Hoefman, Renske; Payakachat, Nalin; van Exel, Job; Kuhlthau, Karen; Kovacs, Erica; Pyne, Jeffrey; Tilford, J. Mick

    2014-01-01

    This study describes the impact of caregiving on parents of children with autism spectrum disorders (ASDs). Secondly, we investigate construct validation of the care-related quality of life instrument (CarerQol) measuring impact of caregiving. Primary caregivers of children with ASDs were included. Many parents experienced considerable problems…

  4. Quality of Life (QoL) Survey in Hong Kong: Understanding the Importance of Housing Environment and Needs of Residents from Different Housing Sectors.

    Science.gov (United States)

    Gou, Zhonghua; Xie, Xiaohuan; Lu, Yi; Khoshbakht, Maryam

    2018-01-27

    This study presents a Quality of Life (QoL) survey to understand the influence of the housing environment and needs of residents from different housing sectors. The research focuses on Hong Kong where living conditions have become the main affect for people's QoL. Through a household survey using a standard instrument "Word Health Organisation (WHO) Quality of Life-BREF", the article found that among the four WHO QoL domains (Physical Health, Psychological Health, Social Relations And Environment), Environment, particularly its constitute aspect housing environment was the most influential factor for overall quality of life for the public rental housing sector where low-income people live. This research also found that different groups of people have differing needs of their housing environments: the low-income group needs better location and privacy while the medium and high-income groups need better architectural quality. Based on differentiating their needs and wants, this research argues for prioritizing the low-income group's needs for effectively improving their QoL.

  5. Measuring care-related quality of life of caregivers for use in economic evaluations: CarerQol tariffs for Australia, Germany, Sweden, the UK and the US.

    NARCIS (Netherlands)

    Hoefman, R.J.; Exel, N.J.A. van; Brouwer, W.B.F.

    2017-01-01

    Background: Informal care is often not included in economic evaluations in healthcare, while the impact of caregiving can be relevant for cost-effectiveness recommendations from a societal perspective. The impact of informal care can be measured and valued with the CarerQol instrument, which

  6. Quality-of-Life (QOL during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

    Directory of Open Access Journals (Sweden)

    Sidra Anwar

    2017-06-01

    Full Text Available Background: Serious adverse events (SAEs and subject replacements occur frequently in phase 1 oncology clinical trials. Whether baseline quality-of-life (QOL or social support can predict risk for SAEs or subject replacement among these patients is not known. Methods: Between 2011–2013, 92 patients undergoing screening for enrollment into one of 22 phase 1 solid tumor clinical trials at Roswell Park Cancer Institute were included in this study. QOL Questionnaires (EORTC QLQ-C30 and FACT-G, Medical Outcomes Study Social Support Survey (MOSSSS, Charlson comorbidity scores (CCS and Royal Marsden scores (RMS were obtained at baseline. Frequency of dose limiting toxicities (DLTs, subject replacement and SAEs that occurred within the first 4 cycles of treatment were recorded. Fisher’s exact test and Mann-Whitney-Wilcoxon test were used to study the association between categorical and continuous variables, respectively. A linear transformation was used to standardize QOL scores. p-value ≤ 0.05 was considered statistically significant. Results: Baseline QOL, MOSSSS, CCS and RMS were not associated with subject replacement nor DLTs. Baseline EORTC QLQ-C30 scores were significantly lower among patients who encountered SAEs within the first 4 cycles (p = 0.04. Conclusions: Lower (worse EORTC QLQ-C30 score at baseline is associated with SAE occurrence during phase 1 oncology trials.

  7. Summary scores captured changes in subjects' QoL as measured by the multiple scales of the EORTC QLQ-C30.

    Science.gov (United States)

    Phillips, Rachel; Gandhi, Mihir; Cheung, Yin Bun; Findlay, Michael P; Win, Khin Maung; Hai, Hoang Hoa; Yang, Jin Mo; Lobo, Rolley Rey; Soo, Khee Chee; Chow, Pierce K H

    2015-08-01

    To examine the performance of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/quality of life (QoL) scale and two summary scores to detect changes in the QoL profile over time, according to changes in the individual scales. Data came from 167 clinical trial patients with unresectable (advanced) hepatocellular carcinoma. The global health status/QoL scale of the questionnaire contained two items: overall health and overall QoL. Nordin and Hinz proposed summary scores for the questionnaire. A mixed-effect model was fitted to estimate trends in scores over time. Predominantly the individual scale scores declined over time; however, the global health status/QoL score was stable [rate of change = -0.3 per month; 95% confidence interval (CI): -1.2, 0.6]. Nordin's summary score, which gave equal weight to the 15 questionnaire scales, and Hinz's summary score, which gave equal weight to the 30 questionnaire items, showed a statistically significant decline over time, 3.4 (95% CI: -4.5, -2.4) and 4.2 (95% CI: -5.3, -3.0) points per month, respectively. In contrast to the global health status/QoL scale, the summary scores proposed by Nordin and Hinz detected changes in subjects' QoL profile described by the EORTC QLQ-C30 individual scales. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. Child- and parent-reported quality of life trajectories in children with epilepsy: A prospective cohort study.

    Science.gov (United States)

    Ferro, Mark A; Avery, Lisa; Fayed, Nora; Streiner, David L; Cunningham, Charles E; Boyle, Michael H; Lach, Lucyna; Glidden, Gina; Rosenbaum, Peter L; Ronen, Gabriel M

    2017-07-01

    To describe the developmental trajectories of quality of life (QoL) in a large cohort of children with epilepsy, and to assess the relative contribution of clinical, psychosocial, and sociodemographic variables on QoL trajectories. Five assessments during a 28-month prospective cohort study were used to model trajectories of QoL. Participants were recruited with their parents from six Canadian tertiary centers. A convenience sample of 506 children aged 8-14 years with epilepsy and without intellectual disability or autism spectrum disorder were enrolled. A total of 894 children were eligible and 330 refused participation. Participating children were, on average, 11.4 years of age, and 49% were female. Nearly one third (32%) had partial seizures. At baseline, 479 and 503 child- and parent-reported questionnaires were completed. In total, 354 children (74%) and 366 parents (73%) completed the 28-month follow-up. QoL was measured using the child- and parent-reported version of the Childhood Epilepsy QoL scale (CHEQOL-25). Child-reported QoL was fitted best by a six-class model and parent-reported QoL by a five-class model. In both models, trajectories remained either stable or improved over 28 months. Of these children, 62% rated their QoL as high or moderately high, defined as at least one standard deviation above the average CHEQOL-25 score. Greater family, classmate, and peer social support, fewer symptoms of child and parent depression, and higher receptive vocabulary were identified as the most robust predictors of better QoL (all p < 0.001). Most children with epilepsy and their parents reported relatively good QoL in this first joint self- and proxy-reported trajectory study. Findings confirm the heterogeneous QoL outcomes for children with epilepsy and the primary importance of psychosocial factors rather than seizure and AED-specific factors in influencing QoL. These predictors that are potentially amenable to change should now be the focus of specific

  9. Measuring depression after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Depression item bank and linkage with PHQ-9.

    Science.gov (United States)

    Tulsky, David S; Kisala, Pamela A; Kalpakjian, Claire Z; Bombardier, Charles H; Pohlig, Ryan T; Heinemann, Allen W; Carle, Adam; Choi, Seung W

    2015-05-01

    To develop a calibrated spinal cord injury-quality of life (SCI-QOL) item bank, computer adaptive test (CAT), and short form to assess depressive symptoms experienced by individuals with SCI, transform scores to the Patient Reported Outcomes Measurement Information System (PROMIS) metric, and create a crosswalk to the Patient Health Questionnaire (PHQ)-9. We used grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, item response theory (IRT) analyses, and statistical linking techniques to transform scores to a PROMIS metric and to provide a crosswalk with the PHQ-9. Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Adults with traumatic SCI. Spinal Cord Injury--Quality of Life (SCI-QOL) Depression Item Bank Individuals with SCI were involved in all phases of SCI-QOL development. A sample of 716 individuals with traumatic SCI completed 35 items assessing depression, 18 of which were PROMIS items. After removing 7 non-PROMIS items, factor analyses confirmed a unidimensional pool of items. We used a graded response IRT model to estimate slopes and thresholds for the 28 retained items. The SCI-QOL Depression measure correlated 0.76 with the PHQ-9. The SCI-QOL Depression item bank provides a reliable and sensitive measure of depressive symptoms with scores reported in terms of general population norms. We provide a crosswalk to the PHQ-9 to facilitate comparisons between measures. The item bank may be administered as a CAT or as a short form and is suitable for research and clinical applications.

  10. Measuring pain phenomena after spinal cord injury: Development and psychometric properties of the SCI-QOL Pain Interference and Pain Behavior assessment tools.

    Science.gov (United States)

    Cohen, Matthew L; Kisala, Pamela A; Dyson-Hudson, Trevor A; Tulsky, David S

    2018-05-01

    To develop modern patient-reported outcome measures that assess pain interference and pain behavior after spinal cord injury (SCI). Grounded-theory based qualitative item development; large-scale item calibration field-testing; confirmatory factor analyses; graded response model item response theory analyses; statistical linking techniques to transform scores to the Patient Reported Outcome Measurement Information System (PROMIS) metric. Five SCI Model Systems centers and one Department of Veterans Affairs medical center in the United States. Adults with traumatic SCI. N/A. Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference item bank, SCI-QOL Pain Interference short form, and SCI-QOL Pain Behavior scale. Seven hundred fifty-seven individuals with traumatic SCI completed 58 items addressing various aspects of pain. Items were then separated by whether they assessed pain interference or pain behavior, and poorly functioning items were removed. Confirmatory factor analyses confirmed that each set of items was unidimensional, and item response theory analyses were used to estimate slopes and thresholds for the items. Ultimately, 7 items (4 from PROMIS) comprised the Pain Behavior scale and 25 items (18 from PROMIS) comprised the Pain Interference item bank. Ten of these 25 items were selected to form the Pain Interference short form. The SCI-QOL Pain Interference item bank and the SCI-QOL Pain Behavior scale demonstrated robust psychometric properties. The Pain Interference item bank is available as a computer adaptive test or short form for research and clinical applications, and scores are transformed to the PROMIS metric.

  11. High-dose radiotherapy or concurrent chemo-radiation in lung cancer patients only induces a temporary, reversible decline in QoL

    International Nuclear Information System (INIS)

    Pijls-Johannesma, Madelon; Houben, Ruud; Boersma, Liesbeth; Grutters, Janneke; Seghers, Katarina; Lambin, Philippe; Wanders, Rinus; De Ruysscher, Dirk

    2009-01-01

    Background and purpose: Aggressive radiotherapy or concurrent chemo-radiation therapy for lung cancer leads to a high incidence of severe, mostly esophageal, toxicity. The purpose of this study was to investigate the evolution of quality of life (QoL) in patients with lung cancer, selected for curative radiotherapy (RT) or chemo-RT. Methods: Seventy-five lung cancer patients completed a longitudinal the EORTC QLQ-C30 and LC13. Linear mixed regression models were fitted to investigate the impact of different factors on overall QoL. Results: Overall QoL decreased shortly after the end of RT (4 points, p = 0.19), but increased back to baseline within 3 months. Mean scores of role functioning (p = 0.018), cognitive functioning (p = 0.002), dyspnoea (EORTC QLQ-LC13; p = 0.043), dysphagia (p = 0.005) and hoarseness (p = 0.029), showed a significant worsening over time. Emotional functioning (p = 0.033) improved significantly over time. Severe esophagitis (≥grade 2) was reported in only 12% of the patients. Next to maximal esophageal toxicity ≥grade 2 (p = .0.010), also tumor stage IIIA (p < 0.001), tumor stage IIIB (p = 0.003), gender (p = 0.042) and fatigue (p < 0.001) appeared to be significant predictors of QoL. Conclusion: High-dose radiotherapy or concurrent chemo-radiation in the treatment of lung cancer seems to be a well-tolerated treatment option with preservation of QoL.

  12. Quality of life improvement in patients with Hashimoto thyroiditis and other goiters after surgery: A prospective cohort study.

    Science.gov (United States)

    Zivaljevic, Vladan R; Bukvic Bacotic, Branka R; Sipetic, Sandra B; Stanisavljevic, Dejana M; Maksimovic, Jadranka M; Diklic, Aleksandar D; Paunovic, Ivan R

    2015-09-01

    Hashimoto thyroiditis (HT) and other benign goiters (BG) might influence patients' quality of life (QoL). The objective of this study was to analyze influence of surgery on these patients' QoL. A prospective cohort study was conducted. The ThyPRO questionnaire was used in the QoL assessment. The HT patients experienced significantly worse hypothyroid symptoms and sex life than the BG patients. The improvement in QoL in the BG patients was significant after surgery in all ThyPRO domains. In the HT patients, the improvement was significant in all but two domains, eye symptoms and cognitive impairment. The best improvement in both groups was in overall QoL. None of the patients developed permanent consequences. The QoL of HT and BG patients is impaired and improves significantly after surgical treatment. Thyroidectomy should be considered as a treatment option in the HT patients more often as in the BG patients. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  13. Depression, anxiety and quality of life in stroke survivors and their family caregivers: A pilot study using an actor/partner interdependence model

    Science.gov (United States)

    Wan-Fei, Khaw; Hassan, Syed Tajuddin Syed; Sann, Lye Munn; Ismail, Siti Irma Fadhilah; Raman, Rosna Abdul; Ibrahim, Faisal

    2017-01-01

    Background Depression and anxiety are common in stroke survivors as well as their family caregivers. However, it is not known whether each person’s emotional distress contributes to their partner’s quality of life (QOL). Objective This study aimed to examine the effect of depression and anxiety on QOL in stroke survivor-caregiver dyads using dyadic analysis technique - the Actor-Partner Interdependence Model (APIM). Methods This was a cross-sectional pilot study with a total of 30 participating dyads (30 stroke survivors and 30 family caregivers) from Hospital Rehabilitasi Cheras, Kuala Lumpur, Malaysia. This pilot study was conducted over a period of 3 months, between December 2014 and February 2015. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS). QOL was assessed using the Short Form-12 Health Survey (SF-12). All analyses were carried out using IBM SPSS version 22. Dyadic data were analysed using multilevel modelling (MLM). Results Depression was uniquely associated with an individual’s own QOL. Survivors and caregivers with higher depression had poorer physical component summary (PCS) scores and mental component summary (MCS) scores. Stroke survivor’s depression exerted a significant actor effect on their PCS (b=−1.42, p=0.001) and MCS (b=−1.52, pdepression exerted a significant actor effect on their PCS (b=−2.53, pdepression exerted a significant partner effect on PCS in stroke survivors (b=−1.19, p=0.003). Caregivers’ depression was also related to their stroke survivors’ poorer QOL, particularly PCS. Conclusion The findings suggest that depression affects the QOL of both stroke survivors and caregivers, not only emotionally but also physically. This dyadic study also has evidence pointing to depression in caregivers and its association with stroke survivors’ physical QOL. PMID:28979724

  14. Conservative management of vestibular schwannoma--a prospective cohort study: treatment, symptoms, and quality of life.

    Science.gov (United States)

    Breivik, Cathrine Nansdal; Varughese, Jobin K; Wentzel-Larsen, Tore; Vassbotn, Flemming; Lund-Johansen, Morten

    2012-05-01

    One hundred ninety-three patients with sporadic unilateral vestibular schwannoma given conservative management were enrolled in a prospective study. To evaluate the efficacy of conservative management and to determine the effect of an initial conservative management on the quality of life (QOL) and severity of audio vestibular symptoms. The patients underwent magnetic resonance imaging scans, clinical examination, and QOL assessment by 2 validated questionnaires, the Short Form-36 (SF-36) and Glasgow Benefit Inventory (GBI). Using regression analysis of clustered data, we analyzed possible associations between tumor growth and symptoms and tested whether our earlier finding that vertigo is associated with reduced QOL could be verified. The median follow-up time was 43 months (range, 9-115 months; SD, 21.48 months). Results are based on 703 clinical controls and 642 (SF-36) and 638 (GBI) questionnaires. Seven patients were lost to follow-up. Approximately 40% of patients were in need of treatment during follow-up. We found a statistically significant association between tinnitus and vertigo and tumor growth. Vertigo was found to significantly reduce QOL. There was a significant drop in the Social Function subscales of both SF-36 and GBI, possibly attributable to progressive hearing loss. Otherwise, there was no overall trend toward any change in QOL during the observation period. In addition, QOL seemed to be little affected by treatment. There was a small but statistically significant improvement in vestibular complaints and no change in the occurrence of tinnitus. Except for hearing loss caused by surgery, treatment did not affect symptoms or QOL significantly. Growth was associated with the occurrence of tinnitus and balance problems.

  15. Depression, quality of life (QoL) and will to live of community-dwelling postmenopausal women in three Asian countries: Korea, China and Japan.

    Science.gov (United States)

    Ina, Koichiro; Hayashi, Toshio; Nomura, Hideki; Ishitsuka, Asako; Hirai, Hisako; Iguchi, Akihisa

    2011-01-01

    The purpose of this study was to examine the prevalence of screening-detected depression and the association of depression with QoL in community-dwelling postmenopausal women living in three Asian countries. We examined self-reported questionnaires and conducted the study. A total of 698 community-dwelling postmenopausal women living in three Asian countries participated in this study. The mean age was 59.4±6.6 years (±SD) Depressive symptoms were assessed using a 15-item geriatric depression scale (GDS-15). Using the cut-off of 5/6 for the GDS-15, the percentages of subjects with depression were 39.0% of the Korean subjects, 29.2% of the Chinese subjects, and 33.9% of the Japanese subjects. For the assessment of QoL, we used the EQ-5D of the EuroQoL Group. The following five dimensions were assessed: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The proportions of subjects reporting problems for each dimension were examined. Subjects with depression had significantly lower levels of some dimensions of QoL than those without depression in all three countries. In all three countries, 29.2-39.0% of community-dwelling postmenopausal women had screening-detected depression, which was significantly associated with a lower level of some dimensions of QoL. These results suggest that clinicians should pay more attention to depression in community-dwelling postmenopausal women. Copyright © 2010. Published by Elsevier Ireland Ltd.

  16. [QOL questionnaire for pediatric patients with bronchial asthma and their parents or caregivers. Preparation and evaluation of the short form version 2008 (Gifu)].

    Science.gov (United States)

    Kondo, Naomi; Hirayama, Koichiro; Matsui, Eiko; Teramoto, Takahide; Kaneko, Hideo; Fukao, Toshiyuki; Orii, Kenji; Kawamoto, Minako; Funato, Michinori; Ohnishi, Hidenori; Kawamoto, Norio; Morita, Hideyuki; Kimura, Takeshi; Nada, Masatoshi; Tokumi, Tetsuji; Hori, Tomohiro; Watanabe, Rinko

    2008-08-01

    The QOL questionnaire version 2001 for pediatric patients with bronchial asthma and their parents or caregivers includes 15 questions for patients under the age of 4 years and 20 questions for patients over the age of 4 years. We have already reported that the QOL questionnaire version 2001 reflects reliability (including reproducibility), factorial validity, and changes in paroxysmal attacks of asthma. In this study, we revised the questionnaire for use in routine medical practice. In this study, based on the data of a previous report, the number of questions was reduced further and it was revised to the questionnaire the short form by integrated data. The revised version 2008 (Gifu) consisted of emotional burden, asthma attack, instability of symptoms and proper acceptance of asthma as a common factor, moreover 4 or more years old added load of exercise factor which consisted of two questions in each factor. This QOL short form questionnaire version 2008 (Gifu) is a disease specific questionnaire in comparison with health control, bronchial asthma and non-asthmatic patients, such as atopic dermatitis and allergic rhinitis. Although Cronbach's alpha fell with reduction of the number of questions, we conclude that it was acceptable in the clinical practice.

  17. Development and validation of the positive affect and well-being scale for the neurology quality of life (Neuro-QOL) measurement system.

    Science.gov (United States)

    Salsman, John M; Victorson, David; Choi, Seung W; Peterman, Amy H; Heinemann, Allen W; Nowinski, Cindy; Cella, David

    2013-11-01

    To develop and validate an item-response theory-based patient-reported outcomes assessment tool of positive affect and well-being (PAW). This is part of a larger NINDS-funded study to develop a health-related quality of life measurement system across major neurological disorders, called Neuro-QOL. Informed by a literature review and qualitative input from clinicians and patients, item pools were created to assess PAW concepts. Items were administered to a general population sample (N = 513) and a group of individuals with a variety of neurologic conditions (N = 581) for calibration and validation purposes, respectively. A 23-item calibrated bank and a 9-item short form of PAW was developed, reflecting components of positive affect, life satisfaction, or an overall sense of purpose and meaning. The Neuro-QOL PAW measure demonstrated sufficient unidimensionality and displayed good internal consistency, test-retest reliability, model fit, convergent and discriminant validity, and responsiveness. The Neuro-QOL PAW measure was designed to aid clinicians and researchers to better evaluate and understand the potential role of positive health processes for individuals with chronic neurological conditions. Further psychometric testing within and between neurological conditions, as well as testing in non-neurologic chronic diseases, will help evaluate the generalizability of this new tool.

  18. The Impact of Hyposalivation on Quality of Life (QoL and Oral Health in the Aging Population of Al Madinah Al Munawarrah

    Directory of Open Access Journals (Sweden)

    Mohammad S. Ahmad

    2017-04-01

    Full Text Available Hyposalivation (HS affects aging individuals by causing pain and discomfort in the oral cavity. The aim here was to determine the impact of hyposalivation and the saliva pH on the quality of life and caries status of geriatrics population. A total of 138 male outpatients attending the Taibah University College of Dentistry (TUCoD dental clinic were included in the study. The saliva flow, pH, Quality of Life (QoL, and caries status were recorded. The QoL was measured using the Arabic version of the Oral Health Impact Profile-14 (OHIP-14, and the caries status was recorded using the Decayed, Missed, Filled Teeth (DMFT index. The mean age was 67.5 years and 64% were classified as having hyposalivation. The older respondents tended to have a lower saliva flow and pH compared to their younger counterparts. There was a significant inverse association (p = 0.02 between the caries status and mean saliva flow rate. There was also a significant (p < 0.001 positive correlation between caries and the OHIP-14 scores (Spearman’s ρ = 0.293. The prevalence of hyposalivation was relatively high and there was an inverse relationship between the age, the saliva flow, and pH. Those with more caries reported significantly poor QoL.

  19. Radiochemotherapy of locally advanced anal canal carcinoma: Prospective assessment of early impact on the quality of life (randomized trial ACCORD 03)

    International Nuclear Information System (INIS)

    Tournier-Rangeard, Laetitia; Mercier, Mariette; Peiffert, Didier; Gerard, Jean-Pierre; Romestaing, Pascale; Lemanski, Claire; Mirabel, Xavier; Pommier, Pascal; Denis, Bernard

    2008-01-01

    Background and purpose: The aim of this study was to prospectively assess the quality of life (QOL) of patients treated by concomitant chemo radiation for locally advanced anal canal carcinoma. Materials and methods: We report on a subgroup of 119 patients enrolled in a 306-patient therapeutic intensification prospective trial (ACCORD 03). This trial evaluated the impact on colostomy-free survival of induction chemotherapy and/or high dose radiotherapy (factorial design 2 * 2 treatment arms). QOL was assessed both before and 2 months after treatment using the EORTC QLQ-C30 questionnaire as well as a questionnaire relating to anal sphincter conservative treatment (AS-CT). Results: Compared to pre-treatment scores, patients reported significant improvement in their emotional function (+8.4 points p = 0.002), global health status (+5.9 points p = 0.0007), as well as a decrease in insomnia (-13.8 points p < 0.0001), constipation (-12.0 points p < 0.0001), appetite loss (-10.3 points p < 0.0001) and pain (-9.6 points p = 0.0002). The AS-CT degree of satisfaction with intestinal functions score was increased (+11.2 points p < 0.0001). Conclusion: This is the first prospective study comparing QOL of patients with advanced anal canal carcinoma, before and 2 months after conservative treatment. Two months after treatment, QOL was improved. Induction chemotherapy and/or high dose radiotherapy did not provide a negative impact on QOL

  20. Prospective memory failures in aviation: effects of cue salience, workload, and individual differences.

    Science.gov (United States)

    Van Benthem, Kathleen D; Herdman, Chris M; Tolton, Rani G; LeFevre, Jo-Anne

    2015-04-01

    Prospective memory allows people to complete intended tasks in the future. Prospective memory failures, such as pilots forgetting to inform pattern traffic of their locations, can have fatal consequences. The present research examined the impact of system factors (memory cue salience and workload) and individual differences (pilot age, cognitive health, and expertise) on prospective memory for communication tasks in the cockpit. Pilots (N = 101) flew a Cessna 172 simulator at a non-towered aerodrome while maintaining communication with traffic and attending to flight parameters. Memory cue salience (the prominence of cues that signal an intended action) and workload were manipulated. Prospective memory was measured as radio call completion rates. Pilots' prospective memory was adversely affected by low-salience cues and high workload. An interaction of cue salience, pilots' age, and cognitive health reflected the effects of system and individual difference factors on prospective memory failures. For example, younger pilots with low levels of cognitive health completed 78% of the radio calls associated with low-salience memory cues, whereas older pilots with low cognitive health scores completed just 61% of similar radio calls. Our findings suggest that technologies designed to signal intended future tasks should target those tasks with inherently low-salience memory cues. In addition, increasing the salience of memory cues is most likely to benefit pilots with lower levels of cognitive health in high-workload conditions.

  1. 75 FR 56857 - Pilot, Flight Instructor, and Pilot School Certification

    Science.gov (United States)

    2010-09-17

    ...-2006-26661; Amendment No., 141-14] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School..., certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools...: Background On August 21, 2009, the FAA published the ``Pilot, Flight Instructor, and Pilot School...

  2. Self-esteem as an important factor in quality of life and depressive symptoms in anosmia: A pilot study.

    Science.gov (United States)

    Kollndorfer, K; Reichert, J L; Brückler, B; Hinterleitner, V; Schöpf, V

    2017-12-01

    Previous research has reported a negative impact of olfactory dysfunction on quality of life (QoL) and depressive symptoms. As self-esteem was identified as a contributing factor to depression, this study aimed to investigate QoL, depressive symptoms and self-esteem in patients with smell loss. Prospective controlled study. Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, in co-operation with the Department of Ear, Nose and Throat Diseases, Medical University of Vienna, Austria. Twenty-two anosmic patients (12 females, 10 males) and 25 healthy controls (15 females, 10 males) participated in this study. Olfactory performance was assessed using the Sniffin' Sticks battery. In addition, psychological questionnaires that covered the topics quality of life (WHOQOL-BREF), depressive symptoms (BDI-II) and self-esteem (MSWS) were conducted. The results of this study revealed a decrease in QoL and reduced body-related self-esteem in anosmic patients. Furthermore, QoL and self-esteem were correlated with depressive symptoms. As self-esteem, QoL and depressive symptoms in anosmia interact with each other, we suggest that self-esteem should be considered in the medical history, in order to provide a personalised intervention, adapted to the patient's needs. © 2017 The Authors. Clinical Otolaryngology Published by John Wiley & Sons Ltd.

  3. Cultural adaptation and validation of the Neuropathy - and Foot Ulcer - Specific Quality of Life instrument (NeuroQol for Brazilian Portuguese - Phase 1 Adaptación cultural y validación del Neuropathy - and Foot Ulcer - Specific Quality of Life (NeuroQol para el idioma portugués de Brasil - Fase 1 Adaptação cultural e validação do Neuropathy - and Foot Ulcer - Specific Quality of Life (NeuroQol para a língua portuguesa do Brasil - Fase 1

    Directory of Open Access Journals (Sweden)

    Antonia Tayana da Franca Xavier

    2011-12-01

    Full Text Available This methodological study aimed to adapt the Neuropathy - and Foot Ulcer - Specific Quality of Life instrument - NeuroQol to Brazilian Portuguese and to analyze its psychometric properties. Participants were 50 people with peripheral diabetic neuropathy and foot ulcers. The floor and ceiling effects, the convergent and discriminant validity and the reliability were analyzed. The Cronbach’s alpha coefficient was used to test the reliability and the Pearson’s correlation coefficient to estimate the convergent validity, the Student’s t test was used to evaluate the discriminant validity in the comparison of the NeuroQol scores between participants with and without ulcers. Floor and ceiling effects were found in some domains of the NeuroQol. The reliability was satisfactory. The correlations between the domains of the NeuroQol and the SF-36 were negative, significant and of moderate to strong magnitude. The findings show that the Brazilian version of the NeuroQol is reliable and valid and may be employed as a useful tool for improving nursing care for people with DM.Estudio metodológico que tuvo como objetivos adaptar el Neuropathy - and Foot Ulcer - Specific Quality of Life - NeuroQol para el idioma portugués de Brasil y analizar sus propiedades psicométricas. Participaron 50 personas con neuropatía diabética periférica y úlceras en los pies. Fueron analizados los efectos floor y ceiling, la validez convergente, la discriminante y la confiabilidad. Fue utilizado el coeficiente alfa de Cronbach para comprobar la confiabilidad y la correlación de Pearson para estimar la validez convergente; el test t-Student fue empleado para evaluar la validez discriminante en la comparación de los puntajes del NeuroQol entre los participantes con y sin úlceras. Se constataron efectos floor y ceiling en algunos dominios del NeuroQol. La confiabilidad fue satisfactoria. Las correlaciones entre los dominios del NeuroQol y SF-36 fueron negativas

  4. Frey's pancreaticojejunostomy in tropical pancreatitis: assessment of quality of life. A prospective study.

    Science.gov (United States)

    Pothula Rajendra, Vamsi Krishna; Sivanpillay Mahadevan, Sivaraj; Parvathareddy, Sivacharan Reddy; Nara, Bharat Kumar; Gorlagunta Ramachandra, Mallikarjuna; Tripuraneni Venkata, Aditya Chowdary; Bathalapalli, Jagan Mohan Reddy; Gudi, Vara Prasada Rao; Sampath, Thirunavukkarasu

    2014-12-01

    Tropical pancreatitis is a form of chronic pancreatitis originally described in the tropics. Prospective studies in Western countries have shown improved quality of life (QOL) following surgery in alcoholic chronic pancreatitis. In studies on Frey's pancreaticojejunostomy for tropical pancreatitis, improvement in pain was considered the endpoint, and there is a paucity of data in the literature with regard to QOL with tropical pancreatitis following surgery. Our objective was to prospectively analyze the outcome of Frey's pancreaticojejunostomy in tropical pancreatitis and health-related QOL following surgery by administering the Short Form 36-item health survey (SF-36). A total of 25 patients underwent Frey's pancreaticojejunostomy between 2010 and 2012 and were included in the study; data were collected prospectively. The visual analog scale (VAS) for pain and the SF-36 form were used to record health-related QOL preoperatively, and at 3 and 12 months post-surgery, comparing the same with the general population. Patients with tropical pancreatitis experience poor QOL (26.71 ± 15.95) compared with the general population (84.54 ± 12.42). Post-operative QOL scores (78.54 ± 15.84) were better than the pre-operative scores (26.71 ± 15.95) at 12-month post-surgery follow-up. The VAS score for pain improved at 12 months post-surgery (1.58 ± 1.41 vs. 8.21 ± 1.64). Two of the three patients (12.5 %) who had diabetes were free from anti-diabetes medication at 12 months post-surgery. Steatorrhea was seen in five patients (20.8 %) before surgery and increased to eight (33.3 %) at 12 months post-surgery. Mean body weight increased from 45.75 kg pre-operatively to 49.25 kg at 12 months post-operatively. Frey's pancreaticojejunostomy effectively reduces pain in tropical pancreatitis, with significant improvement in health-related QOL, which is comparable with the general population in most aspects.

  5. Pilot Boarding Areas

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Pilot boarding areas are locations at sea where pilots familiar with local waters board incoming vessels to navigate their passage to a destination port. Pilotage is...

  6. Effects of music and art education in early life and oral functions on the QOL of the Takarazuka Revue Company OG compared with general elderly females.

    Science.gov (United States)

    Masutani, Takiko; Yamamoto, Yasuji; Konishi, Junya; Maeda, Kiyoshi

    2010-03-01

    Today, Japan is becoming a super-aged society, with senior citizens already constituting over 21% of the population. In this situation, the question of how elderly people can extend their lives and enjoy independent lifestyles is becoming more important. The present study aims to clarify the relationship between the Quality of Life (QOL) of elderly females and their current oral functions and experiences of music and art education in early life. We carried out a survey study focusing on elderly females (Takarazuka Revue Company OG group and general female group) by carrying out a questionnaire survey and comparing cognitive function, oral examinations, cerebral atrophy in magnetic resonance imaging, and other characteristics. It was shown that the Takarazuka Revue Company OG group had greater hippocampal volumes and significantly higher cognitive functions than the general female group. In addition, in the general female group, there was a significant correlation between a decrease in the number of remaining teeth and a decrease in activities in daily living, but in the Takarazuka Revue Company OG group, no such correlation was observed. The results showed that those who have received art education as part of their careers over an extensive period since early life have higher levels of cognitive function, QOL, physical activity, social activity and life satisfaction compared with the general female group; showing that they sense a purpose in life and live with a positive attitude. In contrast, in the general female group, those who have continued to enjoy hobbies have higher levels of cognitive function, QOL, physical activity, social activity and life satisfaction than those who have not, thus showing that they live with a positive attitude.

  7. Predictors of quality of life and survival following Gamma Knife surgery for lung cancer brain metastases: a prospective study.

    Science.gov (United States)

    Bragstad, Sidsel; Flatebø, Marianne; Natvig, Gerd Karin; Eide, Geir Egil; Skeie, Geir Olve; Behbahani, Maziar; Pedersen, Paal-Henning; Enger, Per Øyvind; Skeie, Bente Sandvei

    2017-08-18

    OBJECTIVE Lung cancer (LC) patients who develop brain metastases (BMs) have a poor prognosis. Estimations of survival and risk of treatment-related deterioration in quality of life (QOL) are important when deciding on treatment. Although we know of several prognostic factors for LC patients with BMs, the role of QOL has not been established. Authors of this study set out to evaluate changes in QOL following Gamma Knife surgery (GKS) for BMs in LC patients and QOL as a prognostic factor for survival. METHODS Forty-four of 48 consecutive LC patients with BMs underwent GKS in the period from May 2010 to September 2011, and their QOL was prospectively assessed before and 1, 3, 6, 9, and 12 months after GKS by using the Functional Assessment of Cancer Therapy-Brain (FACT-BR) questionnaire. A mixed linear regression model was used to identify potential predictive factors for QOL and to assess the effect of GKS and the disease course on QOL at follow-up. RESULTS Mean QOL as measured by the brain cancer subscale (BRCS) of the FACT-BR remained stable from baseline (score 53.0) up to 12 months post-GKS (57.1; p = 0.624). The BRCS score improved for 32 patients (72.3%) with a total BM volume ≤ 5 cm 3 . Mean improvement in these patients was 0.45 points each month of follow-up, compared to a decline of 0.50 points each month despite GKS treatment in patients with BM volumes > 5 cm 3 (p = 0.04). Asymptomatic BMs (p = 0.01), a lower recursive partitioning analysis (RPA) classification (p = 0.04), and a higher Karnofsky Performance Scale (KPS) score (p Knife surgery is a safe and effective therapeutic modality that improves QOL for LC patients with a BM volume ≤ 5 cm 3 at treatment. Careful follow-up and salvage therapy on demand seem to prevent worsening of QOL due to relapse of BMs.

  8. Improving Symptom Control, QOL, and Quality of Care for Women with Breast Cancer: Developing a Research Program on Neurological Effects via Doctoral Education

    Science.gov (United States)

    2006-06-01

    orQOL "I CAN’T tell where my feet are" <is> Root Footwear Issues <is> Root Emotional Rx:: Mood effects <is> Root Sx Description <is...time, holding a pen and “scrawling” handwriting , “loss of fine motor skills”, “loss of strength”, “dropping things • LEISURE: turning book pages...interventions on pain in adults with cancer. Oncology Nursing Forum, 31(2), 313-319. Devine, E., & Westlake, S. (1995). The effects of psychoeducational care

  9. Prospective assessment of the quality of life before, during and after image guided intensity modulated radiotherapy for prostate cancer

    International Nuclear Information System (INIS)

    Sveistrup, Joen; Mortensen, Ole Steen; Bjørner, Jakob B; Engelholm, Svend Aage; Munck af Rosenschöld, Per; Petersen, Peter Meidahl

    2016-01-01

    Radiotherapy (RT) in combination with androgen deprivation therapy (ADT) for prostate cancer (PCa) carries a risk of gastrointestinal (GI) and genitourinary toxicity, which might affect the quality of life (QoL). The purpose of this study was to assess the QoL in patients with PCa before, during and after radiotherapy (RT) and to compare the QoL 1 year after RT to a normal population. The QoL was evaluated prospectively by the self-administered questionnaire SF-36 in 87 patients with PCa. The SF-36 was completed before RT (baseline), at start of RT, at end of RT and 1 year after RT. A mixed model analysis was used to determine the changes in QoL at each time point compared to baseline. The patients’ QoL 1 year after RT was compared to a normal population consisting of 462 reference subjects matched on age and education. One year after RT, patients reported significantly less pain and significantly fewer limitations due to their physical health compared to baseline. Compared to the normal population, patients reported significantly less pain 1 year after RT. However, patients also reported significantly less vitality, worse mental health as well as significantly more limitations due to physical and mental health 1 year after RT compared to the normal population. In this study, patients with PCa did not experience significant impairment in the QoL 1 year after RT compared to baseline. However, patients reported significantly worse mental health before, during and 1 year after RT compared to the normal population

  10. A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

    Science.gov (United States)

    Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

    2012-01-01

    Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

  11. The impact of complications on quality of life following colorectal surgery : A prospective cohort study to evaluate the Clavien-Dindo classification system

    NARCIS (Netherlands)

    Bosma, E.; Pullens, M.J.J.; de Vries, J.; Roukema, J.A.

    2016-01-01

    Aim This prospective cohort study was performed to evaluate the impact of complications on quality of life (QOL) in colorectal surgery. The Clavien–Dindo complication classification (CDCC) is promising, but has not been evaluated by relating the classification to patient-reported outcome measures.

  12. Impact of Pediatric Acute Otitis Media on Child and Parental Quality of Life and Associated Productivity Loss in Malaysia: A Prospective Observational Study.

    Science.gov (United States)

    Crawford, Bruce; Hashim, Siti Sabzah Mohd; Prepageran, Narayanan; See, Goh Bee; Meier, Genevieve; Wada, Keiko; Coon, Cheryl; Delgleize, Emmanuelle; DeRosa, Michael

    2017-03-01

    Acute otitis media (AOM) affects both child and parental quality of life (QoL). Data on QoL associated with AOM in Malaysia is sparse, and the burden of indirect costs have not been previously reported. To determine the effect of pediatric AOM on child and parental QoL in Malaysia and its economic impact (indirect costs). We utilized a set of QoL questionnaires (PAR-AOM-QOL, OM-6, and EQ-5D) combined with questions addressing work/productivity loss and financial costs associated with caring for a child during his or her illness in an observational, multicenter, prospective study. One hundred and ten AOM patients aged ≤5 years were included in the analysis. The majority of respondents were the patient's mother. Parental QoL was negatively affected for both emotional and daily disturbance scales, but the level of disturbance was low. Using OM-6, the greatest negative impact was on the child's QoL, followed by caregiver concerns, physical suffering, and emotional distress. Using EQ-5D, a moderately positive relationship between parents' emotional disturbance and daily disturbance, and a weak, negative correlation between parental emotional disturbance and parental health status was found. Parents with paid employment took an average of 21 h from work to care for their child, at an average cost of 321.8 Malaysian ringgit (US$97) in addition to their contribution to direct medical costs. Productivity losses whilst at work, uncompensated wage losses, and leisure time losses are also reported. This study found that AOM is associated with some negative impact on parental QoL and significant economic impact at both patient and societal levels. The findings provide useful data on healthcare resource utilization and disease burden of AOM in Malaysia.

  13. Proxy assessment of patients before and after radiotherapy for brain metastases. Results of a prospective study using the DEGRO brain module

    International Nuclear Information System (INIS)

    Steinmann, D.; Vordermark, D.; Geinitz, H.; Aschoff, R.; Bayerl, A.; Gerstein, J.; Hipp, M.; Schaefer, C.; Oorschot, B. van; Wypior, H.J.

    2013-01-01

    Purpose: Proxies of patients with poor performance status could give useful information about the patients' quality of life (QoL). We applied a newly developed questionnaire in a prospective QoL study of patients undergoing radiotherapy for brain metastases in order to make the first move to validate this instrument, and we compared the results with scores obtained using validated patient-completed instruments. Materials and methods: From January 2007 to June 2010, 166 patients with previously untreated brain metastases were recruited at 14 centers in Germany and Austria. The EORTC-QLQ-C15-PAL and the brain module BN20 were used to assess QoL in patients at the start of treatment and 3 months later. At the same time points, 141 of their proxies estimated the QoL with the new DEGRO brain module (DBM), a ten-item questionnaire rating the general condition as well as functions and impairment by symptoms in areas relevant to patients with brain metastases. Results: At 3 months, 85 of 141 patients (60%) with initial response by a proxy were alive. Sixty-seven of these patients (79% of 3-month survivors) and 65 proxies completed the second set of questionnaires. After 3 months, QoL significantly deteriorated in all items of proxy-assessed QoL except headache. Correlations between self-assessed and proxy-assessed QoL were high in single items such as nausea, headache, and fatigue. Conclusions: The high correlation between self-assessment and proxy ratings as well as a similar change over time for both approaches suggest that in patients with brain metastases, proxy assessment using the DBM questionnaire can be an alternative approach to obtaining QoL data when patients are unable to complete questionnaires themselves. Our self-constructed and first applied DBM is the only highly specific instrument for patients with brain metastases, but further tests are needed for its final validation. (orig.)

  14. 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.

  15. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

    Science.gov (United States)

    Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

    2017-09-01

    To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

  16. 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…

  17. Measuring psychological trauma after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Psychological Trauma item bank and short form.

    Science.gov (United States)

    Kisala, Pamela A; Victorson, David; Pace, Natalie; Heinemann, Allen W; Choi, Seung W; Tulsky, David S

    2015-05-01

    To describe the development and psychometric properties of the SCI-QOL Psychological Trauma item bank and short form. Using a mixed-methods design, we developed and tested a Psychological Trauma item bank with patient and provider focus groups, cognitive interviews, and item response theory based analytic approaches, including tests of model fit, differential item functioning (DIF) and precision. We tested a 31-item pool at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Veterans Administration hospital. A total of 716 individuals with SCI completed the trauma items The 31 items fit a unidimensional model (CFI=0.952; RMSEA=0.061) and demonstrated good precision (theta range between 0.6 and 2.5). Nine items demonstrated negligible DIF with little impact on score estimates. The final calibrated item bank contains 19 items The SCI-QOL Psychological Trauma item bank is a psychometrically robust measurement tool from which a short form and a computer adaptive test (CAT) version are available.

  18. Measuring stigma after spinal cord injury: Development and psychometric characteristics of the SCI-QOL Stigma item bank and short form.

    Science.gov (United States)

    Kisala, Pamela A; Tulsky, David S; Pace, Natalie; Victorson, David; Choi, Seung W; Heinemann, Allen W

    2015-05-01

    To develop a calibrated item bank and computer adaptive test (CAT) to assess the effects of stigma on health-related quality of life in individuals with spinal cord injury (SCI). Grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, and item response theory (IRT)-based psychometric analyses. Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Adults with traumatic SCI. SCI-QOL Stigma Item Bank A sample of 611 individuals with traumatic SCI completed 30 items assessing SCI-related stigma. After 7 items were iteratively removed, factor analyses confirmed a unidimensional pool of items. Graded Response Model IRT analyses were used to estimate slopes and thresholds for the final 23 items. The SCI-QOL Stigma item bank is unique not only in the assessment of SCI-related stigma but also in the inclusion of individuals with SCI in all phases of its development. Use of confirmatory factor analytic and IRT methods provide flexibility and precision of measurement. The item bank may be administered as a CAT or as a 10-item fixed-length short form and can be used for research and clinical applications.

  19. Measuring resilience after spinal cord injury: Development, validation and psychometric characteristics of the SCI-QOL Resilience item bank and short form.

    Science.gov (United States)

    Victorson, David; Tulsky, David S; Kisala, Pamela A; Kalpakjian, Claire Z; Weiland, Brian; Choi, Seung W

    2015-05-01

    To describe the development and psychometric properties of the Spinal Cord Injury--Quality of Life (SCI-QOL) Resilience item bank and short form. Using a mixed-methods design, we developed and tested a resilience item bank through the use of focus groups with individuals with SCI and clinicians with expertise in SCI, cognitive interviews, and item-response theory based analytic approaches, including tests of model fit and differential item functioning (DIF). We tested a 32-item pool at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital and the James J. Peters/Bronx Department of Veterans Affairs medical center. A total of 717 individuals with SCI completed the Resilience items. A unidimensional model was observed (CFI=0.968; RMSEA=0.074) and measurement precision was good (theta range between -3.1 and 0.9). Ten items were flagged for DIF, however, after examination of effect sizes we found this to be negligible with little practical impact on score estimates. The final calibrated item bank resulted in 21 retained items. This study indicates that the SCI-QOL Resilience item bank represents a psychometrically robust measurement tool. Short form items are also suggested and computer adaptive tests are available.

  20. Measuring self-esteem after spinal cord injury: Development, validation and psychometric characteristics of the SCI-QOL Self-esteem item bank and short form.

    Science.gov (United States)

    Kalpakjian, Claire Z; Tate, Denise G; Kisala, Pamela A; Tulsky, David S

    2015-05-01

    To describe the development and psychometric properties of the Spinal Cord Injury-Quality of Life (SCI-QOL) Self-esteem item bank. Using a mixed-methods design, we developed and tested a self-esteem item bank through the use of focus groups with individuals with SCI and clinicians with expertise in SCI, cognitive interviews, and item-response theory-(IRT) based analytic approaches, including tests of model fit, differential item functioning (DIF) and precision. We tested a pool of 30 items at several medical institutions across the United States, including the University of Michigan, Kessler Foundation, the Rehabilitation Institute of Chicago, the University of Washington, Craig Hospital, and the James J. Peters/Bronx Department of Veterans Affairs hospital. A total of 717 individuals with SCI completed the self-esteem items. A unidimensional model was observed (CFI=0.946; RMSEA=0.087) and measurement precision was good (theta range between -2.7 and 0.7). Eleven items were flagged for DIF; however, effect sizes were negligible with little practical impact on score estimates. The final calibrated item bank resulted in 23 retained items. This study indicates that the SCI-QOL Self-esteem item bank represents a psychometrically robust measurement tool. Short form items are also suggested and computer adaptive tests are available.

  1. Korea prospects

    International Nuclear Information System (INIS)

    Wyman, V.

    1990-01-01

    Contacts between the South Korean nuclear industry and a combined United Kingdom mission representing AEA Technology and British Nuclear Fuels Limited (BNFL) are reported. Prospects for entering the Korean market in two areas are perceived. The first is waste management and the second is the Safe Integral Reactor (SIR), an advanced pressurized water reactor design. AEA Technology and three collaborators have been promoting SIR as an inherently safe reactor design. Korean interest could be expressed in financial backing for the building of SIR stations in Korea and the opportunity could arise for BNFL to win fuel supply contracts. (UK)

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

    Science.gov (United States)

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

    2018-03-26

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

  3. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction – a prospective cohort pilot study within a randomized clinical trial

    International Nuclear Information System (INIS)

    Lund, Mikael; Alexandersson von Döbeln, Gabriella; Nilsson, Magnus; Winter, Reidar; Lundell, Lars; Tsai, Jon A; Kalman, Sigridur

    2015-01-01

    Neoadjuvant therapy for cancer of the esophagus or gastroesophageal (GE)-junction is well established. The pros and cons of chemoradiotherapy and chemotherapy are debated. Chemoradiotherapy might impair cardiac function eliciting postoperative morbidity. The aim of this pilot study was to describe acute changes in left ventricular function following chemoradiotherapy or chemotherapy. Patients with esophageal and (GE)-junction cancer enrolled at our center into a multicenter trial comparing neoadjuvant chemoradiotherapy and chemotherapy were eligible. Patients were randomized to receive cisplatin and 5-fluorouracil with or without the addition of 40 Gy radiotherapy prior to surgery. Left ventricular function was evaluated using echocardiography and plasma N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) before and after neoadjuvant treatment. The primary outcome measure was left ventricular global strain (GS). Clinical effects were assessed using repeated exercise tests. Linear mixed models were used to analyze the effects of treatment group, and the interaction between groups. 40 patients participated (chemoradiotherapy, n = 17; chemotherapy, n = 23). In the chemoradiotherapy group there was no change in left ventricular global strain but mitral annular plane systolic excursion (MAPSE) of the ventricular septum, early diastolic filling velocity (E-velocity), and the ratio of early to late ventricular filling velocities (E/A ratio) decreased significantly (p = 0.02, p = 0.01, and p = 0.03, respectively). No changes were observed in the chemotherapy group. There was a trend towards an interaction effect for MAPSE sept and E (p = 0.09 and p = 0.09). NT-proBNP increased following chemoradiotherapy (p = 0.05) but not after chemotherapy (p > 0.99), and there was a trend towards an interaction effect (p = 0.07). Working capacity decreased following neoadjuvant treatment (chemoradiotherapy p = 0.001, chemotherapy p = 0.03) and was more pronounced after

  4. Energy prospects

    International Nuclear Information System (INIS)

    Lyall, K.

    1991-01-01

    The Business Council of Australia's study on Prospects for Improved Energy Efficiency and the Application of Renewable Energy Resources is summarised. The study estimates that replacement of all off-peak electric units in Australia with solar gas boosted systems would reduce electricity consumption for residential water heating by approximately 25% and almost halve carbon dioxide emissions resulting from residential water heating. Furthermore, substitution of all water heating units in Australia with solar gas systems would reduce total emissions by about 80%. The study concludes that while substitution on such a scale could not readily be achieved even within several decades, the estimates do indicate the significant benefits that might be realised by a long term program. 2 refs., 3 tabs

  5. Development and psychometric characteristics of the SCI-QOL Ability to Participate and Satisfaction with Social Roles and Activities item banks and short forms.

    Science.gov (United States)

    Heinemann, Allen W; Kisala, Pamela A; Hahn, Elizabeth A; Tulsky, David S

    2015-05-01

    To develop a spinal cord injury (SCI)-focused version of PROMIS and Neuro-QOL social domain item banks; evaluate the psychometric properties of items developed for adults with SCI; and report information to facilitate clinical and research use. We used a mixed-methods design to develop and evaluate Ability to Participate in Social Roles and Activities and Satisfaction with Social Roles and Activities items. Focus groups helped define the constructs; cognitive interviews helped revise items; and confirmatory factor analysis and item response theory methods helped calibrate item banks and evaluate differential item functioning related to demographic and injury characteristics. Five SCI Model System sites and one Veterans Administration medical center. The calibration sample consisted of 641 individuals; a reliability sample consisted of 245 individuals residing in the community. A subset of 27 Ability to Participate and 35 Satisfaction items demonstrated good measurement properties and negligible differential item functioning related to demographic and injury characteristics. The SCI-specific measures correlate strongly with the PROMIS and Neuro-QOL versions. Ten item short forms correlate >0.96 with the full banks. Variable-length CATs with a minimum of 4 items, variable-length CATs with a minimum of 8 items, fixed-length CATs of 10 items, and the 10-item short forms demonstrate construct coverage and measurement error that is comparable to the full item bank. The Ability to Participate and Satisfaction with Social Roles and Activities CATs and short forms demonstrate excellent psychometric properties and are suitable for clinical and research applications.

  6. Prospective assessment of emotional distress, cognitive function, and quality of life in patients with cancer treated with chemotherapy.

    Science.gov (United States)

    Iconomou, Gregoris; Mega, Vasiliki; Koutras, Angelos; Iconomou, Alexander V; Kalofonos, Haralabos P

    2004-07-15

    The current study sought to delineate prospectively the rates and clinical course of emotional distress, cognitive impairment, and quality of life (QOL) in chemotherapy-naive patients with cancer and to consider the determinants of global QOL. Patients who consented to participate were administered the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, the Mini-Mental State Examination (MMSE), and the Hospital Anxiety and Depression Scale before and at the end of treatment (EOT). Of the 102 patients initially assessed, 80 (78.4%) completed the study. Most aspects of QOL did not change considerably over time. At EOT, patients reported only significant increases in fatigue and significant decreases in sleep disturbance. Although no significant changes emerged in the rates of anxiety or depression throughout chemotherapy, nearly one-third of the patients experienced severe emotional distress at both points in time. In addition, the authors observed neither significant alteration in the cognitive performance over time nor reliable associations between scores on the MMSE and subjective cognitive function, emotional distress, or QOL. Finally, depression proved to be the leading predictor of global QOL at baseline and at EOT. The results indicated that a significant proportion of Greek patients with cancer experienced intense anxiety and depression throughout chemotherapy and confirmed the importance of depression as a strong predictor of global QOL. Routine screening of emotional distress across all phases of cancer is mandatory because it will contribute to the identification of patients who are in need of pharmaceutical and/or psychologic intervention. Copyright 2004 American Cancer Society.

  7. Preparing Pilots for Takeoff

    Science.gov (United States)

    Ravage, Barbara

    2012-01-01

    Why would schools consider partnering with a vendor to operate a pilot? Why not just wait until the final product is released? For starters, pilots provide schools with a golden opportunity to get an early look at the software, take it for a test flight, and ask for changes tailored to their operating environment and business needs. In some cases,…

  8. Oral health-related quality of life following non-surgical (routine tooth extraction: A pilot study

    Directory of Open Access Journals (Sweden)

    Wasiu L Adeyemo

    2012-01-01

    Full Text Available Aim: The study was designed to explore the changes in oral health-related quality of life (QoL in the immediate postoperative period following routine (non-surgical dental extraction. Setting and Design: A prospective study carried out at the Oral and Maxillofacial Surgery clinic of the Lagos University Teaching Hospital, Nigeria. Materials and Methods: Subjects attending who required non-surgical removal of one or two teeth under local anesthesia were included in the study. A baseline QoL questionnaire (oral health impact profile-14 [OHIP-14] was filled by each patient just before surgery, and only those who were considered to have their QoL "not affected" (total score 14 or less were included in the study. After the extraction, each subject was given a modified form of "health related QoL" [OHIP-14]-instrument to be completed by the 3 rd day-after surgery, and were given the opportunity to review the questionnaire on the 7 th day postoperative review. Results: Total OHIP-14 scores ranged between 14 and 48 (mean ± SD, 26.2 ± 8.3. Majority of the subjects (60% reported, "a little affected." Only few subjects (5.8% reported, "not at all affected," and about 32% reported, "quite a lot." Summation of OHIP-14 scores revealed that QoL was "affected" in 41 subjects (34.2% and "not affected" in 79 subjects (65.8%. More than 30% of subjects reported that their ability to chew, ability to open the mouth and enjoyment of food were affected following tooth extraction. Few subjects (14-34% reported deterioration in their speech and less than 20% of subjects reported that change in their appearance was "affected." Only few subjects (12.5-15.1% reported sleep and duty impairment. Thirty-percent of subjects reported their inability to keep social activities, and 41% were not able to continue with their favorite sports and hobbies. Multiple regression analysis revealed no significant association between age, sex, indications for extraction, duration of

  9. 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...

  10. Five-year follow-up of a prospective non-randomised study comparing duodenum-preserving pancreatic head resection with classic Whipple procedure in the treatment of chronic pancreatitis.

    Science.gov (United States)

    Möbius, C; Max, D; Uhlmann, D; Gumpp, K; Behrbohm, J; Horvath, K; Hauss, J; Witzigmann, H

    2007-05-01

    Three prospective randomised studies were conducted to compare pancreatoduodenectomy (PD) with duodenum-preserving pancreatic head resection (DPPHR) in patients suffering from chronic pancreatitis (cP). In these three series, the superiority of the duodenum-preserving technique with regard to quality of life (QOL) and pain relief has been demonstrated. Long-term follow-up investigations have not been published so far. The present paper reports on a 5-year follow-up study of a prospective, non-randomised trial comparing classic Whipple procedure (PD) with Beger DPPHR. Seventy patients were initially enrolled in this study. Fifty-one patients were left for the present long-term outcome analysis (PD, n = 24; DPPHR, n = 27). The follow-up included the following parameters: QOL, pain intensity, endocrine and exocrine function, and body mass index (BMI). The median follow-up was 63.5 (range 56-67) months. Two patients in the DPPHR group and none in the PD group underwent a re-operation. The QOL scores of the relevant symptom scales (nausea, pain, diarrhoea) and functional parameters (physical status, working ability, global QOL) were significantly better in the DPPHR group than in the PD group. Pain intensity as self-assessed by the patients was less pronounced in the DPPHR group (P Whipple procedure in terms of QOL and pain intensity as self-assessed by the patients.

  11. Grappling with the future: The messiness of pilot implementation in information systems design.

    Science.gov (United States)

    Hertzum, Morten; Manikas, Maria Ie; Á Torkilsheyggi, Arnvør

    2017-06-01

    Pilot implementation is a method for avoiding unintended consequences of healthcare information systems. This study investigates how learning from pilot implementations is situated, messy, and therefore difficult. We analyze two pilot implementations by means of observation and interviews. In the first pilot implementation, the involved porters saw their improved overview of pending patient transports as an opportunity for more self-organization, but this opportunity hinged on the unclear prospects of extending the system with functionality for the porters to reply to transport requests. In the second pilot implementation, the involved paramedics had to print the data they had entered into the system because it had not yet been integrated with the electronic patient record. This extra work prolonged every dispatch and influenced the paramedics' experience of the entire system. We discuss how pilot implementations, in spite of their realism, leave room for uncertainty about the implications of the new system.

  12. Grappling with the Future: The Messiness of Pilot Implementation in Information Systems Design

    DEFF Research Database (Denmark)

    Hertzum, Morten; Manikas, Maria Ie; Torkilsheyggi, Arnvør Martinsdóttir á

    2018-01-01

    . In the first pilot implementation the involved porters saw their improved overview of pending patient transports as an opportunity for more self-organization but this opportunity hinged on the unclear prospects of extending the system with functionality for the porters to reply to transport requests....... In the second pilot implementation the involved paramedics had to print the data they entered into the system because it had not yet been integrated with the electronic patient record. This extra work prolonged every dispatch and influenced the paramedics’ experience of the entire system. We discuss how pilot......Pilot implementation is a method for avoiding unintended consequences of healthcare information systems. This study investigates how learning from pilot implementations is situated, messy, and therefore difficult. We analyze two pilot implementations by means of observation and interviews...

  13. Quality of life in postmenopausal women: translation and validation of MSkinQOL questionnaire to measure the effect of a skincare product in USA.

    Science.gov (United States)

    Segot-Chicq, Evelyne; Fanchon, Chantal

    2013-12-01

    The 28-item Menopausal Skin Quality Of Life (MSkinQOL), a previously validated French questionnaire, developed to assess psychological features of menopausal women and to measure the benefits of using cosmetic skincare products was translated and validated to assess a skincare product in the USA. Construct validity, reliability, reproducibility, and responsiveness were assessed with two groups of 100 nonmenopausal (NM) and 100 postmenopausal (PM) women. The group of PM women applied a specially developed skincare product twice daily for 1 month and filled in the same questionnaire after 1 month as well as a general self-assessment questionnaire about the efficacy and cosmetic properties of the product. No ceiling or floor effects were identified. Construct and internal validity was assessed using a multitrait analysis: questionnaire items proved closely correlated, and each dimension covers a different aspect of women answers profile. The three dimensions showed good reliability and stability. Baseline values for social effects of skin appearance, health status, and self-esteem were significantly different between PM and NM volunteers. Values of these three dimensions were significantly improved after 2 weeks of product application, and further improved after 4 weeks. This study shows that a careful translation and a rigorous process of validation lead to a reliable tool adapted to each country to explore and measure quality of life in healthy PM women. © 2013 Wiley Periodicals, Inc.

  14. A prospective observational study assessing home parenteral nutrition in patients with gastrointestinal cancer: benefits for quality of life.

    Science.gov (United States)

    Senesse, Pierre; Tadmouri, Abir; Culine, Stéphane; Dufour, Patrick R; Seys, Patrick; Radji, Abderraouf; Rotarski, Maciej; Balian, Axel; Chambrier, Cecile

    2015-02-01

    Patients with gastrointestinal cancer are at high risk for deterioration of nutrition. Home parenteral nutrition (HPN) could improve nutritional status and quality of life (QoL). The purpose of this study was 1) to evaluate the impact of HPN on QoL, 2) to assess changes in nutritional status, and 3) to assess proxy perception of patient well-being. We conducted a prospective, observational, and a multicenter study. Inclusion criteria were adult patients with gastrointestinal cancer, for whom HPN was indicated and prescribed for at least 14 days. The physician, the patient, and a family member completed questionnaires at inclusion and 28 days later. The QoL was assessed by the patients using the Functional Assessment of Cancer Therapy-General questionnaire, at inclusion and 28 days later. The study included 370 patients with gastrointestinal cancer. The HPN was indicated for cancer-related undernutrition in 89% of the patients and was used as a complement to oral intake in 84%. After 28 days of parenteral intake, global QoL was significantly increased (48.9 at inclusion vs. 50.3, P=0.007). The patients' weight improved significantly by 2.7% (Pnutrition risk screening also decreased significantly (3.2±1.1 vs. 2.8±1.3, P=0.003). HPN could provide benefit for malnourished patients with gastrointestinal cancer. However, randomized controlled studies are required to confirm this benefit and the safety profile. Copyright © 2015. Published by Elsevier Inc.

  15. Pilot Weather Reports

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Aviation weather reports relayed from pilots to FAA air traffic controllers or National Weather Service personnel. Elements include sky cover, turbulence, wind...

  16. Agile Web Pilot Program

    National Research Council Canada - National Science Library

    Lang, Mark

    1997-01-01

    ... in an increasingly competitive global marketplace. The pilot program allowed 18 small and medium sized enterprises to experiment with new agile business practices in competitive manufacturing environments by forming virtual organizations within...

  17. CERN pilot greenhouse

    CERN Multimedia

    1983-01-01

    This pilot installation was situated near Bld. BA6 opposite to the main entrance of the Meyrin site, with respect to Route de Meyrin. See Weekly Bulletin 3/83, and also photo 8305594X, 8505898X, 8302200.

  18. Uranium project. Geochemistry prospection

    International Nuclear Information System (INIS)

    Lambert, J.

    1983-01-01

    Geochemistry studies the distribution of the chemicals elements in the terrestrial crust and its ways to migrate. The terminology used in this report is the following one: 1) Principles of the prospection geochemistry 2) Stages of the prospection geochemistry 3)utility of the prospection geochemistry 4) geochemistry of uranium 5) procedures used within the framework of uranium project 6) Average available 7) Selection of the zones of prospection geochemistry 8) Stages of the prospection, Sample preparation and analisis 9) Presentation of the results

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

    Science.gov (United States)

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

    2014-10-01

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

  20. Psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese mainland patients with methadone maintenance treatment.

    Science.gov (United States)

    Zhou, Kaina; Zhuang, Guihua; Zhang, Hongmei; Liang, Peifeng; Yin, Juan; Kou, Lingling; Hao, Mengmeng; You, Lijuan

    2013-01-01

    To test psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2) and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0) in Chinese mainland patients with methadone maintenance treatment (MMT). A total of 1,212 patients were recruited from two MMT clinics in Xi'an, China. Reliability was estimated with Cronbach's α and intra-class correlation (ICC). Convergent and discriminant validity was assessed using multitrait-multimethod correlation matrix. Sensitivity was measured with ANOVA and relative efficiency. Responsiveness was evaluated by pre-post paired-samples t-test and standardized response mean based on the patients' health status changes following 6-month period. Cronbach's α of the SF-36v2 physical and mental summary components were 0.80 and 0.86 (eight scales range 0.73-0.92) and the QOL-DAv2.0 was 0.96 (four scales range: 0.80-0.93). ICC of the SF-36v2 two components were 0.86 and 0.85 (eight scales range: 0.72-0.87) and the QOL-DAv2.0 was 0.94 (four scales range: 0.88-0.92). Convergent validity was lower between the two instruments (γ <0.70) while discriminant validity was acceptable within each instrument. Sensitivity was satisfied in self-evaluated health status (both instruments) and average daily methadone dose (SF-36v2 physical functioning and vitality scales; QOL-DAv2.0 except psychology scale). Responsiveness was acceptable in the improved health status change (SF-36v2 except vitality scale; QOL-DAv2.0 except psychology and symptoms scales) and deteriorated health status change (SF-36v2 except vitality, social functioning and mental health scales; QOL-DAv2.0 except society scale). The SF-36v2 and the QOL-DAv2.0 are valid tools and can be used independently or complementary according to different emphases of health-related quality of life evaluation in patients with MMT.

  1. Psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2 and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0 in Chinese mainland patients with methadone maintenance treatment.

    Directory of Open Access Journals (Sweden)

    Kaina Zhou

    Full Text Available OBJECTIVE: To test psychometrics of the Short Form 36 Health Survey version 2 (SF-36v2 and the Quality of Life Scale for Drug Addicts (QOL-DAv2.0 in Chinese mainland patients with methadone maintenance treatment (MMT. METHODS: A total of 1,212 patients were recruited from two MMT clinics in Xi'an, China. Reliability was estimated with Cronbach's α and intra-class correlation (ICC. Convergent and discriminant validity was assessed using multitrait-multimethod correlation matrix. Sensitivity was measured with ANOVA and relative efficiency. Responsiveness was evaluated by pre-post paired-samples t-test and standardized response mean based on the patients' health status changes following 6-month period. RESULTS: Cronbach's α of the SF-36v2 physical and mental summary components were 0.80 and 0.86 (eight scales range 0.73-0.92 and the QOL-DAv2.0 was 0.96 (four scales range: 0.80-0.93. ICC of the SF-36v2 two components were 0.86 and 0.85 (eight scales range: 0.72-0.87 and the QOL-DAv2.0 was 0.94 (four scales range: 0.88-0.92. Convergent validity was lower between the two instruments (γ <0.70 while discriminant validity was acceptable within each instrument. Sensitivity was satisfied in self-evaluated health status (both instruments and average daily methadone dose (SF-36v2 physical functioning and vitality scales; QOL-DAv2.0 except psychology scale. Responsiveness was acceptable in the improved health status change (SF-36v2 except vitality scale; QOL-DAv2.0 except psychology and symptoms scales and deteriorated health status change (SF-36v2 except vitality, social functioning and mental health scales; QOL-DAv2.0 except society scale. CONCLUSIONS: The SF-36v2 and the QOL-DAv2.0 are valid tools and can be used independently or complementary according to different emphases of health-related quality of life evaluation in patients with MMT.

  2. DIRAC universal pilots

    Science.gov (United States)

    Stagni, F.; McNab, A.; Luzzi, C.; Krzemien, W.; Consortium, DIRAC

    2017-10-01

    In the last few years, new types of computing models, such as IAAS (Infrastructure as a Service) and IAAC (Infrastructure as a Client), gained popularity. New resources may come as part of pledged resources, while others are in the form of opportunistic ones. Most but not all of these new infrastructures are based on virtualization techniques. In addition, some of them, present opportunities for multi-processor computing slots to the users. Virtual Organizations are therefore facing heterogeneity of the available resources and the use of an Interware software like DIRAC to provide the transparent, uniform interface has become essential. The transparent access to the underlying resources is realized by implementing the pilot model. DIRAC’s newest generation of generic pilots (the so-called Pilots 2.0) are the “pilots for all the skies”, and have been successfully released in production more than a year ago. They use a plugin mechanism that makes them easily adaptable. Pilots 2.0 have been used for fetching and running jobs on every type of resource, being it a Worker Node (WN) behind a CREAM/ARC/HTCondor/DIRAC Computing element, a Virtual Machine running on IaaC infrastructures like Vac or BOINC, on IaaS cloud resources managed by Vcycle, the LHCb High Level Trigger farm nodes, and any type of opportunistic computing resource. Make a machine a “Pilot Machine”, and all diversities between them will disappear. This contribution describes how pilots are made suitable for different resources, and the recent steps taken towards a fully unified framework, including monitoring. Also, the cases of multi-processor computing slots either on real or virtual machines, with the whole node or a partition of it, is discussed.

  3. PULSE Pilot Certification Results

    Directory of Open Access Journals (Sweden)

    Pamela Pape-Lindstrom

    2015-08-01

    Full Text Available The pilot certification process is an ambitious, nationwide endeavor designed to motivate important changes in life sciences education that are in line with the recommendations of the 2011 Vision and Change Report: A Call to Action (American Association for the Advancement of Science [AAAS], 2011.  It is the goal of the certification process to acknowledge departments that have progressed towards full implementation of the tenets of Vision and Change and to motivate departments that have not begun to adopt the recommendations to consider doing so.  More than 70 life science departments applied to be part of the pilot certification process, funded by a National Science Foundation grant, and eight were selected based on initial evidence of transformed and innovative educational practices.  The programs chosen represent a wide variety of schools, including two-year colleges, liberal-arts institutions, regional comprehensive colleges, research universities and minority serving institutions.  Outcomes from this pilot were released June 1, 2015 (www.pulsecommunity.org, with all eight programs being recognized as having progressed along a continuum of change.  Five levels of achievement were defined as PULSE Pilot Progression Levels.  Of the eight departments in the pilot, one achieved “PULSE Progression Level III: Accomplished”.  Six departments achieved “PULSE Progression Level II: Developing” and one pilot department achieved “PULSE Progression Level I: Beginning”.  All of the schools have made significant movement towards the recommendations of Vision and Change relative to a traditional life sciences curriculum.  Overall, the response from the eight pilot schools has been positive. 

  4. Linking the Pilot Structural Model and Pilot Workload

    Science.gov (United States)

    Bachelder, Edward; Hess, Ronald; Aponso, Bimal; Godfroy-Cooper, Martine

    2018-01-01

    Behavioral models are developed that closely reproduced pulsive control response of two pilots using markedly different control techniques while conducting a tracking task. An intriguing find was that the pilots appeared to: 1) produce a continuous, internally-generated stick signal that they integrated in time; 2) integrate the actual stick position; and 3) compare the two integrations to either issue or cease a pulse command. This suggests that the pilots utilized kinesthetic feedback in order to sense and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess's pilot Structural Model. A Pilot Cost Index was developed, whose elements include estimated workload, performance, and the degree to which the pilot employs kinesthetic feedback. Preliminary results suggest that a pilot's operating point (parameter values) may be based on control style and index minimization.

  5. 76 FR 54095 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

    Science.gov (United States)

    2011-08-31

    ... [Docket No.: FAA-2008-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification Rules AGENCY... regulations concerning pilot, flight instructor, and pilot school certification. This rule will require pilot...

  6. NSTAR Smart Grid Pilot

    Energy Technology Data Exchange (ETDEWEB)

    Rabari, Anil [NSTAR Electric, Manchester, NH (United States); Fadipe, Oloruntomi [NSTAR Electric, Manchester, NH (United States)

    2014-03-31

    NSTAR Electric & Gas Corporation (“the Company”, or “NSTAR”) developed and implemented a Smart Grid pilot program beginning in 2010 to demonstrate the viability of leveraging existing automated meter reading (“AMR”) deployments to provide much of the Smart Grid functionality of advanced metering infrastructure (“AMI”), but without the large capital investment that AMI rollouts typically entail. In particular, a central objective of the Smart Energy Pilot was to enable residential dynamic pricing (time-of-use “TOU” and critical peak rates and rebates) and two-way direct load control (“DLC”) by continually capturing AMR meter data transmissions and communicating through customer-sited broadband connections in conjunction with a standardsbased home area network (“HAN”). The pilot was supported by the U.S. Department of Energy’s (“DOE”) through the Smart Grid Demonstration program. NSTAR was very pleased to not only receive the funding support from DOE, but the guidance and support of the DOE throughout the pilot. NSTAR is also pleased to report to the DOE that it was able to execute and deliver a successful pilot on time and on budget. NSTAR looks for future opportunities to work with the DOE and others in future smart grid projects.

  7. User Participation in Pilot Implementation

    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...... implementation as a method for participatory design. We find that to foster participation and learning about user needs a pilot implementation must create a space for reflecting on use, in addition to the space for using the pilot system. The space for reflection must also exist during the activities preparing...... 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....

  8. Effects of martial arts exercise on body composition, serum biomarkers and quality of life in overweight/obese premenopausal women: a pilot study

    Science.gov (United States)

    Chyu, Ming-Chien; Zhang, Yan; Brismée, Jean-Michel; Dagda, Raul Y.; Chaung, Eugene; Von Bergen, Vera; Doctolero, Susan; Shen, Chwan-Li

    2013-01-01

    Various exercise interventions have been shown to benefit weight control and general health in different populations. However, very few studies have been conducted on martial arts exercise (MAE). The objective of this pilot study is to evaluate the efficacy of 12 weeks of MAE intervention on body composition, serum biomarkers and quality of life (QOL) in overweight/obese premenopausal women. We found that subjects in the MAE group did not lose body weight, while they significantly decreased fat-free mass and muscle mass as compared to those in the control group, who demonstrated an increase in these parameters. The MAE group demonstrated an increase in serum IGF-I concentration, but no change in others. MAE may be a feasible and effective approach to improve body composition and QOL in overweight/obese premenopausal women. Our study underscores the need for further studies using larger samples to establish possible benefits of MAE in various populations. PMID:24665215

  9. Quality of Life as Medicine: A Pilot Studyof Patients with Chronic Illness and Pain

    Directory of Open Access Journals (Sweden)

    Soren Ventegodt

    2003-01-01

    Full Text Available An intensive 5-day quality-of-life (QoL session was constructed based on a psychosomatic model. The session was comprised of teaching on philosophy of life, psychotherapy, and body therapy. The three elements were put together in such a way that they mutually supported each other. The synergy attained was considerable. The pilot study demonstrated that in the course of only 1 week, patients had time to revise essential life-denying views and to integrate important, unfinished life events involving negative feelings. Consequently, the patients became more present in the body’s blocked-off areas and subjectively healthier. Nineteen persons with chronic illness and pain (fibromyalgia, chronic tiredness, whiplash, mild depression, and problems involving pain in arms and legs including osteoarthritis, and unemployed for 5–7 years attended the course. In the week before and after the 5-day course, the participants completed the validated SEQOL (Self-Evaluation of Quality of Life Questionnaire including questions on self-evaluated health and the unvalidated “Self-Evaluation of Working-Life Quality Questionnaire” (SEQWL. This pilot study was without a control group or clinical control. As far as diagnoses were concerned, the group was inhomogeneous. Common for the group was a low QoL, poor quality of working life QWL, and numerous health problems. The study showed an 11.2% improvement in QoL (p < 0.05, a 6.3% improvement in QWL (p < 0.05, and a 12.0% improvement in self-perceived physical health (p = 0.08. There was a 17.3% improvement in self-perceived psychological health (p < 0.05 and satisfaction with health in general improved by 21.4% (p < 0.05. Symptoms like pain were almost halved and several of the participants were free of pain for the first time in years. In conclusion it seemed that the combination of training in philosophy of life, psychotherapy, and body therapy can give patients a large, fast, and efficient improvement in QoL, QWL

  10. Construct validity of the items on the Stroke Specific Quality of Life (SS-QOL) questionnaire that evaluate the participation component of the International Classification of Functioning, Disability and Health.

    Science.gov (United States)

    Silva, Soraia Micaela; Corrêa, Fernanda Ishida; Pereira, Gabriela Santos; Faria, Christina Danielli Coelho de Morais; Corrêa, João Carlos Ferrari

    2018-01-01

    Analyze the construct validity and internal consistency of the Stroke Specific Quality of Life (SS-QOL) items that address the participation component of the ICF as well as analyze the ceiling and floor effects. One hundred subjects were analyzed: 85 community-dwelling and 15 institutionalized individuals. The analysis of construct validity was performed using classic psychometrics: (1) the comparison of known groups (individuals without restriction to participation vs. those with restriction to participation) using the Mann-Whitney test and (2) convergent validity - correlation between the scores on the SS-QOL items that address participation and the subscale scores of measures used to evaluate the similar constructs and concepts [the Short-Form Health Survey (SF-36), Functional Independence Measure (FIM) and grip strength test]. Spearman's correlation coefficients were calculated for this analysis. Cronbach's α was used for the analysis of internal consistency and both the ceiling and floor effects were analyzed. The level of significance for all analyses was α = 0.05. The a priori hypotheses regarding construct validity were partially demonstrated, as only five of the eight domains exhibited positive moderate to strong correlations (r > 0.40) with measures that address constructs similar to those addressed on the SS-QOL questionnaire. The items demonstrated adequate internal consistency and are capable of differentiating individuals with and without restriction to participation. The ceiling and floor effects were considered adequate for the total SS-QOL score, but beyond acceptable standards for some domains. The 26 items of the SS-QOL questionnaire measure a multidimensional construct and therefore do not only address participation. However, the items demonstrated adequate internal consistency and are capable of differentiating individuals with and without restriction to participation. Implications for rehabilitation The 26 items of the SS-QOL

  11. Treatment, patient and tumor characteristics impact quality of life (QOL) in patients with locally advanced head and neck cancer: Report of the radiation therapy oncology group (RTOG) trial 90-03

    International Nuclear Information System (INIS)

    Fisher, J.; Scott, C.; Fu, K.; Trotti, A.; Spencer, S.; Garden, A.; Phillips, T.; Movsas, B.; Byhardt, R.; Ang, K.

    2001-01-01

    Purpose: To determine factors that effect QOL in patients with locally advanced squamous cell cancer of the head and neck randomized to standard fractionation radiotherapy (SFX), hyperfractionation (HFX), Accelerated Fractionation with Split (AFX-S) and Accelerated Fractionation with Concomitant Boost (AFX-C). Materials and Methods: RTOG 90-03 used the Head and Neck Performance Status Scale (HNPSS) and the Functional Assessment of Cancer Therapy (FACT-H and N), version 2 to assess QOL. The HNPSS has three components Normalcy of Diet, Eating in Public, and Understandability of Speech. The FACT-H and N has two components: a global QOL questionnaire (FACT-G) consisting of 4 domains; Physical Well Being (PWB), Social Well Being (SWB), Emotional Well Being (EWB), Functional Well Being (FWB), and an additional H and N specific questionnaire (AC). Between 3/92 and 8/97, 1113 pts. were randomized; 718 completed a pretreatment FACT-H and N. Pts. completed the HNPSS and FACT-H and N; pretreatment, 4 weeks post-RT, every 3 months for 1 year. Results: Prior to the start of radiotherapy (RT) 48% of pts had normal diets, 64% had normal public eating, and 77% had normal speech. Age ( 60), KPS, tumor site (oral cavity vs. other), T-stage (T3+T4 vs. T1+T2+TX), N-stage (N0 vs. other), Race (Non-White vs. White), and marital status (single vs. married), FACT-G, PWB, EWB, FWB, AC, use of oral nutrient supplements, feeding tube, and parenteral nutrition predicted for pretreatment diet, public eating, and speech. During the acute toxicity phase diet, eating, and speech were related to the intensity of RT (HFX or AFX-C), marital status (single), tumor site (oral cavity), use of oral nutrient supplements, and feeding tube. At one-year oral cavity tumors, AFX-C, oral nutrient supplements, feeding tube, and single patients had worse diet, eating, and speech. Conclusion: Pretreatment patient and tumor characteristics impact on QOL prior to the initiation of therapy. Intensification of

  12. Geochemical prospecting in Guiana

    International Nuclear Information System (INIS)

    Coulomb, R.

    1957-01-01

    During the last few years geochemical prospecting techniques have become common usage in the field of mineral deposit prospecting. The real scope of these methods lies in their use in the prospecting of large areas. The most promising use of the geochemistry and hydro-geochemistry of uranium is in heavily forested tropical territories, with few outcrops, where radiometry is strongly handicapped. (author) [fr

  13. Endogenous Prospect Theory

    OpenAIRE

    Schmidt, Ulrich; Zank, Horst

    2010-01-01

    In previous models of (cumulative) prospect theory reference-dependence of preferences is imposed beforehand and the location of the reference point is exogenously determined. This paper provides an axiomatization of a new specification of cumulative prospect theory, termed endogenous prospect theory, where reference-dependence is derived from preference conditions and a unique reference point arises endogenously.

  14. 14 CFR 61.73 - Military pilots or former military pilots: Special rules.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Military pilots or former military pilots... Ratings and Pilot Authorizations § 61.73 Military pilots or former military pilots: Special rules. (a... a disciplinary action involving aircraft operations, a U.S. military pilot or former military pilot...

  15. Pilot project as enabler?

    DEFF Research Database (Denmark)

    Neisig, Margit; Glimø, Helle; Holm, Catrine Granzow

    This article deals with a systemic perspective on transition. The field of study addressed is a pilot project as enabler of transition in a highly complex polycentric context. From a Luhmannian systemic approach, a framework is created to understand and address barriers of change occurred using...... pilot projects as enabler of transition. Aspects of how to create trust and deal with distrust during a transition are addressed. The transition in focus is the concept of New Public Management and how it is applied in the management of the Employment Service in Denmark. The transition regards...

  16. Single-Pilot Workload Management

    Science.gov (United States)

    Rogers, Jason; Williams, Kevin; Hackworth, Carla; Burian, Barbara; Pruchnicki, Shawn; Christopher, Bonny; Drechsler, Gena; Silverman, Evan; Runnels, Barry; Mead, Andy

    2013-01-01

    Integrated glass cockpit systems place a heavy cognitive load on pilots (Burian Dismukes, 2007). Researchers from the NASA Ames Flight Cognition Lab and the FAA Flight Deck Human Factors Lab examined task and workload management by single pilots. This poster describes pilot performance regarding programming a reroute while at cruise and meeting a waypoint crossing restriction on the initial descent.

  17. Pilot pulsar surveys with LOFAR

    NARCIS (Netherlands)

    Coenen, T.

    2013-01-01

    We are performing two complementary pilot pulsar surveys as part of LOFAR commissioning. The LOFAR Pilot Pulsar Survey (LPPS) is a shallow all-sky survey using an incoherent combination of LOFAR stations. The LOFAR Tied-Array Survey (LOTAS) is a deeper pilot survey using 19 simultaneous tied-array

  18. Predictors of meaningful improvement in quality of life after temporal lobe epilepsy surgery: A prospective study.

    Science.gov (United States)

    Pauli, Carla; Schwarzbold, Marcelo Liborio; Diaz, Alexandre Paim; de Oliveira Thais, Maria Emilia Rodrigues; Kondageski, Charles; Linhares, Marcelo Neves; Guarnieri, Ricardo; de Lemos Zingano, Bianca; Ben, Juliana; Nunes, Jean Costa; Markowitsch, Hans Joachim; Wolf, Peter; Wiebe, Samuel; Lin, Katia; Walz, Roger

    2017-05-01

    To investigate prospectively the independent predictors of a minimum clinically important change (MCIC) in quality of life (QOL) after anterior temporal lobectomy (ATL) for drug-resistant mesial temporal lobe epilepsy related to hippocampal sclerosis (MTLE-HS) in Brazilian patients. Multiple binary logistic regression analysis was performed to identify the clinical, demographic, radiologic, and electrophysiologic variables independently associated with MCIC in the Quality of Life in Epilepsy-31 Inventory (QOLIE-31) overall score 1 year after ATL in 77 consecutive patients with unilateral MTLE-HS. The overall QOLIE-31 score and all its subscale scores increased significantly (p Epilepsy.

  19. An analysis of quality of life (QOL) in patients with epilepsy and comorbid psychogenic nonepileptic seizures (PNES) after vagus nerve stimulation (VNS).

    Science.gov (United States)

    Vivas, Andrew C; Reitano, Christian J; Waseem, Hena; Benbadis, Selim R; Vale, Fernando L

    2017-08-01

    Patients with epilepsy (PWE) may suffer from comorbid psychogenic nonepileptic seizures (PNES). The efficacy of vagus nerve stimulation (VNS) in the treatment of epilepsy and depression is established, however the impact on PNES is unknown. Since many patients with PNES have comorbid depression, we explored the impact on quality of life (QOL) that VNS has on PWE and PNES. The video electroencephalogram (vEEG) of all patients who underwent VNS at our institution was reviewed. Patients diagnosed with both psychogenic seizures and epileptic seizures on their vEEG were included in this study. These patients were contacted, and given a QOLIE-31 survey to assess their quality of life after VNS. Patients also completed a separate survey created by our group to categorize the quartile of their improvement. Pre-operative psychiatric disease was retrospectively reviewed. From a period of 2001 to 2016, 518 patients underwent placement of VNS for drug resistant epilepsy (DRE) at our institution. In total, 16 patients were diagnosed with both epilepsy and PNES. 11/16 patients responded to our questionnaire and survey. 9 out of 11 patients felt that their epileptic seizures had improved after VNS, while 7 of the 11 patients felt that their psychogenic episodes had improved. 2(28.6%), 1 (14.3%), and 4 (57.1%) of participants said their PNES improved by 25-50%, 50-75%, and 75-100%, respectively. 3(27.3%), 3 (27.3%), 1 (9.1%), and 4 (36.4%) of the participants said their epileptic seizures improved by 0-25%, 25-50%, 50-75%, and 75-100%, respectively. The average overall score for quality of life for the study participants was found to be 51 (±8) out of 100. Patients with epilepsy and comorbid PNES may benefit from VNS. It is unclear whether the benefit is conferred strictly from decreased epileptic seizure burden. The possible effect on PNES may be related to the known effect of VNS on depression. Further studies are necessary to elucidate the role of VNS in the treatment of PNES

  20. Comparison of the EuroQOL-5D with the Oswestry Disability Index, back and leg pain scores in patients with degenerative lumbar spine pathology.

    Science.gov (United States)

    Mueller, Benjamin; Carreon, Leah Y; Glassman, Steven D

    2013-04-20

    Cross-sectional study. To evaluate the response behavior of EuroQOL-5D (EQ-5D) compared with the Oswestry Disability Index (ODI), and back and leg pain scores. Recent changes in policies have highlighted the need for demonstration of both quality and cost effectiveness. In an effort to meet these requirements, surgeons are collecting health-related quality of life and utility data. Unfortunately, the burden of extensive data collection on both physician and patient is considerable. The EQ-5D is a commonly used, easily administered, brief utility measure that can provide both clinical and utility data. The EQ-5D has not yet been validated in spine patients in comparison with established outcome measures. EQ-5D, ODI, back and leg pain (0-10) scores were collected as part of standard clinical practice. Spearman rank correlations between the ODI, back and leg pain scores, and the EQ-5D were determined. A subanalysis to determine dimension-specific effects was done. Data were categorized by level of low back disability and level of back and leg pain. Data from 8385 patients (5046 females, 3339 males), mean age 52 (range, 18-96) were analyzed. There was a strong correlation between EQ-5D and ODI (r = -0.776) and between EQ-5D and back pain (r = -0.648); and moderate correlation between EQ-5D and leg pain scores (r = -0.538). Increasing disability, as measured by ODI, lead to lower EQ-5D scores, with similar response behavior for both back and leg pain scores. All correlations were statistically significant at P < 0.0001. The EQ-5D correlated well with established spine outcome measures, including ODI, and back and leg pain scores. EQ-5D correlated best with ODI scores. Correlation with back pain was stronger than leg pain, but all correlations were relatively strong. The EQ-5D can serve spine surgeons as an effective measure of clinical outcome and health utility for economic analysis.

  1. Measuring health-related quality of life in women with endometriosis: comparing the clinimetric properties of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D).

    Science.gov (United States)

    Aubry, G; Panel, P; Thiollier, G; Huchon, C; Fauconnier, A

    2017-06-01

    Which of the Endometriosis Health Profile-5 (EHP-5) and the EuroQol-5D (EQ-5D) is the most efficient to assess quality of life in women suffering from endometriosis? Although EHP-5 and EQ-5D instruments had an excellent responsiveness, EHP-5 has a better discriminative ability than EQ-5 to measure health-related quality of life (HrQoL). Proper measurement of HrQoL is important in endometriosis. While many quality of life instruments are available, few have been completely validated in endometriosis. The EHP-5 and the EQ-5D are short and practical scales, which may be useful. Literature is lacking to determine which one is the most suitable in clinical practice or in clinical research. This prospective and observational study conducted between 1 January 2012 and 31 December 2013 included a total of 253 consecutive women with proven endometriosis, undergoing medical or surgical treatment, in 2 French tertiary care centers. Women over 18 years consulting for painful symptoms of at least 3 months' duration or for infertility, with endometriosis proven histologically or radiologically, were requested to fill in the 2 scales before (T0) and 12 months after treatment (T1). Construct validity consisted in testing presupposed relationships between the scales and the characteristics of the patients or the endometriosis. Responsiveness to change was calculated for all patients and in each treatment group. Effect sizes were used according to Cohen's d method. A total of 216 women filled in completely all the questionnaires at T0 and 133 (61.6%) at T1. EHP-5 and EQ-5D had good discriminative abilities regarding the patients' symptoms, with significant superiority of EHP-5 concerning three of the nine hypotheses. The largest difference was that calculated for the 'intensity of dysmenorrhea' using the Visual Analogic Scale, with respectively effect size from Cohen's d (ES) = 0.86 95% CI (0.54-1.17) for EHP-5 versus 0.48 95% CI (0.16-0.79) for EQ-5D. There were no differences in

  2. PILOT DECONTAMINATION THROUGH PILOT SEQUENCE HOPPING IN MASSIVE MIMO SYSTEMS

    DEFF Research Database (Denmark)

    2015-01-01

    path between one of the users and one of the base stations define one of the channels. The system comprises a pilot generation unit configured to assign pilot sequences randomly among the users and a pilot processing unit configured to filter the pilot sequences received from a user of interest so...... that the channel coefficient of the channel of the user of interest is determined. The pilot sequences received from the user of interest are contaminated by other non-orthogonal or identical pilot sequences from other users of the cell of interest or other cells. The filter is configured so that the contamination...... caused by the other non-orthogonal or identical pilot sequences from the other users is reduced....

  3. Distress in suspected lung cancer patients following rapid and standard diagnostic programs: a prospective observational study.

    Science.gov (United States)

    Brocken, Pepijn; van der Heijden, Erik H F M; Oud, Karen T M; Bootsma, Gerben; Groen, Harry J M; Donders, A Rogier T; Dekhuijzen, P N Richard; Prins, Judith B

    2015-04-01

    Timeliness may influence emotional distress during the diagnostic phase of suspected lung cancer patients. We performed a prospective observational study to compare distress and quality of life (QoL) in two medical centres with a Rapid Outpatient Diagnostic Program (RODP) and two using conventional Stepwise Diagnostic Approach (SDA) on the basis of trained nurse-led care. Outpatients with radiological suspicion of lung cancer completed the Hospital Anxiety and Depression Scale (HADS), European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (QLQ-C30) and its 13-item Lung Cancer specific module (QLQ-LC13) upon first visit, 2 days later, thereafter weekly for 5 weeks and after 3 months. The 72 SDA patients and 121 RODP patients had a mean pre-diagnostic HADS-total score of 13.5 (SD 7.6); 63.4% had a score ≥10. Baseline QLQ-C30 global QoL was 61.6 (SD 22.7) exceeding reference values for lung cancer patients. Generalized least square models showed a significant centre by time interaction effect: during the first 6 weeks, HADS-total scores decreased in RODP patients (13.8-11.9) but sustained in SDA patients (13.1-13.6), whereas QoL showed no relevant changes. Times to diagnosis and discussion of therapy plan for RODP patients were 7 and 11 days shorter, respectively. Suspected lung cancer patients had high baseline distress levels. A decrease over time was found in RODP compared with SDA patients. QoL did not change relevantly. Albeit observational, these data indicate that patients experience less distress in rapid diagnostic programs than in stepwise diagnostic evaluation. Copyright © 2014 John Wiley & Sons, Ltd.

  4. Single vs. multiple fraction regimens for palliative radiotherapy treatment of multiple myeloma. A prospective randomised study

    International Nuclear Information System (INIS)

    Rudzianskiene, Milda; Inciura, Arturas; Gerbutavicius, Rolandas; Rudzianskas, Viktoras; Dambrauskiene, Ruta; Juozaityte, Elona; Macas, Andrius; Simoliuniene, Renata; Kiavialaitis, Greta Emilia

    2017-01-01

    To compare the impact of a single fraction (8 Gy x 1 fraction) and multifraction (3 Gy x 10 fractions) radiotherapy regimens on pain relief, recalcification and the quality of life (QoL) in patients with bone destructions due to multiple myeloma (MM). In all, 101 patients were included in a randomised prospective clinical trial: 58 patients were included in the control arm (3 Gy x 10 fractions) and 43 patients into the experimental arm (8 Gy x 1 fraction). The response rate was defined according to the International Consensus on Palliative Radiotherapy criteria. Recalcification was evaluated with radiographs. QoL questionnaires were completed before and 4 weeks after treatment. Pain relief was obtained in 81/101 patients (80.2%): complete response in 56 (69%) and partial in 25 patients (30.9%). No significant differences were observed in analgesic response between the groups. Significant factors for pain relief were female gender, age under 65, IgG MM type, presence of recalcification at the irradiated site. Recalcification was found in 32/101 patients (33.7%): complete in 17 (53.2%) and partial in 15 (46.2%). No significant differences were observed in recalcification between the groups. Significant factors for recalcification were Karnofsky index ≥ 60%, haemoglobin level ≤ 80 g/dl, MM stage II and analgesic response at the irradiated site. The QoL after radiotherapy was improved in the control group. The same analgesic and recalcification response was observed using two different radiotherapy regimens. Higher doses should be used to achieve a better QoL. (orig.) [de

  5. Ion Prostate Irradiation (IPI) – a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique

    International Nuclear Information System (INIS)

    Habl, Gregor; Herfarth, Klaus; Hatiboglu, Gencay; Edler, Lutz; Uhl, Matthias; Krause, Sonja; Roethke, Matthias; Schlemmer, Heinz P; Hadaschik, Boris; Debus, Juergen

    2014-01-01

    Due to physical characteristics, ions like protons or carbon ions can administer the dose to the target volume more efficiently than photons since the dose can be lowered at the surrounding normal tissue. Radiation biological considerations are based on the assumption that the α/β value for prostate cancer cells is 1.5 Gy, so that a biologically more effective dose could be administered due to hypofractionation without increasing risks of late effects of bladder (α/β = 4.0) and rectum (α/β = 3.9). The IPI study is a prospective randomized phase II study exploring the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. The study is designed to enroll 92 patients with localized prostate cancer. Primary aim is the assessment of the safety and feasibility of the study treatment on the basis of incidence grade III and IV NCI-CTC-AE (v. 4.02) toxicity and/or the dropout of the patient from the planned therapy due to any reason. Secondary endpoints are PSA-progression free survival (PSA-PFS), overall survival (OS) and quality-of-life (QoL). This pilot study aims at the evaluation of the safety and feasibility of hypofractionated irradiation of the prostate with protons and carbon ions in prostate cancer patients in an active beam technique. Additionally, the safety results will be compared with Japanese results recently published for carbon ion irradiation. Due to the missing data of protons in this hypofractionated scheme, an in depth evaluation of the toxicity will be created to gain basic data for a following comparison study with carbon ion irradiation. Clinical Trial Identifier: http://clinicaltrials.gov/show/NCT01641185 (clinicaltrials.gov)

  6. Evaluatie pilot Financieringslink

    NARCIS (Netherlands)

    Rosenboom, N.; Rougoor, W.; Fijnje, J.; Biesenbeek, C.

    Veel mkb-ondernemers hebben moeite om financiering te krijgen. Daarom heeft het ministerie van Economische Zaken in 2015 de pilot Financieringslink (Fink) opgezet– een online portal waar het mkb een financieringsverkenning kan indienen. Het hoofddoel van Fink is het verbeteren, standaardiseren en

  7. The Epoch Pilot Program.

    Science.gov (United States)

    Uhlenberg, Donald M.; Molenaar, Richard A.

    1982-01-01

    Describes a program for high school students who are between their junior and senior years which provides an opportunity to take part in aviation courses at the University of North Dakota. Students take courses leading to a private pilot license, and earn college credit for their efforts. (JN)

  8. Evaluatie pilot Endogene Factoren

    NARCIS (Netherlands)

    Viet AL; Fiolet D; Voortman JK; Rover C de; Hanning C; Uitenbroek D; Loon AJM van; PZO; GGD Achterhoek; GGD Midden Holland; GG&GD Amsterdam

    2004-01-01

    As a part of the project on the Local and National Monitor for Public Health several pilot studies were carried out in three Municipal Health Centres (GGDs). The first aim was to investigate the feasibility of a physical examination at the health centre in combination with a health interview (or

  9. Quality of Life as Medicine. II. A Pilot Study of a Five-Day �Quality of Life and Health� Cure for Patients with Alcoholism

    Directory of Open Access Journals (Sweden)

    Soren Ventegodt

    2003-01-01

    Full Text Available Alcoholism can be understood as a self-treatment for existential pain. A 5-day treatment was designed to relieve this psychological pain and existential anxiety, and thereby diminish the need for self-treatment with alcohol. The basic principle behind the treatment was holistic, restoring the quality of life (QOL and relationship with self, which according to the life mission theory happens when life-denying views are corrected and inner emotional conflicts are solved. The method in this treatment was a course with teachings in philosophy of life, psychotherapy, and body therapy. The synergy attained was considerable and the outcome demonstrates that in the course of 1 week, people have time to revise essential life-denying views and to integrate important, unfinished life events involving negative feelings. This was demonstrated by an improved QOL and a decrease in their dependency and need for alcohol abuse. In the week before, after the 5-day course, and again after 1 and 3 months, the 16 participants completed the SEQOL questionnaire on QOL and health. This was a pilot study based on a pre-experimental design, without a control group and without clinical control. Common for the group were a low QOL, numerous health problems, and alcohol dependency in spite of treatment with Antabus� (disulfiram. The study showed an increase in QOL from 57.6% before the course to 69.4% 3 months after the course, or an improvement in QOL of 11.8%. There was a 24.0% improvement in self-perceived mental health, and satisfaction with health in general was improved by 11.1%. The total sum of health symptoms in the group was reduced from 59% of maximum to 33%. It is concluded that for this small and motivated group with alcohol problems, it was possible to improve QOL and health in only 5 days with a holistic treatment that combined philosophy of life, psychotherapy, and body therapy, but the results are not final. Further research is needed.

  10. Psychophysiology of prospective memory.

    Science.gov (United States)

    Rothen, Nicolas; Meier, Beat

    2014-01-01

    Prospective memory involves the self-initiated retrieval of an intention upon an appropriate retrieval cue. Cue identification can be considered as an orienting reaction and may thus trigger a psychophysiological response. Here we present two experiments in which skin conductance responses (SCRs) elicited by prospective memory cues were compared to SCRs elicited by aversive stimuli to test whether a single prospective memory cue triggers a similar SCR as an aversive stimulus. In Experiment 2 we also assessed whether cue specificity had a differential influence on prospective memory performance and on SCRs. We found that detecting a single prospective memory cue is as likely to elicit a SCR as an aversive stimulus. Missed prospective memory cues also elicited SCRs. On a behavioural level, specific intentions led to better prospective memory performance. However, on a psychophysiological level specificity had no influence. More generally, the results indicate reliable SCRs for prospective memory cues and point to psychophysiological measures as valuable approach, which offers a new way to study one-off prospective memory tasks. Moreover, the findings are consistent with a theory that posits multiple prospective memory retrieval stages.

  11. Balance and walking involvement in facioscapulohumeral dystrophy: a pilot study on the effects of custom lower limb orthoses.

    Science.gov (United States)

    Aprile, I; Bordieri, C; Gilardi, A; Lainieri Milazzo, M; Russo, G; De Santis, F; Frusciante, R; Iannaccone, E; Erra, C; Ricci, E; Padua, L

    2013-04-01

    Autosomal dominant facioscapulohumeral dystrophy (FSHD), the third most common muscular dystrophy, is characterised by asymmetric and highly variable muscle weakness. In FSHD patients, the coupling of the ankle muscles impairment with the knee, hip and abdominal muscles impairment, causes complex alterations of balance and walking with deterioration of quality of life (QoL). The aim of this pilot study is to evaluate the effects of custom orthoses (foot orthosis-FO and ankle foot orthosis-AFO) on balance, walking and QoL of FSHD patients through a multidimensional approach. Pilot study. Outpatient Rehabilitation Department of Don Gnocchi Foundation. Fifteen patients with facioscapulohumeral muscular dystrophy were studied. On 15 FSHD patients clinical evaluation (Manual Muscle Test-MMT, Clinical Severity Score), performance tests (10 meter Walking test-10mWT and 2 minute Walking Test-2minWT), instrumental assessment (stabilometric evaluation), disability (Rivermead Mobility Index- RMI, Berg Balance Scale-BBS) and patient-oriented (Medical Outcome Study 36-item Short Form-SF-36, North American Spine Society-NASS and Visual Analogue Scale-VAS) measures were performed. Patients were evaluated first, wearing their shoes and then wearing their shoes plus orthoses. This evaluation was performed 1 month after wearing the orthoses. The shoes plus orthoses evaluation, performed after one month in which the patients daily wore the custom lower limb orthoses, showed a significant improvement of walking performance (10-mWT pstudy shows that in FSHD patients' custom lower limb orthoses (foot-orthoses and ankle-foot-orthoses); evaluated by using a multidimensional approach, improve walking, balance and QoL. These preliminary results suggest that custom lower limb orthoses could reduce the risk of falling with a positive effect on our patients' safety. Our results should encourage the scientific community to do efficacy study on this hot topic.

  12. Importance of chewing, saliva, and swallowing function in patients with advanced oral cancer undergoing preoperative chemoradiotherapy: a prospective study of quality of life.

    Science.gov (United States)

    Nemeth, D; Zaleczna, L; Huremovic, A; Engelmann, J; Poeschl, P W; Strasz, M; Holawe, S; Kornek, G; Laskus, A; Sacher, C; Erovic, B M; Perisanidis, C

    2017-10-01

    The primary objective of this study was to investigate the quality of life (QOL) of patients with oral squamous cell carcinoma (OSCC) undergoing curative neoadjuvant chemoradiotherapy followed by radical tumour resection and simultaneous oral cavity reconstruction, using two validated questionnaires. A secondary objective was to assess clinical variables predicting post-treatment dysfunction in chewing, saliva, and swallowing. Thirty-five patients with locally advanced OSCC who underwent preoperative chemoradiotherapy were recruited prospectively. All patients completed both the University of Washington Quality of Life version 4 questionnaire (UW-QOL) and the Functional Assessment of Cancer Therapy-Head & Neck version 4 questionnaire (FACT-H&N). UW-QOL and FACT-H&N items were associated with clinical variables. Nearly three-quarters of OSCC patients perceived good to excellent levels of overall QOL after preoperative chemoradiotherapy. Chewing difficulties, decreased salivary function, and swallowing dysfunction were the most frequent complaints of OSCC patients. Items related to food intake were significantly worse in OSCC patients older than 60 years and those with T4 tumours, as well as those without alcohol intake. Chewing, saliva, and swallowing are the most significant issues in patients with OSCC undergoing preoperative chemoradiotherapy. The results of this study may help guide treatment decisions for OSCC patients based on more accurate expectations of adverse effects of cancer treatment. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  13. Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months-a prospective cohort study.

    Science.gov (United States)

    Nickel, Felix; Schmidt, Lukas; Bruckner, Thomas; Büchler, Markus W; Müller-Stich, Beat-Peter; Fischer, Lars

    2017-02-01

    It has been proven that bariatric surgery affects weight loss. Patients with morbid obesity have a significantly lower quality of life (QOL) and body image compared with the general population. To evaluate QOL, body image, and general self-efficacy (GSE) in patients with morbid obesity undergoing bariatric surgery within clinical parameters. Monocentric, prospective, longitudinal cohort study. Patients completed the short form 36 (SF-36) for QOL, body image questionnaire, and GSE scale 3 times: before surgery and within 6 months and 24 months after surgery. Influence of gender, age, and type of procedure, either laparoscopic sleeve gastrectomy (SG) or laparoscopic Roux-en-Y gastric bypass, were analyzed. Thirty patients completed the questionnaires before and within 6 and 24 months after surgery. SF-36 physical summary score improved significantly from 34.3±11.0 before surgery to 46.0±10.4 within 6 months (Psurgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (Psurgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (Pbariatric surgery. Improvements were independent of gender, age, and type of operation. Mental QOL was influenced by body image and GSE. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  14. 76 FR 63183 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

    Science.gov (United States)

    2011-10-12

    ...-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification Rules; Correction AGENCY: Federal... regulations to revise the pilot, flight instructor, and pilot school certification requirements. In particular...

  15. Spiritual well-being and quality of life among Icelanders receiving palliative care: data from Icelandic pilot-testing of a provisional measure of spiritual well-being from the European Organisation for Research and Treatment of Cancer.

    Science.gov (United States)

    Asgeirsdottir, G H; Sigurdardottir, V; Gunnarsdottir, S; Sigurbjörnsson, E; Traustadottir, R; Kelly, E; Young, T; Vivat, B

    2017-03-01

    Palliative care focuses on improving quality of life (QoL). This study examined the feasibility of the Icelandic version of a provisional European Organisation for Research and Treatment of Cancer (EORTC) measure of spiritual well-being (SWB), and explored the relationship between SWB and QoL for palliative care patients in Iceland. Instruments from the EORTC were used: the provisional measure of SWB, which was undergoing pilot-testing in Iceland, and the EORTC QLQ C15-PAL. The correlation between scores was examined and descriptive statistics were used. Structured interviews explored feasibility. Thirty persons participated with average age 72 years. Belief in God or a higher power had the mean 3.33 on a 1-4 scale and the mean for overall SWB was 5.73 on a 1-7 scale. The mean score for global health/QoL was 59.4, physical functioning 48.5 and emotional functioning 78.9 on a 0-100 scale. Overall QoL was positively correlated with SWB showing r(30) = 0.386, P = 0.035. The participants found that answering the provisional EORTC QLQ-SWB prompted an emotional response and took the opportunity to discuss the subject. The provisional SWB measure was found relevant for the Icelandic context, and the study indicates that SWB and QoL are closely connected. © 2015 John Wiley & Sons Ltd.

  16. Integrated geophysical-geochemical methods for archaeological prospecting

    OpenAIRE

    Persson, Kjell

    2005-01-01

    A great number of field measurements with different methods and instruments were conducted in attempts to develop a method for an optimal combination of various geochemical and geophysical methods in archaeological prospecting. The research presented in this thesis focuses on a study of how different anthropogenic changes in the ground can be detected by geochemical and geophysical mapping and how the results can be presented. A six-year pilot project, Svealand in Vendel and Viking periods (S...

  17. The national conversion pilot project

    International Nuclear Information System (INIS)

    Van Der Puy, M.; Francis, G.; Konczal, M.

    1994-01-01

    The Department of Energy is now faced with the prospect of terminating traditional defense production missions at several Department of Energy sites. Because of this, there is a critical need to develop a DOE process to convert former defense production facilities to private use so that underutilized workers and facilities may be used to minimize the impact on the United States economy. The purpose of the National Conversation Pilot Project (NCPP) at Rocky Flats near Denver, Colorado is to explore and demonstrate the feasibility of economic conversion of DOE facilities, in a manner consistent with ongoing site waste management and cleanup activities, and non-prejudicial to future land use planning decisions. The NCPP is divided into three stages: The first stage, now under way, is one of detailed planning for cleanup and building maintenance activities. The second stage involves building cleanup necessary to support the proposed industrial activities, maintenance of equipment and building infrastructure necessary to assure protection of human health and the environment, declassification work, and some small scale research and development activities. Stage III would involve DOE metals recycling. Specific approval from the DOE is required prior to each project stage. To ensure stakeholder involvement, a steering committee will advise the DOE on the desirability to proceed with the project from stage to stage. A key question in the conversion process is whether a competitive economic and regulatory environment can be created on a DOE facility, allowing an onsite conversion business to effectively compete with offsite businesses. If successful, the Rocky Flats project could become the model for economic conversion at other DOE facilities

  18. Agricultural Pilot's Audiological Profile

    Directory of Open Access Journals (Sweden)

    Foltz, Lucas

    2010-09-01

    Full Text Available Introduction: The agricultural airplane pilot are daily exposed to intense noises, being susceptible to the noise-induced hearing loss (NIHL and its auditory and extra auditory effects. Objective: To analyze the audiological profile of this population, verifying the work's influence on its hearing. Method: It was realized a retrospective, individual, observational, and cross-sectional study through the data obtained by means of a questionnaire and audiometric thresholds of 41 agricultural pilots. To the statistical analysis were utilized the chi-square, Spearman, and Wilcoxon tests with significance level of 5%. Results: It was verified that 95,1% of the pilots use PPE ( personal protective equipment during flight and 58,5% have contact with pesticides. More than half of individuals referred to feel auditory and extra auditory symptoms, being the buzz the more frequent (29,1%. It has the occurrence of 29,3% of NIHL suggestive hearing loss and 68,3% of normality, taking this presence of unilateral notch in 24,4% and bilateral notch in 31,7%. It was found correlation statistically significant in the associations between time of service and the average of the acute frequencies in the right ear (p=0038, and in the left ear (p=0,010. It has a statistical tendency in the association between audiometric configuration and contact with pesticides (p=0,088. Conclusion: The hearing loss prevalence in this study was showed high. More than half of the sample has normal audiometric thresholds with notch configuration. Such data lead to the conclusion that the agricultural pilots, even with PPE use, they still suffer with the damages caused by noise, needing best proposals of hearing loss prevention.

  19. Process Experimental Pilot Plant

    International Nuclear Information System (INIS)

    Henze, H.

    1986-01-01

    The Process Experimental Pilot Plant (PREPP) at the Idaho National Engineering Laboratory (INEL) was built to convert transuranic contaminated solid waste into a form acceptable for disposal at the Waste Isolation Pilot Plant (WIPP), located near Carlsbad, New Mexico. There are about 2.0 million cubic ft of transuranic waste stored at the Transuranic Storage Area of the INEL's Radioactive Waste Management Complex (RWMC). The Stored Waste Examination Pilot Plant (SWEPP) located at the RWMC will examine this stored transuranic waste to determine if the waste is acceptable for direct shipment to and storage at WIPP, or if it requires shipment to PREPP for processing before shipment to WIPP. The PREPP process shreds the waste, incinerates the shredded waste, and cements (grouts) the shredded incinerated waste in new 55-gal drums. Unshreddable items are repackaged and returned to SWEPP. The process off-gas is cleaned prior to its discharge to the atmosphere, and complies with the effluent standards of the State of Idaho, EPA, and DOE. Waste liquid generated is used in the grouting operation

  20. 76 FR 19267 - Pilot, Flight Instructor, and Pilot School Certification; Technical Amendment

    Science.gov (United States)

    2011-04-07

    .... No. 61-127] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School Certification; Technical... for pilots, flight instructors, ground instructors, and pilot schools. This document reinstates two... entitled, ``Pilot, Flight Instructor, and Pilot School Certification; Final Rule'' (74 FR 42500). That...

  1. Associations between gender, disease features and symptom burden in patients with myeloproliferative neoplasms: an analysis by the MPN QOL International Working Group.

    Science.gov (United States)

    Geyer, Holly L; Kosiorek, Heidi; Dueck, Amylou C; Scherber, Robyn; Slot, Stefanie; Zweegman, Sonja; Te Boekhorst, Peter Aw; Senyak, Zhenya; Schouten, Harry C; Sackmann, Federico; Fuentes, Ana Kerguelen; Hernández-Maraver, Dolores; Pahl, Heike L; Griesshammer, Martin; Stegelmann, Frank; Döhner, Konstanze; Lehmann, Thomas; Bonatz, Karin; Reiter, Andreas; Boyer, Francoise; Etienne, Gabriel; Ianotto, Jean-Christophe; Ranta, Dana; Roy, Lydia; Cahn, Jean-Yves; Harrison, Claire N; Radia, Deepti; Muxi, Pablo; Maldonado, Norman; Besses, Carlos; Cervantes, Francisco; Johansson, Peter L; Barbui, Tiziano; Barosi, Giovanni; Vannucchi, Alessandro M; Paoli, Chiara; Passamonti, Francesco; Andreasson, Bjorn; Ferrari, Maria L; Rambaldi, Alessandro; Samuelsson, Jan; Cannon, Keith; Birgegard, Gunnar; Xiao, Zhijian; Xu, Zefeng; Zhang, Yue; Sun, Xiujuan; Xu, Junqing; Kiladjian, Jean-Jacques; Zhang, Peihong; Gale, Robert Peter; Mesa, Ruben A

    2017-01-01

    The myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia and myelofibrosis, are distinguished by their debilitating symptom profiles, life-threatening complications and profound impact on quality of life. The role gender plays in the symptomatology of myeloproliferative neoplasms remains under-investigated. In this study we evaluated how gender relates to patients' characteristics, disease complications and overall symptom expression. A total of 2,006 patients (polycythemia vera=711, essential thrombocythemia=830, myelofibrosis=460, unknown=5) were prospectively evaluated, with patients completing the Myeloproliferative Neoplasm-Symptom Assessment Form and Brief Fatigue Inventory Patient Reported Outcome tools. Information on the individual patients' characteristics, disease complications and laboratory data was collected. Consistent with known literature, most female patients were more likely to have essential thrombocythemia (48.6% versus 33.0%; Pgender contributes to the heterogeneity of myeloproliferative neoplasms by influencing phenotypic profiles and symptom expression. Copyright© Ferrata Storti Foundation.

  2. 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

  3. Continuous operation of a pilot plant for the production of beryllium oxide

    Energy Technology Data Exchange (ETDEWEB)

    Costa, T C; Amaral, S; Silveira, C M.S.; de Oliveira, A P [Instituto de Tecnologia, Governador Valadares (Brazil)

    1975-12-01

    A method of obtaining beryllium oxide with a purity of 99,2% was developed in a pilot plant with a capacity of 7 tons per month destined to operate continuously. The operation market prospects and control of production with the objective of obtaining internacional technical grade beryllium oxide are discussed.

  4. Continuous operation of a pilot plant for the production of beryllium oxide

    International Nuclear Information System (INIS)

    Costa, T.C.; Amaral, S.; Silveira, C.M.S.; Oliveira, A.P. de

    1975-01-01

    A method of obtaining beryllium oxide with a purity of 99,2% was developed in a pilot plant with a capacity of 7 tons per month destined to operate continuously. The operation market prospects and control of production with the objective of obtaining internacional technical grade beryllium oxide are discussed [pt

  5. LANCELOT pilot report, June 2007

    DEFF Research Database (Denmark)

    Levinsen, Karin; Meyer, Bente

    The aim of the Lancelot pilot evaluation process was to understand how teachers learn to teach and to relate to the online environment through the specific context of the Lancelot live online course. Following the Action Research in the autumn of 2006 the LANCELOT live online language course...... was revised for the piloting in the spring of 2007. A second aim of the pilot evaluation has therefore been to assess the revision of the course following the Action Research....

  6. CANDU market prospects

    International Nuclear Information System (INIS)

    Kakaria, B.K.

    1994-01-01

    This 1994 survey of prospective markets for CANDU reactors discusses prospects in Turkey, Thailand, the Philippines, Korea, Indonesia, China and Egypt, and other opportunities, such as in fuel cycles and nuclear safety. It was concluded that foreign partners would be needed to help with financing

  7. Sharpening Intertemporal Prospect Theory

    OpenAIRE

    Pushpa, Rathie; Carlos, Radavelli; Sergio, Da Silva

    2006-01-01

    Prospect theory [4] of risky choices has been extended to encompass intertemporal choices [6]. Presentation of intertemporal prospect theory suffers from minor mistakes, however [2]. To clarify the theory we restate it and show further mistakes in current presentations ([6], [2]) of value and discount functions.

  8. 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...

  9. A pilot study of the effects of behavioral weight loss treatment on fibromyalgia symptoms.

    Science.gov (United States)

    Shapiro, Jennifer R; Anderson, Drew A; Danoff-Burg, Sharon

    2005-11-01

    Previous studies have found a relation between weight loss and pain severity in various chronic pain populations. However, there has been little research examining the relation between body mass index (BMI) and fibromyalgia syndrome (FMS). The purpose of this pilot study was to investigate the relationship between BMI and FMS symptoms and to determine if FMS symptoms would decrease following weight loss. Overweight and obese women participated in a 20-week behavioral weight loss treatment. Participants, on average, lost 9.2 lbs (4.4% of their initial weight), and there were significant pre-postimprovements on several outcome measures. Although weight was not significantly related to pain at baseline, weight loss significantly predicted a reduction in FMS, pain interference, body satisfaction, and quality of life (QOL). Findings suggest that behavioral weight loss treatment could be included in the treatment for overweight/obese women with FMS.

  10. Quality of life outcome measures using UW-QOL questionnaire v4 in early oral cancer/squamous cell cancer resections of the tongue and floor of mouth with reconstruction solely using local methods.

    Science.gov (United States)

    Boyapati, Raghuram P; Shah, Ketan C; Flood, Valerie; Stassen, Leo F A

    2013-09-01

    Cancer treatment either by surgery alone or in a combination of surgery, radiotherapy±chemotherapy has significant consequences on the physical, mental, emotional and psychosocial wellbeing of the patient. Measurement of quality of life (QOL) is necessary to understand the patient's perception of their own treatment, as clinicians' views can be biased. Reconstruction of a cancerous defect with a free vascular flap is ideal in large, often composite defects, provided it is appropriate to the advanced stage and prognosis of the disease, medical condition of the patient, availability of surgical and financial resources and allows the prosthetic rehabilitation of the anatomic area. Using University of Washington Quality of life 4 questionnaire (UW-QOL4), we assessed the QOL of 38 patients, who underwent local surgical reconstructions after resection of T1/T2 tongue/floor of mouth squamous cell carcinoma defects. Objective assessment of speech and swallow function was also carried out using therapy outcome measure (TOM) scores by the speech and language therapy team (SALT) aiming to see the differences in the scores obtained in patients who underwent post-operative radiotherapy. Our study, conducted 6months after completion of all oncologic treatment for the primary disease, showed satisfactory levels of quality of life parameters with good function showing that local reconstructive methods are successful and may have benefits in the management of early oral cancers involving the tongue and floor of mouth. They are beneficial by providing a good quality in terms of function, by reducing the operating time, the surgical morbidity, simplifying post-operative care and thereby becoming an efficient, effective and a cost effective method. Copyright © 2012 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  11. Quality of Life in a Prospective, Multicenter Phase 2 Trial of Neoadjuvant Full-Dose Gemcitabine, Oxaliplatin, and Radiation in Patients With Resectable or Borderline Resectable Pancreatic Adenocarcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Serrano, Pablo E. [Department of Surgery, University Health Network, University of Toronto, Toronto, ON (Canada); Herman, Joseph M. [Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland (United States); Griffith, Kent A.; Zalupski, Mark M. [Center for Cancer Biostatistics, Biostatistics Unit, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Kim, Edward J. [Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Bekaii-Saab, Tanios S. [Division of Medical Oncology, Department of Internal Medicine, The Ohio State University Medical Center, Columbus, Ohio (United States); Ben-Josef, Edgar [Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan (United States); Dawson, Laura A. [Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Ringash, Jolie [Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON (Canada); Wei, Alice C., E-mail: alice.wei@uhn.ca [Department of Surgery, University Health Network, University of Toronto, Toronto, ON (Canada); Princess Margaret Cancer Center, University Health Network, Toronto, ON (Canada); Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON (Canada)

    2014-10-01

    Purpose: To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma. Methods and Materials: Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores were compared with baseline. A change >10% was considered a minimal clinically important difference. Results: Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (−8, P=.02). This was in parallel with deterioration in physical functioning (−14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (−13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit. Conclusions: The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical

  12. Quality of Life in a Prospective, Multicenter Phase 2 Trial of Neoadjuvant Full-Dose Gemcitabine, Oxaliplatin, and Radiation in Patients With Resectable or Borderline Resectable Pancreatic Adenocarcinoma

    International Nuclear Information System (INIS)

    Serrano, Pablo E.; Herman, Joseph M.; Griffith, Kent A.; Zalupski, Mark M.; Kim, Edward J.; Bekaii-Saab, Tanios S.; Ben-Josef, Edgar; Dawson, Laura A.; Ringash, Jolie; Wei, Alice C.

    2014-01-01

    Purpose: To determine the health-related quality of life (QOL) during and after neoadjuvant chemoradiation therapy and surgery for patients with pancreatic adenocarcinoma. Methods and Materials: Participants of a prospective, phase 2 multi-institutional trial treated with neoadjuvant chemoradiation followed by surgery completed QOL questionnaires (European Organization for Research and Treatment in Cancer Quality of Life Questionnaire version 3.0 [EORTC-QLQ C30], EORTC-Pancreatic Cancer module [EORTC-PAN 26], and Functional Assessment of Cancer Therapy Hepatobiliary and Pancreatic subscale [FACT-Hep]) at baseline, after 2 cycles of neoadjuvant therapy, after surgery, at 6 months from initiation of therapy, and at 6-month intervals for 2 years. Mean scores were compared with baseline. A change >10% was considered a minimal clinically important difference. Results: Of 71 participants in the trial, 55 were eligible for QOL analysis. Compliance ranged from 32% to 74%. The EORTC-QLQ C30 global QOL did not significantly decline after neoadjuvant therapy, whereas the Functional Assessment of Cancer Therapy global health measure showed a statistically, but not clinically significant decline (−8, P=.02). This was in parallel with deterioration in physical functioning (−14.1, P=.001), increase in diarrhea (+16.7, P=.044), and an improvement in pancreatic pain (−13, P=.01) as per EORTC-PAN 26. Because of poor patient compliance in the nonsurgical group, long-term analysis was performed only from surgically resected participants (n=36). Among those, global QOL returned to baseline levels after 6 months, remaining near baseline through the 24-month visit. Conclusions: The study regimen consisting of 2 cycles of neoadjuvant therapy was completed without a clinically significant QOL deterioration. A transient increase in gastrointestinal symptoms and a decrease in physical functioning were seen after neoadjuvant chemoradiation. In those patients who underwent surgical

  13. Implementation of a Psychoeducational Program for Cancer Survivors and Family Caregivers at a Cancer Support Community Affiliate: A Pilot Effectiveness Study.

    Science.gov (United States)

    Dockham, Bonnie; Schafenacker, Ann; Yoon, Hyojin; Ronis, David L; Kershaw, Trace; Titler, Marita; Northouse, Laurel

    2016-01-01

    Psychoeducational interventions, tested for efficacy in randomized clinical trials, are seldom implemented in clinical practice where cancer survivors and their family caregivers can benefit from them. This study examined the effectiveness of the FOCUS Program on cancer survivors' and their family caregivers' outcomes when implemented at a Cancer Support Community (CSC) affiliate by agency social workers. Study aims were to (1) test effects of the program on survivor and caregiver outcomes as a unit and (2) determine program feasibility in terms of enrollment, retention, intervention fidelity, and satisfaction. A preintervention and postintervention pilot effectiveness study was conducted with 34 cancer survivor-caregiver dyads (ie, pairs). The FOCUS Program, originally delivered by nurses in dyads' homes, was modified to a small-group format and delivered by CSC social workers. The primary outcome was quality of life (QOL). Intermediary outcomes were benefits of illness/caregiving, communication, support, and self-efficacy. Analyses included repeated-measures analysis of variance. Dyads had significant improvements in total QOL; physical, emotional, and functional QOL; benefits of illness; and self-efficacy. Effect sizes were similar to prior randomized clinical trial findings. Although dyads were difficult to recruit (enrollment, 60%), both retention (92%) and intervention fidelity (94%) were high. It was possible to implement the FOCUS Program at a CSC affiliate by agency staff, obtain positive intervention effects, and maintain intervention fidelity. Researchers and clinicians need to collaborate to implement more evidence-based interventions in practice settings for cancer survivors and their family caregivers.

  14. Quality of life, fatigue and local response of patients with unstable spinal bone metastases under radiation therapy - a prospective trial

    International Nuclear Information System (INIS)

    Rief, Harald; Heinhold, Maximiliane; Bruckner, Thomas; Schlampp, Ingmar; Förster, Robert; Welzel, Thomas; Bostel, Tilman; Debus, Jürgen; Rieken, Stefan

    2014-01-01

    To evaluate the local response according to stability after radiotherapy (RT) with a special focus on quality-of-life (QoL), fatigue, pain and emotional distress in patients with unstable spinal bone metastases. In this prospective trial, 30 patients were treated from September 2011 until March 2013. The stability of osteolytic metastases in the thoracic and lumbar spine was evaluated on the basis of the Taneichi-score after three and six months. EORTC QLQ-BM22, EORTC QLQ-FA13, and QSC-R10 were assessed at baseline, and three months after RT. After 3 months, 25% (n = 6) and after 6 months 33.3% (n = 8) were classified as stable. QoL, fatigue, and emotional distress showed no difference over the course. The pain response 3 months after RT showed a significant difference (p < 0.001). Pathological fractures occurred in 8.3% of the patients (n = 2) within six months following RT. Our trial demonstrated that RT can improve stability in one third of patients over a 6-months period with unstable spinal metastases. Importantly, for these patients pain relief was detected but RT had no impact on QoL, fatigue, and emotional distress

  15. Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

    Science.gov (United States)

    Rosenberg, Evan C; Louik, Jay; Conway, Erin; Devinsky, Orrin; Friedman, Daniel

    2017-08-01

    Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life in Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9-point improvement in overall patient QOLCE (p < 0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior, and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects; however, further studies in placebo-controlled, double-blind trials are necessary to confirm this finding. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  16. Impact of Ospemifene on Quality of Life and Sexual Function in Young Survivors of Cervical Cancer: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Nicoletta De Rosa

    2017-01-01

    Full Text Available Background. Cervical cancer (CC treatments impact quality of life (QoL and sexual function (SF of survivors. Treatment options to reduce sexual dysfunction are limited. The aim of this study was to assess the effectiveness of ospemifene in CC survivors with clinical signs and symptoms of vulvovaginal atrophy (VVA focusing on their QoL and SF. Materials and Methods. Fifty-two patients with previous diagnosis of stage I-IIa CC suffering from VVA and treated with ospemifene were enrolled into a single arm prospective study. Patient underwent 6 months of therapy. At baseline and after 6 months all subjects performed Vaginal Health Index (VHI. The SF and QoL were measured by The European Organization for Research and Treatment of Cancer (EORTC Quality of Life Questionnaire (QLQ and the Cervical Cancer Module (CXC-24. Results. After treatment a significant improvement of each parameter of VHI has been demonstrated. Global health status and emotional and social functioning scores improved significantly. On the contrary, general symptoms scales did not show significant difference from baseline data. Sexual activity, sexual vaginal functioning, body image, and sexual enjoyment scores increased significantly. Conclusion. Ospemifene seems to be effective in decreasing the VVA symptoms in CC survivors.

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

    Directory of Open Access Journals (Sweden)

    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.

  18. Quality of life after laparoscopic gastric banding: Prospective study (152 cases) with a follow-up of 2 years.

    Science.gov (United States)

    Champault, Axèle; Duwat, Olivier; Polliand, Claude; Rizk, Nabil; Champault, Gérard G

    2006-06-01

    To evaluate influence of laparoscopic gastric banding (LGB) on quality of life (QOL) in patients with morbid obesity. Laparoscopic adjustable gastric banding is a popular bariatric operation in Europe. The objectives of surgical therapy in patients with morbid obesity are reduction of body weight, and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients. In a prospective clinical trial, development of the individual patient QOL was analyzed, after LGB in patients with morbid obesity. From October 1999 to January 2001, 152 patients [119 women, 33 men, mean age 38.4 y (range 24 to 62), mean body mass index 44.3 (range 38 to 63)] underwent evaluation for LGB according the following protocol: history of obesity; concise counseling of patients and relative on nonsurgical treatment alternatives, risk of surgery, psychologic testing, questionnaire for eating habits, necessity of lifestyle change after surgery; medical evaluation including endocrinologic and nutritionist work-up, upper GI endoscopy, evaluation of QOL using the Gastro Intestinal Quality of Life Index (GIQLI). Decision for surgery was a multidisciplinary consensus. This group was follow-up at least 2 years, focusing on weight loss and QOL. Mean operative time was 82 minutes; mean hospital stay was 2.3 days and the mean follow-up period was 34 months. The BMI dropped from 44.3 to 29.6 kg/m and all comorbid conditions improved markedly: diabetes melitus resolved in 71% of the patients, hypertension in 33%, and sleep apnea in 90%. However, 26 patients (17%) had late complications requiring reoperation. Preoperative global GIQLI score was 95 (range 56 to 140), significant different of the healthy volunteers score (120) (70 to 140) P < 0.001. Correlated with weight loss (percentage loss of overweight and BMI), the global score of the group increased to 100 at 3 months, 104 at 6, 111 at 1 year to reach 119 at 2 years which is no

  19. Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Klein, Jonathan, E-mail: jonathan.klein@rmp.uhn.on.ca [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Dawson, Laura A. [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Jiang, Haiyan [Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Kim, John; Dinniwell, Rob; Brierley, James; Wong, Rebecca [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Lockwood, Gina [Department of Biostatistics, Princess Margaret Cancer Centre, Toronto, Ontario (Canada); Ringash, Jolie [Department of Radiation Oncology, University of Toronto, Toronto, Ontario (Canada); Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario (Canada)

    2015-09-01

    Purpose: To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver. Methods and Materials: Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were also treated. Results: The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients. Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively. Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival. Conclusions: Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants

  20. Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy

    International Nuclear Information System (INIS)

    Klein, Jonathan; Dawson, Laura A.; Jiang, Haiyan; Kim, John; Dinniwell, Rob; Brierley, James; Wong, Rebecca; Lockwood, Gina; Ringash, Jolie

    2015-01-01

    Purpose: To evaluate quality of life (QoL), an important outcome owing to poor long-term survival, after stereotactic body radiation therapy (SBRT) to the liver. Methods and Materials: Patients (n=222) with hepatocellular carcinoma (HCC), liver metastases, or intrahepatic cholangiocarcinoma and Child-Pugh A liver function received 24-60 Gy of 6-fraction image-guided SBRT. Prospective QoL assessment was completed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and/or Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4) questionnaires at baseline and 1, 3, 6, and 12 months after treatment. Ten HCC patients with Child-Pugh B liver function were also treated. Results: The QLQ-C30 was available for 205 patients, and 196 completed the FACT-Hep. No difference in baseline QoL (P=.17) or overall survival (P=.088) was seen between the HCC, liver metastases, and intrahepatic cholangiocarcinoma patients. Appetite loss and fatigue measured by the QLQ-C30 clinically and statistically worsened by 1 month after treatment but recovered by 3 months. At 3 and 12 months after treatment, respectively, the FACT-Hep score had improved relative to baseline in 13%/19%, worsened in 36%/27%, and remained stable in 51%/54%. Using the QLQ-C30 Global Health score, QoL improved in 16%/23%, worsened in 34%/39%, and remained stable in 50%/38% at 3 and 12 months, respectively. Median survival was 17.0 months (95% confidence interval [CI] 12.3-19.8 months). Higher baseline scores on both FACT-Hep and QLQ-C30 Global Health were associated with improved survival. Hazard ratios for death, per 10-unit decrease in QoL, were 0.90 (95% CI 0.83-0.98; P=.001) and 0.88 (95% CI 0.82-0.95; P=.001), respectively. Tumor size was inversely correlated with survival. Conclusions: Liver SBRT temporarily worsens appetite and fatigue, but not overall QoL. Stereotactic body radiation therapy is well tolerated and warrants

  1. No Impairment of Quality of Life 18 Months After High-Dose Intensity-Modulated Radiotherapy for Localized Prostate Cancer: A Prospective Study

    International Nuclear Information System (INIS)

    Marchand, Virginie; Bourdin, Sylvain; Charbonnel, Christelle; Rio, Emmanuel

    2010-01-01

    Purpose: To determine prospectively intermediate-term toxicity and quality of life (QoL) of prostate cancer patients after intensity-modulated radiotherapy (IMRT). Patients and Methods: Fifty-five patients with localized prostate adenocarcinoma were treated by IMRT (76 Gy). Physicians scored acute and late toxicity using the Common Terminology Criteria for Adverse Events version 3.0. Patients assessed general and prostate-specific QoL before IMRT (baseline) and at 2, 6, and 18 months using European Organization for Research and Treatment of Cancer questionnaires QLQ-C30(+3) and QLQ-PR25. Results: Median age was 73 years (range, 54-80 years). Risk categories were 18% low risk, 60% intermediate risk, and 22% high risk; 45% of patients received hormonal therapy (median duration, 6 months). The incidence of urinary and bowel toxicity immediately after IMRT was, respectively, 38% and 13% (Grade 2) and 2% and none (Grade 3); at 18 months it was 15% and 11% (Grade 2) and none (Grade 3). Significant worsening of QoL was reported at 2 months with regard to fatigue (+11.31, p = 1.10 -7 ), urinary symptoms (+9.07, p = 3.10 -11 ), dyspnea (+7.27, p = 0.008), and emotional (-7.02, p = 0.002), social (-6.36, p = 0.003), cognitive (-4.85, p = 0.004), and physical (-3.39, p = 0.007) functioning. Only fatigue (+5.86, p = 0.003) and urinary symptoms (+5.86, p = 0.0004) had not improved by 6 months. By 18 months all QoL scores except those for dyspnea (+8.02, p = 0.01) and treatment-related symptoms (+4.24, p = 0.01) had returned to baseline. These adverse effects were exacerbated by hormonal therapy. Conclusion: High-dose IMRT with accurate positioning induces only a temporary worsening of QoL.

  2. Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

    Energy Technology Data Exchange (ETDEWEB)

    King, Christopher R., E-mail: crking@mednet.ucla.edu [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Collins, Sean [Department of Radiation Oncology, Georgetown University, Washington, District of Columbia (United States); Fuller, Donald [Genesis Healthcare Partners, San Diego, California (United States); Wang, Pin-Chieh; Kupelian, Patrick; Steinberg, Michael [Department of Radiation Oncology, University of California, Los Angeles, California (United States); Katz, Alan [Flushing Radiation Oncology, Flushing, New York (United States)

    2013-12-01

    Purpose: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). Methods and Materials: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. Results: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. Conclusion: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.

  3. Residual deficits in quality of life one year after intensity-modulated radiotherapy for patients with locally advanced head and neck cancer. Results of a prospective study

    International Nuclear Information System (INIS)

    Tribius, Silke; Raguse, Marieclaire; Voigt, Christian; Petersen, Cordula; Kruell, Andreas; Muenscher, Adrian; Groebe, Alexander; Bergelt, Corinna; Singer, Susanne

    2015-01-01

    Patients with locally advanced head and neck cancer (LAHNC) undergo life-changing treatments that can seriously affect quality of life (QoL). This prospective study examined the key QoL domains during the first year after intensity-modulated radiotherapy (IMRT) and identified predictors of these changes in order to improve patient outcomes. A consecutive series of patients with LAHNC completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core module (QLQ-C30) and the HNC-specific QLQ-HN35 before (t0) and at the end (t1) of definitive or adjuvant IMRT, then at 6-8 weeks (t2), 6 months (t3), and 1 year (t4) after IMRT. Patients (n = 111) completing questionnaires at all five time points were included (baseline response rate: 99 %; dropout rate between t0 and t4: 5 %). QoL deteriorated in all domains during IMRT and improved slowly during the first year thereafter. Many domains recovered to baseline values after 1 year but problems with smelling and tasting, dry mouth, and sticky saliva remained issues at this time. Increases in problems with sticky saliva were greater after 1 year in patients with definitive versus adjuvant IMRT (F = 3.5, P = 0.05). QoL in patients with LAHNC receiving IMRT takes approximately 1 year to return to baseline; some domains remain compromised after 1 year. Although IMRT aims to maintain function and QoL, patients experience long-term dry mouth and sticky saliva, particularly following definitive IMRT. Patients should be counseled at the start of therapy to reduce disappointment with the pace of recovery. (orig.) [de

  4. Comparison of nail lacquer clobetasol efficacy at 0,05%, 1% and 8% in nail psoriasis treatment: prospective, controlled and randomized pilot study Comparação da eficácia do clobetasol em esmalte 0,05%, 1% e 8% no tratamento da psoríase ungueal: estudo piloto, prospectivo, controlado e randomizado

    Directory of Open Access Journals (Sweden)

    Robertha Carvalho Nakamura

    2012-04-01

    Full Text Available BACKGROUND: Nail psoriasis may affect up to 90% of patients with psoriasis in the course of the disease throughout their lives and it is often a therapeutic challenge to dermatologists. Topical treatments described in the literature have demonstrated variable efficacy, and unsatisfactory results have been associated to inefficient penetration of the active ingredient into the nail plate and proximal nail fold. Recently the use of clobetasol on nail lacquer vehicle has been suggested, with satisfactory results and no side effects. OBJECTIVE: To determine the efficacy and safety of clobetasol in nail lacquer vehicle in three concentrations (0.05%, 1% and 8% in patients with nail psoriasis. METHODS: Prospective, controlled, randomized pilot study in fifteen patients with nail bed and/or nail matrix psoriasis in both hands, subdivided into three groups: A(0.05% clobetasol nail lacquer, B(1% clobetasol nail lacquer and C(8% clobetasol nail lacquer. All groups used clobetasol nail lacquer on the left hand and base coat nail lacquer as control on the right, twice a week for 16 weeks. Clinical evaluation was done by photographic records and the NAPSI score of both treated and control hands, as well as modified NAPSI score of the most affected nail of the treated hand. RESULTS: Group C showed a statistically relevant clinical response compared to the other groups, reflected in the improvement of clinical parameters, of treated hand NAPSI score, when compared to the control hand, and modified NAPSI score of the most affected nail in the treated hand. CONCLUSION: The 8% clobetasol nail lacquer was effective and safe, and it can be considered a good option of topical therapy in the treatment of nail psoriasis.FUNDAMENTOS: A psoríase ungueal, de difícil manejo terapêutico, pode afetar até 90% dos portadores de psoríase no transcurso da doença, ao longo de suas vidas. Os tratamentos tópicos descritos na literatura têm eficácia variável, muitas vezes

  5. Pilot plant study

    International Nuclear Information System (INIS)

    Morris, M.E.

    1978-01-01

    Sandia Laboratories undertook the design and fabrication of an 8 ton/day dry sewage sludge irradiatior. The facility is intended (1) to function as a high-gamma-dose rate research facility; (2) to be a testbed for the unique electrical and mechanical components to be used in larger facilities; (3) to fulfill the formal requirements of a pilot plant so that design and construction of a demonstration facility could proceed; and (4) to provide accurate data base on construction and operating experience for the Environmental Impact Assessment (EIA), the Safety Analysis Report (SAR), and the cost analyses for a larger facility. The facility and its component systems are described in detail

  6. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus; Ie Pedersen, Maria

    Abstract. We report on the initial findings of an action research study about effects specifications. It is a part of larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews and a workshop we have identified and specified the main effects that comprise...... the basis for the evaluation of the project. The study indicates that cross-organisational effects specifications cause a significant number of effects. To further prioritize these we argue that both interview and workshop must be facilitated as mutual learning processes between interviewer and interviewee....

  7. Oral Health and Quality of Life in Old Age: A Cross-Sectional Pilot Project in Germany and Poland.

    Science.gov (United States)

    Skośkiewicz-Malinowska, Katarzyna; Noack, Barbara; Kaderali, Lars; Malicka, Barbara; Lorenz, Katrin; Walczak, Katarzyna; Weber, Marie-Theres; Mendak-Ziółko, Magdalena; Hoffmann, Thomas; Ziętek, Marek; Walter, Michael; Kaczmarek, Urszula; Hannig, Christian; Radwan-Oczko, Małgorzata; Raedel, Michael

    2016-01-01

    The process of ageing influences all dimensions of social life and personal well-being, but the influence of health on different dimensions of quality of life (QoL) among the elderly is rarely examined. The aim of the pilot study is to test the feasibility of a comprehensive study design to evaluate general and dental health as well as QoL in a bi-national sample. In addition, this pilot study should allow for the exploration of potential interactions between QoL, socioeconomic, health and oral health variables. Individuals aged 64 years and older (n = 100) from university dental clinics of the Wroclaw Medical University, Poland (n = 50) and of the University Hospital in Dresden, Germany (n = 50) were examined. The oral health status of participants was assessed by clinical examination. Socio-demographic, environmental and general health status were evaluated during the medical interview. General quality of life (GQoL) was assessed by an overall question with a visual analogue scale (VAS) from -5 (worst) to +5 (best). Health-related quality of life (HRQoL) and oral health-related quality of life (OHRQoL) were measured with the EQ-5D and OHIP-14 questionnaires. Statistical analyses comprised Pearson's c2 test, Wilcoxon test, linear regression model for statistical analysis and different multivariate linear regression analyses. For the GQoL-VAS-Score the results for QoL measurements were 1.22 ± 2.62 (x± SD), for EQ-5D-Score 7.45 ± 2.25 (x± SD), and for OHIP-14-ADD-Score 11.04 ± 13.56 (x± SD). Differences between Polish and German populations were observed. The study design proved to be feasible for a senior population. The overall GQoL question, EQ-5D and OHIP-14 were regarded as appropriate instruments. Subjective and objective (oral) health measures showed differences between Germany and Poland. For methodological reasons, these differences are not generalizable, but of value for study hypotheses in larger samples.

  8. Enlisted or Officer Drone Pilots

    Science.gov (United States)

    2010-04-01

    the property of the United States government. AU/ACSC/Rafnson, Gary B/AY10 3 Abstract This paper compares remotely piloted aircraft— drones ...operations in both the US Army and US Air Force. It argues that officers should continue to pilot Air Force drones because of the increased risks and

  9. Prediction of pilot induced oscillations

    Directory of Open Access Journals (Sweden)

    Valentin PANĂ

    2011-03-01

    Full Text Available An important problem in the design of flight-control systems for aircraft under pilotedcontrol is the determination of handling qualities and pilot-induced oscillations (PIO tendencieswhen significant nonlinearities exist in the vehicle description. The paper presents a method to detectpossible pilot-induced oscillations of Category II (with rate and position limiting, a phenomenonusually due to a misadaptation between the pilot and the aircraft response during some tasks in whichtight closed loop control of the aircraft is required from the pilot. For the analysis of Pilot in the LoopOscillations an approach, based on robust stability analysis of a system subject to uncertainparameters, is proposed. In this analysis the nonlinear elements are substituted by linear uncertainparameters. This approach assumes that PIO are characterized by a limit cycle behavior.

  10. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study

    NARCIS (Netherlands)

    von Renteln, Daniel; Fuchs, Karl-Hermann; Fockens, Paul; Bauerfeind, Peter; Vassiliou, Melina C.; Werner, Yuki B.; Fried, Gerald; Breithaupt, Wolfram; Heinrich, Henriette; Bredenoord, Albert J.; Kersten, Jan F.; Verlaan, Tessa; Trevisonno, Michael; Rösch, Thomas

    2013-01-01

    Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months

  11. The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

    Science.gov (United States)

    Perrone, F; Jommi, C; Di Maio, M; Gimigliano, A; Gridelli, C; Pignata, S; Ciardiello, F; Nuzzo, F; de Matteis, A; Del Mastro, L; Bryce, J; Daniele, G; Morabito, A; Piccirillo, M C; Rocco, G; Guizzaro, L; Gallo, C

    2016-12-01

    Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system. Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI). At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings. Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and

  12. Live Piloting and Prototyping

    Directory of Open Access Journals (Sweden)

    Francesca Rizzo

    2013-07-01

    Full Text Available This paper presents current trends in service design research concerning large scale projects aimed at generating changes at a local scale. The strategy adopted to achieve this, is to co-design solutions including future users in the development process, prototyping and testing system of products and services before their actual implementation. On the basis of experience achieved in the European Project Life 2.0, this paper discusses which methods and competencies are applied in the development of these projects, eliciting the lessons learnt especially from the piloting phase in which the participatory design (PD approach plays a major role. In the first part, the topic is introduced jointly with the theoretical background where the user center design and participatory design methods are presented; then the Life 2.0 project development is described; finally the experience is discussed from a service design perspective, eliciting guidelines for piloting and prototyping services in a real context of use. The paper concludes reflecting on the designers’ role and competencies needed in this process.

  13. Perceiving prospects properly

    Czech Academy of Sciences Publication Activity Database

    Steiner, Jakub; Stewart, C.

    2016-01-01

    Roč. 106, č. 7 (2016), s. 1601-1631 ISSN 0002-8282 Institutional support: RVO:67985998 Keywords : evolution * perception bias * prospect theory Subject RIV: AH - Economics Impact factor: 4.026, year: 2016

  14. Pilots 2.0: DIRAC pilots for all the skies

    CERN Document Server

    Stagni, F; McNab, A; Luzzi, C

    2015-01-01

    In the last few years, new types of computing infrastructures, such as IAAS (Infrastructure as a Service) and IAAC (Infrastructure as a Client), gained popularity. New resources may come as part of pledged resources, while others are opportunistic. Most of these new infrastructures are based on virtualization techniques. Meanwhile, some concepts, such as distributed queues, lost appeal, while still supporting a vast amount of resources. Virtual Organizations are therefore facing heterogeneity of the available resources and the use of an Interware software like DIRAC to hide the diversity of underlying resources has become essential. The DIRAC WMS is based on the concept of pilot jobs that was introduced back in 2004. A pilot is what creates the possibility to run jobs on a worker node. Within DIRAC, we developed a new generation of pilot jobs, that we dubbed Pilots 2.0. Pilots 2.0 are not tied to a specific infrastructure; rather they are generic, fully configurable and extendible pilots. A Pilot 2.0 can be s...

  15. Differences in cognitive performance, level of dependency and quality of life (QoL), related to age and cognitive status in a sample of Spanish old adults under and over 80 years of age.

    Science.gov (United States)

    Calero, Dolores; Navarro, Elena

    2011-01-01

    The main objective of this study was to analyze the similarities and differences in cognitive performance, level of dependency, cognitive plasticity and QoL in a sample of young-old adults and old-old adults, bearing in mind both the age-group (under or over 80 years) and the cognitive status of the participants. The study population consisted of 220 people living in sheltered accommodation for elderly people in the South of Spain, with an average age of 80.75 years. Participants were evaluated by means of cognitive performance tests, a QoL questionnaire, a depression scale and a dependency assessment scale. The results indicate that the main differences in the variables analyzed are due to the cognitive status of the sample and not to the fact that the participants are under or over 80 years of age. The findings show that major inter-individual differences in this stage of life depend not only on age but also on cognitive status, which is thus an important factor to take into account when working with this sector of the population. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  16. Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

    Science.gov (United States)

    Mikocka-Walus, Antonina; Hughes, Patrick A; Bampton, Peter; Gordon, Andrea; Campaniello, Melissa A; Mavrangelos, Chris; Stewart, Benjamin J; Esterman, Adrian; Andrews, Jane M

    2017-04-01

    Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease [CD] maintained remission, improved quality of life [QoL] and/or mental health in people with CD as compared to placebo. A parallel randomized double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20 mg daily or placebo, and followed for 12 months. Participants provided blood and stool samples and completed mental health and QoL questionnaires. Immune functions were assessed by stimulated cytokine secretion [CD3/CD28 stimulation] and flow cytometry for cell type. Linear mixed-effects models were used to compare groups. Of the 26 participants, 14 were randomized to receive fluoxetine and 12 to placebo. Overall, 14 [54%] participants were male. The mean age was 37.4 [SD=13.2] years. Fluoxetine had no effect on inflammatory bowel disease activity measured using either the Crohn's Disease Activity Index [F(3, 27.5)=0.064, p=0.978] or faecal calprotectin [F(3, 32.5)=1.08, p=0.371], but did have modest effects on immune function. There was no effect of fluoxetine on physical, psychological, social or environmental QoL, anxiety or depressive symptoms as compared to placebo [all p>0.05]. In this small pilot clinical trial, fluoxetine was not superior to placebo in maintaining remission or improving QoL. [ID: ACTRN12612001067864.]. © European Crohn’s and Colitis Organistion (ECCO) 2016.

  17. A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A. [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Deshields, Teresa L. [Department of Medicine, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Margenthaler, Julie A.; Cyr, Amy E. [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Naughton, Michael [Department of Medicine, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Aft, Rebecca [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Department of Surgery, John Cochran Veterans Hospital, St. Louis, Missouri (United States); Gillanders, William E.; Eberlein, Timothy [Department of Surgery, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Matesa, Melissa A.; Ochoa, Laura L. [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States); Zoberi, Imran, E-mail: izoberi@radonc.wustl.edu [Department of Radiation Oncology, Siteman Cancer Center, Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, Missouri (United States)

    2013-12-01

    Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment.

  18. A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

    International Nuclear Information System (INIS)

    Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A.; Deshields, Teresa L.; Margenthaler, Julie A.; Cyr, Amy E.; Naughton, Michael; Aft, Rebecca; Gillanders, William E.; Eberlein, Timothy; Matesa, Melissa A.; Ochoa, Laura L.; Zoberi, Imran

    2013-01-01

    Purpose: To prospectively examine quality of life (QOL) of patients with early stage breast cancer treated with accelerated partial breast irradiation (APBI) using high-dose-rate (HDR) interstitial brachytherapy. Methods and Materials: Between March 2004 and December 2008, 151 patients with early stage breast cancer were enrolled in a phase 2 prospective clinical trial. Eligible patients included those with Tis-T2 tumors measuring ≤3 cm excised with negative surgical margins and with no nodal involvement. Patients received 3.4 Gy twice daily to a total dose of 34 Gy. QOL was measured using European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, version 3.0, and QLQ-BR23 questionnaires. The QLQ-C30 and QLQ-BR23 questionnaires were evaluated during pretreatment and then at 6 to 8 weeks, 3 to 4 months, 6 to 8 months, and 1 and 2 years after treatment. Results: The median follow-up was 55 months. Breast symptom scores remained stable in the months after treatment, and they significantly improved 6 to 8 months after treatment. Scores for emotional functioning, social functioning, and future perspective showed significant improvement 2 years after treatment. Symptomatic fat necrosis was associated with several changes in QOL, including increased pain, breast symptoms, systemic treatment side effects, dyspnea, and fatigue, as well as decreased role functioning, emotional functioning, and social functioning. Conclusions: HDR multicatheter interstitial brachytherapy was well tolerated, with no significant detrimental effect on measured QOL scales/items through 2 years of follow-up. Compared to pretreatment scores, there was improvement in breast symptoms, emotional functioning, social functioning, and future perspective 2 years after treatment

  19. Single vs. multiple fraction regimens for palliative radiotherapy treatment of multiple myeloma. A prospective randomised study

    Energy Technology Data Exchange (ETDEWEB)

    Rudzianskiene, Milda; Inciura, Arturas; Gerbutavicius, Rolandas; Rudzianskas, Viktoras; Dambrauskiene, Ruta; Juozaityte, Elona [Lithuanian University of Health Sciences, Oncology Institute, Kaunas (Lithuania); Macas, Andrius [Lithuanian University of Health Sciences, Anaesthesiology Department, Kaunas (Lithuania); Simoliuniene, Renata [Lithuanian University of Health Sciences, Department of Physics, Mathematics and Biophysics, Kaunas (Lithuania); Kiavialaitis, Greta Emilia [University Hospital Zurich, Intitute of Anesthesiology, Zurich (Switzerland)

    2017-09-15

    To compare the impact of a single fraction (8 Gy x 1 fraction) and multifraction (3 Gy x 10 fractions) radiotherapy regimens on pain relief, recalcification and the quality of life (QoL) in patients with bone destructions due to multiple myeloma (MM). In all, 101 patients were included in a randomised prospective clinical trial: 58 patients were included in the control arm (3 Gy x 10 fractions) and 43 patients into the experimental arm (8 Gy x 1 fraction). The response rate was defined according to the International Consensus on Palliative Radiotherapy criteria. Recalcification was evaluated with radiographs. QoL questionnaires were completed before and 4 weeks after treatment. Pain relief was obtained in 81/101 patients (80.2%): complete response in 56 (69%) and partial in 25 patients (30.9%). No significant differences were observed in analgesic response between the groups. Significant factors for pain relief were female gender, age under 65, IgG MM type, presence of recalcification at the irradiated site. Recalcification was found in 32/101 patients (33.7%): complete in 17 (53.2%) and partial in 15 (46.2%). No significant differences were observed in recalcification between the groups. Significant factors for recalcification were Karnofsky index ≥ 60%, haemoglobin level ≤ 80 g/dl, MM stage II and analgesic response at the irradiated site. The QoL after radiotherapy was improved in the control group. The same analgesic and recalcification response was observed using two different radiotherapy regimens. Higher doses should be used to achieve a better QoL. (orig.) [German] Vergleich der einzeitigen vs. fraktionierten palliativen Radiotherapie in Bezug auf Schmerzlinderung, Knochenrekalzifizierung und Lebensqualitaet (QoL) bei Patienten mit multiplem Myelom (MM). In die randomisierte, prospektive Studie wurden 101 Patienten eingeschlossen: Die Kontrollgruppe (n = 58) erhielt eine fraktionierte (3 Gy x 10 Fraktionen) und die Experimentgruppe (n = 43) eine

  20. 76 FR 78141 - Pilot, Flight Instructor, and Pilot School Certification; Technical Amendment

    Science.gov (United States)

    2011-12-16

    ...-26661; Amdt. No. 61-129] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School Certification... requirements for pilots, flight instructors, ground instructors, and pilot schools. This document corrects an... a practical test for the issuance of a sport pilot certificate in a light-sport aircraft other than...

  1. 49 CFR 230.110 - Pilots.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Pilots. 230.110 Section 230.110 Transportation... and Equalizing System § 230.110 Pilots. (a) General provisions. Pilots shall be securely attached... clearance. The minimum clearance of pilot above the rail shall be 3 inches and the maximum clearance shall...

  2. Fatty acids measured in plasma and erythrocyte-membrane phospholipids and derived by food-frequency questionnaire and the risk of new-onset type 2 diabetes a pilot study in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk cohort

    NARCIS (Netherlands)

    Patel, P.S.; Sharp, S.J.; Jansen, E.H.J.M.

    2010-01-01

    Background Epidemiologic evidence for the association between types of fatty acid and risk of type 2 diabetes is inconsistent This may in part be due to the limitations of fatty acid measurement methods Objective The objective was to use 3 different measures of fatty acid to estimate the prospective

  3. Development and pilot of an international survey: 'Radiation Therapists and Psychosocial Support'.

    Science.gov (United States)

    Elsner, Kelly L; Naehrig, Diana; Halkett, Georgia K B; Dhillon, Haryana M

    2018-06-07

    Up to one third of radiation therapy patients are reported to have unmet psychosocial needs. Radiation therapists (RTs) have daily contact with patients and can provide daily psychosocial support to reduce patient anxiety, fear and loneliness. However, RTs vary in their values, skills, training, knowledge and involvement in providing psychosocial support. The aims of this study were to: (1) develop an online survey instrument to explore RT values, skills, training and knowledge regarding patient anxiety and psychosocial support, and (2) pilot the instrument with RT professionals to assess content validity, functionality and length. An online cross-sectional survey, titled 'Radiation therapists and psychosocial support' was developed. Items included patient vignettes, embedded items from RT research, and the Professional Quality of Life Scale (ProQOL5). Four radiation oncology departments volunteered to pilot the survey; each nominated four RT staff to participate. Survey data were analysed descriptively and qualitative feedback grouped and coded to determine whether the survey needed to be refined. Thirteen of sixteen RTs completed the pilot survey and feedback form. Median time to completion was 35 mins, with 54% of respondents stating this was too long. Respondents reported content, questions and response options were relevant and appropriate. Feedback was used to: refine the survey instrument, minimise responder burden and drop out and improve functionality and quality of data collection. This pilot of the 'Radiation therapists and psychosocial support' survey instrument demonstrated content validity and usability. The main survey will be circulated to a representative sample of RTs for completion. © 2018 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.

  4. Kvanefjeld refinery pilot plant operations

    International Nuclear Information System (INIS)

    Krebs, Damien; Furfaro, Domenic

    2016-01-01

    Greenland Minerals and Energy is a junior project development company which is listed on the Australian Stock Exchange (asx:GGG). It is developing the Kvanefjeld rare earth and uranium project located in the southern tip of Greenland. The project has completed a Feasibility Study and is currently in the permitting phase. Last year was a busy time for the company as it completed a Feasibility Study, a mining licence application (draft submitted in December 2015) and pilot plant operations. Beneficiation pilot plant operations were completed at GTK in Finland in April 2015. This pilot plant treated approximately 30 tonnes of ore to producing almost 2 tonnes of rare earth mineral concentrate. Later in the year a hydrometallurgical pilot plant was performed which mimicked the Refinery process. This pilot plant was performed at Outotec’s Pori Research laboratories in Finland from September till October 2015. The pilot plant treated approximately 200 kilograms of concentrate over 4 split operating campaigns. Each campaign was performed to focus on the performance of a specific part of the refinery flowsheet. This allowed for full operating focus on a single unit operation to ensure that it was operating correctly. The pilot plant operations were quite successful with no major issues with the flowsheet identified through continuous operation. Some fine tuning of conditions was required to ensure adequate removal of impurities was performed with recycle streams incorporated. Overall the leach extractions observed in the pilot plant exceeded the design assumptions in the Feasibility Study. These programs were partially funded by the EURARE program. The EURARE program aims to encourage the sustainable development of European based rare earth projects. This has the goal of allowing Europe to become less reliant on importation of these key raw materials. The professionalism and performance of both GTK and Outotec contributed significantly to the success of the pilot plant

  5. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus Rotvit Perlt; Pedersen, Maria Ie

    2011-01-01

    Abstract. We report on the initial findings of an exploratory action research study about effects specifications using the systems development method Effects-driven IT development. It is part of a larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews...... and a workshop we have identified and specified effects that comprise the basis for an evaluation of the project between several organisational agents with diverse professional backgrounds. Gathering organisational participants at a workshop with a common goal of discussing and prioritizing a finished list...... of effects has proved to be a valuable approach to create mutual learning process amongst the participants and the facilitators of the workshop. The challenges we experienced during the effects specification process were to balance a dichotomous focus between on one hand the visions of the participants...

  6. Liverpool Telecare Pilot: case studies

    Directory of Open Access Journals (Sweden)

    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.

  7. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

    Science.gov (United States)

    Kulason, Kay; Nouchi, Rui; Hoshikawa, Yasushi; Noda, Masafumi; Okada, Yoshinori; Kawashima, Ryuta

    2018-01-01

    Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA) cognitive training in elderly Japanese postsurgical patients. Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited ( n = 12). Subjects were randomly divided into two groups-one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J), Frontal Assessment Battery (FAB), computerized Cogstate Brief Battery (CBB)] and emotional state [General Health Questionnaire-12 (GHQ-12), Geriatric Depression Scale (GDS), Quality of Life Scale-5 (QOL-5)]. Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved. Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions. Trial registration: This study was registered with

  8. The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Kay Kulason

    2018-03-01

    Full Text Available Background: There has been little research conducted regarding cognitive treatments for the elderly postsurgical population. Patients aged ≥60 years have an increased risk of postoperative cognitive decline, a condition in which cognitive functions are negatively affected. This cognitive decline can lead to a decline in quality of life. In order to maintain a high quality of life, the elderly postsurgical population may benefit from treatment to maintain and/or improve their cognitive functions. This pilot study investigates the effect of simple calculation and reading aloud (SCRA cognitive training in elderly Japanese postsurgical patients.Methods: Elderly patients undergoing non-cardiovascular thoracic surgery under general anesthesia were recruited (n = 12. Subjects were randomly divided into two groups—one that receives 12 weeks of SCRA intervention, and a waitlisted control group. Before and after the intervention, we measured cognitive function [Mini-Mental Status Exam-Japanese (MMSE-J, Frontal Assessment Battery (FAB, computerized Cogstate Brief Battery (CBB] and emotional state [General Health Questionnaire-12 (GHQ-12, Geriatric Depression Scale (GDS, Quality of Life Scale-5 (QOL-5].Results: Group difference analyses using ANCOVA with permutation test showed that the intervention SCRA group had a significant improvement in FAB motor programming sub-score, GDS, and QOL-5 compared to the control group. Within-group analyses using Wilcoxon signed-rank test to compare baseline and follow-up showed that the SCRA intervention group total FAB scores, FAB motor programming sub-scores, and QOL-5 scores were significantly improved.Discussion: This pilot study showed that there are important implications for the beneficial effects of SCRA intervention on cognitive function and emotional state in the postoperative elderly population; however, further investigations are necessary to reach any conclusions.Trial registration: This study was

  9. Worldwide prospects of uranium prospection and production

    International Nuclear Information System (INIS)

    Beaumont, Claude; Duval, B.C.; Sarcia, J.A.

    1978-01-01

    The reserves of uranium ores, at present known in the western world, at a mining price below 80 US dollars per kilo, permit the needs corresponding to the life of the existing reactors to be satisfied until 1988; the more expensive estimated resources taken into account would permit an extension beyond the end of the century. But the transition from available reserves and their renewal to the evaluated reserves necessitates from now a considerable prospecting effort. There are great geological possibilities to cover needs: beside the known types of deposits which give the present production, there exist numerous other prospects which appear of interest to underline; nevertheless, they require a certain amount of progress, other methods of detection such as the metal extractive processes which are not necessarily beyond the reach of science and techniques. Obstacles are due to the fact that the scrupules of ecologic necessities are often slightly inconsiderate, and that states intervene more and more in the extractive industry when the object is not to satisfy their own needs. Lastly, the uncertainty of the long market (breeder or not) risk to discourage the effort of investors [fr

  10. Waste Isolation Pilot Plant Overview

    Energy Technology Data Exchange (ETDEWEB)

    Weaver, Douglas James [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2017-03-27

    The mission of Waste Isolation Pilot Plant (WIPP) is to demonstrate the safe, environmentally sound, cost effective, permanent disposal of Transuranic (TRU) waste left from production of nuclear weapons.

  11. Rockfish Pilot Permit Program (RPP)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The Rockfish Pilot Program was a five-year project that allowed harvesters to form voluntary cooperatives and receive an exclusive harvest privilege for groundfish...

  12. US Daily Pilot Balloon Observations

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Pilot Balloon observational forms for the United States. Taken by Weather Bureau and U.S. Army observers. Period of record 1918-1960. Records scanned from the NCDC...

  13. WIPP: Waste Isolation Pilot Plant

    International Nuclear Information System (INIS)

    1984-01-01

    The following aspects of the Waste Isolation Pilot Plant are discussed briefly: history and site selection; salt as a disposal medium; transporting waste materials; early key events; impacts on New Mexico; project organization; and site certification profile

  14. Vertebral pain in helicopter pilots

    Science.gov (United States)

    Auffret, R.; Delahaye, R. P.; Metges, P. J.; VICENS

    1980-01-01

    Pathological forms of spinal pain engendered by piloting helicopters were clinically studied. Lumbalgia and pathology of the dorsal and cervical spine are discussed along with their clinical and radiological signs and origins.

  15. Piloted Aircraft Environment Simulation Techniques

    Science.gov (United States)

    1978-04-01

    raS’I.Al. lIIf~iiI~.1 labL. lot. Rolmotion -oft. skylicav - ow d Roll rMotion -oft Skylicape - Off Fig 6 a A Effect of roll motion and akyscape, an msatwntn...greater realism and pilot involvement than ground based simu- lation, it still lacks some of the pilot motivating factors of actual combat. Flight

  16. Associations between inadequate knee function detected by KOOS and prospective graft failure in an anterior cruciate ligament-reconstructed knee.

    Science.gov (United States)

    Granan, Lars-Petter; Baste, Valborg; Engebretsen, Lars; Inacio, Maria C S

    2015-04-01

    First, to evaluate whether the 2 year post-operative Knee injury and Osteoarthritis Outcome Score (KOOS) in primary anterior cruciate ligament reconstructions (ACLRs) was significantly different between patients that did not go on to have a subsequent revision after the 2 year post-operative control and the ones that did. Second, to test whether the "clinically failure" value of KOOS quality of life (QoL) < 44 was indicative of a clinically relevant difference in the risk of subsequent revision ACLR. ACLRs reported to the Norwegian Knee Ligament Registry between June 2004 and December 2009. 5,517 primary ACLRs with at least 2-year follow-up with KOOS QoL before revision surgery. There were clinically significant differences, adjusted and unadjusted, in both the KOOS Sport and Recreation and QoL subscales in patients with a later revision surgery compared to those that did not have a revision surgery. In adjusted models, the risk of later ACLR revision was 3.7 (95 % CI 2.2-6.0) higher in patients with a 2-year KOOS QoL < 44 compared to patients with a KOOS QoL ≥ 44. For every 10-point reduction in the KOOS QoL, a 33.6 % (95 % CI 21.2-47.5 %) higher risk for later ACLR revision was observed. This study reveals an association between inadequate knee function, as measured by KOOS, and a prospective ACL-reconstructed graft failure. Prognostic study (prospective cohort study), Level II.

  17. Active Job Monitoring in Pilots

    Science.gov (United States)

    Kuehn, Eileen; Fischer, Max; Giffels, Manuel; Jung, Christopher; Petzold, Andreas

    2015-12-01

    Recent developments in high energy physics (HEP) including multi-core jobs and multi-core pilots require data centres to gain a deep understanding of the system to monitor, design, and upgrade computing clusters. Networking is a critical component. Especially the increased usage of data federations, for example in diskless computing centres or as a fallback solution, relies on WAN connectivity and availability. The specific demands of different experiments and communities, but also the need for identification of misbehaving batch jobs, requires an active monitoring. Existing monitoring tools are not capable of measuring fine-grained information at batch job level. This complicates network-aware scheduling and optimisations. In addition, pilots add another layer of abstraction. They behave like batch systems themselves by managing and executing payloads of jobs internally. The number of real jobs being executed is unknown, as the original batch system has no access to internal information about the scheduling process inside the pilots. Therefore, the comparability of jobs and pilots for predicting run-time behaviour or network performance cannot be ensured. Hence, identifying the actual payload is important. At the GridKa Tier 1 centre a specific tool is in use that allows the monitoring of network traffic information at batch job level. This contribution presents the current monitoring approach and discusses recent efforts and importance to identify pilots and their substructures inside the batch system. It will also show how to determine monitoring data of specific jobs from identified pilots. Finally, the approach is evaluated.

  18. Preliminary evidence that glucose ingestion facilitates prospective memory performance.

    Science.gov (United States)

    Riby, Leigh M; Law, Anna S; McLaughlin, Jennifer; Murray, Jennifer

    2011-05-01

    Previous research has found that the ingestion of glucose boosts task performance in the memory domain (including tasks tapping episodic, semantic, and working memory). The present pilot study tested the hypothesis that glucose ingestion would enhance performance on a test of prospective memory. In a between-subjects design, 56 adults ranging from 17 to 80 years of age performed a computerized prospective memory task and an attention (filler) task after 25 g of glucose or a sweetness-matched placebo. Blood glucose measurements were also taken to assess the impact of individual differences on glucose regulation. After the drink containing glucose, cognitive facilitation was observed on the prospective memory task after excluding subjects with impaired fasting glucose level. Specifically, subjects receiving glucose were 19% more accurate than subjects receiving a placebo, a trend that was marginally nonsignificant, F₁,₄₁ = 3.4, P = .07, but that had a medium effect size, d = 0.58. Subjects receiving glucose were also significantly faster on the prospective memory task, F₁,₃₅ = 4.8, P glucose (indicative of poor glucose regulation) was associated with slower prospective memory responding, F₁,₃₅ = 4.4, P memory and executive functioning can benefit from the increased provision of glucose to the brain. Copyright © 2011 Elsevier Inc. All rights reserved.

  19. The psychological aspects of everyday functioning in a group of patients with varicose veins – an assessment with VEINES Qol/Sym for patients before and after varicose veins surgery

    Directory of Open Access Journals (Sweden)

    Łukasz Migdalski

    2015-10-01

    Full Text Available Psychological functioning of patients in early stages of venous insufficiency has not been a common subject of scientific investigation so far, even though this group of patients experiences many limitations in daily functioning, as well as psychological distress. Varicose veins are the most common type of venous insufficiency, with an epidemiology of up to 50% of the western population. The present study is concerned with the functioning of a group undergoing surgery of varicose veins. The operation was carried out in an ambulatory mode, and such psychological factors as acceptance of illness, anxiety–state, anxiety–trait, and wellbeing (treated as personality construct have been considered. It is the first time that such variables have been used with the new tool for assessing quality of life in venous diseases (VEINES Qol/Sym, and no previous findings about applying VEINES Qol/Sym to assess patients after varicose veins operations exist. The results are promising, especially for combining such psychological variables as anxiety, acceptance of illness, or wellbeing with specific venous measures of quality of life. It has been proved that there is a need for monitoring psychological variables in the group of patients in an early stage of chronic venous illness. Further research on other venous patient groups is necessary to fully understand the specificity of these groups.

  20. Feasibility and Impact of a Combined Supervised Exercise and Nutritional-Behavioral Intervention following Bariatric Surgery: A Pilot Study

    Directory of Open Access Journals (Sweden)

    Friedrich C. Jassil

    2015-01-01

    Full Text Available Background. Lifestyle intervention programs after bariatric surgery have been suggested to maximise health outcomes. This pilot study aimed to investigate the feasibility and impact of an 8-week combined supervised exercise with nutritional-behavioral intervention following Roux-en-Y gastric bypass and sleeve gastrectomy. Methods. Eight female patients (44 ± 8 years old, BMI = 38.5 ± 7.2 kgm−2 completed the program. Before and after intervention, anthropometric measures, six-minute walk test (6MWT, physical activity level, eating behavior, and quality of life (QoL were assessed. Percentage weight loss (%WL outcomes were compared with a historical matched control group. Results. The program significantly improved functional capacity (mean increment in 6MWT was 127 ± 107 meters, p=0.043, increased strenuous intensity exercise (44 ± 49 min/week, p=0.043, increased consumption of fruits and vegetables (p=0.034, reduced consumption of ready meals (p=0.034, and improved “Change in Health” in QoL domain (p=0.039. The intervention group exhibited greater %WL in the 3–12-month postsurgery period compared to historical controls, 12.2 ± 7.5% versus 5.1 ± 5.4%, respectively (p=0.027. Conclusions. Lifestyle intervention program following bariatric surgery is feasible and resulted in several beneficial outcomes. A large randomised control trial is now warranted.

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

    Science.gov (United States)

    Mishima, Masakazu; Cheng, Lixia

    2017-01-01

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

  2. A prospective analysis of long-term quality of life after permanent I-125 brachytherapy for localised prostate cancer

    International Nuclear Information System (INIS)

    Ash, Dan; Bottomley, David; Al-Qaisieh, Bashar; Carey, Brendan; Gould, Kath; Henry, Ann

    2007-01-01

    Background and purpose: To prospectively evaluate long-term urinary, bowel and sexual function after I-125 brachytherapy for localised prostate cancer using patient administered validated Quality of Life (QoL) instruments. Materials and methods: Between March 1995 and March 2004, 673 men underwent brachytherapy and recorded urinary symptoms prospectively using the International Prostate Symptom Score (IPSS). In addition, in a subgroup of 116 patients, the Expanded Prostate Cancer Index Composite (EPIC) was used to record QoL information on urinary, bowel and sexual function before treatment and at regular time intervals for at least two years. Results: Initially, there was a sharp rise in urinary symptoms which was most marked within the first three months. Scores then resolved slowly and returned to within one or two units of pre-treatment level at one year. Subsequently, there was no significant deterioration in urinary symptoms up to nine years following brachytherapy. Few had significant bowel symptoms. Sexual function deteriorated initially and then improved but failed to return to pre-treatment levels by two years. Patients requiring neo-adjuvant hormones experienced significantly more dysfunction. Conclusions: After an initial period of mild to moderate urinary symptoms prostate brachytherapy is well tolerated with relatively little deterioration in long-term quality of life. Long-term reduction in sexual function may be seen particularly in those requiring hormones

  3. Prospects after Major Trauma

    NARCIS (Netherlands)

    Holtslag, H.R.

    2007-01-01

    Introduction. After patients survived major trauma, their prospects, in terms of the consequences for functioning, are uncertain, which may impact severely on patient, family and society. The studies in this thesis describes the long-term outcomes of severe injured patients after major trauma. In

  4. A Prospective Observational Study

    African Journals Online (AJOL)

    Methods: This was a prospective, questionnaire-based observational study. Printed questionnaires were distributed to the visitors of medical, surgical and neurosurgical ICU patients to determine awareness of basic infection control practices among visitors to an ICU. All the ICU staff, including nurses, doctors, consultant ...

  5. Prospects for Tau Physics

    International Nuclear Information System (INIS)

    Lafferty, George D.

    2009-01-01

    The tau lepton is a powerful tool with which to study a wide variety of physics in and beyond the Standard Model. We review the prospects for tau physics in the light of recent progress at the B factories and elsewhere, and we consider the tau physics that may come from future accelerators.

  6. Perceiving prospects properly

    Czech Academy of Sciences Publication Activity Database

    Steiner, Jakub; Stewart, C.

    2016-01-01

    Roč. 106, č. 7 (2016), s. 1601-1631 ISSN 0002-8282 R&D Projects: GA ČR(CZ) GA13-34759S; GA ČR(CZ) GA16-00703S Institutional support: PRVOUK-P23 Keywords : evolution * perception bias * prospect theory Subject RIV: AH - Economics Impact factor: 4.026, year: 2016

  7. Indochina area mineral prospects

    Energy Technology Data Exchange (ETDEWEB)

    1990-10-05

    Prospects for commercial mining of various minerals are considered for Kampuchea (Cambodia), Laos, Vietnam, Myanmar (Burma) and Thailand. Mineral production is much below its geologic potential for economic and political reasons. Resource potential is limited to tin, tungsten, lead and zinc, barytes and gemstones, and coal. 1 fig.

  8. Energy prospects for industry

    Energy Technology Data Exchange (ETDEWEB)

    Hartley, P P; Roberts, G F.I.; Thomas, V E; Davies, D; Crow, L M

    1983-01-01

    Contents: Electricity today and tomorrow; Gas--supply prospects for the future; Petroleum based energy--the UK perspective; Future markets for coal; Flexibility--the key to Dunlop's energy strategy; Energy conservation in Alcan; Present and future energy patterns in Courtaulds PLC; New energy technology for the quarrying industry.

  9. Nuclear power prospects

    International Nuclear Information System (INIS)

    Staebler, K.

    1994-01-01

    The technical, economic and political prospects of nuclear power are described with regard to ecological aspects. The consensus talks, which failed in spite of the fact that they were stripped of emotional elements and in spite of major concessions on the part of the power industry, are discussed with a view to the political and social conditions. (orig.) [de

  10. Toronto hybrid taxi pilot

    Energy Technology Data Exchange (ETDEWEB)

    Stevens, M. [CrossChasm Technologies, Cambridge, ON (Canada); Marans, B. [Toronto Atmospheric Fund, ON (Canada)

    2009-10-15

    This paper provided details of a hybrid taxi pilot program conducted to compare the on-road performance of Toyota Camry hybrid vehicles against conventional vehicles over a 1-year period in order to determine the business case and air emission reductions associated with the use of hybrid taxi cabs. Over 750,000 km worth of fuel consumption was captured from 10 Toyota Camry hybrids, a Toyota Prius, and 5 non-hybrid Camry vehicles over an 18-month period. The average real world fuel consumption for the taxis demonstrated that the Toyota Prius has the lowest cost of ownership, while the non-hybrid Camry has the highest cost of ownership. Carbon dioxide (CO{sub 2}) reductions associated with the 10 Camry hybrid taxis were calculated at 236 tonnes over a 7-year taxi service life. Results suggested that the conversion of Toronto's 5680 taxis would yield annual CO{sub 2} emission reductions of over 19,000 tonnes. All hybrid purchasers identified themselves as highly likely to purchase a hybrid again. 5 tabs., 9 figs.

  11. Fitzmaurice Voicework Pilot Study.

    Science.gov (United States)

    Watson, Lynn; Nayak, Sadhana

    2015-11-01

    A repeated-measures pilot study was used to investigate acoustic changes in the voices of participants in a Fitzmaurice Voicework (FV) teacher certification program. Maximum phonation time (MPT) was also measured. Eleven participants with no reported voice problems were studied. Pretraining and posttraining recordings were made of each participant. Measures of MPT were made, and the recordings were analyzed for jitter, shimmer, and noise-to-harmonics ratio (NHR). The measure of effect size for MPT was moderate, and there was an overall increase in MPT from pretraining to posttraining, with 70% of participants showing an increase in MPT. The measure of effect sizes for jitter, shimmer, and NHR were small, with measurements showing no significant changes from pretraining to posttraining. There were indications that FV training may have positive outcomes for actors and professional voice users, particularly in increasing MPT. Further studies with larger subject groups are needed to investigate the significance of the increase in MPT noted in this study and to test whether FV training can help to lower rates of shimmer and jitter. Copyright © 2015 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  12. Toronto hybrid taxi pilot

    International Nuclear Information System (INIS)

    Stevens, M.; Marans, B.

    2009-10-01

    This paper provided details of a hybrid taxi pilot program conducted to compare the on-road performance of Toyota Camry hybrid vehicles against conventional vehicles over a 1-year period in order to determine the business case and air emission reductions associated with the use of hybrid taxi cabs. Over 750,000 km worth of fuel consumption was captured from 10 Toyota Camry hybrids, a Toyota Prius, and 5 non-hybrid Camry vehicles over an 18-month period. The average real world fuel consumption for the taxis demonstrated that the Toyota Prius has the lowest cost of ownership, while the non-hybrid Camry has the highest cost of ownership. Carbon dioxide (CO 2 ) reductions associated with the 10 Camry hybrid taxis were calculated at 236 tonnes over a 7-year taxi service life. Results suggested that the conversion of Toronto's 5680 taxis would yield annual CO 2 emission reductions of over 19,000 tonnes. All hybrid purchasers identified themselves as highly likely to purchase a hybrid again. 5 tabs., 9 figs.

  13. The Marcoule pilot plant

    International Nuclear Information System (INIS)

    Faugeras, P.; Calame Longjean, A.; Le Bouhellec, J.; Revol, G.

    1986-06-01

    The Marcoule spent fuel reprocessing pilot facility was built in 1960-1961 for extended testing of the PUREX process with various types of fuel under conditions similar to those encountered in a production plant. Extensive modification work was undertaken on the facility in 1983 in the scope of the TOR project, designed with the following objectives: - increase the throughput capacity to at least 5 metric tons of PHENIX equivalent fuel per year, - extend equipment and process R and D capability, - improve job safety by maximum use of remote handling facilities, - maximize waste conditioning treatments to produce waste forms suitable for direct storage, - provide a true industrial process demonstration in continuous operation under centralized control using computerized procedures. The redesigned plant is scheduled to begin operation during the second half of 1986. The proximity of the Industrial Prototypes Service and the ATALANTE radiochemical research laboratory scheduled to begin operation in 1990, will provide a synergistic environment in which R and D program may be carried out under exceptional conditions

  14. Roll paper pilot. [mathematical model for predicting pilot rating of aircraft in roll task

    Science.gov (United States)

    Naylor, F. R.; Dillow, J. D.; Hannen, R. A.

    1973-01-01

    A mathematical model for predicting the pilot rating of an aircraft in a roll task is described. The model includes: (1) the lateral-directional aircraft equations of motion; (2) a stochastic gust model; (3) a pilot model with two free parameters; and (4) a pilot rating expression that is a function of rms roll angle and the pilot lead time constant. The pilot gain and lead time constant are selected to minimize the pilot rating expression. The pilot parameters are then adjusted to provide a 20% stability margin and the adjusted pilot parameters are used to compute a roll paper pilot rating of the aircraft/gust configuration. The roll paper pilot rating was computed for 25 aircraft/gust configurations. A range of actual ratings from 2 to 9 were encountered and the roll paper pilot ratings agree quite well with the actual ratings. In addition there is good correlation between predicted and measured rms roll angle.

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

    Science.gov (United States)

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

    2001-01-01

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

  16. Comparison of early quality of life in patients treated with radiotherapy following mastectomy or breast conservation therapy: A prospective study

    International Nuclear Information System (INIS)

    Munshi, Anusheel; Dutta, Debnarayan; Kakkar, Sajal; Budrukkar, Ashwini; Jalali, Rakesh; Sarin, Rajiv; Gupta, Sudeep; Parmar, Vani; Badwe, Rajendra

    2010-01-01

    Introduction: To compare quality of life (QOL) in breast cancer patients from a developing country after breast conservation surgery (BCS) or mastectomy and adjuvant radiotherapy (RT). Materials and methods: In a 6-month period, all consecutive early and locally advanced breast cancer patients treated with either BCS or mastectomy and treated with RT were analyzed. All patients who underwent mastectomy were treated with 45 Gray/20/4 weeks. Patients with BCS were treated with a dose of 45-50 Gray/25/5 weeks to whole breast followed by tumor bed boost (15 Gray/6/6 days with suitable energy electrons). Prospective evaluation of QOL using EORTC QLQ C30 and breast cancer specific QLQ BR23 was done before starting RT (baseline), at mid-RT and at RT conclusion for all patients. Results: One hundred and thirteen patients had mastectomy and 142 patients underwent BCS. Reliability test (Cronbach alpha) for questionnaire filling was 0.669-0.886. At pre-RT assessment, global QOL scores in mastectomy and BCS groups were 71.1 and 71.3, respectively. There was no significant difference in pre-RT EORTC QLQ C30 functional and symptom domains between mastectomy and BCS patients. However, social function domain score was higher in patients who underwent mastectomy (83 versus 73.9; p = 0.018). In QLQ BR23 domains, body image and sexual functioning domains were similar between the two groups. However, sexual enjoyment (10.9 versus 47.6; p = 0.006) and future perspective (7.4 versus 37.1; p = 0.036) domains were significantly better in BCS arm. There was no difference between systemic side effect (BRSSE), breast symptom (BRBS) and arm symptom (BRAS) domain scores between the groups. There was no significant difference in change of QOL scores between mastectomy and BCS patients at RT completion as compared to baseline. Conclusions: There was no significant difference in quality of life in patients with BCS versus those with mastectomy. However, patients who underwent BCS had better

  17. Factors affecting the quality of life after total knee arthroplasties: a prospective study

    Directory of Open Access Journals (Sweden)

    Papakostidou Ippolyti

    2012-06-01

    Full Text Available Abstract Background The purpose of the study is to evaluate the self-reported outcomes in the first year after primary total knee arthroplasty (TKA, and to determine factors influencing the quality of life (QoL 6 weeks, 3, 6, and 12 months after TKA. Methods A cohort of patients with knee osteoarthritis undergoing primary TKA at two hospitals (a regional university hospital and a capital’s metropolitan hospital was prospectively followed for 12 months. Patients were assessed preoperatively and at 4 postoperative time-points, with the use of self-reported measurements for pain, physical function and depression with the following evaluation tools: Western Ontario and McMaster Osteoarthritis Index [WOMAC], Knee Society Scoring system [KSS], Centre for Epidemiological Studies Depression Scale, [CES-D10] and visual analog scale [VAS] for pain. General linear modelling for repeated measures was used to evaluate the effect of each independent variable including clinical and sociodemographic data. Differences between groups at different time points were tested by the independent samples t-test. Results Of the 224 eligible patients, 204 (162 females, mean age 69.2 were included in the analysis. Response rate at one year was 90%. At 6 weeks after surgery, despite improvement in pain and alleviation of the depressive mood, the physical function remained less satisfactory. Females presented lower scores in terms of quality of life, both preoperatively and 6 weeks after TKA. Significant improvement was already experienced at 3 months postoperatively. According to WOMAC, KSS, CES-D10 and pain VAS scores the Qol was significantly improved 12 months after TKA (P  Conclusions Patients experienced great improvement in their QoL after TKA in spite of a less satisfactory physical function in the first 6 weeks after surgery, with noticeable differences in the QoL among genders in the same time period. After that period all patients experienced

  18. Increasing Performance of Professional Soccer Players and Elite Track and Field Athletes with Peak Performance Training and Biofeedback: A Pilot Study

    OpenAIRE

    Rijken, Noortje H.; Soer, Remko; de Maar, Ewold; Prins, Hilco; Teeuw, Wouter B.; Peuscher, Jan; Oosterveld, Frits G. J.

    2016-01-01

    The aim of this pilot study was to investigate the effects of an intervention consisting of mental coaching combined with either electro encephalogram (EEG) alpha power feedback or heart rate variability (HRV) feedback on HRV, EEG outcomes and self-reported factors related to stress, performance, recovery and sleep quality in elite athletes. A prospective pilot study was performed with two distinct cohorts. Soccer players were provided with four sessions of mental coaching combined with daily...

  19. Oral health-related quality of life following non-surgical (routine) tooth extraction: A pilot study

    Science.gov (United States)

    Adeyemo, Wasiu L.; Taiwo, Olanrewaju A.; Oderinu, Olabisi H.; Adeyemi, Moshood F.; Ladeinde, Akinola L.; Ogunlewe, Mobolanle O.

    2012-01-01

    Aim: The study was designed to explore the changes in oral health-related quality of life (QoL) in the immediate postoperative period following routine (non-surgical) dental extraction. Setting and Design: A prospective study carried out at the Oral and Maxillofacial Surgery clinic of the Lagos University Teaching Hospital, Nigeria. Materials and Methods: Subjects attending who required non-surgical removal of one or two teeth under local anesthesia were included in the study. A baseline QoL questionnaire (oral health impact profile-14 [OHIP-14]) was filled by each patient just before surgery, and only those who were considered to have their QoL “not affected” (total score 14 or less) were included in the study. After the extraction, each subject was given a modified form of “health related QoL” [OHIP-14]-instrument to be completed by the 3rd day-after surgery, and were given the opportunity to review the questionnaire on the 7th day postoperative review. Results: Total OHIP-14 scores ranged between 14 and 48 (mean ± SD, 26.2 ± 8.3). Majority of the subjects (60%) reported, “a little affected.” Only few subjects (5.8%) reported, “not at all affected,” and about 32% reported, “quite a lot.” Summation of OHIP-14 scores revealed that QoL was “affected” in 41 subjects (34.2%) and “not affected” in 79 subjects (65.8%). More than 30% of subjects reported that their ability to chew, ability to open the mouth and enjoyment of food were affected following tooth extraction. Few subjects (14-34%) reported deterioration in their speech and less than 20% of subjects reported that change in their appearance was “affected.” Only few subjects (12.5-15.1%) reported sleep and duty impairment. Thirty-percent of subjects reported their inability to keep social activities, and 41% were not able to continue with their favorite sports and hobbies. Multiple regression analysis revealed no significant association between age, sex, indications for

  20. Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study.

    Science.gov (United States)

    Little, Andrew S; Kelly, Daniel F; Milligan, John; Griffiths, Chester; Prevedello, Daniel M; Carrau, Ricardo L; Rosseau, Gail; Barkhoudarian, Garni; Jahnke, Heidi; Chaloner, Charlene; Jelinek, Kathryn L; Chapple, Kristina; White, William L

    2015-09-01

    Despite the widespread adoption of endoscopic transsphenoidal surgery for pituitary adenomas, the sinonasal quality of life (QOL) and health status in patients who have undergone this technique have not been compared with these findings in patients who have undergone the traditional direct uninostril microsurgical technique. In this study, the authors compared the sinonasal QOL and patient-reported health status after use of these 2 surgical techniques. The study design was a nonblinded prospective cohort study. Adult patients with sellar pathology and planned transsphenoidal surgery were screened at 4 pituitary centers in the US between October 2011 and August 2013. The primary end point of the study was postoperative patient-reported sinonasal QOL as measured by the Anterior Skull Base Nasal Inventory-12 (ASK Nasal-12). Supplementary end points included patient-reported health status estimated by the 8-Item Short Form Health Survey (SF-8) and EuroQol (EQ)-5D-5L instruments, and sinonasal complications. Patients were followed for 6 months after surgery. A total of 301 patients were screened and 235 were enrolled in the study. Of these, 218 were analyzed (111 microsurgery patients, 107 endoscopic surgery patients). Demographic and tumor characteristics were similar between groups (p ≥ 0.12 for all comparisons). The most common complication in both groups was sinusitis (7% in the microsurgery group, 13% in the endoscopic surgery group; p = 0.15). Patients treated with the endoscopic technique were more likely to have postoperative nasal debridements (p surgery, but then returned to baseline at 3 months. At 3 months after surgery, patients treated with endoscopy reported statistically better sinonasal QOL compared with patients treated using the microscopic technique (p = 0.02), but there were no significant differences at any of the other postoperative time points. This is the first multicenter study to examine the effect of the transsphenoidal surgical technique

  1. The roles of herbal remedies in survival and quality of life among long-term breast cancer survivors - results of a prospective study

    Directory of Open Access Journals (Sweden)

    Sullivan-Halley Jane

    2011-06-01

    Full Text Available Abstract Background Few data exist on survival or health-related quality of life (QOL related to herbal remedy use among long-term breast cancer survivors. The objective of this report is to examine whether herbal remedy use is associated with survival or the health-related QOL of these long-term breast cancer survivors. Methods In 1999-2000, we collected the information of herbal remedy use and QOL during a telephone interview with 371 Los Angeles Non-Hispanic/Hispanic white women who had survived more than 10 years after breast cancer diagnosis. QOL was measured using the Medical Outcomes Study Short Form-36 (SF-36 questionnaire. Patients were followed for mortality from the baseline interview through 2007. 299 surviving patients completed a second telephone interview on QOL in 2002-2004. We used multivariable Cox proportional hazards methods to estimate relative risks (RR and 95% confidence intervals (CI for mortality and applied multivariable linear regression models to compare average SF-36 change scores (follow-up - baseline between herbal remedy users and non-users. Results Fifty-nine percent of participants were herbal remedy users at baseline. The most commonly used herbal remedies were echinacea, herbal teas, and ginko biloba. Herbal remedy use was associated with non-statistically significant increases in the risks for all-cause (44 deaths, RR = 1.28, 95% CI = 0.62-2.64 and breast cancer (33 deaths, RR = 1.78, 95% CI = 0.72-4.40 mortality. Both herbal remedy users' and non-users' mental component summary scores on the SF-36 increased similarly from the first survey to the second survey (P = 0.16, but herbal remedy users' physical component summary scores decreased more than those of non-users (-5.7 vs. -3.2, P = 0.02. Conclusions Our data provide some evidence that herbal remedy use is associated with poorer survival and a poorer physical component score for health-related QOL among women who have survived breast cancer for at least

  2. Climatotherapy in Japan: a pilot study

    Science.gov (United States)

    Kanayama, Hitomi; Kusaka, Yukinori; Hirai, Takayoshi; Inoue, Hiroyuki; Agishi, Yuko; Schuh, Angela

    2017-12-01

    Twenty-nine urban inhabitants participated in a half-day climatotherapy programme at the moderate mountain area and lowland area in the northwest part of the main island of Japan. The current study was aimed to investigate physically and mentally the objective and subjective influence of our short programme, which was a prospective pilot study of single intervention. Blood pressure was significantly descended during terrain cure at the uphill mountain path and returned after fresh-air rest cure, while there was no significant change throughout the programme at lowland flat path. Heart rate was significantly ascended and descended at both area, and more clearly changed at the mountain path. Profile of Mood Status brief form Japanese version administered before and after our half-day programme. Age adjusted T score of negative subscales, `tension-anxiety', `depression', `anger-hostility', `fatigue' and `confusion' were significantly lower after climatotherapy at both sites. Whereas, there was no significant change concerning `vigour' score. This short-version climatotherapy programme has been designed for people without enough time for long stay at health resort. It turned out our half-day climatotherapy programme contribute to mood status improvement. In addition, repeated practice of our short-version programme including endurance exercise with cool body shell using uphill path can be expected that blood pressure will go toward the normal range and heart rate will decrease both in usual time and during exercise. Therefore, health benefits can be expected of this climatotherapy programme.

  3. Clinical Holistic Medicine: Pilot Study on the Effect of Vaginal Acupressure (Hippocratic Pelvic Massage

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2006-01-01

    Full Text Available This is a pilot study of 20 female patients with a long history of sexual problems (mean is 8.92 years who received vaginal acupressure (VA with a quantitative and qualitative evaluation: 56% experienced help and none reported setbacks, 89% rated the treatment to be of high quality, and 89% rated it as valuable. After the treatment, most reported their problems to be less serious and their general quality of life improved. Only 17% reported minor or temporary side effects. VA was found statistically and clinically significant (p < 0.05, improvement more than 0.5 step on a 5-point Likert scale to help patients with chronic genital pains, pain or discomfort during sexual intercourse, lack of desire or orgasm, and subjective sexual insufficiency, and all patients taken as one group (about 1 step up a 5-point Likert scale. Self-evaluated physical and mental health was significantly improved for the total group; the relationship with partner, the subjective sexual ability, and the quality of life that were measured with QOL1 and QOL5 questionnaires were all significantly improved. VA or Hippocratic pelvic massage is technically a simple procedure corresponding to the explorative phase of the standard pelvic examination, supplemented with the patient’s report on the feelings provoked followed by processing and integration of these feelings, but ethical aspects are complicated. Acupressure through the vagina/pelvic massage must be done according to the highest ethical standard with great care, after obtaining consent and the necessary trust of the patient within the framework of the local laws. It must be followed by conversational therapy and further holistic existential processing.

  4. 14 CFR 121.437 - Pilot qualification: Certificates required.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Pilot qualification: Certificates required... Pilot qualification: Certificates required. (a) No pilot may act as pilot in command of an aircraft (or... pilots) unless he holds an airline transport pilot certificate and an appropriate type rating for that...

  5. 49 CFR 381.400 - What is a pilot program?

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false What is a pilot program? 381.400 Section 381.400... PILOT PROGRAMS Initiation of Pilot Programs § 381.400 What is a pilot program? (a) A pilot program is a... that would be subject to the regulations. (b) During a pilot program, the participants would be given...

  6. 75 FR 53007 - Gulf Opportunity Pilot Loan Program (GO Loan Pilot)

    Science.gov (United States)

    2010-08-30

    ... SMALL BUSINESS ADMINISTRATION Gulf Opportunity Pilot Loan Program (GO Loan Pilot) AGENCY: U.S...'s GO Loan Pilot until September 30, 2011. Due to the scope and magnitude of the devastation to... streamlined and centralized loan processing available through the GO Loan Pilot to small businesses in the...

  7. 77 FR 61721 - Pilot, Flight Instructor, and Pilot School Certification; Technical Amendment

    Science.gov (United States)

    2012-10-11

    ...-26661; Amdt. No. 61-129A] RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School Certification... revise the training, qualification, certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools. A portion of the codified text was inadvertently deleted...

  8. 76 FR 60960 - Gulf Opportunity Pilot Loan Program (GO Loan Pilot)

    Science.gov (United States)

    2011-09-30

    ... SMALL BUSINESS ADMINISTRATION Gulf Opportunity Pilot Loan Program (GO Loan Pilot) AGENCY: U.S.... SUMMARY: This notice announces the extension of SBA's GO Loan Pilot, with modifications, until December 31... processing available through the GO Loan Pilot to small businesses in the eligible parishes/counties through...

  9. Radimetric autotransported prospecting survey

    International Nuclear Information System (INIS)

    Coco, A.L.; Azamor, L.A.; Agost, E.J.

    1977-10-01

    A procedure of prospection of minerals (''carborne''). It is characterized to be rapid and low costly if a sufficiently dense highway network is available or if transit with a vehicle across the fields is possible. Instruments, methods and results that may be obtained are given. The detector, a scintillation counter, is mounted on the top of an appropiate car registering continuously the measured values. Subsequently data are put on cartography, obtaining thus the values of iso-radiactivity which determine the values of ''background'' and the favorable zones for pursuing prospection work by other methods. The application of the method to the zone of the Chihuidos, province of Neuquen, is described in details and the obtained conclusions are given. (author) [es

  10. The uranium market prospects

    International Nuclear Information System (INIS)

    Lloyd, R.

    1981-01-01

    A historical analysis of the uranium market points out the cyclical nature of the market and suggests that the spot price, exploration levels, and mill capacity utilization rate are dependent on economic factors. An examination of the current uranium market suggests that the effects of the forecasted surplus supply, the diminishing returns in exploration and the long lead times and high costs of development may mean that future production levels are uncertain. The general prospects for the uranium industry are also uncertain because of barriers to trade, environmental regulations and public opinion. The paper concludes that by the use of long term contracts, appropriate inventory policy and greater discussion between producers and consumers the prospects for the uranium market can be made more certain and further imbalances in demand and supply can be avoided. (author)

  11. Future prospects of pregeometry

    International Nuclear Information System (INIS)

    Terazawa, Hidezumi.

    1991-06-01

    Pregeometry is a theory, first suggested by Sakharov in 1967, in which gravity is taken as a quantum effect of matter fields and in which Einstein's theory of general relativity for gravity appears as an approximate and effective theory at long distances. It is shown by reviewing the extensive developments of pregeometric theories of gravity for the last more than a decade that the original idea by Sakharov is really working. Many future prospects of the theories are discussed in some detail. (author)

  12. 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...

  13. Long-term prospective longitudinal evaluation of emotional distress and quality of life in cervical cancer patients who remained disease-free 2-years from diagnosis.

    Science.gov (United States)

    Mantegna, Giovanna; Petrillo, Marco; Fuoco, Gilda; Venditti, Laura; Terzano, Serena; Anchora, Luigi Pedone; Scambia, Giovanni; Ferrandina, Gabriella

    2013-03-18

    A long-term prospective assessment of QoL in cervical cancer patients is still lacking. Here, we provide the first 2-years prospective, longitudinal study evaluating emotional distress and QoL in early stage (ECC) and locally advanced (LACC) cervical cancer patients who remained disease-free 2-years from diagnosis. The questionnaires: Hospital Anxiety and Depression Scale (HADS), Global Health Status items of EORTC QLQ-C30 (GHS), and EORTC QLQ-CX24 (CX24) have been administered by a dedicated team of psycho-oncologists, administered at baseline, and after 3, 6, 12 and 24 months from surgery The Generalized Linear Model for repeated measure was used to analyze modifications of QoL measures over time. In both groups, an early reduction of the percentage of patients with anxiety levels ≥11 was observed at the 3-month evaluation (ECC: 25.7% at baseline Vs 14.7% after 3 months, p value=0.001; LACC: 22.2% at baseline Vs 15.4% after 3 months, p value=0.001). Despite this favorable trend, after 2 years from diagnosis, 11.9% of ECC and 15.6% of LACC patients still showed an anxiety score ≥11. No significant changes over time were observed in term of Depression levels. Focusing on QoL issues, mean GHS and Sexual Activity scores showed an improvement over time in both groups compared to baseline (GHS: 5.7% difference for ECC, p value=0.001, and 11.0% in LACC, p value=0.001; SXA: 13.9% difference for ECC, p value=0.001; and 6.1% in LACC, p value=0.008). On the other hand, Body Image mean scores were significantly impaired by chemoradiation administration in LACC patients, without long-term recovery (7.5% difference, p value=0.001). Finally, in both groups, lymphedema (LY) and menopausal symptoms (MS) showed an early worsening which persisted 2-year after surgery (LY: 19.5% difference for ECC, p value=0.014, and 27.3% in LACC, p value=0.001; MS: 14.4% difference for ECC, p value=0.004, and 16.0% in LACC, p value=0.002). Despite a significant improvement over time, elevated

  14. Health values and prospect theory.

    Science.gov (United States)

    Treadwell, J R; Lenert, L A

    1999-01-01

    Health values are important components of medical decisions. Experimental data suggest that people value health in complex and dynamic ways. Prospect theory is a descriptive theory of choice that may accurately characterize how people assign values to health states. The authors first provide background on prospect theory and how it can be applied to health values. Next, they review the relevant health rese