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

PubMed

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.

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

PubMed

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.

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.

PubMed

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.

Quality of life (QOL) of older adult community choral singers in Finland

PubMed Central

Johnson, Julene K; Louhivuori, Jukka; Stewart, Anita L; Tolvanen, Asko; Ross, Leslie; Era, Pertti

2013-01-01

Background Enhancing quality of life (QOL) of older adults is an international area of focus. Identifying factors and experiences that contribute to QOL of older adults helps promote optimal levels of functioning. This study examines the relationship between perceived benefits associated with choral singing and quality of life (QOL) among community-dwelling older adults. Methods One hundred and seventeen older adults who sing in community choirs in Jyväskylä, Finland completed self-report measures of QOL (WHOQOL-Bref), depressive symptoms, and a questionnaire about the benefits of singing in choir. Correlational analyses and linear regression models were used to examine the association between the benefits of singing in choir and QOL. Results Both correlation and regression analyses found significant relationships between the benefits of choral singing and three QOL domains: psychological, social relationships, and environment but not physical. These associations remained significant after adjusting for age and depressive symptoms. As hypothesized, older choral singers who reported greater benefits of choir singing had higher QOL in multiple domains. The older choral singers in the study also reported few symptoms of depression and high overall QOL and satisfaction with health. Conclusion Results suggest that singing in a community choir as an older adult may positively influence several aspects of QOL. These results suggest that community choral singing may one potential avenue for promoting quality of life in older adults. PMID:23574947

Physical activity and pelvic floor muscle training in patients with pelvic organ prolapse: a pilot study.

PubMed

Ouchi, Mifuka; Kato, Kumiko; Gotoh, Momokazu; Suzuki, Shigeyuki

2017-12-01

The details of the physical activity in patients with mild to moderate pelvic organ prolapse (Pmoderate pelvic organ prolapse (POP) remain under-studied. The purpose of the present study was to investigate objective physical activity levels and the changes in pelvic floor muscle(PFM) strength, symptoms and quality of life (QOL) between before and after PFM training (PFMT) in patients with POP. In a prospective pilot study, 29 patients with stage II or III POP completed approximately 16 weeks of PFMT. A reliable activity monitor was used to measure physical activity parameters including step counts, activity and total calories expended, and duration at each intensity level. Maximum vaginal squeeze pressure, POP symptoms and QOL were assessed. Changes in these outcome measures were compared before and after PFMT. The step counts per day (mean ± SD) of women with POP was 7,272.9 ± 3,091.7 before PFMT and 7,553.4 ± 2,831.0 after PFMT. There was no significant change between before and PFMT. PFM strength was significantly increased after PFMT. POP-related symptoms including stress urinary incontinence, frequency, postmicturition dribble and interference with emptying the bowels were significantly improved. The QOL scores for general health, physical limitations, emotion, and severity measures were significantly improved after PFMT. Although PFMT changed PFM strength symptoms, and QOL, there were no changes for any physical activity parameters before and after PFMT. This is probably because the physical activity levels in patients with mild to moderate POP were almost same as in age-matched healthy women.

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.

PubMed

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.

Associations between fatigue, physical activity, and QoL in patients with myeloproliferative neoplasms.

PubMed

Tolstrup Larsen, Rasmus; Tang, Lars H; Brochmann, Nana; Meulengracht Flachs, Esben; Illemann Christensen, Anne; Hasselbalch, Hans C; Zwisler, Ann-Dorthe

2018-06-01

Patients with Philadelphia chromosome-negative Myeloproliferative Neoplasms (MPNs) report fatigue as the most common symptom and contributing significantly to reduction in their quality of life (QoL). Targeted non-pharmacological intervention to increase levels of physical activity is suggested as a fatigue-reducing and QoL-enhancing intervention in MPN patients. The interrelationship between physical activity, fatigue, and QoL has, to our knowledge, never been reported. We analyzed data from 1807 MPN patients. The primary analysis included a multiple regression model allowing fatigue to mediate the relationship between physical activity and QoL. We herein report the first and the largest study of patients with MPNs, in whom we have investigated the interrelationship between fatigue, physical activity, and QoL. Sedentary patients were more likely to report fatigue compared to highly active patients. There was a negative association between fatigue and QoL, and there was a positive association between physical activity and QoL. There was no interaction between fatigue and physical activity in the association with QoL. We found positive associations between level of physical activity and QoL, independently of fatigue being present. More research is needed before physical activity can be introduced as a targeted intervention to reduce fatigue and increase QoL in the management of patients. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

PubMed

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.

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

PubMed

Jubert-Esteve, E; Del Pozo-Hernando, L J; Izquierdo-Herce, N; Bauzá-Alonso, A; Martín-Santiago, A; Jones-Caballero, M

2015-10-01

Actinic keratosis (AK) lesions are in situ squamous cell carcinoma. These lesions have a low risk of progressing to invasive disease but significant impact on patients' quality of life (QoL). The aim of this study was to assess QoL and side effects in patients with AK receiving treatment with ingenol mebutate. This was a prospective, non-randomized pilot study carried out in Spain. The target population was adults with a clinical diagnosis of AK affecting any part of the body. Outcomes were assessed on the basis of a QoL questionnaire (Skindex-29), local skin response, the Treatment Satisfaction Questionnaire for Medication (TSQM 1.4), and clinical response. A total of 19 patients were studied. Most of the participants were men (89.5%) and mean age was 76.2 years. After treatment with ingenol mebutate, significant improvement was observed in the Skindex-29 subscales relating to symptom severity (P=.041), the patients' emotional state (P=.026), and in the overall score (P=.014). Erythema, crusting, and flaking or scaling were the local skin responses with highest median score (2.0 in all 3 cases). Imiquimod 5% and ingenol mebutate achieved higher median scores for effectiveness and global satisfaction than any other previous treatments (as measured by TSQM 1.4). In the patients' assessment of convenience, ingenol mebutate had a higher median score than previous treatments. Over half of the patients (52.6%) had an improvement of at least 75% at month 3. QoL in patients with AK improves after treatment with ingenol mebutate. The presence of side effects did not affect QoL or patient satisfaction with treatment. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

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

PubMed

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.

Minority population group status and QOL change: The case of older Israelis.

PubMed

Damri, Noam; Litwin, Howard

2016-12-01

This study explores minority group status in relation to change in Quality of Life (QOL) among three population groups in Israel-Veteran Jews, Arab-Israelis and immigrants from the Former Soviet Union (FSU)-controlling for a set of known predictors. The study uses panel data from two waves (2009/10 and 2013) of the Israeli component of the Survey of Health, Ageing and Retirement in Europe, (N=1,590). A set of Ordinary Least Squares regressions is used to predict positive QOL change over the two waves. Interaction terms in a number of selected areas are considered. The results show that minority group status (Arab-Israelis and FSU immigrants) is negatively related to positive QOL change, compared to the majority group (Veteran Jews). Moreover, being employed was found to improve QOL for older FSU immigrants, underscoring the realm of work in the well-being of this population group. In comparison, it was exchange with family members that had a positive effect on QOL change among the Arab-Israelis, emphasizing the importance of that particular aspect of their lives in older age. In sum, the results highlight the risk of minority group status to well-being in late life and confirms the observation that positive QOL change correlates with characteristically different factors among different population groups.

Prostate cancer: how assessment of QoL can improve delivery of care.

PubMed

Brown, Michelle

Prostate cancer treatments often affect quality of life and problems may present at any point during treatment. Measuring and identifying issues of quality of life (QoL) may create an opportunity for the patient to discuss problems and induce information transfer from health professional to patient and vice versa. Many practitioners already assess QoL in patients with prostate cancer because treatment for the disease can have a dramatic impact on lifestyle. QoL may facilitate a more holistic approach to patient care. Using a QoL assessment tool may promote and enhance the current service provision and aid identification of bothersome side-effects, for example loss of libido, gynaecomastia (i.e. abnormal over-development of the breasts in a man), and hot flushes. The Functional Assessment of Cancer Therapy-Prostate scale (FACT-P) (Cella et al, 1993) is a prostate-specific QoL assessment tool, which can be self-administered and takes little time to complete. This may be a useful tool in the ongoing management of patients with advanced prostate cancer. With the emphasis on quality of service for cancer patients (Department of Health (DH), 2000; DH, 2007a; National Health Service Improvement, 2009), it is paramount that health professionals continually examine practice and the quality of the service delivered. Addressing QoL issues for the patient with cancer should be a priority. This article will outline the significant side-effects that a patient with advanced prostate cancer may sustain and attempts to indicate how QoL assessment tools may contribute to care management and delivery.

Validation of the traditional Chinese version of the prolapse quality of life questionnaire (P-QOL) in a Mandarin-speaking Taiwanese population.

PubMed

Chuang, Fei-Chi; Chu, Li-Ching; Kung, Fu-Tsai; Huang, Kuan-Hui

2016-10-01

To validate the traditional Chinese translated version of the prolapse quality of life questionnaire (P-QOL). The P-QOL questionnaire was translated into traditional Chinese characters and administered to women recruited from gynecologic outpatient clinics of Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan. After the test-retest reliability and internal consistency were established in a pilot study, all participants completed the P-QOL questionnaire and were examined in the lithotomy position using the Pelvic Organ Prolapse Quantification System (POP-Q). The construct validity was assessed by comparing symptom scores and quality-of-life domain scores between symptomatic and asymptomatic women. Of the 244 women recruited, 159 were symptomatic for pelvic organ prolapse, and 85 were asymptomatic. The test-retest reliability confirmed a significant positive monotonic correlation between the total scores of each domain (n = 30, Spearman's rho was from 0.411 to 0.888, p < 0.05 of all). All items achieved a Cronbach α > 0.80 showing good internal consistency. Among the 18 symptom questions, the scores differed significantly between symptomatic and asymptomatic women for 12/18 symptom questions. These 12 questions referred to the prolapse/vaginal symptoms. All the quality of life domains differed significantly (p < 0.05) between symptomatic and asymptomatic women except for the domain of sleep/energy (p = 0.108). The traditional Chinese language version of the P-QOL is a reliable instrument for the assessment of symptom severity and impact on quality of life in women with pelvic organ prolapse. Copyright © 2016. Published by Elsevier B.V.

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

PubMed

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.

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

ERIC Educational Resources Information Center

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…

Theoretical Perspectives Guiding QOL Indicator Projects

ERIC Educational Resources Information Center

Sirgy, M. Joseph

2011-01-01

Most of the theoretically based QOL indicators projects can be classified in terms of six major theoretical concepts: (a) socio-economic development (b) personal utility, (c) just society, (d) human development, (e) sustainability, and (f) functioning. I explain the core aspects of these six theoretical paradigms and show how they help guide QOL…

The effects of virgin coconut oil (VCO) as supplementation on quality of life (QOL) among breast cancer patients.

PubMed

Law, Kim Sooi; Azman, Nizuwan; Omar, Eshaifol Azam; Musa, Muhammad Yusri; Yusoff, Narazah Mohd; Sulaiman, Siti Amrah; Hussain, Nik Hazlina Nik

2014-08-27

Breast cancer is the most common cancer amongst Malaysian women. Both the disease and its treatment can disrupt the lives of the woman and adversely affect all aspects of life and thus can alter a woman's quality of life. The aim of this study was to examine the effect of virgin coconut oil (VCO) on the quality of life (QOL) of patients diagnosed with breast cancer. This was a prospective study of breast cancer patients admitted into the Oncology Unit of Hospital Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia. The sample consisted of 60 patients with stage III and IV breast cancer allocated to either an intervention group (n = 30) or a control group (n = 30) using a simple random table. QOL was evaluated from the first cycle of chemotherapy to the sixth cycle, and data were collected using a validated Bahasa Malaysia version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ-C30) and its breast-specific module (QLQ-BR 23). The mean age of breast cancer patients was 50.2 (SD = 13.5) years. There were significant mean score differences for functioning and global QOL between groups (α < 0.01). The intervention group also had better scores for symptoms including fatigue, dyspnea, sleep difficulties, and loss of appetite compared to the control group. Although there are deteriorations for sexual enjoyment, the intervention group exhibited improvement in breast functioning and symptom scores for body image, sexual function, future perspective, breast symptoms, and systemic therapy side effects. VCO consumption during chemotherapy helped improve the functional status and global QOL of breast cancer patients. In addition, it reduced the symptoms related to side effects of chemotherapy.

Validation of a Quality of Life Questionnaire for Bronchiectasis: psychometric analyses of the Spanish QOL-B-V3.0.

PubMed

Olveira, Casilda; Olveira, Gabriel; Espildora, Francisco; Giron, Rosa-Maria; Muñoz, Gerard; Quittner, Alexandra L; Martinez-Garcia, Miguel-Angel

2014-05-01

Bronchiectasis is a chronic disease, leading to worsening of health-related quality of life. This study evaluated the psychometric properties of a new patient-reported outcome for non-cystic fibrosis bronchiectasis, the Quality of Life Questionnaire Bronchiectasis, translated into Spanish (QOL-B-Sp-V3.0). This prospective study recruited clinically stable patients with non-cystic fibrosis bronchiectasis at 4 Spanish centers. Health status was assessed with multiple indicators (dyspnea, exacerbations, bronchorrhea, etc.), microbiological, radiological, spirometric, and anthropometric parameters plus St-George Respiratory Questionnaire (SGRQ). Psychometric analyses included internal consistency, test-retest reliability, convergent validity, predictive validity, and responsivity to change. The 207 stable patients (mean age 57.2 years) had a Bhalla score of 11.53 ± 7.39 and FEV1% of 68.3 ± 22.2 %. One hundred and sixty-one stable patients repeated the test 2 weeks later, and 80 patients who had an exacerbation within 6 months of the assessment also repeated it. Internal consistency was high across all scales (Cronbach's alpha >0.70). Thirty-six of 37 items correlated more strongly with their assigned scale than a competing scale. Test-retest coefficients were strong (intraclass correlations r = 0.68-0.88). All scales, except Treatment Burden, discriminated significantly between patients with mild, moderate, and severe disease according to FEV1% and other respiratory parameters. Strong convergence was found between the QOL-B-Sp-V3.0 and SGRQ. Significant correlations were found between QOL-B-Sp-V3.0 and various clinical, spirometric, radiological, and anthropometric variables. Significant differences were found on all QOL-B-Sp-V3.0 scales, except emotional functioning, between the baseline responses and onset of an exacerbation; robust sensitivity to change was observed on the Respiratory Symptoms scale. The QOL-B-Sp-V3.0 questionnaire demonstrated strong reliability

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

PubMed

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.

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

PubMed

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.

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial

PubMed Central

El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen

2018-01-01

Background The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. Objective The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App – A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. Methods The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. Results This trial will recruit 50 patients over a period of 12 months. Follow-up will be

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study.

PubMed

Minagawa, Tomonori; Saitou, Tetsuichi; Suzuki, Toshiro; Domen, Takahisa; Yokoyama, Hitoshi; Ishikawa, Masakuni; Hirakata, Shiro; Nagai, Takashi; Nakazawa, Masaki; Ogawa, Teruyuki; Ishizuka, Osamu

2016-12-09

Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC). Participants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC. A total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use. The results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC. UMIN000019333 (UMIN-CTR, Registered October-15

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

PubMed

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, p<0.001), while weak correlations were found between measures 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/.

Cross-cultural adaption and validation of the Persian version of the SWAL-QOL.

PubMed

Tarameshlu, Maryam; Azimi, Amir Reza; Jalaie, Shohreh; Ghelichi, Leila; Ansari, Noureddin Nakhostin

2017-06-01

The aim of this study was to translate and cross-culturally adapt the swallowing quality-of-life questionnaire (SWAL-QOL) to Persian language and to determine validity and reliability of the Persian version of the swallow quality-of-life questionnaire (PSWAL-QOL) in the patients with oropharyngeal dysphagia.The cross-sectional survey was designed to translate and cross-culturally adapt SWAL-QOL to Persian language following steps recommended in guideline. A total of 142 patients with dysphagia (mean age = 56.7 ± 12.22 years) were selected by non-probability consecutive sampling method to evaluate construct validity and internal consistency. Thirty patients with dysphagia were completed the PSWAL-QOL 2 weeks later for test-retest reliability.The PSWAL-QOL was favorably accepted with no missing items. The floor effect was ranged 0% to 21% and ceiling effect was ranged 0% to 16%. The construct validity was established via exploratory factor analysis. Internal consistency was confirmed with Cronbach α >0.7 for all scales except eating duration (α = 0.68). The test-retest reliability was excellent with intraclass correlation coefficient (ICC) ≥0.75 for all scales.The SWAL-QOL was cross-culturally adapted to Persian and demonstrated to be a valid and reliable self-report questionnaire to measure the impact of dysphagia on the quality-of-life in the Persian patients with oropharyngeal dysphagia.

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

PubMed Central

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

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

PubMed

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

2015-10-13

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

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

PubMed

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.

Factors influencing quality of life (QOL) for Korean patients with rheumatoid arthritis (RA).

PubMed

Cho, Soo-Kyung; Kim, Dam; Jun, Jae-Bum; Bae, Sang-Cheol; Sung, Yoon-Kyoung

2013-01-01

The aim of the study was to identify factors influencing the health-related quality of life (HR-QOL) for Korean RA patients and factors associated with each dimension of the EQ-5D. Two hundred and twenty-five RA patients were recruited from one University Hospital in Seoul, South Korea. Their clinical and socio-demographic data were widely collected by means of interviews, self-administered questionnaires, and clinical examinations. Multiple logistic regression analyses were performed to determine the factors influencing QOL and factors associated with each dimension of the EQ-5D. The mean EQ-5D utility observed for Korean RA patients was 0.60 (-0.29 to 1.0). Functional disability measured with Health Assessment Questionnaire (OR = 10.0, CI 2.8-34.5), disease activity score (DAS) 28 (OR = 2.6, CI 1.4-4.9), and pain VAS (OR = 2.2, CI 1.2-4.1) was three main factors influencing on QOL of RA patients. Although the functional disability consistently showed significant associations with all dimensions, various factors were associated with the each five specific dimension of EQ-5D. Pain (OR = 2.5, CI 1.4-4.6), history of hospitalization (OR = 2.1, CI 1.0-4.3), and men (OR = 2.6, CI 1.0-6.8) were associated with lower QOL in mobility. Use of alternative medicine (OR = 2.0, CI 1.1-3.7) and disease activity (OR = 3.1, CI 1.7-5.7) were associated with lower self-care QOL. For the patients with discomfort in usual activity, pain (OR = 4.7, CI 2.4-9.2) and the presence of anemia (OR = 2.3, CI 1.2-4.5) were major influencing factors. Higher disease activity (OR = 4.5, CI 1.0-21.2) and pain (OR = 3.3, CI 1.9-5.8) were associated with the pain/discomfort dimension of EQ-5D, and the pain (OR = 3.3, CI 1.9-5.8) was an independent associating factor of anxiety/depression. The strongest determinants of lower QOL in Korean RA patients were functional disability, higher disease activity, and subjective pain. However, various factors are influencing on the QOL for RA patients according

Cross-cultural adaption and validation of the Persian version of the SWAL-QOL

PubMed Central

Tarameshlu, Maryam; Azimi, Amir Reza; Jalaie, Shohreh; Ghelichi, Leila; Ansari, Noureddin Nakhostin

2017-01-01

Abstract The aim of this study was to translate and cross-culturally adapt the swallowing quality-of-life questionnaire (SWAL-QOL) to Persian language and to determine validity and reliability of the Persian version of the swallow quality-of-life questionnaire (PSWAL-QOL) in the patients with oropharyngeal dysphagia. The cross-sectional survey was designed to translate and cross-culturally adapt SWAL-QOL to Persian language following steps recommended in guideline. A total of 142 patients with dysphagia (mean age = 56.7 ± 12.22 years) were selected by non-probability consecutive sampling method to evaluate construct validity and internal consistency. Thirty patients with dysphagia were completed the PSWAL-QOL 2 weeks later for test–retest reliability. The PSWAL-QOL was favorably accepted with no missing items. The floor effect was ranged 0% to 21% and ceiling effect was ranged 0% to 16%. The construct validity was established via exploratory factor analysis. Internal consistency was confirmed with Cronbach α >0.7 for all scales except eating duration (α = 0.68). The test–retest reliability was excellent with intraclass correlation coefficient (ICC) ≥0.75 for all scales. The SWAL-QOL was cross-culturally adapted to Persian and demonstrated to be a valid and reliable self-report questionnaire to measure the impact of dysphagia on the quality-of-life in the Persian patients with oropharyngeal dysphagia. PMID:28658118

Quality of life in children with epilepsy and cognitive impairment: a review and a pilot study.

PubMed

Soria, Carmen; El Sabbagh, Sandra; Escolano, Sylvie; Bobet, René; Bulteau, Christine; Dellatolas, Georges

2007-01-01

Various methods have recently been proposed to assess the physical, psychological or social dimensions of quality of life (QoL) in children with epilepsy (CwE) and their families. Some methods are based exclusively on parental report and others emphasize the importance of an interview with the patient himself. In children with epilepsy and severe cognitive deficit only parental report is possible in practice; however, some parental based methods to evaluate QoL in CwE have excluded children with cognitive deficit. The present pilot study explores which items are suitable for a parental-based QoL evaluation in CwE and special educational needs, and the most frequently reported parental concerns in this special population of children.

Oncologic Therapy Support Via Means of a Dedicated Mobile App (OPTIMISE-1): Protocol for a Prospective Pilot Trial.

PubMed

El Shafie, Rami A; Bougatf, Nina; Sprave, Tanja; Weber, Dorothea; Oetzel, Dieter; Machmer, Timo; Huber, Peter E; Debus, Jürgen; Nicolay, Nils H

2018-03-06

The increasing role of consumer electronics and Web-enabled mobile devices in the medical sector opens up promising possibilities for integrating novel technical solutions into therapy and patient support for oncologic illnesses. A recent survey carried out at Heidelberg University Hospital suggested a high acceptance among patients for an additional approach to patient care during radiotherapy based on patient-reported outcomes by a dedicated mobile app. The aim of this trial (OPTIMISE-1: Oncologic Therapy Support Via Means of a Dedicated Mobile App - A Prospective Feasibility Evaluation) is to prospectively evaluate the feasibility of employing a mobile app for the systematic support of radiooncological patients throughout the course of their radiotherapy by monitoring symptoms and patient performance, and facilitating the background-exchange of relevant information between patient and physician. The present single-center, prospective, exploratory trial, conducted at Heidelberg University Hospital, assesses the feasibility of integrating an app-based approach into patient-care during radiotherapy. Patients undergoing curative radiotherapy for thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related quality of life (QoL) and symptoms, and their need to personally consult a physician by means of a mobile app during treatment. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and health-related QoL is assessed by the Patient Satisfaction Questionnaire Short Form (PSQ-18) and the European Organization for Research and Treatment of Cancer (EORTC) questionnaires at the beginning (baseline) and end of radiotherapy, and at the first follow-up. This trial will recruit 50 patients over a period of 12 months. Follow-up will be completed after 18 months, and publication

Hearing Loss and Quality of Life (QOL) among Human Immunodeficiency Virus (HIV)-Infected and Uninfected Adults

PubMed Central

Duong, N; Torre, P; Springer, G; Cox, C; Plankey, MW

2017-01-01

Objective Research has established that human immunodeficiency virus (HIV) causes hearing loss. Studies have yet to evaluate the impact on quality of life (QOL). This project evaluates the effect of hearing loss on QOL by HIV status. Methods The study participants were from the Multicenter AIDS Cohort Study (MACS) and the Women's Interagency HIV study (WIHS). A total of 248 men and 127 women participated. Pure-tone air conduction thresholds were collected for each ear at frequencies from 250 through 8000 Hz. Pure-tone averages (PTAs) for each ear were calculated as the mean of air conduction thresholds in low frequencies (i.e., 250, 500, 1000 and 2000 Hz) and high frequencies (i.e., 3000, 4000, 6000 and 8000 Hz). QOL data were gathered with the Short Form 36 Health Survey and Medical Outcome Study (MOS)-HIV instrument in the MACS and WIHS, respectively. A median regression analysis was performed to test the association of PTAs with QOL by HIV status. Results There was no significant association between hearing loss and QOL scores at low and high pure tone averages in HIV positive and negative individuals. HIV status, HIV biomarkers and treatment did not change the lack of association of low and high pure tone averages with poorer QOL. Conclusion Although we did not find a statistically significant association of hearing loss with QOL by HIV status, testing for hearing loss with aging and recommending treatment may offset any presumed later life decline in QOL. PMID:28217403

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

PubMed

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.

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

PubMed

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 (p<0.05). In Q1(perception on quality of life) and Q2 (perception on quality of health) domain, QOL score was marginally higher than average in both the groups. In Y-BOCS scale, no statistical significant association was found between severity of OCD and QOL score in each of the domains (p>0.05). 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.

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

PubMed Central

Vasudev, Roopesh Gopal Nariyandada; Yallappa, Sudarshan Chikkanayakanahalli

2015-01-01

Introduction There is paucity of data on Quality of Life (QOL) in non-psychotic mental disorders. Aim To assess the Quality of Life (QOL) in Obsessive Compulsive Disorder (OCD) and compare it with Dysthymic Disorder (DD). Materials and Methods 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. Results 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 (p<0.05). In Q1(perception on quality of life) and Q2 (perception on quality of health) domain, QOL score was marginally higher than average in both the groups. In Y-BOCS scale, no statistical significant association was found between severity of OCD and QOL score in each of the domains (p>0.05). Conclusion 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. PMID:26155540

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

PubMed

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.

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

PubMed

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.

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

PubMed

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

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

PubMed

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.

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

PubMed

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 < 0.05), followed by the Bonferroni procedure, showed the following: the total QOL of 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.

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

PubMed Central

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

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

PubMed

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 < 0.001), which was correlated with 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.

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

PubMed Central

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

2015-01-01

Objective To develop a comprehensive, psychometrically sound, and conceptually grounded patient reported outcomes (PRO) measurement system for individuals with spinal cord injury (SCI). Methods 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. Participants and Procedures 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. Results 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. Conclusions 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. PMID:26010963

Effect of an essential oil mixture on skin reactions in women undergoing radiotherapy for breast cancer: a pilot study.

PubMed

Halm, Margo A; Baker, Clarice; Harshe, Val

2014-12-01

This pilot study compared the effects of an essential oil mixture versus standard care on skin reactions in breast cancer patients receiving radiation. Using an experimental design, 24 patients were randomized to standard care (i.e., RadiaPlexRx™ ointment) or an essential oil mixture. Products were applied topically three times a day until 1 month postradiation. Weekly skin assessments were recorded and women completed patient satisfaction and quality of life (QOL) instruments at 3-, 6-, and 10-week intervals. No significant differences were found for skin, QOL, or patient satisfaction at interim or follow-up time points. Effect sizes were as follows: skin = .01 to .07 (small-medium effect); QOL = .01 to .04 (small effect); patient satisfaction = .02 (small effect). The essential oil mixture did not provide a better skin protectant effect than standard care. These findings suggest the essential oil mixture is equivalent to RadiaPlexRx, a common product used as standard care since it has been shown to be effective in protecting skin from radiation. Thus, this pilot provides evidence to support botanical or nonpharmaceutical options for women during radiotherapy for breast cancer. © The Author(s) 2014.

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

PubMed

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.

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

PubMed

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.

Psychometric properties of the Portuguese version of the Quality of Life Questionnaire (QOL-Q).

PubMed

Albuquerque, Cristina P

2012-09-01

This study analyzes the psychometric properties of the Portuguese version of the Quality of Life Questionnaire (QOL-Q; Quality of Life Questionnaire Manual - 1993 Manual and 2004 Revision. 2004, IDS Publishing Company, Worthington, OH; Schalock & Keith 2004). The analysis of the factorial structure was carried out on a sample of 304 adults with intellectual disabilities, through the use of confirmatory (CFA) and exploratory (EFA) factor analysis. The relationships of the QOL-Q with life satisfaction and self-concept measures were determined in groups composed of respectively 72 and 78 adults with intellectual disabilities. Confirmatory factorial analysis indicated a poor adjustment of the original factor structure to the Portuguese data. EFA indicated the existence of four factors, which include 30 items, and that were also supported by CFA. The total score of the QOL-Q revealed a reduced correlation with life satisfaction, and a moderate correlation with the self-concept. The Portuguese version of the QOL-Q shows satisfactory psychometric properties, but also some limitations. © 2012 Blackwell Publishing Ltd.

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

PubMed

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.

Evaluation of the Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire in diarrheal-predominant irritable bowel syndrome patients

PubMed Central

2013-01-01

Background Diarrhea-predominant irritable bowel syndrome (IBS-d) significantly diminishes the health-related quality of life (HRQOL) of patients. Psychological and social impacts are common with many IBS-d patients reporting comorbid depression, anxiety, decreased intimacy, and lost working days. The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire is a 34-item instrument developed and validated for measurement of HRQOL in non-subtyped IBS patients. The current paper assesses this previously-validated instrument employing data collected from 754 patients who participated in a randomized clinical trial of a novel treatment, eluxadoline, for IBS-d. Methods Psychometric methods common to HRQOL research were employed to evaluate the IBS-QOL. Many of the historical analyses of the IBS-QOL validations were used. Other techniques that extended the original methods were applied where more appropriate for the current dataset. In IBS-d patients, we analyzed the items and substructure of the IBS-QOL via item reduction, factor structure, internal consistency, reproducibility, construct validity, and ability to detect change. Results This study supports the IBS-QOL as a psychometrically valid measure. Factor analyses suggested that IBS-specific QOL as measured by the IBS-QOL is a unidimensional construct. Construct validity was further buttressed by significant correlations between IBS-QOL total scores and related measures of IBS-d severity including the historically-relevant Irritable Bowel Syndrome Adequate Relief (IBS-AR) item and the FDA’s Clinical Responder definition. The IBS-QOL also showed a significant ability to detect change as evidenced by analysis of treatment effects. A minority of the items, unrelated to the IBS-d, performed less well by the standards set by the original authors. Conclusions We established that the IBS-QOL total score is a psychometrically valid measure of HRQOL in IBS-d patients enrolled in this study. Our analyses suggest that

Quality of life measured with EuroQol-five dimensions questionnaire predicts long-term mortality, response, and reverse remodelling in cardiac resynchronization therapy patients.

PubMed

Nagy, Klaudia Vivien; Széplaki, Gábor; Perge, Péter; Boros, András Mihály; Kosztin, Annamária; Apor, Astrid; Molnár, Levente; Szilágyi, Szabolcs; Tahin, Tamás; Zima, Endre; Kutyifa, Valentina; Gellér, László; Merkely, Béla

2017-11-22

There are previous studies on quality of life (QoL) in cardiac resynchronization therapy (CRT) patients; however, there are no data with the short EuroQol-five dimensions (EQ-5D) questionnaire predicting outcomes. We aimed to assess the predictive role of baseline QoL and QoL change at 6 months after CRT with EQ-5D on 5-year mortality and response. In our prospective follow-up study, 130 heart failure (HF) patients undergoing CRT were enrolled. Clinical evaluation, echocardiography, and EQ-5D were performed at baseline and at 6 months of follow-up, continued to 5 years. Primary endpoint was all-cause mortality at 5 years. Secondary endpoints were (i) clinical response with at least one class improvement in New York Heart Association without HF hospitalization and (ii) reverse remodelling with 15% reduction in left ventricular end-systolic volume at 6 months. Fifty-four (41.5%) patients died during 5 years, 85 (65.3%) clinical responders were identified, and 63 patients (48.5%) had reverse remodelling. Baseline issues with mobility were associated with lower response [odds ratio (OR) 0.36, 95% confidence interval (CI) 0.16-0.84; P = 0.018]. Lack of reverse remodelling correlated with self-care issues at baseline (OR 0.10, 95% CI 0.01-0.94; P = 0.04). Furthermore, self-care difficulties [hazard ratio (HR) 2.39, 95% CI 1.17-4.86; P = 0.01) or more anxiety (HR 1.51, 95% CI 1.00-2.26; P = 0.04) predicted worse long-term survival. At 6 months, mobility (HR 3.95, 95% CI 1.89-8.20; P < 0.001), self-care (HR 7.69, 95% CI 2.23-25.9; P = 0.001), or ≥ 10% visual analogue scale (VAS) (HR 2.24, 95% CI 1.27-3.94; P = 0.005) improvement anticipated better survival at 5 years. EuroQol-five dimension is a simple method assessing QoL in CRT population. Mobility issues at baseline are associated with lower clinical response, whereas self-care issues predict lack of reverse remodelling. Problems with mobility or anxiety before CRT and persistent

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

PubMed

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.

How organizations can enhance the quality of life of their clients and assess their results: the concept of QOL enhancement.

PubMed

Reinders, Hans S; Schalock, Robert L

2014-07-01

This article presents the framework of a dynamic approach to quality of life (QOL) enhancement based on the conceptualization and measurement of individual-referenced quality of life. Sections of the article summarize the premises of QOL enhancement, provide the rationale for a dynamic approach to QOL enhancement, discuss six components of QOL enhancement, and discuss the parameters of an emerging theory of quality of life and the contributions such a theory would make to service delivery, policy development, and QOL-related research.

Zonisamide in Brain Tumor-Related Epilepsy: An Observational Pilot Study.

PubMed

Maschio, Marta; Dinapoli, Loredana; Zarabla, Alessia; Maialetti, Andrea; Giannarelli, Diana; Fabi, Alessandra; Vidiri, Antonello; Cantelmi, Tonino

Epilepsy heavily affects the quality of life (QoL) of patients with brain tumor because in addition to taking treatments for the oncological illness, patients are required to live with the long-term taking of antiepileptic drugs (AEDs). The AEDs' adverse effects are common in these patients and can negatively influence their perceptions of their QoL.We conducted an observational pilot study in patients with brain tumor-related epilepsy to verify efficacy, tolerability, and impact on QoL and global neurocognitive performances of zonisamide (ZNS) in add-on. We recruited 13 patients (5 females, 8 males; mean age, 49.6 years) presenting uncontrolled seizures. At first visit and at final follow-up at 6 months, patients underwent neurological examination, evaluation of adverse events, and cognitive and QoL tests. A seizure diary was given. Eight patients underwent chemotherapy, 3 underwent radiotherapy, and 5 had disease progression. Mean dosage of ZNS at final follow-up was 300 mg/d.Of 9 patients who reached the sixth month follow-up, the mean weekly seizure number before ZNS had been 3.2 ± 5.0, and at final follow-up, the mean weekly seizure number was 0.18 ± 0.41 (P = 0.05).Compared with baseline, we observed stability in all cognitive domains, except for verbal fluency that significantly worsened.Results on QoL tests showed that QoL remained unchanged over time, which could indicate that ZNS did not influence the patients' perceived QoL. Zonisamide as add-on in our patients seems to be well tolerated and efficacious in controlling seizures. Despite having limitations represented by the fact that our study is observational, with a small study population and a short follow-up period, our results confirm that when choosing an AED, in addition to efficacy, the drug's effect on patients' QoL also needs to be considered, especially for patients facing many psychosocial challenges, such as those with brain tumor-related epilepsy.

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early-Phase Pediatric Oncology Clinical Trial: A Pilot Study.

PubMed

Crane, Stacey; Backus, Lori; Stockman, Beth; Carpenter, Janet S; Lin, Li; Haase, Joan

Early-phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention and completion of measures. Measures completed included the following: demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition.

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

PubMed Central

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, p<0.001). Caregiver’s depression exerted a significant actor effect on their PCS (b=−2.53, p<0.001) and MCS (b=−1.51, p=0.004). Caregivers’ anxiety negatively influenced their own MCS (b=−0.58, p=0.031). Furthermore, depression 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

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

PubMed

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

2015-01-01

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

Applying mixed methods to pretest the Pressure Ulcer Quality of Life (PU-QOL) instrument.

PubMed

Gorecki, C; Lamping, D L; Nixon, J; Brown, J M; Cano, S

2012-04-01

Pretesting is key in the development of patient-reported outcome (PRO) instruments. We describe a mixed-methods approach based on interviews and Rasch measurement methods in the pretesting of the Pressure Ulcer Quality of Life (PU-QOL) instrument. We used cognitive interviews to pretest the PU-QOL in 35 patients with pressure ulcers with the view to identifying problematic items, followed by Rasch analysis to examine response options, appropriateness of the item series and biases due to question ordering (item fit). We then compared findings in an interactive and iterative process to identify potential strengths and weaknesses of PU-QOL items, and guide decision-making about further revisions to items and design/layout. Although cognitive interviews largely supported items, they highlighted problems with layout, response options and comprehension. Findings from the Rasch analysis identified problems with response options through reversed thresholds. The use of a mixed-methods approach in pretesting the PU-QOL instrument proved beneficial for identifying problems with scale layout, response options and framing/wording of items. Rasch measurement methods are a useful addition to standard qualitative pretesting for evaluating strengths and weaknesses of early stage PRO instruments.

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

PubMed

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.

[Relationship between the swallowing function and the health-related QOL among community-dwelling dependent elderly persons].

PubMed

Morisaki, Naoko; Miura, Hiroko; Moriya, Shingo; Hara, Shuichi

2014-01-01

We examined the relationship between the swallowing function and the health-related QOL (quality of life) among community-dwelling dependent elderly persons. The subjects included 191 community-dwelling dependent elderly persons. Data were collected via questionnaires, including information regarding age, gender, the level of care required, post-cerebrovascular disease, the health-related QOL and the swallowing function. We used the SF-8 to measure the health-related QOL and the DRACE (Dysphagia Risk Assessment for the Community-dwelling Elderly) to evaluate the swallowing function. The average DRACE score was 4.29±3.81. In addition, the swallowing risk was found to be related to the SF (social functioning) and MH (mental health) subscales of the SF-8. Our results suggest that the swallowing function is significantly related to the health-related QOL among community-dwelling dependent elderly persons.

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.

PubMed

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

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

ERIC Educational Resources Information Center

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…

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

PubMed

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

2016-08-02

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

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

PubMed Central

2014-01-01

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

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

PubMed

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.

Implementation of a mobile inpatient quality of life (QoL) assessment for oncology nursing.

PubMed

Schuler, Markus K; Trautmann, Freya; Radloff, Mirko; Schmädig, Roman; Hentschel, Leopold; Eberlein-Gonska, Maria; Petzold, Thomas; Vetter, Heike; Oberlack, Sebastian; Ehninger, Gerhard; Schmitt, Jochen

2016-08-01

Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early Phase Pediatric Oncology Clinical Trial: A Pilot Study

PubMed Central

BACKUS, LORI; STOCKMAN, BETH; CARPENTER, JANET S.; LIN, LI; HAASE, JOAN

2017-01-01

Purpose Early phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. Methods In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention, and completion of measures. Measures completed included: Demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Results Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. Conclusions While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition. PMID:28849701

How Organizations Can Enhance the Quality of Life of Their Clients and Assess Their Results: The Concept of QOL Enhancement

ERIC Educational Resources Information Center

Reinders, Hans S.; Schalock, Robert L.

2014-01-01

This article presents the framework of a dynamic approach to quality of life (QOL) enhancement based on the conceptualization and measurement of individual-referenced quality of life. Sections of the article summarize the premises of QOL enhancement, provide the rationale for a dynamic approach to QOL enhancement, discuss six components of QOL…

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

PubMed

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

2012-09-01

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

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

PubMed

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

2018-01-05

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

Does treatment (nonoperative and operative) improve the two-year quality of life in patients with adult symptomatic lumbar scoliosis: a prospective multicenter evidence-based medicine study.

PubMed

Bridwell, Keith H; Glassman, Steven; Horton, William; Shaffrey, Christopher; Schwab, Frank; Zebala, Lukas P; Lenke, Lawrence G; Hilton, Joan F; Shainline, Michael; Baldus, Christine; Wootten, David

2009-09-15

Prospective observational cohort study with matched and unmatched comparisons. Level II evidence. The purpose of this study is to compare results of adult symptomatic lumbar scoliosis (ASLS) patients treated nonoperatively and operatively. This is an evidence-based prospective multicenter study to answer the question of whether nonoperative and operative treatment improves the quality of life (QOL) in these patients at 2-year follow-up. Only 1 paper in the peer-reviewed published data directly addresses this question. That paper suggested that operative treatment was more beneficial than nonoperative care, but the limitations relate to historical context (all patients treated with Harrington implants) and the absence of validated patient-reported QOL (QOL) data. This study assesses 160 consecutively enrolled patients (ages 40-80 years) with baseline and 2-year follow-up data from 5 centers. Lumbar scoliosis without prior surgical treatment was defined as a minimum Cobb angle of 30 degrees (mean: 54 degrees for patients in this study). All patients had either an Oswestry Disability Index (ODI) score of 20 or more (mean: 33) or Scoliosis Research Society (SRS) domain scores of 4 or less in pain, function, and self-image (mean: 3.2) at baseline. Pretreatment and 2-year follow-up data collected prospectively included basic radiographic parameters, complications and SRS QOL, ODI, and Numerical Rating Scale back and leg pain scores. At 2 years, follow-up on the operative patients was 95% and for the nonoperative patients it was 45%. The demographics for the nonoperative patients who were followed up for 2 years versus those who were lost to follow-up were identical. The operative cohort significantly improved in all QOL measures. The nonoperative cohort did not improve and nonsignificant decline in QOL scores was common. At minimum 2-year follow-up, operative patients outperformed nonoperative patients by all measures. It would appear from this study that common

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

PubMed

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.

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

PubMed

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; p<0.05). The questionnaire had also been demonstrated to have a good validity with a proven high correlation to each question of SF-36 (p<0.05). the Indonesian version of GERD-QOL questionnaire has been proven valid and reliable to evaluate the quality of life of GERD patients.

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

PubMed

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 < 0.001), role physical (beta = -3.64, p < 0.001), bodily pain (beta = -3.27, p < 0.001) and general health (beta = -3.14, p = 0.001). Psychological stress response had a negative correlation with social functioning (beta = -0.74, p = 0.024), role-emotional (beta = -2.34, p < 0.007) and mental health (beta = -0.97, p = 0.024) as determined by multiple regression analysis. The goodness-of-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.

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

PubMed

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

The Quality of Life of a Child with Asperger's Disorder in a General Education Setting: A Pilot Case Study

ERIC Educational Resources Information Center

Mayton, Michael R.

2005-01-01

This pilot qualitative case study was designed to investigate how the quality of life (QOL) of a child with Asperger's Disorder was impacted by her placement in an inclusive education setting which provided no specialized social skills instruction. Direct and indirect data were gathered and examined regarding themes that centered around QOL…

[Valuation and prospect of function preserving gastrectomy].

PubMed

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.

Cysticlean® a highly pac standardized content in the prevention of recurrent urinary tract infections: an observational, prospective cohort study.

PubMed

Sánchez Ballester, Francisco; Ruiz Vidal, Vicente; López Alcina, Emilio; Domenech Perez, Cristina; Escudero Fontano, Eva; Oltra Benavent, Ana; Montoliu García, Ana; Sobrón Bustamante, Marco

2013-06-05

The present study was aimed at determining the prophylactic efficacy of American cranberry (AC) extract (Cysticlean®) in women with recurrent symptomatic postcoital urinary tract infections (PCUTI), non-consumer of AC extract in the past 3 months before inclusion, and to determine changes in their quality of life (QoL). This was a single center, observational, prospective study in a total of 20 women (mean age 35.2 years; 50.0% were married). Patients were followed up for 3 and 6 months during treatment. The number of PCUTIs in the previous 3 months prior to start the treatment with Cysticlean® was 2.8±1.3 and it was reduced to 0.2±0.5 at Month 6 (P<0.0001), which represent a 93% improvement. At baseline, the mean score on the VAS scale (range from 0 to 100) for assessing the QoL was 62.4±19.1, increasing to 78.2±12.4 at Month 6 (P=0.0002), which represents a 20% improvement. All patients had an infection with positive urine culture at baseline, after 6 months there were only 3 symptomatic infections (P<0.001). The most common bacterium was Escherichia coli. Prophylaxis with American cranberry extract (Cysticlean®) could be an alternative to classical therapies with antibiotics. Further studies are needed to confirm results obtained in this pilot study.

Cysticlean® a highly pac standardized content in the prevention of recurrent urinary tract infections: an observational, prospective cohort study

PubMed Central

2013-01-01

Background The present study was aimed at determining the prophylactic efficacy of American cranberry (AC) extract (Cysticlean®) in women with recurrent symptomatic postcoital urinary tract infections (PCUTI), non-consumer of AC extract in the past 3 months before inclusion, and to determine changes in their quality of life (QoL). Methods This was a single center, observational, prospective study in a total of 20 women (mean age 35.2 years; 50.0% were married). Patients were followed up for 3 and 6 months during treatment. Results The number of PCUTIs in the previous 3 months prior to start the treatment with Cysticlean® was 2.8±1.3 and it was reduced to 0.2±0.5 at Month 6 (P<0.0001), which represent a 93% improvement. At baseline, the mean score on the VAS scale (range from 0 to 100) for assessing the QoL was 62.4±19.1, increasing to 78.2±12.4 at Month 6 (P=0.0002), which represents a 20% improvement. All patients had an infection with positive urine culture at baseline, after 6 months there were only 3 symptomatic infections (P<0.001). The most common bacterium was Escherichia coli. Conclusions Prophylaxis with American cranberry extract (Cysticlean®) could be an alternative to classical therapies with antibiotics. Further studies are needed to confirm results obtained in this pilot study. PMID:23738867

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

PubMed

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.

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.

PubMed

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.

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

PubMed

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.

Coalbed-methane pilots - timing, design, and analysis

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

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

2009-10-15

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

Measuring Care-Related Quality of Life of Caregivers for Use in Economic Evaluations: CarerQol Tariffs for Australia, Germany, Sweden, UK, and US.

PubMed

Hoefman, Renske J; van Exel, Job; Brouwer, Werner B F

2017-04-01

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 measures the impact of informal care on seven important burden dimensions (CarerQol-7D) and values this in terms of general quality of life (CarerQol-VAS). The CarerQol can be included at the effect side of multi-criteria analyses of patient interventions or in cost-effectiveness or utility analysis of interventions targeted at caregivers. At present, utility scores based on relative utility weights for the CarerQol-7D are only available for the Netherlands. This study calculates CarerQol-7D tariffs for Australia, Germany, Sweden, UK, and US. Data were collected among the general population in Australia, Germany, Sweden, UK, and US by an Internet survey. Utility weights were collected with a discrete choice experiment with two unlabeled alternatives described in terms of the seven CarerQol-7D dimensions. An efficient experimental design with priors obtained from the Netherlands was used to create the choice sets. Data was analyzed with a panel mixed multinomial logit model with random parameters. In all five countries, the CarerQol-7D dimensions were significantly associated with the utility of informal care situations. Physical health problems were most strongly associated with the utility for informal care situations. The tariff was constructed by adding up the relative utility weights per category of all CarerQol-7D dimensions for each country separately. The CarerQol tariffs for Australia, Germany, Sweden, UK, and US facilitate the inclusion of informal care in economic evaluations.

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

PubMed

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

2015-08-01

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

A comparison of scoring weights for the EuroQol derived from patients and the general public.

PubMed

Polsky, D; Willke, R J; Scott, K; Schulman, K A; Glick, H A

2001-01-01

General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public. The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public. The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%. The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of

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

PubMed

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

2016-03-01

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

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

PubMed

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.

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

NASA Astrophysics Data System (ADS)

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.

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

PubMed

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.

Sexual function and quality of life in women with cervical cancer before radiotherapy: a pilot study.

PubMed

Grion, Regina Celia; Baccaro, Luiz Francisco; Vaz, Ana Francisca; Costa-Paiva, Lúcia; Conde, Délio Marques; Pinto-Neto, Aarão Mendes

2016-04-01

To achieve a better understanding of issues related to sexual function and quality of life (QOL) of women with cervical cancer before radiotherapy treatment. A pilot study with 80 women with cervical cancer from Jan/2013 to Mar/2014. The outcome variables were sexual function assessed using the Female Sexual Function Index (FSFI) and QOL, assessed using the World Health Organization questionnaire. Independent variables were clinical and sociodemographic data. Statistical analysis was carried out using Student's t test, Mann-Whitney test, ANOVA and multiple linear regression. The mean age was 48.1 years, 57.5 % were premenopausal and 55 % had clinical stage IIIB. Thirty percent had been sexually active in the 3 months prior to their interviews. The main adverse events during sexual intercourse were bleeding (41.7 %), lack of pleasure (33.3 %), dyspareunia (25 %), and vaginal dryness (16.7 %). The 18 women who had been sexually active in the previous month showed significant sexual dysfunction (total mean FSFI score = 25.6). Advanced clinical stage, using any chronic medication and not having undergone surgery for cancer were negatively correlated with QOL. Higher family income, a longer duration of schooling and no smoking were positive correlated with QOL. One-third of women with cervical cancer were sexually active 3 months prior to their interviews, but have concomitant significant sexual dysfunction. Factors related to the disease are primarily responsible for the deterioration of sexual function. QOL is influenced not only by factors related to the cancer itself, but also by lifestyle habits, comorbidities, and sociodemographic characteristics.

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

PubMed

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.

The Quality-of-Life (QOL) Research Movement: Past, Present, and Future

ERIC Educational Resources Information Center

Sirgy, M. Joseph; Michalos, Alex C.; Ferriss, Abbott L.; Easterlin, Richard A.; Pavot, William; Patrick, Donald

2006-01-01

The purpose of this paper is to trace the history of the social indicators or quality-of-life (QOL) research movement up to today, forecast future developments, and pave the way for future growth. Broadly speaking, we tried to review historical antecedents from the point of view of different disciplines, with specialists in each discipline…

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

PubMed

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.

A prospective study of postoperative symptoms in sinonasal quality-of-life following endoscopic skull-base surgery: dissociations based on specific symptoms.

PubMed

Bedrosian, Jeffrey C; McCoul, Edward D; Raithatha, Roheen; Akselrod, Olga A; Anand, Vijay K; Schwartz, Theodore H

2013-08-01

Endoscopic skull-base surgery (ESBS) is a minimal access approach to cranial base pathology; however, it significantly disrupts the intranasal mucosa and intranasal structures, the long-term effects of which are still being studied. We prospectively assessed postoperative changes in sinonasal QOL symptoms following ESBS. Eighty-five patients were prospectively assessed with the Anterior Skull Base Questionnaire (ASBQ), a validated QOL instrument, preoperatively and up to 1 year postoperatively at each subsequent office visit. A subset of these data was analyzed to assess the effect of endoscopic pituitary surgery on postoperative taste, smell, appetite, nasal secretions, and vision. ESBS patients were divided into 2 cohorts: those undergoing pituitary adenoma surgery and those undergoing ESBS for all other pathologies. Preoperative smell (3.11 vs 3.76, p = 0.03) and taste (3.04 vs 3.69, p = 0.03) were significantly lower in the nonpituitary group. Within the pituitary group both taste (3.69 vs 2.95, p = 0.03) and smell (3.76 vs 2.61, p ≤ 0.001) were significantly decreased by 6 weeks postoperatively. However, by 12 months both taste and smell scores returned to baseline. Vision scores improved by 3 weeks postoperatively with durable results at 1 year (2.80 vs 3.33, p = 0.04 vs 3.59, p = 0.03, respectively). Within the nonpituitary group, smell was decreased at 3 weeks, but was not significantly changed at any other time points. Our study indicates a dissociation between the nasal and visual QOL after ESBS. While nasal QOL transiently decreases, visual QOL progressively improves. These data should not be lumped together for the purposes of statistical analysis. © 2013 ARS-AAOA, LLC.

Development and psychometric characteristics of the SCI-QOL Pressure Ulcers scale and short form.

PubMed

Kisala, Pamela A; Tulsky, David S; Choi, Seung W; Kirshblum, Steven C

2015-05-01

To develop a self-reported measure of the subjective impact of pressure ulcers on health-related quality of life (HRQOL) in individuals with spinal cord injury (SCI) as part of the SCI quality of life (SCI-QOL) measurement system. Grounded-theory based qualitative item development methods, large-scale item calibration testing, confirmatory factor analysis (CFA), and item response theory-based psychometric analysis. Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Adults with traumatic SCI. SCI-QOL Pressure Ulcers scale. 189 individuals with traumatic SCI who experienced a pressure ulcer within the past 7 days completed 30 items related to pressure ulcers. CFA confirmed a unidimensional pool of items. IRT analyses were conducted. A constrained Graded Response Model with a constant slope parameter was used to estimate item thresholds for the 12 retained items. The 12-item SCI-QOL Pressure Ulcers scale is unique in that it is specifically targeted to individuals with spinal cord injury and at every stage of development has included input from individuals with SCI. Furthermore, use of CFA and IRT methods provide flexibility and precision of measurement. The scale may be administered in its entirety or as a 7-item "short form" and is available for both research and clinical practice.

Levocetirizine in persistent allergic rhinitis: continuous or on-demand use? A pilot study.

PubMed

Canonica, Giorgio Walter; Fumagalli, Federica; Guerra, Laura; Baiardini, Ilaria; Compalati, Enrico; Rogkakou, Anthi; Massacane, Pierangela; Gamalero, Cinzia; Riccio, Anna Maria; Scordamaglia, Antonio; Passalacqua, Giovanni

2008-10-01

Allergic rhinitis is a high-prevalence disease that affects quality of life (QOL), sleep quality and productivity of patients. According to the ARIA initiative, it is classified as intermittent and persistent, the latter being the most troublesome. The aim of this randomized, open-label, 6-month, pilot study was to determine whether levocetirizine 5 mg administered continuously once daily in the morning was better than levocetirizine 5 mg on-demand in symptomatic subjects with persistent allergic rhinitis. Total and individual symptom scores were recorded in a diary card throughout the study. QOL, quality of sleep, nasal cytology, rate of drug intake, and safety were also assessed at pre-defined time-points. In all, adult patients (31 in each group) were enrolled, of whom 22 dropped out. Both treatment regimens considerably decreased the total and individual symptoms scores from baseline and achieved similar levels up to week 14. Continuous treatment was generally better than on-demand from week 15 onwards, reaching statistical significance from weeks 17 to 21 (from week 19 to 21 for nasal pruritus). Both regimens substantially improved QOL and sleep quality. Both treatments were well tolerated, although the on-demand group reported more adverse events. The present open label study in 62 patients indicates that levocetirizine 5 mg reliably controls persistent rhinitis over a period of 6 months, and shows a trend to be more effective in controlling the symptoms of rhinitis, improving QOL and decreasing nasal inflammation, when administered as long-term continuous therapy rather than as on-demand therapy.

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

PubMed

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 p<0.05. Of the 2000 respondents, 98.3% were edentulous, 73.0% reported half or more missing teeth, 76.9% used dental prostheses and 23.7% had related eating problems. Older age, lower social class and lower education were related to edentulism. Individuals with fewer teeth and dental prostheses had lower EQ-VAS scores (p<0.05) and dental prosthesis did not improve EQ-VAS scores (p=0.22). Edentulism also showed a significant negative correlation with EQ-VAS scores (rho= -0.102, p<0.01). In summary, EQ-VAS is a useful tool for measuring 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.

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

ERIC Educational Resources Information Center

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.…

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

PubMed

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.

Oral Health and Quality of Life in Old Age: A Cross-Sectional Pilot Project in Germany and Poland.

PubMed

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.

COVD-QOL questionnaire: An adaptation for school vision screening using Rasch analysis

PubMed Central

Abu Bakar, Nurul Farhana; Ai Hong, Chen; Pik Pin, Goh

2012-01-01

Purpose To adapt the College of Optometrist in Vision Development (COVD-QOL) questionnaire as a vision screening tool for primary school children. Methods An interview session was conducted with children, teachers or guardians regarding visual symptoms of 88 children (45 from special education classes and 43 from mainstream classes) in government primary schools. Data was assessed for response categories, fit items (infit/outfit: 0.6–1.4) and separation reliability (item/person: 0.80). The COVD-QOL questionnaire results were compared with vision assessment in identifying three categories of vision disorders: reduce visual acuity, accommodative response anomaly and convergence insufficiency. Analysis on the screening performance using the simplified version of the questionnaire was evaluated based on receiver-operating characteristic analysis for detection of any type of target conditions for both types of classes. Predictive validity analysis was used a Spearman rank correlation (>0.3). Results Two of the response categories were underutilized and therefore collapsed to the adjacent category and items were reduced to 14. Item separation reliability for the simplified version of the questionnaire was acceptable (0.86) but the person separation reliability was inadequate for special education classes (0.79) similar to mainstream classes (0.78). The discriminant cut-off score of 9 (mainstream classes) and 3 (special education classes) from the 14 items provided sensitivity and specificity of (65% and 54%) and (78% and 80%) with Spearman rank correlation of 0.16 and 0.40 respectively. Conclusion The simplified version of COVD-QOL questionnaire (14-items) performs adequately among children in special education classes suggesting its suitability as a vision screening tool.

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

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

Hunter, Klaudia U.; Schipper, Matthew; Feng, Felix Y.

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 Adversemore » 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

Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study.

PubMed

Chen, J; Li, Y; Wang, Z; McCulloch, P; Hu, L; Chen, W; Liu, G; Li, J; Lang, J

2018-02-01

To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. 20 Chinese hospitals. 2411 Chinese women with symptomatic fibroids. Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study. © 2017 Royal College of Obstetricians and

Development and psychometric characteristics of the SCI-QOL Pressure Ulcers scale and short form

PubMed Central

Kisala, Pamela A.; Tulsky, David S.; Choi, Seung W.; Kirshblum, Steven C.

2015-01-01

Objective To develop a self-reported measure of the subjective impact of pressure ulcers on health-related quality of life (HRQOL) in individuals with spinal cord injury (SCI) as part of the SCI quality of life (SCI-QOL) measurement system. Design Grounded-theory based qualitative item development methods, large-scale item calibration testing, confirmatory factor analysis (CFA), and item response theory-based psychometric analysis. Setting Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Participants Adults with traumatic SCI. Main Outcome Measures SCI-QOL Pressure Ulcers scale. Results 189 individuals with traumatic SCI who experienced a pressure ulcer within the past 7 days completed 30 items related to pressure ulcers. CFA confirmed a unidimensional pool of items. IRT analyses were conducted. A constrained Graded Response Model with a constant slope parameter was used to estimate item thresholds for the 12 retained items. Conclusions The 12-item SCI-QOL Pressure Ulcers scale is unique in that it is specifically targeted to individuals with spinal cord injury and at every stage of development has included input from individuals with SCI. Furthermore, use of CFA and IRT methods provide flexibility and precision of measurement. The scale may be administered in its entirety or as a 7-item “short form” and is available for both research and clinical practice. PMID:26010965

Denver Spirited Heart: Mixed-Methods Pilot Study of a Psychospiritual Intervention for Heart Failure Patients.

PubMed

Hooker, Stephanie A; Ross, Kaile; Masters, Kevin S; Park, Crystal L; Hale, Amy E; Allen, Larry A; Bekelman, David B

Increased spiritual well-being is related to quality of life (QOL) in patients with heart failure (HF). However, consistent and deliberate integration of spirituality into HF patient care has received limited attention. The aim of this study was to evaluate the feasibility, acceptability, and preliminary evidence regarding the efficacy of a resource-sparing psychospiritual intervention to improve QOL in HF patients. A 12-week mail-based intervention addressing spirituality, stress, coping, and adjusting to illness was developed and tested using a mixed-methods, 1-group pretest-posttest pilot study design. A convenience sample of patients with HF completed prestudy and poststudy questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Patient Health Questionnaire, Meaning in Life Questionnaire, and Functional Assessment of Chronic Illness Therapy-Spiritual. Research staff conducted semistructured interviews with program completers. Interviews were coded and analyzed using conventional content analysis. Participants (N = 33; 82% male; mean age, 61 years) completed 87% of baseline data collection, an average of 9 intervention modules, and 55% of poststudy questionnaires. Participants rated all the modules as at least moderately helpful, and qualitative themes suggested that patients found the intervention acceptable and beneficial. Most participants believed spirituality should continue to be included, although they disagreed on the extent to which religion should remain. Participants who completed the intervention reported evidence suggesting increased QOL (Kansas City Cardiomyopathy Questionnaire; effect size [ES], 0.53), decreased depressive symptoms (Patient Health Questionnaire-9; ES, 0.62), and less searching for meaning (Meaning in Life Questionnaire; ES, 0.52). Results indicate that a module-based program integrating spirituality and psychosocial coping strategies was feasible and acceptable and may improve QOL. This preliminary study suggests

Early asthma prophylaxis, natural history, skeletal development and economy (EASE): a pilot randomised controlled trial.

PubMed

Baxter-Jones, A D; Helms, P J; Russell, G; Grant, A; Ross, S; Cairns, J A; Ritchie, L; Taylor, R; Reid, D M; Osman, L M; Robins, S; Fletcher, M E

2000-01-01

(1) To establish recruitment rates of newly presenting asthmatic children. (2) To establish acceptability of study protocols. (3) To pilot age-specific quality of life (QoL) assessment. (4) To assess short-term (6 months) outcomes of inhaled corticosteroids (ICS) treatment. (5) To refine sample size calculations for a definitive study. A randomised pragmatic longitudinal trial design was used, with no blinding or placebo, to examine early ICS introduction similar to its use in practice. Subjects were assessed at entry, 3 and 6 months. Subjects were recruited from six general practices. Children under 6 years were assessed at the Craig Research and Investigation Unit, Royal Aberdeen Children's Hospital, or their family home, and subjects 6 years and over were assessed at their general practice. Children (aged 6 months-16 years) with symptoms suggestive of asthma/wheeze that had commenced no longer than 12 months before were identified retrospectively and prospectively from general practices. Subjects were also required to be naïve to prophylactic therapy with no other lung disease/concomitant illness. Subjects were randomised to ss2-agonist (ss2-only group) or ss2-agonist and ICS (ICS group) for 6 months. Physicians could later prescribe ICS in controls if needed. (1) Pulmonary function. (2) Asthma symptom diary. (3) Symptomatic health status questionnaire. (4) Caregiver's and child's QoL. (5) Growth. (6) Bone mass. (7) Bone turnover. (8) Economic issues. Of over 15,000 children yielded from general practice records, 11% had symptoms suggestive of asthma/wheeze, and two-thirds of these already used ICS. Of the remaining, 141 subjects met the criterion of early asthma, and 86 were randomised. Two-thirds of those randomised were < 6 years old, the males:females ratio was 2:1, and 67% had a family history of atopy. RESULTS - PHYSIOLOGICAL DEVELOPMENT: Pulmonary function did not significantly improve in the older children. Although tidal breathing measures in the pre

[Item function analysis on the Quality of Life-Alzheimer's Disease(QOL-AD)Chinese version, based on the Item Response Theory(IRT)].

PubMed

Wan, Li-ping; He, Run-lian; Ai, Yong-mei; Zhang, Hui-min; Xing, Min; Yang, Lin; Song, Yan-long; Yu, Hong-mei

2013-07-01

To introduce the Item Function Analysis(IFA) of Quality of Life- Alzheimer's disease(QOL-AD)Chinese version and to explore the feasibility of its application on Chinese patients with AD. Two hundred AD patients were interviewed and assessed by QOL-AD, through the stratified cluster sampling method. Multilog 7.03. was used for Item Function Analysis. Difference scale(a), difficulty scale(b)and Item Characteristic Curve(ICC) of each item of QOL-AD were provided. Different scales of the item 1, 7 were below 0.6, while all the others were above 0.6. As for ICC. The first and last lines for the other items were monotonic in which the two in between were in inverted V-shape, with very steep slopes, except for the item 1 and 7. Results form the IFA showed that QOL-AD was applicable to be used in the Chinese patients with AD.

Pilot study of probiotic dietary supplementation for promoting healthy kidney function in patients with chronic kidney disease.

PubMed

Ranganathan, Natarajan; Ranganathan, Pari; Friedman, Eli A; Joseph, Anthony; Delano, Barbara; Goldfarb, David S; Tam, Paul; Rao, A Venketeshwer; Anteyi, Emmanuel; Musso, Carlos Guido

2010-09-01

Uremic syndrome consists of nitrogenous waste retention, deficiency in kidney-derived hormones, and reduced acid excretion, and, if untreated, may progress to coma and eventual death. Previous experience suggests that oral administration of a probiotic formulation of selected microbial strains may extend renoprotection via intraintestinal extraction of toxic waste solutes in patients with chronic kidney disease (CKD)stages 3 and 4. This report presents preliminary data from a pilot study. This was a 6-month prospective, randomized, double-blind, placebo-controlled crossover trial of a probiotic bacterial formulation conducted in four countries, at five institutions, on 46 outpatients with CKD stages 3 an nd 4: USA (n=10), Canada (n=113), Nigeria (n=115), and Argentina (n=8). Outcomes were compared using biochemical parameters:blood urea nitrogen (BUN), serum creatinine, and uric acid. General well-being was assessed as a secondary parameter by a quality of life (QQOL) questionnaire on a subjective scale of 1-10. Oral ingestion of probiotics (90 billion colony forming units [CFUs]/day) was well tolerated and safe during the entire trial period at all sites. BUN levels decreased in 29 patients (63%, P<0.05), creatinine levels decreased in 20 patients (43%, no statistical significance), and uric acid levels decreased in 15 patients (33%, no statistical significance). Almost all subjects expressed a perceived substantial overall improvement in QOL (86%, P<0.05). The main outcomes of this preliminary trial include a significant reduction of BUN, enhanced well-being, and absence of serious adverse effects, thus supporting the use of the chosen probiotic formulation for bowel-based toxic solute extraction. QOL and BUN levels showed statistically significant differences in outcome (P<0.05) between placebo and probiotic treatment periods at all four sites (46 patients). A major limitation of this trial is the small sample size nd elated inconsistencies.

Evaluation of a brief pilot psychoeducational support group intervention for family caregivers of cancer patients: a quasi-experimental mixed-methods study.

PubMed

Mahendran, Rathi; Lim, Haikel A; Tan, Joyce Y S; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok; Griva, Konstadina

2017-01-23

Family caregivers of cancer patients often experience an impaired quality of life (QOL) and emotional distress as a result of their caregiving duties, which may potentially influence the quality of care of their care recipients. The COPE (Caregivers of cancer Outpatients' Psycho-Education support group therapy) intervention was developed as a response to the lack of work done among family caregivers of ambulatory cancer patients in Asia. This group intervention comprised four weekly sessions simultaneously targeting psychoeducation, skills training, and supportive therapy. The present study sought to evaluate the pilot COPE intervention using both quantitative and qualitative measures. The Hospital Anxiety and Depression Scale (HADS) was used to measure both depression and anxiety, while the Caregiver QOL - Cancer (CQOLC) measured caregiver QOL. These instruments were measured at baseline pre-intervention, and immediately post-intervention. A waitlist control group design was adopted. A subset of caregivers from the intervention group were invited for a semi-structured interview post-intervention. Quantitative analyses suggest that while QOL remained stable in control group participants, intervention group participants experienced QOL improvements - both in overall QOL and in the specific domain of burden. There were no significant differences in the trajectories of depression and anxiety in both groups. Qualitative analyses suggest that this might have been a result of the intervention not only equipping participants with the relevant coping skills, but also providing a platform for emotional expression and situational reappraisal. The COPE intervention has shown some efficacy in helping family caregivers of cancer patients, but more work is required before this can be implemented. Current Controlled Trials NCT02120183 . Registered 17 April 2014. Retrospectively registered.

Postoperative long-term evaluation of interposition reconstruction compared with Roux-en-Y after total gastrectomy in gastric cancer: prospective randomized controlled trial.

PubMed

Ishigami, Sumiya; Natsugoe, Shoji; Hokita, Shuichi; Aoki, Teruaki; Kashiwagi, Hideyuki; Hirakawa, Kosei; Sawada, Tetsuji; Yamamura, Yoshitaka; Itoh, Seiji; Hirata, Koichi; Ohta, Keiichiro; Mafune, Kenichi; Nakane, Yasushi; Kanda, Tatsuo; Furukawa, Hiroshi; Sasaki, Iwao; Kubota, Tetsuro; Kitajima, Masaki; Aikou, Takashi

2011-09-01

The postoperative clinical superiority of the interposition of jejunum reconstruction (INT) to Roux-en-Y reconstruction (RY) after total gastrectomy has not been clarified. Postoperative quality of life (QOL) was evaluated between the 2 methods by a multi-institutional prospective randomized trial. A total of 103 patients with gastric cancer were prospectively randomly divided into groups for RY (n = 51) or INT reconstruction (n = 52) after total gastrectomy. They were stratified by sex, age, institute, histology, and degree of lymph node dissection. Postoperatively, body mass index (BMI) and nutritional conditions were measured serially, and QOL and postoperative squalor scores were evaluated at 3, 12, and 60 months and compared between the 2 groups. After removing patients who did not complete the follow-up survey or censured cases, 24 patients in the RY group and 18 patients in the INT group were clinically available and their postoperative status was assessed. QOL scores were increased and complication scores were improved in the postoperative periods (P < .01). Postoperative BMI significantly deteriorated compared with preoperative BMI in each group. The postoperative QOL and complication scores at 60 months after surgery were significantly better than those at 3 months after surgery in each group (P < .01). However, there was no significant difference of QOL scores and postoperative complication scores between the 2 reconstruction groups. The nutritional condition in the INT group was nearly the same as that in the RY group. Although our patient sample was small and patients who did not complete the follow-up survey were present, we could not identify any clinical difference between INT and RY after total gastrectomy 60 months after surgery. The safer and simpler RY method may be a more suitable reconstruction method than INT after total gastrectomy. Copyright © 2011. Published by Elsevier Inc.

Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer

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

Caffo, Orazio; Fellin, Gianni; Bolner, Andrea

2006-09-01

Purpose: Permanent interstitial brachytherapy (IB) has become an increasingly appealing therapeutic option for localized prostate cancer (LPC) among physicians and patients because it involves short hospitalization and treatment and its postulated low degree of toxicity may reduce its impact on the patients' quality of life (QoL). The aim of this prospective study was to assess the impact of IB on the QoL of patients with LPC. Methods and Materials: A validated self-completed questionnaire was administered to the patients before and after IB and then at yearly intervals. The items allowed the identification of seven subscales exploring physical well-being (PHY), physicalmore » autonomy (POW), psychological well-being (PSY), relational life (REL), urinary function (URI), rectal function (REC), and sexual function (SEX). Results: The assessment of the QoL of 147 patients treated between May 2000 and February 2005 revealed no relevant differences in the PHY scale scores 1 month after IB or later, and the same was true of the POW, PSY, and REL scales. Urinary function significantly worsened after IB and returned to pretreatment levels only after 3 years; the impact of the treatment on the URI scale was greater in the patients with good baseline urinary function than in those presenting more urinary symptoms before IB. Rectal and sexual functions were significantly worse only at the post-IB evaluation. Conclusions: The results of the present study confirm that the impact of IB on the patients' QoL is low despite its transient negative effects on some function, and extend existing knowledge concerning QoL after IB.« less

Risk factors for worsened quality of life in patients on mechanical ventilation. A prospective multicenter study.

PubMed

Busico, M; Intile, D; Sívori, M; Irastorza, N; Alvarez, A L; Quintana, J; Vazquez, L; Plotnikow, G; Villarejo, F; Desmery, P

2016-10-01

To identify risk factors for worsened quality of life (QoL) and activities of daily living (ADL) at 3 and 12 months after discharge from the Intensive Care Unit (ICU) in patients on mechanical ventilation (MV). A prospective, multicentric observational study was made. Three ICUs in Argentina. The study included a total of 84 out of 129 mainly clinical patients admitted between 2011-2012 and requiring over 24hours of MV. No interventions were carried out. Quality of life was assessed with the EQ-5D (version for Argentina), and ADL with the Barthel index. The EQ-5D and Barthel scores were assessed upon admission to the ICU (baseline) and after three months and one year of follow-up. Comorbidities, delirium, ICU acquired weakness (ICUAW), and medication received were daily assessed during ICU stay. The baseline QoL of the global sample showed a median index of [0.831 (IQR25-75% 0.527-0.931)], versus [0.513 (IQR0.245-0.838)] after three months and [0.850 (IQR0.573-1.00)] after one year. Significant differences were observed compared with QoL in the Argentinean general population [mean 0.880 (CI 0.872-0.888), p<0.001; p<0.001; p0.002]. Individual analysis showed that 67% of the patients had worsened their QoL at three months, while 33% had recovered their QoL. In the multivariate analysis, the variables found to be independent predictors of worsened QoL were a hospital stay ≥21 days [OR 12.57 (2.75-57.47)], age ≥50 years [OR 5.61 (1.27-24.83)], previous poor QoL [OR 0.11 (0.02-0.54)] and persistent ICUAW [OR 8.32 (1.22-56.74)]. Similar results were found for the worsening of ADL. Quality of life is altered after critical illness, and its recovery is gradual over time. Age, length of hospital stay, previous QoL and persistent ICUAW seem to be risk factors for worsened QoL. Copyright © 2016 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

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

PubMed

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% (p<0.001). Participants' ratings of the food's taste were unchanged, but their ratings of how well they were taking care of themselves improved. CRP, lymphocytes, T cells, and B cells did not change significantly, but CD4, CD8, and NK cells decreased slightly. A stay at a raw 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.

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

PubMed

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

2016-06-01

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

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

PubMed

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.

Compassion Satisfaction, Compassion Fatigue, and Burnout in Spain and Brazil: ProQOL Validation and Cross-cultural Diagnosis.

PubMed

Galiana, Laura; Arena, Fernanda; Oliver, Amparo; Sansó, Noemí; Benito, Enric

2017-03-01

Palliative care professionals' quality of life has emerged as a growing issue of interest in health care literature, centered on concerns about professionals' compassion within a context of work characterized by pain and death. The aim of this study was threefold: 1) to study the psychometric properties of both the Spanish and the Portuguese versions of the ProQOL scale, by means of confirmatory factor analyses; 2) to offer a diagnosis of compassion satisfaction and compassion fatigue levels of Spanish and Brazilian palliative care professionals; and 3) to compare levels in ProQOL between countries. Two surveys with a cross-sectional design were carried out; 161 Brazilian palliative care professionals and 385 Spanish participated in this study. Confirmatory factor analysis for both the Spanish and the Portuguese versions showed an adequate fit. Reliability estimates were also adequate, with problems with the burnout dimension. Spanish and Brazilian palliative care professionals showed high levels of compassion satisfaction (specially, for the Brazilian samples), medium levels of secondary traumatic stress, and low levels of burnout. Finally, statistically significant differences in Spanish and Brazilian levels of compassion satisfaction and secondary traumatic stress were found, but not in burnout. The ProQOL shows psychometric goodness in its Spanish and Portuguese versions, although some items should be revised. The ProQOL is also useful for diagnosis and is sensitive enough to distinguish nuances as that found between Brazilian and Spanish professionals. Copyright © 2016 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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

PubMed

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.

Quality of life after parotid-sparing IMRT for head-and-neck cancer: a prospective longitudinal study.

PubMed

Lin, Alexander; Kim, Hyungjin M; Terrell, Jeffrey E; Dawson, Laura A; Ship, Jonathan A; Eisbruch, Avraham

2003-09-01

Parotid-sparing intensity-modulated radiotherapy (IMRT) for head-and-neck cancer reduces xerostomia compared with standard RT. To assess potential improvements in broader aspects of quality of life (QOL), we initiated a study of patient-reported QOL and its predictors after IMRT. This was a prospective longitudinal study of head-and-neck cancer patients receiving multisegmental static IMRT. Patients were given a validated xerostomia questionnaire (XQ), and a validated head-and-neck cancer-related QOL questionnaire consisting of four multi-item domains: Eating, Communication, Pain, and Emotion. The Eating domain contains one question (total of six) asking directly about xerostomia. In both questionnaires, higher scores denote worse symptoms or QOL. The questionnaires and measurements of salivary output from the major glands were completed before RT started (pre-RT) and at 3, 6, and 12 months after RT. The association between the QOL scores and patient-, tumor-, and therapy-related factors was assessed using the random effects model. Thirty-six patients participating in the study completed the questionnaires through 12 months. The XQ scores worsened significantly at 3 months compared with the pre-RT scores, but later they improved gradually through 12 months (p = 0.003), in parallel with an increase in the salivary output from the spared salivary glands. The QOL summary scores were stable between the baseline (pre-RT) and 3 months after RT scores. Patients receiving postoperative RT (whose pre-RT questionnaires were taken a few weeks after surgery) tended to have improved scores after RT, reflecting the subsidence of acute postoperative sequelae, compared with a tendency toward worsened scores in patients receiving definitive RT. After 3 months, statistically significant improvement was noted in the summary QOL scores for all patients, through 12 months after RT (p = 0.01). The salivary flow rates, tumor doses, mean oral cavity dose, age, gender, sites or stages of

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

PubMed

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.

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

PubMed

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

2015-12-30

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. It is a 12 months prospective cohort study. Two hundred and twenty one female patients were included in the study. They were assessed at the time of diagnosis, 6 months and 12 month using Hospital Anxiety and Depression Scale (HADS), Quality-of-Life Questionnaire (QLQ-C30), Version 3.0 of the EORTC Study Group and Multidimensional Scale of Perceived Social Support (MSPSS). The information of age, ethnicity, types of treatment, and staging of cancer were collected. The HADS anxiety and depression subscales scores of the subjects were relatively low. The level of anxiety reduced significantly at 6 and 12 months (Baseline - 6 months, p = 0.002; Baseline - 12 months, p < 0.001). There were no changes in the level of depression over the study period. The global status of QoL and MSPSS scores were relatively high. Correlation between the global status of QoL and MSPSS for the study subjects was positive (Spearman's rho = 0.31-0.36). Global status of QoL and MSPSS scores were negatively correlated with anxiety and depression. Malaysian breast cancer women had relatively better QoL with lower level of anxiety and depression. Perceived social support was an important factor for better QoL and low level of psychological distress. It reflects the importance of attention on activities that enhance and maintain the social support system for breast cancer patients.

Rotigotine Objectively Improves Sleep in Parkinson's Disease: An Open-Label Pilot Study with Actigraphic Recording.

PubMed

Calandra-Buonaura, Giovanna; Guaraldi, Pietro; Doria, Andrea; Zanigni, Stefano; Nassetti, Stefania; Favoni, Valentina; Cevoli, Sabina; Provini, Federica; Cortelli, Pietro

2016-01-01

Sleep disturbances represent important predictors of poor quality of life (QoL) in Parkinson's disease (PD). This open-label pilot study aimed to objectively assess, by means of actigraphic recording, effect of rotigotine on sleep in PD patients with self-reported sleep complaints. 15 PD patients underwent one-week actigraphic recording before (T0) and during (T1) rotigotine treatment, which was titrated to the dose subjectively improving motor symptoms (4-8 mg/24 h). Sleep disturbances, daytime sleepiness, cognitive performance, QoL, and depression were also evaluated with questionnaires. Actigraphic recordings showed a significant reduction in nocturnal motor activity and mean duration of wake episodes after sleep onset during rotigotine treatment compared to baseline. In 10 patients presenting objective evidence of poor sleep quality at T0 (sleep efficiency ≤ 85%), rotigotine also significantly improved other sleep parameters and further reduced nocturnal motor activity and mean duration of wake episodes. A significant decrease in number and duration of daytime sleep episodes was also observed at T1. Finally we confirmed that rotigotine significantly improves perceived sleep quality and QoL. Our study showed for the first time that rotigotine is associated with an objective improvement of nocturnal and diurnal sleep disturbances in PD patients with self-reported sleep complaints. This study is registered with AIFA-observational study registry number 12021.

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

PubMed Central

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% (p<0.001). Participants’ ratings of the food’s taste were unchanged, but their ratings of how well they were taking care of themselves improved. CRP, lymphocytes, T cells, and B cells did not change significantly, but CD4, CD8, and NK cells decreased slightly. Conclusions A stay at a raw 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

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

NASA Astrophysics Data System (ADS)

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 < 0.05. In addition, it was also found that five out of the eight domains of QoL; the 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.

Abdominal pain, cramping or discomfort impairs quality of life in women: An internet-based observational pilot study focussing on impact of treatment.

PubMed

Enck, Paul; Koehler, Ursula; Weigmann, Harald; Mueller-Lissner, Stefan

2017-03-01

Background  Abdominal pain, cramping, and discomfort (APCD) are experienced by up to 30 % of adults in Europe. Objective  To assess the impact of APCD on quality of life (QoL) and to investigate the effectiveness, tolerability, and impact on QoL of hyoscine butylbromide (HBB, Buscopan ® ) compared with STW 5 (Iberogast ® ) or analgesics in women with APCD. Methods  An internet-based observational pilot study was conducted in Germany in women who had predominantly used HBB, STW 5, or analgesics (n = 240 per treatment) to treat APCD. This online survey included questions on QoL, effectiveness, and tolerability. Results  A total of 720 completed questionnaires was evaluated. APCD had a major impact on QoL, with 96 % of women reporting that daily activities were disrupted at least sometimes, and 44 % at least often. Other aspects of QoL, such as quality of work, eating habits, and social activities, were also affected in most women. After taking their medication of choice, 91 % of women in the HBB group reported they could "very often" or "often" continue with their daily activities, compared with 84 % and 85 % in the STW 5 and analgesic groups, respectively (p < 0.05 for both comparisons). HBB was perceived to be the "best solution" to overcome APCD symptoms "very often" or "often" by more women (86 %) than STW 5 (75 %) and analgesics (74 %) (p < 0.05 for both comparisons). Conclusion  Women with APCD have impaired QoL. All treatments were considered effective by the majority of participants. Compared with STW 5 or analgesics, HBB was reported to facilitate return to daily activities more frequently. © Georg Thieme Verlag KG Stuttgart · New York.

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

PubMed

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

2018-06-01

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

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

PubMed

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

2006-01-01

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

Enhanced external counterpulsation - effect on angina pectoris, QoL and exercise capacity after 1 year.

PubMed

May, Ole; Lynggaard, Vibeke; Mortensen, Jesper C A; Malczynski, Jerzy

2015-02-01

Enhanced external counterpulsation (EECP) is a new therapy offered to patients with refractory angina pectoris (AP). To assess the effect of EECP on AP, quality of life (QoL) and exercise capacity in a design starting with a control period to avoid the influence of regression-towards-the-mean. Patients were examined two months before EECP, just before, just after, and three and 12 months after EECP. EECP was given for 1 h 5 days a week in 7 weeks. Three sets of pneumatic cuffs were mounted on the lower extremities and inflated sequentially in diastole to 260 mm Hg. 50 patients were included (male 72%, mean age: 62.5 years). Mean daily AP attacks were reduced during EECP from 2.7 to 0.9 (p < 0.005) and the Canadian Cardiovascular Society classification was reduced by at least 1 class in 82% just after EECP, 79% 3 months and 76% 12 months after EECP (p < 0.0002). Generic (SF36) and disease-specific QoL (Seattle AP questionnaire) improved just after, 3 and 12 months after compared with that before EECP. There was a significant improvement in exercise capacity and exercise-induced chest pain just after, three and 12 months after EECP (p < 0.02). No change was detected during the control period. EECP improves generic and disease-specific QoL, angina intensity and exercise capacity in at least 12 months.

[SF-36 and EQ-5D in the evaluation of QOL in the osteoporotic patients as the generic questionnaires].

PubMed

Tanaka, Kiyoshi; Fujii, Ayano; Kuwabara, Akiko

2012-02-01

Health-related quality of life (HRQOL) , abbreviated as QOL, can be evaluated by various questionnaires, which are classified as generic and disease-targeted ones. Generic questionnaires are further subdivided into profile-type and preference-based ones. SF-36 and EQ-5D are the best known examples for the former and the latter, respectively. In SF-36 and its shortened one SF-8, the subjects' QOL is expressed by several profiles or subscales. Their advantages include well-conducted validation and availability of national norms. In EQ-5D, a single value representing the subjects' QOL status (utility) is obtained through 5 questions. These generic questionnaires are applicable to patients with various diseases or even to healthy citizens. In contrast, disease-targeted questionnaires lack such features, but can include items that are specifically related to the disease but devoid of general applicability. Thus, generic and disease-targeted questionnaires have their own pros and cons. Selection of the questionnaires depends on the object of the study.

Piloted aircraft simulation concepts and overview

NASA Technical Reports Server (NTRS)

Sinacori, J. B.

1978-01-01

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

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.

PubMed

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.

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

PubMed

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

2018-05-01

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

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

PubMed

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.

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

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

Antunes, Alberto A.; Carnevale, Francisco C., E-mail: fcarnevale@uol.com.br; Motta Leal Filho, Joaquim M. da

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,more » 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.« less

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

PubMed

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.

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.

PubMed

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

Randomised factorial mixed method pilot study of aerobic and resistance exercise in haemodialysis patients: DIALY-SIZE!

PubMed Central

Thompson, Stephanie; Klarenbach, Scott; Molzahn, Anita; Lloyd, Anita; Gabrys, Iwona; Haykowsky, Mark; Tonelli, Marcello

2016-01-01

Objectives For people with end-stage renal disease requiring haemodialysis, exercise can improve aspects of quality of life (QoL). However, the relative benefits and risks of different types of exercise in this population are unknown. Therefore, this pilot study aimed to evaluate the feasibility of a main study evaluating the efficacy of cycling and resistance exercise each performed during the haemodialysis treatment on QoL. Methods In this factorial (2×2) pilot trial, 31 haemodialysis patients were randomised to cycling, resistance, cycling and resistance, or an attention control. Feasibility was defined a priori by criteria on recruitment, fidelity to the protocol and patient response to the intervention. To better understand feasibility, we conducted interviews with dialysis unit staff and trial participants. As secondary outcomes, we estimated the main effect of cycling and weights each compared with control on QoL, physical function and strength. Findings We exceeded the target accrual of 28 participants over 12 weeks. Irrespective of exercise group allocation, adherence was high; of the 1038 training sessions offered, 87% were initiated and over 80% of exercise sessions were performed as per protocol. Progression based on perceived exertion, individual instruction and interactions with the kinesiologist facilitated acceptability across exercise groups. Using an attention control, measures of contamination and attrition were low. Important barriers to unit staff readiness for the intervention were initial safety and workflow concerns, unit workload and onerous data collection. Secondary outcomes were not statistically significant. Adverse events were low and did not increase with a higher volume of exercise. Conclusions The main study is feasible with minor modifications. In addition to practical assistance, involvement from unit staff could increase patient participation and improve trial implementation. Strategies to increase acceptability of the

Remotely piloted aircraft in the civil environment

NASA Technical Reports Server (NTRS)

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

1977-01-01

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

Treatment of depression in patients with temporal lobe epilepsy: A pilot study of cognitive behavioral therapy vs. selective serotonin reuptake inhibitors.

PubMed

Orjuela-Rojas, Juan Manuel; Martínez-Juárez, Iris E; Ruiz-Chow, Angel; Crail-Melendez, Daniel

2015-10-01

There is a high prevalence of depression in patients with epilepsy, which negatively impacts their quality of life (QOL) and seizure control. Currently, the first-line of treatment for depression in patients with epilepsy is based on selective serotonin reuptake inhibitors (SSRIs). The main objective of this pilot study was to compare cognitive behavioral therapy (CBT) versus SSRIs for the treatment of major depressive disorder (MDD) in patients with temporal lobe epilepsy (TLE). Seven patients who received group CBT were compared with eight patients treated with SSRIs. All were diagnosed with MDD and TLE. Patients were assessed at baseline before treatment and at six and 12weeks during treatment with the Quality of Life in Epilepsy Scale of 31 items (QOLIE 31), the Beck Depression Inventory (BDI), and the Hospital Anxiety and Depression Scale (HADS). Seizure records were also taken on a monthly basis. After 12weeks of treatment, both groups showed improved QOL and reduced severity of depression symptoms. There were no statistically significant group differences in the final scores for the BDI (p=0.40) and QOLIE 31 (p=0.72), although the effect size on QOL was higher for the group receiving CBT. In conclusion, the present study suggests that both CBT and SSRIs may improve MDD and QOL in patients with TLE. We found no significant outcome differences between both treatment modalities. These findings support further study using a double-blind controlled design to demonstrate the efficacy of CBT and SSRIs in the treatment of MDD and QOL in patients with TLE. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

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

2015-01-01

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

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

PubMed

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.

Evaluation of quality of life (QoL) of students of the University of Third Age (U3A) on the basis of socio-demographic factors and health status.

PubMed

Zielińska-Więczkowska, Halina; Kędziora-Kornatowska, Kornelia; Ciemnoczołowski, Waldemar

2011-01-01

In times of the modern global societies, concern for QoL is a priority for gerontology, being an interdisciplinary field. The aim of this study was to assess the QoL of students of the U3A based on socio-demographic factors, subjectively reported diseases and/or discomfort, and well-being. The study comprised 257 students of the U3A in Poland, located in the city of Bydgoszcz. The study group consisted of 237 women and 20 men at an average age of 64.54 ± 6.01 years. The vast majority of the study group were married individuals and individuals with a secondary education. Just over half of the group stated that they are in good health and have no afflictions. All of the respondents were fully mobile. The QoL was assessed using the Polish version of the WHOQOL-Bref and the geriatric depression screening (GDS) scale. The QoL in its different areas balanced out at a medium level (average range: 13.30-13.87). The level of education of the U3A students proved to have a significant relation ith the environmental domain of QoL. No significant influence of age, gender, or marital statues on the QoL of the U3A students was found. A significant relation between subjectively reported diseases and/or discomfort with the QoL was demonstrated in the physical domain. Nearly 75% of the respondents showed no signs of depressive moods. The occurrence of depression indeed disrupted the QoL in all the studied domains, although least in the physical domain. Elderly individuals participating in permanent education display, in the face of progressive senile involution, average and at the same time stable parameters of QoL in all areas of functioning, which can be considered satisfactory, given this phase of life. The level of QoL of the U3A students significantly denotes the level of education of respondents, existing illnesses and afflictions, and the presents of depression. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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

2018-04-01

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

Comprehensive Quality of Life (QoL) in Neurofibromatosis Type II (NF2): Development, Refinement and Standardization of a Multi-Dimensional Metric

DTIC Science & Technology

2012-12-01

or any other aspect of this collection of information, including suggestions for reducing this burden to Department of Defense, Washington...University. 9 Additionally, incorporation of NF2 specific QoL metrics is progressing in all aspects of NF care at NYU. The baseline QoL data will...utilization of mental health providers to provide both counseling, and when necessary, treatment of this currently under-recognized aspect of NF2

Mindful movement program for older breast cancer survivors: a pilot study.

PubMed

Crane-Okada, Rebecca; Kiger, Holly; Sugerman, Fred; Uman, Gwen C; Shapiro, Shauna L; Wyman-McGinty, Wendy; Anderson, Nancy L R

2012-01-01

Older breast cancer survivors (BCSs) are at risk for late and long-term treatment effects on quality of life (QOL), including lower physical functioning and fear of recurrence. Two promising approaches to address this include dance/movement therapy and mindfulness. The purpose of this 2-group randomized controlled pilot feasibility study was to test short-term effects of a 12-week Mindful Movement Program (MMP) intervention combining mindfulness with self-directed movement on QOL and mindfulness in female BCSs 50 years or older and at 12 months or more following treatment. Consented participants were randomized to an experimental group (EG) (12 weekly MMP sessions) or a control group (no sessions). All completed questionnaires 3 times. The EG participants kept home practice diaries. Analysis was conducted after intervention for immediate effects on outcome variables and 6 weeks later for maintenance of effects. Participants (n = 49) ranged in age from 50 to 90 years (average, 65.6 years) and were at 9.8 years since diagnosis (range, 1-32 years), and the majority were white, unpartnered, and retired. After intervention, EG participants showed improved QOL via decreased fear of recurrence and increased mindfulness attitude. At 6 weeks, initial effects were retained. The MMP appears to benefit older BCSs by reducing fear of recurrence and improving mindfulness attitude. Although these findings are promising, a larger study is needed to determine more specifically what short- and long-term effects are possible. The combination of self-directed movement and mindfulness, as tested here, may be a valuable tool for promoting health and well-being in older long-term survivors of breast cancer.

Prospective external convergence evaluation of two different quality-of-life instruments in lung resection patients.

PubMed

Pompili, Cecilia; Brunelli, Alessandro; Xiumé, Francesco; Refai, Majed; Salati, Michele; Socci, Laura; Di Nunzio, Luca; Sabbatini, Armando

2011-07-01

The interpretation of studies on quality of life (QoL) after lung surgery is often difficult owing to the use of multiple instruments with inconsistent scales and metrics. Although a more standardized approach would be desirable, the most appropriate instrument to be used in this setting is still largely undefined. The aim of the study was to assess the respective ability of two validated QoL instruments (European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30/L13 and Short Form (36) Health Survey (SF-36)) to detect perioperative changes in QoL of patients submitted to pulmonary resection for non-small-cell lung cancer (NSCLC). A prospective study on 33 consecutive patients (May 2009-December 2009) was submitted to pulmonary resection. All patients completed both EORTC QLQ-C30 with lung module 13 and SF-36 pre- and postoperatively (3 months). Preoperative changes of all SF-36 and EORTC scales were assessed by using the Cohen's effect-size method. External convergence between different instruments (SF-36 vs EORTC) was assessed by measuring the correlation of scales evaluating the same concepts (physical, psychosocial, and emotional). The correlation coefficients between standardized perioperative changes (effect sizes) of objective functional parameters (forced expiratory volume in 1s (FEV1) and diffusion lung capacity for carbon monoxide (DLCO)) and SF-36 or EORTC scales were also investigated. A poor correlation (r < 0.5) was detected between most of the scales of the two instruments measuring the same QoL concepts, indicating that they may be complementary in investigating different aspects of QoL. Only the SF-36 and EORTC social functioning scales and the SF-36 mental health and EORTC emotional functioning scales had a correlation coefficient >0.5. In general, EORTC was more sensitive in detecting physical or emotional declines but was more conservative in detecting improvements. Both SF-36 and EORTC showed poor correlations (r < 0.5) between

A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration: Interim Results

PubMed Central

Rezk, Youssef A; Hurley, Karen E; Carter, Jeanne; Dao, Fanny; Bochner, Bernard H; Aubey, Janice J; Caceres, Aileen; Einstein, M. Heather; Abu-Rustum, Nadeem R; Barakat, Richard R; Chi, Dennis S; Maker, Vicky

2014-01-01

Purpose Little prospective data exist on quality of life (QOL) after pelvic exenteration (PE). This ongoing study prospectively examines the QOL-changes following this radical procedure using a comprehensive battery of psychological instruments. Methods Since 2005, enrolled patients were interviewed (EORTC QLQ-C30, EORTC QLQ-CR38, EORTC QLQ-BLM30, BFI, BPI-SF, IADL, CES-D, IES-R) preoperatively and at 3, 6, and 12 months after PE for physical/psychological symptoms. Data were examined using repeated measure ANOVA. Results Sixteen women (3 anterior, 1 posterior, and 12 total PE’s), with more than one year of follow up, completed all scheduled interviews. Median age was 58 years (28–76). Overall QOL (F=6.3, p<0.02), ability to perform instrumental daily activities (F=6.8, p<0.02), body image (F=11.9, p<0.00) and sexual function (F=8.0, p<0.01) all declined at 3 months but were near baseline by 12 months after PE. Although, overall, physical function followed a similar trend (F=14.8, p<0.00), it did not return to baseline. At the 12-month interview, patients reported increased gastrointestinal symptoms (F=8.9, p<0.01) but significantly less stress-related ideation (F=6.1, p<0.03) compared to baseline. Pain levels did not change significantly during the study period (F=0.4, p<0.74). Conclusions Although patients report lingering gastrointestinal symptoms and some persistent decline in physical function after PE, most adjust well, returning to almost baseline functioning within a year. Providers can counsel patients that many, though not all, symptoms in the first 3 months following exenteration are likely to improve as they adapt to their changed health status. These preliminary results await confirmation of a larger analysis. PMID:23063761

Assessment of quality of life in patients with rectal cancer treated by preoperative radiotherapy: A longitudinal prospective study

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

Allal, Abdelkarim S.; Gervaz, Pascal; Gertsch, Philippe

2005-03-15

Purpose: To assess prospectively the quality of life (QOL) of patients treated by preoperative radiotherapy (RT) and surgery for locally advanced rectal cancer. Methods and materials: We studied 53 patients treated with bi-fractionated RT (50 Gy in 40 fractions within 4 weeks) followed at a median interval of 45 days by abdominoperineal resection in 11 patients and low anterior resection in 42 patients. Their QOL was assessed using two self-rating questionnaires developed by the European Organization for Research and Treatment of Cancer (EORTC): one was cancer specific (EORTC QLQ-C30) and one was site specific (EORTC QLQ-C38). The questionnaires were completedmore » before RT and 12-16 months after RT, at which time 17 patients had undergone colostomy. We hypothesized that at least some scores of the various scales would vary between the two analyses. Results: Compared with the pre-RT scores, at 1 year, patients reported statistically significant improvement in their emotional state (median 75 vs. 100, p <0.0001), perspective of the future (67 vs. 100, p = 0.0004), and their global QOL (75 vs. 83, p = 0.0008), as well as a decrease in GI symptoms (13 vs. 0, p = 0.002). However, the sexual dysfunction score increased significantly, particularly in men (17 vs. 83, p = 0.0045), and a trend toward a lower body image score was observed (100 vs. 89, p = 0.068). At 1 year, patients with colostomies reported similar or significantly improved symptom scores for fatigue, pain, GI problems, and sleep disturbance, but no such improvements were observed in patients without stomas. Conclusion: One year after combined treatment for locally advanced rectal cancer, patients exhibited statistically significant improvement in some important QOL outcomes, including global QOL, despite a decrease in sexual function and body image. Any additional improvement in QOL outcome may require refinements in the RT and surgical techniques to reduce late sequelae, particularly sexual

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

PubMed

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

2010-12-01

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

A Prospective Longitudinal Clinical Trial Evaluating Quality of Life After Breast-Conserving Surgery and High-Dose-Rate Interstitial Brachytherapy for Early-Stage Breast Cancer

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

Garsa, Adam A.; Ferraro, Daniel J.; DeWees, Todd A.

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, versionmore » 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.« less

Associations between physical activity and quality of life in cancer patients receiving palliative care: a pilot survey.

PubMed

Lowe, Sonya S; Watanabe, Sharon M; Baracos, Vickie E; Courneya, Kerry S

2009-11-01

The primary aim of this study was to examine the association between physical activity and quality of life (QoL) in cancer patients receiving palliative care. Fifty advanced cancer patients aged 18 years or older with clinician-estimated life expectancy of 3-12 months and Palliative Performance Status Scale scores greater than 30% were recruited from an outpatient palliative care clinic and palliative home care. Participants completed a cross-sectional survey by means of face-to-face interview assessing self-reported QoL (McGill Quality of Life Questionnaire [MQOL]), self-reported physical function (Late-Life Function and Disability Instrument), symptoms (Edmonton Symptom Assessment System), and physical activity behavior. Seventy-six percent (38 of 50) of the participants were deceased at the time of data analysis, with a median survival of 104 days from time of survey to time of death. Walking was the most common reported physical activity. Analyses of variance indicated that participants who reported walking more than 30 minutes per day also reported higher existential subscores (+/-0.8 [95% CI, 0.0-1.5]; P=0.045), support subscores (+/-0.7 [95% CI, 0.1-1.4]; P=0.027), and total scores (+/-0.5 [95% CI, 0.0-0.9]; P=0.046) on the MQOL. There were no significant differences for self-reported physical function or symptoms. Our findings show a significant positive association between physical activity and QoL scores in this sample of patients with advanced cancer. A pilot intervention trial testing the causal effects of physical activity on QoL in cancer patients receiving palliative care is warranted.

Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

PubMed

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.

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

PubMed Central

Xie, Xiaohuan; Khoshbakht, Maryam

2018-01-01

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. PMID:29382071

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

PubMed

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.

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

PubMed

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.

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

PubMed

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

2018-03-01

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

Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

PubMed

Bakitas, Marie; Dionne-Odom, J Nicholas; Pamboukian, Salpy V; Tallaj, Jose; Kvale, Elizabeth; Swetz, Keith M; Frost, Jennifer; Wells, Rachel; Azuero, Andres; Keebler, Konda; Akyar, Imatullah; Ejem, Deborah; Steinhauser, Karen; Smith, Tasha; Durant, Raegan; Kono, Alan T

2017-08-31

Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

Effectiveness of an Intervention to Promote Self-Efficacy on Quality of Life of Patients with Nasopharyngeal Carcinoma of the Zhuang Tribe Minority in Guangxi, China: A Prospective Study

PubMed Central

Lu, Jiamei; Zeng, Xiaofen; Liao, Jinlian; Zhang, Yong; Yang, Li; Li, Yuming; Lv, Jun

2017-01-01

Background Nasopharyngeal carcinoma (NPC) is endemic in China and patient self-management is poor. Minorities may suffer from psychological problems during treatments for NPC. This study aimed to implement an intervention to promote self-efficacy of minority patients (Zhuang tribe, Guangxi, China) with NPC to improve their quality of life (QOL). Material/Methods This was a prospective study of 120 patients with NPC treated at the First Affiliated Hospital of Guangxi Medical University (Guangxi, China), randomized to conventional care (n=60, controls) or conventional care plus self-efficacy interventions based on health education, behavior therapy, and psychological intervention (n=60, self-efficacy group). Self-efficacy was evaluated using the general self-efficacy scale, and QOL using the EORTC QLQ-C30. The questionnaires were completed at discharge, at 6 months, and at 1 and 2 years. The primary outcome was QOL. Results There was no difference in QOL at baseline. From study start to hospital discharge, overall QOL scores decreased in both groups, but this decrease was more important in the control group (controls: −39.31 vs. self-efficacy: −27.04, P<0.05). After discharge, each functional field QOL scores and overall QOL increased with time in the 2 groups, and they were significantly higher in the self-efficacy group. Conclusions This intervention promoting self-efficacy could increase patients’ own potential and initiative, enhance their confidence and ability to solve health problems, improve their coping with adverse effects of treatments, and have positive effects on their QOL. Self-efficacy theory-based interventions could be worth popularization during the treatment and recovery of minority patients with NPC. PMID:28832557

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

PubMed

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.

Associations between inadequate knee function detected by KOOS and prospective graft failure in an anterior cruciate ligament-reconstructed knee.

PubMed

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.

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

PubMed

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.

Negative pressure wound therapy versus standard wound care on quality of life: a systematic review.

PubMed

Janssen, A H J; Mommers, E H H; Notter, J; de Vries Reilingh, T S; Wegdam, J A

2016-03-01

Negative pressure wound therapy (NPWT) is a widely accepted treatment modality for open or infected wounds. Premature ending of NPWT occasionally occurs due to negative effects on the quality of life (QoL), however, the actual impact on QoL is unknown. The aim of this review is to analyse the effect of NPWT versus standard wound care (SWC) on QoL when used for the treatment of open or infected wounds. A systematic literature search in a range of databases (PubMed, CINAHL, Medline, Web of Science, Science Direct Freedom Collection, SwetsWise, PSYCArticles and Infrotrac Custom Journals) using the following search terms; 'standard wound care', 'wound dressing', 'dressing', 'treatment', OR 'negative pressure wound therapy [MESH]', OR 'vacuum assisted closure' AND 'quality of life [MESH]', 'patient-satisfaction', OR 'experiences' was performed. Methodological quality was assessed using the methodological index for non-randomised studies (MINORS) checklist. There were 42 studies identified, five matched the inclusion criteria: two randomised clinical trials (RCTs), one clinical comparative study, one exploratory prospective cohort study and one quasi experimental pilot study. Median MINORS-score was 75% (58%-96%). There were seven different questionnaires used to measure QoL or a subsidiary outcome. QoL in the NPWT group was lower in the first week, though no difference in QoL was observed thereafter. This systematic review observed that QoL improved at the end of therapy independent of which therapy was used. NPWT led to a lower QoL during the first week of treatment, possible due to aniexty, after which a similar or better QoL was reported when compared with SWC. It could be suggested that NPWT might be associated with increased anxiety. All authors of this publication have received no financial support or have personal interests conflicting with the objectivity of this manuscript.

The development of the 'Quality-of-life for Respiratory Illness Questionnaire (QOL-RIQ)': a disease-specific quality-of-life questionnaire for patients with mild to moderate chronic non-specific lung disease.

PubMed

Maillé, A R; Koning, C J; Zwinderman, A H; Willems, L N; Dijkman, J H; Kaptein, A A

1997-05-01

Chronic non-specific lung disease (CNSLD) encompasses asthma as well as chronic obstructive pulmonary disease (COPD). Recently in health care, there has been increasing awareness in the functional, psychological and social aspects of the health of patients; their quality of life (QOL). Quality-of-life research addressing CNSLD patients has been rather underdeveloped for a long period of time. Recently, however, the importance of QOL is being increasingly recognized, and several research groups have started to study QOL in CNSLD patients in more detail. This paper describes the construction of a disease-specific QOL instrument for patients with mild to moderately severe CNSLD. Items relating to several domains of QOL were listed, and 171 CNSLD patients in general practice were asked how much of a problem each item had been (assessed on a seven-point Likert scale). After applying an item-selection procedure, a uni-dimensional QOL questionnaire was constructed consisting of 55 items divided into seven domain subscales: breathing problems, physical problems, emotions, situations triggering or enhancing breathing problems, general activities, daily and domestic activities, and social activities, relationships and sexuality. Reliability estimates of the domain subscales of the constructed questionnaire varied from 0.68 to 0.89, and was 0.92 for the QOL for Respiratory Illness Questionnaire (QOL-RIQ) total scale. A first impression of the construct validity of the questionnaire was gained by investigation of the relationship between the QOL domain subscales and several indicators of illness severity, as well as the relative contribution of illness severity variables, background characteristics and symptoms to QOL, using regression analysis. Further research to validate the questionnaire to a greater extent (construct validity, test-retest reliability and responsiveness to change) is currently taking place.

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial.

PubMed

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

The Beneficial Effects of Cognitive Training With Simple Calculation and Reading Aloud (SCRA) in the Elderly Postoperative Population: A Pilot Randomized Controlled Trial

PubMed Central

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

A Prospective Study of Salivary Gland Function in Lymphoma Patients Receiving Head and Neck Irradiation

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

Rodrigues, Neesha A.; Killion, Leah; Hickey, Gail

2009-11-15

Purpose: To determine the radiation dose-response relationship on salivary dysfunction and quality of life (QOL) over time in patients with lymphoma receiving radiation therapy (RT) to the head and neck (H and N). Methods and Materials: We conducted a prospective study on salivary-gland function in lymphoma patients receiving RT to the H and N. Fifteen patients were enrolled on the study. Dose-volume histograms and mean doses to the salivary glands were generated. Radiation-related toxicities and H and N-specific QOL were assessed before treatment and at prespecified time points posttreatment. Factors predicting a decrement in QOL were explored using Fisher's exactmore » test. Results: During RT, 47% of patients experienced Grade >= 2 acute toxicity of the salivary gland, mucous membrane, or both. QOL scores improved over time, but up to one third of patients continued to have persistent oral symptoms at 2 years. At 6 months, a mean dose to at least one of the parotids of > 31 Gy was significantly associated with persistent dry mouth (100% vs. 17%, p = 0.02) and sticky saliva (100% vs. 25%, p = 0.04); a mean dose of > 11 Gy to the minor salivary glands was significantly associated with persistent sticky saliva (100% vs. 25%, p = 0.04), although the difference was no longer significant at 1 year. Conclusions: Limiting the mean parotid dose to <= 31 Gy and mean minor salivary gland dose to <= 11 Gy in lymphoma patients treated to the H and N may help reduce the risk of subacute xerostomia.« less

The influence of lower-extremity function in elderly individuals' quality of life (QOL): an analysis of the correlation between SPPB and EQ-5D.

PubMed

Oh, Bumjo; Cho, Belong; Choi, Ho-Chun; Son, Ki-Young; Park, Sang Min; Chun, Sohyun; Cho, Sung-Il

2014-01-01

If an association between a decline in physical performance and subjective QOL is confirmed, the SPPB could be used as a predictor for declining QOL in older people. This study aimed to elucidate the association between the short physical performance battery (SPPB) and QOL (EQ-5D) to determine the utility of the SPPB as a predictor of declining QOL. The SPPB and the EQ-5D test were performed with a random sample of participants nested in the Korean Longitudinal Study of Aging (KLoSA) panel. Comparisons of the adjusted mean scores on the EQ-5D index between normal and abnormal SPPB groups were performed. We selected the quartiles of the EQ-5D index variables for the analysis. The association between the EQ-5D index and SPPB abnormality was examined using multinomial logistic regression analysis. Additionally, the associations between gait speed and chair stand time and the EQ-5D index were examined using the same analysis. Four hundred and twenty-two subjects were included in the analysis. The adjusted means for the EQ-5D index were significantly lower when the SPPB score was abnormal (p=0.022 for men, p=0.047 for women). An abnormal SPPB score was significantly associated with the lowest quartile of EQ-5D index score (adjusted OR 3.54 in the lowest quartile for men; adjusted OR 2.50 and 3.37 in the lowest and second quartiles for women). Gait speed was significantly associated with the EQ-5D index for participants of both sexes, but standup time was associated with the EQ-5D index only for men. An abnormal SPPB score was associated with lower QOL. Thus, the SPPB has the potential to be used as an early predictor of declining QOL in clinical settings and epidemiological studies. Copyright © 2013. Published by Elsevier Ireland Ltd.

Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study

PubMed Central

Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

2016-01-01

Abstract Objectives: Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. Methods: This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Results: Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], −3.37 to −0.30) at 2-week follow-up and 1.73 points lower (95% CI, −3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. Conclusions: This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems. PMID:26669255

Effects of Ayurvedic Oil-Dripping Treatment with Sesame Oil vs. with Warm Water on Sleep: A Randomized Single-Blinded Crossover Pilot Study.

PubMed

Tokinobu, Akiko; Yorifuji, Takashi; Tsuda, Toshihide; Doi, Hiroyuki

2016-01-01

Ayurvedic oil-dripping treatment (Shirodhara) is often used for treating sleep problems. However, few properly designed studies have been conducted, and the quantitative effect of Shirodhara is unclear. This study sought to quantitatively evaluate the effect of sesame oil Shirodhara (SOS) against warm water Shirodhara (WWS) on improving sleep quality and quality of life (QOL) among persons reporting sleep problems. This randomized, single-blinded, crossover study recruited 20 participants. Each participant received seven 30-minute sessions within 2 weeks with either liquid. The washout period was at least 2 months. The Shirodhara procedure was conducted by a robotic oil-drip system. The outcomes were assessed by the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, Epworth Sleepiness Scale (ESS) for daytime sleepiness, World Health Organization Quality of Life 26 (WHO-QOL26) for QOL, and a sleep monitor instrument for objective sleep measures. Changes between baseline and follow-up periods were compared between the two types of Shirodhara. Analysis was performed with generalized estimating equations. Of 20 participants, 15 completed the study. SOS improved sleep quality, as measured by PSQI. The SOS score was 1.83 points lower (95% confidence interval [CI], -3.37 to -0.30) at 2-week follow-up and 1.73 points lower (95% CI, -3.84 to 0.38) than WWS at 6-week follow-up. Although marginally significant, SOS also improved QOL by 0.22 points at 2-week follow-up and 0.19 points at 6-week follow-up compared with WWS. After SOS, no beneficial effects were observed on daytime sleepiness or objective sleep measures. This pilot study demonstrated that SOS may be a safe potential treatment to improve sleep quality and QOL in persons with sleep problems.

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

ERIC Educational Resources Information Center

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…

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

ERIC Educational Resources Information Center

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

2012-01-01

Purpose: To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. Design and Methods: A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic…

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.

PubMed

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 < 0.001), whereas the frequency of acute episodes and analgesic medication did not differ between the two groups. No difference was observed between the two groups with regard to endocrine and exocrine function. The values of the median body mass index (BMI) in the PD group [23.4 (range 18.5-25.0) kg/m(2)] and in the DPPHR group [24.2 (range 17.9-27.8) kg/m(2)] were comparable. The 5-year outcome remained stable compared to the early post-operative data published elsewhere. This 5-year long-term outcome analysis documents the superiority of the Beger duodenum-preserving technique over the classic Whipple procedure in terms of QOL and pain intensity as self-assessed by the patients.

[Home-oxygen therapy and QOL support for the in the home setting patient].

PubMed

Saito, N

1998-12-01

As a synthetic fiber maker, we Teijin Ltd. used polymer chemistry technology to develop an industrial oxygen-enriching membrane. With this membrane, Teijin had made first domestically manufactured membrane-type oxygen concentrator and entered home oxygen therapy market in 1982, which was three years prior to the start of medical insurance reimbursement for home oxygen therapy. Since then, the company has developed an adsorption-type oxygen concentrator, focused on power and noise reduction, and developed both the "Ultressa," a small, lightweight, portable tank used for outside activities and the "Sanso Saver," an oxygen-conserving device. Teijin also markets the "NIP Nasal", a nasal intemittent positive pressure ventilator. To maintain a development system meeting the needs of health care providers and patients, Teijin operates a direct sales system, currently staffed by specialist representatives in 60 sales offices throughout Japan who provide a rapid response, 24 hours a day, under our motto of "Peace of Mind and Reliability." Teijin not only provides devices; but also sees its function as that of assisting and pursuing QOL for home-based patients through the following services. 1. Teijin has developed TOMS, a monitoring unit connected to an oxygen concentrator in a patient home, which automatically advises a sales office as to the operating condition of the device. TOMS is installed on request, providing peace of mind for those living alone or in isolated locations. 2. When a patient travels, an oxygen concentrator can be installed at any destination in Japan and used free of charge. 3. Teijin supports get-togethers for patients and takes an active part in facilitating bus travel and other recreational activities. 4. To improve ADL and QOL, Teijin has made recent efforts to promote pulmonary rehabilitation, producing videos and booklets available through health care providers. 5. Based on lessons learned from the Great Hanshin Earthquake, the company has

A prospective observational study assessing home parenteral nutrition in patients with gastrointestinal cancer: benefits for quality of life.

PubMed

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% (P<0.001). The nutrition 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.

Predictors of meaningful improvement in quality of life after temporal lobe epilepsy surgery: A prospective study.

PubMed

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 < 0.0001) 1 year after ATL. In the final logistic regression model, absence of presurgical diagnosis of depression (adjusted odds ratio [OR] 4.4, 95% confidence interval [CI] 1.1-16.1, p = 0.02) and a complete postoperative seizure control (adjusted OR 4.1, 95% CI 1.2-14.5, p = 0.03) were independently associated with improvement equal to or greater than the MCIC in QOL after ATL. The overall model accuracy for MCIC improvement in the QOL was 85.6%, with a 95.2% of sensitivity and 46.7% of specificity. These results in Brazilian patients reinforce the external validation of previous findings in Canadian patients showing that presurgical depression and complete seizure control after surgery are independent predictors for meaningful improvement in QOL after ATL, and have implications for the surgical management of MTLE patients. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

A pilot study to evaluate multi-dimensional effects of dance for people with Parkinson's disease.

PubMed

Ventura, Maria I; Barnes, Deborah E; Ross, Jessica M; Lanni, Kimberly E; Sigvardt, Karen A; Disbrow, Elizabeth A

2016-11-01

Parkinson's disease (PD) is a progressive neurodegenerative disease associated with deficits in motor, cognitive, and emotion/quality of life (QOL) domains, yet most pharmacologic and behavioral interventions focus only on motor function. Our goal was to perform a pilot study of Dance for Parkinson's-a community-based program that is growing in popularity-in order to compare effect sizes across multiple outcomes and to inform selection of primary and secondary outcomes for a larger trial. Study participants were people with PD who self-enrolled in either Dance for Parkinson's classes (intervention group, N=8) or PD support groups (control group, N=7). Assessments of motor function (Timed-Up-and-Go, Gait Speed, Standing Balance Test), cognitive function (Test of Everyday Attention, Verbal Fluency, Alternate Uses, Digit Span Forward and Backward), and emotion/QOL (Geriatric Depression Scale, Falls Efficacy Scale-International, Parkinson's Disease Questionnaire-39 (total score and Activities of Daily Living subscale)) were performed in both groups at baseline and follow-up. Standardized effect sizes were calculated within each group and between groups for all 12 measures. Effect sizes were positive (suggesting improvement) for all 12 measures within the intervention group and 7 of 12 measures within the control group. The largest between-group differences were observed for the Test of Everyday Attention (a measure of cognitive switching), gait speed and falls efficacy. Our findings suggest that dance has potential to improve multiple outcomes in people with PD. Future trials should consider co-primary outcomes given potential benefits in motor, cognitive and emotion/QOL domains. Copyright © 2016 Elsevier Inc. All rights reserved.

Fluoxetine for Maintenance of Remission and to Improve Quality of Life in Patients with Crohn's Disease: a Pilot Randomized Placebo-Controlled Trial.

PubMed

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.

Willingness-to-pay stated preferences for 8 health-related quality-of-life domains in psoriatic arthritis: a pilot study.

PubMed

Hu, Stephanie W; Holt, Elizabeth W; Husni, M Elaine; Qureshi, Abrar A

2010-04-01

Psoriatic arthritis (PsA) is a seronegative inflammatory arthritis found in up to 5 to 42% of patients with psoriasis. As current instruments do not fully capture health-related quality of life (HR-QOL) in PsA from the patient's perspective, we piloted a novel application of "willingness-to-pay" (WTP) as a Patient Reported Outcome to measure the relative impact of PsA in 8 domains of HR-QOL. Fifty-nine PsA patients were interviewed on 8 WTP HR-QOL domains (physical, emotional, sleep, work, social, self-care, intimacy, and concentration). Participants were asked to rank the 8 domains of health in order of HR-QOL impact. In each domain, participants were asked whether PsA affected that domain, whether they were willing to pay for a cure in that domain, and the amount they were willing to pay. Median WTP amounts were compared with the proportion of participants affected by and willing to pay in each domain. Responses in US dollars were interpreted as strength of preference rather than absolute monetary values. The majority of participants were white (98%), > or =45 years of age (70%), insured (98%), and earned >$65,000/yr (66%). The physical domain was most affected by PsA; intimacy and concentration were ranked lowest. Participants reported a wide range of WTP amounts ($0 to $1,000,000), and median WTP amounts were highest in the physical, work, sleep, and self-care domains. Related domains elicited median WTP amounts that were highly correlated. No significant differences in median WTP amounts were found across ages, genders, and income levels for the different domains. WTP is a novel quantitative patient-perspective measure that is comprehensible and feasible to administer in PsA patients. It represents a unique tool for capturing the complex manifestations of PsA and its impact on the individual, allowing the quantification of specific HR-QOL parameters and providing the potential for comparison across various disease processes in a given individual. Copyright

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2014-10-01

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

Effects of martial arts exercise on body composition, serum biomarkers and quality of life in overweight/obese premenopausal women: a pilot study

PubMed Central

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

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

PubMed

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 < 0.01) at baseline were predictors for a high, stable QOL after GKS. After multivariate analysis, a high KPS score (p < 0.01) remained the only positive predictor of a high, stable QOL post-GKS. Median survival post-GKS was 5.6 months (95% CI 1.0-10.3). A higher BRCS score (p = 0.01), higher KPS score (p = 0.01), female sex (p = 0.01), and the absence of liver (p = 0.02), adrenal (p = 0.02), and bone metastases (p = 0

Oral health-related quality of life following non-surgical (routine) tooth extraction: A pilot study

PubMed Central

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

A pilot study to evaluate multi-dimensional effects of dance for people with Parkinson’s disease

PubMed Central

Ventura, Maria I.; Barnes, Deborah E.; Ross, Jessica M.; Lanni, Kimberly E.; Sigvardt, Karen A.; Disbrow, Elizabeth A.

2016-01-01

Parkinson’s disease (PD) is a progressive neurodegenerative disease associated with deficits in motor, cognitive, and emotion/quality of life (QOL) domains, yet most pharmacologic and behavioral interventions focus only on motor function. Our goal was to perform a pilot study of Dance for Parkinson’s—a community-based program that is growing in popularity—in order to compare effect sizes across multiple outcomes and to inform selection of primary and secondary outcomes for a larger trial. Study participants were people with PD who self-enrolled in either Dance for Parkinson’s classes (intervention group, N=8) or PD support groups (control group, N=7). Assessments of motor function (Timed-Up-and-Go, Gait Speed, Standing Balance Test), cognitive function (Test of Everyday Attention, Verbal Fluency, Alternate Uses, Digit Span Forward and Backward), and emotion/QOL (Geriatric Depression Scale, Falls Efficacy Scale-International, Parkinson’s Disease Questionnaire-39 (total score and Activities of Daily Living subscale)) were performed in both groups at baseline and follow-up. Standardized effect sizes were calculated within each group and between groups for all 12 measures. Effect sizes were positive (suggesting improvement) for all 12 measures within the intervention group and 7 of 12 measures within the control group. The largest between-group differences were observed for the Test of Everyday Attention (a measure of cognitive switching), gait speed and falls efficacy. Our findings suggest that dance has potential to improve multiple outcomes in people with PD. Future trials should consider co-primary outcomes given potential benefits in motor, cognitive and emotion/QOL domains. PMID:27765693

The effects of short-term fasting on quality of life and tolerance to chemotherapy in patients with breast and ovarian cancer: a randomized cross-over pilot study.

PubMed

Bauersfeld, Stephan P; Kessler, Christian S; Wischnewsky, Manfred; Jaensch, Annette; Steckhan, Nico; Stange, Rainer; Kunz, Barbara; Brückner, Barbara; Sehouli, Jalid; Michalsen, Andreas

2018-04-27

This pilot trial aimed to study the feasibility and effects on quality of life (QOL) and well-being of short-term fasting (STF) during chemotherapy in patients with gynecological cancer. In an individually-randomized cross-over trial patients with gynecological cancer, 4 to 6 planned chemotherapy cycles were included. Thirty-four patients were randomized to STF in the first half of chemotherapies followed by normocaloric diet (group A;n = 18) or vice versa (group B;n = 16). Fasting started 36 h before and ended 24 h after chemotherapy (60 h-fasting period). QOL was assessed by the FACIT-measurement system. The chemotherapy-induced reduction of QOL was less than the Minimally Important Difference (MID; FACT-G = 5) with STF but greater than the MID for non-fasted periods. The mean chemotherapy-induced deterioration of total FACIT-F was 10.4 ± 5.3 for fasted and 27.0 ± 6.3 for non-fasted cycles in group A and 14.1 ± 5.6 for non-fasted and 11.0 ± 5.6 for fasted cycles in group B. There were no serious adverse effects. STF during chemotherapy is well tolerated and appears to improve QOL and fatigue during chemotherapy. Larger studies should prove the effect of STF as an adjunct to chemotherapy. This trial was registered at clinicaltrials.gov: NCT01954836 .

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

PubMed

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

2017-01-01

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

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


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

NASA Technical Reports Server (NTRS)

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

2001-01-01

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

Prospective study of the impact on quality of life of cystectomy with ileal conduit urinary diversion for neurogenic bladder dysfunction.

PubMed

Guillotreau, Julien; Castel-Lacanal, Evelyne; Roumiguié, Mathieu; Bordier, Benoit; Doumerc, Nicolas; De Boissezon, Xavier; Malavaud, Bernard; Marque, Philippe; Rischmann, Pascal; Gamé, Xavier

2011-11-01

Neurogenic bladder dysfunction has a negative impact on the patient's quality of life (QoL). Cystectomy with ileal conduit urinary diversion is a treatment option in patients in failure after conservative management. The objective of this study was to evaluate the impact of ileal conduit urinary diversion on the QoL of patients with neurogenic bladder dysfunction. From March 2004 to November 2010, 48 patients (36 women and 12 men with a mean age of 50.6  ±  11.8 years) treated by cystectomy with ileal conduit urinary diversion for neurogenic bladder dysfunction, prospectively completed, before and after surgery, two self-administered QoL questionnaires. Neurological diseases were multiple sclerosis in 38 cases, spinal cord injury in 7 cases, and other neurological disease in 3 cases. Cystectomy was performed by laparoscopy in all patients. QoL was measured by using two self-administered questionnaires, one questionnaire specific for urinary disorders validated in neurological patients, Qualiveen®, and the generic SF36-v2® questionnaire. Data were compared by Student's t test. Comparison of the Qualiveen® self-administered questionnaire scores and indices before and after surgery showed that, after surgery, patients presented a significant reduction of limitations (0.57 ± 0.64 vs. 1.55 ± 1.35, P < 0.001), constraints (2.12  ±  0.83 vs. 2.64  ±  1.12, P = 0.046) scores and the SIUP index (1.29 ± 0.65 vs. 1.79 ± 0.95, P = 0.015). No significant change in SF36-v2® scores was observed postoperatively. Ileal conduit urinary diversion improves the urinary QoL of patients with neurogenic bladder dysfunction by decreasing limitations and constraints induced by urinary disorders, but has no impact on general QoL. Copyright © 2011 Wiley Periodicals, Inc.

Prospective Longitudinal Assessment of Quality of Life for Liver Cancer Patients Treated With Stereotactic Body Radiation Therapy

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

Klein, Jonathan, E-mail: jonathan.klein@rmp.uhn.on.ca; Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, Ontario; Dawson, Laura A.

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 alsomore » 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

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

PubMed

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.

Improvement in quality of life after catheter ablation for paroxysmal versus long-standing persistent atrial fibrillation: a prospective study with 3-year follow-up.

PubMed

Bulková, Veronika; Fiala, Martin; Havránek, Stěpán; Simek, Jan; Skňouřil, Libor; Januška, Jaroslav; Spinar, Jindřich; Wichterle, Dan

2014-07-18

Changes in quality of life (QoL) after catheter ablation for long-standing persistent atrial fibrillation (LSPAF) are not well described. We sought to compare QoL improvement after catheter ablation of paroxysmal atrial fibrillation (PAF) versus that after LSPAF. A total of 261 PAF and 126 LSPAF ablation recipients were prospectively followed for arrhythmia recurrence, QoL, hospital stay, and sick leave. In PAF versus LSPAF groups, 1.3±0.6 versus 1.6±0.7 procedures were performed per patient (P<0.00001) during a 3-year follow-up. Good arrhythmia control was achieved in 86% versus 87% of patients (P=0.69) and in 69% versus 69% of patients not receiving antiarrhythmic drugs (P=0.99). The baseline QoL was better in the PAF than in the LSPAF group (European Quality of Life Group instrument self-report questionnaire visual analog scale: 66.4±14.2 versus 61.0±14.2, P=0.0005; European Quality of Life Group 3-level, 5-dimensional descriptive system: 71.4±9.2 versus 67.7±13.8, P=0.002). Postablation 3-year increase in QoL was significant in both groups (all P<0.00001) and significantly lower in PAF versus LSPAF patients (visual analog scale: +5.0±14.5 versus +10.2±12.8, P=0.001; descriptive system: +5.9±14.3 versus +9.3±13.9, P=0.03). In multivariate analysis, LSPAF, less advanced age, shorter history of AF and good arrhythmia control were consistently associated with postablation 3-year improvement in QoL. Days of hospital stay for cardiovascular reasons and days on sick leave per patient/year were significantly reduced in both groups. Patients with LSPAF had worse baseline QoL. The magnitude of QoL improvement after ablation of LSPAF was significantly greater compared with after ablation of PAF, particularly when good arrhythmia control was achieved without the use of antiarrhythmic drugs. © 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

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

PubMed

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.

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

PubMed

Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

2018-02-01

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

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

PubMed

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

2012-01-01

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

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

PubMed

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

2016-01-01

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

Health-Related Quality of Life After Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Results From a Multi-institutional Consortium of Prospective Trials

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

King, Christopher R., E-mail: crking@mednet.ucla.edu; Collins, Sean; Fuller, Donald

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 yearsmore » 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.« less

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

PubMed

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

2017-02-01

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

Ethnic variation in localized prostate cancer: a pilot study of preferences, optimism, and quality of life among black and white veterans.

PubMed

Knight, Sara J; Siston, Amy K; Chmiel, Joan S; Slimack, Nicholas; Elstein, Arthur S; Chapman, Gretchen B; Nadler, Robert B; Bennett, Charles L

2004-06-01

Ethnic variations that may influence the preferences and outcomes associated with prostate cancer treatment are not well delineated. Our objective was to evaluate prospectively preferences, optimism, involvement in care, and quality of life (QOL) in black and white veterans newly diagnosed with localized prostate cancer. A total of 95 men who identified themselves as black/African-American or white who had newly diagnosed, localized prostate cancer completed a "time trade-off" task to assess utilities for current health and mild, moderate, and severe functional impairment; importance rankings for attributes associated with prostate cancer (eg, urinary function); and baseline and follow-up measures of optimism, involvement in care, and QOL. Interviews were scheduled before treatment, and at 3 and 12 months after treatment. At baseline, both blacks and whites ranked pain, bowel, and bladder function as their most important concerns. Optimism, involvement in care, and QOL were similar. Utilities for mild impairment were lower for blacks than whites, but were similar for moderate and severe problems. Decline in QOL at 3 and 12 months compared to baseline occurred for both groups. However, even with adjustment for marital status, education level, and treatment, blacks had less increase in nausea and vomiting and more increase in difficulty with sexual interest and weight gain compared with whites. Black and white veterans entered localized prostate cancer treatment with similar priorities, optimism, and involvement in care. Quality-of-life declines were common to both groups during the first year after diagnosis, but ethnic variation occurred with respect to nausea and vomiting, sexual interest, and weight gain.

The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

PubMed

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

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.

PubMed

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.

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

PubMed

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.

The quality of life of patients with malignant gliomas and their caregivers.

PubMed

Muñoz, Connie; Juarez, Gloria; Muñoz, Maria L; Portnow, Jana; Fineman, Igor; Badie, Behnam; Mamelak, Adam; Ferrell, Betty

2008-01-01

The grim prognosis that accompanies a diagnosis of a malignant glioma affects quality of life (QOL) as patients attempt to adapt to overwhelming losses. Caregivers also experience negative changes in QOL as responsibilities grow. This pilot study measured the QOL of patients with malignant gliomas prior to tumor progression and the QOL of their caregivers. It examined negative and positive factors that impacted the QOL while highlighting positive factors often overlooked in brain tumor QOL research. Standardized QOL questionnaires and focus groups were utilized. Patients experienced distress in the domains of physical, psychological, and social QOL but in all four of the QOL domains there were also positive outcomes. Caregiver data demonstrated mostly positive outcomes in the four QOL domains except for loved one's declining health and fear that the loved one would die.

EuroQol 5D Quality of Life in Meniere's Disorder Can Be Explained with Symptoms and Disabilities

ERIC Educational Resources Information Center

Levo, Hilla; Stephens, Dafydd; Poe, Dennis; Kentala, Erna; Rasku, Jyrki; Pyykko, Ilmari

2012-01-01

The purpose of this study was to determine the factors explaining changes in the generic quality of life among patients with Meniere's disorder (MD) and to evaluate the EuroQol 5D (EQ-5D) quality-of-life measures. A questionnaire focusing on symptoms and disabilities caused by MD was collected from 726 individuals. General health-related quality…

The course of newly presented unexplained complaints in general practice patients: a prospective cohort study.

PubMed

Koch, H; van Bokhoven, M A; Bindels, P J E; van der Weijden, T; Dinant, G J; ter Riet, G

2009-12-01

Newly presented unexplained complaints (UCs) are common in general practice. Factors influencing the transition of newly presented into persistent UCs have been scarcely investigated. We studied the number and the nature of diagnoses made over time, as well as factors associated with UCs becoming persistent. Finally, we longitudinally studied factors associated with quality of life (QoL). Prospective cohort study in general practice of patients presenting with a new UC. Data sources were case record forms, patient questionnaires and electronic medical registries at inclusion, 1, 6 and 12 months. Presence of complaints and diagnoses made over time were documented. Potential risk factors were assessed in mixed-effect logistic and linear regression models. Sixty-three GPs included 444 patients (73% women; median age 42) with unexplained fatigue (70%), abdominal complaints (14%) and musculoskeletal complaints (16%). At 12 months, 43% of the patients suffered from their initial complaints. Fifty-seven percent of the UCs remained unexplained. UCs had (non-life-threatening) somatic origins in 18% of the patients. QoL was often poor at presentation and tended to remain poor. Being a male [odds ratio (OR) 0.6; 95% confidence interval (CI) 0.4-0.8] and GPs' being more certain about the absence of serious disease (OR 0.9; 95% CI 0.8-0.9) were the strongest predictors of a diminished probability that the complaints would still be present and unexplained after 12 months. The strongest determinants of complaint persistence [regardless of (un)explicability] were duration of complaints >4 weeks before presentation (OR 2.6; 95% CI 1.6-4.3), musculoskeletal complaint at baseline (OR 2.3; 1.2-4.5), while the passage of time acted positively (OR 0.8 per month; 95% CI 0.78-0.84). Musculoskeletal complaints, compared to fatigue, decreased QoL on the physical domain (4.6 points; 2.6-6.7), while presence of psychosocial factors decreased mental QoL (5.0; 3.1-6.9). One year after initial

Importance of chewing, saliva, and swallowing function in patients with advanced oral cancer undergoing preoperative chemoradiotherapy: a prospective study of quality of life.

PubMed

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.

Long-term prospective longitudinal evaluation of emotional distress and quality of life in cervical cancer patients who remained disease-free 2-years from diagnosis.

PubMed

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

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

PubMed

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.

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.

PubMed

Anwar, Sidra; Tan, Wei; Hong, Chi-Chen; Admane, Sonal; Dozier, Askia; Siedlecki, Francine; Whitworth, Amy; DiRaddo, Ann Marie; DePaolo, Dawn; Jacob, Sandra M; Ma, Wen Wee; Miller, Austin; Adjei, Alex A; Dy, Grace K

2017-06-26

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.

Development and pilot of an international survey: 'Radiation Therapists and Psychosocial Support'.

PubMed

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.

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

PubMed

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.

A cost-utility analysis of NRG Oncology/Gynecologic Oncology Group Protocol 218: incorporating prospectively collected quality-of-life scores in an economic model of treatment of ovarian cancer.

PubMed

Cohn, David E; Barnett, Jason C; Wenzel, Lari; Monk, Bradley J; Burger, Robert A; Straughn, J Michael; Myers, Evan R; Havrilesky, Laura J

2015-02-01

To estimate quality-of-life (QOL)-adjusted cost-utility with addition of bevacizumab (B) to intravenous paclitaxel/carboplatin (PC) for primary treatment of advanced-stage epithelial ovarian cancer. A modified Markov state transition model of 3 regimens evaluated in GOG 218 (PC, PC+concurrent B [PCB], and PCB+maintenance B [PCB+B]) was populated by prospectively collected survival, adverse event, and QOL data from GOG 218. Progression-free survival (PFS) and overall survival (OS) were modeled using primary event data. Costs of grade 4 hypertension, grade 3-5 bowel events, and growth factor support were incorporated. QOL scores were converted to utilities and incorporated into the model. Monte Carlo probabilistic sensitivity analysis was performed to account for uncertainty in estimates. PC was the least expensive ($4044) and least effective (mean 1.1 quality-adjusted progression-free years [QA-PFY]) regimen. PCB ($43,703 and 1.13 QA-PFY) was dominated by a combination of PC and PCB+B. PCB+B ($122,700 and 1.25 QA-PFY) was the most expensive regimen with an incremental cost-effectiveness ratio of $792,380/QA-PFY compared to PC. In a model not incorporating QOL, the incremental cost-effectiveness ratio (ICER) of PCB+B was $632,571/PFY compared to PC. In this cost-utility model, incorporation of QOL into an analysis of GOG 218 led to less favorable ICER (by >$150,000/QA-PFY) in regimens containing B compared with those that do not include B. Continued investigation of populations with ovarian cancer in whom the efficacy of treatment with bevacizumab is expected to be increased (or in whom QOL is expected to increase with use) is critical. Copyright © 2014 Elsevier Inc. All rights reserved.

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

PubMed

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

2014-06-01

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

Influence of bariatric surgery on quality of life, body image, and general self-efficacy within 6 and 24 months-a prospective cohort study.

PubMed

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 (P<.001) and to 49.8±8.2 within 24 months (P<.001) after surgery. SF-36 mental summary score improved significantly from 42.1±14.7 before surgery to 52.3±8.4 within 6 months (P<.001) and to 48.4±12.2 within 24 months (P<.001) after surgery. There were no significant differences between gender, age, and type of operation. Body image and GSE improved significantly after bariatric surgery (P<.001), and both correlated to the SF-36 mental summary score. QOL, body image, and GSE improved significantly within 6 months and remained stable within 24 months after bariatric 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.

Treatment options in idiopathic subglottic stenosis: protocol for a prospective international multicentre pragmatic trial

PubMed Central

Shyr, Yu; Berry, Lynne; Hillel, Alexander T; Ekbom, Dale C; Edell, Eric S; Kasperbauer, Jan L; Lott, David G; Donovan, Donald T; Garrett, C. Gaelyn; Sandhu, Guri; Daniero, James J; Netterville, James L; Schindler, Josh S; Smith, Marshall E; Bryson, Paul C; Lorenz, Robert R; Francis, David O

2018-01-01

Introduction Idiopathic subglottic stenosis (iSGS) is an unexplained progressive obstruction of the upper airway that occurs almost exclusively in adult, Caucasian women. The disease is characterised by mucosal inflammation and localised fibrosis resulting in life-threatening blockage of the upper airway. Because of high recurrence rates, patients with iSGS will frequently require multiple procedures following their initial diagnosis. Both the disease and its therapies profoundly affect patients’ ability to breathe, communicate and swallow. A variety of treatments have been advanced to manage this condition. However, comparative data on effectiveness and side effects of the unique approaches have never been systematically evaluated. This study will create an international, multi-institutional prospective cohort of patients with iSGS. It will compare three surgical approaches to determine how well the most commonly used treatments in iSGS ‘work’ and what quality of life (QOL) trade-offs are associated with each approach. Methods and analysis A prospective pragmatic trial comparing the ‘Standard of Care’ for iSGS at multiple international institutions. Patients with a diagnosis of iSGS without clinical or laboratory evidence of vasculitis or a history of endotracheal intubation 2 years prior to symptom onset will be included in the study. Prospective evaluation of disease recurrence requiring operative intervention, validated patient-reported outcome (PRO) measures as well as patient-generated health data (mobile peak flow recordings and daily steps taken) will be longitudinally tracked for 36 months. The primary endpoint is treatment effectiveness defined as time to recurrent operative procedure. Secondary endpoints relate to treatment side effects and include PRO measures in voice, swallowing, breathing and global QOL as well as patient-generated health data. Ethics and dissemination This protocol was approved by the local IRB Committee of the

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

ERIC Educational Resources Information Center

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…

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

ERIC Educational Resources Information Center

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…

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

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

Does subthalamic nucleus deep brain stimulation really improve quality of life in Parkinson's disease?

PubMed

Gronchi-Perrin, Aline; Viollier, Sarah; Ghika, Joseph; Combremont, Pierre; Villemure, Jean-Guy; Bogousslavsky, Julien; Burkhard, Pierre R; Vingerhoets, François

2006-09-01

We investigated the impact of subthalamic nucleus (STN) deep brain stimulation (DBS) on quality of life (QOL) in patients with advanced Parkinson's disease, as self-assessed before and after surgery by completing the Parkinson's Disease Questionnaire (PDQ39). In addition to this prospective evaluation, we asked patients postoperatively to evaluate their preoperative QOL. In the prospective assessment, results showed that patients perceived a general improvement of QOL after the STN DBS. However, when evaluated retrospectively, they tended to overestimate their preoperative functioning, therefore obscuring the improvement found prospectively. This observation highlights the impact of the method used on obtained results when assessing the effects of STN DBS. (c) 2006 Movement Disorder Society.

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

PubMed

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

2018-06-08

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

Estimating the direct and indirect costs of lung cancer: a prospective analysis in a Greek University Pulmonary Department.

PubMed

Zarogoulidou, Vasiliki; Panagopoulou, Efharis; Papakosta, Despina; Petridis, Dimitris; Porpodis, Konstantinos; Zarogoulidis, Konstantinos; Zarogoulidis, Paul; Arvanitidou, Malamatenia

2015-02-01

Lung cancer (LC) is a disease with high morbidity and mortality while the prevention and treatment constitutes a significant financial burden. This economic burden has an increasing trend, with hospitalization being the highest cost factor in most studies, while the patients' quality of life (QoL) and response to treatment is not proven to be positively affected. To evaluate the direct and indirect cost of managing patients with LC in Greece according to stage and histological type of cancer, total chemotherapy cycles, age, gender, smoking habit, overall survival (OS), treatment outcome (TO) and QoL. One hundred thirteen of 128 consecutive patients met the inclusion criteria and were included in this prospective study. Patient enrolment started in August 2011 and ended in November 2011. The duration of the patient follow up was 32 months after diagnosis until end of registry. Total direct cost included diagnosis and treatment cost. Indirect cost constituted of patient's and family caregivers lost days of productivity. QoL was assessed with EORTC-QLQ-30 and Lung Cancer Symptom Scale (LCSS) questionnaires before treatment and every three months. Total direct cost was €1,853,984 and chemotherapy drugs was the highest cost factor (€1,216,421). Total indirect cost was 28,774 days of which 27,293 were related to patients. Total direct cost was significantly related to the increased number of total chemotherapy cycles, longer OS, histological type of adenocarcinoma, female gender and younger patients. No relation was found between total indirect cost and the above factors. When the association between total direct/indirect cost and QoL was examined no significant results were drawn. The burden of LC on health care systems remains very high and was associated with the increased number of total chemotherapy cycles, longer OS, adenocarcinoma histological type of cancer, female gender and younger patients. Chemotherapy drugs constituted the higher factor of total direct

Prospective markets and design concepts for civilian remotely piloted aircraft

NASA Technical Reports Server (NTRS)

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

1976-01-01

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

Predictors of postherpetic neuralgia in patients with herpes zoster: a pooled analysis of prospective cohort studies from North and Latin America and Asia.

PubMed

Kawai, Kosuke; Rampakakis, Emmanouil; Tsai, Tsen-Fang; Cheong, Hee Jin; Dhitavat, Jittima; Covarrubias, Alejandro Ortiz; Yang, Lin; Cashat-Cruz, Miguel; Monsanto, Homero; Johnson, Kelly; Sampalis, John S; Acosta, Camilo J

2015-05-01

The most common complication of herpes zoster (HZ) is postherpetic neuralgia (PHN), a persistent pain that can substantially affect quality of life (QoL). This analysis aimed to evaluate predictors of PHN in HZ patients. A pooled analysis of prospective cohort studies of HZ patients aged ≥ 50 years from North America (Canada), Latin America (Brazil, Mexico, and Argentina), and Asia (Taiwan, South Korea, and Thailand) was performed. Patients within 14 days of rash onset were included. The incidence of PHN was defined as a worst pain score of ≥ 3, persisting/appearing at >90 days after rash onset. Socio-demographics, HZ disease characteristics, treatment, pain-related interference with activities of daily living, and health-related QoL were assessed. Of 702 patients with HZ, 148 (21.1%) developed PHN. Similar risks of PHN were observed across geographic regions. On multivariate analysis, older age, greater severity of pain at rash onset, employment status, walking problems at enrollment, and pain interference affecting social relationships were significantly associated with the development of PHN. In addition to older age and severe acute pain, this study suggests that impaired physical and social functioning from acute zoster pain may play a role in the development of PHN in this prospective cohort study of HZ patients from North and Latin America and Asia. Copyright © 2015. Published by Elsevier Ltd.

Internet-orientated Assessment of QOL and Actual Treatment Status in Japanese Patients with Inflammatory Bowel Disease: The 3I survey.

PubMed

Matsumoto, Takayuki; Yanai, Shunichi; Toya, Yosuke; Ueno, Masato; Nakamura, Shotaro

2015-06-01

This survey aimed to compare actual lifestyle factors and QOL between Japanese IBD patients and healthy Japanese controls, by questionnaire using an internet-web system. Through the internet-web system, we asked 464 patients with Crohn's disease [CD], 360 patients with ulcerative colitis [UC], and 4100 healthy controls to answer a questionnaire including an eight-item short-form health survey [SF-8]. The survey was conducted until data had been accumulated from the predetermined numbers of patients [120 patients each with CD and UC] and healthy controls [240 subjects]. QOL assessment by SF-8 revealed scores for six of the eight subscale items and the summary score for the mental component to be significantly lower in the CD and UC groups than in controls. There was a significant negative correlation between each SF-8 score and the degree of CD and UC symptoms. The marriage rate in adult patients was significantly lower in the CD than in the UC group or the controls. The mean annual income and the employment rate were significantly lower in the CD than in the UC group or the controls. CD patients receiving biologicals were more frequently satisfied with the efficacy of treatment than UC patients were with their treatment regimens [56% vs 29%]. Actual lifestyle factors and QOL appear to be impaired in Japanese patients with IBD, especially those with CD. The subjective efficacy of biologicals might be greater in CD than in UC. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Patient Self-reported quality of life assessment in Type 2 diabetes mellitus: A pilot study.

PubMed

PrasannaKumar, H R; Mahesh, M G; Menon, V B; Srinath, K M; Shashidhara, K C; Ashok, P

2018-03-01

Quality of life (QoL) is an important outcome measure to assess the diabetic care and is increasingly replacing the traditional indicators of health. The aim is to evaluate the QoL in patients with type 2 diabetes mellitus (DM) using a third generation individualized QoL instrument like an audit of diabetes-dependent QoL (ADDQoL) questionnaire and to determine the predictors. Patients who met the inclusion and exclusion criteria were recruited from a tertiary care hospital by convenience sampling. Sociodemographic and other relevant details were collected from the study patients, and ADDQoL questionnaire were administered to them. A total of 200 patients were included in the study among which 66% of patients had uncontrolled type 2 DM as suggested by their glycated hemoglobin (HbA1c) values. The mean QoL score was 0.07 (0.91) and diabetes-dependent QoL was -1.33 (0.58). Approximately 38% were associated with poor health-related QoL with a mean average weighted impact score of -0.51 (0.51). Most frequently affected life domain was the freedom to eat. A positive correlation was observed between QoL and gender, age, domicile, education status, occupation, family structure, duration of type 2 DM, HbA1c, insulin treatment, and the presence of comorbidities. The study highlights the impact of type 2 DM on QoL. Improving QoL of type 2 diabetic patients is important and knowledge of these preventable risk factors help to implement strategies to better management of type 2 DM and ultimately improve therapeutic outcome.

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

PubMed

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

2016-11-01

Does prospective embryo selection using the results from the Eava Test (Early Embryo Viability Assessment) in combination with standard morphology increase the pregnancy rate of IVF and ICSI patients compared to embryo selection based on morphology only? Embryo selection using the Eeva Test plus standard morphology on Day 3 results in comparable pregnancy rates as conventional morphological embryo selection. Time-lapse monitoring of embryo development may represent a superior way to culture and select embryos in vitro. The Eeva Test records the development of each embryo with a cell-tracking system and predicts the likelihood (High, Medium or Low) that an embryo will form a blastocyst based on an automated analysis of early cell division timings. This trial was designed as a prospective, observational, two-center pilot study with a propensity matched control group. The analysis involved 280 of 302 enrolled patients who were included in the Eeva Test group in 2013 and 560 control patients who were treated in the years 2011-2013. The majority of transfers (98%) were single embryo transfers. Two academic hospitals (VUmc Amsterdam and UZ Gent) enrolled patients <41 years old, with <3 previous attempts and ≥5 normally fertilized eggs. Propensity matching was used to identify a propensity matched control group from a cohort of 1777 patients based on age, cycle number, oocyte number and number of fertilized oocytes. There was no difference in patient baseline characteristics between the two groups. The ongoing pregnancy rate (OPR) of patients enrolled in the Eeva Test group (34.3%; 96/280) did not differ significantly from the OPR in the propensity matched control group (34.6%, 194/560; P = 0.92). However, significantly less top quality embryos (eight-cell embryos with ≤25% fragmentation) were transferred in the Eeva Test group compared to the propensity matched control group (70.4% vs. 82.3%; P < 0.001). The transfer of Eeva High and Medium embryos resulted in a

The association of dopamine agonists with daytime sleepiness, sleep problems and quality of life in patients with Parkinson's disease--a prospective study.

PubMed

Happe, S; Berger, K

2001-12-01

Reports that dopamine agonists (DA) precipitate sudden daytime sleep episodes in Parkinson's disease (PD) patients have received widespread attention. It remains unclear if non-ergoline and ergoline DAs have differential sedating effects or if sedation rather represents a class effect of DAs. The aim of this study was the evaluation of sleep disturbances and the quality of life (QoL) in PD patients with different dopaminergic treatment strategies. This analysis is part of the FAQT-study, a prospective German cohort study evaluating determinants of QoL in PD patients. A subgroup of 111 PD patients was evaluated twice, at baseline and after one year of follow-up, using standardised and validated questionnaires (Unified Parkinson's disease rating scale (UPDRS), Hoehn and Yahr classification, Center for Epidemiologic Studies Depression Scale (CESD), Short Form-36 (SF-36), Parkinson Disease Questionnaire (PDQ-39)). The impact of treatment strategies on sleep problems, daytime sleepiness, bad dreams and hallucinations, depression and QoL in PD patients was analysed separately for ergoline DAs, non-ergoline DAs and the patient group taking no DA. At baseline, sleep problems were reported by about one third of the patients with and without DA medication. Excessive daytime sleepiness (EDS) was higher in the two DA groups (ergoline 11.9%, non-ergoline 9.1%) than among patients not taking DAs (4.5 %). At follow-up, sleep problems in general had decreased among patients taking DAs continuously and among those newly taking DAs, while the sleep problems increased in patients discontinuing DAs. However, EDS had increased to 25% in patients newly taking DAs, and decreased to 15.9% in those taking them continuously. QoL scores at follow-up were slightly increased in the patient groups newly taking and discontinuing DAs (the latter except in physical functioning) while those on continuing DA-medication remained unchanged. No differential effects of ergoline or non-ergoline DAs on

Patient-reported health-related quality of life for men treated with low-dose-rate prostate brachytherapy as monotherapy with 125-iodine, 103-palladium, or 131-cesium: Results of a prospective phase II study.

PubMed

Blanchard, Pierre; Pugh, Thomas J; Swanson, David A; Mahmood, Usama; Chen, Hsiang-Chun; Wang, Xuemei; Graber, William J; Kudchadker, Rajat J; Bruno, Teresa; Feeley, Thomas; Frank, Steven J

To compare quality of life (QoL) after brachytherapy with one of the three approved radioactive isotopes. Patients with mostly favorable intermediate-risk prostate cancer were treated on this prospective phase II trial with brachytherapy as monotherapy, without hormonal therapy. QoL was recorded at baseline and each follow-up by using the Expanded Prostate Cancer Index Composite instrument. The minimal clinically important difference was defined as half the standard deviation of the baseline score for each domain. Mixed effect models were used to compare the different isotopes, and time-driven activity-based costing was used to compute costs. From 2006 to 2013, 300 patients were treated with iodine-125 (I-125, n = 98, prescribed dose [PD] = 145 Gy), palladium-103 (Pd-103, n = 102, PD = 125 Gy), or cesium-131 (Cs-131, n = 100, PD = 115 Gy). Median age was 64.9 years. Median follow-up time was 5.1 years for the entire cohort, and 7.1, 4.8 and 3.3 years for I-125, Pd-103, and Cs-131 groups, respectively. All three isotope groups showed an initial drop in QoL at first follow-up, which gradually improved over the first 2 years for urinary and bowel domains. QoL profiles were similar between I-125 and Pd-103, whereas Cs-131 showed a statistically significant decrease in QoL regarding bowel and sexual function at 12 months compared with Pd-103. However, these differences did not reach the minimal clinically important difference. Compared with I-125, the use of Pd-103 or Cs-131 resulted in cost increases of 18% and 34% respectively. The three different isotopes produced a similar QoL profile. Statistically significant differences favored Pd-103/I-125 over Cs-131 for bowel and sexual QoL, but this did not reach clinical significance. Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2011-01-01

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

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

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

Serrano, Pablo E.; Herman, Joseph M.; Griffith, Kent A.

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 weremore » 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

Comparison of sinonasal quality of life and health status in patients undergoing microscopic and endoscopic transsphenoidal surgery for pituitary lesions: a prospective cohort study.

PubMed

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 < 0.001). The ASK Nasal-12 and SF-8 scores worsened substantially for both groups at 2 weeks after 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

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

PubMed

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.

Quality of life after maxillectomy and prosthetic obturator rehabilitation.

PubMed

Chigurupati, Radhika; Aloor, Neelam; Salas, Richard; Schmidt, Brian L

2013-08-01

Surgical resection of midface neoplasms and subsequent reconstruction have been shown to have significant negative effects on quality of life (QOL). The purpose of this pilot study was to assess individuals' health-related QOL after maxillectomy and reconstruction with a prosthetic obturator. The QOL of 25 of 43 patients who underwent maxillectomy and prosthetic obturator reconstruction at the University of California-San Francisco was assessed using 3 questionnaires: University of Washington Quality of Life version 4 (UWQOL), Obturator Functioning Scale (OFS), and Mental Health Inventory (MHI). The response rate to the QOL questionnaires was 92% (23 of 25 patients). Time elapsed from maxillectomy and prosthetic obturator reconstruction to the QOL survey response ranged from 0.3 to 6.6 years (mean, 2.7 years; standard deviation [SD], 1.9 years). The post-treatment mean QOL scores were 77.3 (SD, 13.6) for UWQOL, 72.0 (SD, 12.6) for OFS, and 4.5 (SD, 0.9) for Mental Health Inventory. Individuals who received adjuvant radiation scored lower for speech and appearance (OFS, P = .05, P = .03, respectively) as well as for saliva and overall QOL (UWQOL, P = .02, P = .08, respectively). There was a strong correlation between QOL scores in OFS and UWQOL questionnaires (r = 0.78, P < .001). The results of this pilot study suggest that postoperative radiation therapy was the strongest variable affecting QOL in patients with maxillectomy and prosthetic obturator reconstruction. There is further need for a multicenter trial with a larger sample to identify how factors affecting QOL of patients after maxillectomy might influence the choice of reconstruction. Copyright © 2013 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

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.

PubMed

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

Quality of life after laparoscopic gastric banding: Prospective study (152 cases) with a follow-up of 2 years.

PubMed

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

A pilot study using dynamic contrast enhanced-MRI as a response biomarker of the radioprotective effect of memantine in patients receiving whole brain radiotherapy

PubMed Central

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

2016-01-01

Purpose This pilot prospective study sought to determine whether dynamic contrast enhanced MRI (DCE-MRI) could be used as a clinical imaging biomarker of tissue toxicity from whole brain radiotherapy (WBRT). Method 14 patients who received WBRT were imaged using dynamic contrast enhanced DCE-MRI prior to and at 8-weeks, 16-weeks and 24-weeks after the initiation of WBRT. Twelve of the patients were also enrolled in the RTOG 0614 trial, which randomized patients to the use of placebo or memantine. After the unblinding of the treatments received by RTOG 0614 patients, DCE-MRI measures of tumor tissue and normal appearing white matter (NAWM) vascular permeability (Initial Area Under the Curve (AUC) Blood Adjusted) was analyzed. Cognitive, quality-of-life (QOL) assessment and blood samples were collected according to the patient's ability to tolerate the exams. Circulating endothelial cells (CEC) were measured using flow cytometry. Results Following WBRT, there was an increasing trend in the vascular permeability of tumors (p=0.09) and NAWM (p=0.06) with time. Memantine significantly (p=0.01) reduced NAWM AUC changes following radiotherapy. Patients on memantine retained (COWA p= 0.03) better cognitive functions than those on placebo. No association was observed between the level of CEC and DCE-MRI changes, time from radiotherapy or memantine use. Conclusions DCE-MRI can detect vascular damage secondary to WBRT. Our data suggests that memantine reduces WBRT-induced brain vasculature damages. PMID:27248467

A pilot study using dynamic contrast enhanced-MRI as a response biomarker of the radioprotective effect of memantine in patients receiving whole brain radiotherapy.

PubMed

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

2016-08-09

This pilot prospective study sought to determine whether dynamic contrast enhanced MRI (DCE-MRI) could be used as a clinical imaging biomarker of tissue toxicity from whole brain radiotherapy (WBRT). 14 patients who received WBRT were imaged using dynamic contrast enhanced DCE-MRI prior to and at 8-weeks, 16-weeks and 24-weeks after the initiation of WBRT. Twelve of the patients were also enrolled in the RTOG 0614 trial, which randomized patients to the use of placebo or memantine. After the unblinding of the treatments received by RTOG 0614 patients, DCE-MRI measures of tumor tissue and normal appearing white matter (NAWM) vascular permeability (Initial Area Under the Curve (AUC) Blood Adjusted) was analyzed. Cognitive, quality-of-life (QOL) assessment and blood samples were collected according to the patient's ability to tolerate the exams. Circulating endothelial cells (CEC) were measured using flow cytometry. Following WBRT, there was an increasing trend in the vascular permeability of tumors (p=0.09) and NAWM (p=0.06) with time. Memantine significantly (p=0.01) reduced NAWM AUC changes following radiotherapy. Patients on memantine retained (COWA p= 0.03) better cognitive functions than those on placebo. No association was observed between the level of CEC and DCE-MRI changes, time from radiotherapy or memantine use. DCE-MRI can detect vascular damage secondary to WBRT. Our data suggests that memantine reduces WBRT-induced brain vasculature damages.

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

PubMed

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.

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

PubMed

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

2012-01-01

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

14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or a...

14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or a...

14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or a...

14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or a...

14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or a...

76 FR 54095 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... 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... and permits pilot schools and provisional pilot schools to apply for a combined private pilot...

Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study.

PubMed

Komiya, Akira; Suzuki, Hiroyoshi; Awa, Yusuke; Egoshi, Ken-ichi; Onishi, Tetsuro; Nakatsu, Hiroomi; Ohki, Takemasa; Mikami, Kazuo; Sato, Naohide; Araki, Kazuhiro; Ota, Sho; Naya, Yukio; Ichikawa, Tomohiko

2010-06-01

To investigate the benefit of alpha1-adrenoceptor antagonist naftopidil on the quality of life (QOL) of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS). A total of 99 men with BPH/LUTS were prospectively recruited. The Short Form-8 (SF-8) was used for generic QOL assessment and each parameter was compared with the norm in these patients. Longitudinal changes were evaluated using the SF-8 and the International Prostatic Symptoms Score (I-PSS) at baseline, 4 and 8 weeks after naftopidil administration. The relationship between SF-8 and I-PSS was analyzed. Five of eight components in the SF-8 were significantly lower than the Japanese national norm at baseline. SF-8 score was improved by naftopidil at 4 and 8 weeks in general health (GH) and physical component summary (PCS) in the patients in their 70s. Mental health (MH) and mental component summary (MCS) were improved at 8 weeks in patients in their 60s. When analyzing the whole cohort, SF-8 GH, role emotional (RE) and MH had improved at 8 weeks, which was similar to the norm, and bodily pain (BP) results were better. Compared with the baseline, total I-PSS, storage/voiding symptoms and QOL index scores improved significantly under naftopidil. Each component of I-PSS (except for hesitancy) correlated with SF-8 sub-scales (except for BP) to some extent. BPH/LUTS impairs generic QOL, which is improved by naftopidil treatment. SF-8 can be a useful instrument to assess the efficacy of BPH/LUTS treatment because its simplicity to complete and analyze, and its meaningful relationship to I-PSS.

Oligofructose promotes satiety in healthy human: a pilot study.

PubMed

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

2006-05-01

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

Linking the Pilot Structural Model and Pilot Workload

NASA Technical Reports Server (NTRS)

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.

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

PubMed

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

2016-02-01

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

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

PubMed Central

Stroustrup, Annemarie; Plafkin, Callie

2016-01-01

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

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

PubMed

Stroustrup, A; Plafkin, C

2016-05-01

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

Quality of Life in Patients With Chronic Rhinosinusitis and Sleep Dysfunction Undergoing Endoscopic Sinus Surgery: A Pilot Investigation of Comorbid Obstructive Sleep Apnea.

PubMed

Alt, Jeremiah A; DeConde, Adam S; Mace, Jess C; Steele, Toby O; Orlandi, Richard R; Smith, Timothy L

2015-10-01

Patients with chronic rhinosinusitis (CRS) have reduced sleep quality linked to their overall well-being and disease-specific quality of life (QOL). Other primary sleep disorders also affect QOL. To determine the impact of comorbid obstructive sleep apnea (OSA) on CRS disease-specific QOL and sleep dysfunction in patients with CRS following functional endoscopic sinus surgery. Prospective multisite cohort study conducted between October 2011 and November 2014 at academic, tertiary referral centers with a population-based sample of 405 adults. Functional endoscopic sinus surgery for medically refractory symptoms of CRS. Primary outcome measures consisted of preoperative and postoperative scores operationalized by the Rhinosinusitis Disability Index (RSDI) survey, the 22-item Sinonasal Outcome Test (SNOT-22), and the Pittsburgh Sleep Quality Index (PSQI). Obstructive sleep apnea was the primary, independent risk factor. Of 405 participants, 60 (15%) had comorbid OSA. A total of 285 (70%) participants provided preoperative and postoperative survey responses, with a mean (SD) of 13.7 (5.3) months of follow-up. Significant postoperative improvement (P < .05) was reported across all mean disease-specific QOL measures for both participants with and without comorbid OSA. Participants without OSA reported significant greater improvement in unadjusted mean (SD) RSDI global scores (−25.0 [23.3] vs. −16.5 [22.1]; P = .03), RSDI physical (−10.7 [9.2] vs. −7.3 [9.1]; P = .03) and functional (−8.4 [8.7] vs. −5.1 [7.5]; P = .03) subdomain scores, and SNOT-22 rhinologic symptom domain scores (−9.1 [7.7] vs. −5.7 [6.9]; P = .008). Participants without OSA also reported greater improvements on mean (SD) PSQI global (−1.9 [4.0] vs. −0.5 [3.7]; P = .03), sleep quality (−0.4 [0.8] vs. −0.03 [0.7]; P = .02), and sleep disturbance (−0.4 [0.7] vs. −0.1 [0.7]; P = .03) scores. The majority of these associations were found to be durable after adjustment for

A pilot study of the effects of behavioral weight loss treatment on fibromyalgia symptoms.

PubMed

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.

Fatigue in people with localized colorectal cancer who do and do not receive chemotherapy: a longitudinal prospective study

PubMed Central

Vardy, J. L.; Dhillon, H. M.; Pond, G. R.; Renton, C.; Dodd, A.; Zhang, H.; Clarke, S. J.; Tannock, I. F.

2016-01-01

Background Fatigue is associated with cancer and chemotherapy and may be sustained. Here, we describe a prospective longitudinal study evaluating fatigue and putative mechanisms in people with colorectal cancer (CRC). Patients and methods People with localized CRC completed the Functional Assessment of Cancer Treatment-Fatigue (FACT-F) questionnaire at baseline (before chemotherapy, if given), 6, 12, and 24 months. Healthy controls (HCs) were assessed at the first three time points. Fatigue was defined by standardized FACT-F scores ≤68/100. Quality-of-life (QoL, assessed by the FACT-G questionnaire), affective, and cognitive symptoms were evaluated. Associations were sought between fatigue, baseline factors, and blood tests (including hemoglobin, cytokines, and sex hormones). Regression analyses, Fisher's exact tests, and Wilcoxon rank-sum tests assessed levels of fatigue at each time point and change in fatigue from baseline. A repeated-measures analysis investigated prognostic factors of fatigue across all time points. Results A total of 289 subjects with localized CRC (173 received chemotherapy) and 72 HCs were assessed. More CRC patients had fatigue than HCs at baseline (52% versus 26%, P < 0.001). Fatigue was increased in the chemotherapy (CTh) group at 6 months [CTh+ 70% versus CTh− 31% (P < 0.001), HCs 22%] and remained more common at 12 [CTh+ 44% versus CTh− 31% (P = 0.079)] and 24 months [CTh+ 39% versus CTh− 24% (P = 0.047)]. There was no significant difference between those not receiving chemotherapy and HCs at follow-up assessments. Fatigue was associated with poor QoL, affective and cognitive symptoms, but not consistently with cytokine levels. Predictors for sustained fatigue were baseline fatigue, treatment group, cognitive and affective symptoms, poorer QoL, and comorbidities. Conclusions CRC patients have more fatigue than HCs at baseline. Fatigue peaks immediately after adjuvant chemotherapy, but remains common for 2 years in those who

Quality of life in bipolar disorder: towards a dynamic understanding.

PubMed

Morton, E; Murray, G; Michalak, E E; Lam, R W; Beaulieu, S; Sharma, V; Cervantes, P; Parikh, S V; Yatham, L N

2018-05-01

Although quality of life (QoL) is receiving increasing attention in bipolar disorder (BD) research and practice, little is known about its naturalistic trajectory. The dual aims of this study were to prospectively investigate: (a) the trajectory of QoL under guideline-driven treatment and (b) the dynamic relationship between mood symptoms and QoL. In total, 362 patients with BD receiving guideline-driven treatment were prospectively followed at 3-month intervals for up to 5 years. Mental (Mental Component Score - MCS) and physical (Physical Component Score - PCS) QoL were measured using the self-report SF-36. Clinician-rated symptom data were recorded for mania and depression. Multilevel modelling was used to analyse MCS and PCS over time, QoL trajectories predicted by time-lagged symptoms, and symptom trajectories predicted by time-lagged QoL. MCS exhibited a positive trajectory, while PCS worsened over time. Investigation of temporal relationships between QoL and symptoms suggested bidirectional effects: earlier depressive symptoms were negatively associated with mental QoL, and earlier manic symptoms were negatively associated with physical QoL. Importantly, earlier MCS and PCS were both negatively associated with downstream symptoms of mania and depression. The present investigation illustrates real-world outcomes for QoL under guideline-driven BD treatment: improvements in mental QoL and decrements in physical QoL were observed. The data permitted investigation of dynamic interactions between QoL and symptoms, generating novel evidence for bidirectional effects and encouraging further research into this important interplay. Investigation of relevant time-varying covariates (e.g. medications) was beyond scope. Future research should investigate possible determinants of QoL and the interplay between symptoms and wellbeing/satisfaction-centric measures of QoL.

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.

PubMed

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.

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

PubMed Central

Zhou, Kaina; Zhuang, Guihua; Zhang, Hongmei; Liang, Peifeng; Yin, Juan; Kou, Lingling; Hao, Mengmeng; You, Lijuan

2013-01-01

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. PMID:24278188

Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi-institutional study.

PubMed

Smith, Timothy L; Kern, Robert C; Palmer, James N; Schlosser, Rodney J; Chandra, Rakesh K; Chiu, Alexander G; Conley, David; Mace, Jess C; Fu, Rongwei F; Stankiewicz, James A

2011-01-01

Evidence evaluating the comparative effectiveness of various treatments for chronic rhinosinusitis (CRS) is insufficient. This study evaluates outcomes in patients who failed initial medical management and elect a subsequent treatment option, either continued medical management or endoscopic sinus surgery (ESS) coupled with continued medical management. Adult subjects were prospectively enrolled into a nonrandomized, multi-institutional cohort. Baseline characteristics and objective clinical findings were collected. Primary outcome measures included 2 disease-specific quality-of-life (QOL) instruments: the Rhinosinusitis Disability Index (RSDI) and Chronic Sinusitis Survey (CSS). Bivariate and multivariate analyses compared QOL improvement by treatment type, as well as differences in antibiotic and oral steroid utilization and work/school productivity. Subjects (n = 180) were enrolled between March 2009 and April 2010. Patients electing medical management (n = 55) reported significantly better baseline QOL on 1 instrument relative to surgery patients (CSS symptom [p = 0.019] and total scores [p = 0.010]). Surgical patients (n = 75) reported significantly more improvement than medically managed patients (RSDI, p = 0.015; CSS, p < 0.001). Surgical patients reported significantly fewer oral antibiotics (p = 0.002), oral steroids (p = 0.042), and missed days of work/school (p < 0.001) following ESS. After adjustment, more frequent improvement was found within the surgical cohort as measured by the RSDI physical (78.7% vs 56.4%; odds ratio [OR], 3.36; 95% confidence interval [CI], 1.15-9.87; p = 0.027), CSS symptom (80.6% vs 57.4%; OR, 2.65; 95% CI, 1.06-6.66; p = 0.038), medication (49.3% vs 29.6%; OR, 2.33; 95% CI, 0.96-5.64; p = 0.060), and total scores (76.4% vs 53.7%; OR, 2.20; 95% CI, 0.86-5.59; p = 0.099). Patients electing ESS experienced significantly higher levels of improvement in several outcomes. Further investigation with a larger cohort is warranted as

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

PubMed

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

2015-04-14

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

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

PubMed Central

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

2015-01-01

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

Correcting bias in self-rated quality of life: an application of anchoring vignettes and ordinal regression models to better understand QoL differences across commuting modes.

PubMed

Crane, Melanie; Rissel, Chris; Greaves, Stephen; Gebel, Klaus

2016-02-01

Likert scales are frequently used in public health research, but are subject to scale perception bias. This study sought to explore scale perception bias in quality-of-life (QoL) self-assessment and assess its relationships with commuting mode in the Sydney Travel and Health Study. Multilevel ordinal logistic regression analysis was used to analyse the association between two global QoL items about overall QoL and health satisfaction, with usual travel mode to work or study. Anchoring vignettes were applied using parametric and simpler nonparametric methods to detect and adjust for differences in reporting behaviour across age, sex, education, and income groups. The anchoring vignettes exposed differences in scale responses across demographic groups. After adjusting for these biases, public transport users (OR = 0.37, 95 % CI 0.21-0.65), walkers (OR = 0.44, 95 % CI 0.24-0.82), and motor vehicle users (OR = 0.47, 95 % CI 0.25-0.86) were all found to have lower odds of reporting high QoL compared with bicycle commuters. Similarly, the odds of reporting high health satisfaction were found to be proportionally lower amongst all competing travel modes: motor vehicle users (OR = 0.31, 95 % CI 0.18-0.56), public transport users (OR = 0.34, 95 % CI 0.20-0.57), and walkers (OR = 0.35, 95 % CI 0.20-0.64) when compared with cyclists. Fewer differences were observed in the unadjusted models. Application of the vignettes by the two approaches removed scaling biases, thereby improving the accuracy of the analyses of the associations between travel mode and quality of life. The adjusted results revealed higher quality of life in bicycle commuters compared with all other travel mode users.

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

ERIC Educational Resources Information Center

Mishima, Masakazu; Cheng, Lixia

2017-01-01

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

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

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

Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.

Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores overmore » time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.« less

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

PubMed

Rollmann, Denise C; Novotny, Paul J; Petersen, Ivy A; Garces, Yolanda I; Bauer, Heather J; Yan, Elizabeth S; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A; Issa Laack, Nadia N

2015-07-01

The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. Copyright © 2015 Elsevier Inc. All rights reserved.

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

PubMed

Tamburrino, Pasquale; Castellacci, Enrico

2016-12-01

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

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

PubMed

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

2014-06-11

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

Social outcomes and quality of life of childhood cancer survivors in Japan: a cross-sectional study on marriage, education, employment and health-related QOL (SF-36).

PubMed

Ishida, Yasushi; Honda, Misato; Kamibeppu, Kiyoko; Ozono, Shuichi; Okamura, Jun; Asami, Keiko; Maeda, Naoko; Sakamoto, Naoko; Inada, Hiroko; Iwai, Tsuyako; Kakee, Naoko; Horibe, Keizo

2011-05-01

Social outcomes and quality of life (QOL) of childhood cancer survivors (CCSs) remain unknown in Japan. We investigated these outcomes in young adult CCSs compared to those of their siblings in Japan, and analyzed the association between social outcome and SF-36 health survey subscale scores. Between 2007 and 2009, we performed a cross-sectional survey using self-rating questionnaires. We estimated social outcomes and health-related QOL by performing the SF-36 in each group: CCSs with or without stem cell transplantation (SCT)/radiotherapy (RT) and their siblings. Adjusted odds ratios for outcomes of interest were estimated using logistic regression analysis. Questionnaires from 185 CCSs and 72 CCS's siblings were analyzed. There were no differences in educational attainment or annual income. The SF-36 subscale scores of CCSs with SCT and RT were significantly lower than those of siblings in physical functioning (PF) (p < 0.001 and 0.003, respectively) and general health (GH) (both p = 0.001). Lower PF scores correlated with recurrence (p = 0.041) and late effects (p = 0.010), and poor GH scores with late effects (p = 0.006). The CCSs had made efforts to attain educational/vocational goals; however, a significant proportion of CCSs who had experienced late effects remain at increased risk of experiencing diminished QOL.

Quality of life at the retirement transition: Life course pathways in an early 'baby boom' birth cohort.

PubMed

Wildman, Josephine M; Moffatt, Suzanne; Pearce, Mark

2018-06-01

Promoting quality of life (QoL) in later life is an important policy goal. However, studies using prospective data to explore the mechanisms by which earlier events influence QoL in older age are lacking. This study is the first to use prospective data to investigate pathways by which a range of measures of life-course socioeconomic status contribute to later-life QoL. The study uses data from the Newcastle Thousand Families Study cohort (N = 1142), an early 'baby-boom' birth cohort born in 1947 in Newcastle upon Tyne, an industrial city in north-east England. Using prospective survey data collected between birth and later adulthood (N = 393), a path analysis investigated the effects and relative contributions of a range of life-course socioeconomic factors to QoL at age 62-64 measured using the CASP-19 scale. Strong positive effects on later-life QoL were found for advantaged occupational status in mid-life and better self-reported health, employment and mortgage-freedom in later adulthood. Significant positive indirect effects on QoL were found from social class at birth and achieved education level, mediated through later-life socioeconomic advantage. Experiencing no adverse events by age five had a large total positive effect on QoL at age 62-64, comprising a direct effect and indirect effects, mediated through education, mid-life social class and later-life self-reported health. Results support a pathway model with the effects of factors in earlier life acting via later-life factors, and an accumulation model with earlier-life factors having large total, cumulative effects on later-life QoL. The presence of a direct effect of adverse childhood events by age five on QoL suggests a 'critical period' and indicates that policies across the life-course are needed to promote later-life QoL, with policies directed towards older adults perhaps too late to 'undo the damage' of earlier adverse events. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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.

[A case of gastric metastasis and carcinomatous peritonitis of breast cancer with improved QOL by stent implantation and gemcitabine].

PubMed

Mukaibashi, Tomoe; Kojima, Izumi; Yamanaka, Ayumi; Nishiyama, Sachiko; Yamanaka, Takashi; Nakayama, Hirotaka; Matsuura, Hitoshi; Matsuzu, Kenichi; Inaba, Masaaki; Yoshida, Akira; Shimizu, Satoru

2013-08-01

A 73-year-old woman had undergone mastectomy for left breast cancer. One year later, bone metastasis was detected. After 7 years, the patient experienced epigastric discomfort, and gastrointestinal endoscopy showed stenosis of the pylorus and enlarged gastric folds. Stomach cancer was suspected at first, but gastric metastasis of breast cancer was diagnosed on the basis of endoscopic reexamination and computed tomography(CT)images. The patient could not drink water, and therefore, gastrointestinal stenting was performed, which facilitated ingestion to some extent. However, at the same time, an elevated serum carcinoembryonic antigen(CEA)level and jaundice were observed. Therefore, biliary tract stenosis due to carcinomatous peritonitis was diagnosed. We attempted to treat the jaundice with endoscopic retrograde cholangiopancreatography( ERCP)or percutaneous transhepatic cholangiography(PTCD), but the treatment was not successful, and an increase in ascites was noted. Accordingly, gemcitabine was administered as systemic therapy. As a result, ascites decreased and jaundice improved. Patients with gastric metastasis of breast cancer have poor quality of life(QOL)because of difficulties in ingestion or vomiting, and poor prognoses, because of frequent concurrent carcinomatous peritonitis. We experienced a case of gastric metastasis and carcinomatous peritonitis, and were able to improve the patient's QOL by gastrointestinal stenting and gemcitabine administration.

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

PubMed

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 < .0001), with the LP group having higher mean scores. These differences were larger for older students (Grades 5-8) than younger students (Grades 1-4; p < .01). The LD/QOL15 is a brief and reliable measure that is valid to assess quality of life and, potentially, outcomes in children and adolescents with LP.

A pilot study to test psychophonetics methodology for self-care and empathy in compassion fatigue, burnout and secondary traumatic stress

PubMed Central

Butler, Nadine

2013-01-01

Abstract Background Home-based care is recognised as being a stressful occupation. Practitioners working with patients experiencing high levels of trauma may be susceptible to compassion fatigue, with the sustained need to remain empathic being a contributing factor. Objectives The aim of this research was to evaluate psychophonetics methodology for self-care and empathy skills as an intervention for compassion fatigue. Objectives were to measure levels of compassion fatigue pre-intervention, then to apply the intervention and retest levels one month and six months post-intervention. Method The research applied a pilot test of a developed intervention as a quasi-experiment. The study sample comprised home-based carers working with HIV-positive patients at a hospice in Grabouw, a settlement in the Western Cape facing socioeconomic challenge. Results The result of the pilot study showed a statistically-significant improvement in secondary traumatic stress, a component of compassion fatigue, measured with the ProQOL v5 instrument post-intervention. Conclusion The results gave adequate indication for the implementation of a larger study in order to apply and test the intervention. The study highlights a dire need for further research in this field.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-23

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

Pilots 2.0: DIRAC pilots for all the skies

NASA Astrophysics Data System (ADS)

Stagni, F.; Tsaregorodtsev, A.; McNab, A.; Luzzi, C.

2015-12-01

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 sent, as a script to be run, or it can be fetched from a remote location. A pilot 2.0 can run on every computing resource, e.g.: on CREAM Computing elements, on DIRAC Computing elements, on Virtual Machines as part of the contextualization script, or IAAC resources, provided that these machines are properly configured, hiding all the details of the Worker Nodes (WNs) infrastructure. Pilots 2.0 can be generated server and client side. Pilots 2.0 are the “pilots to fly in all the skies”, aiming at easy use of computing power, in whatever form it is presented. Another aim is the unification and simplification of the monitoring infrastructure for all kinds of computing resources, by using pilots as a network of distributed sensors coordinated by a central resource monitoring system. Pilots 2.0 have been developed using the command pattern. VOs using DIRAC can tune pilots 2.0 as they need, and extend or replace each and every pilot command in an easy way. In this

Effects of surgical vs. nonsurgical therapy on erectile dysfunction and quality of life in obstructive sleep apnea syndrome: a pilot study.

PubMed

Shin, Hyun-Woo; Park, Ju-Hyun; Park, Jong-Wan; Rhee, Chae-Seo; Lee, Chul Hee; Min, Yang-Gi; Kim, Dong-Young

2013-08-01

Obstructive sleep apnea syndrome (OSAS) is associated with erectile dysfunction (ED). The improvement of ED after medical therapy including continuous positive airway pressure (CPAP) or mandibular advancement devices (MADs) is still controversial. Furthermore, the efficacy of surgical treatment has been little investigated. The aim of this nonrandomized prospective study was to evaluate the effects of surgical (uvulopalatopharyngoplasty [UPPP]) and nonsurgical approaches (CPAP and MAD) on ED and quality of life (QOL) in OSAS. OSAS patients underwent UPPP (N = 30), CPAP (N = 16), or MAD (N = 10) and completed the Korean versions of the International Index of Erectile Function questionnaire (KIIEF-5) and the Calgary Sleep Apnea Quality of Life Index (SAQLI) before and after a median of 7 months of treatment (interquartile range, 4-15 months). All patients underwent a full-night in-laboratory polysomnography at baseline and follow-up. The main outcome measures are the KIIEF-5 and SAQLI scores. CPAP group showed older age, higher body mass index, and more severe OSAS than other groups. Apnea-hypopnea index and lowest oxygen saturation level improved significantly in all groups, but Epworth Sleepiness Scale score decreased significantly in UPPP and MAD groups. Significant increase of KIIEF-5 was observed in patients who underwent UPPP (P = 0.039, paired t-test), but not in nonsurgical treatment group. All groups had the tendency of better QOL after treatment, but statistical significance was found only in MAD group. Neck circumference (r = 0.360, P = 0.006) and KIIEF-5 score (r = -0.484, P < 0.001) at baseline were significantly related to the improvement of KIIEF-5. This study demonstrated that ED in OSAS may improve following UPPP. Better disease-specific QOL was observed after both surgical and nonsurgical therapies in OSAS. These findings suggest that interventions for OSAS can provide the alleviation of ED and increase QOL in OSAS

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

PubMed

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

2015-07-01

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

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

PubMed

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

2017-02-01

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

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

PubMed

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

2018-05-21

Background Context As increasing numbers of elderly Americans undergo spinal surgery, it is important to identify which patients are at highest risk for poor cognitive and functional recovery. Frailty is a geriatric syndrome which has been closely linked to poor outcomes, and short form screening may be a helpful tool for preoperative identification of at risk patients. Purpose To conduct a pilot study on the usefulness of a short-form screening tool to identify elderly patients at increased risk for prolonged cognitive and functional recovery following elective spine surgery. Study Design/Setting Prospective, comparative cohort study. Patient Sample 100 patients over age 65 undergoing elective spinal surgery (cervical or lumbar) at a single, large academic medical center from 2013-2014. Outcome Measures FRAIL scale, Quality of Recovery Scale (PQRS), and Instrumental Activities (IADLs) scores. Methods Included patients were given the FRAIL scale and stratified as robust, pre-frail, or frail. Post-operative Quality of Recovery Scale (PQRS) and Instrumental Activities (IADLs) scores were also obtained. Patients were re-examined at 1 day, 3 days, 1 month, and 3 months after surgery for cognitive recovery at 3-months, and secondarily, functional recovery at 3-months. This study was funded in part by grants from the National Institute on Aging (K23-17-015, National Institutes of Health, Bethesda, Maryland, USA) and the American Federation for Aging Research (New York City, NY, USA). Results At 3-months, only 50% of frail patients had recovered to their cognitive baseline compared to 60.7% of pre-frail and 69.2% of robust patients (trend). At 3-months, 66.7% of frail patients had recovered to their functional baseline compared to 57% of pre-frail and 76.9% of robust patients (trend). Using multivariate regression modelling, at 3 months, frail patients were less likely to have recovered to their cognitive baseline compared to pre-frail and robust patients (OR 0.39, CI 0

Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Accelerated Radiation Plus Cisplatin With or Without Cetuximab for Locally Advanced Head and Neck Carcinoma: NRG Oncology Radiation Therapy Oncology Group 0522.

PubMed

Truong, Minh Tam; Zhang, Qiang; Rosenthal, David I; List, Marcie; Axelrod, Rita; Sherman, Eric; Weber, Randal; Nguyen-Tân, Phuc Felix; El-Naggar, Adel; Konski, André; Galvin, James; Schwartz, David; Trotti, Andy; Silverman, Craig; Singh, Anurag; Godette, Karen; Bonner, James A; Jones, Christopher U; Garden, Adam S; Shenouda, George; Matthiesen, Chance; Le, Quynh-Thu; Bruner, Deborah

2017-03-15

To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year. Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years. The pretreatment QOL/PS scores were correlated with outcome and p16 status in patients with oropharyngeal cancer (OPC). Of 818 analyzable patients, the 1-year change from baseline score for FACT-HN total was -0.41 (CIS arm) and -5.11 (CET/CIS arm) (P=.016), representing a 3.2% between-arm change of the FACT-HN total score. The mean EQ-5D index and PSS-HN scores were not significantly different between arms. The p16-positive OPC patients had significantly higher baseline and 1-year scores for PSS-HN, FACT-HN total, physical and functional subscales, and 2-years for the EQ-5D index compared with p16-negative OPC patients. Higher pretreatment PSS-HN diet, PSS-HN eating, FACT-HN, and EQ-5D index scores were associated with better overall survival (OS) and progression-free (PFS) survival on multivariate analysis. Higher baseline FACT-HN total, functional, physical subscale, and EQ-5D index scores were associated with improved OS and PFS in p16-positive OPC patients but not in p16-negative and non-OPC patients. There was no clinically meaningful difference in QOL/PS between arms. The p16-positive OPC patients had significantly higher QOL/PS than did p16-negative patients. Pretreatment QOL/PS is a significant independent predictor of outcome in locally advanced HNC. Copyright © 2016 Elsevier Inc. All rights reserved.

Rupatadine in Established Treatment Schemes Improves Chronic Spontaneous Urticaria Symptoms and Patients' Quality of Life: a Prospective, Non-interventional Trial.

PubMed

Metz, Martin; Weller, Karsten; Neumeister, Claudia; Izquierdo, Iñaki; Bödeker, Rolf-Hasso; Schwantes, Ulrich; Maurer, Marcus

2015-12-01

Chronic spontaneous urticaria (CSU) is a common and hard to treat condition associated with a substantial negative impact on patients' quality of life (QoL). Clinical studies have shown that rupatadine is effective and safe in the treatment of CSU, but data from routine clinical care are scarce. Therefore, we assessed the effectiveness and tolerability of rupatadine in established dosages on CSU activity and patients' QoL in a routine daily practice setting. This was an open, prospective, non-interventional study performed in 146 dermatological practices in Germany. CSU patients for whom treatment with rupatadine was indicated were eligible to participate. Key symptoms of urticaria activity and their impact on patients' QoL were assessed at the beginning and the end of treatment. Adverse events (AEs) and withdrawals, as well as the dosage regimens chosen, were documented. Patients and physicians were requested to rate effectiveness and tolerability of therapy at the final visit. All statistical analyses were descriptive. The majority of the 660 patients screened to be treated (median age 44 years, IQR = 31-59 years, n = 654) received rupatadine 10 mg tablets once (477 patients) or twice (105 patients) daily for a median time of 28 days. After treatment, 93.2% of the patients (606/650) reported a clear overall improvement of symptoms. Rupatadine significantly reduced the urticaria activity score (UAS7) as well as the frequency and severity of existing angioedema episodes. Similarly all domains of the urticaria-specific QoL questionnaire (CU-Q 2 oL) were markedly improved. The majority of physicians and patients rated rupatadine treatment as effective and well tolerated. There were 39 (5.9%) early treatment withdrawals, and 21 patients (3.2%) experienced AEs. Rupatadine when given according to the routine treating schemes improves symptoms and CU-Q 2 oL of CSU patients; the drug is also safe and well tolerated. Dr. R. Pfleger GmbH.

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

PubMed Central

2014-01-01

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

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

PubMed Central

2013-01-01

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

A prospective study on the impact of heart rate control achieved with metoprolol on cardiac performance, motor function and quality of life in Chinese chronic heart failure patients.

PubMed

Meng, Yong; Liu, Xuelu; Liu, Juan; Cheng, Xianliang

2017-01-15

To prospectively evaluate the impact of metoprolol achieved heart rate (HR) on cardiac-motor function and quality of life (QoL) in chronic heart failure (CHF) patients. Between February 2013 to April 2016, association of HR reduction with haemodynamic indices, motor function and QoL in CHF patients with HR>80bpm receiving metoprolol 23.75mg or 47.5mgq.d was studied. Overall, 154 patients (median age, 66.39years; males, n=101; females, n=53) were enrolled, whose average resting HR decreased significantly from baseline value of 82.72±6.73 to 69.38±3.57, 67.72±2.61, 66.50±3.14 and 64.86±3.21bpm in the 1st, 3rd, 6th and 12th months post metoprolol intervention, respectively (P<0.0001). Similarly, the ejection fraction (r=-0.6461, P<0.0001), cardiac output (r=-0.5238, P<0.0001), cardiac index (r=-0.5378, P<0.0001) and veterans specific activity questionnaire scores (r=-0.4088, P<0.0001) were significantly associated with the reduction in HR after 12months. The improvement in 6-min walk test was independent of HR reduction (P=0.005). Similarly, QoL as measured by short form-8 questionnaire (SF-8) but not Minnesota Living with Heart Failure was significantly improved at the 12th-month. However, this was not associated with the reductions in HR. Metoprolol achieved HR control was associated with improvement in cardiac performance and motor function but not QoL in patients with CHF. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

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

PubMed

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.

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

PubMed

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

2005-01-01

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

14 CFR 61.73 - Military pilots or former military pilots: Special rules.

Code of Federal Regulations, 2010 CFR

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...

A prospective, randomized, controlled study of a suspension positioning system used with elderly bedridden patients with neurogenic fecal incontinence.

PubMed

Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong

2015-01-01

Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.

Effects of a Two-Year Intensive Multidisciplinary Rehabilitation Program for Patients with Huntington’s Disease: a Prospective Intervention Study

PubMed Central

Piira, Anu; van Walsem, Marleen R.; Mikalsen, Geir; Øie, Lars; Frich, Jan C.; Knutsen, Synnove

2014-01-01

Objective: To assess effects of a two year intensive, multidisciplinary rehabilitation program for patients with early- to mid-stage Huntington’s disease. Design: A prospective intervention study. Setting: One inpatient rehabilitation center in Norway. Subjects: 10 patients, with early- to mid-stage Huntington’s disease. Interventions: A two year rehabilitation program, consisting of six admissions of three weeks each, and two evaluation stays approximately three months after the third and sixth rehabilitation admission. The program focused on physical exercise, social activities, and group/teaching sessions. Main outcome measures: Standard measures for motor function, including gait and balance, cognitive function, including MMSE and UHDRS cognitive assessment, anxiety and depression, activities of daily living (ADL), health related quality of life (QoL) and Body Mass Index (BMI). Results: Six out of ten patients completed the full program. Slight, but non-significant, decline was observed for gait and balance from baseline to the evaluation stay after two years. Non-significant improvements were observed in physical QoL, anxiety and depression, and BMI. ADL-function remained stable with no significant decline. None of the cognitive measures showed a significant decline. An analysis of individual cases revealed that four out of the six participants who completed the program sustained or improved their motor function, while motor function declined in two participants. All the six patients who completed the program reported improved or stable QoL throughout the study period. Conclusion: Our findings suggest that participation in an intensive rehabilitation program is well tolerated among motivated patients with early to mid-stage HD. The findings should be interpreted with caution due to the small sample size in this study. PMID:25642382

Long-term major adverse cardiovascular events and quality of life after coronary angiography in elderly patients with acute coronary syndrome.

PubMed

Sigurjonsdottir, R; Barywani, S; Albertsson, P; Fu, M

2016-11-01

Although the elderly comprise the majority of acute coronary syndrome (ACS) patients, limited data exist on major adverse cardiovascular events (MACEs) and quality of life (QoL). To study MACEs and QoL prospectively in ACS patients >70years referred for coronary angiography. A prospective observational study that included ACS patients >70years undergoing coronary angiography. The outcomes were MACEs and QoL 3years after inclusion. MACEs were defined as death, recurrent ACS, new-onset of heart failure and repeated revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). A QoL questionnaire was completed by the patients along with a physical examination and a personal interview at the 3-year follow-up. Multivariate analysis was performed to identify the predictors for MACEs. In total, 138 patients (mean age 78.8±3.8years) with ACS were included in the study. Mean follow-up was 1196±296days. In all, 42% of the patients had MACEs and 25% had post-ACS heart failure. The mortality rate was 11%. After adjusting for significant cardiovascular risk factors, the following factors were significantly associated with MACEs: Age, high-sensitive troponin T (hsTNT), use of diuretics and reduced left ventricular ejection fraction (LVEF). Furthermore, the QoL evaluated with SF-36 in survivors from ACS at the end of study was similar to the QoL in an age-matched healthy Swedish population. In this prospective study on elderly ACS patients MACEs still occurred in 42% of the cases (despite low mortality and good QoL), with post-ACS heart failure as the most important event. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cross-cultural development of a quality-of-life measure for patients with melanoma: phase 3 testing of an EORTC Melanoma Module.

PubMed

Winstanley, Julie B; Young, Teresa E; Boyle, Frances M; Bergenmar, Mia; Bottomley, Andrew; Burmeister, Bryan; Campana, Luca G; Garioch, Jennifer J; King, Madeleine; Nikolic, Dejan V; van de Poll-Franse, Lonneke V; Saw, Robyn; Thompson, John F; White, Edward G

2015-02-01

Melanoma is an increasingly common skin cancer worldwide. Recent treatment advances have provided patients and healthcare professionals (HCPs) with choices where quality of life (QoL) and toxicity are important considerations. A melanoma-specific QoL questionnaire is being developed in a cross-cultural setting using a four phase process developed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group. In phase 1, a literature search identified a list of pertinent QoL issues; this was shown to HCPs and patients in eight countries and rated for importance and relevance. Questions were constructed for the highest-rated issues (phase 2) and piloted in another patient sample (phase 3). Using EORTC Quality of Life Group criteria and sequential use of factor and Rasch analysis, scales were hypothesized for field testing (phase 4). Seven QoL domains (disease symptoms, treatment issues, financial issues, access/quality of information, satisfaction with care, psychosocial issues and support), comprising 73 QoL issues, were rated by 46 HCPs and 78 patients. Fifty-six issues were rephrased as questions and piloted with 132 patients. A 38-item questionnaire (QLQ-MEL38) is available for field testing in conjunction with the EORTC QLQ-C30. This study has shown that melanoma patients have important QoL issues that have been incorporated into a new cross-culturally validated instrument. Future testing of this EORTC module is planned and will be an important step forward in providing reliable QoL data to aid future decision-making in the management and clinical trials of this complex group of patients.

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

PubMed

Barer, A S

2007-01-01

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

14 CFR 61.73 - Military pilots or former military pilots: Special rules.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Military pilots or former military pilots... TRANSPORTATION (CONTINUED) AIRMEN CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND INSTRUCTORS Aircraft Ratings and Pilot Authorizations § 61.73 Military pilots or former military pilots: Special rules. (a...

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

PubMed Central

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

2015-01-01

Objective 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). Design Grounded-theory based qualitative item development methods, large-scale item calibration field testing, confirmatory factor analysis, and item response theory (IRT)-based psychometric analyses. Setting Five SCI Model System centers and one Department of Veterans Affairs medical center in the United States. Participants Adults with traumatic SCI. Main Outcome Measures SCI-QOL Stigma Item Bank Results 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. Conclusions 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. PMID:26010973

Exercise training in adults with repaired tetralogy of Fallot: A randomized controlled pilot study of continuous versus interval training.

PubMed

Novaković, Marko; Prokšelj, Katja; Rajkovič, Uroš; Vižintin Cuderman, Tjaša; Janša Trontelj, Katja; Fras, Zlatko; Jug, Borut

2018-03-15

Adults with repaired tetralogy of Fallot (ToF) have impaired exercise capacity, vascular and cardiac autonomic function, and quality of life (QoL). Specific effects of high-intensity interval or moderate continuous exercise training on these parameters in adults with repaired ToF remain unknown. Thirty adults with repaired ToF were randomized to either high-intensity interval, moderate intensity continuous training (36 sessions, 2-3 times a week) or usual care (no supervised exercise). Exercise capacity, flow-mediated vasodilation, pulse wave velocity, NT-proBNP and fibrinogen levels, heart rate variability and recovery, and QoL (SF-36 questionnaire) were determined at baseline and after the intervention period. Twenty-seven patients (mean age 39±9years, 63% females, 9 from each group) completed this pilot study. Both training groups improved in at least some parameters of cardiovascular health compared to no exercise. Interval-but not continuous-training improved VO2peak (21.2 to 22.9ml/kg/min, p=0.004), flow-mediated vasodilation (8.4 to 12.9%, p=0.019), pulse wave velocity (5.4 to 4.8m/s, p=0.028), NT-proBNP (202 to 190ng/L, p=0.032) and fibrinogen levels (2.67 to 2.46g/L, p=0.018). Conversely, continuous-but not interval-training improved heart rate variability (low-frequency domain, 0.32 to 0.22, p=0.039), heart rate recovery after 2min post-exercise (40 to 47 beats, p=0.023) and mental domain of SF-36 (87 to 95, p=0.028). Both interval and continuous exercise training modalities were safe. Interval training seems more efficacious in improving exercise capacity, vascular function, NT-proBNP and fibrinogen levels, while continuous training seems more efficacious in improving cardiac autonomic function and QoL. (Clinicaltrials.gov, NCT02643810). Copyright © 2018 Elsevier Ireland Ltd. All rights reserved.

Quality of Life in Patients with Noninfectious Uveitis Treated with or without Systemic Anti-inflammatory Therapy.

PubMed

Gui, Wei; Dombrow, Matthew; Marcus, Inna; Stowe, Meredith H; Tessier-Sherman, Baylah; Yang, Elizabeth; Huang, John J

2015-04-01

To compare vision-related (VR-QOL) and health-related quality of life (HR-QOL) in patients with noninfectious uveitis treated with systemic anti-inflammatory therapy versus nonsystemic therapy. A prospective, cross-sectional study design was employed. VR-QOL and HR-QOL were assessed by the 25-Item Visual Function Questionnaire (VFQ-25) and the Short Form 12-Item Health Survey (SF-12), respectively. Multivariate regression analysis was performed to assess the VR-QOL and HR-QOL based on treatment. Among the 80 patients, the median age was 51 years with 28 males (35%). The adjusted effect of treatment modality on VR-QOL or HR-QOL showed no statistically significant difference in all subscores of VFQ-25 or physical component score (PCS) and mental component score (MCS) of SF-12. Systemic therapy did not compromise VR-QOL or HR-QOL compared to nonsystemic therapy. Systemic therapy can be effectively used to control serious cases of noninfectious uveitis without significant relative adverse impact on quality of life.

Noninvasive ventilation improves sleep in amyotrophic lateral sclerosis: a prospective polysomnographic study.

PubMed

Vrijsen, Bart; Buyse, Bertien; Belge, Catharina; Robberecht, Wim; Van Damme, Philip; Decramer, Marc; Testelmans, Dries

2015-04-15

To evaluate the effects of noninvasive ventilation (NIV) on sleep in patients with amyotrophic lateral sclerosis (ALS) after meticulous titration with polysomnography (PSG). In this prospective observational study, 24 ALS patients were admitted to the sleep laboratory during 4 nights for in-hospital NIV titration with PSG and nocturnal capnography. Questionnaires were used to assess subjective sleep quality and quality of life (QoL). Patients were readmitted after one month. In the total group, slow wave sleep and REM sleep increased and the arousal-awakening index improved. The group without bulbar involvement (non-bulbar) showed the same improvements, together with an increase in sleep efficiency. Nocturnal oxygen and carbon dioxide levels improved in the total and non-bulbar group. Except for oxygen saturation during REM sleep, no improvement in respiratory function or sleep structure was found in bulbar patients. However, these patients showed less room for improvement. Patient-reported outcomes showed improvement in sleep quality and QoL for the total and non-bulbar group, while bulbar patients only reported improvements in very few subscores. This study shows an improvement of sleep architecture, carbon dioxide, and nocturnal oxygen saturation at the end of NIV titration and after one month of NIV in ALS patients. More studies are needed to identify the appropriate time to start NIV in bulbar patients. Our results suggest that accurate titration of NIV by PSG improves sleep quality. A commentary on this article appears in this issue on page 511. © 2015 American Academy of Sleep Medicine.

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

PubMed

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

2018-06-19

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

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

PubMed

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

2017-04-01

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

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

PubMed Central

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

2016-01-01

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

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

PubMed

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

2017-01-01

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

Herpes zoster-associated severity and duration of pain, health-related quality of life, and healthcare utilization in Taiwan: a prospective observational study.

PubMed

Tsai, Tsen-Fang; Yao, Chien-An; Yu, Hsin-Su; Lan, Cheng-Che; Chao, Sheau-Chiou; Yang, Jen-Hung; Yang, Kuo-Chia; Chen, Ching-Yu; White, Ron R; Psaradellis, Eliofotisti; Rampakakis, Emmanouil; Kawai, Kosuke; Acosta, Camilo J; Sampalis, John S

2015-01-01

To assess the severity and duration of herpes zoster (HZ)-associated pain (ZAP) and its impact on quality of life (QoL) and healthcare utilization (HCRU) from a patient perspective in routine care in Taiwan. A prospective, observational, single-cohort study was conducted in five centers across Taiwan. Patients were recruited at different time points during their HZ episode and were followed for ≤180 days. ZAP was assessed with the Initial Zoster Impact Questionnaire and the Zoster Brief Pain Inventory, QoL with the EQ-5D, and HCRU with a simple questionnaire. A total of 150 patients were included with a mean age of 64.9 years and mean time since rash onset of 18.8 days. Prodromal pain was experienced by 64.7% of patients, of whom 91.8% reported moderate-to-severe pain. At enrollment, 98.0% of patients experienced ZAP. Mean ± SD worst pain score decreased from 5.95 ± 3.09 at enrollment to 2.65 ± 2.98 at 30 days and 0.28 ± 0.83 at 180 days. Postherpetic neuralgia was observed in 20.7% of patients. Mean ± SD EQ-5D score significantly decreased (P < 0.001) from 0.91 ± 0.16 before rash onset to 0.67 ± 0.18 after rash onset, showing significant QoL deterioration up to 60 days. The impact of HZ on QoL and pain severity was similar across age groups. Significant HCRU was observed including visits to the doctor (83.3% of patients), specialist (30.7%), emergency department (24.7%), physiotherapist (23.3%), and hospitalizations (20.7%). Severe morbidity and significant HCRU are associated with HZ in Taiwan, supporting the need for early intervention and preventive strategies to reduce the HZ-associated burden of illness. © 2014 The International Society of Dermatology.

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

PubMed

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

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

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

PubMed Central

2014-01-01

Background 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. Objective The purpose of this study was to examine the influence of cognitive factors on patients with oral dryness. Methods 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. Results 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. Conclusion 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. PMID:26019720

Short-term quality of life after subthalamic stimulation depends on non-motor symptoms in Parkinson's disease.

PubMed

Dafsari, Haidar Salimi; Weiß, Luisa; Silverdale, Monty; Rizos, Alexandra; Reddy, Prashanth; Ashkan, Keyoumars; Evans, Julian; Reker, Paul; Petry-Schmelzer, Jan Niklas; Samuel, Michael; Visser-Vandewalle, Veerle; Antonini, Angelo; Martinez-Martin, Pablo; Ray-Chaudhuri, K; Timmermann, Lars

2018-02-24

Subthalamic nucleus (STN) deep brain stimulation (DBS) improves quality of life (QoL), motor, and non-motor symptoms (NMS) in advanced Parkinson's disease (PD). However, considerable inter-individual variability has been observed for QoL outcome. We hypothesized that demographic and preoperative NMS characteristics can predict postoperative QoL outcome. In this ongoing, prospective, multicenter study (Cologne, Manchester, London) including 88 patients, we collected the following scales preoperatively and on follow-up 6 months postoperatively: PDQuestionnaire-8 (PDQ-8), NMSScale (NMSS), NMSQuestionnaire (NMSQ), Scales for Outcomes in PD (SCOPA)-motor examination, -complications, and -activities of daily living, levodopa equivalent daily dose. We dichotomized patients into "QoL responders"/"non-responders" and screened for factors associated with QoL improvement with (1) Spearman-correlations between baseline test scores and QoL improvement, (2) step-wise linear regressions with baseline test scores as independent and QoL improvement as dependent variables, (3) logistic regressions using aforementioned "responders/non-responders" as dependent variable. All outcomes improved significantly on follow-up. However, approximately 44% of patients were categorized as "QoL non-responders". Spearman-correlations, linear and logistic regression analyses were significant for NMSS and NMSQ but not for SCOPA-motor examination. Post-hoc, we identified specific NMS (flat moods, difficulties experiencing pleasure, pain, bladder voiding) as significant contributors to QoL outcome. Our results provide evidence that QoL improvement after STN-DBS depends on preoperative NMS characteristics. These findings are important in the advising and selection of individuals for DBS therapy. Future studies investigating motor and non-motor PD clusters may enable stratifying QoL outcomes and help predict patients' individual prospects of benefiting from DBS. Copyright © 2018. Published by Elsevier

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

PubMed

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

2016-11-04

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

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

PubMed

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

Venous sinus stenting for reduction of intracranial pressure in IIH: a prospective pilot study.

PubMed

Liu, Kenneth C; Starke, Robert M; Durst, Christopher R; Wang, Tony R; Ding, Dale; Crowley, R Webster; Newman, Steven A

2017-11-01

OBJECTIVE Idiopathic intracranial hypertension (IIH) may cause blindness due to elevated intracranial pressure (ICP). Venous sinus stenosis has been identified in select patients, leading to stenting as a potential treatment, but its effects on global ICP have not been completely defined. The purpose of this pilot study was to assess the effects of venous sinus stenting on ICP in a small group of patients with IIH. METHODS Ten patients for whom medical therapy had failed were prospectively followed. Ophthalmological examinations were assessed, and patients with venous sinus stenosis on MR angiography proceeded to catheter angiography, venography with assessment of pressure gradient, and ICP monitoring. Patients with elevated ICP measurements and an elevated pressure gradient across the stenosis were treated with stent placement. RESULTS All patients had elevated venous pressure (mean 39.5 ± 14.9 mm Hg), an elevated gradient across the venous sinus stenosis (30.0 ± 13.2 mm Hg), and elevated ICP (42.2 ± 15.9 mm Hg). Following stent placement, all patients had resolution of the stenosis and gradient (1 ± 1 mm Hg). The ICP values showed an immediate decrease (to a mean of 17.0 ± 8.3 mm Hg), and further decreased overnight (to a mean of 8 ± 4.2 mm Hg). All patients had subjective and objective improvement, and all but one improved during follow-up (median 23.4 months; range 15.7-31.6 months). Two patients developed stent-adjacent stenosis; retreatment abolished the stenosis and gradient in both cases. Patients presenting with papilledema had resolution on follow-up funduscopic imaging and optical coherence tomography (OCT) and improvement on visual field testing. Patients presenting with optic atrophy had optic nerve thinning on follow-up OCT, but improved visual fields. CONCLUSIONS For selected patients with IIH and venous sinus stenosis with an elevated pressure gradient and elevated ICP, venous sinus stenting results in resolution of the venous pressure

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

PubMed

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

2016-08-18

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

Benefits of combined aerobic/resistance/inspiratory training in patients with chronic heart failure. A complete exercise model? A prospective randomised study.

PubMed

Laoutaris, Ioannis D; Adamopoulos, Stamatis; Manginas, Athanassios; Panagiotakos, Demosthenes B; Kallistratos, Manolis S; Doulaptsis, Costas; Kouloubinis, Alexandros; Voudris, Vasilis; Pavlides, Gregory; Cokkinos, Dennis V; Dritsas, Athanasios

2013-09-01

We hypothesised that combined aerobic training (AT) with resistance training (RT) and inspiratory muscle training (IMT) could result in additional benefits over AT alone in patients with chronic heart failure (CHF). Twenty-seven patients, age 58 ± 9 years, NYHA II/III and LVEF 29 ± 7% were randomly assigned to a 12-week AT (n=14) or a combined AT/RT/IMT (ARIS) (n=13) exercise program. AT consisted of bike exercise at 70-80% of max heart rate. ARIS training consisted of AT with RT of the quadriceps at 50% of 1 repetition maximum (1RM) and upper limb exercises using dumbbells of 1-2 kg as well as IMT at 60% of sustained maximal inspiratory pressure (SPI(max)). At baseline and after intervention patients underwent cardiopulmonary exercise testing, echocardiography, evaluation of dyspnea, muscle function and quality of life (QoL) scores. The ARIS program as compared to AT alone, resulted in additional improvement in quadriceps muscle strength (1RM, p=0.005) and endurance (50%1 RM × number of max repetitions, p=0.01), SPI(max) (p<0.001), exercise time (p=0.01), circulatory power (peak oxygen consumption × peak systolic blood pressure, p=0.05), dyspnea (p=0.03) and QoL (p=0.03). ARIS training was safe and resulted in incremental benefits in both peripheral and respiratory muscle weakness, cardiopulmonary function and QoL compared to that of AT. The present findings may add a new prospective to cardiac rehabilitation programs of heart failure patients whilst the clinical significance of these outcomes need to be addressed in larger randomised studies. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Triptorelin for the relief of lower urinary tract symptoms in men with advanced prostate cancer: results of a prospective, observational, grouped-analysis study

PubMed Central

Gil, Thierry; Aoun, Fouad; Cabri, Patrick; Perrot, Valérie; van Velthoven, Roland

2017-01-01

Background: Lower urinary tract symptoms (LUTSs) may develop in men with prostate cancer (PCa) and can impact quality of life (QoL). Gonadotropin-releasing hormone (GnRH) agonists as androgen deprivation therapy are standard treatment for PCa, however, data are limited on their effects on LUTSs. A grouped analysis of national observational, non-interventional studies initiated in clinical practice was performed to assess the effectiveness of triptorelin in reducing moderate or severe LUTSs, measured using the International Prostate Symptom Score (IPSS) in men with advanced or metastatic PCa. Methods: Men with PCa and LUTSs scheduled to receive triptorelin (3-month or 1-month extended release formulation) were recruited into prospective, non-interventional studies at centres in Algeria, Australia, Belgium, China, Hungary, Romania and South Korea. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTSs, assessed by IPSS, after 48 weeks. Secondary endpoints included: total IPSS, QoL due to urinary symptoms (IPSS Question 8) and prostate-specific antigen (PSA) levels at 24 and 48 weeks. Results: A total of 2701 patients were recruited; 1851 patients with moderate or severe LUTSs at baseline (IPSS > 7), received triptorelin and had follow-up IPSS (efficacy population). The proportion of patients with moderate or severe LUTSs was reduced to 67.2% from baseline at week 48, following a reduction to 75.9% at week 24: the overall time effect was significant (p < 0.001). QoL due to urinary symptoms significantly improved from a mean score of 3.7 at baseline, to adjusted means of 2.5 and 2.1, at weeks 24 and 48, respectively (p < 0.001 versus baseline). Mean PSA levels were reduced from 158.8 ng/ml at baseline to 11.5 and 16.0 ng/ml at weeks 24 and 48, respectively. Conclusions: Within the limitations of these observational studies, improvements in LUTSs and QoL observed after 24 weeks and maintained at 48 weeks indicate that triptorelin

76 FR 63183 - Pilot in Command Proficiency Check and Other Changes to the Pilot and Pilot School Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-12

...-0938; Amendment Nos. 61-128, 91-324, 141-15, and 142-7] RIN 2120-AJ18 Pilot in Command Proficiency..., the FAA expanded the obligation for a pilot-in-command (PIC) proficiency check to pilots of all... as follows: Sec. 61.58 Pilot-in-command proficiency check: Operation of aircraft requiring more than...

14 CFR 61.113 - Private pilot privileges and limitations: Pilot in command.

Code of Federal Regulations, 2011 CFR

2011-01-01

...: Pilot in command. 61.113 Section 61.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... INSTRUCTORS Private Pilots § 61.113 Private pilot privileges and limitations: Pilot in command. (a) Except as... act as pilot in command of an aircraft that is carrying passengers or property for compensation or...

14 CFR 61.113 - Private pilot privileges and limitations: Pilot in command.

Code of Federal Regulations, 2013 CFR

2013-01-01

...: Pilot in command. 61.113 Section 61.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... INSTRUCTORS Private Pilots § 61.113 Private pilot privileges and limitations: Pilot in command. (a) Except as... act as pilot in command of an aircraft that is carrying passengers or property for compensation or...

14 CFR 61.113 - Private pilot privileges and limitations: Pilot in command.

Code of Federal Regulations, 2012 CFR

2012-01-01

...: Pilot in command. 61.113 Section 61.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... INSTRUCTORS Private Pilots § 61.113 Private pilot privileges and limitations: Pilot in command. (a) Except as... act as pilot in command of an aircraft that is carrying passengers or property for compensation or...

14 CFR 61.113 - Private pilot privileges and limitations: Pilot in command.

Code of Federal Regulations, 2010 CFR

2010-01-01

...: Pilot in command. 61.113 Section 61.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... INSTRUCTORS Private Pilots § 61.113 Private pilot privileges and limitations: Pilot in command. (a) Except as... act as pilot in command of an aircraft that is carrying passengers or property for compensation or...

14 CFR 61.113 - Private pilot privileges and limitations: Pilot in command.

Code of Federal Regulations, 2014 CFR

2014-01-01

...: Pilot in command. 61.113 Section 61.113 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... INSTRUCTORS Private Pilots § 61.113 Private pilot privileges and limitations: Pilot in command. (a) Except as... act as pilot in command of an aircraft that is carrying passengers or property for compensation or...

Somatostatin analogue-induced pancreatic exocrine insufficiency in patients with neuroendocrine tumours: results of a prospective observational study.

PubMed

Lamarca, Angela; McCallum, Lynne; Nuttall, Christina; Barriuso, Jorge; Backen, Alison; Frizziero, Melissa; Leon, Rebecca; Mansoor, Was; McNamara, Mairéad G; Hubner, Richard A; Valle, Juan W

2018-06-20

Background Patients with advanced well-differentiated neuroendocrine tumours(Wd-NETs) are commonly treated with somatostatin analogues(SSAs). Some patients may develop SSA-related side effects such as pancreatic exocrine insufficiency(PEI). Methods In this single-institution, prospective, observational study, the frequency of SSA-induced PEI in 50 sequential patients with advanced Wd-NETs treated with SSAs was investigated. Toxicity was assessed monthly and faecal elastase-1 (FE1) and quality of life (QoL) were assessed 3-monthly. Results The median age was 65.8 years, 58% were male and the majority (92%) of patients had metastatic disease; patients received 4-weekly long acting octreotide (60%) or lanreotide (40%). Twelve patients (24%) developed SSA-related PEI after a median of 2.9 months from SSA initiation; FE1 was a reliable screening tool, especially in symptomatic patients (risk ratio 8.25 (95% confidence interval 1.15-59.01)). Most of these patients (11/12; 92%) required PERT. Other SSA-related adverse events (any grade) included flatulence (50%), abdominal pain (32%), diarrhoea (30%) and fatigue (20%). Development of PEI did not significantly worsen overall QoL, however gastrointestinal symptoms and diarrhoea were increased. Conclusion This study demonstrated that PEI occurs at a higher rate than previously reported; clinicians need to diagnose and treat this SSA-related adverse-event which occurs in 1 in 4 patients with Wd-NETs treated with SSAs.

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

PubMed Central

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

2012-01-01

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

A longitudinal examination of positive changes in quality-of-life after traumatic brain injury.

PubMed

Gould, Kate R; Ponsford, Jennie L

2015-01-01

Most studies of quality-of-life (QoL) after traumatic brain injury (TBI) reveal a largely negative picture, yet some survivors show positive changes (PC). Understanding PC in QoL may assist clinicians in facilitating post-injury adjustment. This study aimed to prospectively explore changes in QoL from pre- to post-injury, identify those with PC and examine predictive and associated factors. Ninety-five participants, recruited from consecutive admissions to a rehabilitation hospital, were prospectively assessed at least once over the first 4 years post-injury. Measures of QoL, psychiatric disorders, coping style and psychosocial outcome were administered at each assessment. Participants' mean QoL was in the average range pre-injury and at follow-up. A third demonstrated PC post-injury, which tended to remain stable. PC participants tended to rate their relatives as of greater importance than other participants, but did not rate their health as high. Group membership was not predicted by pre-injury demographic or injury factors, but it was significantly associated with psychosocial and functional outcome. Even after a significant brain injury, some individuals show sustained improved QoL. Factors such as lack of 'good old days' bias and increased value placed on family may have important clinical utility.

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

PubMed Central

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

2015-01-01

Objective To describe the development and psychometric properties of the SCI-QOL Psychological Trauma item bank and short form. Design 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. Setting 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. Participants A total of 716 individuals with SCI completed the trauma items Results 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 Conclusion 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. PMID:26010967

Changes in quality of life over 1 year in patients with head and neck cancer.

PubMed

Ronis, David L; Duffy, Sonia A; Fowler, Karen E; Khan, Mumtaz J; Terrell, Jeffrey E

2008-03-01

To characterize and compare quality of life (QOL) in patients with head and neck cancer shortly before initial treatment and 1 year later and to study the predictors of changes in QOL over 1 year. Prospective cohort study. Three otolaryngology clinics. Three hundred sixteen patients having newly diagnosed squamous cell head and neck cancer. Health-related QOL was assessed using the 36-item Short-Form Health Survey and a head and neck cancer-specific QOL scale. Over 1 year, QOL decreased for physical functioning measures and eating but improved for mental health QOL. Depression and smoking were major predictors of poor QOL at baseline. Major predictors of change in QOL from baseline to 1 year were treatment factors, especially feeding tube placement (9 scales), chemotherapy (3 scales), and radiation therapy (3 scales). Baseline smoking and depressive symptoms also remained significant predictors of several QOL scales at 1 year. Health-related physical QOL tended to decline over 1 year and mental health QOL improved. The major predictors of change in QOL were treatment factors, smoking, and depressive symptoms. Physicians should alert patients to the relative effects on QOL one may experience with different treatments.

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

PubMed

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

2013-01-01

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

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

PubMed

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.

A prospective study of personality as a predictor of quality of life after pelvic pouch surgery.

PubMed

Weinryb, R M; Gustavsson, J P; Liljeqvist, L; Poppen, B; Rössel, R J

1997-02-01

Surgeons often "know" preoperatively which patients will achieve good postoperative quality of life (QOL). This intuition is probably based on impressions of the patient's personality. The present aim was to examine whether preoperative personality traits predict postoperative QOL. In 53 patients undergoing pelvic pouch surgery for ulcerative colitis the relationship between preoperative personality traits, and surgical functional outcome and QOL was examined at a median of 17 months postoperatively. Personality assessment instruments (KAPP and KSP), and specific measures of alexithymia were used. Postoperatively, the Psychosocial Adjustment to Illness Scale (PAIS), and surgical functional outcome scales were used. Using multiple correlation/regression, analysis lack of alexithymia, poor frustration tolerance, anxiety proneness, and poor socialization (resentment over childhood and present life situation) were found to predict poor postoperative QOL. The findings suggest personality traits, in addition to surgical functional outcome, to be important for the patient's postoperative QOL.

Clinical Holistic Medicine: A Pilot Study on HIV and Quality of Life and a Suggested Cure for HIV and AIDS

PubMed Central

Ventegodt, Søren; Flensborg-Madsen, Trine; Andersen, Niels Jørgen; Morad, Mohammed; Merrick, Joav

2004-01-01

This study was undertaken to examine the association between the immunological impact of HIV (measured by CD4 count) and global self-assessed quality of life (QOL) (measured with QOL1) for people suffering from HIV, to see if the connection was large and statistically strong enough to support our hypothesis of a strong QOL-immunological connection through the nonspecific, nonreceptor-mediated immune system, and thus to give a rationale for a holistic cure for HIV. This cross-sectional population study in Uganda included 20 HIV infected persons with no symptoms of AIDS and a CD4 count above 200 mill./liter. The main outcome measures were CD4 count, global QOL measured with the validated questionnaire QOL1, translated to Luganda and translated back to English. We found a large, clinically significant correlation between the number of T-helper cells (CD4) and global self-assessed quality of life (QOL1) (r = 0.57, p = 0.021), when controlled for age, gender, and years of infection. Together with other studies and holistic medicine theory, the results have given rationale for a holistic cure for HIV. We suggest, based on our findings and theoretical considerations, that HIV patients who improve their global QOL, also will improve their CD4 counts. Using the technique of holistic medicine based on the life mission theory and the holistic process theory of healing, we hypothesize that the improvement of QOL can have sufficient biological effect on the CD4, which could avoid or postpone the development of AIDS. A holistic HIV/AIDS cure improving the QOL draws on hidden resources in the person and is thus affordable for everybody. Improving global QOL also means a higher consciousness and a more ethical attitude, making it more difficult for the HIV-infected person to pass on the infection. PMID:15167940

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

PubMed

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

2002-01-01

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

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

PubMed

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

2013-04-01

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

One year quality of life measured with SEC-QoL in levonorgestrel 52 mg IUS users.

PubMed

Cristobal, Ignacio; Lete, Luis Ignacio; Viuda, Esther de la; Perulero, Nuria; Arbat, Agnes; Canals, Ignasi

2016-04-01

The present study aims to prospectively evaluate quality of life (QoL) of women using 52-mg levonorgestrel intrauterine system (LNG-IUS) for contraception determined through the Sociedad Española de Contracepción (Spanish contraception Society) (SEC)-QoL, a questionnaire specifically designed to assess the impact of contraceptive methods on QoL of fertile women. We conducted a prospective observational multicenter study of 201 reproductive age women who initiated the LNG-IUS for contraception. Sociodemographic and clinical data were collected at baseline and 12 months afterwards. Participants filled in the SEC-QoL questionnaire at both visits. SEQ-QoL scores range from 0 (worst QoL) to 100 (best QoL). Participants claimed an increased QoL 12 months after insertion in all five dimensions of SEC-QoL due to its high contraceptive efficacy and its capability to reduce other menstrual symptoms (e.g., heavy menstrual bleeding or dysmenorrhoea), overall exerting a positive impact on user's satisfaction. SEC-QoL general overall score went from a mean (S.D.) score of 46.3 (17.3) at baseline to 72.2 (14.8) 12 months afterwards (p<.001). Overall, 94.6% of women claimed having found additional benefits other than contraception. No pregnancies were reported during the 12 months of study duration, and only 14 women discontinued use of LNG-IUS (only two of them due to an adverse event), representing a continuation rate of 93%. Women using LNG-IUS for contraception have an increased QoL after 12 months of use, demonstrated by the increased score in all dimensions of the SEC-QoL questionnaire. The present study prospectively evaluated QoL of women using LNG-IUS for contraception through the SEC-QoL questionnaire. Participants claimed increased QoL 12 months afterwards, implying that women using LNG-IUS for contraception in usual clinical practise also benefit from the reduction of period-related symptoms, overall leading to very low discontinuation rates. Copyright © 2016

Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation.

PubMed

Hung, Yun-Chi; Bauer, Judith; Horsley, Pamela; Waterhouse, Mary; Bashford, John; Isenring, Elisabeth

2013-06-01

This pilot exploratory study aimed to describe the changes in nutritional status, body composition, quality of life (QoL), and physical activity levels (PAL) of cancer patients undergoing high-dose conditioning and autologous peripheral blood stem cell transplantation (PBSCT) at pre-admission, hospital discharge, and at 100 days post-transplantation, and to examine if changes in these parameters are interrelated. Twenty-four patients (56.2 ± 12.9 years; 7 females, 17 males) were recruited from an Australian transplant center. Assessment was prospectively conducted at pre-admission, hospital discharge, and 100 days post-transplantation using the scored patient-generated subjective global assessment, air displacement plethysmography, EORTC QLQ-C30 (version 3), and the international physical activity questionnaire. At discharge, nutritional status deteriorated (patient-generated subjective global assessment (PG-SGA) median, +8.0; interquartile range, 6.0-13.0; p < 0.001) and the number of malnourished patients increased (n = 8/23; p = 0.023). Patients experienced significant loss of lean body mass (LBM; -2.2 kg, CI 95% -3.0, -1.4; p < 0.001), and decrease in QoL (-10.6, CI 95% -24.1, 2.9; p = 0.117); the proportion of patients with high PAL decreased (p = 0.012). By 100 days post-transplantation, all patients were well-nourished; however, LBM remained lower -1.0 kg (CI 95% -1.9, -0.1; p = 0.028). Change in nutritional status (PG-SGA score) was associated with weight (r = -0.46; p = 0.039) and fat mass (r = -0.57; p = 0.013). Change in QoL was associated with nutritional reservoir (i.e., fat; r = 0.54; p = 0.024); QoL was consistently higher for patients with high PAL. High-dose conditioning and autologous PBSCT is associated with deterioration in nutritional status, QoL and PAL, with LBM remaining below baseline levels at 100 days post-transplantation. A nutrition and exercise intervention program post

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

PubMed

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

2018-04-10

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

Accident rates for novice glider pilots vs. pilots with experience.

PubMed

Jarvis, Steve; Harris, Don

2007-12-01

It is a popular notion in gliding that newly soloed pilots have a low accident rate. The intention of this study was to review the support for such a hypothesis from literature and to explore it using UK accident totals and measures of flying exposure. Log sheets from UK gliding clubs were used to estimate flying exposure for inexperienced glider pilots. This was used along with accident data and annual flight statistics for the period 2004-2006 in order to estimate accident rates that could be compared between the pilot groups. The UK accident rate for glider pilots from 2004-2006 was 1 accident in every 3534 launches and 1590 flying hours. The lowest estimated rate for pilots with up to 1 h of experience was 1 accident every 976 launches and 149 h flown. For pilots with up to 10 h of experience the figures were 1 accident in 1274 launches and 503 h. From 2004-2006 UK glider pilots with 10 h or less experience in command had twice the number of accidents per launch and three times as many accidents per hour flown than average for UK glider pilots. Pilots with only 1 h of experience or less were involved in at least 10 times the number of accidents per hour flown than the UK average and had more than 3.5 times the number of accidents per launch.

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

PubMed

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

2017-01-01

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

Quality of life is modestly improved in older patients with mild primary hyperparathyroidism postoperatively: results of a prospective multicenter study.

PubMed

Blanchard, Claire; Mathonnet, Muriel; Sebag, Frédéric; Caillard, Cécile; Kubis, Caroline; Drui, Delphine; van Nuvel, Elise; Ansquer, Catherine; Henry, Jean-François; Masson, Damien; Kraeber-Bodéré, Françoise; Hardouin, Jean-Benoît; Zarnegar, Rasa; Hamy, Antoine; Mirallié, Eric

2014-10-01

The objectives of this study were to evaluate, in mild primary hyperparathyroidism (pHPT) patients, the quality of life (QoL) using the SF-36 questionnaire before and after parathyroidectomy and to detect preoperatively patients who benefit the most from surgery. Most pHPT patients present a mild pHPT defined by calcemia ≤11.4 mg/dL. For these patients, there is debate about whether they should be managed with surveillance, medical therapy, or surgery. A prospective multicenter study investigated QoL (SF-36) in patients with mild pHPT before and after parathyroidectomy in four university hospitals. Laboratory results and SF-36 scores were obtained preoperatively and postoperatively (3, 6, and 12 months). One hundred sixteen patients were included. After surgery, the biochemical cure rate was 98%. Preoperatively, the mental component summary and the physical component summary (PCS) were 38.69 of 100 and 39.53 of 100, respectively. At 1 year, the MCS and the PCS were 41.29 of 100 and 42.03 of 100. The subgroup analysis showed a more significant improvement in patients < 70 years and with calcemia ≥10.4 mg/dL. Postoperative PCS was correlated with age and preoperative PCS: variation = 32.11 - 0.21 × age - 0.4 × preoperative PCS. Men did not improve their MCS postoperatively. Only women with a preoperative MCS <43.6 of 100 showed postoperative improvement. This study showed, in patients with mild pHPT, an improvement of QoL 1 year after parathyroidectomy. Patients <70 years and with calcemia ≥10.4 mg/dL had a more significant improvement.

76 FR 19267 - Pilot, Flight Instructor, and Pilot School Certification; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

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... Aviation and Commercial Division, Flight Standards Service, Federal Aviation Administration, 800...

Debilitating beliefs and emotional distress in patients given immunotherapy for insect sting allergy: a prospective study.

PubMed

Confino-Cohen, Ronit; Melamed, Samuel; Goldberg, Arnon

2009-01-01

Patients who receive venom immunotherapy (VIT) for systemic reactions (SRs) to insect stings are advised that once they reach the maintenance dose they are almost 100% protected against future SRs. However, initial evidence indicates that some patients continue to perceive themselves as highly debilitated by the allergy and are preoccupied with the allergic event. These factors have significant impact on their emotional well-being and allergy-related quality of life (ARQOL). We aimed to explore prospectively whether patients would experience these adverse psychological outcomes after receiving VIT coupled with professional explanation and reassurance of protection. Thirty-four patients who received VIT for systemic insect allergy and were under close medical surveillance were included. Before and 1 year after initiation of treatment, patients completed a questionnaire that measured debilitating beliefs, preoccupation with the SR event, emotional distress ARQOL, and QOL in general. Physician-graded severity of the reaction was recorded as well. VIT had a beneficial effect on all allergy-related variables. Self-imposed debilitating beliefs, preoccupation with the anaphylactic event, and ARQOL significantly but modestly improved over time. No association was found between ARQOL and QOL in general. The later variable as well as emotional distress remained unchanged after the VIT. This study shows that patients with sting allergy guided by trained personnel and treated with VIT show a reduction in dysfunctional beliefs and an improvement in ARQOL. Disputing medically unfounded beliefs that persist in some patients might improve their ARQOL.

Ventral hernia repair with poly-4-hydroxybutyrate mesh.

PubMed

Plymale, Margaret A; Davenport, Daniel L; Dugan, Adam; Zachem, Amanda; Roth, John Scott

2018-04-01

Biomaterial research has made available a biologically derived fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for use in ventral and incisional hernia repair (VIHR). This study evaluates outcomes of patients undergoing VIHR with P4HB mesh. An IRB-approved prospective pilot study was conducted to assess clinical and quality of life (QOL) outcomes for patients undergoing VIHR with P4HB mesh. Perioperative characteristics were defined. Clinical outcomes, employment status, QOL using 12-item short form survey (SF-12), and pain assessments were followed for 24 months postoperatively. 31 patients underwent VIHR with bioresorbable mesh via a Rives-Stoppa approach with retrorectus mesh placement. The median patient age was 52 years, median body mass index was 33 kg/m 2 , and just over half of the patients were female. Surgical site occurrences occurred in 19% of patients, most of which were seroma. Hernia recurrence rate was 0% (median follow-up = 414 days). Patients had significantly improved QOL at 24 months compared to baseline for SF-12 physical component summary and role emotional (p < 0.05). Ventral hernia repair with P4HB bioresorbable mesh results in favorable outcomes. Early hernia recurrence was not identified among the patient cohort. Quality of life improvements were noted at 24 months versus baseline for this cohort of patients with bioresorbable mesh. Use of P4HB mesh for ventral hernia repair was found to be feasible in this patient population. (ClinicalTrials.gov Identifier: NCT01863030).

Cancer wasting and quality of life react to early individualized nutritional counselling!

PubMed

Ravasco, Paula; Monteiro Grillo, Isabel; Camilo, Maria

2007-02-01

To devise a meaningful nutritional therapy in cancer, a greater understanding of nutritional dimensions as well as patients' expectations and disease impact is essential. We have shown that nutritional deterioration in patients with gastrointestinal and head and neck cancer was multifactorial and mainly determined by the tumour burden and location. In a larger cohort, stage and location were yet again the major determinants of patients' quality of life (QoL), despite the fact that nutritional deterioration combined with intake deficits were functionally more relevant than cancer stage. Based on this framework, the potential role of integrated oral nutritional support on outcomes was investigated. In a pilot study using individualized nutritional counselling on a heterogeneous patient population, the achieved improvement of nutritional intake was proportional to a better QoL. The role of early nutritional support was further analysed in a prospective randomized controlled trial in head and neck cancer patients stratified by stage undergoing radiotherapy. Pre-defined outcomes were: nutritional status and intake, morbidity and QoL, at the end and 3 months after radiotherapy. Nutritional interventions, only given during radiotherapy, consisted of three randomization arms: (1) individualized nutritional counselling vs. (2) ad libitum diet+high protein supplements vs. (3) ad libitum diet. Nutritional interventions 1 and 2 positively influenced outcomes during radiotherapy; however, 3 months after its completion individualized nutritional counselling was the single method capable of sustaining a significant impact on patients' outcomes. The early provision of the appropriate mixture of foods and textures using regular foods may modulate outcomes in cancer patients.

Roll paper pilot. [mathematical model for predicting pilot rating of aircraft in roll task

NASA Technical Reports Server (NTRS)

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.

Recreational Pilot and Private Pilot Knowledge Test Guide

DOT National Transportation Integrated Search

1995-01-01

The Flight Standards Service of the Federal Aviation Administration (FAA) has developed this guide to help : applicants meet the knowledge requirements for recreational pilot and private pilot certification. : This guide contains information about el...

Prospective study comparing laparoscopic and open adenomectomy: Surgical and functional results.

PubMed

Garcia-Segui, A; Angulo, J C

Open adenomectomy (OA) is the surgery of choice for large volume benign prostatic hyperplasia, and laparoscopic adenomectomy (LA) represents a minimally invasive alternative. We present a long-term, prospective study comparing both techniques. The study consecutively included 199 patients with benign prostatic hyperplasia and prostate volumes>80g who were followed for more than 12 months. The patients underwent OA (n=97) or LA (n=102). We recorded and compared demographic and perioperative data, functional results and complications using a descriptive statistical analysis. The mean age was 69.2±7.7 years (range 42-87), and the mean prostate volume (measured by TRUS) was 112.1±32.7mL (range 78-260). There were no baseline differences among the groups in terms of age, ASA scale, prostate volume, PSA levels, Qmax, IPSS, QoL or treatments prior to the surgery. The surgical time (P<.0001) and catheter time (P<.0002) were longer in the LA group. Operative bleeding (P<.0001), transfusion rate (P=.0015) and mean stay (P<.0001) were significantly lower in the LA group. The LA group had a lower rate of complications (P=.04), but there were no significant differences between the groups in terms of major complications (Clavien score≥3) (P=.13) or in the rate of late complications (at one year) (P=.66). There were also no differences between the groups in the functional postoperative results: IPSS (P=.17), QoL (P=.3) and Qmax (P=.17). LA is a reasonable, safe and effective alternative that results in less bleeding, fewer transfusions, shorter hospital stays and lower morbidity than OA. LA has similar functional results to OA, at the expense of longer surgical times and longer catheter times. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

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

PubMed Central

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

2015-01-01

Objective To describe the development and psychometric properties of the Spinal Cord Injury - Quality of Life (SCI-QOL) Resilience item bank and short form. Design 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). Setting 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. Participants A total of 717 individuals with SCI completed the Resilience items. Results 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. Conclusion 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. PMID:26010971

Impaired quality of life in patients with treated acromegaly despite long-term biochemically stable disease: Results from a 5-years prospective study.

PubMed

Kyriakakis, Nikolaos; Lynch, Julie; Gilbey, Stephen G; Webb, Susan M; Murray, Robert D

2017-06-01

Patients with acromegaly demonstrate impaired quality of life (QoL), but data on long-term QoL changes in treated acromegaly are limited. This study evaluates and identifies factors that influence QoL in patients with long-term biochemical remission. The study consists of a cross-sectional arm comparing QoL between patients with treated and controlled acromegaly and healthy controls; and a longitudinal arm assessing QoL changes in patients with biochemically stable disease during 5.7±0.6 years of follow-up. A total of 58 patients and 116 matched controls were recruited for the cross-sectional arm; 28 patients completed the longitudinal arm. Three generic questionnaires (Psychological General Well-Being Schedule [PGWBS], 36-item Short-Form [SF-36], EuroQoL [EQ-5D]) and the disease-specific acromegaly QoL questionnaire (AcroQoL) were applied. Quality of life assessment was performed 11.6±8.2 years following diagnosis and treatment of acromegaly. Patients with treated acromegaly had lower QoL scores compared with controls in all questionnaires with the exception of the PGWBS "Anxiety" subscale. The AcroQoL "Appearance" subscale and the "Physical Function" subscales of the remaining questionnaires were the most underscored domains. No difference in the total and subscale scores of all questionnaires was observed between baseline and follow-up, with the exception of the SF-36 "Physical Function," where a decline was found (58.5±24.7% vs 43.1±31.1%; P=.002). However, after adjusting for covariates, no significant change in any of the QoL scores was seen. Duration of IGF-1/GH control was positively correlated with QoL scores in most questionnaires at baseline, whereas use of GH lowering therapy at the time of QoL assessment was a negative predictive factor of QoL. Patients with biochemically controlled acromegaly demonstrate impaired QoL, which persists despite long-term disease control. This primarily consists of impaired physical function and secondly of impaired

The Health Initiative Program for Kids (HIP Kids): effects of a 1-year multidisciplinary lifestyle intervention on adiposity and quality of life in obese children and adolescents--a longitudinal pilot intervention study.

PubMed

Bock, Dirk E; Robinson, Tracy; Seabrook, Jamie A; Rombeek, Meghan; Norozi, Kambiz; Filler, Guido; Rauch, Ralf; Clarson, Cheril L

2014-12-05

Though recent data suggest that multidisciplinary outpatient interventions can have a positive effect on childhood obesity, it is still unclear which program components are most beneficial and how they affect quality of life (QoL). The aim of this study was to determine if a 1-year multidisciplinary, family-centered outpatient intervention based on social cognitive theory would be effective in (i) preventing further increases in BMI and BMI z-score, and (ii) improving QoL in obese children and adolescents. Obese children and adolescents 8-17 years of age and their families participated in this 1-year longitudinal pilot intervention study. The intervention consisted of fifteen 90-minute educational sessions led by a dietitian, exercise specialist, and social worker. Anthropometric measures, body composition, and QoL (Pediatric Quality of Life Inventory 4.0), were assessed at baseline, 3 months, and 12 months. Laboratory values were measured at baseline and 12 months. The primary outcome measures were change in BMI and BMI z-score, secondary outcome measures included change in QoL and body composition. A paired sample t-test was used to assess within-group differences and 95% confidence intervals were reported for the mean differences. 42 obese children and adolescents (21 girls) completed the 1-year intervention (mean age 12.8 ± 3.14 years). Mean baseline BMI was 31.96 ± 5.94 kg/m(2) and BMI z-score was +2.19 ± 0.34. Baseline QoL (self-assessments and parental assessments) was impaired: mean baseline scores were 74.5 ± 16.5 and 63.7 ± 19.4 for physical functioning and 69.0 ± 14.9 and 64.0 ± 18.3 for emotional functioning, respectively. At 12 months, BMI z-score had decreased (-0.07 ± 0.11, 95% CI: -0.11 to -0.04). BMI (0.80 ± 1.57 kg/m(2), 95% CI 0.31 to 1.29) and fat-free mass (4.02 ± 6.27 kg, 95% CI 1.90 to 6.14) increased, but % body fat and waist circumference did not. Both the parent-reported physical

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

PubMed

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

2018-03-01

Intraoperative cochlear implant device testing provides valuable information regarding device integrity, electrode position, and may assist with determining initial stimulation settings. Manual intraoperative device testing during cochlear implantation requires the time and expertise of a trained audiologist. The purpose of the current study is to investigate the feasibility of using automated remote intraoperative cochlear implant reverse telemetry testing as an alternative to standard testing. Prospective pilot study evaluating intraoperative remote automated impedance and Automatic Neural Response Telemetry (AutoNRT) testing in 34 consecutive cochlear implant surgeries using the Intraoperative Remote Assistant (Cochlear Nucleus CR120). In all cases, remote intraoperative device testing was performed by trained operating room staff. A comparison was made to the "gold standard" of manual testing by an experienced cochlear implant audiologist. Electrode position and absence of tip fold-over was confirmed using plain film x-ray. Automated remote reverse telemetry testing was successfully completed in all patients. Intraoperative x-ray demonstrated normal electrode position without tip fold-over. Average impedance values were significantly higher using standard testing versus CR120 remote testing (standard mean 10.7 kΩ, SD 1.2 vs. CR120 mean 7.5 kΩ, SD 0.7, p < 0.001). There was strong agreement between standard manual testing and remote automated testing with regard to the presence of open or short circuits along the array. There were, however, two cases in which standard testing identified an open circuit, when CR120 testing showed the circuit to be closed. Neural responses were successfully obtained in all patients using both systems. There was no difference in basal electrode responses (standard mean 195.0 μV, SD 14.10 vs. CR120 194.5 μV, SD 14.23; p = 0.7814); however, more favorable (lower μV amplitude) results were obtained with the remote

Early intervention following trauma may mitigate genetic risk for PTSD in civilians: a pilot prospective emergency department study.

PubMed

Rothbaum, Barbara O; Kearns, Megan C; Reiser, Emily; Davis, Jennifer S; Kerley, Kimberly A; Rothbaum, Alex O; Mercer, Kristina B; Price, Matthew; Houry, Debra; Ressler, Kerry J

2014-12-01

for age, sex, race, education, income, and childhood trauma. Using logistic regression, the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 (P < .05). This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma. A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk. The role of genetic predictors of risk and resilience should be further evaluated in larger, prospective intervention and prevention trials. ClinicalTrials.gov identifier: NCT00895518. © Copyright 2014 Physicians Postgraduate Press, Inc.

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

PubMed Central

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

2010-01-01

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

Quality of life and physicians' perception in myelodysplastic syndromes

PubMed Central

Oliva, Esther Natalie; Finelli, Carlo; Santini, Valeria; Poloni, Antonella; Liso, Vincenzo; Cilloni, Daniela; Impera, Stefana; Terenzi, Adelmo; Levis, Alessandro; Cortelezzi, Agostino; Ghio, Riccardo; Musto, Pellegrino; Semenzato, Gianpietro; Clissa, Cristina; Lunghi, Teresa; Trappolini, Silvia; Gaidano, Valentina; Salvi, Flavia; Reda, Gianluigi; Villani, Oreste; Binotto, Gianni; Cufari, Patrizia; Cavalieri, Elena; Spiriti, Maria Antonietta Aloe

2012-01-01

To detect factors associated with quality of life (QOL) of patients with myelodysplastic syndrome (MDS) and to compare the MDS patients’ self-assessed QOL with that perceived by their physicians. In an observational, non-interventional, prospective, multicentre study, QOL was evaluated in 148 patients with newly diagnosed low- and intermediate-risk IPSS MDS. QOL measures (QOL-E v.2, LASA and EQ-5D) and patient-related candidate determinants of QOL were assessed for up to 18 months. Patients' QOL scores were compared with those obtained by appointed hematologists’ assessment and with ECOG performance status (PS). Fatigue was not prevalent at diagnosis, though physical QOL and energy levels were low. Transfusion-dependent patients had worse QOL scores. In multivariate analysis, Hb levels and comorbidities were a major determinant of QOL. Physicians’ perception of patients’ well-being correlated with patients’ QOL. Physicians underestimated the impact of disturbances on patients’ QOL, mainly in the MDS-specific components. ECOG PS did not discriminate patients according to QOL status. In conclusion, the association of anemia with QOL is confirmed, while co-morbidities emerge as an independent predictor of QOL in MDS. Fatigue is not a major concern. ECOG PS is not a valuable surrogate of patient’s QOL, thus highlighting that physician’s judgment of patient’s well-being must not substitute patient-reported outcomes. Appropriate questionnaires should be used to assess MDS patients’ QOL in order to improve communication and therapeutic choice. PMID:22762033

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.

PubMed

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.

Pilot-optimal augmentation synthesis

NASA Technical Reports Server (NTRS)

Schmidt, D. K.

1978-01-01

An augmentation synthesis method usable in the absence of quantitative handling qualities specifications, and yet explicitly including design objectives based on pilot-rating concepts, is presented. The algorithm involves the unique approach of simultaneously solving for the stability augmentation system (SAS) gains, pilot equalization and pilot rating prediction via optimal control techniques. Simultaneous solution is required in this case since the pilot model (gains, etc.) depends upon the augmented plant dynamics, and the augmentation is obviously not a priori known. Another special feature is the use of the pilot's objective function (from which the pilot model evolves) to design the SAS.

Predicting Pilot Error in Nextgen: Pilot Performance Modeling and Validation Efforts

NASA Technical Reports Server (NTRS)

Wickens, Christopher; Sebok, Angelia; Gore, Brian; Hooey, Becky

2012-01-01

We review 25 articles presenting 5 general classes of computational models to predict pilot error. This more targeted review is placed within the context of the broader review of computational models of pilot cognition and performance, including such aspects as models of situation awareness or pilot-automation interaction. Particular emphasis is placed on the degree of validation of such models against empirical pilot data, and the relevance of the modeling and validation efforts to Next Gen technology and procedures.

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

PubMed Central

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

2013-01-01

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

Prospective evaluation of the prevalence and severity of fatigue in patients with prostate cancer undergoing radical external beam radiotherapy and neoadjuvant hormone therapy.

PubMed

Truong, Pauline T; Berthelet, Eric; Lee, Junella C; Petersen, Ross; Lim, Jan T W; Gaul, Catherine A; Pai, Howard; Blood, Paul; Ludgate, Charles M

2006-06-01

To prospectively evaluate the prevalence and severity of fatigue and its impact on quality of life (QOL) during and after radical external beam radiotherapy (RT) for prostate cancer. Twenty-eight men with prostate cancer undergoing RT over 6-8 consecutive weeks were prospectively accrued. The Brief Fatigue Inventory (BFI), a validated fatigue assessment tool, was administered at five time points: baseline (week 1), middle of RT (week 3-4), end of RT (last week of RT), and follow-up (median 6.5 weeks after RT). The BFI contained nine questions, each using 0-10 ratings to quantify fatigue severity and interference with six QOL domains. The prevalence of moderate-severe fatigue was plotted as a function of time. Mean sum and subscale scores at each time point were compared to baseline scores using Wilcoxon tests. Linear regression analyses were performed to assess associations between fatigue scores and age, tumor and treatment characteristics. The median age was 69 years (range 57-84), Gleason score 7 (range 6-10), and presenting PSA 9.0 ng/mL (range 2.5 ng/mL-103.0 ng/mL). Patients were treated once daily to a median dose of 74 Gy (range 60 Gy-78 Gy) over a median of 37 fractions (range 30-39). Hormone therapy was used in all patients (median duration 12.2 months). The prevalence of moderate-severe present fatigue increased from 7% at baseline to 8% at mid-RT and 32% at RT completion. Compared to baseline (mean score 11.5), fatigue increased significantly mid-RT (mean score 14.6, p = 0.03) and peaked at the end of RT (mean score 23.5, p = 0.001). Fatigue significantly interfered with walking ability, normal work, daily chores, and enjoyment of life only at the end of RT. After RT completion, fatigue improved but remained higher compared to baseline at 6.5 weeks of follow-up (mean score 15.0, p = 0.02). On linear regression analysis, age, Gleason score, PSA, T-stage, hormone therapy duration, RT dose and fractions were not significantly associated with mean fatigue

Quality of life in Chinese patients with breast cancer.

PubMed

Sun, Angela; Wong-Kim, Evaon; Stearman, Sarah; Chow, Edward A

2005-12-15

Chinese are the largest Asian group in the U.S., constituting 23.8% of the nation's total Asian-American population. Cancer is the leading cause of death for female Asian Americans, and breast cancer is the most frequently diagnosed cancer among females for all racial/ethic groups in San Francisco, which ranks 4th in the number of Asian Americans and where 152,620 Chinese account for 19.6% of the city's total population. Previous observations among Chinese immigrant women suggested that a diagnosis of breast cancer may be more detrimental to their well being compared with Chinese women who are born and raised in the U.S. This difference may be due to the lower socioeconomic status, limited English proficiency, poor understanding of the Western medical system among immigrants or other educational or financial considerations. In this qualitative pilot study, the authors sought to increase understanding of the relation between cultural beliefs and quality of life (QOL) among immigrant Chinese women with breast cancer in San Francisco. Specific objectives were 1) to identify these patients' beliefs regarding cancer, life expectancy, and discussion of advance directives; 2) to explore how these beliefs relate to patient QOL; and 3) to generate hypotheses for further study. The overall objective of the pilot study was to investigate questions central to the QOL issue, including what defines QOL for immigrant women and how QOL for them is similar to or different from that for American-born Chinese women. Cancer 2005. (c) 2005 American Cancer Society.

Evaluating a new methodology for providing individualized feedback in healthcare on quality of life and its importance, using the WHOQOL-BREF in a community population.

PubMed

Llewellyn, Alison M; Skevington, Suzanne M

2016-03-01

We conducted an evaluation to find out how a novel quality of life (QoL) intervention containing guided individualized feedback was appraised. The importance of QoL was matched with QoL assessment for each subjective dimension, using graphical feedback. We examined whether this information was acceptable, feasible and valued beyond the clinical context, among the community. Using a mixed-methods cross-sectional design, the intervention was piloted with 129 participants from communities and registered in primary care. WHOQOL-BREF and WHOQOL Importance scores were graphically matched by dimension. Results were inspected and interpreted with directed guidance to identify good and poor QoL. We report the post-intervention evaluation of feedback, including qualitative themes. Follow-up interviews among those expecting feedback to be helpful explored potential self-management and healthcare uses. After feedback, 65 % reported changes in thoughts and perceptions of QoL, often describing insights as self-affirming. Goals or expectations changed for 34 %, and motivation to change was reported. Over 50 % evaluated the feedback as helpful in the short term or for the future. Follow-up interviews endorsed the value of the feedback and its usefulness in sharing with a healthcare professional (92 %), suggesting it would facilitate professionals' understandings of patients and enable health advice to be targeted. The benefits of using this novel feedback can be extended to the general population, as directed guidance aids interpretation, thereby saving health service costs. This complex pilot intervention needs testing in a blinded fully randomized controlled trial. Beyond independent self-management, graphs could be used during clinical decision-making.

Pilot Certification, Age of Pilot, and Drug Use in Fatal Civil Aviation Accidents.

PubMed

Akparibo, Issaka Y; Stolfi, Adrienne

2017-10-01

This study examined the association between mean age of pilot, pilot license, pilot medical certificate and drug use trends in pilots fatally injured in aircraft accidents. The prevalence of prescription drugs, OTC drugs, controlled drugs and drugs that may be potentially impairing was also examined. This study was a descriptive observational study in which the NTSB Aviation Accident Database was searched from the period beginning January 1, 2012 to December 31, 2014. During the study period a total of 706 accidents involving 711 fatalities were investigated by the NTSB. This study included 633 of these accidents, involving 646 fatalities. Of these pilots, 42.1% had drugs in their biological samples. The prevalence of prescription drugs, controlled drugs, OTC drugs, opioids, and potentially impairing drugs in the fatally injured pilot population over the study period was 28.9%, 15.0%, 20.1%, 5.1%, and 25.5%, respectively. Pilots with any drugs in their samples were significantly older than those without drugs. Medical certificate held was associated with drug use; pilots who held third class certificates had the highest prevalence at 54.1%. Pilot license was not associated with drug use. In 3.8% of the accidents, drugs were a contributing factor in the cause. Despite current FAA medical regulations, potentially impairing drugs are frequently found in biological samples of fatally injured pilots in the U.S. More education of airmen by aviation medical examiners is needed on the safety of drug use.Akparibo IY, Stolfi A. Pilot certification, age of pilot, and drug use in fatal civil aviation accidents. Aerosp Med Hum Perform. 2017; 88(10):931-936.

Activities of daily living and quality of life during treatment with neoadjuvant chemoradiotherapy and after surgery in patients with esophageal cancer.

PubMed

Haj Mohammad, Nadia; De Rooij, Sophia; Hulshof, Maarten; Ruurda, Jelle; Wijnhoven, Bas; Erdkamp, Frans; Sosef, Meindert; Gisbertz, Suzanne; van Berge Henegouwen, Mark; Sprangers, Mirjam; van Laarhoven, Hanneke

2016-11-01

Neoadjuvant chemoradiation (nCRT) followed by esophagectomy is a treatment with curative intent for resectable esophageal cancer. The aim of this study was to measure activities of daily living (ADL) and quality of life (QoL), and to examine correlates of changes in ADL and QoL. A prospective study was performed with three time points (baseline, 1 week after the end of nCRT, 3-months post-surgery) together with a cross-sectional post-treatment study. ADL was measured with the Amsterdam Linear Disability Score (ALDS), and QoL with the EORTC QLQ-C30 and the OES-18. Regression analysis was performed to identify factors associated with changes in ADL and QoL. Seventy-six patients were included in the prospective study, 79 in the cross-sectional study. After nCRT, ALDS decreased from 90 to 88 (P < 0.01) and remained stable after surgery. Global QoL decreased from 75 to 61 (P < 0.01); no significant changes were observed after surgery. Only timing of the measurement of ALDS was negatively associated with non-maximum ALDS (n = 155, based on both studies) and QoL (n = 76) (P < 0.01). Patients who undergo nCRT plus surgery should be prepared to experience a short-term decline in ADL and QoL. The findings of this study can support patients and healthcare workers to guide expectations. J. Surg. Oncol. 2016;114:684-690. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

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

PubMed

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

2017-12-21

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

Characterization of Pilot Technique

NASA Technical Reports Server (NTRS)

Bachelder, Edward; Aponso, Bimal; Godfroy, Martine

2017-01-01

Skilled pilots often use pulse control when controlling higher order (i.e. acceleration-command) vehicle dynamics. Pulsing does not produce a stick response that resembles what the human Crossover Model predicts. The Crossover Model (CM) assumes the pilot provides compensation necessary (lead or lag) such that the suite of display-human-vehicle approximates an integrator in the region of crossover frequency. However, it is shown that the CM does appear to drive the pilots pulsing behavior in a very predictable manner. Roughly speaking, the pilot generates pulses such that the area under the pulse (pulse amplitude multiplied by pulse width) is approximately equal to area under the hypothetical CM output. This can allow a pilot to employ constant amplitude pulsing so that only the pulse duration (width) is modulated a drastic simplification over the demands of continuous tracking. A pilot pulse model is developed, with which the parameters of the pilots internally-generated CM can be computed in real time for pilot monitoring and display compensation. It is also demonstrated that pursuit tracking may be activated when pulse control is employed.

Depressive and Anxiety Symptoms Predict Sustained Quality of Life Deficits in HIV-Positive Ugandan Adults Despite Antiretroviral Therapy: A Prospective Cohort Study.

PubMed

Ezeamama, Amara E; Woolfork, Makhabele N; Guwatudde, David; Bagenda, Danstan; Manabe, Yukari C; Fawzi, Wafaie W; Smith Fawzi, Mary C

2016-03-01

The impact of psychosocial status at onset of antiretroviral therapy on changes in quality of life (QOL) and subjectively rated health (SRH) among adults on highly active antiretroviral therapy (HAART) in resource-limited settings is poorly understood. Therefore, we evaluate the association between stigma, anxiety, depression, and social support and change in QOL and SRH in HIV-infected Ugandan adults during an 18-month period. Psychosocial indicators were assessed at enrollment using structured questionnaires. QOL and SRH measures were assessed at months 0, 6, 12, and 18 using the Medical Outcomes Survey-HIV. Linear mixed models determined risk estimated differences in QOL and SRH in relation to quartiles of each psychosocial status indicator. Repeated measures generalized estimating equations modeling was implemented to assess differences in likelihood of improved versus nonimproved SRH during follow-up.QOL scores and SRH improved significantly for all participants over 18 months (P < 0.0001). The gain in QOL increased dose-dependently as baseline depressive symptoms (time*depression P < 0.001) and anxiety levels (time*anxiety P < 0.001) declined. Lower social support was associated with worse QOL at baseline (P = 0.0005) but QOL improvement during follow-up was not dependent on baseline level of social support (time*social support P = 0.8943) or number of stigmatizing experiences (time*stigma P = 0.8662). Psychosocial determinants did not predict changes in SRH in this study. High levels of depression and anxiety symptoms at HAART initiation predicts lower gains in QOL for HIV-positive patients for as long as 18 months. Long-term QOL improvements in HIV-infected adults may be enhanced by implementation of psychosocial interventions to reduce depression and anxiety in HIV-infected adults.

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

PubMed

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.

Modeling Pilot Pulse Control

NASA Technical Reports Server (NTRS)

Bachelder, Edward; Hess, Ronald; Godfroy-Cooper, Martine; Aponso, Bimal

2017-01-01

In this study, behavioral models are developed that closely reproduced pulsive control response of two pilots from the experimental pool using markedly different control techniques (styles) 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 issue and cease pulse commands. This suggests that the pilots utilized kinesthetic feedback in order to perceive and integrate stick position, supporting the hypothesis that pilots can access and employ the proprioceptive inner feedback loop proposed by Hess' pilot Structural Model. The Pulse Models used in conjunction with the pilot Structural Model closely recreated the pilot data both in the frequency and time domains during closed-loop simulation. This indicates that for the range of tasks and control styles encountered, the models captured the fundamental mechanisms governing pulsive and control processes. The pilot Pulse Models give important insight for the amount of remnant (stick output uncorrelated with the forcing function) that arises from nonlinear pilot technique, and for the remaining remnant arising from different sources unrelated to tracking control (i.e. neuromuscular tremor, reallocation of cognitive resources, etc.).

Propolis nasal spray effectively improves recovery from infectious acute rhinitis and common cold symptoms in children: a pilot study.

PubMed

Marti, J; López, F; Gascón, I; Julve, J

2017-01-01

Currently, treatment for acute rhinitis (AR) is symptomatic but no clear agreement exists to control its development. Propolis extract may appear as a promising natural treatment for AR, but its beneficial effects have not yet been fully tested. Forty children suffering from AR and common cold symptoms aged between 2-12 years were enrolled in a prospective epidemiological multicentre study. A 7-day treatment with propolis nasal spray (3 times/day) was applied and a comparison of symptomatology, subjective global improvement and quality of life (QoL) between baseline (day 1) and final (day 7) visits were performed. The main goal was to evaluate the changes in symptom intensity using the Jackson’s scoring test. After 7 days of treatment there was a significant decrease of symptoms both in the total score (p less than 0.0001) and in regard to each AR symptom (p less than 0.01). On the whole, the sample reported no symptoms by day 7, and the resolution of symptoms occurred approximately at day 4. Furthermore, there was no need for supplementary treatment. Both the subjective global improvement impression and the QoL of patients appeared to significantly improve after treatment. No adverse events (AEs) were found globally. It can be concluded that propolis nasal spray effectively improves recovery from infectious AR and common cold symptoms in children and is an optimal alternative in the treatment of this disease without need for any adjuvant treatment.

Testicular growth and spermatogenesis: new goals for pubertal hormone replacement in boys with hypogonadotropic hypogonadism? -a multicentre prospective study of hCG/rFSH treatment outcomes during adolescence.

PubMed

Rohayem, Julia; Hauffa, Berthold P; Zacharin, Margaret; Kliesch, Sabine; Zitzmann, Michael

2017-01-01

Testosterone treatment for pubertal induction in boys with hypogonadotropic hypogonadism (HH) provides virilization, but does not induce testicular growth or fertility. Larger studies evaluating the outcomes of gonadotropin replacement during adolescence have not been reported to date; whether previous testosterone substitution affects testicular responses is unresolved. We aimed to assess the effects of human chorionic gonadotropin (hCG) and recombinant FSH (rFSH) in boys and adolescents with HH with respect to a) testicular growth, b) spermatogenesis, c) quality of life (QoL) and to identify factors influencing therapeutic success. A prospective case study was conducted in 26 paediatric endocrine centres PATIENTS/INTERVENTIONS: HCG and rFSH were administered until cessation of testicular growth and plateauing of spermatogenesis to (1) prepubertal HH boys with absent or early arrested puberty (group A) and to (2) HH adolescents who had previously received full testosterone replacement (group B). Bi-testicular volumes (BTVs), sperm concentrations and QoL. Sixty (34 A/26 B) HH patients aged 14-22 years were enrolled. BTVs rose from 5 ± 5 to 34 ± 3 ml in group A vs 5 ± 3 to 32 ± 3 ml in group B, with normal final BTVs (≥24 ml) attained in 74%/70% after 25/23 months in A/B, respectively. Sperm in the ejaculate were found in 21/23(91%)/18/19(95%), with plateauing concentrations after 31/30 months of hCG and 25/25 months of combined treatment in A/B. Sperm concentrations were normal (≥15 mill/ml) in 61%/32%, with mean concentrations of 40 ± 73 vs 19 ± 38 mill/ml in A/B (n.s.). Outcomes were better in patients without bilateral cryptorchidism, with non-congenital HH causes, higher baseline BTVs, and higher baseline inhibin B and AMH levels. QoL increased in both groups. HCG/rFSH replacement during adolescence successfully induces testicular growth and spermatogenesis, irrespective of previous testosterone replacement, and enhances QoL. © 2016 John Wiley & Sons

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

PubMed

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

2014-01-01

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

Pilot performance

NASA Technical Reports Server (NTRS)

Nicholls, Jennifer

1988-01-01

For many years, the emphasis has been placed on the performance of the aircraft, rather than on those who fly the aircraft. This is largely due to the relative safety of flying. Just in the last few years there have been several major accidents that have shown that flying is not quite as safe as it was thought to be. Sixty-five percent of these accidents are a result of pilot performance decrements, and so it is obvious that there is a need to reduce that figure. A study has been mandated to evaluate the performance of pilots. This includes workload, circadium rhythms, jet lag, and any other factors which might affect a pilot's performance in the cockpit. The purpose of this study is to find out when and why the decrement in a pilot's performance occur and how to remedy the situation.

Photoselective vaporization of the prostate for the treatment of benign prostatic hyperplasia: 12-month results from the first United States multicenter prospective trial.

PubMed

Te, Alexis E; Malloy, Terrence R; Stein, Barry S; Ulchaker, James C; Nseyo, Unyime O; Hai, Mahmood A; Malek, Reza S

2004-10-01

We report the 1-year efficacy and safety of photoselective vaporization of the prostate (PVP) for symptomatic and obstructive benign prostatic hyperplasia (BPH). A prospective clinical trial was performed in 139 men clinically diagnosed with symptomatic bladder outlet obstruction secondary to BPH who were enrolled and treated with a high power, 80 W, quasicontinuous wave potassium-titanyl-phosphate laser at 6 American medical centers across the country. Efficacy parameters were mean and percent changes from baseline in the American Urological Association Symptom Index (AUA-SI) score, quality of life score (QOL), peak urinary flow rate (Qmax), post-void residual urine volume (PVR) and transrectal ultrasound prostate volume measurement. Patients were evaluated 1, 3, 6 and 12 months following treatment. At each followup evaluation side effects were elicited. Significant improvements in AUA-SI score, QOL score, Qmax and PVR were noted as early as 1 month after PVP treatment. At 12 months the mean AUA-SI score decreased from 23.9 to 4.3 (p <0.0001) and the QOL score decreased from 4.3 to 1.1 (p <0.0001), while mean Qmax increased from 7.8 to 22.6 ml per second (p <0.0001). PVR decreased from 114.3 to 24.8 ml (p <0.0001), while the transrectal ultrasound volume reduction went from 54.6 ml at baseline to 34.4 ml. There was no significant blood loss or fluid absorption during or immediately after PVP. Complications consisted of transient hematuria, dysuria and urinary retention in 12 (8.6%), 13 (9.3%) and 7 (5%) patients, respectively. PVP is a unique, safe and effective outpatient modality that provides immediate symptomatic and urodynamic relief of bladder outlet obstruction secondary to BPH. Long-term followup is needed to validate further the maintenance of clinical efficacy beyond 1 year.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically

Prevalence of Pituitary Hormone Dysfunction, Metabolic Syndrome, and Impaired Quality of Life in Retired Professional Football Players: A Prospective Study

PubMed Central

Chaloner, Charlene; Evans, Diana; Mathews, Amy; Cohan, Pejman; Wang, Christina; Swerdloff, Ronald; Sim, Myung-Shin; Lee, Jihey; Wright, Mathew J.; Kernan, Claudia; Barkhoudarian, Garni; Yuen, Kevin C.J.; Guskiewicz, Kevin

2014-01-01

Abstract Hypopituitarism is common after moderate and severe traumatic brain injury (TBI). Herein, we address the association between mild TBI (mTBI) and pituitary and metabolic function in retired football players. Retirees 30–65 years of age, with one or more years of National Football League (NFL) play and poor quality of life (QoL) based on Short Form 36 (SF-36) Mental Component Score (MCS) were prospectively enrolled. Pituitary hormonal and metabolic syndrome (MetS) testing was performed. Using a glucagon stimulation test, growth hormone deficiency (GHD) was defined with a standard cut point of 3 ng/mL and with a more stringent body mass index (BMI)-adjusted cut point. Subjects with and without hormonal deficiency (HD) were compared in terms of QoL, International Index of Erectile Function (IIEF) scores, metabolic parameters, and football career data. Of 74 subjects, 6 were excluded because of significant non-football-related TBIs. Of the remaining 68 subjects (mean age, 47.3±10.2 years; median NFL years, 5; median NFL concussions, 3; mean BMI, 33.8±6.0), 28 (41.2%) were GHD using a peak GH cutoff of <3 ng/mL. However, with a BMI-adjusted definition of GHD, 13 of 68 (19.1%) were GHD. Using this BMI-adjusted definition, overall HD was found in 16 (23.5%) subjects: 10 (14.7%) with isolated GHD; 3 (4.4%) with isolated hypogonadism; and 3 (4.4%) with both GHD and hypogonadism. Subjects with HD had lower mean scores on the IIEF survey (p=0.016) and trended toward lower scores on the SF-36 MCS (p=0.113). MetS was present in 50% of subjects, including 5 of 6 (83%) with hypogonadism, and 29 of 62 (46.8%) without hypogonadism (p=0.087). Age, BMI, median years in NFL, games played, number of concussions, and acknowledged use of performance-enhancing steroids were similar between HD and non-HD groups. In summary, in this cohort of retired NFL players with poor QoL, 23.5% had HD, including 19% with GHD (using a BMI-adjusted definition), 9% with hypogonadism, and

Prevalence of pituitary hormone dysfunction, metabolic syndrome, and impaired quality of life in retired professional football players: a prospective study.

PubMed

Kelly, Daniel F; Chaloner, Charlene; Evans, Diana; Mathews, Amy; Cohan, Pejman; Wang, Christina; Swerdloff, Ronald; Sim, Myung-Shin; Lee, Jihey; Wright, Mathew J; Kernan, Claudia; Barkhoudarian, Garni; Yuen, Kevin C J; Guskiewicz, Kevin

2014-07-01

Hypopituitarism is common after moderate and severe traumatic brain injury (TBI). Herein, we address the association between mild TBI (mTBI) and pituitary and metabolic function in retired football players. Retirees 30-65 years of age, with one or more years of National Football League (NFL) play and poor quality of life (QoL) based on Short Form 36 (SF-36) Mental Component Score (MCS) were prospectively enrolled. Pituitary hormonal and metabolic syndrome (MetS) testing was performed. Using a glucagon stimulation test, growth hormone deficiency (GHD) was defined with a standard cut point of 3 ng/mL and with a more stringent body mass index (BMI)-adjusted cut point. Subjects with and without hormonal deficiency (HD) were compared in terms of QoL, International Index of Erectile Function (IIEF) scores, metabolic parameters, and football career data. Of 74 subjects, 6 were excluded because of significant non-football-related TBIs. Of the remaining 68 subjects (mean age, 47.3±10.2 years; median NFL years, 5; median NFL concussions, 3; mean BMI, 33.8±6.0), 28 (41.2%) were GHD using a peak GH cutoff of <3 ng/mL. However, with a BMI-adjusted definition of GHD, 13 of 68 (19.1%) were GHD. Using this BMI-adjusted definition, overall HD was found in 16 (23.5%) subjects: 10 (14.7%) with isolated GHD; 3 (4.4%) with isolated hypogonadism; and 3 (4.4%) with both GHD and hypogonadism. Subjects with HD had lower mean scores on the IIEF survey (p=0.016) and trended toward lower scores on the SF-36 MCS (p=0.113). MetS was present in 50% of subjects, including 5 of 6 (83%) with hypogonadism, and 29 of 62 (46.8%) without hypogonadism (p=0.087). Age, BMI, median years in NFL, games played, number of concussions, and acknowledged use of performance-enhancing steroids were similar between HD and non-HD groups. In summary, in this cohort of retired NFL players with poor QoL, 23.5% had HD, including 19% with GHD (using a BMI-adjusted definition), 9% with hypogonadism, and 50% had Met

Prospective Evaluation of Acute Toxicity and Quality of Life After IMRT and Concurrent Chemotherapy for Anal Canal and Perianal Cancer

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

Han, Kathy; Cummings, Bernard J.; Lindsay, Patricia

Purpose: A prospective cohort study was conducted to evaluate toxicity, quality of life (QOL), and clinical outcomes in patients treated with intensity modulated radiation therapy (IMRT) and concurrent chemotherapy for anal and perianal cancer. Methods and Materials: From June 2008 to November 2010, patients with anal or perianal cancer treated with IMRT were eligible. Radiation dose was 27 Gy in 15 fractions to 36 Gy in 20 fractions for elective targets and 45 Gy in 25 fractions to 63 Gy in 35 fractions for gross targets using standardized, institutional guidelines, with no planned treatment breaks. The chemotherapy regimen was 5-fluorouracil and mitomycin C. Toxicitymore » was graded with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR29 questionnaires. Correlations between dosimetric parameters and both physician-graded toxicities and patient-reported outcomes were evaluated by polyserial correlation. Results: Fifty-eight patients were enrolled. The median follow-up time was 34 months; the median age was 56 years; 52% of patients were female; and 19% were human immunodeficiency virus—positive. Stage I, II, III, and IV disease was found in 9%, 57%, 26%, and 9% of patients, respectively. Twenty-six patients (45%) required a treatment break because of acute toxicity, mainly dermatitis (23/26). Acute grade 3 + toxicities included skin 46%, hematologic 38%, gastrointestinal 9%, and genitourinary 0. The 2-year overall survival (OS), disease-free survival (DFS), colostomy-free survival (CFS), and cumulative locoregional failure (LRF) rates were 90%, 77%, 84%, and 16%, respectively. The global QOL/health status, skin, defecation, and pain scores were significantly worse at the end of treatment than at baseline, but they returned to baseline 3 months after treatment. Social functioning and appetite scores were

Prospective evaluation of biomarkers for prediction of quality of life in community-acquired pneumonia.

PubMed

Nickler, Manuela; Schaffner, Daniela; Christ-Crain, Mirjam; Ottiger, Manuel; Thomann, Robert; Hoess, Claus; Henzen, Christoph; Mueller, Beat; Schuetz, Philipp

2016-11-01

Most clinical research investigated prognostic biomarkers for their ability to predict cardiovascular events or mortality. It is unknown whether biomarkers allow prediction of quality of life (QoL) after survival of the acute event. Herein, we investigated the prognostic potential of well-established inflammatory/cardiovascular blood biomarkers including white blood cells (WBC), C-reactive protein (CRP), procalcitonin (PCT), pro-adrenomedullin (proADM) and pro-atrial natriuretic peptide (proANP) in regard to a decline in QoL in a well-defined cohort of patients with community-acquired pneumonia (CAP). Within this secondary analysis including 753 patients with a final inpatient diagnosis of CAP from a multicenter trial, we investigated associations between admission biomarker levels and decline in QoL assessed by the EQ-5D health questionnaire from admission to day 30 and after 6 years. Admission proADM and proANP levels significantly predicted decline of the weighted EQ-5D index after 30 days (n=753) with adjusted odds ratios (ORs) of 2.0 ([95% CI 1.1-3.8]; p=0.027) and 3.7 ([95% CI 2.2-6.0]; p<0.001). Results for 6-year outcomes (n=349) were similar with ORs of 3.3 ([95% CI 1.3-8.3]; p=0.012) and 6.2 ([95% CI 2.7-14.2]; p<0.001). The markers were associated with most of the different QoL dimensions including mobility, self-care, and usual activities, but not pain/discomfort and to a lesser degree anxiety/depression and the visual analogue scale (VAS). Initial WBC, PCT and CRP values did not well predict QoL at any time point. ProADM and proANP accurately predict short- and long-term decline in QoL across most dimensions in CAP patients. It will be interesting to reveal underlying physiopathology in future studies.

14 CFR 91.1089 - Qualifications: Check pilots (aircraft) and check pilots (simulator).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Qualifications: Check pilots (aircraft) and check pilots (simulator). 91.1089 Section 91.1089 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... RULES Fractional Ownership Operations Program Management § 91.1089 Qualifications: Check pilots...

14 CFR 91.1089 - Qualifications: Check pilots (aircraft) and check pilots (simulator).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Qualifications: Check pilots (aircraft) and check pilots (simulator). 91.1089 Section 91.1089 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION... RULES Fractional Ownership Operations Program Management § 91.1089 Qualifications: Check pilots...

Acceleration effects on neck muscle strength: pilots vs. non-pilots.

PubMed

Seng, Kok-Yong; Lam, Pin-Min; Lee, Vee-Sin

2003-02-01

Conditioning of neck muscles, if any, due to repeated exposures to +Gz forces has received little research attention. This study was conducted to evaluate and compare the neck muscle strength of test volunteers representative of the general populations of fighter aircraft pilots and non-pilots. The tests were performed using a special attachment device on a computerized dynamometer. Ten pilots and ten non-pilots volunteered as test subjects. Each individual's maximal isometric neck muscle strength was evaluated in the extension, flexion, and left and right lateral bending directions in a single day. Peak values from the measurements were used for data analysis. Overall neck strength was calculated as the mean values for the four directions in each group. The overall muscular strength of the necks of pilots did not differ significantly from that of non-pilots, nor did exposure to +Gz forces lead to specific changes in isometric muscle strength across any of the four principal directions. Neck muscle strength in the four measured directions pooled across the two subgroups were statistically significant. The widespread practice of adopting protective head-positioning strategies to minimize neck strains, coupled with results from this research study, suggest that the neck muscles are subjected to reduced in-flight strengthening workouts during exposures to +Gz forces. To maximize in-flight performance and minimize +Gz-induced neck injuries, fighter pilots should be encouraged to perform on-land neck muscle strengthening exercise and in-flight head-positioning techniques. More research is needed to fine-tune this countermeasure strategy against cervical spine injury.

Impact of Response Shift on Time to Deterioration in Quality of Life Scores in Breast Cancer Patients

PubMed Central

Hamidou, Zeinab; Dabakuyo-Yonli, Tienhan S.; Guillemin, Francis; Conroy, Thierry; Velten, Michel; Jolly, Damien; Causeret, Sylvain; Graesslin, Olivier; Gauthier, Mélanie; Mercier, Mariette; Bonnetain, Franck.

2014-01-01

Background This prospective multicenter study aimed to study the impact of the recalibration component of response-shift (RS) on time to deterioration (TTD) in health related quality of life (QoL) scores in breast cancer (BC) patients and the influence of baseline QoL expectations on TTD. Methods The EORTC-QLQ-C30 and BR-23 questionnaires were used to assess the QoL in a prospective multicenter study at inclusion (T0), at the end of the first hospitalization (T1) and, three (T2) and 6 months after the first hospitalization (T3). Recalibration was investigated by the then-test method. QoL expectancy was assessed at diagnosis. Deterioration was defined as a 5-point decrease in QoL scores, considered a minimal clinically important difference (MCID). TTD was estimated using the Kaplan-Meier method. Cox regression analyses were used to identify factors influencing TTD. Results From February 2006 to February 2008, 381 women were included. Recalibration of breast cancer patients' internal standards in the assessment of their QoL had an impact on TTD. Median TTD were significantly shorter when recalibration was not taken into account than when recalibration was taken into account for global health, role-functioning, social-functioning, body-image and side effects of systemic therapy. Cox multivariate analyses showed that for body image, when recalibration was taken into account, radiotherapy was associated with a shorter TTD (HR: 0.60[0.38–0.94], whereas, no significant impact of surgery type on TTD was observed. For global health, cognitive and social functioning dimensions, patients expecting a deterioration in their QoL at baseline had a significantly shorter TTD. Conclusions Our results showed that RS and baseline QoL expectations were associated with time to deterioration in breast cancer patients. PMID:24828426

Commentary on "Patient-reported outcomes after 3-dimensional conformal, intensity-modulated, or proton beam radiotherapy for localized prostate cancer." Gray PJ, Paly JJ, Yeap BY, Sanda MG, Sandler HM, Michalski JM, Talcott JA, Coen JJ, Hamstra DA, Shipley WU, Hahn SM, Zietman AL, Bekelman JE, Efstathiou JA. Harvard Radiation Oncology Program, Boston, MA.: Cancer 2013;119(9):1729-35. doi: 10.1002/cncr.27956. [Epub 2013 Feb 22].

PubMed

Gottschalk, Alexander

2014-04-01

Recent studies have suggested differing toxicity patterns for patients with prostate cancer who receive treatment with 3-dimensional conformal radiotherapy (3DCRT), intensity-modulated radiotherapy (IMRT), or proton beam therapy (PBT). The authors reviewed patient-reported outcomes data collected prospectively using validated instruments that assessed bowel and urinary quality of life (QOL) for patients with localized prostate cancer who received 3DCRT (n = 123), IMRT (n = 153) or PBT (n = 95). Clinically meaningful differences in mean QOL scores were defined as those exceeding half the standard deviation of the baseline mean value. Changes from baseline were compared within groups at the first post-treatment follow-up (2-3 months from the start of treatment) and at 12 months and 24 months. At the first post-treatment follow-up, patients who received 3DCRT and IMRT, but not those who received PBT, reported a clinically meaningful decrement in bowel QOL. At 12 months and 24 months, all 3 cohorts reported clinically meaningful decrements in bowel QOL. Patients who received IMRT reported clinically meaningful decrements in the domains of urinary irritation/obstruction and incontinence at the first post-treatment follow-up. At 12 months, patients who received PBT, but not those who received IMRT or 3DCRT, reported a clinically meaningful decrement in the urinary irritation/obstruction domain. At 24 months, none of the 3 cohorts reported clinically meaningful changes in urinary QOL. Patients who received 3DCRT, IMRT, or PBT reported distinct patterns of treatment-related QOL. Although the timing of toxicity varied between the cohorts, patients reported similar modest QOL decrements in the bowel domain and minimal QOL decrements in the urinary domains at 24 months. Prospective randomized trials are needed to further examine these differences. © 2013 Published by Elsevier Inc.

Understanding quality of life and patient expectations among adolescents with neonatal brachial plexus palsy: a qualitative and quantitative pilot study.

PubMed

Squitieri, Lee; Larson, Bradley P; Chang, Kate W C; Yang, Lynda J S; Chung, Kevin C

2013-12-01

To explore the quality of life (QOL) and patient expectations among adolescents with neonatal brachial plexus palsy (NBPP)and their parents using qualitative and quantitative approaches. A total of 18 adolescents (10-17 y) with residual NBPP impairment and their parents under went separate 1-hour tape-recorded semistructured interviews. We also collected quantitative physical examination measures and patient-rated outcome scores, specifically the Pediatric Outcomes Data Collection Instrument and the Child Health Questionnaire, to quantify the severity of each adolescent’s functional deficit and increase our understanding of QOL and patient expectations. Through qualitative analysis, we identified several patient- and system-dependent factors contributing to QOL, such as social impact and peer acceptance, emotional adjustment,aesthetic concerns and body image, functional limitations, physical and occupational therapy, finances, pain, and family dynamics. Despite residual impairment, most adolescents and their parents reported a good overall QOL according to quantitative outcome measures. Our study results showed that functional and aesthetic factors were responsible for most observed differences in QOL among NBPP adolescents. We also found that the Pediatric Outcomes Data Collection Instrument might be more sensitive than the Child Health Questionnaire in assessing patient expectations and QOL among this patient population. Understanding patient expectations and QOL in NBPP adolescents is essential for medical decision making and advancing care. Physical examination measurements alone may not be sufficient for measuring outcome, and knowledge regarding environmental factors and family dynamics is important for clinicians to consider when counseling families of children with NBPP and improving overall outcome. Prognostic IV.

Non-invasive versus invasive management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: study design of the pilot randomised controlled trial and registry (CABG-ACS)

PubMed Central

Lee, Matthew M Y; Petrie, Mark C; Rocchiccioli, Paul; Simpson, Joanne; Jackson, Colette; Brown, Ammani; Corcoran, David; Mangion, Kenneth; McEntegart, Margaret; Shaukat, Aadil; Rae, Alan; Hood, Stuart; Peat, Eileen; Findlay, Iain; Murphy, Clare; Cormack, Alistair; Bukov, Nikolay; Balachandran, Kanarath; Papworth, Richard; Ford, Ian; Briggs, Andrew; Berry, Colin

2016-01-01

Introduction There is an evidence gap about how to best treat patients with prior coronary artery bypass grafts (CABGs) presenting with non-ST segment elevation acute coronary syndromes (NSTE-ACS) because historically, these patients were excluded from pivotal randomised trials. We aim to undertake a pilot trial of routine non-invasive management versus routine invasive management in patients with NSTE-ACS with prior CABG and optimal medical therapy during routine clinical care. Our trial is a proof-of-concept study for feasibility, safety, potential efficacy and health economic modelling. We hypothesise that a routine invasive approach in patients with NSTE-ACS with prior CABG is not superior to a non-invasive approach with optimal medical therapy. Methods and analysis 60 patients will be enrolled in a randomised clinical trial in 4 hospitals. A screening log will be prospectively completed. Patients not randomised due to lack of eligibility criteria and/or patient or physician preference and who give consent will be included in a registry. We will gather information about screening, enrolment, eligibility, randomisation, patient characteristics and adverse events (including post-discharge). The primary efficacy outcome is the composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction and hospitalisation for heart failure. The primary safety outcome is the composite of bleeding, stroke, procedure-related myocardial infarction and worsening renal function. Health status will be assessed using EuroQol 5 Dimensions (EQ-5D) assessed at baseline and 6 monthly intervals, for at least 18 months. Trial registration number NCT01895751 (ClinicalTrials.gov). PMID:27110377

Evaluating a measure of social health derived from two mental health recovery measures: the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program Consumer Survey (MHSIP).

PubMed

Carlson, Jordan A; Sarkin, Andrew J; Levack, Ashley E; Sklar, Marisa; Tally, Steven R; Gilmer, Todd P; Groessl, Erik J

2011-08-01

Social health is important to measure when assessing outcomes in community mental health. Our objective was to validate social health scales using items from two broader commonly used measures that assess mental health outcomes. Participants were 609 adults receiving psychological treatment services. Items were identified from the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program (MHSIP) outcome measures by their conceptual correspondence with social health and compared to the Social Functioning Questionnaire (SFQ) using correlational analyses. Pearson correlations for the identified CA-QOL and MSHIP items with the SFQ ranged from .42 to .62, and the identified scale scores produced Pearson correlation coefficients of .56, .70, and, .70 with the SFQ. Concurrent validity with social health was supported for the identified scales. The current inclusion of these assessment tools allows community mental health programs to include social health in their assessments.

Bruxism in military pilots and non-pilots: tooth wear and psychological stress.

PubMed

Lurie, Orit; Zadik, Yehuda; Einy, Shmuel; Tarrasch, Ricardo; Raviv, Gil; Goldstein, Liav

2007-02-01

Bruxism is the diurnal or nocturnal para-functional habit of clenching or grinding the teeth and affects 5-10% of the general western population. Bruxism can cause pain and irreversible damage to the teeth, periodontium, masticatory muscles, and temporo-mandibular joint. Variables such as general stress, work-related stress, and personality traits have been increasingly considered as initiating, predisposing, and perpetuating factors for bruxism. We sought to evaluate the potential of work-related stress and personality factors to induce bruxism among military pilots and non-pilot officers. Subjects were 57 healthy male Israel Air Force officers (mean age 25.8+/-4.3 yr). Of these, 17 were jet-pilots, 18 helicopter-pilots, and 22 non-pilot officers. Tooth-wear was classified according to a six-point scale. In addition, the subjects responded to a battery of psychological questionnaires for self-assessment of stress at the workplace and their coping behavior. Bruxism of clinical importance (i.e., with dentin exposure) was found in 69% of the aircrew members but only 27% of the non-pilot group. No difference was found between groups regarding stress levels. Military aircrews may be relatively vulnerable to deleterious bruxism as well as other signs of chronic stress. Among bruxers, pilots tended to show coping strategies that were significantly more emotional and less task-oriented than non-pilots, whereas non-bruxers showed no significant differences in coping behavior. This study suggest that integrating dental and psychological preventive intervention may be helpful.

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

PubMed

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

2016-12-01

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

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

ERIC Educational Resources Information Center

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

2010-01-01

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

Communication, Coping, and Quality of Life of Breast Cancer Survivors and Family/Friend Dyads: A Pilot Study of Chinese- and Korean-Americans

PubMed Central

Lim, Jung-won

2014-01-01

Objective This study aimed to understand the dyadic relationships between family communication and quality of life (QOL) and between coping and QOL in Chinese- and Korean-American breast cancer survivor (BCS)-family member dyads. Methods A cross-sectional survey design was used. A total of 32 Chinese- and Korean-American BCS-family member dyads were recruited from the California Cancer Surveillance Program and area hospitals in Los Angeles County, California, United States. The dyadic data were analyzed using a pooled regression actor-partner interdependence model. Results The study findings demonstrated that the survivors’ general communication and use of reframing coping positively predicted their own QOL. The survivors’ and family members’ general communication was also a strong predictor of the family members’ physical-related QOL score specifically. Meanwhile, each person’s use of mobilizing coping negatively predicted his or her partner’s QOL. Conclusions The study findings add important information to the scarce literature on the QOL of Asian-American survivors of breast cancer. The findings suggest that Chinese- and Korean-American BCS and their family members may benefit from interventions that enhance communication and coping within the family unit. PMID:24700695

Impact of pelvic floor muscle training in the postpartum period.

PubMed

Gagnon, Louise-Helene; Boucher, Jodi; Robert, Magali

2016-02-01

Our study piloted a novel, two-tiered approach to delivering pelvic floor muscle training (PFMT) to postpartum women involving a standardized group workshop followed by the opportunity to self-select for individual PFMT sessions. The aim of the study was to evaluate the outcomes in women who self-selected for individual PFMT using validated quality of life (QoL) questionnaires, the Pelvic Floor Distress Inventory-20 (PFDI-20), the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), as well as the Modified Oxford Scale (MOS) for strength. Women's satisfaction with the program was also assessed. This was a single-center prospective cohort study conducted between December 2013 and September 2014. Changes from baseline to postintervention QoL and MOS scores were tested using the Wilcoxon signed-rank test. Two hundred and eighteen women attended the workshop, 54 enrolled in PFMT sessions, and 50 completed follow-up. Significant improvements were seen in the PFDI-20 (mean change -41.8, p < 0.001) and PFIQ-7 (mean change -23.0, p < 0.001) questionnaires. Results for the PISQ-12 could not be tabulated, as there were too many missing responses. The MOS score was significantly improved from baseline (4; range {0-5} compared with 3; range {0-4}; p < 0.001). Forty-nine of 50 women's expectations for the program were met [9 of 10; standard deviation (SD) 1.4]. Results suggest that a two-tiered, self-selection approach to administering PFMT in the postpartum period contributes to significant improvements in pelvic floor function, QoL, MOS strength, and to high satisfaction rates.

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

PubMed

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

2016-12-01

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

Health Related Quality of Life Following Reconstruction for Common Head and Neck Surgical Defects

PubMed Central

Cohen, Wess; Albornoz, Claudia R.; Cordeiro, Peter G.; Cracchiolo, Jennifer; Encarnacion, Elizabeth; Lee, Meghan; Cavalli, Michele; Patel, Snehal; Pusic, Andrea L.; Matros, Evan

2017-01-01

Background Improved understanding and management of health-related quality of life (HR-QOL) represents one of the greatest unmet needs for patients with head and neck (H&N) malignancies. The purpose of the current study is to prospectively measure HR-QOL associated with different anatomical (H&N) surgical resections. Methods A prospective analysis of HR-QOL was performed in patients undergoing surgical resection with flap reconstruction for stage II or III H&N malignancies. Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Core Quality-of-Life Questionnaire 30 and EORTC H&N Cancer Module 35 preoperatively, and at set postoperative time points. Scores were compared with a paired t-test. Results 75 patients were analyzed. The proportion of the cohort not alive at 2 years was 53%. Physical, role, and social functioning scores at 3 months were significantly lower than preoperative values (p<.05). At 12 months postoperatively, none of the function or global QOL scores differed from preoperative levels, whereas 5 of the symptom scales remained below baseline. At one year postoperatively maxillectomy, partial glossectomy, and oral lining defects had better function and less symptoms than mandibulectomy, laryngectomy, and total glossectomy. From 6 to 12 months postoperatively, partial glossectomy and oral lining defects had greater global QOL than laryngectomies (p<.05). Conclusion Postoperative HR-QOL is associated with the anatomic location of the H&N surgical resection. Preoperative teaching should be targeted for common ablative defects with postoperative expectations adjusted appropriately. Because surgery negatively impacts HR-QOL in the immediate post-operative period, the limited survivorship should be reviewed with patients. PMID:27879602

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

PubMed Central

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

2015-01-01

Objective To describe the development and psychometric properties of the Spinal Cord Injury-Quality of Life (SCI-QOL) Self-esteem item bank. Design 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. Setting 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. Participants A total of 717 individuals with SCI completed the self-esteem items. Results 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. Conclusion 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. PMID:26010972

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

PubMed

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

2017-05-01

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

Piloting Changes to Changing Aircraft Dynamics: What Do Pilots Need to Know?

NASA Technical Reports Server (NTRS)

Trujillo, Anna C.; Gregory, Irene M.

2011-01-01

An experiment was conducted to quantify the effects of changing dynamics on a subject s ability to track a signal in order to eventually model a pilot adapting to changing aircraft dynamics. The data will be used to identify primary aircraft dynamics variables that influence changes in pilot s response and produce a simplified pilot model that incorporates this relationship. Each run incorporated a different set of second-order aircraft dynamics representing short period transfer function pitch attitude response: damping ratio, frequency, gain, zero location, and time delay. The subject s ability to conduct the tracking task was the greatest source of root mean square error tracking variability. As for the aircraft dynamics, the factors that affected the subjects ability to conduct the tracking were the time delay, frequency, and zero location. In addition to creating a simplified pilot model, the results of the experiment can be utilized in an advisory capacity. A situation awareness/prediction aid based on the pilot behavior and aircraft dynamics may help tailor pilot s inputs more quickly so that PIO or an upset condition can be avoided.

The effect of neck dissection on quality of life after chemoradiation.

PubMed

Donatelli-Lassig, Amy Anne; Duffy, Sonia A; Fowler, Karen E; Ronis, David L; Chepeha, Douglas B; Terrell, Jeffrey E

2008-10-01

To determine differences in quality of life (QOL) between patients with head and neck cancer who receive chemoradiation versus chemoradiation and neck dissection. A prospective cohort study was conducted at two tertiary otolaryngology clinics and a Veterans Administration hospital. 103 oropharyngeal patients with Stage IV squamous cell carcinoma treated via chemoradiation +/- neck dissection. self-administered health survey to collect health, demographic, and QOL information pretreatment and 1 year later. QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health/clinical characteristics, demographics, and QOL scores. t tests evaluated changes in QOL over time. Sixty-five patients underwent chemoradiation and 38 patients underwent chemoradiation and neck dissection. Only the pain index of the SF-36 showed a significant difference between groups (P < 0.05) with the neck dissection group reporting greater pain. After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients who underwent chemoradiation alone.

The effect of neck dissection on quality of life after chemoradiation

PubMed Central

Lassig, Amy Anne Donatelli; Duffy, Sonia A.; Fowler, Karen E.; Ronis, David L.; Chepeha, Douglas B.; Terrell, Jeffrey E.

2010-01-01

Objective To determine differences in QOL between head and neck cancer patients receiving chemoradiation versus chemoradiation and neck dissection. Methods A prospective cohort study was conducted at 2 tertiary otolaryngology clinics and a VA. Sample: 103 oropharyngeal Stage IV SCCA patients treated via chemoradiation +/− neck dissection. Intervention: self-administered health survey collecting health, demographic, and QOL information pretreatment and 1 year later. Main outcome measures: QOL via SF-36 and HNQoL. Descriptive statistics were calculated for health / clinical characteristics, demographics, and QOL scores. T-tests evaluated changes in QOL over time. Results 65 patients received chemoradiation and 38 chemoradiation + neck dissection. Only the pain index of the SF-36 showed a significant difference between groups (p<.05) with the neck dissection group reporting greater pain. Conclusions After post-treatment neck dissection, patients experience statistically significant decrement in bodily pain domain scores, but other QOL scores are similar to those of patients undergoing chemoradiation alone. PMID:18922336

Pilot Decision-Making Training

DTIC Science & Technology

1990-05-01

Pilot Decisional Attitude Questionnaire (PDAQ). 2. Aeronautical Decision Making . a. The pilot judgment problem b. Relationship of judgment to training...lmEr OAT . REPOR TYPE ANO GATES COVEIRO May 1990 Final - June 1985 - December 1988 4 .MU AN m . .m m t 4i C ’u. SUM L FUNING MUMBRS Pilot Decision - Making ...13 AGSTRACT (Maxu’m 200 wo f -The effectiveness of a simulator-based approach to training pilot skills in risk assessment and decision making was

49 CFR 230.110 - Pilots.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 4 2011-10-01 2011-10-01 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...

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.

PubMed

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Q max ) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

PubMed Central

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

Objective The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Patients and methods Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. Results LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. Conclusion The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years. PMID:27921028

Binge Eating and Weight-Related Quality of Life in Obese Adolescents

PubMed Central

Ranzenhofer, Lisa M.; Columbo, Kelli M.; Tanofsky-Kraff, Marian; Shomaker, Lauren B.; Cassidy, Omni; Matheson, Brittany E.; Kolotkin, Ronette L.; Checchi, Jenna M.; Keil, Margaret; McDuffie, Jennifer R.; Yanovski, Jack A.

2012-01-01

Limited data exist regarding the association between binge eating and quality of life (QOL) in obese adolescent girls and boys. We, therefore, studied binge eating and QOL in 158 obese (BMI ≥ 95th percentile) adolescents (14.5 ± 1.4 years, 68.0% female, 59% African-American) prior to weight-loss treatment. Youth completed an interview to assess binge eating and a questionnaire measure of QOL. Controlling for body composition, binge eating youth (n = 35), overall, reported poorer QOL in domains of health, mobility, and self-esteem compared to those without binge eating (ps < 0.05). Also, girls, overall, reported poorer QOL than boys in activities of daily-living, mobility, self-esteem, and social/interpersonal functioning (ps < 0.05). Girls with binge eating reported the greatest impairments in activities of daily living, mobility, self-esteem, social/interpersonal functioning, and work/school QOL (ps < 0.05). Among treatment-seeking obese adolescents, binge eating appears to be a marker of QOL impairment, especially among girls. Prospective and treatment designs are needed to explore the directional relationship between binge eating and QOL and their impact on weight outcomes. PMID:22666544

Double-blind placebo-controlled study of mesalamine in post-infective irritable bowel syndrome--a pilot study.

PubMed

Tuteja, Ashok K; Fang, John C; Al-Suqi, Manal; Stoddard, Gregory J; Hale, Devon C

2012-10-01

Post-infective irritable bowel syndrome (PI-IBS) is characterized by continuing symptoms of irritable bowel syndrome, typically diarrhea-predominant, following an episode of acute gastroenteritis. There is often an increase in sub-epithelial inflammatory and neuroendocrine cells on colonic mucosal biopsy. Mesalamine is an anti-inflammatory agent, effective in the treatment of inflammatory bowel disease. The goal of this study was to compare mesalamine to placebo on symptoms and quality-of-life (QOL) in PI-IBS. Twenty patients who developed diarrhea-predominant IBS after gastroenteritis were randomized to receive mesalamine (Asacol®) 1.6 gm b.i.d. or placebo for 12 weeks in a double-blind placebo-controlled study. QOL was assessed using the IBS-QOL questionnaire. Stool frequency, stool consistency, urgency, severity of abdominal pain, severity of bloating, and global-improvement scale were recorded in daily diaries for 7 days at baseline and every 4 weeks. Data were analyzed by comparing the change from baseline to last follow-up. One patient withdrew after randomization; data were incomplete in two patients. Thus, data were analyzed from 17 patients (11 men and 6 women, median age: 27 years, range 22-45 years). Mesalamine was not associated with significant improvement in global symptoms, abdominal pain, bloating, stool urgency, frequency, or consistency (all p ≥ 0.11) or QOL (p ≥ 0.16). There was no significant improvement in global symptoms or overall QOL with mesalamine in patients with PI-IBS.

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

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

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

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

Communication, coping, and quality of life of breast cancer survivors and family/friend dyads: a pilot study of Chinese-Americans and Korean-Americans.

PubMed

Lim, Jung-Won

2014-11-01

This study aimed to understand the dyadic relationships between family communication and quality of life (QOL) and between coping and QOL in Chinese-American and Korean-American breast cancer survivor (BCS)-family member dyads. A cross-sectional survey design was used. A total of 32 Chinese-American and Korean-American BCS-family member dyads were recruited from the California Cancer Surveillance Program and area hospitals in Los Angeles County, California, USA. The dyadic data were analyzed using a pooled regression actor-partner interdependence model. The study findings demonstrated that the survivors' general communication and use of reframing coping positively predicted their own QOL. The survivors' and family members' general communication was also a strong predictor of the family members' physical-related QOL score specifically. Meanwhile, each person's use of mobilizing coping negatively predicted his or her partner's QOL. The study findings add important information to the scarce literature on the QOL of Asian-American survivors of breast cancer. The findings suggest that Chinese-American and Korean-American BCS and their family members may benefit from interventions that enhance communication and coping within the family unit. Copyright © 2014 John Wiley & Sons, Ltd.

Assessing Aircraft Susceptibility to Nonlinear Aircraft-Pilot Coupling/Pilot-Induced Oscillations

NASA Technical Reports Server (NTRS)

Hess, R.A.; Stout, P. W.

1997-01-01

A unified approach for assessing aircraft susceptibility to aircraft-pilot coupling (or pilot-induced oscillations) which was previously reported in the literature and applied to linear systems is extended to nonlinear systems, with emphasis upon vehicles with actuator rate saturation. The linear methodology provided a tool for predicting: (1) handling qualities levels, (2) pilot-induced oscillation rating levels and (3) a frequency range in which pilot-induced oscillations are likely to occur. The extension to nonlinear systems provides a methodology for predicting the latter two quantities. Eight examples are presented to illustrate the use of the technique. The dearth of experimental flight-test data involving systematic variation and assessment of the effects of actuator rate limits presently prevents a more thorough evaluation of the methodology.

14 CFR 91.5 - Pilot in command of aircraft requiring more than one required pilot.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Pilot in command of aircraft requiring more... RULES General § 91.5 Pilot in command of aircraft requiring more than one required pilot. No person may... the pilot in command meets the requirements of § 61.58 of this chapter. ...

14 CFR 91.5 - Pilot in command of aircraft requiring more than one required pilot.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false Pilot in command of aircraft requiring more... RULES General § 91.5 Pilot in command of aircraft requiring more than one required pilot. No person may... the pilot in command meets the requirements of § 61.58 of this chapter. ...

14 CFR 91.5 - Pilot in command of aircraft requiring more than one required pilot.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false Pilot in command of aircraft requiring more... RULES General § 91.5 Pilot in command of aircraft requiring more than one required pilot. No person may... the pilot in command meets the requirements of § 61.58 of this chapter. ...

14 CFR 91.5 - Pilot in command of aircraft requiring more than one required pilot.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Pilot in command of aircraft requiring more... RULES General § 91.5 Pilot in command of aircraft requiring more than one required pilot. No person may... the pilot in command meets the requirements of § 61.58 of this chapter. ...

14 CFR 91.5 - Pilot in command of aircraft requiring more than one required pilot.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false Pilot in command of aircraft requiring more... RULES General § 91.5 Pilot in command of aircraft requiring more than one required pilot. No person may... the pilot in command meets the requirements of § 61.58 of this chapter. ...

Pilot weather advisor

NASA Technical Reports Server (NTRS)

Kilgore, W. A.; Seth, S.; Crabill, N. L.; Shipley, S. T.; Graffman, I.; Oneill, J.

1992-01-01

The results of the work performed by ViGYAN, Inc., to demonstrate the Pilot Weather Advisor cockpit weather data system using a broadcast satellite communication system are presented. The Pilot Weather Advisor demonstrated that the technical problems involved with transmitting significant amount of weather data to an aircraft in-flight or on-the-ground via satellite are solvable with today's technology. The Pilot Weather Advisor appears to be a viable solution for providing accurate and timely weather information for general aviation aircraft.

Mood, anxiety, and incomplete seizure control affect quality of life after epilepsy surgery

PubMed Central

Blackmon, Karen; Cong, Xiangyu; Dziura, James; Atlas, Lauren Y.; Vickrey, Barbara G.; Berg, Anne T.; Bazil, Carl W.; Langfitt, John T.; Walczak, Thaddeus S.; Sperling, Michael R.; Shinnar, Shlomo; Devinsky, Orrin

2014-01-01

Objective: We examined the complex relationship between depression, anxiety, and seizure control and quality of life (QOL) outcomes after epilepsy surgery. Methods: Seven epilepsy centers enrolled 373 patients and completed a comprehensive diagnostic workup and psychiatric and follow-up QOL evaluation. Subjects were evaluated before surgery and then at 3, 6, 12, 24, 48, and 60 months after surgery. Standardized assessments included the Quality of Life in Epilepsy Inventory–89, Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). A mixed-model repeated-measures analysis was used to analyze associations of depression, anxiety, seizure outcome, and seizure history with overall QOL score and QOL subscores (cognitive distress, physical health, mental health, epilepsy-targeted) prospectively. Results: The groups with excellent and good seizure control showed a significant positive effect on the overall QOL compared to the groups with fair and poor seizure control. The BDI and BAI scores were both highly and negatively associated with overall QOL; increases in BDI and BAI scores were associated with decreased overall QOL score. Conclusions: Depression and anxiety are strongly and independently associated with worse QOL after epilepsy surgery. Interestingly, even partial seizure control, controlling for depression and anxiety levels, improved QOL. Management of mood and anxiety is a critical component to postsurgical care. PMID:24489129

A comparison of donor and control group quality of life.

PubMed

Tumin, Makmor; Abdul Talib Abdul Mutalib, Muzalwana; Mohd Satar, Nurulhuda; Abdullah, Nawi; Chong, Chin-Sieng; Ng, Kok-Peng; Lim, Soo-Kun

2014-03-03

Informed consent of prospective donors should include information about the quality of life (QoL) of existing donors, especially those within the relevant country. This study aimed to provide information on Malaysian organ donors' QoL relative to a control group. Using a shorter version of the SF-36, QoL of 80 donors from the University of Malaya Medical Center (UMMC), Malaysia was surveyed and compared to QoL of 80 selected healthy individuals. ANOVA and General Linear Model (GLM) procedure were each applied for the QoL comparison, which was based on gender and age. Donors recorded a better QoL relative to the control group. Comparison across gender revealed that differences are more obvious for males than females. Donor/control comparison across age groups reveals that donors aged 56 and above reported significantly better QoL in most domains relative to other age groups. Information on donor QoL should be made available to the public to present a comprehensive picture of the consequences of organ donation. Nonetheless, we also argue that, despite the merits of organ donation, caution is required before concluding that donors have better QoL because the present research outcomes may reflect a self-selection bias in which respondents only included donors engaging in regular follow-ups.

Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial.

PubMed

Al Tmimi, L; Van Hemelrijck, J; Van de Velde, M; Sergeant, P; Meyns, B; Missant, C; Jochmans, I; Poesen, K; Coburn, M; Rex, S

2015-10-01

Off-pump coronary artery bypass (OPCAB) surgery carries a high risk for haemodynamic instability and perioperative organ injury. Favourable haemodynamic effects and organ-protective properties could render xenon an attractive anaesthetic for OPCAB surgery. The primary aim of this study was to assess whether xenon anaesthesia for OPCAB surgery is non-inferior to sevoflurane anaesthesia with regard to intraoperative vasopressor requirements. Forty-two patients undergoing elective OPCAB surgery were enrolled in this prospective, single-blind, randomized controlled pilot trial. Patients were randomized to either xenon (50-60 vol%) or sevoflurane (1.1-1.4 vol%) anaesthesia. Primary outcome was intraoperative noradrenaline requirements necessary to achieve predefined haemodynamic goals. Secondary outcomes included safety variables such as the occurrence of adverse events (intraoperatively and during a 6-month follow-up after surgery) and the perioperative cardiorespiratory and inflammatory profile. Baseline and intraoperative data did not differ between groups. Xenon was non-inferior to sevoflurane, as xenon patients required significantly less noradrenaline intraoperatively to achieve the predefined haemodynamic goals {geometric mean 428 [95% confidence interval (CI) 312, 588] vs 1702 [1267, 2285] µg, P<0.0001}. No differences were found for safety. Significantly more sevoflurane patients developed postoperative delirium (POD) (hazard ratio 4.2, P=0.044). The average arterial pressure was lower in the sevoflurane group {median75 [interquartile range (IQR) 6] vs 72 [4] mmHg, P=0.002}. No differences were found for other haemodynamic parameters, the respiratory profile and the perioperative release of inflammatory cytokines, troponin T, serum protein S-100β and erythropoietin. Compared with sevoflurane, xenon anaesthesia allows a significant reduction in vasopressor administration in OPCAB surgery. Moreover, xenon anaesthesia was associated with a lower risk for POD, a

Stereotactic body radiation therapy with concurrent full-dose gemcitabine for locally advanced pancreatic cancer: a pilot trial demonstrating safety

PubMed Central

2013-01-01

Background Concurrent chemoradiation is a standard option for locally advanced pancreatic cancer (LAPC). Concurrent conventional radiation with full-dose gemcitabine has significant toxicity. Stereotactic body radiation therapy (SBRT) may provide the opportunity to administer radiation in a shorter time frame with similar efficacy and reduced toxicity. This Pilot study assessed the safety of concurrent full-dose gemcitabine with SBRT for LAPC. Methods Patients received gemcitabine, 1000 mg/m2 for 6 cycles. During week 4 of cycle 1, patients received SBRT (25 Gy delivered in five consecutive daily fractions of 5 Gy prescribed to the 75-83% isodose line). Acute and late toxicities were assessed using NIH CTCAE v3. Tumor response was assessed by RECIST. Patients underwent an esophagogastroduodenoscopy at baseline, 2, and 6 months to assess the duodenal mucosa. Quality of life (QoL) data was collected before and after treatment using the QLQ-C30 and QLQ-PAN26 questionnaires. Results Between September 2009 and February 2011, 11 patients enrolled with one withdrawal during radiation therapy. Patients had grade 1 to 2 gastrointestinal toxicity from the start of SBRT to 2 weeks after treatment. There were no grade 3 or greater radiation-related toxicities or delays for cycle 2 of gemcitabine. On endoscopy, there were no grade 2 or higher mucosal toxicities. Two patients had a partial response. The median progression free and overall survival were 6.8 and 12.2 months, respectively. Global QoL did not change between baseline and immediately after radiation treatment. Conclusions SBRT with concurrent full dose gemcitabine is safe when administered to patients with LAPC. There is no delay in administration of radiation or chemotherapy, and radiation is completed with minimal toxicity. PMID:23452509

Quality of life in patients with advanced lung cancer treated at home and at a palliative care unit.

PubMed

Leppert, Wojciech; Turska, Anna; Majkowicz, Mikolaj; Dziegielewska, Sylwia; Pankiewicz, Piotr; Mess, Eleonora

2012-08-01

To assess quality of life (QOL) in patients with advanced lung cancer. A prospective study of 78 patients cared at home and at a palliative care unit (PCU) with 2 QOL assessments was conducted. Fifty patients completed the study. In the EORTC QLQ-C30 role, cognitive, social functioning, global QOL, fatigue, pain, dyspnea, and appetite deteriorated; nausea/vomiting improved; dyspnea was more intense in the case of in-home patients. In the EORTC QLQ-LC13 hemoptysis improved; pain in other parts was more intense in the PCU patients. Pain (Visual Analogue scale) was more intense in the PCU patients; the level of activity (Karnofsky) decreased in the case of patients treated at home. QOL deteriorated with few differences between home and the PCU patients.

Prospective patients rate practice factors: development of a questionnaire.

PubMed

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

2011-02-01

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

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

PubMed Central

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

2016-01-01

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

DIRAC universal pilots

NASA Astrophysics Data System (ADS)

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.

Voice- and swallow-related quality of life in idiopathic Parkinson's disease.

PubMed

van Hooren, Michel R A; Baijens, Laura W J; Vos, Rein; Pilz, Walmari; Kuijpers, Laura M F; Kremer, Bernd; Michou, Emilia

2016-02-01

This study explores whether changes in voice- and swallow-related QoL are associated with progression of idiopathic Parkinson's disease (IPD). Furthermore, it examines the relationship between patients' perception of both voice and swallowing disorders in IPD. Prospective clinical study, quality of life (QoL). One-hundred mentally competent IPD patients with voice and swallowing complaints were asked to answer four QoL questionnaires (Voice Handicap Index, MD Anderson Dysphagia Inventory, Visual Analog Scale [VAS] voice, and Dysphagia Severity Scale [DSS]). Differences in means for the QoL questionnaires and their subscales within Hoehn and Yahr stage groups were calculated using one-way analysis of variance. The relationship between voice- and swallow-related QoL questionnaires was determined with the Spearman correlation coefficient. Scores on both voice and swallow questionnaires suggest an overall decrease in QoL with progression of IPD. A plateau in QoL for VAS voice and the DSS was seen in the early Hoehn and Yahr stages. Finally, scores on voice-related QoL questionnaires were significantly correlated with swallow-related QoL outcomes. Voice- and swallow-related QoL decreases with progression of IPD. A significant association was found between voice- and swallow-related QoL questionnaires. Healthcare professionals can benefit from voice- and swallow-related QoL questionnaires in a multidimensional voice- or swallow-assessment protocol. The patient's perception of his/her voice and swallowing disorders and its impact on QoL in IPD should not be disregarded. 2b. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

76 FR 62813 - Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

...] Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program Results... voluntary pilot program that enabled participating pharmaceutical firms to evaluate proposed proprietary... public meeting at the end of fiscal year 2011 to discuss the results of the pilot program, but the Agency...

A pilot study addressing the impact of religious practice on quality of life of breast cancer patients during chemotherapy.

PubMed

Paiva, Carlos Eduardo; Paiva, Bianca Sakamoto Ribeiro; de Castro, Rafael Amaral; Souza, Cristiano de Pádua; de Paiva Maia, Yara Cristina; Ayres, Jairo Aparecido; Michelin, Odair Carlito

2013-03-01

The aim of this preliminary study was to investigate whether religious practice can modify quality of life (QoL) in BC patients during chemotherapy. QoL and religion practice questionnaire (RPQ) scores were evaluated in a sample of BC patients in different moments. Before chemotherapy initiation, women with lower physical and social functional scores displayed higher RPQ scores. On the other hand, low RPQ patients worsened some QoL scores over time. Body image acceptance was positively correlated with religious practice and specifically praying activity. This preliminary study suggests the importance of religion in coping with cancer chemotherapy.

Single-Pilot Workload Management

NASA Technical Reports Server (NTRS)

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.

Prospective study of outcomes after percutaneous biliary drainage for malignant biliary obstruction

PubMed Central

Robson, P. C.; Heffernan, N.; Gonen, M.; Thornton, R.; Brody, L. A.; Holmes, R.; Brown, K. T.; Covey, A. M.; Fleischer, D.; Getrajdman, G. I.; Jarnagin, W.; Sofocleous, C.; Blumgart, L.; D’Angelica, M.

2015-01-01

Purpose Percutaneous biliary drainage (PBD) is used to relieve malignant bile duct obstruction (MBO) when endoscopic drainage is not feasible. Little is known about the effects of PBD on the quality of life (QoL) in patients with MBO. The aim of this study was to evaluate changes in QoL and pruritus after PBD and to explore the variables that impact these changes. Patients and Methods Eligible patients reported their QoL and pruritus before and after PBD using the Functional Assessment of Cancer Therapy – Hepatobiliary instrument (FACT-HS) and the Visual Analog Scale for Pruritus (VASP). Instruments were completed pre-procedure and at one and four weeks following PBD. Results One hundred and nine (60 male/49 female) patients enrolled, 102 (94%) had unresectable disease. PBD was technically successful (hepatic ducts cannulated at the conclusion of procedure) in all patients. There were two procedure-related deaths. All-cause mortality was 10% (N=11) at 4 weeks and 28% (N=31) at 8 weeks post PBD with a median survival of 4.74 months. The mean FACT-HS scores declined significantly (P<.01) over time (101.3, 94.8, 94.7 at baseline, 1 week, 4 weeks, respectively). The VASP scores showed significant improvement at 1 week with continued improvement at 4 weeks (P<.01). Conclusion PBD improves pruritus but not QoL in patients with MBO and advanced malignancy. There is high early mortality in this population. PMID:20358300

Pilot-model measurements of pilot responses in a lateral-directional control task

NASA Technical Reports Server (NTRS)

Adams, J. J.

1976-01-01

Pilot response during an aircraft bank-angle compensatory control task was measured by using an adaptive modeling technique. In the main control loop, which is the bank angle to aileron command loop, the pilot response was the same as that measured previously in single-input, single-output systems. The pilot used a rudder to aileron control coordination that canceled up to 80 percent of the vehicle yawing moment due to aileron deflection.

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

NASA Technical Reports Server (NTRS)

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

2013-01-01

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

Unmanned Aircraft: A Pilot's Perspective

NASA Technical Reports Server (NTRS)

Pestana, Mark E.

2010-01-01

This slide presentation reviews some of the challenges of "piloting" a unmanned aircraft. The topic include the pilot-vehicle interact design, the concept of pilot/operator, and role of NASA's Ikhana UAS in the western states fire mission.

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

PubMed

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

2007-01-01

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

Clinical outcome and quality of life after reoperative CABG: off-pump versus on-pump – observational pilot study

PubMed Central

2013-01-01

Background Coronary artery bypass grafting (CABG) on cardiopulmonary bypass (CBP) is associated with significant morbidity and mortality. In high-risk patients, doomed for reoperation the adverse effects of CBP may be more striking. We evaluated the results of reoperative CABG (redo-CABG) by either off-pump (OPCAB) or on-pump (ONCAB). Clinical endpoints were perioperative myocardial infarction, mortality, survival and as the most striking difference between prior studies the quality of life (QoL). Methods We performed a prospective, non-randomized assessment for patients who underwent redo-CABG by redo-OPCAB (n = 40) or redo-ONCAB (n = 40) at our institution between January 2007 and December 2010. For evaluation of QoL the SF-36 health survey was used with self-administered assessment. Results During follow-up 37 of 40 patients were alive in the redo-OPCAB group versus 32 of 40 patients in the redo-ONCAB group (p < 0.05). The shorter operation time, less blood loss, fewer perioperative myocardial infarctions, the higher rate of totally arterial revascularisation and shorter intensive care stay were the significantly beneficial differences for patients in the redo-OPCAB group (p < 0.05). The 3-year survival rate was higher in the redo-OPCAB group with 81 ± 12% versus 63 ± 9%in the redo-ONCAB group. The quality of life survey did not reveal any significant differences between both groups. Conclusion In conclusion, with our present retrospective study, we could demonstrate the safety and efficacy of the redo-OPCAB technique with even higher 3-year survival rate. Both techniques seem to have similar impact on the outcome of patients. PMID:23561396

Novel Estimation of Pilot Performance Characteristics

NASA Technical Reports Server (NTRS)

Bachelder, Edward N.; Aponso, Bimal

2017-01-01

Two mechanisms internal to the pilot that affect performance during a tracking task are: 1) Pilot equalization (i.e. lead/lag); and 2) Pilot gain (i.e. sensitivity to the error signal). For some applications McRuer's Crossover Model can be used to anticipate what equalization will be employed to control a vehicle's dynamics. McRuer also established approximate time delays associated with different types of equalization - the more cognitive processing that is required due to equalization difficulty, the larger the time delay. However, the Crossover Model does not predict what the pilot gain will be. A nonlinear pilot control technique, observed and coined by the authors as 'amplitude clipping', is shown to improve stability, performance, and reduce workload when employed with vehicle dynamics that require high lead compensation by the pilot. Combining linear and nonlinear methods a novel approach is used to measure the pilot control parameters when amplitude clipping is present, allowing precise measurement in real time of key pilot control parameters. Based on the results of an experiment which was designed to probe workload primary drivers, a method is developed that estimates pilot spare capacity from readily observable measures and is tested for generality using multi-axis flight data. This paper documents the initial steps to developing a novel, simple objective metric for assessing pilot workload and its variation over time across a wide variety of tasks. Additionally, it offers a tangible, easily implementable methodology for anticipating a pilot's operating parameters and workload, and an effective design tool. The model shows promise in being able to precisely predict the actual pilot settings and workload, and observed tolerance of pilot parameter variation over the course of operation. Finally, an approach is proposed for generating Cooper-Harper ratings based on the workload and parameter estimation methodology.

14 CFR 183.23 - Pilot examiners.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 3 2011-01-01 2011-01-01 false Pilot examiners. 183.23 Section 183.23... REGULATIONS REPRESENTATIVES OF THE ADMINISTRATOR Kinds of Designations: Privileges § 183.23 Pilot examiners. Any pilot examiner, instrument rating examiner, or airline transport pilot examiner may— (a) As...

14 CFR 183.23 - Pilot examiners.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 3 2010-01-01 2010-01-01 false Pilot examiners. 183.23 Section 183.23... REGULATIONS REPRESENTATIVES OF THE ADMINISTRATOR Kinds of Designations: Privileges § 183.23 Pilot examiners. Any pilot examiner, instrument rating examiner, or airline transport pilot examiner may— (a) As...

Pilot-Wave Hydrodynamics

NASA Astrophysics Data System (ADS)

Bush, John W. M.

2015-01-01

Yves Couder, Emmanuel Fort, and coworkers recently discovered that a millimetric droplet sustained on the surface of a vibrating fluid bath may self-propel through a resonant interaction with its own wave field. This article reviews experimental evidence indicating that the walking droplets exhibit certain features previously thought to be exclusive to the microscopic, quantum realm. It then reviews theoretical descriptions of this hydrodynamic pilot-wave system that yield insight into the origins of its quantum-like behavior. Quantization arises from the dynamic constraint imposed on the droplet by its pilot-wave field, and multimodal statistics appear to be a feature of chaotic pilot-wave dynamics. I attempt to assess the potential and limitations of this hydrodynamic system as a quantum analog. This fluid system is compared to quantum pilot-wave theories, shown to be markedly different from Bohmian mechanics and more closely related to de Broglie's original conception of quantum dynamics, his double-solution theory, and its relatively recent extensions through researchers in stochastic electrodynamics.

Patient satisfaction with psychotropic drugs: sensitivity to change and relationship to clinical status, quality-of-life, compliance and effectiveness of treatment. Results from a nation-wide 6-month prospective study.

PubMed

Gasquet, Isabelle; Tcherny-Lessenot, Stéphanie; Lépine, Jean-Pierre; Falissard, Bruno

2006-12-01

To see if patient satisfaction with psychotropics (PSP) could be used as a patient-oriented outcome variable in the evaluation of PSP drugs in clinical epidemiological studies, relationships between PSP, clinical status, QoL, compliance and the type of antipsychotic were analyzed. Elements of validation of PSP were also assessed. In a 6-month prospective study, 933 schizophrenic outpatients with initiation or change to their antipsychotic treatment were enrolled. Psychiatrists completed five CGI-SCH scales (positive, negative, cognitive, depressive and global), hospitalization, compliance, and prescription variables. Patients completed PSP, EuroQoL scales, sexual function and compliance variables. A satisfactory structural equation model was obtained showing significant relationships PSP/compliance (coef.=0.16), QoL/PSP (coef.=0.37), clinical status/QoL (coef.=0.61), clinical status/compliance (coef.=0.09). Patients receiving olanzapine were more satisfied than patients receiving other atypicals (coef.=012) and had better clinical status than patients treated with typicals (coef.=0.08). Evolution of PSP was related to clinical status, QoL, and continuation of treatment (all P<001). Sensitivity to change of PSP was moderate (effect size=0.2). PSP produced consistent results in relation to validated outcome variables. However, a single-item measure was not sufficiently sensitive to change. Multi-item questionnaires evaluating different dimensions are needed.

Prospective, multicenter, controlled study of quality of life, psychological adjustment process and medical outcomes of patients receiving a preemptive kidney transplant compared to a similar population of recipients after a dialysis period of less than three years--The PreKit-QoL study protocol.

PubMed

Sébille, Véronique; Hardouin, Jean-Benoit; Giral, Magali; Bonnaud-Antignac, Angélique; Tessier, Philippe; Papuchon, Emmanuelle; Jobert, Alexandra; Faurel-Paul, Elodie; Gentile, Stéphanie; Cassuto, Elisabeth; Morélon, Emmanuel; Rostaing, Lionel; Glotz, Denis; Sberro-Soussan, Rebecca; Foucher, Yohann; Meurette, Aurélie

2016-01-19

Treatment of end stage renal disease has an impact on patients' physical and psychological health, including quality of life (QoL). Nowadays, it is known that reducing the dialysis period has many advantages regarding QoL and medical outcomes. Although preemptive transplantation is the preferred strategy to prevent patients undergoing dialysis, its psychological impact is unknown. Moreover, transplantation can be experienced in a completely different manner among patients who were on dialysis and those who still had a functioning kidney at the time of surgery. Longitudinal data are often collected to allow analyzing the evolution of patients' QoL over time using questionnaires. Such data are often difficult to interpret due to the patients' changing standards, values, or conceptualization of what the questionnaire is intended to measure (e.g. QoL). This phenomenon is referred to as response shift and is often linked to the way the patients might adapt or cope with their disease experience. Whether response shift is experienced in a different way among patients who were on dialysis and those who still had a functioning kidney at time of surgery is unknown and will be studied in the PreKit-QoL study (trial registration number: NCT02154815). Understanding the psychological impact of pre-emptive transplantation is an important issue since it can be associated with long-term patient and graft survival. Adult patients with a pre-emptive transplantation (n = 130) will be prospectively included along with a control group of patients with a pre-transplant dialysis period < 36 months (n = 260). Only first and single kidney transplantation will be considered. Endpoints include: comparison of change between groups in QoL, anxiety and depressive disorders, perceived stress, taking into account response shift. These criteria will be evaluated every 6 months prior to surgery, at hospital discharge, at three and six months, one and two years after transplantation

Epilepsy surgery in a pediatric population: a retrospective study of 129 children from a tertiary care hospital in a developing country along with assessment of quality of life.

PubMed

Dagar, Amit; Chandra, P Sarat; Chaudhary, Kapil; Avnish, Chauhan; Bal, C S; Gaikwad, Shailesh; Garg, Ajay; Sarkar, Chitra; Srivastava, A; Padma, M V; Rekha, Diwedi; Gulati, Sheffali; Paul, Vinod; Prasad, K; Singh, M B; Tripathi, Manjari

2011-01-01

To assess the outcome of a pediatric population operated for drug-resistant epilepsy from a large tertiary care center in India. Retrospectively: quality of life (QOL); prospectively: preoperative assessment included interictal EEG, MRI (as per epilepsy protocol), video-EEG. Ictal SPECT (with subtraction) and PET were performed when required. QOL scores were assessed using the HASS or SSQ for seizure severity, Quality of Life in Childhood Epilepsy (QOLCE) for QOL, and Child Behavior Check List (CBCL) for behavior. 142 were operated from January 2000 to June 2011 by the senior author. 118 patients with at least 1 year of follow-up were included in the study. Mean age at surgery was 9.8 ± 4.3 years. In addition, 40 patients underwent QOL assessment prospectively both before and after surgery. Mean duration of epilepsy was 5.3 ± 3.3 years. A class I outcome (Engel's) was seen in 79.5% patients, class II in 8.6%, class III in 10.7%, and class IV in 1 patient. As per surgical procedures, class I outcome in patients who underwent temporal resection, hemispherotomy and extratemporal resection was 76, 87 and 72%, respectively. QOL scores correlated with duration of seizures, epileptic encephalopathy and outcome of surgery, but not with side of surgery, age and sex. This study, the largest reported from India, has demonstrated satisfactory results for epilepsy surgery in children. Copyright © 2011 S. Karger AG, Basel.

33 CFR 385.12 - Pilot projects.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 3 2010-07-01 2010-07-01 false Pilot projects. 385.12 Section... Processes § 385.12 Pilot projects. (a) The Plan includes pilot projects to address uncertainties associated... management, and wastewater reuse. The purpose of the pilot projects is to develop information necessary to...

14 CFR 23.771 - Pilot compartment.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Pilot compartment. 23.771 Section 23.771... Cargo Accommodations § 23.771 Pilot compartment. For each pilot compartment— (a) The compartment and its equipment must allow each pilot to perform his duties without unreasonable concentration or fatigue; (b...

14 CFR 61.51 - Pilot logbooks.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Pilot logbooks. 61.51 Section 61.51... CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND INSTRUCTORS General § 61.51 Pilot logbooks. (a) Training... training device, or aviation training device, as appropriate. (v) The name of a safety pilot, if required...

14 CFR 29.771 - Pilot compartment.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Pilot compartment. 29.771 Section 29.771... Pilot compartment. For each pilot compartment— (a) The compartment and its equipment must allow each pilot to perform his duties without unreasonable concentration or fatigue; (b) If there is provision for...

14 CFR 61.51 - Pilot logbooks.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false Pilot logbooks. 61.51 Section 61.51... CERTIFICATION: PILOTS, FLIGHT INSTRUCTORS, AND GROUND INSTRUCTORS General § 61.51 Pilot logbooks. (a) Training... training device, or aviation training device, as appropriate. (v) The name of a safety pilot, if required...

33 CFR 385.12 - Pilot projects.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 3 2011-07-01 2011-07-01 false Pilot projects. 385.12 Section... Processes § 385.12 Pilot projects. (a) The Plan includes pilot projects to address uncertainties associated... management, and wastewater reuse. The purpose of the pilot projects is to develop information necessary to...

14 CFR 29.771 - Pilot compartment.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Pilot compartment. 29.771 Section 29.771... Pilot compartment. For each pilot compartment— (a) The compartment and its equipment must allow each pilot to perform his duties without unreasonable concentration or fatigue; (b) If there is provision for...

33 CFR 385.12 - Pilot projects.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 3 2014-07-01 2014-07-01 false Pilot projects. 385.12 Section... Processes § 385.12 Pilot projects. (a) The Plan includes pilot projects to address uncertainties associated... management, and wastewater reuse. The purpose of the pilot projects is to develop information necessary to...