WorldWideScience

Sample records for clinical observational study

  1. Use of maraviroc in clinical practice: a multicenter observational study

    Directory of Open Access Journals (Sweden)

    C Dentone

    2012-11-01

    Full Text Available Purpose of the study: Promising research suggest that maraviroc (MVC has favourable clinical outcome in HIV-infected patients (pts. Aim of the study is to assess: durability, safety profile and immunovirological recovery in a large MVC-based cohort. Methods: All HIV pts treated with antiretroviral therapy (ART containing MVC for at least 6 months (all viruses CCR-5 tropic analyzed by genotypic and phenotypic test were recruited in an observational multicenter study. Eight Infectious Diseases Centers in Liguria and Piedmont (Italy collected at baseline and every 3 months demographics, clinical and immunovirological data on a web-based system (by MedinfoDist, University of Genoa. We used SPSS for Pearson Chi square test and for generalized estimating equation (GEE; in this model for longitudinal data and frequency analysis we considered altered: TCD4+≤350/mmc, HIVRNA>50 cp/ml, total cholesterol >200 mg/dl, triglycerides >160 mg/dl, transaminase>40 mg/dl, creatinine>1.3 mg/dl and we divided data in 5 time periods: baseline, 1–6, 9–12, 15–24 and 24–45 months. Summary of results: We enrolled 55 pts: 36 (65% males, median age 49.6 years (yrs (range [r] 18.2–76.6, IQR 44.5–53.3, 11 (20% HCVRNA-positive, 4 (7% HBsAg-positive, 1 both infection. Twenty-four (44% pts were classified as CDC C stage, median nadir TCD4+ was 219/mmc (r 11-529, IQR 125–317, median duration of ART was 15.3 yrs (r 1.3–27.3, IQR 12–16.8, median duration of treatment with MVC was 23 months (r 6–47, IQR 14–36. At baseline 42 (76% pts had HIVRNA >50 cp/ml, 11 (20% HIVRNA≤50 cp/ml, 2 (4% pts no data; on treatment at the last examination 53 pts (96% had HIVRNA≤50 cp/ml, 2 pts still had HIVRNA>50 cp/ml (CCR5 tropic and median TCD4+ count was 469/mmc (r 73–1802, IQR 302–592. One pt died and only 2 pts shifted to X4. Chi square test at 9–12 months showed p=0.0001 and the 80% of pts had TCD4+>350/mmc; at the same observation time 83.3% of pts had HIVRNA

  2. Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis.

    Science.gov (United States)

    Lopetegui, Marcelo A; Bai, Shasha; Yen, Po-Yin; Lai, Albert; Embi, Peter; Payne, Philip R O

    2013-01-01

    Understanding clinical workflow is critical for researchers and healthcare decision makers. Current workflow studies tend to oversimplify and underrepresent the complexity of clinical workflow. Continuous observation time motion studies (TMS) could enhance clinical workflow studies by providing rich quantitative data required for in-depth workflow analyses. However, methodological inconsistencies have been reported in continuous observation TMS, potentially reducing the validity of TMS' data and limiting their contribution to the general state of knowledge. We believe that a cornerstone in standardizing TMS is to ensure the reliability of the human observers. In this manuscript we review the approaches for inter-observer reliability assessment (IORA) in a representative sample of TMS focusing on clinical workflow. We found that IORA is an uncommon practice, inconsistently reported, and often uses methods that provide partial and overestimated measures of agreement. Since a comprehensive approach to IORA is yet to be proposed and validated, we provide initial recommendations for IORA reporting in continuous observation TMS.

  3. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    Directory of Open Access Journals (Sweden)

    Oguzhan Sıtkı Dizdar

    2016-02-01

    Full Text Available Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002 and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40, 46.6% (n = 29, 39.7% (n = 27, 35.3% (n = 24, 14.1% (n = 9, respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission.

  4. Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study).

    Science.gov (United States)

    Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin; Lee, Woo Je; Lee, Byung-Wan

    2017-01-01

    The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration (P < 0.0001), baseline HbA1c (P < 0.0001), and DC type (P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea.

  5. Coronary revascularization in ischemic heart disease: lessons from observational studies and randomized clinical trials

    NARCIS (Netherlands)

    N.F. Mercado (Nestor)

    2003-01-01

    textabstractThis thesis presents an overview of clinical trials and observational studies on coronary revascularization and evaluates the results obtained with revascularization in different subsets of patients treated with percutaneous coronary intervention or coronary artery bypass

  6. The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.

    Science.gov (United States)

    Chan, Yu-Feng Yvonne; Wang, Pei; Rogers, Linda; Tignor, Nicole; Zweig, Micol; Hershman, Steven G; Genes, Nicholas; Scott, Erick R; Krock, Eric; Badgeley, Marcus; Edgar, Ron; Violante, Samantha; Wright, Rosalind; Powell, Charles A; Dudley, Joel T; Schadt, Eric E

    2017-04-01

    The feasibility of using mobile health applications to conduct observational clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment, consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys, devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires. Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.

  7. Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study

    Directory of Open Access Journals (Sweden)

    Sunghwan Suh

    2017-01-01

    Full Text Available The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM. Data were pooled from the vildagliptin postmarketing survey (PMS, the vildagliptin/metformin fixed drug combination (DC PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC. The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%, receiving care at the hospital versus clinic (67.95% versus 52.33%, and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%. Multivariate logistic regression analysis indicated that disease duration (P<0.0001, baseline HbA1c (P<0.0001, and DC type (P=0.0103 had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea.

  8. Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study

    OpenAIRE

    van Halsema, CL; Chihota, VN; Gey van Pittius, NC; Fielding, KL; Lewis, JJ; van Helden, PD; Churchyard, GJ; Grant, AD

    2015-01-01

    Background. The clinical relevance of nontuberculous mycobacteria (NTM), detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. Methods. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and ...

  9. To belong or not to belong: nursing students' interactions with clinical learning environments - an observational study.

    Science.gov (United States)

    Liljedahl, Matilda; Björck, Erik; Kalén, Susanne; Ponzer, Sari; Bolander Laksov, Klara

    2016-08-05

    Belongingness has been argued to be a prerequisite for students' learning in the clinical setting but making students feel like they belong to the workplace is a challenge. From a sociocultural perspective, workplace participatory practices is a framework that views clinical learning environments to be created in interaction between students and the workplace and hence, are dependent on them both. The aim of this study was to explore the interdependence between affordances and engagement in clinical learning environments. The research question was: How are nursing students influenced in their interactions with clinical learning environments? An observational study with field observations and follow-up interviews was performed. The study setting comprised three academic teaching hospitals. Field observations included shadowing undergraduate nursing students during entire shifts. Fifty-five hours of field observations and ten follow-up interviews with students, supervisors and clinical managers formed the study data. A thematic approach to the analysis was taken and performed iteratively with the data collection. The results revealed that students strived to fill out the role they were offered in an aspirational way but that they became overwhelmed when given the responsibility of care. When students' basic values did not align with those enacted by the workplace, they were not willing to compromise their own values. Workplaces succeeded in inviting students into the community of nurses and the practice of care. Students demonstrated hesitance regarding their desire to belong to the workplace community. The results imply that the challenge for clinical education is not to increase the experience of belongingness but to maintain students' critical and reflective approach to health care practice. Additionally, results suggest students to be included as an important stakeholder in creating clinical learning environments rather than being viewed as consumer of clinical

  10. Identifying Opportunities for Peer Learning: An Observational Study of Medical Students on Clinical Placements.

    Science.gov (United States)

    Tai, Joanna H; Canny, Benedict J; Haines, Terry P; Molloy, Elizabeth K

    2017-01-01

    Phenomenon: Peer assisted learning (PAL) is frequently employed and researched in preclinical medical education. Fewer studies have examined PAL in the clinical context: These have focused mainly on the accuracy of peer assessment and potential benefits to learner communication and teamwork skills. Research has also examined the positive and negative effects of formal, structured PAL activities in the clinical setting. Given the prevalence of PAL activities during preclinical years, and the unstructured nature of clinical placements, it is likely that nonformal PAL activities are also undertaken. How PAL happens formally and informally and why students find PAL useful in this clinical setting remain poorly understood. This study aimed to describe PAL activities within the context of clinical placement learning and to explore students' perceptions of these activities. An ethnographic study was conducted to gather empirical data on engagement in clinical placement learning activities, including observations and interviews with students in their 1st clinical year, along with their supervising clinicians. Thematic analysis was used to interrogate the data. On average, students used PAL for 5.19 hours per week in a range of activities, of a total of 29.29 hours undertaking placements. PAL was recognized as a means of vicarious learning and had greater perceived value when an educator was present to guide or moderate the learning. Trust between students was seen as a requirement for PAL to be effective. Students found passive observation a barrier to PAL and were able to identify ways to adopt an active stance when observing peers interacting with patients. For example, learners reported that the expectation that they had to provide feedback to peers after task observation, resulted in them taking on a more critical gaze where they were encouraged to consider notions of good practice. Insights: Students use PAL in formal (i.e., tutorial) and nonformal (e.g., peer

  11. Admission interview scores are associated with clinical performance in an undergraduate physiotherapy course: an observational study.

    Science.gov (United States)

    Edgar, Susan; Mercer, Annette; Hamer, Peter

    2014-12-01

    The purpose of this study was to determine if there is an association between admission interview score and subsequent academic and clinical performance, in a four-year undergraduate physiotherapy course. Retrospective observational study. 141 physiotherapy students enrolled in two entry year groups. Individual student performance in all course units, practical examinations, clinical placements as well as year level and overall Grade Point Average. Predictor variables included admission interview scores, admission academic scores and demographic data (gender, age and entry level). Interview score demonstrated a significant association with performance in three of six clinical placements through the course. This association was stronger than for any other admission criterion although effect sizes were small to moderate. Further, it was the only admission score to have a significant association with overall Clinical Grade Point Average for the two year groups analysed (r=0.322). By contrast, academic scores on entry showed significant associations with all year level Grade Point Averages except Year 4, the clinical year. This is the first study to review the predictive validity of an admission interview for entry into a physiotherapy course in Australia. The results show that performance in this admission interview is associated with overall performance in clinical placements through the course, while academic admission scoring is not. These findings suggest that there is a role for both academic and non-academic selection processes for entry into physiotherapy. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  12. Observational study of patient and surgeon preoperative preparation in ten companion animal clinics in Ontario, Canada.

    Science.gov (United States)

    Anderson, Maureen E C; Foster, Brittany A; Weese, J Scott

    2013-10-05

    Surgical site infections (SSIs) are a recognized risk of any surgical procedure in veterinary medicine. One of the keys to prevention of SSIs is reducing exposure of the surgical site to endogenous and exogenous microbes, beginning in the preoperative period. While guidelines are available for preoperative preparation procedures, there has been no objective investigation of compliance with these recommendations in veterinary practices. The objectives of this pilot study were to describe preoperative patient and surgeon preparation practices in a sample of non-equine companion animal veterinary clinics, and to determine if there were any areas that consistently did not meet current guidelines. Observation of preparation practices was performed in 10 clinics over 9-14 days each using up to 3 small wireless surveillance cameras. Data were coded for 148 surgical patients, and 31 surgeons performing 190 preoperative preparations. When patient hair removal was observed, it was most commonly done using clippers (117/133, 88%), and in only one case was it performed prior to anesthetic induction. Patient contact time with soap ranged from 10-462 s (average of clinic means 75 s, average of clinic medians 67 s), and with alcohol from 3-220 s (average of clinic means 44 s, average of clinic medians 37 s). Alcohol-based hand rub (AHR) was used preoperatively in 2/10 facilities, but soap-and-water hand scrub was most commonly used at all clinics. Proximal-to-distal scrubbing was noted in 95/142 (67%) of soap-and-water scrubs. Contact time during surgeon hand preparation ranged from 7-529 s (average mean 121 s, average median 122 s) for soap-and-water and from 4-123 s (average mean 25 s, average median 19 s) for AHR. No significant changes in practices were identified over time during the observation period. Practices that did not conform to guidelines available in major companion animal surgical textbooks were commonly observed. Some preoperative preparation practices were

  13. Using direct clinical observation to assess the quality of cesarean delivery in Afghanistan: an exploratory study.

    Science.gov (United States)

    Evans, Cherrie Lynn; Kim, Young Mi; Yari, Khalid; Ansari, Nasratullah; Tappis, Hannah

    2014-05-27

    As part of a National Emergency Obstetric and Newborn Care (EmONC) Needs Assessment, a special study was undertaken in July 2010 to examine the quality of cesarean deliveries in Afghanistan and examine the utility of direct clinical observation as an assessment method in low-resource settings. This cross-sectional assessment of the quality of cesareans at 14 facilities in Afghanistan included a survey of surgeons regarding their routine cesarean practices, direct observation of 29 cesarean deliveries and comparison of observations with facility records for 34 additional cesareans conducted during the 3 days prior to the observation period at each facility. For both observed cases and record reviews, we assessed time intervals between specified points of care-arrival to the ward, first evaluation, detection of a complication, decision for cesarean, incision, and birth. All time intervals with the exception of "decision to skin incision" were longer in the record reviews than in observed cases. Prior cesarean was the most common primary indication for all cases. All mothers in both groups observed survived through one hour postpartum. Among newborns there were two stillbirths (7%) in observed births and seven (21%) record reviews. Although our sample is too small to show statistical significance, the difference is noteworthy. In six of the reviewed cesareans resulting in stillbirth, a fetal heart rate was recorded in the operating theater, although four were recorded as macerated. For the two fresh stillbirths, the cesarean surgeries were recorded as scheduled and not urgent. Direct observation of cesarean deliveries enabled us to assess a number of preoperative, postoperative, and intraoperative procedures that are often not described in medical records in low resource settings. Comparison of observations with findings from provider interviews and facility records allowed us to infer whether observed practices were typical of providers and facilities and detect

  14. Clinical observed performance evaluation: a prospective study in final year students of surgery.

    LENUS (Irish Health Repository)

    Markey, G C

    2010-06-24

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series of assessments in a 25-week teaching programme. Over time, several clinicians from a pool of 16 surgical consultants and registrars evaluated each student by direct observation. A structured rating form was used for assessment data. Variance component analysis (VCA), internal consistency and inter-rater agreement were used to estimate reliability. The predictive and convergent validity of COPE in relation to summative OSCE, long case, and overall final examination was estimated. Median number of COPE assessments per student was 7. Generalisability of a mean score over 7 COPE assessments was 0.66, equal to that of an 8 x 7.5 min station final OSCE. Internal consistency was 0.88-0.97 and inter-rater agreement 0.82. Significant correlations were observed with OSCE performance (R = 0.55 disattenuated) and long case (R = 0.47 disattenuated). Convergent validity was 0.81 by VCA. Overall final examination performance was linearly related to mean COPE score with standard error 3.7%. COPE permitted efficient serial assessment of a large cohort of final year students in a real world setting. Its psychometric quality compared well with conventional assessments and with other direct observation instruments as reported in the literature. Effect on learning, and translation to clinical care, are directions for future research.

  15. Governing body nurses' experiences of clinical commissioning groups: an observational study of two clinical commissioning groups (CCGs) in England

    OpenAIRE

    Allan, Helen T.; Dixon, Roz; Lee, Gay; Savage, Jan; Tapson, Christine

    2017-01-01

    Clinical commissioning groups (CCGs) were set up under the Health & Social Care Act (2012) in England to commission healthcare services for local communities. Governing body nurses (GBNs) provide nursing leadership to commissioning services on CCGs. Little is known about how nurses function on clinical commissioning groups. We conducted observations of seven formal meetings, three informal observation sessions, and seven interviews from January 2015 to July 2015 in two CCGs in the South of En...

  16. Clinical Research Methodology 2: Observational Clinical Research.

    Science.gov (United States)

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

    Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.

  17. Factors Related to Early Clinical Effects of Quetiapine Extended-Release: A Multinational, Prospective, Observational Study.

    Science.gov (United States)

    Molina, Luis; Recinos, Byron; Paz, Bezner; Rovelo, Mauricio; Elias Rodriguez, Fanny Elizabeth; Calderón, José; Arellano, Arturo; Pomata, Santiago; Rey, María Verónica; Perez-Lloret, Santiago

    2016-06-01

    The first weeks of treatment with antipsychotics are important for the development of their long-term efficacy. The objective of this study was to identify factors related to early clinical effects and quality of life (QoL) improvements with quetiapine extended-release (XR). Six hundred and sixty-five patients starting with quetiapine XR were followed up for 8 weeks (schizophrenia = 153, major depression = 200, bipolar depression = 252, other psychiatric conditions = 60). Clinical effects were assessed by the Clinical Global Impression of Change scale (CGI-C), QoL by the visual analog scale (VAS) of the EQ-5D (QoL-VAS), and adherence by the Moriksy scale. Adverse events were explored: movement disorders by the UKU and Simpson-Angus scales, weight gain by calibrated balances, and diurnal somnolence by the Epworth Somnolence Scale (ESS). The mean dose of quetiapine XR during follow-up was 195.6 ± 154.8 mg/day. CGI and QoL-VAS scores improved significantly at week 8 by 2.7 ± 0.1 points and 25.1 ± 0.9 points. Adverse events were observed in 34 and 26 % of patients at weeks 4 and 8, respectively. A significant reduction in ESS score was also observed at week 8. Factors independently associated with change in QoL-VAS ≥20 points (n = 292, 43 %) were female gender, more severe disease at baseline, higher antipsychotic dose during follow-up, and improvements in somnolence. Factors independently associated with clinically significant improvement (CGI-C ≥5, n = 610, 93 %) were greater change in QoL-VAS, less frequent movement disorders at baseline, and lack of adverse events during follow-up, especially somnolence. Results from this real-setting, large observational study in Central America suggest that disease severity at baseline, gender, antipsychotic dose, and occurrence of adverse reactions has a significant impact on the early clinical effects of quetiapine XR. Clinicaltrials.gov registration number NCT02409823.

  18. Increased healing in diabetic toe ulcers in a multidisciplinary foot clinic-An observational cohort study.

    Science.gov (United States)

    Almdal, T; Nielsen, A Anker; Nielsen, K E; Jørgensen, M E; Rasmussen, A; Hangaard, S; Siersma, V; Holstein, P E

    2015-12-01

    To study toe ulcer healing in patients with diabetic foot ulcers attending a multidisciplinary foot clinic over a 10 years period. The study was retrospective, consecutive and observational during 2001 through 2011. The patients were treated according to the International Consensus on the Diabetic Foot. During the period the chiropodist staffing in the foot clinic was doubled; new offloading material and orthopedic foot corrections for recalcitrant ulcers were introduced. Healing was investigated in toe ulcers in Cox regression models. 2634 patients developed foot ulcers, of which 1461 developed toe ulcers; in 790 patients these were neuropathic, in 551 they were neuro-ischemic and in 120 they were critically ischemic. One-year healing rates increased in the period 2001-2011 from 75% to 91% for neuropathic toe ulcers and from 72% to 80% for neuro-ischemic toe ulcers, while no changes was observed for ischemic toe ulcers. Adjusted for changes in the patient population, the overall rate of healing for neuropathic and neuro-ischemic toe ulcers almost doubled (HR=1.95 [95% CI: 1.36-2.80]). The results show that the healing of toe ulcers improved. This outcome could not be explained by changes in the patient characteristics, but coincided with a number of improvements in organization and therapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  19. Ethnic bias and clinical decision-making among New Zealand medical students: an observational study.

    Science.gov (United States)

    Harris, Ricci; Cormack, Donna; Stanley, James; Curtis, Elana; Jones, Rhys; Lacey, Cameron

    2018-01-23

    Health professional racial/ethnic bias may impact on clinical decision-making and contribute to subsequent ethnic health inequities. However, limited research has been undertaken among medical students. This paper presents findings from the Bias and Decision-Making in Medicine (BDMM) study, which sought to examine ethnic bias (Māori (indigenous peoples) compared with New Zealand European) among medical students and associations with clinical decision-making. All final year New Zealand (NZ) medical students in 2014 and 2015 (n = 888) were invited to participate in a cross-sectional online study. Key components included: two chronic disease vignettes (cardiovascular disease (CVD) and depression) with randomized patient ethnicity (Māori or NZ European) and questions on patient management; implicit bias measures (an ethnicity preference Implicit Association Test (IAT) and an ethnicity and compliant patient IAT); and, explicit ethnic bias questions. Associations between ethnic bias and clinical decision-making responses to vignettes were tested using linear regression. Three hundred and two students participated (34% response rate). Implicit and explicit ethnic bias favoring NZ Europeans was apparent among medical students. In the CVD vignette, no significant differences in clinical decision-making by patient ethnicity were observed. There were also no differential associations by patient ethnicity between any measures of ethnic bias (implicit or explicit) and patient management responses in the CVD vignette. In the depression vignette, some differences in the ranking of recommended treatment options were observed by patient ethnicity and explicit preference for NZ Europeans was associated with increased reporting that NZ European patients would benefit from treatment but not Māori (slope difference 0.34, 95% CI 0.08, 0.60; p = 0.011), although this was the only significant finding in these analyses. NZ medical students demonstrated ethnic bias, although

  20. [Learning in clinical simulation: observational study on satisfaction perceived by students of nursing].

    Science.gov (United States)

    Rubbi, Ivan; Ferri, Paola; Andreina, Giulia; Cremonini, Valeria

    2016-01-01

    Simulation in the context of the educational workshop is becoming an important learning method, as it allows to play realistic clinical-care situations. These vocational training activities promote the development of cognitive, affective and psychomotor skills in a pedagogical context safe and risk-free, but need to be accounted for using by valid and reliable instruments. To inspect the level of satisfaction of the students of a Degree in Nursing in northern Italy about static and high-fidelity exercises with simulators and clinical cases. A prospective observational study has been conducted involving a non-probabili- stic sample of 51 third-year students throughout the academic year 2013/14. The data collection instrument consists of three questionnaires Student Satisfaction and Self-confidence in Learning Scale, Educational Practices Questionnaire, Simulation Design Scale and 3 questions on overall satisfaction. Statistical analysis was performed with SPSS 20.0 and Office 2003 Excel. The response rate of 89.5% is obtained. The Cronbach Alfa showed a good internal reliability (α = .982). The students were generally satisfied with the activities carried out in the teaching laboratory, showing more enthusiasm for the simulation with static mannequins (71%) and with high-fidelity simulators (60%), activities for which they have experienced a significant involvement and active learning. The teaching with clinical cases scored a lesser degree of satisfaction (38%) and for this method it was found the largest number of elements of weakness.

  1. Prevalence and clinical features of atrial fibrillation in diabetic neuropathy: a cross-sectional, observational study.

    Science.gov (United States)

    Koçağra Yağız, İdil Gökçen; Bayata, Serdar; Yeşil, Murat; Kurt İncesu, Tülay; Arıkan, Erdinç; Postacı, Nursen

    2012-12-01

    This cross-sectional, observational study investigated prevalence and clinical features of atrial fibrillation (AF) in diabetic patient groups with or without autonomic neuropathy. One hundred and fourteen consecutive patients with pharmacologically treated type-II diabetes mellitus were enrolled for this study in our institution between January 2010 and December 2010. All patients underwent 12-lead electrocardiography on the day of enrollment for AF detection. All diabetic patients underwent neurologic examination for the presence of diabetic autonomic neuropathy (DAN). Following clinical evaluation, sympathetic skin responses (SSR) and RR interval variability (RRIV) analysis were used for the detection of autonomic neurologic involvement. Patients were divided into two groups according to presence (Group 1) or absence (Group 2) of DAN. Patient groups with or without DAN were compared for AF occurrence. Continuous and categorical data were compared with independent samples t- test and Chi-square statistical tests respectively. Atrial fibrillation prevalence was 24% (n=29) in study population. Diabetic autonomic neuropathy was diagnosed in 47 (39%) patients. Basal characteristics of patients with or without DAN were comparable except glycosylated hemoglobin A (HbA1c) levels. HbA1c levels were found significantly higher in patients with DAN. Atrial fibrillation was diagnosed in 14 patients in Group 1 and in 15 patients in Group 2. Significantly increased AF prevalence (31.9% vs. 20.8%, p=0.014, in groups with and without DAN respectively) was observed in patient group with diabetic autonomic neuropathy. The results of this study demonstrated an increased prevalence of AF in patients with diabetic autonomic neuropathy compared with non-neuropathic, diabetic patients. Further investigation of this relation with prospective studies is needed to demonstrate a causal relationship between diabetic autonomic neuropathy and AF.

  2. Clinical Impact Research - how to choose experimental or observational intervention study?

    Science.gov (United States)

    Malmivaara, Antti

    2016-11-01

    Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

  3. Celiac disease: clinical observations

    Directory of Open Access Journals (Sweden)

    Yu. A. Emel’yanova

    2016-01-01

    Full Text Available Presented clinical cases of patients with a diagnosis of gluten enteropathy in treatment in the department of gastroenterology Regional Clinical Hospital. The case is of interest to doctors of different specialties for the differential diagnosis of anemia and malabsorption syndrome, demonstrate both the classic version, and atypical forms of the disease course. Diagnosis of celiac disease is based on three key positions: clinical findings, histology and serological markers. The clinical picture of celiac disease is characterized by pronounced polymorphism, by going beyond the a gastroenterological pathology. For screening of gluten sensitive celiac typically used an antibody to tissue transglutaminase. Morphological research of the mucous membrane of the small intestine is the determining criterion in the diagnosis of celiac disease. The use of specific gluten-free diet leads to the positive dynamics of the disease and improve the quality of life of patients.

  4. Clinical observations in thrombocytopenia:

    NARCIS (Netherlands)

    M.C. Kappers-Klunne (Mies)

    2006-01-01

    textabstractWe investigated clinical and laboratory aspects in three different situations of thrombocytopenia in which an immune mechanism is active, i.e. thrombocytopenia caused by autoantibodies (thrombocytopenia induced by the anticoagulant drug heparin (HITT) and immune thrombocytopenic

  5. Agomelatine in the treatment of depressive disorders in clinical practice: multicenter observational CHRONOS study

    Directory of Open Access Journals (Sweden)

    Ivanov SV

    2014-04-01

    Full Text Available Stanislav V Ivanov, Marina A Samushiya Department of “Borderline” Mental Pathology and Psychosomatic Disorders, Mental Health Research Center of the Russian Academy of Medical Science, Moscow, Russian Federation Background: CHRONOS was a large naturalistic study designed to evaluate the effectiveness and safety of agomelatine in the management of patients with major depression in routine clinical practice. Methods: Patients (n=6,276 with a moderate or severe major depressive episode without psychotic symptoms were treated initially as outpatients (80.2% or in psychiatric facilities (19.8% in 54 regions of the Russian Federation. Patients received a flexible-dosing regimen of agomelatine 25 mg or 50 mg once daily for 8 weeks, with frequent study visits (weeks 1, 2, 3, 4, 6, and 8. Results: Patients (mean age 44 years, 72.6% female showed progressive improvement on the 17-item Hamilton Rating Scale for Depression (HAMD-17 total score from 22±6.9 at baseline to 4.7±4.7 at week 8 (P<0.0001. The proportion of responders (HAMD-17 decrease of ≥50% was 90.1% and the proportion of remitters (HAMD-17 <7 was 79.1% at week 8. All individual HAMD-17 item scores improved rapidly, and the change relative to baseline was significant (P<0.0001 at week 1 and at each subsequent visit in all cases. There were corresponding rapid improvements in Clinical Global Impression Severity and Improvement scores. In the subgroup of patients with more severe illness (HAMD-17 ≥21 at baseline; n=3,478, the proportions of responders and remitters were 92.4% and 72.8%, respectively, at week 8. Conclusion: Agomelatine was effective and well tolerated in a large sample of depressed patients in an observational treatment setting, and showed a rapid onset of benefit across all HAMD-17 items. Keywords: agomelatine, antidepressant, Hamilton Rating Scale for Depression, major depressive disorder, observational study

  6. Clinical features of severe malaria associated with death: a 13-year observational study in the Gambia.

    Directory of Open Access Journals (Sweden)

    Muminatou Jallow

    Full Text Available Severe malaria (SM is a major cause of death in sub-Saharan Africa. Identification of both specific and sensitive clinical features to predict death is needed to improve clinical management.A 13-year observational study was conducted from 1997 through 2009 of 2,901 children with SM enrolled at the Royal Victoria Teaching Hospital in The Gambia to identify sensitive and specific predictors of poor outcome in Gambian children with severe malaria between the ages 4 months to 14 years. We have measured the sensitivity and specificity of clinical features that predict death or development of neurological sequelae.Impaired consciousness (odds ratio {OR} 4.4 [95% confidence interval {CI}, 2.7-7.3], respiratory distress (OR 2.4 [95%CI, 1.7-3.2], hypoglycemia (OR 1.7 [95%CI, 1.2-2.3], jaundice (OR 1.9 [95%CI, 1.2-2.9] and renal failure (OR 11.1 [95%CI, 3.3-36.5] were independently associated with death in children with SM. The clinical features that showed the highest sensitivity and specificity to predict death were respiratory distress (area under the curve 0.63 [95%CI, 0.60-0.65] and impaired consciousness (AUC 0.61[95%CI, 0.59-0.63], which were comparable to the ability of hyperlactatemia (blood lactate>5 mM to predict death (AUC 0.64 [95%CI, 0.55-0.72]. A Blantyre coma score (BCS of 2 or less had a sensitivity of 74% and specificity of 67% to predict death (AUC 0.70 [95% C.I. 0.68-0.72], and sensitivity and specificity of 74% and 69%, respectively to predict development of neurological sequelae (AUC 0.72 [95% CI, 0.67-0.76].The specificity of this BCS threshold to identify children at risk of dying improved in children less than 3 years of age (AUC 0.74, [95% C.I 0.71-0.76].The BCS is a quantitative predictor of death. A BCS of 2 or less is the most sensitive and specific clinical feature to predict death or development of neurological sequelae in children with SM.

  7. Predicting and communicating risk of clinical deterioration: an observational cohort study of internal medicine residents.

    Science.gov (United States)

    Ratelle, John T; Kelm, Diana J; Halvorsen, Andrew J; West, Colin P; Oxentenko, Amy S

    2015-04-01

    Despite its importance, little is known about internal medicine (IM) residents' ability to assess and communicate a patient's overnight risk during the resident-to-resident handoff. To evaluate IM residents' ability to identify patients at risk for clinical deterioration using the Patient Acuity Rating (PAR) tool (scored on a 1-7 symmetric scale; 1="Extremely unlikely", 7="Extremely likely"), and to measure how well IM residents conveyed a patient's potential for clinical deterioration during day-to-night handoff. Observational cohort study of 46 postgraduate year 1 (PGY-1) and 32 postgraduate year 3 (PGY-3) internal medicine residents rotating on one of four general medicine services from October 2013 through January 2014. Primary outcomes were (1) level of agreement between resident handoff giver and receiver regarding patients' clinical risk and (2) accuracy of resident-assigned PAR score in predicting a patient's risk of clinical deterioration over the subsequent 24 hours. Analysis of PGY-1 giver-receiver handoff agreement revealed an intraclass correlation coefficient (ICC) (95 % CI) of 0.51 (0.45-0.56), while PGY-3 giver-receiver agreement yielded an ICC (95 % CI) of 0.42 (0.36-0.47). Based on 865 ratings of 378 patients, PGY-1 handoff giver PAR scores of 5 and 6+ were significantly associated with increased odds of clinical deterioration within 24 hours (aOR = 6.5 and 12.4; P = 0.03 and 0.005, respectively). For the 1,170 PAR ratings of 438 patients assigned by PGY-3 handoff givers, PAR scores of 4, 5, and 6+ were significantly associated with increased odds of an event within 24 hours (aORs = 6.0, 9.6, and 18.1; P = 0.03, 0.01, and 0.0008, respectively). The PAR is a useful tool to quantify IM residents' judgment of patient stability, and may be particularly valuable during resident handoff, given that the level of agreement between giver and receiver regarding patient risk is only fair.

  8. Semaphorin 3F expression is reduced in pregnancy complicated by preeclampsia. An observational clinical study.

    Science.gov (United States)

    Stallone, Giovanni; Matteo, Maria; Netti, Giuseppe Stefano; Infante, Barbara; Di Lorenzo, Adelaide; Prattichizzo, Clelia; Carlucci, Stefania; Trezza, Federica; Gesualdo, Loreto; Greco, Pantaleo; Grandaliano, Giuseppe

    2017-01-01

    Preeclampsia is a systemic disorder, affecting 2-10% of pregnancies, characterized by a deregulated pro- and anti-angiogenic balance. Semaphorin 3F is an angiogenesis inhibitor. We aimed to investigate whether semaphorin 3F expression is modulated in preeclampsia. We performed two observational single center cohort studies between March 2013 and August 2014. In the first we enrolled 110 consecutive women, undergoing an elective cesarean section; in the second we included 150 consecutive women undergoing amniocentesis for routine clinical indications at 16-18 week of gestation. Semaphorin 3F concentration was evaluated in maternal peripheral blood, venous umbilical blood and amniotic fluid, along with its placenta protein expression at the time of delivery in the first study group and in the amniotic fluid at 16-18 weeks of gestation in the second study group. In the first study 19 patients presented at delivery with preeclampsia. Semaphorin 3F placenta tissue expression was significantly reduced in preeclampsia. In addition, semaphorin 3F level at delivery was significantly lower in serum, amniotic fluid and venous umbilical blood of preeclamptic patients compared with normal pregnant women. In the prospective cohort study 14 women developed preeclampsia. In this setting, semaphorin 3F amniotic level at 16-18 weeks of gestation was reduced in women who subsequently developed preeclampsia compared to women with a normal pregnancy. ROC curve analysis showed that semaphorin 3F amniotic levels could identify women at higher risk of preeclampsia. Semaphorin 3F might represent a predictive biomarker of preeclampsia.

  9. Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study

    Science.gov (United States)

    Peng, Kun; Xu, Keyang; Liu, Luna; Hendricks, Robert; Delarosa, Reginald; Erickson, Rich; Budha, Nageshwar; Leabman, Maya; Song, An; Kaur, Surinder; Fischer, Saloumeh K

    2014-01-01

    RG7652 is a human immunoglobulin 1 (IgG1) monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) and is designed for the treatment of hypercholesterolemia. A target-binding enzyme-linked immunosorbent assay (ELISA) was developed to measure RG7652 levels in human serum in a Phase I study. Although target-binding assay formats are generally used to quantify free therapeutic, the actual therapeutic species being measured are affected by assay conditions, such as sample dilution and incubation time, and levels of soluble target in the samples. Therefore, in the presence of high concentrations of circulating target, the choice of reagents and assay conditions can have a significant effect on the observed pharmacokinetic (PK) profiles. Phase I RG7652 PK analysis using the ELISA data resulted in a nonlinear dose normalized exposure. An investigation was conducted to characterize the ELISA to determine whether the assay format and reagents may have contributed to the PK observation. In addition, to confirm the ELISA results, a second orthogonal method, liquid chromatography tandem mass spectrometry (LC-MS/MS) using a signature peptide as surrogate, was developed and implemented. A subset of PK samples, randomly selected from half of the subjects in the 6 single ascending dose (SAD) cohorts in the Phase I clinical study, was analyzed with the LC-MS/MS assay, and the data were found to be comparable to the ELISA data. This paper illustrates the importance of reagent characterization, as well as the benefits of using an orthogonal approach to eliminate bioanalytical contributions when encountering unexpected observations. PMID:25484037

  10. Daily pilates exercise or inactivity for patients with low back pain: a clinical prospective observational study.

    Science.gov (United States)

    Notarnicola, A; Fischetti, F; Maccagnano, G; Comes, R; Tafuri, S; Moretti, B

    2014-02-01

    Studies have shown the effectiveness of a few weekly pilates sessions as helping to reduce lower back pain (LBP). However many patients fear that physical activity can actually make the pain and disability worse. We carried out this observational prospective clinical study to look at the effects that taking part in daily pilates has one on side and on the other the effects of LBP management without physical exercise. The volunteers who participated in this study were recruited from among some local cultural associations. Patients affected by LBP were evaluated. The subjects were 60 volunteers (27 males and 33 females) with a mean age of 51.2 years who had chronic low back pain (CLBP). They were allocated to pilates group (N.=30) or inactivity control group (N.=30). The pilates group performed one-hour lesson of pilates exercise, 5 lessons per week during the following 6 months. The inactivity group continued with their normal daily activities. The Roland-Morris Disability, the Oswestry, the SF-36 and the Spinal Functional Sort Questionaries of all subjects were measured at the baseline (T1) and at 6 months (T2). At T2 improvements were observed in the pilates group with increases in physical and social functioning, general health and vitality (Pmeasures at T2. We found an important improvement of pain, disability and physical and psychological perception of health in individuals who did the daily sessions of pilates. Some authors underlined the possible risk of a lack of adherence to an exercise program at home. This study suggests that a daily pilates program is effective for the management of CLBP. On the other hand, the inactivity contributes to further worsening, inducing a vicious cycle in which pain and physical activity intolerance follow each other.

  11. Prediction of manifest Huntington's disease with clinical and imaging measures: a prospective observational study.

    Science.gov (United States)

    Paulsen, Jane S; Long, Jeffrey D; Ross, Christopher A; Harrington, Deborah L; Erwin, Cheryl J; Williams, Janet K; Westervelt, Holly James; Johnson, Hans J; Aylward, Elizabeth H; Zhang, Ying; Bockholt, H Jeremy; Barker, Roger A

    2014-12-01

    Although the association between cytosine-adenine-guanine (CAG) repeat length and age at onset of Huntington's disease is well known, improved prediction of onset would be advantageous for clinical trial design and prognostic counselling. We compared various measures for tracking progression and predicting conversion to manifest Huntington's disease. In this prospective observational study, we assessed the ability of 40 measures in five domains (motor, cognitive, psychiatric, functional, and imaging) to predict time to motor diagnosis of Huntington's disease, accounting for CAG repeat length, age, and the interaction of CAG repeat length and age. Eligible participants were individuals from the PREDICT-HD study (from 33 centres in six countries [USA, Canada, Germany, Australia, Spain, UK]) with the gene mutation for Huntington's disease but without a motor diagnosis (a rating below 4 on the diagnostic confidence level from the 15-item motor assessment of the Unified Huntington's Disease Rating Scale). Participants were followed up between September, 2002, and July, 2014. We used joint modelling of longitudinal and survival data to examine the extent to which baseline and change of measures analysed separately was predictive of CAG-adjusted age at motor diagnosis. 1078 individuals with a CAG expansion were included in this analysis. Participants were followed up for a mean of 5·1 years (SD 3·3, range 0·0-12·0). 225 (21%) of these participants received a motor diagnosis of Huntington's disease during the study. 37 of 40 cross-sectional and longitudinal clinical and imaging measures were significant predictors of motor diagnosis beyond CAG repeat length and age. The strongest predictors were in the motor, imaging, and cognitive domains: an increase of one SD in total motor score (motor domain) increased the risk of a motor diagnosis by 3·07 times (95% CI 2·26-4·16), a reduction of one SD in putamen volume (imaging domain) increased risk by 3·32 times (2·37-4

  12. Vitamin K status and vascular calcification: evidence from observational and clinical studies.

    Science.gov (United States)

    Shea, M Kyla; Holden, Rachel M

    2012-03-01

    Vascular calcification occurs when calcium accumulates in the intima (associated with atherosclerosis) and/or media layers of the vessel wall. Coronary artery calcification (CAC) reflects the calcium burden within the intima and media of the coronary arteries. In population-based studies, CAC independently predicts cardiovascular disease (CVD) and mortality. A preventive role for vitamin K in vascular calcification has been proposed based on its role in activating matrix Gla protein (MGP), a calcification inhibitor that is expressed in vascular tissue. Although animal and in vitro data support this role of vitamin K, overall data from human studies are inconsistent. The majority of population-based studies have relied on vitamin K intake to measure status. Phylloquinone is the primary dietary form of vitamin K and available supplementation trials, albeit limited, suggest phylloquinone supplementation is relevant to CAC. Yet observational studies have found higher dietary menaquinone, but not phylloquinone, to be associated with less calcification. Vascular calcification is highly prevalent in certain patient populations, especially in those with chronic kidney disease (CKD), and it is plausible vitamin K may contribute to reducing vascular calcification in patients at higher risk. Subclinical vitamin K deficiency has been reported in CKD patients, but studies linking vitamin K status to calcification outcomes in CKD are needed to clarify whether or not improving vitamin K status is associated with improved vascular health in CKD. This review summarizes the available evidence of vitamin K and vascular calcification in population-based studies and clinic-based studies, with a specific focus on CKD patients.

  13. Extended pelvic lymphadenectomy in patients with clinically localised prostate cancer: A prospective observational study.

    Science.gov (United States)

    Ramos, J G; Caicedo, J I; Cataño, J G; Villarraga, L G; Trujillo, C G; Robledo, D; Plata, M

    2016-09-01

    To determine the frequency of lymph node involvement in patients with clinically localised prostate adenocarcinoma who had radical prostatectomy and extended pelvic lymphadenectomy. A prospective observational study was conducted on 137 patients with clinically localised prostate cancer of low, intermediate or high risk according to the D'Amico classification. All participants underwent radical prostatectomy plus extended pelvic lymphadenectomy in 3 reference centres in Bogota, Colombia, between 2013 and 2014. The following variables were assessed: age, prostate specific antigen levels, Gleason score of the biopsy, probability of lymph node involvement calculated with Partin tables and the histopathology result of the surgical specimen, with the definitive Gleason pattern and the total number of resected and involved lymph nodes per tumour, according to the territory of the dissection. A total of 2,876 lymph nodes were extracted (an average of 20.99 lymph nodes per patient). There was lymph node involvement in 14 (10.22%) patients. The high-risk and intermediate-risk group presented lymph node metastases in 28.57% and 5.25%, respectively. There was no lymph node involvement in the low-risk group. Of the patients at risk of lymph node involvement (≥2% according to the Partin tables), 19.40% had lymph node metastases. Lymph node involvement in our population is similar to that reported in the worldwide literature. Extended pelvic lymphadenectomy increased the probability of detecting lymph node metastases in our community. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Clinical Observation on Hyperthyroidism

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Kyu Bo; Kang, Bann; Song, Suk Ho; Park, Hi Myung; Whnag, Kee Suk [Kyungpook National University School of Medicine, Deagu (Korea, Republic of)

    1969-09-15

    A clinical analysis was made on 161 cases of hyperthyroidism seen at the Radioisotope Laboratory of Kyungpook National University Hospital. This series consisted of 144 cases of diffuse goiter and 17 cases of nodular goiter. 1) Hyperthyroidism was most prevalent in the 4th decade and male to female ratio was 1 : 4.6. 2) Cardinal symptoms in the order of frequency were weakness, easy fatigability, palpitation, weight loss, nervousness, perspiration, heat intolerance, increased appetite, insomnia and dysmenorrhoea. 3) Major physical findings in the order of frequency were goiter, fine tremor, tachycardia, wide pulse pressure, emaciation, warm moist skin, exophthalmos, systolic hypertension and atrial fibrillation. 4) The complications were ophthalmopathy (34.2%), thyrotoxic heart disease (5.6%), thyroid crisis (1 case), pretibial myxedema (1 case) and thyrotoxic myopathy (1 case). 5) Mean values of the six hour and twenty-four hour {sup 131}I uptakes by the thyroid glands were 67.5% and 71.6%, respectively, in diffuse goiter and 64.5% and 65.0%, respectively, in nodular goiter. 6) Mean values of twenty-four PB{sup 131}I conversion ratio were 76.3% in diffuse goiter and 70.2% in nodular goiter and those of the basal metabolic rate was +51% in the former and +41% in the latter. Mean serum cholesterol level was 152 mg% in diffuse goiter and that in nodular goiter was 175 mg%. 7) Among the 134 cases treated with {sup 131}I, 66 cases (49.3%) were successfully controlled with single dose and in the majority of the cases the initial therapeutic dose required was 4.1-4.0 mC in diffuse goiter and 5.1-6.0 mC in nodular goiter. 8) With {sup 131}I treatment the symptoms improved in the following order: heat intolerance, emaciation, nervousness, insomnia, easy fatigability, weakness, fine tremor, goiter, perspiration, exertional dyspnea and palpitation. And in a few cases improvement of even exophthalmos was seen. 9) Following {sup 131}I treatment myxedema occurred in 4 cases (3

  15. [Comparative study of the clinical observation on traumatic perforation of tympanic membrane].

    Science.gov (United States)

    Xin, Wenjun; Zhang, Xiaotong; Cui, Long; Wei, Miao; Yang, Guang; Lei, Juanjuan

    2015-09-01

    To explore the clinical treatment effects of sea buckthorn oil for in different size traumatic perforation of tympanic membrane in different size. Prospective, randomized study of 199 outpatients with traumatic perforation of tympanic membrane who were enrolled between December 2012 and December 2014 after informed consent. The patients were divided into treatment group (101 cases) and control group (98 cases). According to the size of the perforations, patients in each group were divided into large perforation group, middle perforation groups and small perforation group. The cases in large perforation group, middle perforation groups and small perforation group were 36, 34, 31 in treatment group and 35, 33, 30 in control group. The patients in treatment group were treated with sea buckthorn oil once a week, while the patient in control group were self-healing and checked once a week. All the patients were followed-up in two months. The healing rate of two groups was applied for the evaluation indicator of clinical effect. We compared the healing rate, average healing time and phological change of tympanic membrane of patients at the first and second month. The total healing ratio of patients in treatment group is 62.4% and 79.2% compared with 29.6% and 57.1% in control group at the first and second month (P ratios of middle, large perforation groups in treatment group and control group (P ratios of small perforation group in treatment group and control group (P > 0.05). The average healing time of large, middle and small perforation group at the second month are significantly shorter than the control group. It is better to apply observation method and let it self-healed for small traumatic tympanic membrane perforation according to its higher healing ratio. While, it is better to apply sea buckthorn oil method for middle and large traumatic tympanic membrane perforation according to its lower healing ratios. Sea buckthorn oil treatment is benefitial for increasing

  16. Interprofessional communication supporting clinical handover in emergency departments: An observation study.

    Science.gov (United States)

    Redley, Bernice; Botti, Mari; Wood, Beverley; Bucknall, Tracey

    2017-08-01

    Poor interprofessional communication poses a risk to patient safety at change-of-shift in emergency departments (EDs). The purpose of this study was to identify and describe patterns and processes of interprofessional communication impacting quality of ED change-of-shift handovers. Observation of 66 change-of-shift handovers at two acute hospital EDs in Victoria, Australia. Focus groups with 34 nurse participants complemented the observations. Qualitative data analysis involved content and thematic methods. Four structural components of ED handover processes emerged represented by (ABCD): (1) Antecedents; (2) Behaviours and interactions; (3) Content; and (4) Delegation of ongoing care. Infrequent and ad hoc interprofessional communication and discipline-specific handover content and processes emerged as specific risks to patient safety at change-of-shift handovers. Three themes related to risky and effective practices to support interprofessional communications across the four stages of ED handovers emerged: 1) standard processes and practices, 2) teamwork and interactions and 3) communication activities and practices. Unreliable interprofessional communication can impact the quality of change-of-shift handovers in EDs and poses risk to patient safety. Structured reflective analysis of existing practices can identify opportunities for standardisation, enhanced team practices and effective communication across four stages of the handover process to support clinicians to enhance local handover practices. Future research should test and refine models to support analysis of practice, and identify and test strategies to enhance ED interprofessional communication to support clinical handovers. Copyright © 2017 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

  17. Clinical and sonographic risk factors for hemiplegic shoulder pain: A longitudinal observational study.

    Science.gov (United States)

    Kim, Yeo Hyung; Jung, Sung Jin; Yang, Eun Joo; Paik, Nam Jong

    2014-01-01

    To identify baseline risk factors associated with hemiplegic shoulder pain during the first 6 months after a stroke and to investigate changes in these risk factors over time. Longitudinal observational study. A total of 94 patients with first-ever unilateral stroke lesion within 1 month after stroke. Clinical, radiological and sonographic evaluations were performed at baseline. Hemiplegic shoulder pain was assessed at 1, 3 and 6 months post-stroke. Associations between baseline factors and hemiplegic shoulder pain during the first 6 months and hemiplegic shoulder pain at 1, 3 and 6 months poststroke were analysed. Poor arm motor function, indicated by a poor National Institutes of Health Stroke Scale item 5 score (odds ratio (OR) = 3.0; 95% confidence interval (CI) = 1.1-7.7) and the presence of supraspinatus tendon pathology (OR = 4.2; 95% CI = 1.4-12.9), were associated with hemiplegic shoulder pain. While patients with adhesive capsulitis, glenohumeral subluxation, or long head of biceps tendon effusion showed a higher prevalence of hemiplegic shoulder pain at 1 month after stroke, those with supraspinatus tendon pathology showed a higher prevalence at 3 and 6 months. Patients at high risk of hemiplegic shoulder pain with severe arm paralysis and supraspinatus tendon pathology require more careful attention during the rehabilitation period.

  18. Clinical-Genetic Associations in the Prospective Huntington at Risk Observational Study (PHAROS): Implications for Clinical Trials.

    Science.gov (United States)

    Biglan, Kevin Michael; Shoulson, Ira; Kieburtz, Karl; Oakes, David; Kayson, Elise; Shinaman, M Aileen; Zhao, Hongwei; Romer, Megan; Young, Anne; Hersch, Steven; Penney, Jack; Marder, Karen; Paulsen, Jane; Quaid, Kimberly; Siemers, Eric; Tanner, Caroline; Mallonee, William; Suter, Greg; Dubinsky, Richard; Gray, Carolyn; Nance, Martha; Bundlie, Scott; Radtke, Dawn; Kostyk, Sandra; Baic, Corrine; Caress, James; Walker, Francis; Hunt, Victoria; O'Neill, Christine; Chouinard, Sylvain; Factor, Stewart; Greenamyre, Timothy; Wood-Siverio, Cathy; Corey-Bloom, Jody; Song, David; Peavy, Guerry; Moskowitz, Carol; Wesson, Melissa; Samii, Ali; Bird, Thomas; Lipe, Hillary; Blindauer, Karen; Marshall, Frederick; Zimmerman, Carol; Goldstein, Jody; Rosas, Diana; Novak, Peter; Caviness, John; Adler, Charles; Duffy, Amy; Wheelock, Vicki; Tempkin, Teresa; Richman, David; Seeberger, Lauren; Albin, Roger; Chou, Kelvin L; Racette, Brad; Perlmutter, Joel S; Perlman, Susan; Bordelon, Yvette; Martin, Wayne; Wieler, Marguerite; Leavitt, Blair; Raymond, Lynn; Decolongon, Joji; Clarke, Lorne; Jankovic, Joseph; Hunter, Christine; Hauser, Robert A; Sanchez-Ramos, Juan; Furtado, Sarah; Suchowersky, Oksana; Klimek, Mary Lou; Guttman, Mark; Sethna, Rustom; Feigin, Andrew; Cox, Marie; Shannon, Barbara; Percy, Alan; Dure, Leon; Harrison, Madaline; Johnson, William; Higgins, Donald; Molho, Eric; Nickerson, Constance; Evans, Sharon; Hobson, Douglas; Singer, Carlos; Galvez-Jimenez, Nestor; Shannon, Kathleen; Comella, Cynthia; Ross, Christopher; Saint-Hilaire, Marie H; Testa, Claudia; Rosenblatt, Adam; Hogarth, Penelope; Weiner, William; Como, Peter; Kumar, Rajeev; Cotto, Candace; Stout, Julie; Brocht, Alicia; Watts, Arthur; Eberly, Shirley; Weaver, Christine; Foroud, Tatiana; Gusella, James; MacDonald, Marcy; Myers, Richard; Fahn, Stanley; Shults, Clifford

    2016-01-01

    Identifying measures that are associated with the cytosine-adenine-guanine (CAG) expansion in individuals before diagnosis of Huntington disease (HD) has implications for designing clinical trials. To identify the earliest features associated with the motor diagnosis of HD in the Prospective Huntington at Risk Observational Study (PHAROS). A prospective, multicenter, longitudinal cohort study was conducted at 43 US and Canadian Huntington Study Group research sites from July 9, 1999, through December 17, 2009. Participants included 983 unaffected adults at risk for HD who had chosen to remain unaware of their mutation status. Baseline comparability between CAG expansion (≥37 repeats) and nonexpansion (Huntington disease mutation status in individuals with CAG expansion vs without CAG expansion. Unified Huntington's Disease Rating Scale motor (score range, 0-124; higher scores indicate greater impairment), cognitive (symbol digits modality is the total number of correct responses in 90 seconds; lower scores indicate greater impairment), behavioral (score range, 0-176; higher scores indicate greater behavioral symptoms), and functional (Total Functional Capacity score range, 0-13; lower scores indicate reduced functional ability) domains were assessed at baseline and every 9 months up to a maximum of 10 years. Among the 983 research participants at risk for HD in the longitudinal cohort, 345 (35.1%) carried the CAG expansion and 638 (64.9%) did not. The mean (SD) duration of follow-up was 5.8 (3.0) years. At baseline, participants with expansions had more impaired motor (3.0 [4.2] vs 1.9 [2.8]; P < .001), cognitive (P < .05 for all measures except Verbal Fluency, P = .52), and behavioral domain scores (9.4 [11.4] vs 6.5 [8.5]; P < .001) but not significantly different measures of functional capacity (12.9 [0.3] vs 13.0 [0.2]; P = .23). With findings reported as mean slope (95% CI), in the longitudinal analyses, participants with CAG expansions

  19. To belong or not to belong: nursing students? interactions with clinical learning environments ? an observational study

    OpenAIRE

    Liljedahl, Matilda; Bj?rck, Erik; Kal?n, Susanne; Ponzer, Sari; Bolander Laksov, Klara

    2016-01-01

    Background Belongingness has been argued to be a prerequisite for students? learning in the clinical setting but making students feel like they belong to the workplace is a challenge. From a sociocultural perspective, workplace participatory practices is a framework that views clinical learning environments to be created in interaction between students and the workplace and hence, are dependent on them both. The aim of this study was to explore the interdependence between affordances and enga...

  20. Time to publication for publicly funded clinical trials in Australia: an observational study.

    Science.gov (United States)

    Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

    2017-03-22

    To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. 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/.

  1. Assessing preoperative anxiety using a questionnaire and clinical rating: a prospective observational study.

    Science.gov (United States)

    Laufenberg-Feldmann, Rita; Kappis, Bernd

    2013-12-01

    Preoperative anxiety and need for information can be detected during preoperative consultation via structured and standardised screening by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire. To identify the prevalence of preoperative anxiety and need for information, with regard to influencing factors such as age, sex, previous operation and grade of surgery, and to examine the level of agreement between patients' self-rating and physicians' ratings. Prospective observational study. Department of Anaesthesiology, University Medical Centre of the Johannes Gutenberg University Mainz, Germany. Two hundred seventeen patients scheduled for elective surgery. The patients completed questionnaires prior to the interaction with the anaesthesiologist. Physicians were blinded to the patients' ratings and provided their subjective ratings about patients' anxiety and need for information immediately after seeing the patient. Degree of anxiety and need for information, agreement of patients' self-reports and physician's rating. 18.9% of patients were classified as 'anxiety cases' (31.8% in women and 10.6% in men). The grade of the intended surgery but no other investigated factor was related to patients' anxiety. Age (older patients) was correlated with information requirement (r = 0.21, P = 0.002). Analysis of agreement showed only weak correlations between patients' self-reports and physicians' ratings, demonstrated in low weighted Kappa-coefficients (0.12 to 0.32). The APAIS is a useful instrument to assess the level of patients' preoperative anxiety and the need for information. Given the relationship between preoperative anxiety and postoperative outcome, it seems justified to incorporate this approach into the preoperative consultation. German Clinical Trials Register DRKS00003084.

  2. Congenital erythropoietic porphyria: a single-observer clinical study of 29 cases.

    Science.gov (United States)

    Katugampola, R P; Badminton, M N; Finlay, A Y; Whatley, S; Woolf, J; Mason, N; Deybach, J C; Puy, H; Ged, C; de Verneuil, H; Hanneken, S; Minder, E; Schneider-Yin, X; Anstey, A V

    2012-10-01

    Congenital erythropoietic porphyria (CEP) is an autosomal recessive cutaneous porphyria caused by decreased activity of uroporphyrinogen III synthase (UROS). Its predominant characteristics include bullous cutaneous photosensitivity to visible light from early infancy, progressive photomutilation and chronic haemolytic anaemia. Due to its rarity and genetic heterogeneity, clinical phenotypes are unclear and its impact on health-related quality of life (HRQoL) has not been previously assessed. To define comprehensively CEP phenotypes and assess their impact on HRQoL, and to correlate these factors with laboratory parameters. A single observer assessed patients with CEP from four European countries. Twenty-seven unrelated patients with CEP, aged between 7.6 and 65 years, participated in the study. The patients came from the U.K. (17), France (4), Switzerland (4) and Germany (2). Additional data were obtained for two deceased patients. Newly characterized features of CEP include acute-onset cutaneous and noncutaneous symptoms immediately following sunlight exposure, and pink erythematous facial papules. There was a lack of consistent genotype-phenotype correlation in CEP. The main poor prognostic factors in CEP are the early age of disease onset and haematological complications. CEP is a multisystem disease; cutaneous, ocular, oral and skeletal manifestations also contribute to disease severity and impact on HRQoL, in addition to the haematological complications. The rarity of the disease can lead to delayed diagnosis. The lack of consistent genotype-phenotype correlation in CEP suggests a contribution to phenotype from other factors, such as environment, patients' photoprotective behaviour and genes other than UROS. There is currently an unmet need for multidisciplinary management of patients with CEP. © 2012 The Authors. BJD © 2012 British Association of Dermatologists.

  3. Harm caused by adverse events in primary care: a clinical observational study.

    NARCIS (Netherlands)

    Wetzels, R.; Wolters, R.J.; Weel, C. van; Wensing, M.J.P.

    2009-01-01

    RATIONALE, AIMS AND OBJECTIVES: Patient safety in primary care is important, but not well studied. The aim of our study was to determine the actual and potential harm caused by adverse events in primary care. METHOD: Observational study in two general practices, including the patients of five

  4. Why are multi-centre clinical observational studies still so difficult to run?

    Science.gov (United States)

    Sandy, J; Kilpatrick, N; Persson, M; Bessel, A; Waylen, A; Ness, A; Ireland, A

    2011-07-22

    Despite the introduction of IRAS, obtaining R&D approvals for multicentre studies is a major rate limiting step. Our experience with cleft research demonstrates that this approvals process must be drastically and rapidly improved if we wish to continue attract clinical research to the UK.

  5. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics.

    Science.gov (United States)

    Ramirez, Veronica; Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

    2016-04-19

    There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manage their chronic diseases. An observational study was conducted with patients of the Internal Medicine resident primary care clinics of Los Angeles County and University of Southern California (LAC+USC) Medical Center. Self-reported information regarding demographics, current mobile phone usage, current mobile health app and social media usage, barriers to using mobile phones or mobile health apps, and interest in using a mobile health app was collected. Ninety-one percent of patients owned a mobile phone, with 76% (169/223) of these reporting having a mobile phone with Internet capability. Fifty-seven percent of subjects used mobile apps on their mobile phones, and 32% (41/130) of these used mobile apps related to their health. Eighty-six percent (207/241) of respondents voiced interest in using a mobile app to improve their health, and 40% (88/221) stated they would use such an app daily. Patients stated they would find the mobile health app most useful for nutrition, exercise, and obtaining general information on medical conditions. Despite the fact that the majority of our primary care patients were of lower socioeconomic status, they utilized mobile phones with Internet and mobile app capabilities to a great extent. There was substantial interest among our patients in using mobile health technology to both manage chronic disease and improve overall health. Given that cultural, educational, and socioeconomic disparities strongly correlate with higher rates of chronic diseases such as obesity

  6. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics

    Science.gov (United States)

    Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

    2016-01-01

    Background There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. Objective The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manage their chronic diseases. Methods An observational study was conducted with patients of the Internal Medicine resident primary care clinics of Los Angeles County and University of Southern California (LAC+USC) Medical Center. Self-reported information regarding demographics, current mobile phone usage, current mobile health app and social media usage, barriers to using mobile phones or mobile health apps, and interest in using a mobile health app was collected. Results Ninety-one percent of patients owned a mobile phone, with 76% (169/223) of these reporting having a mobile phone with Internet capability. Fifty-seven percent of subjects used mobile apps on their mobile phones, and 32% (41/130) of these used mobile apps related to their health. Eighty-six percent (207/241) of respondents voiced interest in using a mobile app to improve their health, and 40% (88/221) stated they would use such an app daily. Patients stated they would find the mobile health app most useful for nutrition, exercise, and obtaining general information on medical conditions. Conclusions Despite the fact that the majority of our primary care patients were of lower socioeconomic status, they utilized mobile phones with Internet and mobile app capabilities to a great extent. There was substantial interest among our patients in using mobile health technology to both manage chronic disease and improve overall health. Given that cultural, educational, and socioeconomic disparities strongly correlate with

  7. [Families of the economic crisis in paediatric Primary Care clinics: descriptive observational study].

    Science.gov (United States)

    Martín Martín, R; Sánchez Bayle, M; Gancedo García, C; Teruel de Francisco, M C; Coullaut López, A

    2016-04-01

    To study the impact of the economic crisis on the families of the children who attend Primary Health Care and its relationship with their socioeconomic status. Observational descriptive study was conducted by analysing the results of 453 questionnaires, given to the parents of children between 1 and 7 years old who attended 4 paediatric clinics in Madrid. The raw data was analysed, and comparisons between groups and multivariate analysis were performed. In the multivariate analysis, the variables related to the non-acquisition of prescribed medication are: lower income level OR=0.118, p<.0001 and lower educational level OR=0.464, p<.001; the variables related to the reduction of food expenditure are: lower income level OR=0.100, p<.0001 and a higher number of family members OR=1.308, p=.045; the variables related to anti-pneumococcal vaccination without public funding are: higher income level OR=2.170, p=.0001, higher educational level OR=1.835, p=.013, and not being an immigrant OR=0.532, p=.037. The presence of health problems from the beginning of the economic crisis is related to unemployment OR=4.079, p=.032, lower educational level R=0.678, p=.042, and income level OR=0.342, p<.0001. In all cases, the models achieved a statistical significance of p<.0001. The economic crisis has greater impact on the group with the lowest income level in all analysed variables. The lower educational level and higher number of family members has an impact on the reduction in food expenditure. The fact of being an immigrant has an impact on not receiving the anti-pneumococcal and rotavirus vaccination. Unemployment leads to an increase in health problems in the family. To sum up, the economic crisis has increased inequalities according to socioeconomic status. Copyright © 2015 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  8. Communication about children's clinical trials as observed and experienced: qualitative study of parents and practitioners.

    Science.gov (United States)

    Shilling, Valerie; Williamson, Paula R; Hickey, Helen; Sowden, Emma; Beresford, Michael W; Smyth, Rosalind L; Young, Bridget

    2011-01-01

    Recruiting children to clinical trials is perceived to be challenging. To identify ways to optimise recruitment and its conduct, we compared how parents and practitioners described their experiences of recruitment to clinical trials. This qualitative study ran alongside four children's clinical trials in 11 UK research sites. It compared analyses of semi-structured interviews with analyses of audio-recordings of practitioner-family dialogue during trial recruitment discussions. Parents from 59 families were interviewed; 41 had participated in audio-recorded recruitment discussions. 31 practitioners were interviewed. Parents said little in the recruitment discussions contributing a median 16% of the total dialogue and asking a median of one question. Despite this, parents reported a positive experience of the trial approach describing a sense of comfort and safety. Even if they declined or if the discussion took place at a difficult time, parents understood the need to approach them and spoke of the value of research. Some parents viewed participation as an 'exciting' opportunity. By contrast, practitioners often worried that approaching families about research burdened families. Some practitioners implied that recruiting to clinical trials was something which they found aversive. Many were also concerned about the amount of information they had to provide and believed this overwhelmed families. Whilst some practitioners thought the trial information leaflets were of little use to families, parents reported that they used and valued the leaflets. However, both parties agreed that the leaflets were too long and wanted them to be more reader-friendly. Parents were more positive about being approached to enter their child into a clinical trial than practitioners anticipated. The concerns of some practitioners, that parents would be overburdened, were unfounded. Educating practitioners about how families perceive clinical trials and providing them with 'moral' support

  9. How Norwegian casualty clinics handle contacts related to mental illness: A prospective observational study

    Directory of Open Access Journals (Sweden)

    Johansen Ingrid H

    2012-04-01

    Full Text Available Abstract Background Low-threshold and out-of-hours services play an important role in the emergency care for people with mental illness. In Norway casualty clinic doctors are responsible for a substantial share of acute referrals to psychiatric wards. This study’s aim was to identify patients contacting the casualty clinic for mental illness related problems and study interventions and diagnoses. Methods At four Norwegian casualty clinics information on treatment, diagnoses and referral were retrieved from the medical records of patients judged by doctors to present problems related to mental illness including substance misuse. Also, routine information and relation to mental illness were gathered for all consecutive contacts to the casualty clinics. Results In the initial contacts to the casualty clinics (n = 28527 a relation to mental illness was reported in 2.5% of contacts, whereas the corresponding proportion in the doctor registered consultations, home-visits and emergency call-outs (n = 9487 was 9.3%. Compared to other contacts, mental illness contacts were relatively more urgent and more frequent during night time. Common interventions were advice from a nurse, laboratory testing, prescriptions and minor surgical treatment. A third of patients in contact with doctors were referred to in-patient treatment, mostly non-psychiatric wards. Many patients were not given diagnoses signalling mental problems. When police was involved, they often presented the patient for examination. Conclusions Most mental illness related contacts are managed in Norwegian casualty clinics without referral to in-patient care. The patients benefit from a wide range of interventions, of which psychiatric admission is only one.

  10. Current clinical nutrition practices in critically ill patients in Latin America: a multinational observational study.

    Science.gov (United States)

    Vallejo, Karin Papapietro; Martínez, Carolina Méndez; Matos Adames, Alfredo A; Fuchs-Tarlovsky, Vanessa; Nogales, Guillermo Carlos Contreras; Paz, Roger Enrique Riofrio; Perman, Mario Ignacio; Correia, Maria Isabel Toulson Davisson; Waitzberg, Dan Linetzky

    2017-08-25

    Malnutrition in critically ill adults in the intensive care unit (ICU) is associated with a significantly elevated risk of mortality. Adequate nutrition therapy is crucial to optimise outcomes. Currently, there is a paucity of such data in Latin America. Our aims were to characterise current clinical nutrition practices in the ICU setting in Latin America and evaluate whether current practices meet caloric and protein requirements in critically ill patients receiving nutrition therapy. We conducted a cross-sectional, retrospective, observational study in eight Latin American countries (Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Panama, and Peru). Eligible patients were critically ill adults hospitalised in the ICU and receiving enteral nutrition (EN) and/or parenteral nutrition (PN) on the Screening Day and the previous day (day -1). Caloric and protein balance on day -1, nutritional status, and prescribed nutrition therapy were recorded. Multivariable logistic regression analysis was performed to identify independent predictors of reaching daily caloric and protein targets. The analysis included 1053 patients from 116 hospitals. Evaluation of nutritional status showed that 74.1% of patients had suspected/moderate or severe malnutrition according to the Subjective Global Assessment. Prescribed nutrition therapy included EN alone (79.9%), PN alone (9.4%), and EN + PN (10.7%). Caloric intake met >90% of the daily target in 59.7% of patients on day -1; a caloric deficit was present in 40.3%, with a mean (±SD) daily caloric deficit of -688.8 ± 455.2 kcal. Multivariable logistic regression analysis showed that combined administration of EN + PN was associated with a statistically significant increase in the probability of meeting >90% of daily caloric and protein targets compared with EN alone (odds ratio, 1.56; 95% confidence interval, 1.02-2.39; p = 0.038). In the ICU setting in Latin America, malnutrition was highly prevalent and caloric

  11. Clinical research on postoperative trauma care: has the position of observational studies changed?

    Science.gov (United States)

    Smeeing, D P J; Houwert, R M; Kruyt, M C; van der Meijden, O A J; Hietbrink, F

    2017-02-01

    The postoperative care regimes of ankle fractures are studied for over 30 years and recommendations have shifted only slightly in the last decades. However, study methodology might have evolved. The aim of this study was to evaluate the changes in time in the design, quality and outcome measures of studies investigating the postoperative care of ankle fractures. The MEDLINE and EMBASE database were searched for both RCTs and cohort studies. The original studies were divided into decades of publication over the last 30 years. The methodological quality of the studies was assessed using the 'traditional' risk of bias assessment tool provided by The Cochrane Collaboration and the 'newer' MINORS criteria. The percentage of RCTs on this subject declined from 67 to 38 % in the last decades. According to the Cochrane tool, the reported quality of RCTs has improved in the last three decades whereas the reported quality of observational studies has remained unchanged. However, when quality was evaluated with the MINORS criteria, equal improvement was observed for both RCTs and observational studies. In the 80s, 67 % of all studies used the range of motion as the primary outcome measure, which decreased to 45 % in the 90s. In the 00s, none of the studies used the range of motion as the primary outcome. For postoperative care of ankle fractures, results of this study showed a relative decrease in the published number of RCTs. The overall quality of the published articles did not decline. In addition, a gradual shift from physician measured to patient-reported outcome variables was observed. However, it should be borne in mind that the findings are based on a small sample (n = 25).

  12. Sociodemographic and clinical predictors of compliance with antidepressants for depressive disorders: systematic review of observational studies

    Directory of Open Access Journals (Sweden)

    Rivero-Santana A

    2013-03-01

    Full Text Available Amado Rivero-Santana,1 Lilisbeth Perestelo-Perez,2,3 Jeanette Pérez-Ramos,1 Pedro Serrano-Aguilar,2,3 Carlos De las Cuevas2,4 1Canary Islands Foundation of Health and Research, 2Red de Investigacion en Servicios de Salud en Enfermedades Cronicas (REDISSEC, Santa Cruz de Tenerife, 3Evaluation Unit, Canary Islands Health Service, Santa Cruz de Tenerife, 4Department of Psychiatry, University of La Laguna, Canary Islands, Spain Background: The literature shows that compliance with antidepressant treatment is unsatisfactory. Several personal and disease-related variables have been shown to be related to compliance behavior. The objective of this study was to review the literature about sociodemographic and clinical predictors of compliance in patients with depressive disorders. Methods: The Medline, Embase, Cochrane Central, PsycInfo, and Cinahl databases were searched until May 2012. Studies that analyzed sociodemographic and clinical predictors or correlates of compliance in patients with depressive disorder were included. A quantitative synthesis was not performed because of the heterogeneity and availability of the data reported. For similar reasons, the results were not classified according to the different phases of treatment. The search was limited to studies published in English and Spanish. Results: Thirty-two studies fulfilled the inclusion criteria. The most consistent associations with compliance were found for age (older patients showed more compliance and race (white patients were more likely to adhere to treatment than minority ethnic groups. Few studies assessed clinical factors, and the most plausible predictors of compliance were certain comorbidities and substance abuse. Severity of depression did not play an important role in predicting compliance. Conclusion: The impact of the variables studied on compliance behavior appeared to be inconsistent. Identifying potential predictors of compliance with antidepressant treatment is

  13. Breast cancer care compared with clinical Guidelines: an observational study in France

    Directory of Open Access Journals (Sweden)

    Daban Alain

    2011-01-01

    Full Text Available Abstract Background Great variability in breast cancer (BC treatment practices according to patient, tumour or organisation of care characteristics has been reported but the relation between these factors is not well known. In two French regions, we measured compliance with Clinical Practice Guidelines for non-metastatic BC care management and identified factors associated with non-compliance at clinical and organisational levels. Methods Eligible patients had invasive unilateral BC without distant metastases and at least two contacts with one of the two regional healthcare systems (2003-2004 in the first year after diagnosis. Medical data were collected from patient medical records in all public and private hospitals (99 hospitals. The care process was defined by 20 criteria: clinical decisions for treatment and therapeutic procedures. Each criterion was classified according to level of compliance ("Compliant", "Justifiable" and "Not Compliant" and factors of non-compliance were identified (mixed effect logistic regression. Results 926 women were included. Non-compliance with clinical decisions for treatment was associated with older patient age (OR 2.1; 95%CI: 1.3-3.6 and region (OR 3.0; 95%CI: 1.2-7.4. Non-compliance with clinical decisions for radiotherapy was associated with lymph node involvement or the presence of peritumoural vascular invasion (OR 1.5; 95%CI: 1.01-2.3 and non-compliance with overall treatment (clinical decisions for treatment + therapeutic procedures was associated with the presence of positive lymph nodes (OR 2.0; 95%CI: 1.2-3.3, grade III versus grade I (OR 2.9; 95%CI: 1.4-6.2, and one region of care versus another (OR 3.5; 95%CI: 1.7-7.1. Finally, heterogeneity of compliance in overall treatment sequence was identified between local cancer units (p Conclusion This study provides interesting insights into factors of non-compliance in non-metastatic BC management and could lead to quality care improvements.

  14. Acute toluene intoxication--clinical presentation, management and prognosis: a prospective observational study.

    Science.gov (United States)

    Camara-Lemarroy, Carlos Rodrigo; Rodríguez-Gutiérrez, René; Monreal-Robles, Roberto; González-González, José Gerardo

    2015-08-18

    Toluene is one of the most widely abused inhaled drugs due to its acute neurologic effects including euphoria and subsequent depression. However, dangerous metabolic abnormalities are associated to acute toluene intoxication. It has been previously reported that rhabdomyolysis and acute hepatorenal injury could be hallmarks of the condition, and could constitute risk factors for poor outcomes. The objective was to describe the clinical presentation, to characterize the renal and liver abnormalities, the management and prognosis associated to acute toluene intoxication. We prospectively assessed 20 patients that were admitted to a single center's emergency department from September 2012 to June 2014 with clinical and metabolic alterations due to acute toluene intoxication. The main clinical presentation consisted of weakness associated to severe hypokalemia and acidosis. Renal glomerular injury (proteinuria) is ubiquitous. Biliary tract injury (alkaline phosphatase and gamma-glutamyl transpeptidase elevations) disproportional to hepatocellular injury is common. Rhabdomyolysis occurred in 80% of patients, probably due to hypokalemia and hypophosphatemia. There were three deaths, all female, and all associated with altered mental status, severe acidosis, hypokalemia and acute oliguric renal failure. The cause of death was in all cases due to cardiac rhythm abnormalities. The hallmarks of acute toluene intoxication are hypokalemic paralysis and metabolic acidosis. Liver injury and rhabdomyolysis are common. On admission, altered mental status, renal failure, severe acidemia and female gender (not significant in our study, but present in all three deaths) could be associated with a poor outcome, and patients with these characteristics should be considered to be treated in an intensive care unit.

  15. Depressive symptoms, HIV medication adherence, and HIV clinical outcomes in Tanzania: a prospective, observational study.

    Science.gov (United States)

    Belenky, Nadya M; Cole, Stephen R; Pence, Brian W; Itemba, Dafrosa; Maro, Venance; Whetten, Kathryn

    2014-01-01

    Depressive symptoms have been shown to independently affect both antiretroviral therapy (ART) adherence and HIV clinical outcomes in high-income countries. We examined the prospective relationship between depressive symptoms and adherence, virologic failure, and suppressed immune function in people living with HIV/AIDS in Tanzania. Data from 403 study participants who were on stable ART and engaged in HIV clinical care were analyzed. We assessed crude and adjusted associations of depressive symptoms and ART adherence, both at baseline and at 12 months, using logistic regression. We used logistic generalized estimating equations to assess the association and 95% confidence intervals (CI) between depressive symptoms and both virologic failure and suppressed immune function. Ten percent of participants reported moderate or severe depressive symptoms at baseline and 31% of participants experienced virologic failure (>150 copies/ml) over two years. Depressive symptoms were associated with greater odds of reported medication nonadherence at both baseline (Odds Ratio [OR] per 1-unit increase = 1.18, 95% CI [1.12, 1.24]) and 12 months (OR = 1.08, 95% CI [1.03, 1.14]). By contrast, increases in depressive symptom score were inversely related to both virologic failure (OR = 0.93, 95% CI [0.87, 1.00]) and immune system suppression (OR = 0.88, 95% CI [0.79, 0.99]), though the association between depressive symptoms and clinical outcomes was less precise than for the association with nonadherence. Findings indicate a positive association between depressive symptoms and nonadherence, and also an inverse relationship between depressive symptoms and clinical outcomes, possibly due to informative loss to follow-up.

  16. Depressive symptoms, HIV medication adherence, and HIV clinical outcomes in Tanzania: a prospective, observational study.

    Directory of Open Access Journals (Sweden)

    Nadya M Belenky

    Full Text Available Depressive symptoms have been shown to independently affect both antiretroviral therapy (ART adherence and HIV clinical outcomes in high-income countries. We examined the prospective relationship between depressive symptoms and adherence, virologic failure, and suppressed immune function in people living with HIV/AIDS in Tanzania. Data from 403 study participants who were on stable ART and engaged in HIV clinical care were analyzed. We assessed crude and adjusted associations of depressive symptoms and ART adherence, both at baseline and at 12 months, using logistic regression. We used logistic generalized estimating equations to assess the association and 95% confidence intervals (CI between depressive symptoms and both virologic failure and suppressed immune function. Ten percent of participants reported moderate or severe depressive symptoms at baseline and 31% of participants experienced virologic failure (>150 copies/ml over two years. Depressive symptoms were associated with greater odds of reported medication nonadherence at both baseline (Odds Ratio [OR] per 1-unit increase = 1.18, 95% CI [1.12, 1.24] and 12 months (OR = 1.08, 95% CI [1.03, 1.14]. By contrast, increases in depressive symptom score were inversely related to both virologic failure (OR = 0.93, 95% CI [0.87, 1.00] and immune system suppression (OR = 0.88, 95% CI [0.79, 0.99], though the association between depressive symptoms and clinical outcomes was less precise than for the association with nonadherence. Findings indicate a positive association between depressive symptoms and nonadherence, and also an inverse relationship between depressive symptoms and clinical outcomes, possibly due to informative loss to follow-up.

  17. Clinical and Ultrasonographic Evaluation of Lower-extremity Vein Thrombosis in Behcet Syndrome: An Observational Study.

    Science.gov (United States)

    Seyahi, Emire; Cakmak, Osman Serdal; Tutar, Burcin; Arslan, Caner; Dikici, Atilla Suleyman; Sut, Necdet; Kantarci, Fatih; Tuzun, Hasan; Melikoglu, Melike; Yazici, Hasan

    2015-11-01

    Vascular involvement can be seen in up to 40% of patients with Behcet syndrome (BS), the lower-extremity vein thrombosis (LEVT) being the most common type. The aim of the current study was to compare venous Doppler findings and clinical features between BS patients with LEVT and control patients diagnosed as having LEVT due to other causes.All consecutive 78 patients (71 men, 7 women; mean age 38.6 ± 10.3 years) with LEVT due to BS and 50 control patients (29 men, 21 women; mean age 42.0 ± 12.5 years) who had LEVT due to other causes, or idiopathic, were studied with the help of a Doppler ultrasonography after a detailed clinical examination. Patterns of venous disease were identified by cluster analyses. Clinical features of chronic venous disease were assessed using 2 classification systems. Venous claudication was also assessed.Patients with BS were more likely to be men, had significantly earlier age of onset of thrombosis, and were treated mainly with immunosuppressives and less frequently with anticoagulants. Furthermore, they had significantly more bilateral involvement, less complete recanalization, and more frequent collateral formation. While control patients had a disorganized pattern of venous involvement, BS patients had a contiguous and symmetric pattern, involving all deep and superficial veins of the lower extremities, with less affinity for crural veins. Clinical assessment, as measured by the 2 classification systems, also indicated a more severe disease among the BS patients. In line, 51% of the BS patients suffered from severe post-thrombotic syndrome (PTS) and 32% from venous claudication, whereas these were present in 8% and 12%, respectively, among the controls. Among BS patients, a longer duration of thrombosis, bilateral femoral vein involvement, and using no anticoagulation along with immunosuppressive treatment when first diagnosed were found to be associated independently with severe PTS.Lower-extremity vein thrombosis

  18. Observational study identifies non-attendance characteristics in two hospital outpatient clinics

    DEFF Research Database (Denmark)

    Blæhr, Emely; Søgaard, Rikke; Kristensen, Thomas

    2016-01-01

    INTRODUCTION: Non-attended hospital appointments are receiving increasing attention in times when rapid access and efficient service delivery at public hospitals are on the agenda. The aim of this study was to investigate the extent of non-attendance in a Danish outpatient setting and its...... association with user-level and provider-level characteristics. METHODS: The study was based on appointments scheduled from June 2013 to March 2015 at an orthopaedic and a radiologic outpatient clinic. Data on outcomes of cancellation on the part of the user or the provider, and non-attendance without giving......-attendance and thereby to improve the efficiency of Danish outpatient services. Future studies should investigate the effect of initiatives such as nudging and fines targeting the appointments that have the highest non-attendance rates. FUNDING: Danish Regions, the Danish Ministry of Health and the Central Denmark...

  19. 10-year survival evaluation for glass-fiber-supported postendodontic restoration: a prospective observational clinical study.

    Science.gov (United States)

    Naumann, Michael; Koelpin, Manja; Beuer, Florian; Meyer-Lueckel, Hendrik

    2012-04-01

    Glass-fiber-reinforced endodontic posts (GFRPs), in combination with composite resin core materials, are commonly used to build up damaged endodontically treated teeth. However, long-term clinical data are scarce. Thus, the aim of this investigation was to evaluate the survival of 3 different GFRP systems, taking into account several other relevant factors. One-hundred forty-nine GFRPs in 122 patients were followed for up to 120 months. GFRPs were adhesively luted using the etch-and-rinse technique. The core was built with a chemically curing composite resin and restored according to the specific prosthetic treatment plan. Cox proportional hazards models were used to evaluate the association between clinical variables and the time until failure. Within 10 years, 55 failures could be observed (annual failure rate = 4.6%) with the most frequent ones being post fracture, loss of post retention (both n = 17), endodontic problems (n = 7), and those resulting in tooth extraction (n = 10). Sixty posts could be followed up for 105 to 120 months (34 posts lost to follow-up, [mean (standard deviation) survival time: 74 (43) months]). In crude analyses, only the tooth type in favor of posterior teeth compared with anterior teeth and the number of remaining cavity walls (in favor of ≥ 1 compared with no wall) were significantly associated with the failure rate. Cox regression analysis revealed a significant hazard ratio of 2.0 (95% confidence interval, 1.1-3.5; P = .021) for tooth type in favor of posterior teeth. The relatively high annual failure rate of GFRPs highlights that the treatment decision should take into account the most relevant factors as tooth type and the number of remaining cavity walls. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  20. The Role of Vitamin K Status in Cardiovascular Health: Evidence from Observational and Clinical Studies

    OpenAIRE

    van Ballegooijen, A. J.; Beulens, J. W.

    2017-01-01

    Purpose of Review Vitamin K is a fat-soluble vitamin required for the activation of several vitamin K-dependent proteins to confer functioning. A growing body of evidence supports that vitamin K has beneficial effects on bone and cardiovascular health. This review summarizes key evidence on vitamin K status as measured by circulating measures and cardiovascular outcomes. Recent Findings Overall, observational studies indicate that low vitamin K status as measured by high dephosphorylated unca...

  1. Observations of veterinary medicine students' approaches to study in pre-clinical years.

    Science.gov (United States)

    Ryan, Marion T; Irwin, Jane A; Bannon, Finian J; Mulholland, Clive W; Baird, Alan W

    2004-01-01

    This study has two purposes. The first is to explore an instrument of evaluation of the approaches to study (deep, strategic, and surface) adopted by students in the pre-clinical years of their veterinary degree program. The second is to examine relationships between these approaches and a broad range of further factors deemed relevant to the veterinary medicine context. We envisage that a greater knowledge of how these students learn will aid curriculum reform in a way that will enrich the learning experience of veterinary students. A questionnaire consisting of the 52-question Approaches to Study Inventory (ASI) and an additional 49 questions relating mainly to teaching, assessment, and study skills was distributed to 215 veterinary medicine (MVB) students in their pre-clinical years of study. Factor analysis was used to ensure that the ASI section of the questionnaire maintained previously reported structure. The internal reliability of the approaches measured was tested using Cronbach alpha analysis. The approaches were described as frequency distributions. Associations between the parameters (deep, strategic, and surface) and 49 additional context-specific factors were investigated using loglinear analysis. (1) Factor analysis revealed that the integrity and structure of the instrument in this context was generally comparable to previous studies. (2) The impact of a high workload was evident in the surface approach, with fear of failure becoming a strong motivating factor and syllabus boundness a widely used strategy. (3) Associations made between the approaches and 49 context-specific factors showed strong associations between both workload and lack of prior knowledge with the surface approach. (4) Grades were associated positively with both the deep and strategic approaches but negatively with the surface approach. (5) A range of learning and study skills were associated positively with the deep and strategic approaches and negatively with the surface

  2. [Clinical, prognostic, and preventive significance of "premorbid" psychic states in adolescents and youths (observational study)].

    Science.gov (United States)

    Chubarovskiĭ, V V

    2009-01-01

    This paper presents results of observational, clinico-epidemiological, and catamnestic studies including 856 adolescents and youths attending schools, professional and higher education institutions in Moscow. The data are analysed in terms of the prevalence, structure, and dynamics of different borderline psychic states depending on age. The frequency of "premorbid" psychic abnormalities in adolescents is shown to be 52.6% compared with 15.46% in youths. It is argued that subclinical psychic disorders in adolescents have more favourable prognosis and should be regarded as adaptive reactions to the processes associated with physiological pubertal crisis. Recommendations are proposed for differential primary and secondary prophylaxis of age-related premorbid psychic states.

  3. Do Case Rates Affect Physicians' Clinical Practice in Radiation Oncology?: An Observational Study.

    Directory of Open Access Journals (Sweden)

    Bryan A Loy

    Full Text Available Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011 and after (2013 the payment method introduction using relative risks (RR. After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p<0.05. For the aggregate of all cancers, the under-treatment rate significantly declined (p = 0.008 from 4% to 0% after the introduction of case rate payments, while the over-treatment rate remained steady at 9%, with no significant change (p = 0.20. These findings suggest that the introduction of case rate payments did not adversely affect the rate of guideline-based care at the provider examined. Additional research is needed to isolate the effect of the payment model and assess implications in other populations.

  4. Quality of life in patients referring to private osteopathic clinical practice: a prospective observational study.

    Science.gov (United States)

    Cerritelli, Francesco; Verzella, Marco; Barlafante, Gina

    2014-08-01

    Health improvement is one of the main priorities of both public and private health systems. In recent years, more attention has been given to the use of complementary and alternative medicines, including osteopathic manipulative treatment (OMT), as possible effective interventions in increasing patients' health reported outcomes. With regard to OMT, very little research was focused on its effectiveness in enhancing health in the general population. To explore the extent to which OMT is effective in improving quality of life in referring patients. Cohort study. Private osteopathic clinical practices in Italy. 25 osteopaths from Central and Southern Italy participated in the study. Self-referred patients, with a diagnosed musculo-skeletal disorder and older than 18 years of age, who did not undergo any OMT session in the previous 12 months and/or contemporarily additional manual therapies were enrolled. Changing from baseline SF36 general health sub-domain scores was used as the study primary outcomes. 1000 patients with primary diagnosis of musculo-skeletal disorder were initially enrolled. 988 patients completed the study. After 4 weeks, mean general health score was 14.7 points higher (95% CI 13.9-15.6; Cohen's d=0.84). Similarly, physical and mental component scores increased (11.5; 95% CI 10.8-12.1; d=0.87 and 9.6; 95% CI 8.6-10.5; d=0.61 respectively). No association between SF36 domains and socio-demographic exposures was found to be statistically significant. Positive changes on various quality of life dimensions were reported by patients receiving osteopathic treatment. The trial was registered on clinicaltrials.gov (identifier NCT01965678). Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Feasibility of Post-Intensive Care Unit Clinics: an observational cohort study of two different approaches

    NARCIS (Netherlands)

    Dettling-Ihnenfeldt, D. S.; de Graaff, A. E.; Nollet, F.; van der Schaaf, M.

    2015-01-01

    Post-ICU clinics have been advocated to reduce long-term physical and psychological impairments among ICU survivors. A format for optimal structure, timing, and care content has not yet been established. We developed and implemented two post-ICU clinics in different hospital settings and evaluated

  6. Accuracy of clinical prediction rules in peptic ulcer perforation: an observational study

    DEFF Research Database (Denmark)

    Buck, David Levarett; Vester-Andersen, Morten; Møller, Morten Hylander

    2012-01-01

    (APACHE) II score, and the sepsis score. Material and methods. Design: an observational multicenter study. Participants and settings: a total of 117 patients surgically treated for PPU between 1 January 2008 and 31 December 2009 in seven gastrointestinal departments in Denmark were included. Pregnant......% of the patients had at least one co-existing disease. The 30-day mortality proportion was 17% (20/117). The AUCs: the Boey score, 0.63; the sepsis score, 0.69; the ASA score, 0.73; and the APACHE II score, 0.76. Overall, the PPVs of all four prediction rules were low and the NPVs high. Conclusions. The Boey score......, the ASA score, the APACHE II score, and the sepsis score predict mortality poorly in patients with PPU....

  7. Clinical characteristics associated with diagnostic delay of pulmonary embolism in primary care: a retrospective observational study

    Science.gov (United States)

    Hendriksen, Janneke M T; Koster-van Ree, Marleen; Morgenstern, Marcus J; Oudega, Ruud; Schutgens, Roger E G; Moons, Karel G M; Geersing, Geert-Jan

    2017-01-01

    Objectives To evaluate the extent of delay in the diagnosis of pulmonary embolism (PE) in primary care, and to identify determinants that are associated with such diagnostic delay. Design Retrospective observational study. Setting 6 primary care practices across the Netherlands. Participants Data from patients with an objectively confirmed diagnosis of PE (International Classification of Primary Care (ICPC) code K93) up to June 2015 were extracted from the electronic medical records. For all these PE events, we reviewed all consultations with their general practitioner (GP) and scored any signs and symptoms that could be attributed to PE in the 3 months prior to the event. Also, we documented actual comorbidity and the diagnosis considered initially. Primary and secondary outcome measures Delay was defined as a time gap of >7 days between the first potentially PE-related contact with the GP and the final PE diagnosis. Multivariable logistic regression analysis was performed to identify independent determinants for delay. Results In total, 180 incident PE cases were identified, of whom 128 patients had 1 or more potential PE-related contact with their GP within the 3 months prior to the diagnosis. Based on our definition, in 33 of these patients (26%), diagnostic delay was observed. Older age (age >75 years; OR 5.1 (95% CI 1.8 to 14.1)) and the absence of chest symptoms (ie, chest pain or pain on inspiration; OR 5.4 (95% CI 1.9 to 15.2)) were independent determinants for diagnostic delay. A respiratory tract infection prior to the PE diagnosis was reported in 13% of cases without delay, and in 33% of patients with delay (p=0.008). Conclusions Diagnostic delay of more than 7 days in the diagnosis of PE is common in primary care, especially in the elderly, and if chest symptoms, like pain on inspiration, are absent. PMID:28279993

  8. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Castillo Ana

    2012-09-01

    Full Text Available Abstract Background No studies on continuous renal replacement therapy (CRRT have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Methods Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. Results The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03. The incidence of weight under P3 was greater in younger children (p = 0.007 and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047. The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight P3 (51% vs 33%; p = 0.037. In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032. Conclusions The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight.

  9. Nutritional status and clinical outcome of children on continuous renal replacement therapy: a prospective observational study.

    Science.gov (United States)

    Castillo, Ana; Santiago, Maria J; López-Herce, Jesús; Montoro, Sandra; López, Jorge; Bustinza, Amaya; Moral, Ramón; Bellón, Jose M

    2012-09-27

    No studies on continuous renal replacement therapy (CRRT) have analyzed nutritional status in children. The objective of this study was to assess the association between mortality and nutritional status of children receiving CRRT. Prospective observational study to analyze the nutritional status of children receiving CRRT and its association with mortality. The variables recorded were age, weight, sex, diagnosis, albumin, creatinine, urea, uric acid, severity of illness scores, CRRT-related complications, duration of admission to the pediatric intensive care unit, and mortality. The sample comprised 174 critically ill children on CRRT. The median weight of the patients was 10 kg, 35% were under percentile (P) 3, and 56% had a weight/P50 ratio of less than 0.85. Only two patients were above P95. The mean age for patients under P3 was significantly lower than that of the other patients (p = 0.03). The incidence of weight under P3 was greater in younger children (p = 0.007) and in cardiac patients and in those who had previous chronic renal insufficiency (p = 0.047). The mortality analysis did not include patients with pre-existing renal disease. Mortality was 38.9%. Mortality for patients with weight P3 (51% vs 33%; p = 0.037). In the univariate and multivariate logistic regression analyses, the only factor associated with mortality was protein-energy wasting (malnutrition) (OR, 2.11; 95% CI, 1.067-4.173; p = 0.032). The frequency of protein-energy wasting in children who require CRRT is high, and the frequency of obesity is low. Protein-energy wasting is more frequent in children with previous end-stage renal disease and heart disease. Underweight children present a higher mortality rate than patients with normal body weight.

  10. Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study.

    Science.gov (United States)

    Marin-Gomez, L M; Gomez-Bravo, M A; Alamo-Martinez, J A; Barrera-Pulido, L; Bernal Bellido, C; Suárez Artacho, G; Pascasio, J M

    2009-01-01

    To present the correlation between dosage and plasma concentration of tacrolimus and the consequences for short-term hepatorenal function of conversion to Advagraf (tacrolimus extended-release capsules) in liver transplant recipients. This observational study on adult liver transplant recipients examined tacrolimus levels after conversion to Advagraf therapy. Mean (SD) patient age was 51 (44-59) years. Conversion occurred at 43 (19-85) months posttransplantation, and follow-up was 193 (106.5-243.25) days. Dosage was adjusted milligram for milligram. Levels of tacrolimus, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and creatinine were recorded on the day before conversion to Advagraf and 1, 3, 6, and months afterward. Of the 79 patients in whom therapy was converted to Advagraf, 31 (39.2%) had alcoholic cirrhosis, 19 (24.1%) had viral disease, 10 (12.7) had mixed disease, 8 (10.1%) had cholestatic disease, 4 (5.1%) had metabolic disease, and 7 (8.8%) had other diseases. Despite no modification of Advagraf dosage during follow-up in most patients, mean tacrolimus levels decreased from the first month after conversion; however, at 6 months after conversion, they tended to equal the initial value. Renal function and liver biochemistry values demonstrated no significant change during follow-up. Although tacrolimus levels decreased initially after conversion to Advagraf therapy, 1:1 conversion is safe for hepatorenal function in liver transplant recipients.

  11. Effect of respiratory pattern on automated clinical blood pressure measurement: an observational study with normotensive subjects.

    Science.gov (United States)

    Herakova, Natalia; Nwobodo, Nnenna Harmony Nzeribe; Wang, Ying; Chen, Fei; Zheng, Dingchang

    2017-01-01

    It has been reported that deep breathing could reduce blood pressures (BP) in general. It is also known that BP is decreased during inhalation and increased during exhalation. Therefore, the measured BPs could be potentially different during deep breathing with different lengths of inhalation and exhalation. This study aimed to quantitatively investigate the effect of different respiratory patterns on BPs. Forty healthy subjects (20 males and 20 females, aged from 18 to 60 years) were recruited. Systolic and diastolic BPs (SBP and DBP) were measured using a clinically validated automated BP device. There were two repeated measurement sessions for each subject. Within each session, eight BP measurements were performed, including 4 measurements during deep breathing with different respiratory patterns (Pattern 1: 4.5 s vs 4.5 s; Patter 2: 6 s vs 2 s; Pattern 3: 2 s vs 6 s; and Pattern 4: 1.5 s vs 1.5 s, respectively for the durations of inhalation and exhalation) and additional 4 measurements from 1 min after the four different respiratory patterns. At the beginning and end of the two repeated measurement sessions, there were two baseline BP measurements under resting condition. The key experimental results showed that overall automated SBP significantly decreased by 3.7 ± 5.7 mmHg, 3.9 ± 5.2 mmHg, 1.7 ± 5.9 mmHg and 3.3 ± 5.3 mmHg during deep breathing, respectively for Patterns 1, 2, 3 and 4 (all p Pattern 3). Similarly, the automated DBPs during deep breathing in pattern 1, 2 and 4 decreased by 3.7 ± 5.0 mmHg, 3.7 ± 4.9 mmHg and 4.6 ± 3.9 mmHg respectively (all p Pattern 3 with a decrease of 1.0 ± 4.3 mmHg, p = 0.14). Correspondingly, after deep breathing, automated BPs recovered back to normal with no significant difference in comparison with baseline BP (all p > 0.05, except for SBP in Pattern 4). In summary, this study has quantitatively demonstrated that the measured automated BPs decreased

  12. Observable phenomena that reveal medical students' clinical reasoning ability during expert assessment of their history taking: a qualitative study

    NARCIS (Netherlands)

    Haring, C.M.; Cools, B.M.; Gurp, P.J.M. van; Meer, J.W.M. van der; Postma, C.T.

    2017-01-01

    BACKGROUND: During their clerkships, medical students are meant to expand their clinical reasoning skills during their patient encounters. Observation of these encounters could reveal important information on the students' clinical reasoning abilities, especially during history taking. METHODS: A

  13. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease.

    Science.gov (United States)

    Miravitlles, Marc; Price, David; Rabe, Klaus F; Schmidt, Hendrik; Metzdorf, Norbert; Celli, Bartolome

    2015-01-01

    There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD) seen in real-life clinical settings are represented in randomized controlled trials (RCTs) of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors. We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0), patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV) endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies. We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our search criteria. The Global initiative for chronic Obstructive Lung Disease (GOLD) staging of patients in the RCTs differed from that in observational studies: the proportion of patients with GOLD stages I+II disease ranged from 40.0% to 51.5% in the RCTs but 24.5% to 44.1% in the observational studies; for GOLD stage III or IV disease these ranges were 7.2%-45.8% (RCTs) and 13.7-42.1% (observational studies). The comorbidities with the highest prevalence reported in the RCTs and observational studies were: hypertension (39.4%-40.0% vs 40.1%-60.6%), other ischemic heart disease (12.3%-14.2% vs 12.5%-41.0%), diabetes (10.3%-10.9% vs 4.0%-38.9%), depression (8.5%-9.5% vs 17.0%-20.6%), and cardiac arrhythmia (7.8%-11.4% vs 11.3%-15.8%). The clinical profile of COPD patients treated in the tiotropium trial

  14. Trends in clinical development timeframes for antiviral drugs launched in the UK, 1981-2014: a retrospective observational study.

    Science.gov (United States)

    Ward, Derek J; Hammond, Edward; Linden-Phillips, Luan; Stevens, Andrew J

    2015-11-16

    Recent decades have witnessed the development of highly innovative new antiviral drug therapies. However, there are concerns that rising costs and lengthening development times could have implications for future patient access to innovative new drugs. We sought to establish whether the time taken for the clinical development of new antiviral drugs launched in the UK had increased since the 1980s. Retrospective observational study of all new antiviral drugs licensed for use in the UK. Duration of clinical development (from initiation of studies in humans to receipt of Marketing Authorisation), subdivided into clinical trial and regulatory approval periods by the date of Marketing Authorisation Application. 48 new antiviral drugs were licensed for use in the UK between 1981 and 2014 (inclusive), over half (54%) initially for HIV infection. The overall mean duration of clinical development was 77.2 months, of which 64.6 months was spent in clinical trials before regulatory submission. The total time in clinical development increased from 41.7 months for drugs licensed 1981-1992 to 91.7 months for drugs licensed 2004-2014. This increase was accounted for by an increase in the clinical trials period and not the regulatory approval period, for which there was no observable trend. Drugs initially licensed to treat hepatitis C had a longer duration of clinical development than those indicated for other viral infections. However, the, initially shorter clinical development durations of drugs indicated for HIV infection increased more rapidly across the study period than those indicated for other viral infections. The time spent by antiviral drugs in clinical development has increased markedly in recent decades despite many initiatives to speed access to innovative new drugs. However, this represents only one part of the translational research pathway, and a complete picture of development timeframes is lacking. Published by the BMJ Publishing Group Limited. For

  15. Characterization of patients with an inadequate clinical outcome from osteoporosis therapy: the Observational Study of Severe Osteoporosis (OSSO).

    Science.gov (United States)

    Jakob, F; Marín, F; Martín-Mola, E; Torgerson, D; Fardellone, P; Adami, S; Thalassinos, N C; Sykes, D; Melo-Gomes, J; Chinn, C; Nicholson, T; Cooper, C

    2006-08-01

    Osteoporotic fractures remain a major public health problem. Currently available osteoporosis therapies significantly reduce the risk of fractures, but up to 50% of patients have an inadequate clinical outcome to therapy. To describe the clinical and quality of life (QOL) of a study population meeting a proposed definition of inadequate clinical outcome to osteoporosis therapy, recruited for the Observational Study of Severe Osteoporosis (OSSO). Cross-sectional, observational study. Post-menopausal women with osteoporosis (n = 2314) were divided into Group 1 (those who had previously experienced a fragility fracture despite osteoporosis drug therapy for at least 12 months) (n = 1309, 57%), or Group 2 (those who had previously discontinued osteoporosis drug therapy due to non-compliance or side-effects) (n = 1005; 43%). Baseline clinical characteristics, quality of life (QOL) and osteoporosis/falls risk factors were analysed. The overall population had low BMD (mean +/- SD T-score at lumbar spine -3.1 +/- 1.1), and risk factors for fracture such as previous fractures (67.8%), family history (15.1%), and prolonged glucocorticoid use (17.5%). QOL was poor: total QUALEFFO and EQ-5D scores were 46.8 +/- 18.7, and 0.50 +/- 0.33, respectively. Patients in Group 1 had higher age and body mass index, fewer hours of exercise, more previous fragility fractures and falls, and poorer QOL scores. Our definition of inadequate clinical outcome from osteoporosis drug therapy identifies a severe osteoporosis cohort with poor QOL and increased fracture risk. Using such a definition may lead to earlier recognition of inadequate clinical outcome to osteoporosis therapy, and improved interventions and results.

  16. Safety and efficacy of mirabegron in daily clinical practice: a prospective observational study.

    Science.gov (United States)

    Kallner, Helena Kopp; Christensson, Anna Almén; Elmér, Caroline; Flam, Benjamin; Altman, Daniel

    2016-08-01

    To determine risks associated with prescribing mirabegron, the first-in-class β3-adrenoreceptor agonist, to non-selected female patients with overactive bladder. Routine female patients seeking treatment for overactive bladder (n=221) in a urology/gynecology outpatient clinic. Data on adverse events, cardiovascular outcomes, condition specific symptoms and drug discontinuation was collected at two months follow-up (FU). Non-parametric statistics was used as appropriate. Odds ratios (ORs) with 95% confidence intervals (CIs) for outcome association analyses using logistic regression. 16 patients (7.2%) discontinued treatment because of side effects. There were no significant associations between cardiovascular adverse events and pre-existing cardiovascular disease (OR 0.3, 95% CI 0.3-2.6), or pre-existing ECG abnormalities (OR 2.3, 95% CI 0.3-16.3). At FU ECGs there were no de novo cases of tachyarrhythmias and no significant difference in mean QTc between baseline (403ms, SD 21.7) and the 2 months follow-up ECG (403ms, SD 20.3) (p=0.75). There was a significant decrease in the mean systolic blood pressure (p=0.03) but no significant change in mean diastolic pressure (p=0.8) or heart rates (p=0.2) from baseline to FU. Overactive bladder specific symptoms and quality of life improved significantly (p<0.001 respectively). Mirabegron treatment is associated with a satisfactory cardiovascular safety profile, as well as, significant symptomatic improvement also in a heterogeneous population of non-selected women with overactive bladder presenting in everyday clinical practice. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  17. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].

    Science.gov (United States)

    Pato-Pato, A; Midaglia, L; Costa-Arpin, E; Rodriguez-Regal, A; Puy-Nunez, A; Rodriguez-Rodriguez, M; Lopez-Real, A; Llaneza-Gonzalez, M A; Garcia-Estevez, D A; Moreno-Carretero, M J; Escriche-Jaime, D; Aguado-Valcarcel, M L; Munoz, D; Prieto, J M; Lorenzo-Gonzalez, J R; Amigo-Jorrin, M C

    2016-09-05

    The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.

  18. Effects of hydrotalcite combined with esomeprazole on gastric ulcer healing quality: A clinical observation study.

    Science.gov (United States)

    Yang, Rui-Qi; Mao, Hua; Huang, Li-Yun; Su, Pei-Zhu; Lu, Min

    2017-02-21

    To evaluate the effects of hydrotalcite combined with esomeprazole on gastric ulcer healing quality. Forty-eight patients diagnosed with gastric ulcer between June 2014 and February 2016 were randomly allocated to the combination therapy group or monotherapy group. The former received hydrotalcite combined with esomeprazole, and the latter received esomeprazole alone, for 8 wk. Twenty-four healthy volunteers were recruited and acted as the healthy control group. Endoscopic ulcer healing was observed using white light endoscopy and narrow band imaging magnifying endoscopy. The composition of collagen fibers, amount of collagen deposition, expression of factor VIII and TGF-β1, and hydroxyproline content were analyzed by Masson staining, immunohistochemistry, immunofluorescent imaging and ELISA. Following treatment, changes in the gastric microvascular network were statistically different between the combination therapy group and the monotherapy group (P esomeprazole is superior to esomeprazole alone in improving gastric ulcer healing quality in terms of improving microvascular morphology, degree of structure maturity and function of regenerated mucosa.

  19. Clinical progression of moderate-to-severe Alzheimer's disease and caregiver burden: a 12-month multicenter prospective observational study.

    Science.gov (United States)

    Agüera-Ortiz, Luis; Frank-García, Ana; Gil, Pedro; Moreno, Alfonso

    2010-12-01

    Prospective studies on the clinical progression of Alzheimer's disease (AD) and its relationship to caregiver burden are needed to improve illness management and use of resources. This national, multicenter, observational study evaluated 1235 moderate to severe AD patients under routine care in Spain. Baseline cross-sectional sociodemographic and clinical data, and changes from baseline to month 12 of various neuropsychological tests and clinical ratings, including Blessed Dementia Scale, Mini-mental State Examination (MMSE), Hughes Clinical Dementia Rating sum-of-boxes (CDR-SB), Clinical Global Impression of Change (CGIC) and Zarit Caregiver Burden scales, were recorded and comprehensively analyzed. Baseline data were in accordance with characteristics consistently reported to influence AD risk regarding anthropometrics, sociocultural features and comorbidities. Significant progressive functional impairments (i.e. in routine activities and essential daily tasks) and cognitive (i.e. MMSE and CDR-SB) impairments were found at month 12. However, patients' behavior and caregivers' burden improved slightly, but significantly, corroborating the major influence of behavioral symptoms on caregivers' distress. Caregivers showed significantly lower burden with patients with higher levels of education and, to a lesser extent, when patients received AD-specific medication. Physicians accurately detected AD clinical evolution as their CGIC ratings significantly correlated with all tests. These findings reinforce previous AD knowledge and add data on the clinical course of advanced stages of AD. Caregiver burden depended more on patients' behavioral alterations than on their functional or cognitive declines; and it was diminished by their patients having higher levels of education and being treated with AD-specific medications. Research into unexplored factors that might reduce caregiver burden, ultimately benefiting both patients and caregivers, is encouraged.

  20. Clinical characteristics and outcome of heart failure and captagon amphetamine use: An observational prospective study

    Directory of Open Access Journals (Sweden)

    Abdelfatah A. Elasfar

    2014-03-01

    Conclusios: Captagon use was found to be an independent risk factor of death and other morbidities in patients presented with cardiomyopathy and acute heart failure. Our study underscores the importance of improving education concerning the cardiac risks of captagon use.

  1. Patients' perception of own efforts versus clinically observed outcomes of non-surgical periodontal therapy in a Norwegian population: an observational study.

    Science.gov (United States)

    Vatne, Jon F; Gjermo, Per; Sandvik, Leiv; Preus, Hans R

    2015-05-17

    Most periodontal intervention studies have focused on biomedical qualities like change in pocket depth and clinical attachment levels. Very few studies have described patient response in terms of how patients' general lives are affected by disease, treatment, and communication with therapy providers. Thus the aim of the present study was to investigate patient response to systematic periodontal information, motivation and treatment strategy (primary aim) by comparing the patients' perception of own efforts and results with those clinically registered in a trans-sectional, observational study (secondary aim). One year after treatment of 184 patients, 152 completed a questionnaire covering aspects of received oral health information and instruction, expectations, communication with the therapeutic team, behavioral change, self-perceived outcomes and satisfaction. More than 90% of the patients were satisfied with the interaction with the specialist team. 98% were satisfied with the information and instruction they had been given. 84% said that the information had been necessary to make them change their behavior towards better oral hygiene. Pain and discomfort, as well as bleeding were reduced substantially from before to after treatment, and 28 patients reported to have stopped smoking. In all questions regarding well-being there were statistically significant changes towards positive impact following therapy. Periodontal treatment, including customized information and education on the etiology and pathogenesis, prevention and treatment as well as maintenance of periodontal diseases resulted in a high degree of short- and long term compliance, and very good patient centered outcomes, which again had a positive impact on the patients' satisfaction. The patient centered outcomes correlated mostly with the compared clinical endpoints. ClinicalTrials.gov: NCT01318928.

  2. Oral polymorphonuclear neutrophil characteristics in relation to oral health: A cross-sectional, observational clinical study

    NARCIS (Netherlands)

    Rijkschroeff, P.; Jansen, I.D.C.; Weijden, F.A. van der; Keijser, B.J.F.; Loos, B.G.; Nicu, E.A.

    2016-01-01

    Polymorphonuclear neutrophils (PMNs) have a major role in the innate immune system. However, little is known about PMN contribution in relation to oral health. The objective of this study was to investigate the numbers and functional characteristics of oral PMNs (oPMNs) compared with circulatory

  3. Comorbidities of patients in tiotropium clinical trials: comparison with observational studies of patients with chronic obstructive pulmonary disease

    Directory of Open Access Journals (Sweden)

    Miravitlles M

    2015-03-01

    Full Text Available Marc Miravitlles,1 David Price,2 Klaus F Rabe,3,7 Hendrik Schmidt,4 Norbert Metzdorf,5 Bartolome Celli6 1Pneumology Department, Hospital Universitari Vall d’Hebron, Ciber de Enfermedades Respiratorias (CIBERES, Barcelona, Spain; 2Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 3Department of Medicine, Christian-Albrechts-Universität zu Kiel (CAU, Großhansdorf, Germany; 4Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim am Rhein, Germany; 6Pulmonary Division, Brigham and Women’s Hospital, Boston, MA, USA; 7LungenClinic Grosshansdorf, Großhansdorf, Germany Background: There is an ongoing debate on whether patients with chronic obstructive pulmonary disease (COPD seen in real-life clinical settings are represented in randomized controlled trials (RCTs of COPD. It is thought that the stringent inclusion and exclusion criteria of RCTs may prevent the participation of patients with specific characteristics or risk factors.Methods: We surveyed a database of patients recruited into 35 placebo-controlled tiotropium RCTs and also conducted a systematic literature review of large-scale observational studies conducted in patients with a documented diagnosis of COPD between 1990 and 2013. Patient demographics and comorbidities with a high prevalence in patients with COPD were compared between the two patient populations at baseline. Using the Medical Dictionary for Regulatory Activities (MedDRA; v 14.0, patient comorbidities in the pooled tiotropium RCTs were classified according to system organ class, pharmacovigilance (PV endpoints, and Standardised MedDRA Queries to enable comparison with the observational studies.Results: We identified 24,555 patients in the pooled tiotropium RCTs and 61,361 patients among the 13 observational studies that met our

  4. Prevalence of Barrett's esophagus: An observational study from a gastroenterology clinic

    Directory of Open Access Journals (Sweden)

    J.L. Herrera Elizondo

    2017-10-01

    Full Text Available Introduction and aims: Barrett's esophagus is a condition that predisposes to esophageal adenocarcinoma. Our aim was to establish the prevalence of Barrett's esophagus at our center, as well as determine its associated factors. Materials and methods: We retrospectively assessed the endoscopic reports of 500 outpatients seen at our Gastroenterology Service from November 2014 to April 2016. We determined the prevalence of Barrett's esophagus and analyzed the demographic, clinical, and endoscopic findings associated with that pathology. Results: The prevalence of Barrett's esophagus was 1.8%. The mean age of the patients with Barrett's esophagus was 58.7 years (range: 45-70 and there was a predominance of men (66%. In the subgroup of patients with symptoms of gastroesophageal reflux (n = 125, Barrett's esophagus prevalence was 7.2%. In the multivariate analysis, the factors that were independently associated with Barrett's esophagus were gastroesophageal reflux (P=.005 and hiatal hernia (P=.006. Conclusions: The overall prevalence of Barrett's esophagus was 1.8% in our population, with a prevalence of 7.2% in patients that had symptoms of gastroesophageal reflux. Resumen: Introducción y objetivos: El esófago de Barrett es una condición que predispone al adenocarcinoma esofágico. Nuestro objetivo fue establecer la prevalencia de esófago de Barrett en nuestro centro, así como los factores asociados a esta condición. Material y métodos: Evaluamos retrospectivamente los reportes de 500 endoscopias superiores de pacientes ambulatorios de nuestro Servicio de Gastroenterología entre noviembre del 2014 y abril del 2016. Se determinó la prevalencia de esófago de Barrett y se analizaron los datos demográficos, clínicos y endoscópicos asociados a esta patología. Resultados: La prevalencia de esófago de Barrett fue del 1.8%. La edad media en los pacientes con esófago de Barrett fue de 58.7 años (rango: 45-70, con predominancia del sexo

  5. HIV-1 resistance rarely observed in subjects using darunavir once-daily regimens across clinical studies.

    Science.gov (United States)

    Lathouwers, Erkki; Wong, Eric Y; Luo, Donghan; Seyedkazemi, Sareh; De Meyer, Sandra; Brown, Kimberley

    2017-11-16

    Darunavir 800 mg once daily (QD) is indicated for HIV-1-infected treatment-naïve and treatment-experienced (without darunavir resistance-associated mutations [RAMs]) individuals, and has been evaluated in phase 2/3 studies with durations between 48 and 192 weeks. To summarize the development (or identification) of post-baseline resistance (RAMs and antiretroviral phenotypic susceptibility) among subjects receiving darunavir QD dosing. Seven phase 2/3 studies with available genotypes/phenotypes for subjects treated with ritonavir- or cobicistat-boosted darunavir 800 mg QD regimens were assessed: ARTEMIS (NCT00258557; n = 343), GS-US-299-0102 (NCT01565850; n = 153), GS-US-216-0130 (NCT01440569; n = 313), ODIN (NCT00524368; n = 294), INROADS (NCT01199939; n = 54), MONET (NCT00458302; n = 256), and PROTEA (NCT01448707; n = 273). Genotypic analyses were conducted at baseline (except switch studies enrolling virologically suppressed subjects [MONET, PROTEA]). Criteria for post-baseline resistance testing and evaluation of the development (or identification [switch studies]) of RAMs (respective IAS-USA mutations) varied slightly across studies. Among 1686 subjects treated with darunavir 800 mg QD regimens, 184 had protocol-defined virologic failure; 182 had post-baseline genotypes analyzed. Overall, 4/1686 (0.2%) developed (or had identified [switch studies]) primary protease inhibitor and/or darunavir RAMs (ARTEMIS, n = 1; GS-US-216-0130, n = 1; ODIN, n = 1; MONET, n = 1). Only 1/1686 (1%) subject lost darunavir phenotypic susceptibility (ODIN; possibly related to prior ritonavir-boosted lopinavir virologic failure). Among 1103 subjects using a nucleos(t)ide reverse transcriptase inhibitor (N[t]RTI) backbone, 10 (0.9%) developed ≥ 1 N(t)RTI RAM (8 had the emtricitabine RAM M184I/V). Darunavir has a high genetic barrier to resistance. Across a diverse population of HIV-1-infected subjects treated with darunavir 800 mg QD regimens, the

  6. Assessing the Use of Mobile Health Technology by Patients: An Observational Study in Primary Care Clinics

    OpenAIRE

    Ramirez, Veronica; Johnson, Emily; Gonzalez, Cesar; Ramirez, Vanessa; Rubino, Barbara; Rossetti, Gina

    2016-01-01

    Background There is significant potential for mobile health technology to improve health outcomes for patients with chronic diseases. However, there is a need for further development of mobile health technology that would help to improve the health of lower-income communities. Objective The study objective was to assess mobile phone and app usage among a culturally diverse patient population, and to determine whether patients would be interested in using mobile health technology to help manag...

  7. Observational study identifies non-attendance characteristics in two hospital outpatient clinics

    DEFF Research Database (Denmark)

    Blæhr, Emely; Søgaard, Rikke; Kristensen, Thomas

    2016-01-01

    INTRODUCTION: Non-attended hospital appointments are receiving increasing attention in times when rapid access and efficient service delivery at public hospitals are on the agenda. The aim of this study was to investigate the extent of non-attendance in a Danish outpatient setting and its...... notice were collected from administrative systems along with appointment characteristics. Logistic regression was used for statistical analysis. RESULTS: Of the 54,987 and 31,538 appointments scheduled at the two departments, 4,524 (8%) and 5,479 (17%) were cancelled and 2,905 (5%) and 1,249 (4%) were...

  8. Improvement of skin quality after fat grafting: clinical observation and an animal study.

    Science.gov (United States)

    Mojallal, Ali; Lequeux, Charlotte; Shipkov, Christo; Breton, Pierre; Foyatier, Jean-Louis; Braye, Fabienne; Damour, Odile

    2009-09-01

    Restoration of volume and contour defects is a challenge in plastic surgery. Autologous fat tissue transfer is gaining increasing popularity in this field. The aim of this study was to investigate the histologic modifications of the skin after fat tissue grafting on an animal model. Thirty nude mice, divided into three groups, were used in the experiment. All 30 mice received human fat tissue on one side. On the opposite side, 10 mice received nothing (negative control group), 10 mice received cell proliferation medium, and the remaining 10 mice received only subcutaneous tunneling. Eight weeks later, biopsies of the skin and subcutaneous tissue were performed and specimens were analyzed by hematoxylin-phloxin-saffron staining. Dermis thickness was measured. To differentiate human from murine collagen fibers, human and murine collagen type I antibodies were used. The other types of collagen were investigated by immunohistochemistry (immunostaining) using collagen type III, V, and VI antibodies. Fat tissue was found in all animals. Macroscopically, fat tissue presented normal aspects, with abundant peripheral neovascularization. Histologic examination showed abundant extracellular matrix around the injected human fat tissue. This was attributable to increased type I collagen fibers of murine origin as a result of the murine fibroblast stimulation by the grafted human fat tissue. Dermal thickness after fat grafting was significantly greater. This was not attributable to inflammatory reactions, because no modification was detected in our control groups. This study shows that fat tissue grafting stimulates a neosynthesis of collagen fibers at the recipient site and makes the dermis thicker. However, the long-term effects remain undetermined and need further investigation.

  9. The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

    Science.gov (United States)

    2014-01-01

    Background Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Methods Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). Results 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). Conclusions The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design. PMID:24607083

  10. Characterisation of patients receiving moxifloxacin for acute bacterial rhinosinusitis in clinical practice: results from an international, observational cohort study.

    Directory of Open Access Journals (Sweden)

    Ralph Mösges

    Full Text Available We conducted a prospective, non-controlled, multi-centre Phase IV observational cohort study of patients with acute bacterial rhinosinusitis who were treated with moxifloxacin in clinical practice in 19 countries in Asia Pacific, Europe and the Middle East. With the data collected we evaluated the presentation and course of the current disease episode, particularly in terms of the principal clinical signs and symptoms of acute rhinosinusitis and diagnostic procedures. A final assessment of moxifloxacin therapy was made to evaluate the impact of the sinusitis episode on activities of daily life and on sleep disturbance, and to evaluate the clinical outcome of treatment. A total of 7,090 patients were enrolled, of whom 3909 (57.6% were included in the valid for clinical outcome and safety population. Regional differences were observed in the main symptoms of acute rhinosinusitis and, according to several characteristics, disease episodes appeared to be more severe in patients in Europe than in the Asia Pacific or Middle East regions. The sinusitis episode impacted on daily living for mean (SD periods of 3.6 (3.2, 4.6 (3.9 and 3.1 (3.0 days and disturbed sleep for 3.6 (3.2, 4.6 (3.9 and 3.1 (3.0 nights in the Asia Pacific, Europe and Middle East regions, respectively. With moxifloxacin treatment, the mean (SD time to improvement of symptoms was 3.0 (1.5, 3.4 (1.6 and 3.2 (1.5 days, and the time to resolution of symptoms was 4.8 (2.6 days, 5.7 (2.4 days and 5.5 (2.5 days, in the Asia Pacific, Europe and Middle East regions, respectively. In conclusion, acute rhinosinusitis remains a substantial health burden with significant impact on patients' quality of life, and there are differences between global regions in the clinical presentation, diagnosis and clinical course of disease episodes. Moxifloxacin was an effective and well-tolerated treatment option in the overall population.ClinicalTrials.gov Identifier: NCT00930488.

  11. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations.......Within the last 25 years composite resin materials have in many countries successively replaced amalgam as a restorative for posterior teeth. Resin materials and bonding systems are continuously being improved by the manufactures, adhesive procedures are now included in the curriculum of most...

  12. Clinical and Microbiological Characteristics of Visceral Leishmaniasis Outbreak in a Northern Italian Nonendemic Area: A Retrospective Observational Study

    Directory of Open Access Journals (Sweden)

    E. Franceschini

    2016-01-01

    Full Text Available Background. Visceral leishmaniasis (VL caused by Leishmania infantum is endemic in the Mediterranean area. In the last decades a northward spread of the parasite has been observed in Italy. This paper describes a VL outbreak in Modena province (Emilia-Romagna, Northern Italy between 2012 and 2015. Methods. Retrospective, observational study to evaluate epidemiological, microbiological characteristics, and clinical management of VL in patients referring to Policlinico Modena Hospital. Results. Sixteen cases of VL occurred in the study period. An immunosuppressive condition was present in 81.3%. Clinical presentation included anemia, fever, leukopenia, thrombocytopenia, and hepatosplenomegaly. Serology was positive in 73.3% of cases, peripheral blood PCR in 92.3%, and bone marrow blood PCR in 100%. Culture was positive in 3/6 cases (50% and all the isolates were identified as L. infantum by ITS1/ITS2 sequencing. The median time between symptom onset and diagnosis was 22 days (range 6–131 days. All patients were treated with liposomal amphotericin b. 18.8% had a VL recurrence and were treated with miltefosine. Attributable mortality was 6.3%. Conclusions. VL due to L. infantum could determine periodical outbreaks, as the one described; thus it is important to include VL in the differential diagnosis of fever of unknown origin, even in low-endemic areas.

  13. Observable phenomena that reveal medical students' clinical reasoning ability during expert assessment of their history taking: a qualitative study.

    Science.gov (United States)

    Haring, Catharina M; Cools, Bernadette M; van Gurp, Petra J M; van der Meer, Jos W M; Postma, Cornelis T

    2017-08-29

    During their clerkships, medical students are meant to expand their clinical reasoning skills during their patient encounters. Observation of these encounters could reveal important information on the students' clinical reasoning abilities, especially during history taking. A grounded theory approach was used to analyze what expert physicians apply as indicators in their assessment of medical students' diagnostic reasoning abilities during history taking. Twelve randomly selected clinical encounter recordings of students at the end of the internal medicine clerkships were observed by six expert assessors, who were prompted to formulate their assessment criteria in a think-aloud procedure. These formulations were then analyzed to identify the common denominators and leading principles. The main indicators of clinical reasoning ability were abstracted from students' observable acts during history taking in the encounter. These were: taking control, recognizing and responding to relevant information, specifying symptoms, asking specific questions that point to pathophysiological thinking, placing questions in a logical order, checking agreement with patients, summarizing and body language. In addition, patients' acts and the course, result and efficiency of the conversation were identified as indicators of clinical reasoning, whereas context, using self as a reference, and emotion/feelings were identified by the clinicians as variables in their assessment of clinical reasoning. In observing and assessing clinical reasoning during history taking by medical students, general and specific phenomena to be used as indicators for this process could be identified. These phenomena can be traced back to theories on the development and the process of clinical reasoning.

  14. Cervical spine disc herniation at C2-C3 level: Study of a Clinical Observation and Literature Review

    Directory of Open Access Journals (Sweden)

    Oka Dominique N'Dri

    2015-12-01

    Full Text Available Cervical C2-C3 herniated disc is rare. It is characterized by its clinical polymorphism. Several surgical approaches have been described for the discectomy of a herniated disc. This work aims at discussing through personal observations and literature review clinical semiology and surgical treatment.

  15. A Complex Multiherbal Regimen Based on Ayurveda Medicine for the Management of Hepatic Cirrhosis Complicated by Ascites: Nonrandomized, Uncontrolled, Single Group, Open-Label Observational Clinical Study

    National Research Council Canada - National Science Library

    Patel, Manish V; Patel, Kalapi B; Gupta, Shivenarain; Michalsen, Andreas; Stapelfeldt, Elmar; Kessler, Christian S

    2015-01-01

    ...). In form of a nonrandomized, uncontrolled, single group, open-label observational clinical study, 56 patients fulfilling standardized diagnostic criteria for HCcA were observed during their treatment at the P. D...

  16. Efficacy of trastuzumab in routine clinical practice and after progression for metastatic breast cancer patients: the observational Hermine study.

    Science.gov (United States)

    Extra, Jean-Marc; Antoine, Eric C; Vincent-Salomon, Anne; Delozier, Thierry; Kerbrat, Pierre; Bethune-Volters, Anne; Guastalla, Jean-Paul; Spielmann, Marc; Mauriac, Louis; Misset, Jean-Louis; Serin, Daniel; Campone, Mario; Hebert, Christophe; Remblier, Céline; Bergougnoux, Loïc; Campana, Frank; Namer, Moïse

    2010-01-01

    The Hermine study observed the use of trastuzumab for metastatic breast cancer (MBC) in routine practice, including patients who received trastuzumab treatment beyond progression (TBP). The study observed 623 patients for > or = 2 years. Treatment was given according to oncologists' normal clinical practices. Endpoints included duration of treatment, efficacy, and cardiac safety. The TBP subanalysis compared overall survival (OS) in 177 patients who received first-line trastuzumab and either continued trastuzumab for > or = 30 days following progression or stopped at or before progression. The median treatment duration was 13.3 months. In the first-, second-, and third-line or beyond treatment groups, the median time to progression (TTP) were 10.3 months, 9.0 months, and 6.3 months, and the median OS times were 30.3 months, 27.1 months, and 23.2 months, respectively. Heart failure was observed in 2.6% of patients, although no cardiac-associated deaths occurred. In the TBP subanalysis, the median OS duration from treatment initiation and time of disease progression were longer in patients who continued receiving trastuzumab TBP (>27.8 months and 21.3 months, respectively) than in those who stopped (16.8 months and 4.6 months, respectively). However, the groups were not completely comparable, because patients who continued trastuzumab TBP had better prognoses at treatment initiation. The median TTP was longer in patients who continued trastuzumab TBP (10.2 months) than in those who stopped (7.1 months). The Hermine findings confirm that the pivotal trials of first-line trastuzumab treatment in MBC patients are applicable in clinical practice. The subanalysis suggests that trastuzumab TBP offers a survival benefit to MBC patients treated with first-line trastuzumab.

  17. Clinical observation on parathion poisoning

    Energy Technology Data Exchange (ETDEWEB)

    Park, Heung Il; Kwun, Chung Sik [Chonnam University Medical School, Kwangju (Korea, Republic of)

    1972-09-15

    A total of 158 cases of parathion poisoning were clinically observed in Chonnam University Hospital from January, 1968 to June, 1972 with the following results. 1. The males were 133 and the females, 25 (radio, about 5:1) with 93 patients (58.9%) in the age group of 21 to 40 years old and the majority of the patients were farmers. 2. 158 cases could be divided into 38 cases of inhalation group (group I) and 120 cases of ingestion group (group II). The group I entirely occurred by accident during spraying the parathion, whereas the group II mostly developed by ingestion of the parathion for the suicide purpose. 3. During the period from 1968 to 1972, more frequent incidence of parathion poisoning showed up in 1971 and 1972. Inhalation group mostly occurred on July, August, and September, but several cases appeared sporadically in the rest of the months. 4. Most patients came to our Hospital within 4 hours after parathion poisoning and were discharged from the Hospital within one or two days after admission. Mortality was 2 cases (5.3%) out of 38 cases in inhalation group and was 26 cases (21.7%) out of 120 cases in ingestion group. 5. Clinical signs and symptoms showing high incidence were bronchorrhoea (incidence of 38.6%), dyspnea (57.6%), vomiting (62.0%), abdominal cramps (20.0%), sialorrhoea (53.8%), tachycardia (32.2%), miosis (67.7%), fasciculation (19.0%), hypertension (27.9%), drowsiness and confusion (50.0%), leukocytosis (58.3%), elevation of SGOT (23.0%), whereas mydriasis (5.7%), and proteinuria (4.0%) were low in incidence. All the ten cases (6.3%) showing involuntary defecation expired. 6. Roentgenographs of the chest were taken to 39 cases out of a total of 158 cases and revealed 21 cases (54.0%) of normal chest, 11 cases (28.0%) of bilateral pulmonary congestion, 7 cases (18.0%) of pulmonary edema or pneumonic consolidation.

  18. Patients enrolled in randomised clinical trials are not representative of critically ill patients in clinical practice: observational study focus on tigecycline.

    Science.gov (United States)

    Zimmermann, Johannes B; Horscht, Julia J; Weigand, Markus A; Bruckner, Thomas; Martin, Eike O; Hoppe-Tichy, Torsten; Swoboda, Stefanie

    2013-11-01

    It is being increasingly recognised by clinicians and scientists that participants in randomised clinical trials (RCTs) of antibiotics of last resort do not represent the patients who will later be treated with these drugs. Data on this subject are limited and have not been investigated systematically. This observational study aimed to examine this hypothesis quantitatively, using the example of tigecycline. To evaluate the influence of recruitment, patients eligible for clinical trials were retrospectively compared with ineligible patients regarding baseline and clinical characteristics as well as outcome parameters, e.g. length of hospital stay, intensive care unit (ICU) stay, ventilation and mortality. The clinical characteristics of 187 patients illustrated differences in the nature and severity of disease, co-morbidities and outcome. Eligible and ineligible patients differed in a number of parameters, e.g. median APACHE II score (15.5 vs. 28.0), number of liver transplantations (5% vs. 18%; P=0.048), septic shock (21% vs. 49%; P=0.001), need for mechanical ventilation (30% vs. 79%; P<0.001), mean length of ICU stay (19.3 days vs. 40.7 days) and death (19% vs. 46%; P=0.001). Critically ill patients were under-represented in clinical trials. Moreover, only a minority of patients in clinical practice (13%) were potentially eligible for a pivotal RCT. The disparities likely result from strict exclusion criteria in RCTs and recruitment bias. These data emphasise the importance of including critically ill patients in RCTs of antibiotics against multiresistant bacteria in order to account for those who will later be treated. Copyright © 2013 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  19. Using Clinically Accessible Tools to Measure Sound Levels and Sleep Disruption in the ICU: A Prospective Multicenter Observational Study.

    Science.gov (United States)

    Litton, Edward; Elliott, Rosalind; Thompson, Kelly; Watts, Nicola; Seppelt, Ian; Webb, Steven A R

    2017-06-01

    To use clinically accessible tools to determine unit-level and individual patient factors associated with sound levels and sleep disruption in a range of representative ICUs. A cross-sectional, observational study. Australian and New Zealand ICUs. All patients 16 years or over occupying an ICU bed on one of two Point Prevalence study days in 2015. Ambient sound was measured for 1 minute using an application downloaded to a personal mobile device. Bedside nurses also recorded the total time and number of awakening for each patient overnight. The study included 539 participants with sound level recorded using an application downloaded to a personal mobile device from 39 ICUs. Maximum and mean sound levels were 78 dB (SD, 9) and 62 dB (SD, 8), respectively. Maximum sound levels were higher in ICUs with a sleep policy or protocol compared with those without maximum sound levels 81 dB (95% CI, 79-83) versus 77 dB (95% CI, 77-78), mean difference 4 dB (95% CI, 0-2), p sound levels regardless of single room occupancy, mechanical ventilation status, or illness severity. Clinical nursing staff in all 39 ICUs were able to record sleep assessment in 15-minute intervals. The median time awake and number of prolonged disruptions were 3 hours (interquartile range, 1-4) and three (interquartile range, 2-5), respectively. Across a large number of ICUs, patients were exposed to high sound levels and substantial sleep disruption irrespective of factors including previous implementation of a sleep policy. Sound and sleep measurement using simple and accessible tools can facilitate future studies and could feasibly be implemented into clinical practice.

  20. The relationship between Vitamin D, clinical outcomes and mortality rate in ICU patients: A prospective observational study

    Directory of Open Access Journals (Sweden)

    Nooshin Vosoughi

    2016-01-01

    Full Text Available Background: According to the high prevalence of Vitamin D deficiency, a few studies have been conducted to clarify the relationship between 25-hydroxyvitamin D (25(OHD and clinical outcomes in critically ill patients. The objective of this study was to determine this probable association. Materials and Methods: Serum 25(OHD, C-reactive protein, malnutrition measurements, and Intensive Care Unit (ICU-acquired infection from 185 patients in ICU were assessed in the first 24 h of admission and they were followed for the other outcomes. Results: About 93.5% of patients were classified as deficient and insufficient while the others were categorized in sufficient group. 25(OHD status was not significantly associated with mortality rate (P = 0.66, and no significant differences in ventilation time were observed (P = 0.97. Sufficient group left the ICU sooner, but the difference was not significant (P = 0.75. Besides the results of relationship between 25(OHD concentration and nutritional status (P = 0.69 were not significant. In addition, sufficient group suffered from infection more than insufficient patients, but this relationship was not significant (P = 0.11. Conclusion: In this study, we found that 25(OHD insufficiency is common in ICU patients, but no significant association between low 25(OHD levels and ICU outcomes were observed. Hence, because of vital roles of Vitamin D in human′s body, comprehensive study should conduct to determine the decisive results.

  1. Internet health seeking behaviour of parents attending a general paediatric outpatient clinic: A cross-sectional observational study.

    Science.gov (United States)

    Sebelefsky, Christian; Karner, Denise; Voitl, Jasmin; Klein, Frederic; Voitl, Peter; Böck, Andreas

    2015-10-01

    Our aim was to examine the internet health seeking behaviour of parents attending a general paediatric outpatient clinic. For this purpose, the proportion of parents going online to obtain child health information, the most commonly used online resources, and factors having an influence on internet usage were identified. This cross-sectional observational study was conducted at a general paediatric outpatient clinic in Vienna, Austria. Data collection was done by means of an anonymous questionnaire containing 14 items. A total number of 500 questionnaires were collected. Among parents visiting the outpatient clinic, 94.4% use the internet to obtain child health information in general and 21% to be informed about the reason for consultation. Most commonly used online resources are Google (91.4%), websites run by doctors (84.8%), Wikipedia (84.7%), health portals (76.4%), the outpatient clinic's homepage (76.4%), as well as health forums and communities (61.9%). Younger parents (p = 0.022) and parents of younger children (p parents with different completed educational levels (mothers: p = 0.078; fathers: p = 0.388) do not differ in this behaviour. Important reasons for high internet use might be the inexperience of young parents regarding child health as well as the frequent infections, vaccinations, and preventive check-ups which are associated with young age of children. In contrast to former findings relating to health seekers in general, internet usage of parents is independent of their sex and educational level. © The Author(s) 2015.

  2. Contrast-induced nephropathy in patients undergoing computed tomography (CONNECT) - a clinical problem in daily practice? A multicenter observational study

    Energy Technology Data Exchange (ETDEWEB)

    Lencioni, Riccardo (Div. of Diagnostic Imaging and Intervention, Dept. of Liver Transplantation, Hepatology, Pisa Univ. Hospital, Pisa (Italy)), e-mail: lencioni@med.unipi.it; Fattori, Rossella (Dept. of Radiology-Cardiovascular Unit, Univ. Hospital S. Orsola, Bologna (Italy)); Morana, Giovanni (Dept. of Radiology, General Hospital ' Ca' Foncello' , Treviso (Italy)); Stacul, Fulvio (Dept. of Radiology, Univ. Hospital of Trieste, Ospedale Maggiore, Trieste (Italy))

    2010-09-15

    Background: Although several studies have examined contrast-induced nephropathy (CIN) following computed tomography (CT) procedures under closely controlled clinical trial conditions, less is known about the incidence of CIN (or its key predictive factors) in a 'real world' clinical setting. Purpose: A multicenter, observational registry study was undertaken in Italian hospital radiology departments to retrospectively assess the incidence of CIN in at-risk patients undergoing iodixanol-enhanced CT procedures. Material and Methods: Each department used center-specific (non standardized) CT protocols. Data were available from 493 at-risk patients; most (76.4%) had 1 risk factor for CIN, 19.8% had 2, and 3.4% had 3. In all, 169 patients (34.3%) had reduced renal function (estimated glomerular filtration rate [eGFR] <60 ml/min/1.73m2). Prophylactic volume expansion was not used in 70.6% of the study population. Results: The overall incidence of CIN (defined as a =44.2 mumol/l [0.5 mg/dl] increase in serum creatinine from baseline 72 h post procedure) was 2.6%; in the subpopulation of patients with renal impairment (with or without other risk factors), CIN incidence was 4.7%. Multivariate analysis identified renal insufficiency as the only risk factor predictive of CIN (relative risk, 3.850; 95% confidence interval, 1.200-12.348; P=0.023). Conclusion: In the clinical setting of hospital CT radiology practice, where guideline-recommended strategies for CIN prevention may not be consistently followed, use of the iso-osmolar agent iodixanol appears to be associated with a low incidence of CIN in at-risk patients. Keywords CT, intravenous contrast agents, kidney, vascular

  3. Physical assessment and anthropometric measures for use in clinical research conducted in critically ill patient populations: an analytic observational study.

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    Simpson, Fiona; Doig, Gordon S

    2015-03-01

    Accurate assessment of nutrition status is essential in identifying subpopulations of critically ill patients who are malnourished and at higher mortality risk. The aim of this analytic observational study was to assess the performance of physical assessment and anthropometric measures commonly used in clinical research. A prospective study was undertaken in 31 intensive care units (ICUs) with a focus on patients with short-term contraindications to enteral nutrition. Within 24 hours of admission to the ICU, the following measures were collected: the Subjective Global Assessment components measuring subcutaneous fat loss and muscle wasting, height, weight, mid-upper-arm circumference, and triceps skinfold thickness (TSF). Mid-arm muscle circumference and body mass index (BMI) were calculated. BMI was assessed as a continuous variable and categorized according to the World Health Organization (WHO) categories. The primary outcome was hospital discharge mortality. In total, 1363 patients were enrolled. BMI, analyzed according to WHO categories (P = .09), and TSF (P = .32) failed to demonstrate statistically significant predictive ability. TSF failed to demonstrate statistically significant clinical utility (area under the receiver operating characteristic curve, 0.52; 95% confidence interval, 0.48-0.56). All other individual measures demonstrated statistically significant predictive ability and statistically significant clinical utility. On the basis of the results of our ICU cohort, we recommend caution when using BMI categorized according to WHO definitions. We cannot recommend collection of TSF. More research is required to understand reliability, performance, and use before our results are able to be generalized to other ICU populations. © 2013 American Society for Parenteral and Enteral Nutrition.

  4. Effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir for hepatitis C virus in clinical practice: A population-based observational study.

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    Maya Leventer-Roberts

    Full Text Available Direct acting antivirals for hepatitis C virus have shown dramatic results in clinical trials. However, their effectiveness has yet to be demonstrated within observational cohorts which lack exclusion criteria found in randomized control trials.To determine the effectiveness of dasabuvir/ombitasvir/paritaprevir/ritonavir in achieving sustained virological response.Retrospective observational cohort study of all Clalit Health Services members with hepatitis C virus genotype 1 who were dispensed dasabuvir/ombitasvir/paritaprevir/ritonavir from January 1, 2015 to-November 31, 2015.There were 564 participants during the study period. The average age was 61.9 years, 52.0% were male, and 61.5% were born Eastern/Central Europe or Central Asia. The prevalence of diabetes was 31.7% and 70.3% were overweight/obese. Cirrhosis was present in 41.0% of participants, of whom 52.8% had stage 4 fibrosis. Of the cohort, 416 (74.8% had follow-up viral load testing at 10 or more weeks after the end of treatment. We report a sustained virological response of 98.8% among those tested.Treatment with dasabuvir/ombitasvir/paritaprevir/ritonavir demonstrated a near universal effectiveness in achieving a sustained virological response among HCV patients in a large cohort.

  5. Incidence and clinical course of radionecrosis in children with brain tumors. A 20-year longitudinal observational study

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    Strenger, V.; Lackner, H. [Graz Medical Univ. (Austria). Div. of Pediatric Hematology/Oncology; Mayer, R. [EBG MedAustron GmbH, Wiener Neustadt (Austria). Dept. of Radiotherapy] [and others

    2013-09-15

    Radionecrosis (RN) in children treated for brain tumors represents a potentially severe long-term complication. Its diagnosis is challenging, since magnetic resonance imaging (MRI) cannot clearly discriminate between RN and tumor recurrence. A retrospective single-center study was undertaken to describe the incidence and clinical course of RN in a cohort of 107 children treated with external radiotherapy (RT) for various brain tumors between 1992 and 2012. During a median follow-up of 4.6 years (range 0.29-20.1 years), RN was implied by suspicious MRI findings in in 5 children (4.7 %), 5-131 months after RT. Suspicion was confirmed histologically (1 patient) or substantiated by FDG positron-emission tomography (FDG-PET, 2 patients) or by FDG-PET and MR spectroscopy (1 patient). Before developing RN, all 5 patients had received cytotoxic chemotherapy in addition to RT. In addition to standard treatment protocols, 2 patients had received further chemotherapy for progression or relapse. Median radiation dose expressed as the biologically equivalent total dose applied in 2 Gy fractions (EQD2) was 51.7 Gy (range 51.0-60.0 Gy). At RN onset, 4 children presented with neurological symptoms. Treatment of RN included resection (n = 1), corticosteroids (n = 2) and a combination of corticosteroids, hyperbaric oxygen (HBO) and bevacizumab (n = 1). One patient with asymptomatic RN was not treated. Complete radiological regression of the lesions was observed in all patients. Clinical symptoms normalized in 3 patients, whereas 2 developed permanent severe neurological deficits. RN represents a severe long-term treatment complication in children with brain tumors. The spectrum of clinical presentation is wide; ranging from asymptomatic lesions to progressive neurological deterioration. FDG-PET and MR spectroscopy may be useful for distinguishing between RN and tumor recurrence. Treatment options in patients with symptomatic RN include conservative management (steroids, HBO

  6. Long Term Clinical Prognostic Factors in Relapsing-Remitting Multiple Sclerosis: Insights from a 10-Year Observational Study.

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    Gabriel Bsteh

    Full Text Available Multiple sclerosis (MS has a highly heterogenic course making prediction of long term outcome very difficult.The objective was to evaluate current and identify additional clinical factors that are linked to long term outcome of relapsing-remitting MS assessed by disability status 10 years after disease onset.This observational study included 793 patients with relapsing-remitting MS. Clinical factors hypothesized to influence long term outcome measured by EDSS scores 10 years after disease onset were analysed by Kaplan-Meier-estimates. Multinomial logistic regression models regarding mild (EDSS ≤2.5, moderate (EDSS 3.0-5.5 or severe (EDSS ≥6.0 disability were calculated to correct for confounders.Secondary progression was the strongest predictor of severe disability (Hazard ratio [HR] 503.8, 95% confidence interval [CI] 160.0-1580.1; p<0.001. Complete remission of neurological symptoms at onset reduced the risk of moderate disability (HR 0.42; CI 0.23-0.77; p = 0.005, while depression (HR 3.59; CI 1.14-11.24; p = 0.028 and cognitive dysfunction (HR 4.64; CI 1.11-19.50; p = 0.036 10 years after disease onset were associated with severe disability. Oligoclonal bands and pregnancy were not correlated with disability.We were able to identify clinically apparent chronic depression and cognitive dysfunction to be associated with adverse long term outcome in MS and to confirm that pregnancy has no negative impact. Additionally, we emphasize the positive predictive value of complete remission of initial symptoms.

  7. Clinical and economic burdens experienced by patients with painful diabetic peripheral neuropathy: An observational study using a Japanese claims database.

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    Nozomi Ebata-Kogure

    Full Text Available Diabetic peripheral neuropathy (DPN may often be painful. Despite the high prevalence of painful DPN (pDPN among patients with diabetes mellitus (DM, understanding of its clinical and economic burden is limited. This study aimed to describe the clinical and economic burdens faced by patients with pDPN in Japan, and compared them with those experienced by patients with DPN but without painful symptoms (non-pDPN.This retrospective, observational study used data from a large-scale, hospital-based Japanese claims database collected from April 2008 to June 2015. Comorbidities, clinical departments visited, length of hospital stay, and medical costs for the period of ± 6 months from the diagnosis of pDPN or non-pDPN were described for each group. Glycemic control status was examined for each group for patients with glycated hemoglobin data.The data of 8,740 patients with pDPN (mean age 70.0 years, 53.4% male and 12,592 patients with non-pDPN (mean age 67.7 years, 55.7% male were analyzed. Patients with pDPN had more comorbidities than patients with non-pDPN; 48.7% and 30.9% of patients in the respective groups had 20 or more comorbidities. The median length of hospital stay was 5 days longer in patients with pDPN. The median total medical costs were higher in patients with pDPN (\\517,762 than in patients with non-pDPN (\\359,909. Patients with pDPN spent higher median costs for medications, but the costs for glycemic control drugs were similar in both groups. For 3,372 patients with glycated hemoglobin data, glycemic control was similar between the two groups.Patients with pDPN experienced greater clinical and economic burdens than patients with non-pDPN, suggesting that patients who develop pDPN may suffer not only from the complications of DM and pain, but also from other comorbid disorders.

  8. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients.

    Science.gov (United States)

    Barbieri, Carlo; Molina, Manuel; Ponce, Pedro; Tothova, Monika; Cattinelli, Isabella; Ion Titapiccolo, Jasmine; Mari, Flavio; Amato, Claudia; Leipold, Frank; Wehmeyer, Wolfgang; Stuard, Stefano; Stopper, Andrea; Canaud, Bernard

    2016-08-01

    Managing anemia in hemodialysis patients can be challenging because of competing therapeutic targets and individual variability. Because therapy recommendations provided by a decision support system can benefit both patients and doctors, we evaluated the impact of an artificial intelligence decision support system, the Anemia Control Model (ACM), on anemia outcomes. Based on patient profiles, the ACM was built to recommend suitable erythropoietic-stimulating agent doses. Our retrospective study consisted of a 12-month control phase (standard anemia care), followed by a 12-month observation phase (ACM-guided care) encompassing 752 patients undergoing hemodialysis therapy in 3 NephroCare clinics located in separate countries. The percentage of hemoglobin values on target, the median darbepoetin dose, and individual hemoglobin fluctuation (estimated from the intrapatient hemoglobin standard deviation) were deemed primary outcomes. In the observation phase, median darbepoetin consumption significantly decreased from 0.63 to 0.46 μg/kg/month, whereas on-target hemoglobin values significantly increased from 70.6% to 76.6%, reaching 83.2% when the ACM suggestions were implemented. Moreover, ACM introduction led to a significant decrease in hemoglobin fluctuation (intrapatient standard deviation decreased from 0.95 g/dl to 0.83 g/dl). Thus, ACM support helped improve anemia outcomes of hemodialysis patients, minimizing erythropoietic-stimulating agent use with the potential to reduce the cost of treatment. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

  9. Anti-hypertensive drugs as disease-modifying agents for Parkinson's disease: evidence from observational studies and clinical trials.

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    Rees, Karen; Stowe, Rebecca; Patel, Smitaa; Ives, Natalie; Breen, Kieran; Ben-Shlomo, Yoav; Clarke, Carl E

    2011-11-09

    Current treatment for Parkinson's disease (PD) is focused on relieving symptoms, at present there is nothing that is widely accepted to halt or slow disease progression. Potential neuroprotective or disease modifying agents have been identified from preclinical studies. One such group of compounds are anti-hypertensive drugs. 1) Do anti-hypertensive drugs prevent the onset of PD? (primary prevention)2) Are anti-hypertensive drugs disease modifying agents in PD, do they slow the progression of disease once PD is established? (secondary prevention)3) What are the adverse effects of taking anti-hypertensive drugs for patients with PD? Electronic databases including trial registers were searched, complemented with handsearching of conference proceedings and searching the citations of key articles (updated May 2011). Authors were contacted, to provide additional information, where necessary. For the primary prevention review, primary prevention trials and observational studies (cohort and case control studies) were sought. Participants were free of PD when exposure to anti-hypertensive drugs was assessed. For the secondary prevention review, clinical trials in patients with well defined PD were sought. Two people independently selected studies for inclusion using predetermined criteria. Data were abstracted from the source papers and methodological quality was assessed independently by two review authors. Results for both reviews were dealt with descriptively. Two cohort studies and four case control studies met the inclusion criteria for the primary prevention review. The two cohort studies found no effect of exposure to calcium channel blockers on the risk of developing PD. Three case control studies looked at the effects of exposure to calcium channel blockers and beta blockers on the risk of developing PD but the assessment periods of exposure were markedly different prior to PD onset, and different subclasses of drugs were examined, so results were not comparable

  10. The Power of Flash Mob Research Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day

    NARCIS (Netherlands)

    Alsma, Jelmer; van Saase, Jan L. C. M.; Nanayakkara, Prabath W. B.; Schouten, W. E. M. Ineke; Baten, Anique; Bauer, Martijn P.; Holleman, Frits; Ligtenberg, Jack J. M.; Stassen, Patricia M.; Kaasjager, Karin H. A. H.; Haak, Harm R.; Bosch, Frank H.; Schuit, Stephanie C. E.

    BACKGROUND: Capillary refill time (CRT) is a clinical test used to evaluate the circulatory status of patients; various methods are available to assess CRT. Conventional clinical research often demands large numbers of patients, making it costly, labor-intensive, and time-consuming. We studied the

  11. Nursing students' emotional intelligence, coping styles and learning satisfaction in clinically simulated palliative care scenarios: An observational study.

    Science.gov (United States)

    Alconero-Camarero, Ana Rosa; Sarabia-Cobo, Carmen María; González-Gómez, Silvia; Ibáñez-Rementería, Isabel; Lavín-Alconero, Lucía; Sarabia-Cobo, Ana Belén

    2017-11-16

    Emotional intelligence is highly relevant in palliative care training, considering the coping styles used by nursing students. Clinical simulation provides the opportunity to evaluate these variables in a realistic and natural context. To analyze the possible relation between emotional intelligence, coping styles and satisfaction with one's own self-learning in nursing students participating in simulated scenarios related to palliative care at the end of life. A descriptive, observational and correlational study of students in their second year of nursing at a Spanish University during the 2015/2016 academic year. Three variables were measured: emotional intelligence (Trait Meta-Mood Scale-24), coping styles (the Questionnaire for Dealing with Stress) and satisfaction with students' own learning (Student Satisfaction and Self-Confidence in Learning Scale, Spanish version CSLS-Sv). In total, 74 students participated in this study (ME: 20.3years). An association was found between satisfaction with learning, according to the EI attention subscale (in which the highest scores were registered) and two specific coping styles (FSP, with high scores and open emotional expression). Emotional intelligence and coping styles are desirable qualities in students, especially as they have a relevant role in satisfaction with one's own learning. Nonetheless, in part, these results depend on the characteristics of the educational activities designed, which is especially relevant in simulation applied to palliative care. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Biomedical ethics and clinical oversight in multisite observational neuroimaging studies with children and adolescents: The ABCD experience.

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    Clark, Duncan B; Fisher, Celia B; Bookheimer, Susan; Brown, Sandra A; Evans, John H; Hopfer, Christian; Hudziak, James; Montoya, Ivan; Murray, Margaret; Pfefferbaum, Adolf; Yurgelun-Todd, Deborah

    2017-06-28

    Observational neuroimaging studies with children and adolescents may identify neurological anomalies and other clinically relevant findings. Planning for the management of this information involves ethical considerations that may influence informed consent, confidentiality, and communication with participants about assessment results. Biomedical ethics principles include respect for autonomy, beneficence, non-maleficence, and justice. Each project presents unique challenges. The Adolescent Brain and Cognitive Development study (ABCD) collaborators have systematically developed recommendations with written guidelines for identifying and responding to potential risks that adhere to biomedical ethics principles. To illustrate, we will review the ABCD approach to three areas: (1) hazardous substance use; (2) neurological anomalies; and (3) imminent potential for self-harm or harm to others. Each ABCD site is responsible for implementing procedures consistent with these guidelines in accordance with their Institutional Review Board approved protocols, state regulations, and local resources. To assure that each site has related plans and resources in place, site emergency procedures manuals have been developed, documented and reviewed for adherence to ABCD guidelines. This article will describe the principles and process used to develop these ABCD bioethics and medical oversight guidelines, the concerns and options considered, and the resulting approaches advised to sites. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Clinical and economic outcomes in an observational study of COPD maintenance therapies: multivariable regression versus propensity score matching

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    Roberts MH

    2012-03-01

    Full Text Available Melissa H Roberts1, Anand A Dalal21Lovelace Clinic Foundation, (Lovelace Respiratory Research Institute at the time of the study, Albuquerque, NM, 2US Health Outcomes, GlaxoSmithKline, Durham, NC, USAPurpose: To investigate equivalency of results from multivariable regression (MR and propensity score matching (PSM models, observational research methods used to mitigate bias stemming from non-randomization (and consequently unbalanced groups at baseline, using, as an example, a large study of chronic obstructive pulmonary disease (COPD initial maintenance therapy.Methods: Patients were 32,338 health plan members, age ≥40 years, with COPD initially treated with fluticasone propionate/salmeterol combination (FSC, tiotropium (TIO, or ipratropium (IPR alone or in combination with albuterol. Using MR and PSM methods, the proportion of patients with COPD-related health care utilization, mean costs, odds ratios (ORs, and incidence rate ratios (IRRs for utilization events were calculated for the 12 months following therapy initiation.Results: Of 12,595 FSC, 9126 TIO, and 10,617 IPR patients meeting MR inclusion criteria, 89.1% (8135 of TIO and 80.2% (8514 of IPR patients were matched to FSC patients for the PSM analysis. Methods produced substantially similar findings for mean cost comparisons, ORs, and IRRs for most utilization events. In contrast to MR, for TIO compared to FSC, PSM did not produce statistically significant ORs for hospitalization or outpatient visit with antibiotic or significant IRRs for hospitalization or outpatient visit with oral corticosteroid. As in the MR analysis, compared to FSC, ORs and IRRs for all other utilization events, as well as mean costs, were less favorable for IPR and TIO.Conclusion: In this example of an observational study of maintenance therapy for COPD, more than 80% of the original treatment groups used in the MR analysis were matched to comparison treatment groups for the PSM analysis. While some sample

  14. Prevalence, clinical consequences and management of acute faecal incontinence with diarrhoea in the ICU: The FIRST™ Observational Study.

    Science.gov (United States)

    Binks, Rachel; De Luca, Enrico; Dierkes, Christine; Franci, Andrea; Herrero, Eva; Niederalt, Georg

    2015-11-01

    There are limited data on the incidence and management of acute faecal incontinence with diarrhoea in the ICU. The FIRST™ Observational Study was undertaken to obtain data on clinical practices used in the ICU for the management of acute faecal incontinence with diarrhoea in Germany, UK, Spain and Italy. ICU-hospitalised patients ≥18 years of age experiencing a second episode of acute faecal incontinence with diarrhoea in 24 h were recruited, and management practices of acute faecal incontinence with diarrhoea were recorded for up to 15 days. A total of 372 patients had complete data sets; the mean duration of study was 6.8 days. At baseline, 40% of patients experienced mild or moderate-to-severe skin excoriation, which increased to 63% in patients with acute faecal incontinence with diarrhoea lasting >15 days. At baseline, 27% of patients presented with a pressure ulcer, which increased to 37%, 45% and 49% at days 5, 10 and 15, respectively. Traditional methods (pads, sheets and tubes) were more commonly used compared to faecal management systems during days 1-4 (76% vs. 47% faecal management system), while the use of a faecal management system increased to 56% at days 5-9 and 61% at days 10-15. At baseline, only 26% of nurses were satisfied with traditional management methods compared to 69% with faecal management systems. For patients still experiencing acute faecal incontinence with diarrhoea after 15 days, 82% of nurses using a faecal management systems to manage acute faecal incontinence with diarrhoea were satisfied or very satisfied, compared to 37% using traditional methods. These results highlight that acute faecal incontinence with diarrhoea remains an important healthcare challenge in ICUs in Europe; skin breakdown and pressure ulcers remain common complications in patients with acute faecal incontinence with diarrhoea in the ICU.

  15. Squamous Cell Carcinoma: Clinical and Pathological Features and Associated Risk Factors in an Observational Study of 118 Patients.

    Science.gov (United States)

    Díaz-Corpas, T; Morales-Suárez-Varela, M; Rausell Fontestad, N; Fuertes Prósper, A; Marquina-Vila, A; Jordá-Cuevas, E

    2015-12-01

    In the latest edition of its cancer staging manual, the American Joint Committee on Cancer (AJCC) revised the criteria for staging squamous cell carcinoma (SCC) by introducing high-risk tumor features to define tumor stage (T) and help to identify tumors with a higher risk of metastasis. The aim of this study was to investigate the characteristics associated with SCC meeting the high-risk criteria defined by the AJCC for T2 lesions. We performed a case-case observational study in which patients with SCC were included over a period of 18 months. We collected clinical, anthropometric, and tumor data, and analyzed these using PASW Statistics (SPSS) version 18. One-hundred eighteen patients, the majority of whom were men, were included. Mean age was 77 years. Over 70% of the tumors were located in the head region and a majority of tumors measured 2 cm or less. The prevalence of SCC T2 was 61.9%. The risk factors significantly associated with SCC T2 were an age of over 85 years (odds ratio [OR], 4.48), location in the head and neck region (OR, 3.38), presence of solar elastosis in the peritumoral tissue (OR, 2.08), a higher tumor growth rate (>1.5 mm·wk(-1); OR, 5.73), and higher cumulative exposure to smoking (>20 pack-years, OR, 3.63). Advanced age, location in the head and neck region, presence of solar elastosis, high tumor growth rate, and high cumulative smoking exposure were all significantly associated with the presence of SCC T2. Copyright © 2015 Elsevier España, S.L.U. and AEDV. All rights reserved.

  16. Clinical features and predictors for disease natural progression in adults with Pompe disease: a nationwide prospective observational study

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    van der Beek Nadine AME

    2012-11-01

    Full Text Available Abstract Background Due partly to physicians’ unawareness, many adults with Pompe disease are diagnosed with great delay. Besides, it is not well known which factors influence the rate of disease progression, and thus disease outcome. We delineated the specific clinical features of Pompe disease in adults, and mapped out the distribution and severity of muscle weakness, and the sequence of involvement of the individual muscle groups. Furthermore, we defined the natural disease course and identified prognostic factors for disease progression. Methods We conducted a single-center, prospective, observational study. Muscle strength (manual muscle testing, and hand-held dynamometry, muscle function (quick motor function test, and pulmonary function (forced vital capacity in sitting and supine positions were assessed every 3–6 months and analyzed using repeated-measures ANOVA. Results Between October 2004 and August 2009, 94 patients aged between 25 and 75 years were included in the study. Although skeletal muscle weakness was typically distributed in a limb-girdle pattern, many patients had unfamiliar features such as ptosis (23%, bulbar weakness (28%, and scapular winging (33%. During follow-up (average 1.6 years, range 0.5-4.2 years, skeletal muscle strength deteriorated significantly (mean declines of −1.3% point/year for manual muscle testing and of −2.6% points/year for hand-held dynamometry; both p15 years and pulmonary involvement (forced vital capacity in sitting position Conclusions Recognizing patterns of common and less familiar characteristics in adults with Pompe disease facilitates timely diagnosis. Longer disease duration and reduced pulmonary function stand out as predictors of rapid disease progression, and aid in deciding whether to initiate enzyme replacement therapy, or when.

  17. Further data on beta-blockers and cancer risk: observational study and meta-analysis of randomized clinical trials.

    Science.gov (United States)

    Monami, Matteo; Filippi, Luca; Ungar, Andrea; Sgrilli, Federica; Antenore, Alessandro; Dicembrini, Ilaria; Bagnoli, Paola; Marchionni, Niccolò; Rotella, Carlo Maria; Mannucci, Edoardo

    2013-04-01

    The aim of the present paper is to provide some further data on the relationship between β-blocker treatment and the incidence of cancer, using two different approaches (epidemiological study and meta-analysis of clinical trials). In a consecutive series of 1340 diabetic patients starting insulin therapy, 112 cases of cancer during a mean follow-up of 75.9 months were identified as first hospital admission or death. For each case, the controls were chosen randomly from those members of the cohort matched for age, sex and BMI. The main predefined analysis was the comparison of cases and controls for length of exposure to β-blockers and proportion of patients exposed using a conditional logistic regression which takes into account the matching structure. For the meta-analytic sub-study, an extensive search of Medline and the Cochrane Library (any date up to December 31st, 2011) was performed for all trials in which a β-blocker was used. Mantel-Haenszel Odds Ratios (MH-OR) with 95% confidence intervals for incident malignancies were calculated using a random effect model. After adjusting for mean daily dose of glargine and metformin, and ischemic heart disease, exposure to β-blockers was associated with a reduced overall risk of cancer (HR 0.33 [0.13; 0.83], p = 0.019; HR for each month of exposure 0.87 [0.77; 0.98], p = 0.025). In the meta-analysis sub-study, performed on nine trials, β-blockers were associated with a non-significant trend toward lower risk of cancer (MH-OR 0.93 [0.86; 1.01], p = 0.070). Limitations of the observational study are the small sample size that limits the statistical power of analyses, that it was performed on diabetic patients only, and that diagnoses of malignancies were derived from administrative data. In conclusion, this research seem to confirm a possible beneficial effect of β-blockers against the risk of cancer development.

  18. Clinical management of unruptured intracranial aneurysm in Germany: a nationwide observational study over a 5-year period (2005-2009).

    Science.gov (United States)

    Walendy, Victor; Stang, Andreas

    2017-01-17

    Our aim was to provide nationwide age-standardised rates (ASR) on the usage of endovascular coiling and neurosurgical clipping for unruptured intracranial aneurysm (UIA) treatment in Germany. Nationwide observational study using the Diagnosis-Related-Groups (DRG) statistics for the years 2005-2009 (overall 83 million hospitalisations). From 2005 to 2009, overall 39 155 hospitalisations with a diagnosis of UIA occurred in Germany. Age-specific and age-standardised hospitalisation rates for UIA with the midyear population of Germany in 2007 as the standard. Of the 10 221 hospitalisations with UIA during the observation period, 6098 (59.7%) and 4123 (40.3%) included coiling and clipping, respectively. Overall hospitalisation rates for UIA increased by 39.5% (95% CI 24.7% to 56.0%) and 50.4% (95% CI 39.6% to 62.1%) among men and women, respectively. In 2005, the ASR per 100 000 person years for coiling was 0.7 (95% CI 0.62 to 0.78) for men and 1.7 (95% CI 1.58 to 1.82) for women. In 2009, the ASR was 1.0 (95% CI 0.90 to 1.10) and 2.4 (95% CI 2.24 to 2.56), respectively. Similarly, the ASR for clipping in 2005 amounted to 0.6 (95% CI 0.52 to 0.68) for men and 1.1 (95% CI 1.00 to 1.20) for women. These rates increased in 2009 to 0.8 (95% CI 0.72 to 0.88) and 1.7 (95% CI 1.58 to 1.82), respectively. We observed a marked geographical variation of ASR for coiling and less pronounced for clipping. For the federal state of Saarland, the ASR for coiling was 5.64 (95% CI 4.76 to 6.52) compared with 0.68 (95% CI 0.48 to 0.88; per 100 000 person years) in Saxony-Anhalt, whereas, ASR for clipping were highest in Rhineland-Palatinate (2.48, 95% CI 2.17 to 4.75) and lowest in Saxony-Anhalt (0.52, 95% CI 0.34 to 0.70). To the best of our knowledge, we presented the first representative, nationwide analysis of the clinical management of UIA in Germany. The ASR increased markedly and showed substantial geographical variation among federal states for all treatment modalities

  19. Leadership in the clinical workplace: what residents report to observe and supervisors report to display: an exploratory questionnaire study.

    Science.gov (United States)

    van der Wal, Martha A; Scheele, Fedde; Schönrock-Adema, Johanna; Jaarsma, A Debbie C; Cohen-Schotanus, Janke

    2015-11-02

    Within the current health care system, leadership is considered important for physicians. leadership is mostly self-taught, through observing and practicing. Does the practice environment offer residents enough opportunities to observe the supervisor leadership behaviours they have to learn? In the current study we investigate which leadership behaviours residents observe throughout their training, which behaviours supervisors report to display and whether residents and supervisors have a need for more formal training. We performed two questionnaire studies. Study 1: Residents (n = 117) answered questions about the extent to which they observed four basic and observable Situational Leadership behaviours in their supervisors. Study 2: Supervisors (n = 201) answered questions about the extent to which they perceived to display these Situational Leadership behaviours in medical practice. We asked both groups of participants whether they experienced a need for formal leadership training. One-third of the residents did not observe the four basic Situational Leadership behaviours. The same pattern was found among starting, intermediate and experienced residents. Moreover, not all supervisors showed these 4 leadership behaviours. Both supervisors and residents expressed a need for formal leadership training. Both findings together suggest that current practice does not offer residents enough opportunities to acquire these leadership behaviours by solely observing their supervisors. Moreover, residents and supervisors both express a need for more formal leadership training. More explicit attention should be paid to leadership development, for example by providing formal leadership training for supervisors and residents.

  20. An observational cohort study on shortened dental arches--clinical course during a period of 27-35 years

    NARCIS (Netherlands)

    Gerritsen, A.E.; Witter, D.J.; Bronkhorst, E.M.; Creugers, N.H.J.

    2013-01-01

    OBJECTIVES: The objective of this study was to investigate the clinical course of shortened dental arches ('SDA group') compared to SDAs plus removable denture prosthesis ('SDA plus RDP group') and complete dental arches ('CDA group', controls). MATERIALS AND METHODS: Data (numbers of direct and

  1. The clinical assessment study of the foot (CASF): study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    National Research Council Canada - National Science Library

    Roddy, Edward; Myers, Helen; Thomas, Martin J; Marshall, Michelle; D'Cruz, Deborah; Menz, Hylton B; Belcher, John; Muller, Sara; Peat, George

    2011-01-01

    .... This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings...

  2. Temperature thresholds in assessment of the clinical course of acquired cold contact urticaria: a prospective observational one-year study.

    Science.gov (United States)

    Martinez-Escala, M Estela; Curto-Barredo, Laia; Carnero, Lluïsa; Pujol, Ramon M; Giménez-Arnau, Ana M

    2015-03-01

    Cold contact urticaria is the second most common subtype of physical urticaria. Cold stimulation standardized tests are mandatory to confirm the diagnosis. The aim of this study is to define the utility of determining thresholds (critical time and temperature) in assessment of the clinical course of typical acquired cold contact urticaria. Nineteen adult patients (10 women and 9 men; mean age 45 years) were included in the study and the diagnosis was confirmed with the ice-cube test and TempTest 3.0. Patients were treated continuously for 1 year with 20 mg/day rupatadine (anti-H1). Thresholds measurements were made before and after treatment. Improvements in temperature and critical time thresholds were found in the study sample, demonstrating the efficacy of continuous treatment with rupatadine. In most cases association with a clinical improvement was found. We propose an algorithm for the management of acquired cold contact urticaria based on these results.

  3. How well do second-year students learn physical diagnosis? Observational study of an objective structured clinical examination (OSCE

    Directory of Open Access Journals (Sweden)

    Simon Steven R

    2002-01-01

    Full Text Available Abstract Background Little is known about using the Objective Structured Clinical Examination (OSCE in physical diagnosis courses. The purpose of this study was to describe student performance on an OSCE in a physical diagnosis course. Methods Cross-sectional study at Harvard Medical School, 1997–1999, for 489 second-year students. Results Average total OSCE score was 57% (range 39–75%. Among clinical skills, students scored highest on patient interaction (72%, followed by examination technique (65%, abnormality identification (62%, history-taking (60%, patient presentation (60%, physical examination knowledge (47%, and differential diagnosis (40% (p Conclusions Students scored higher on interpersonal and technical skills than on interpretive or integrative skills. Station scores identified specific content that needs improved teaching.

  4. Clinical success of stainless steel crowns placed under general anaesthesia in primary molars: an observational follow up study.

    Science.gov (United States)

    Schüler, I M; Hiller, M; Roloff, T; Kühnisch, J; Heinrich-Weltzien, R

    2014-11-01

    Quality assessment of stainless steel crowns (SSCs) placed in primary molars of high caries risk children after 1, 3 and 5 years of service time. Out of 1149 SSCs placed 1, 3 or 5 years before the evaluation period in 558 children, 428 (37.2%) SSCs were clinically evaluated in 171 (30.6%) children aged between 1.1 and 8.6 years. Marginal adaptation, extension and proximal contacts of SSCs, plaque and gingival bleeding at SSC were assessed. Caries experience was recorded by WHO standards. Caries experience was 7.8 dmft/18.4 dmfs before treatment. The overall success rate of SSCs was 97.2%, regardless of the extent of carious lesions or pulp treatment of the tooth. Loss of SSCs (1.9%), pathological tooth mobility (0.7%) and perforation of the crown (0.2%) were scored as clinical failures. The majority of SSCs had sealed margins and the marginal extension reached sub-gingival level. Open proximal contacts occurred mesially and distally (21.7%, 20%). All qualitative defects increased with service time. Secondary caries was not diagnosed. Of the SSCs, 46.4% were free of dental plaque. Gingival bleeding after probing was observed in 72.1% of all SSCs. Gingivitis was significantly associated with increased dmft-values (OR=1.108, 95%CI: 1.03-1.19) and plaque at SSCs (OR=0.29, 95%CI: 0.18-0.47). Children with migration background exhibited significantly more often insufficient oral hygiene and higher rates of gingival bleeding and caries experience than did German children. SSCs are clinically successful restorations in primary molars of high caries risk children. High caries prevalence and insufficient oral hygiene were greater determining factors for the occurrence of gingivitis than the quality of the SSCs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Clinical interval and diagnostic characteristics in a cohort of bladder cancer patients in Spain: a multicenter observational study.

    Science.gov (United States)

    Bonfill, Xavier; Martinez-Zapata, María José; Vernooij, Robin W M; Sánchez, María José; Suárez-Varela, María Morales; De la Cruz, Javier; Emparanza, José Ignacio; Ferrer, Montserrat; Pijoan, José Ignacio; Palou, Joan; Schmidt, Stefanie; Madrid, Eva; Abraira, Víctor; Zamora, Javier

    2017-12-07

    We performed a cohort study in seven hospitals in Spain to determine the clinical characteristics of incident patients with bladder cancer, the diagnostic process, and the conditions that might affect health care interval times. 314 patients with bladder cancer were included, 70.3 (Standard Deviation [SD] 11.2) years old and 85.0% male. Clinical stage was T1 in 45.9% of patients. The median interval time between first consultation and diagnosis was of 104.0 days (Inter quartile range [IQR]:112.0; range from 0 to 986), being shorter for those patients who attended a hospital for their first consultation. The median interval time between diagnosis and first treatment was of 0.0 days (IQR: 0.0; range from 0 to 366), being longer when the patient had a pathologic tumor stage ≥ T2a.

  6. Clinical use of fungal PCR from deep tissue samples in the diagnosis of invasive fungal diseases: a retrospective observational study.

    Science.gov (United States)

    Ala-Houhala, M; Koukila-Kähkölä, P; Antikainen, J; Valve, J; Kirveskari, J; Anttila, V-J

    2017-09-01

    To assess the clinical use of panfungal PCR for diagnosis of invasive fungal diseases (IFDs). We focused on the deep tissue samples. We first described the design of panfungal PCR, which is in clinical use at Helsinki University Hospital. Next we retrospectively evaluated the results of 307 fungal PCR tests performed from 2013 to 2015. Samples were taken from normally sterile tissues and fluids. The patient population was nonselected. We classified the likelihood of IFD according to the criteria of the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG), comparing the fungal PCR results to the likelihood of IFD along with culture and microscopy results. There were 48 positive (16%) and 259 negative (84%) PCR results. The sensitivity and specificity of PCR for diagnosing IFDs were 60.5% and 91.7%, respectively, while the negative predictive value and positive predictive value were 93.4% and 54.2%, respectively. The concordance between the PCR and the culture results was 86% and 87% between PCR and microscopy, respectively. Of the 48 patients with positive PCR results, 23 had a proven or probable IFD. Fungal PCR can be useful for diagnosing IFDs in deep tissue samples. It is beneficial to combine fungal PCR with culture and microscopy. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  7. Clinical features and treatment outcomes of dental implant-related paranasal sinusitis: A 2-year prospective observational study.

    Science.gov (United States)

    Kim, So Jeong; Park, Jee Soo; Kim, Hee Tae; Lee, Cha Hee; Park, Yun Hwi; Bae, Jung Ho

    2016-11-01

    As dental implant-related paranasal sinusitis has different pathophysiology and clinical features from primarily rhinogenic paranasal sinusitis, the standard treatment protocol for dental implant-related paranasal sinusitis has not yet been established. The aim of this study was to analyze the clinical characteristics and treatment results of dental implant-related paranasal sinusitis. We conducted a prospective single-center study of 19 patients who were treated for odontogenic sinusitis developing in relation to dental implant from September 2008 through May 2012. The age of the patients ranged from 33 to 78 years, with the mean age of 54.5 years. Foul odor and postnasal dripping were the two most common complaints. All patients underwent nasal endoscopic examination and paranasal sinus CT before treatment, and initial conservative treatment for 1 week. Patients unresponsive to medical treatment underwent endoscopic sinus surgery (ESS). All patients were classified into the conservative and surgical groups for analysis and followed up for 2 years after initial diagnosis. Four patients (21%) were successfully treated conservatively, while 15 patients (79%) underwent surgical treatment. One of these 15 patients required revision surgery. After 2 years, all patients were successfully treated, so there were no more clinical signs of recurrent sinusitis in any patients. The survival rate of implants was 100%. Compared to those of the conservative group, symptom duration, the Lund-MacKay CT score, status of the ostiomeatal unit (OMU), and the condition of the maxillary sinus floor were significantly more severe in the surgical group. In our study, the majority of patients who once developed paranasal sinusitis associated with dental implants required surgical treatment. Findings of paranasal sinus CT may be important in determining treatment option. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  8. Learn about Clinical Studies

    Science.gov (United States)

    ... Glossary of Common Site Terms Learn About Clinical Studies Contents What Is a Clinical Study? Clinical Trials ... Participation Questions to Ask What Is a Clinical Study? A clinical study involves research using human volunteers ( ...

  9. Novel Signs and Their Clinical Utility in Diagnosing Complex Regional Pain Syndrome (CRPS): A Prospective Observational Cohort Study.

    Science.gov (United States)

    Kuttikat, Anoop; Shaikh, Maliha; Oomatia, Amin; Parker, Richard; Shenker, Nicholas

    2017-06-01

    Delays in diagnosis occur with complex regional pain syndrome (CRPS). We define and prospectively demonstrate that novel bedside tests measuring body perception disruption can identify patients with CRPS postfracture. The objectives of our study were to define and validate 4 bedside tests, to identify the prevalence of positive tests in patients with CRPS and other chronic pain conditions, and to assess the clinical utility (sensitivity, specificity, positive predictive value, negative predictive value) for identifying CRPS within a Fracture cohort. This was a single UK teaching hospital prospective cohort study with 313 recruits from pain-free volunteers and patients with chronic pain conditions.Four novel tests were Finger Perception (FP), Hand Laterality identification (HL), Astereognosis (AS), and Body Scheme (BS) report. Five questionnaires (Brief Pain Inventory, Upper Extremity Functional Index, Lower Extremity Functional Index, Neglect-like Symptom Questionnaire, Hospital Anxiety and Depression Score) assessed the multidimensional pain experience. FP and BS were the best performing tests. Prospective monitoring of fracture patients showed that out of 7 fracture patients (total n=47) who had both finger misperception and abnormal BS report at initial testing, 3 developed persistent pain with 1 having a formal diagnosis of CRPS. Novel signs are reliable, easy to perform, and present in chronic pain patients. FP and BS have significant clinical utility in predicting persistent pain in a fracture group thereby allowing targeted early intervention.

  10. Interventional Treatment of Severe Tricuspid Regurgitation: Early Clinical Experience in a Multicenter, Observational, First-in-Man Study.

    Science.gov (United States)

    Lauten, Alexander; Figulla, Hans R; Unbehaun, Axel; Fam, Neil; Schofer, Joachim; Doenst, Torsten; Hausleiter, Joerg; Franz, Marcus; Jung, Christian; Dreger, Henryk; Leistner, David; Alushi, Brunilda; Stundl, Anja; Landmesser, Ulf; Falk, Volkmar; Stangl, Karl; Laule, Michael

    2018-02-01

    Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. Twenty-five patients (mean age, 73.9±7.6 years; women, 52.0%) with severe symptomatic TR despite optimal medical treatment deemed unsuitable for surgery were treated with caval valve implantation under a compassionate clinical use program. Technical feasibility defined as procedural success, hemodynamic effect defined as venous pressure reduction, and safety defined as periprocedural adverse events were evaluated, with clinical follow-up at discharge and up to 12 months. The functional impact was evaluated by assessment of New York Heart Association class at the time of hospital discharge. The total number of valves implanted in the caval position was 31. Patients were treated with single (inferior vena cava-only; n=19; 76.0%) or bicaval valve implantation (inferior vena cava+superior vena cava; n=6; 24.0%). Either balloon-expandable valves (Sapien XT/3: n=18; 72.0%) or self-expandable valves (TricValve: n=6; 24.0%; Directflow: n=1; 4.0%) were used. Procedural success was achieved in 96% (n=24). Early and late valve migration requiring surgical intervention occurred in 1 patient each. Thirty-day and in-hospital mortality were 8% (2 of 25) and 16% (4 of 25). Causes of in-hospital mortality included respiratory (n=1) or multiple organ failure (n=3) and were not linked to the procedure. Mean overall survival in the study cohort was 316±453 days (14-1540 days). Caval valve implantation for the treatment of severe TR and advanced right ventricular failure is associated with a high procedural success rate and seems safe and feasible in an excessive

  11. An observational cohort study on shortened dental arches--clinical course during a period of 27-35 years.

    Science.gov (United States)

    Gerritsen, Anneloes E; Witter, Dick J; Bronkhorst, Ewald M; Creugers, Nico H J

    2013-04-01

    The objective of this study was to investigate the clinical course of shortened dental arches ('SDA group') compared to SDAs plus removable denture prosthesis ('SDA plus RDP group') and complete dental arches ('CDA group', controls). Data (numbers of direct and indirect restorations, endodontic treatments, tooth loss and tooth replacements) were extracted from patient records of subjects attending the Nijmegen Dental School who previously participated in a cohort study on shortened dental arches with three to four posterior occluding pairs (POPs). Records of 35 % of the original cohort were retrievable. At the end of the follow-up (27.4 ± 7.1 years), 20 out of 23 SDA subjects still had SDA with 3-4 POPs compared to 6 out of 13 for SDA plus RDP subjects (follow-up 32.6 ± 7.3 years). Sixteen out of 23 CDA subjects still had CDA; none of them lost more than one POP (follow-up 35.0 ± 5.6 years). SDA group lost 67 teeth: 16 were not replaced, 16 were replaced by FDP and 35 teeth (lost in three subjects) replaced by RDP. Mean number of treatments per year in SDA subjects differed not significantly compared to CDA subjects except for indirect restorations in the upper jaw. Shortened dental arches can last for 27 years and over. Clinical course in SDA plus RDP is unfavourable, especially when RDP-related interventions are taken into account. The shortened dental arch concept seems to be a relevant approach from a cost-effective point of view. Replacement of absent posterior teeth by free-end RDP cannot be recommended.

  12. Using clinical parameters to guide fluid therapy in high-risk thoracic surgery. A retrospective, observational study

    DEFF Research Database (Denmark)

    Bjerregaard, Lars Stryhn; Møller-Sørensen, Hasse; Hansen, Kristoffer Lindskov

    2015-01-01

    the use of central venous oxygen saturation and intended low urine output to guide therapy in the early postoperative period. Here we evaluate the consequences of our changes. METHODS: Retrospective, observational study of 30 consecutive patients undergoing EPP; 18 who had surgery before and 12 who had......BACKGROUND: Despite extensive research, the debate continues as to the optimal way of guiding intraoperative and postoperative fluid therapy. In 2009 we changed our institutional guideline for perioperative fluid therapy in patients undergoing extrapleural pneumonectomy (EPP) and implemented...

  13. Report from the OMERACT Hand Osteoarthritis Working Group: Set of Core Domains and Preliminary Set of Instruments for Use in Clinical Trials and Observational Studies

    NARCIS (Netherlands)

    Kloppenburg, Margreet; Bøyesen, Pernille; Visser, A. Willemien; Haugen, Ida K.; Boers, Maarten; Boonen, Annelies; Conaghan, Philip G.; Hawker, Gillian A.; Kvien, Tore K.; Landewé, Robert; Uhlig, Till; Smeets, Wilma; Greibrokk, Elsie; van der Heijde, Désirée M.

    2015-01-01

    During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary

  14. The Impact of Social Media on Dissemination and Implementation of Clinical Practice Guidelines: A Longitudinal Observational Study.

    Science.gov (United States)

    Narayanaswami, Pushpa; Gronseth, Gary; Dubinsky, Richard; Penfold-Murray, Rebecca; Cox, Julie; Bever, Christopher; Martins, Yolanda; Rheaume, Carol; Shouse, Denise; Getchius, Thomas S D

    2015-08-13

    Evidence-based clinical practice guidelines (CPGs) are statements that provide recommendations to optimize patient care for a specific clinical problem or question. Merely reading a guideline rarely leads to implementation of recommendations. The American Academy of Neurology (AAN) has a formal process of guideline development and dissemination. The last few years have seen a burgeoning of social media such as Facebook, Twitter, and LinkedIn, and newer methods of dissemination such as podcasts and webinars. The role of these media in guideline dissemination has not been studied. Systematic evaluation of dissemination methods and comparison of the effectiveness of newer methods with traditional methods is not available. It is also not known whether specific dissemination methods may be more effectively targeted to specific audiences. Our aim was to (1) develop an innovative dissemination strategy by adding social media-based dissemination methods to traditional methods for the AAN clinical practice guidelines "Complementary and alternative medicine in multiple sclerosis" ("CAM in MS") and (2) evaluate whether the addition of social media outreach improves awareness of the CPG and knowledge of CPG recommendations, and affects implementation of those recommendations. Outcomes were measured by four surveys in each of the two target populations: patients and physicians/clinicians ("physicians"). The primary outcome was the difference in participants' intent to discuss use of complementary and alternative medicine (CAM) with their physicians or patients, respectively, after novel dissemination, as compared with that after traditional dissemination. Secondary outcomes were changes in awareness of the CPG, knowledge of CPG content, and behavior regarding CAM use in multiple sclerosis (MS). Response rates were 25.08% (622/2480) for physicians and 43.5% (348/800) for patients. Awareness of the CPG increased after traditional dissemination (absolute difference, 95% confidence

  15. Derivation and validation of a clinical prediction rule for delirium in patients admitted to a medical ward: an observational study

    Science.gov (United States)

    Martinez, Juan Antonio; Belastegui, Ana; Basabe, Iban; Goicoechea, Xabier; Aguirre, Cristina; Lizeaga, Nerea; Urreta, Iratxe; Emparanza, Jose Ignacio

    2012-01-01

    Objectives To develop and validate a simple clinical prediction rule, based on variables easily measurable at admission, to identify patients at high risk of developing delirium during their hospital stay on an internal medicine ward. Design Prospective study of two cohorts of patients admitted between 1 May and 30 June 2008 (derivation cohort), and between 1 May and 30 June 2009 (validation cohort). Setting A tertiary hospital in Donostia-Gipuzkoa (Spain). Participants In total 397 patients participated in the study. The mean age and incidence of delirium were 75.9 years and 13%, respectively, in the derivation cohort, and 75.8 years and 25% in the validation cohort. Main outcome measures The predictive variables analysed and finally included in the rule were: being aged 85 years old or older, being dependent in five or more activities of daily living, and taking two or more psychotropic drugs (antipsychotics, benzodiazepines, antidepressants, anticonvulsant and/or antidementia drugs). The variable of interest was delirium as defined by the short Confusion Assessment Method, which assesses four characteristics: acute onset and fluctuating course, inattention, disorganised thinking and altered level of consciousness. Results We developed a rule in which the individual risk of delirium is obtained by adding one point for each criterion met (age≥85, high level of dependence, and being on psychotropic medication). The result is considered positive if the score is ≥1. The rule accuracy was: sensitivity=93.4% (95% CI 85.5% to 97.2%), specificity=60.6% (95% CI 54.1% to 66.8%), positive predictive value=44.4% (95% CI 36.9% to 52.1%) and negative predictive value=96.5% (95% CI: 92% to 98.5%). The area under the receiver operator characteristic (ROC) curve was 0.85 for the validation cohort. Conclusions The presence or absence of any of the three predictive factors (age≥85, high level of dependence and psychotropic medication) allowed us to classify patients on

  16. Leadership in the clinical workplace: what residents report to observe and supervisors report to display: an exploratory questionnaire study

    NARCIS (Netherlands)

    van der Wal, M.A.; Scheele, F.; Schonrock-Adema, J.; Jaarsma, A.D.C.; Cohen-Schotanus, J.

    2015-01-01

    Background: Within the current health care system, leadership is considered important for physicians. leadership is mostly self-taught, through observing and practicing. Does the practice environment offer residents enough opportunities to observe the supervisor leadership behaviours they have to

  17. Leadership in the clinical workplace : what residents report to observe and supervisors report to display: an exploratory questionnaire study

    NARCIS (Netherlands)

    van der Wal, Martha A.; Scheele, Fedde; Schonrock-Adema, Johanna; Jaarsma, A. Debbie C.; Cohen-Schotanus, Janke

    2015-01-01

    Background: Within the current health care system, leadership is considered important for physicians. leadership is mostly self-taught, through observing and practicing. Does the practice environment offer residents enough opportunities to observe the supervisor leadership behaviours they have to

  18. Speed of spinal vs general anaesthesia for category-1 caesarean section: a simulation and clinical observation-based study.

    Science.gov (United States)

    Kathirgamanathan, A; Douglas, M J; Tyler, J; Saran, S; Gunka, V; Preston, R; Kliffer, P

    2013-07-01

    Controversy exists as to whether effective spinal anaesthesia can be achieved as quickly as general anaesthesia for a category-1 caesarean section. Sixteen consultants and three fellows in obstetric anaesthesia were timed performing spinal and general anaesthesia for category-1 caesarean section on a simulator. The simulation time commenced upon entry of the anaesthetist into the operating theatre and finished for the spinal anaesthetic at the end of intrathecal injection and for the general anaesthetic when the anaesthetist was happy for surgery to start. In the second clinical part of the study, the time from intrathecal administration to 'adequate surgical anaesthesia' (defined as adequate for start of a category-1 caesarean section) was estimated in 100 elective (category-4) caesarean sections. The median (IQR [range]) times (min:s) for spinal procedure, onset of spinal block and general anaesthesia were 2:56 (2:32-3:32 [1:22-3:50]), 5:56 (4:23-7:39 [2:9-13:32]) and 1:56 (1:39-2:9 [1:13-3:12]), respectively. The limiting factor in urgent spinal anaesthesia is the unpredictable time needed for adequate surgical block to develop. Anaesthesia © 2013 The Association of Anaesthetists of Great Britain and Ireland.

  19. Clinical and microbiological observational study on AmpC β-lactamase-producing Enterobacteriaceae in a hospital of Nepal

    Directory of Open Access Journals (Sweden)

    Pankaj Baral

    2013-04-01

    Full Text Available Limited information is available regarding AmpC β-lactamase (ABL-producing Enterobacteriaceae compared to extended-spectrum β-lactamase-producing enterobacteria. Since ABL-producing organisms are often resistant to multiple antimicrobial agents, therapeutic options against these pathogens are limited. Among 230 clinical Enterobacteriaceae isolates, 64 (27.8% were found to produce ABL in our study. Escherichia coli (83.9% was a predominant pathogen, followed by Citrobacter freundii (5.2%. A significant proportion of ABL-producing isolates (81.3% were found to be multidrug resistant against commonly used antibiotics. Univariate analysis showed that prior history of taking antibiotics (odds ratio [OR], 5.278; confidence interval [CI], 2.838-9.817; p < 0.001 and being inpatients (OR, 4.587; CI, 2.132-9.9; p < 0.001 were associated with ABL positivity. Regular antimicrobial resistance surveillance for ABL-producing Enterobacteriaceae is warranted for proper antimicrobial treatment strategy and policy making due to ABL-positive infections.

  20. A clinical observational study analysing the factors associated with hyperventilation during actual cardiopulmonary resuscitation in the emergency department.

    Science.gov (United States)

    Park, Sang O; Shin, Dong Hyuk; Baek, Kwang Je; Hong, Dae Young; Kim, Eun Jung; Kim, Sang Chul; Lee, Kyeong Ryong

    2013-03-01

    This is the first study to identify the factors associated with hyperventilation during actual cardiopulmonary resuscitation (CPR) in the emergency department (ED). All CPR events in the ED were recorded by video from April 2011 to December 2011. The following variables were analysed using review of the recorded CPR data: ventilation rate (VR) during each minute and its associated factors including provider factors (experience, advanced cardiovascular life support (ACLS) certification), clinical factors (auscultation to confirm successful intubation, suctioning, and comments by the team leader) and time factors (time or day of CPR). Fifty-five adult CPR cases including a total of 673 min sectors were analysed. The higher rates of hyperventilation (VR>10/min) were delivered by inexperienced (53.3% versus 14.2%) or uncertified ACLS provider (52.2% versus 10.8%), during night time (61.0 versus 34.5%) or weekend CPR (53.1% versus 35.6%) and when auscultation to confirm successful intubation was performed (93.5% versus 52.8%) than not (all pHyperventilation during CPR was associated with inexperienced or uncertified ACLS provider, auscultation to confirm intubation, and night time or weekend CPR. And to deliver proper ventilation, comments by the team leader should be given regardless of providers' expert level. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. Self-care, quality of life and clinical outcomes of type 2 diabetes patients: an observational cross-sectional study.

    Science.gov (United States)

    Ausili, Davide; Bulgheroni, Monica; Ballatore, Paola; Specchia, Claudia; Ajdini, Ajtena; Bezze, Sabrina; Di Mauro, Stefania; Genovese, Stefano

    2017-11-01

    To describe self-care of T2DM patients and to evaluate outcomes associated with self-care in T2DM patients. A multicentre cross-sectional study was conducted on a sample of 302 randomly selected T2DM patients. Clinical and socio-demographic data were collected by medical records. The Summary of Diabetes Self-care Activities was used to measure self-care about diet, blood testing, exercise and foot care. The EQ-5D was used to measure perceived quality of life. Multiple regression models were used to evaluate the associations between self-care and body mass index (BMI), glycated haemoglobin (HbA1c), presence of diabetes complications and quality of life (QoL). Self-care was lower about exercise (median = 2.0) and foot care (median = 3.5) than about diet (median = 5.2) and blood testing (median = 4.5). HbA1c was associated with diet (p = 0.025), exercise (p = 0.017) and blood testing (p = 0.034). BMI was associated with exercise (p = 0.0071). Diabetes complications were associated with exercise (p = 0.031) and blood testing (p < 0.009). QoL was associated with exercise (p < 0.0001), blood testing (p = 0.032) and foot care (p = 0.013). Self-care influences both clinical outcomes and quality of life of T2DM patients. Although exercise is more frequently associated with positive outcomes, it is particularly poor in T2DM population. Blood testing and foot care should be performed to prevent complications and not only when a health problem is already occurred. Interventions aimed to improve exercise are recommended. Further research is needed to explore barriers to exercise.

  2. Epidemiology of alcohol dependence in UK primary care: Results from a large observational study using the Clinical Practice Research Datalink.

    Directory of Open Access Journals (Sweden)

    Andrew Thompson

    Full Text Available This study aims to investigate the incidence and annual presentation rates of alcohol dependence in general practice in the UK, and examine age-, gender-, socioeconomic-, and region-specific variation. We conducted a retrospective 'open' cohort study using the Clinical Practice Research Datalink (CPRD, an anonymised primary care database. Prior to data extraction, a case definition for alcohol dependence in CPRD was established using 47 Read codes, which included primary alcohol dependence and consequences of alcohol dependence. Directly standardised rates for incidence and annual presentation were calculated for each year between 1990 and 2013. Rates were compared by gender, age, UK home nation, and practice-level Index of Multiple Deprivation. The directly standardised annual incidence rates were 8.3 and 3.7 per 10,000 male and female patients, respectively. The estimated annual rates of presentation per 10,000 were 17.1 for males and 7.6 for females. Female to male rate ratios were: 0.40 (95% CI: 0.39-0.41 for incident cases; and 0.37 (95% CI: 0.36-0.39 for annual presentation. Rates were highest in those aged 35-54 for both measures and across genders, and lowest in those aged over 75 years. With England as the reference nation, Northern Ireland and Scotland had significantly higher rates for both measures. Patients from the most deprived areas had the highest incidence and annual presentation rates. There is unequal distribution of patients with severe alcohol dependence across population subgroups in general practice. Given the health and economic burden associated with dependent drinking, these data will be useful in informing future public health initiatives.

  3. Clinical and haematological predictors of antibiotic prescribing for acute cough in adults in Swiss practices--an observational study.

    Science.gov (United States)

    Streit, Sven; Frey, Peter; Singer, Sarah; Bollag, Ueli; Meli, Damian N

    2015-02-06

    Acute cough is a common problem in general practice and is often caused by a self-limiting, viral infection. Nonetheless, antibiotics are often prescribed in this situation, which may lead to unnecessary side effects and, even worse, the development of antibiotic resistant microorganisms worldwide. This study assessed the role of point-of-care C-reactive protein (CRP) testing and other predictors of antibiotic prescription in patients who present with acute cough in general practice. Patient characteristics, symptoms, signs, and laboratory and X-ray findings from 348 patients presenting to 39 general practitioners with acute cough, as well as the GPs themselves, were recorded by fourth-year medical students during their three-week clerkships in general practice. Patient and clinician characteristics of those prescribed and not-prescribed antibiotics were compared using a mixed-effects model. Of 315 patients included in the study, 22% were prescribed antibiotics. The two groups of patients, those prescribed antibiotics and those treated symptomatically, differed significantly in age, demand for antibiotics, days of cough, rhinitis, lung auscultation, haemoglobin level, white blood cell count, CRP level and the GP's license to self-dispense antibiotics. After regression analysis, only the CRP level, the white blood cell count and the duration of the symptoms were statistically significant predictors of antibiotic prescription. The antibiotic prescription rate of 22% in adult patients with acute cough in the Swiss primary care setting is low compared to other countries. GPs appear to use point-of-care CRP testing in addition to the duration of clinical symptoms to help them decide whether or not to prescribe antibiotics.

  4. Quality of written narrative feedback and reflection in a modified mini-clinical evaluation exercise: an observational study

    NARCIS (Netherlands)

    Pelgrim, E.A.M.; Kramer, A.W.M.; Mokkink, H.G.A.; Vleuten, C.P.M. van der

    2012-01-01

    ABSTRACT: BACKGROUND: Research has shown that narrative feedback, (self) reflections and a plan to undertake and evaluate improvements are key factors for effective feedback on clinical performance. We investigated the quantity of narrative comments comprising feedback (by trainers),

  5. How clinical observation enhances recruitment and selection.

    Science.gov (United States)

    Sutherland, Clare

    2012-11-01

    A survey of nurse managers in Derby Hospitals NHS Foundation Trust in 2010 found 51 practitioners working at an advanced clinical level, but there were variations in titles, pay bands, clinical skills and academic qualifications. This prompted the introduction of a local framework to support the development of the advanced nurse practitioner (ANP) role and a review of the interview process to enable managers to assess applicants' skills, competencies and knowledge. The process is now used in practice, with candidates' clinical skills now observed as part of the ANP selection process. This article describes how the new process works.

  6. Report from the OMERACT Hand Osteoarthritis Working Group: Set of Core Domains and Preliminary Set of Instruments for Use in Clinical Trials and Observational Studies.

    Science.gov (United States)

    Kloppenburg, Margreet; Bøyesen, Pernille; Visser, A Willemien; Haugen, Ida K; Boers, Maarten; Boonen, Annelies; Conaghan, Philip G; Hawker, Gillian A; Kvien, Tore K; Landewé, Robert; Uhlig, Till; Smeets, Wilma; Greibrokk, Elsie; van der Heijde, Désirée M

    2015-11-01

    During OMERACT 12, a workshop was held with the aim to endorse a core set of domains for 3 settings: clinical trials of symptom and structure modification and observational studies. Additional goals were to endorse a core set of contextual factors for these settings, and to define preliminary instruments for each core domain. Finally, an agenda for future research in hand osteoarthritis (OA) was to be proposed. Literature reviews of preliminary instruments for each core domain of the proposed core set for hand OA in the settings described above. Literature review of radiographic scoring methods and modern imaging in hand OA were also performed. Proposed contextual factors for a core set were identified through 2 Delphi exercises with participation of hand OA experts, patient partners, and OMERACT participants. Results from Delphi exercises and systematic literature reviews were presented and discussed. It was agreed that a preliminary core domain set for the setting clinical trials of symptom modification should contain at least "pain, physical function, patient global assessment, joint activity and hand strength." The settings clinical trial of structure modification and observational studies would in addition include structural damage. Preliminary instruments for the proposed domains were agreed on. A list of prioritized contextual factors was defined and endorsed for further research. A research agenda was proposed for domain instrument validation according to the OMERACT Filter 2.0. Preliminary core sets for clinical trials of symptom and structure modification and observational studies in hand osteoarthritis, including preliminary instruments and contextual factors, were agreed upon during OMERACT 12.

  7. [Multicenter Prospective Observational Study of Fungal Keratitis--Current Status of Patients' Background, Clinical Findings, Treatment and Prognosis].

    Science.gov (United States)

    Inoue, Yoshitsugu; Ohashi, Yuichi; Suzuki, Takashi; Shimomura, Yoshikazu; Fukuda, Masahiko; Sotozono, Chie; Hatano, Hiroshi; Eguchi, Hiroshi; Araki-Sasaki, Kaoru; Hoshi, Saichi; Sunada, Atsuko; Asari, Seishi; Yaguchi, Takashi; Makimura, Koichi; Yokokura, Shunji; Mochizuki, Kiyofumi; Monden, Yu; Nejima, Ryohei

    2016-01-01

    To investigate the current status of fungal keratitis in Japan. The patients with fungal keratitis were examined at 27 facilities in Japan from November 1st 2011 to October 31st 2013, concerning isolates, patient background, clinical findings, treatment and prognosis. Out of 139 cases, 133 were diagnosed as fungal keratitis, of which fungi were isolated from 72 samples of 71 cases (yeast-like fungi 32 strains and filamentous fungi 40 strains). The corrected visual acuity at the first visit of 88 cases (66.2%) was less than 20/200 and 42 cases (31.6%) were involved with deep stromal lesions, indicating high proportion of severe cases in this study. Three months later, 56 cases (42.1%) were still under treatment, and corrected visual acuity of 57 cases (42.9%) was less than 20/200. In cases with yeast-like fungi, there were significantly more cases with past history of corneal diseases, ocular surgery including keratoplasty, and eye drops' use such as steroids than those with filamentous fungi. On the other hand, there were significantly more cases of filamentous fungi, with trauma on the onset and with intervention of previously attending doctors than those with yeast-like fungi. Logistic regression analyses revealed that contact lens wearing was a significant factor of good prognosis, and yeast-like fungi as one of poor outcome compared with no fungal isolation. Although the choice of antifungal drugs has been increasing, fungal keratitis is still severe, refractory and vision-threatening disease.

  8. The clinical and economic burden of pneumonia in patients enrolled in Medicare receiving dialysis: a retrospective, observational cohort study.

    Science.gov (United States)

    Sibbel, Scott; Sato, Reiko; Hunt, Abigail; Turenne, Wendy; Brunelli, Steven M

    2016-12-12

    End-stage renal disease (ESRD) patients receiving dialysis are at particular risk for infection. We assessed the clinical and economic burden of pneumonia in a population of Medicare-enrolled ESRD patients with respect to incidence and case fatality rates, rates of all-cause and cardiovascular hospitalization, and costs. Patients received dialysis between 01 January 2009 and 31 December 2011 and were enrolled in Medicare Parts A and B. Pneumonia episodes were identified from institutional and supplier claims. Patients were considered at-risk from first date of Medicare coverage and were censored upon transplant, withdrawal from dialysis, recovery of renal function, loss of Medicare benefits, or death. Linear mixed-effects models were used to assess hospitalization rates and costs over the 3 months prior to and 12 months following pneumonia episodes. The pneumonia incidence rate for the study period was 21.4 events/100 patient-years; the majority of episodes (90.1%) required inpatient treatment. The 30-day case fatality rate was 10.7%. Compared to month -3 prior to event, rates of all-cause and cardiovascular hospitalization were higher in the month of the pneumonia episode (IRR, 4.61 and 4.30). All-cause admission rates remained elevated through month 12; cardiovascular admission rates remained elevated through month 6. Mean per-patient per-month costs were $10,976 higher in the month of index episode compared to month -3, largely driven by increased inpatient costs, and remained elevated through end of 12-month follow-up. Pneumonia episodes are frequent among ESRD patients and result in hospitalizations and greater overall costs to Medicare over the following year.

  9. An observational clinical and video-polysomnographic study of the effects of rotigotine in sleep disorder in Parkinson's disease.

    Science.gov (United States)

    Wang, Yan; Yang, Yue-Chang; Lan, Dan-Mei; Wu, Hui -Juan; Zhao, Zhong-Xin

    2017-05-01

    Sleep disturbance is common in Parkinson's disease (PD) and negatively impacts quality of life. There is little data on how dopamine agonists influence nocturnal sleep in PD, particularly in sleep laboratory data to measure sleep parameters and their changes objectively. The goal of this open-label study was to objectively evaluate the effect of rotigotine on sleep in PD patients by video-polysomnographic methods. A total of 25 PD patients with complaints of nocturnal sleep impairment were enrolled. The sleep quality before and after stable rotigotine therapy was evaluated subjectively through questionnaire assessments and objectively measured by video-polysomnographic methods. The Parkinsonism, depression, anxiety, and quality of life of PD patients were also evaluated through questionnaire assessments. At the end of rotigotine treatment, the PD daytime functioning, motor performance, depression, subjective quality of sleep, and the quality of life improved. Video-polysomnographic analysis showed that the sleep efficiency and stage N1% were increased, while the sleep latency, wake after sleep onset, and the periodic leg movements in sleep index were decreased after rotigotine treatment. Video-polysomnographic analysis confirmed the subjective improvement of sleep after rotigotine treatment. This observation suggests that in PD rotigotine is a treatment option for patients complaining from sleep disturbances.

  10. The Italian compassionate use of sofosbuvir observational cohort study for the treatment of recurrent hepatitis C: clinical and virological outcomes.

    Science.gov (United States)

    Carrai, Paola; Morelli, Cristina; Cordone, Gabriella; Romano, Antonietta; Tamé, Mariarosa; Lionetti, Raffaella; Pietrosi, Giada; Lenci, Ilaria; Piai, Guido; Russo, Francesco Paolo; Coppola, Carmine; Melazzini, Mario; Montilla, Simona; Pani, Luca; Petraglia, Sandra; Russo, Pierluigi; Trotta, Maria Paola; Martini, Silvia; Toniutto, Pierluigi

    2017-12-01

    Direct antivirals are available for treating recurrent hepatitis C (RHC). This study reported outcomes of 424 patients with METAVIR F3-F4 RHC who were treated for 24 weeks with sofosbuvir/ribavirin and followed for 12 weeks within the Italian sofosbuvir compassionate use program. In 55 patients, daclatasvir or simeprevir were added. Child-Pugh class and model of end stage liver disease (MELD) scores were evaluated at baseline and 36 weeks after the start of therapy. The sustained viral response (SVR) was 86.7% (316/365) in patients who received sofosbuvir/ribavirin and 98.3% (58/59) in patients who received a second antiviral (P < 0.01). In patients treated with sofosbuvir/ribavirin, a significant difference in SVR was observed between patients diagnosed with METAVIR F4 (211/250; 84.4%), METAVIR F3 (95/105; 90.5%) and fibrosing cholestatic hepatitis (10/10; 100%) (P = 0.049). A significant association was found between patients who worsened from Child-Pugh class A and who experienced viral relapse (4/26 vs. 8/189, P = 0.02). In patients with a baseline MELD score <15, a significant association was found between maintaining a final MELD score <15 and the achievement of SVR (187/219 vs. 6/10, P = 0.031). This real-world study indicates that sofosbuvir/ribavirin treatment for 24 weeks was effective, and the achievement of SVR was associated with a reduced probability of developing worsening liver function. © 2017 Steunstichting ESOT.

  11. A cohort evaluation of clinical use and performance characteristics of Ambu® AuraGain™: A prospective observational study

    Directory of Open Access Journals (Sweden)

    Devangi A Parikh

    2017-01-01

    Full Text Available Background and Aims: Ambu® AuraGain™ (AG (Ambu, Ballerup, Denmark is a supraglottic device which has a design facilitating its use as a conduit for intubation. We designed this prospective observational study to assess the ease of AG placement in paralysed patients, determine its position and alignment to the glottis and assess its utility as a conduit for intubation. Methods: One hundred patients, aged 18–60 years, American Society of Anesthesiologists physical status I–II, undergoing elective surgery under general anaesthesia were included in the study. The ease and number of attempts for successful insertion, ease of gastric tube insertion, leak pressures, fibre-optic grade of view, number of attempts and time for tracheal intubation, time for AG removal and complications were recorded. The mean, standard deviation (SD, interquartile range (IQR and range were calculated. The upper limit of confidence interval for overall failure rate was calculated using Wilson's score method. Results: AG was successfully inserted in all patients. The mean (SD time taken for insertion was 17.32 (8.48 s. The median [IQR] leak pressures were 24 [20–28] cm of H2O. Optimal laryngeal view for intubation was obtained in 68 patients. Eighty-eight patients could be intubated in the first attempt. Five patients could not be intubated. The overall failure rate of device was 9%. Conclusion: AMBU® AuraGain™ serves as an effective ventilating aid, but caution is suggested before using it as a conduit for endotracheal intubation.

  12. Prevalence and predictors of unexplained neurological symptoms in an academic neurology outpatient clinic--an observational study.

    NARCIS (Netherlands)

    Snijders, T.J.; Leeuw, H.F. de; Klumpers, U.M.H.; Kappelle, L.J.; Gijn, J. van

    2004-01-01

    OBJECTIVES: (a) To determine the prevalence of unexplained symptoms among newly referred patients in a Dutch academic outpatient clinic for general neurology; (b) To identify factors that can serve as characteristics and possibly as screening instruments for unexplained symptoms in this population.

  13. Clinical features and predictors for disease natural progression in adults with Pompe disease : a nationwide prospective observational study

    NARCIS (Netherlands)

    van der Beek, Nadine A. M. E.; de Vries, Juna M.; Hagemans, Marloes L. C.; Hop, Wim C. J.; Kroos, Marian A.; Wokke, John H. J.; de Visser, Marianne; van Engelen, Baziel G. M.; Kuks, Jan B. M.; van der Kooi, Anneke J.; Notermans, Nicolette C.; Faber, Karin G.; Verschuuren, Jan J. G. M.; Reuser, Arnold J. J.; van der Ploeg, Ans T.; van Doorn, Pieter A.

    2012-01-01

    Background: Due partly to physicians' unawareness, many adults with Pompe disease are diagnosed with great delay. Besides, it is not well known which factors influence the rate of disease progression, and thus disease outcome. We delineated the specific clinical features of Pompe disease in adults,

  14. Circadian variations in clinical symptoms and concentrations of inflammatory cytokines, melatonin, and cortisol in polymyalgia rheumatica before and during prednisolone treatment: a controlled, observational, clinical experimental study.

    Science.gov (United States)

    Galbo, Henrik; Kall, Lisbeth

    2016-07-26

    In contrast to rheumatoid arthritis (RA), no systematic investigation of diurnal variation has been carried out in polymyalgia rheumatica (PMR). The aim of the study was to provide the often-requested documentation of the 24-h time course of clinical symptoms in PMR and relate them to concentrations during the day of melatonin, inflammatory cytokines, and cortisol. Furthermore, the effects of 14 days of prednisolone treatment were studied. Ten glucocorticoid-naive patients newly diagnosed with PMR and seven non-PMR control subjects were studied for 24 h before treatment and during the 14th day of treatment with 20 mg/day of prednisolone. Global pain and generalized muscle stiffness were monitored by using visual analogue scales, and blood was drawn repeatedly. In untreated patients, pain and stiffness peaked in the early morning, showing a plateau between 04:00 and 08:00, and then declined to a nadir at 16:00 (2P melatonin and cortisol were consistently higher in patients (2P melatonin, IL-6, IL-8, and TNF-α concentrations (2P melatonin, several pro- and anti-inflammatory cytokines, and cortisol are increased throughout the day and show diurnal variation, as also seen in healthy subjects. The time courses and the inhibitory effects of prednisolone indicate that in PMR, as proposed for RA, melatonin stimulates cytokine production, which in turn accounts at least partly for the symptoms. Furthermore, overall, cortisol may downregulate cytokine production and symptoms. Stimulation of IL-10 secretion may participate in the anti-inflammatory effects of prednisolone. These findings support use of chronotherapy in PMR and encourage study of circadian variations in other inflammatory autoimmune diseases.

  15. Cinacalcet and achievement of the NKF/K-DOQI recommended target values for bone and mineral metabolism in real-world clinical practice--the ECHO observational study

    DEFF Research Database (Denmark)

    Urena, P.; Jacobson, S.H.; Zitt, E.

    2009-01-01

    sevelamer; use of calcium-based phosphate binders increased by 5.6%. There was no unexpected safety or tolerability concerns. CONCLUSION: This analysis of current European clinical practice shows that-consistent with findings from randomized controlled trials and retrospective observational studies......BACKGROUND: The use and effectiveness of cinacalcet in 'real-world' clinical practice was investigated in a pan-European observational study in dialysis patients with secondary hyperparathyroidism (SHPT) of varying severity. METHODS: Adult patients with chronic kidney disease on dialysis who had......% and 68%, respectively). At Month 12, 18% of patients had achieved the combined target for iPTH + Ca x P compared with 2% at baseline. Most patients (65%) received

  16. Comparison of clinical features between non-smokers with COPD and smokers with COPD: a retrospective observational study

    Directory of Open Access Journals (Sweden)

    Zhang J

    2014-01-01

    Full Text Available Jing Zhang,* Xin-feng Lin,* Chun-xue Bai Department of Pulmonary Medicine, Zhongshan Hospital, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China *These authors contributed equally to this paper Background: Smoking is a major risk factor for chronic obstructive pulmonary disease (COPD; however, the similarities and differences in clinical presentation between smokers and nonsmokers are not fully described in patients with COPD. This study was designed to address this issue in a general teaching hospital in the People’s Republic of China. Methods: The medical records of patients hospitalized with a lung mass for further evaluation at Zhongshan Hospital, Fudan University, from January 2006 to December 2010 were reviewed and the data of interest were collected. The definition of COPD was according to Global Initiative for Chronic Obstructive Lung Disease (GOLD spirometric criteria. Participants who had a previous exacerbation within 4 weeks of admission, airflow limitation due to abnormalities in the large airways, or with other pulmonary diseases were excluded. Included subjects were divided into nonsmokers with COPD and smokers with COPD by a cutoff of a 5 pack-year smoking history. Results: A total of 605 subjects were included in the final analysis. The average age was 64.8±8.5 years and 62.0% (375/605 were smokers. Eighty percent of the patients had mild to moderate disease (GOLD grade 1–2. Age and years with COPD were comparable between the two groups. Compared with smokers with COPD, nonsmokers with COPD were more likely to be female, reported less chronic cough and sputum, have less emphysema on radiologic examination, and higher measures of forced expiratory volume in the first second percent predicted (FEV1, forced expiratory volume in one second/forced vital capacity (FEV1/FVC% percent predicted, maximal voluntary ventilation percent predicted, diffusing capacity of lung (DLCO percent predicted, and

  17. Clinical, geographical, and temporal risk factors associated with presentation and outcome of vivax malaria imported into the United Kingdom over 27 years: observational study

    OpenAIRE

    Broderick, C; Nadjm, B; Smith, V.; Blaze, M; Checkley, A; Chiodini, PL; Whitty, CJ

    2015-01-01

    Objective To examine temporal and geographical trends, risk factors, and seasonality of imported vivax malaria in the United Kingdom to inform clinical advice and policy. Design Observational study. Setting National surveillance data from the UK Public Health England Malaria Reference Laboratory, data from the International Passenger Survey, and international climactic data. Participants All confirmed and notified cases of malaria in the UK (n=50?187) from 1987 to 2013, focusing on 12?769 cas...

  18. Prevention and treatment of chemotherapy-induced neutropenia with the biosimilar filgrastim: a non-interventional observational study of clinical practice patterns.

    Science.gov (United States)

    Tesch, Hans; Ulshöfer, Thomas; Vehling-Kaiser, Ursula; Ottillinger, Bertram; Bulenda, Dietmar; Turner, Matthew

    2015-01-01

    Biosimilars are similar but non-identical versions of existing biological drugs. The HEXAFIL study was an observational study that assessed the clinical usage, safety and efficacy of the biosimilar filgrastim in routine clinical practice in Germany. A total of 1,337 cancer patients received the biosimilar filgrastim for primary prophylaxis (PP), secondary prophylaxis (SP) or interventional treatment (TX) plus chemotherapy. Data including neutropenic complications and adverse events (AEs) were documented for up to 3 consecutive cycles. In cycle 1, 44.9% of the patients received the biosimilar filgrastim as PP, 31.0% as SP, and 23.6% as TX. Approximately 90% of the patients required no modifications to their chemotherapy regimen, with lower rates among the PP/SP versus the TX patients. Neutropenic complications occurred in 7.9%, 6.9%, and 3.9% of the patients (cycles 1, 2, and 3, respectively). Only 1.8% of the patients experienced febrile neutropenia during cycle 1. Earlier and longer filgrastim treatment reduced grade 3/4 leukopenia and neutropenic complications. The observed safety/tolerability profile was as expected; the most common AE (4.3%) was musculoskeletal back/bone pain. In this observational real-life study of clinical practice, the biosimilar filgrastim was effective and well tolerated, with results consistent with those reported in phase II and phase III trials. © 2015 S. Karger GmbH, Freiburg.

  19. Epidemiological and clinical characteristics of childhood pandemic 2009 H1N1 virus infection: an observational cohort study

    Directory of Open Access Journals (Sweden)

    Youn You-Sook

    2011-08-01

    Full Text Available Abstract Background There was a pandemic influenza around the world in 2009 including South Korea since last pandemic occurred four decades ago. We aimed to evaluate the epidemiological and clinical characteristics of this infection in childhood. Methods We evaluated the epidemiologic characteristics of all the subjects infected with the 2009 H1N1 influenza A virus (2,971 patients, ≤ 15 years of age, and the clinical and laboratory findings of the inpatients (217 patients, 80 had pneumonia between 1 September 2009 and 31 January 2010 in a single hospital throughout the epidemic. Results The age distribution of all the subjects was relatively even. Over 90% of cases occurred during a two-month period. Two hundred and five patients (94.5% received oseltamivir within 48 h of fever onset, and 97% of inpatients defervesced within 48 h of medication. The group with pneumonia included more males than females, and had higher leukocytes counts with lower lymphocyte differentials than the group without pneumonia. The white blood cell count and lymphocyte differential were associated with the severity of pneumonia. Corticosteroid treatment for severe pneumonia patients was highly effective in preventing disease progression. Conclusion Children of all ages affected with even rates of infection, but males were predominant in pneumonia patients. Pneumonia patients showed lymphopenia and its severity was associated with the severity of illness. Our results suggest that the mechanism of lung injury in 2009 H1N1 virus infection may be associated with the host immune response.

  20. Clinical observation: congenital cystic adenomatoid malformation

    Directory of Open Access Journals (Sweden)

    Chernenkov Yu.V.

    2014-06-01

    Full Text Available The aim of the article is to describe the case of congenital cystic adenomatoid malformation. The definition of this pathology, its morphology, classification, frequency and clinical forms are considered in the work. The data of the observation of a newborn with a complicated form of the defect have been determined: the peculiarities of the neonatal adaptation, the results of examination and treatment.

  1. Clinical outcome of pneumococcal meningitis during the emergence of pencillin-resistant Streptococcus pneumoniae: an observational study

    Directory of Open Access Journals (Sweden)

    Gouveia Edilane L

    2011-11-01

    Full Text Available Abstract Background Prior to the availability of generic third-generation cephalosporins, penicillins were widely used for treatment of pneumococcal meningitis in developing countries despite concerns about rising levels of penicillin resistance among pneumococcal isolates. We examined the impact of penicillin resistance on outcomes of pneumococcal meningitis over a ten year period in an infectious diseases hospital in Brazil. Methods Clinical presentation, antimicrobial therapy and outcomes were reviewed for 548 patients with culture-confirmed pneumococcal meningitis from December, 1995, to November, 2005. Pneumococcal isolates from meningitis patients were defined as penicillin-resistant if Minimum Inhibitory Concentrations for penicillin were greater than 0.06 μg/ml. Proportional hazards regression was used to identify risk factors for fatal outcomes. Results During the ten-year period, ceftriaxone replaced ampicillin as first-line therapy for suspected bacterial meningitis. In hospital case-fatality for pneumococcal meningitis was 37%. Of 548 pneumococcal isolates from meningitis cases, 92 (17% were resistant to penicillin. After controlling for age and severity of disease at admission, penicillin resistance was associated with higher case-fatality (Hazard Ratio [HR], 1.62; 95% Confidence Interval [CI], 1.08-2.43. Penicillin-resistance remained associated with higher case-fatality when initial therapy included ceftriaxone (HR, 1.68; 95% CI 1.02-2.76. Conclusions Findings support the use of third generation cephalosporin antibiotics for treatment of suspected pneumococcal meningitis even at low prevalence of pneumococcal resistance to penicillins.

  2. Characteristics and outcomes of adult Ethiopian patients enrolled in HIV care and treatment: a multi-clinic observational study.

    Science.gov (United States)

    Melaku, Zenebe; Lamb, Matthew R; Wang, Chunhui; Lulseged, Sileshi; Gadisa, Tsigereda; Ahmed, Solomon; Habtamu, Zelalem; Alemu, Hailubeza; Assefa, Tamrat; Abrams, Elaine J

    2015-05-03

    We describe trends in characteristics and outcomes among adults initiating HIV care and treatment in Ethiopia from 2006-2011. We conducted a retrospective longitudinal analysis of HIV-positive adults (≥ 15 years) enrolling at 56 Ethiopian health facilities from 2006-2011. We investigated trends over time in the proportion enrolling through provider-initiated counseling and testing (PITC), baseline CD4+ cell counts and WHO stage. Additionally, we assessed outcomes (recorded death, loss to follow-up (LTF), transfer, and total attrition (recorded death plus LTF)) before and after ART initiation. Kaplan-Meier techniques estimated cumulative incidence of these outcomes through 36 months after ART initiation. Factors associated with LTF and death after ART initiation were estimated using Hazard Ratios accounting for within-clinic correlation. 93,418 adults enrolled into HIV care; 53,300 (57%) initiated ART. The proportion enrolled through PITC increased from 27.6% (2006-2007) to 44.8% (2010-2011) (p enrollment CD4+ cell count increased from 158 to 208 cells/mm(3) (p enrollment in HIV care through outpatient PITC increased and patients enrolled into HIV care at earlier disease stages across all HIV testing points. However, median CD4+ cell count at ART initiation remained steady. Pre- and post-ART attrition (particularly in the first 6 months) have remained major challenges in ensuring prompt ART initiation and retention on ART.

  3. [The impact of goal directed analgesia on mechanical ventilated patients's outcomes in intensive care unit: a clinical observational study].

    Science.gov (United States)

    Li, Q D; Wan, X Y; Zhang, Y L; Li, S W; Han, L L; Li, W W; Shi, H Y

    2017-11-01

    To investigate the impact of goal directed analgesia on the outcome of patients with mechanical ventilation in intensive care unit.A total of 126 patients who needed mechanical ventilation were recruited.With a method of before and after paired comparison, they were divided into two group: (1) analgesia with empirical administration or control group; (2) goal directed analgesia based on critical-care pain observation tool (CPOT). Compared with the control group, after goal directed analgesia was applied, the consumption of midazolam significantly dropped from (368.47±27.41) mg to (151.27±29.31) mg(Pventilator duration was significantly shortened from (168.49±11.41) h to (142.38±13.24) h(Pventilation time and shorter ICU length of stay, suggesting that the general outcome is improved.

  4. A two-stage clinical decision support system for early recognition and stratification of patients with sepsis: an observational cohort study.

    Science.gov (United States)

    Amland, Robert C; Lyons, Jason J; Greene, Tracy L; Haley, James M

    2015-10-01

    To examine the diagnostic accuracy of a two-stage clinical decision support system for early recognition and stratification of patients with sepsis. Observational cohort study employing a two-stage sepsis clinical decision support to recognise and stratify patients with sepsis. The stage one component was comprised of a cloud-based clinical decision support with 24/7 surveillance to detect patients at risk of sepsis. The cloud-based clinical decision support delivered notifications to the patients' designated nurse, who then electronically contacted a provider. The second stage component comprised a sepsis screening and stratification form integrated into the patient electronic health record, essentially an evidence-based decision aid, used by providers to assess patients at bedside. Urban, 284 acute bed community hospital in the USA; 16,000 hospitalisations annually. Data on 2620 adult patients were collected retrospectively in 2014 after the clinical decision support was implemented. 'Suspected infection' was the established gold standard to assess clinical decision support clinimetric performance. A sepsis alert activated on 417 (16%) of 2620 adult patients hospitalised. Applying 'suspected infection' as standard, the patient population characteristics showed 72% sensitivity and 73% positive predictive value. A postalert screening conducted by providers at bedside of 417 patients achieved 81% sensitivity and 94% positive predictive value. Providers documented against 89% patients with an alert activated by clinical decision support and completed 75% of bedside screening and stratification of patients with sepsis within one hour from notification. A clinical decision support binary alarm system with cross-checking functionality improves early recognition and facilitates stratification of patients with sepsis.

  5. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Directory of Open Access Journals (Sweden)

    Franziska Ruëff

    Full Text Available BACKGROUND: Treatment failure during venom immunotherapy (VIT may be associated with a variety of risk factors. OBJECTIVE: Our aim was to evaluate the association of baseline serum tryptase concentration (BTC and of other parameters with the frequency of VIT failure during the maintenance phase. METHODS: In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154 or patient self-reporting of the outcome of a field sting (n = 203. Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. RESULTS: 22 patients (6.2% developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios <3 of BTC were still possible, and were also suggested by a selective analysis of patients who had a sting challenge. The most important factor associated with VIT failure was a honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. INTERPRETATION: It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  6. Clinical effectiveness of hymenoptera venom immunotherapy: a prospective observational multicenter study of the European academy of allergology and clinical immunology interest group on insect venom hypersensitivity.

    Science.gov (United States)

    Ruëff, Franziska; Przybilla, Bernhard; Biló, Maria Beatrice; Müller, Ulrich; Scheipl, Fabian; Seitz, Michael J; Aberer, Werner; Bodzenta-Lukaszyk, Anna; Bonifazi, Floriano; Campi, Paolo; Darsow, Ulf; Haeberli, Gabrielle; Hawranek, Thomas; Küchenhoff, Helmut; Lang, Roland; Quercia, Oliviero; Reider, Norbert; Schmid-Grendelmeier, Peter; Severino, Maurizio; Sturm, Gunter Johannes; Treudler, Regina; Wüthrich, Brunello

    2013-01-01

    Treatment failure during venom immunotherapy (VIT) may be associated with a variety of risk factors. Our aim was to evaluate the association of baseline serum tryptase concentration (BTC) and of other parameters with the frequency of VIT failure during the maintenance phase. In this observational prospective multicenter study, we followed 357 patients with established honey bee or vespid venom allergy after the maintenance dose of VIT had been reached. In all patients, VIT effectiveness was either verified by sting challenge (n = 154) or patient self-reporting of the outcome of a field sting (n = 203). Data were collected on BTC, age, gender, preventive use of anti-allergic drugs (oral antihistamines and/or corticosteroids) right after a field sting, venom dose, antihypertensive medication, type of venom, side effects during VIT, severity of index sting reaction preceding VIT, and duration of VIT. Relative rates were calculated with generalized additive models. 22 patients (6.2%) developed generalized symptoms during sting challenge or after a field sting. A strong association between the frequency of VIT failure and BTC could be excluded. Due to wide confidence bands, however, weaker effects (odds ratios honey bee venom allergy. Preventive use of anti-allergic drugs may be associated with a higher protection rate. It is unlikely that an elevated BTC has a strong negative effect on the rate of treatment failures. The magnitude of the latter, however, may depend on the method of effectiveness assessment. Failure rate is higher in patients suffering from bee venom allergy.

  7. Next-generation sequencing diagnostics of bacteremia in sepsis (Next GeneSiS-Trial): Study protocol of a prospective, observational, noninterventional, multicenter, clinical trial.

    Science.gov (United States)

    Brenner, Thorsten; Decker, Sebastian O; Grumaz, Silke; Stevens, Philip; Bruckner, Thomas; Schmoch, Thomas; Pletz, Mathias W; Bracht, Hendrik; Hofer, Stefan; Marx, Gernot; Weigand, Markus A; Sohn, Kai

    2018-02-01

    Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime. In this context, culture-based diagnostic procedures (e.g., blood cultures) represent the standard of care, although they are associated with relevant limitations. Accordingly, culture-independent molecular diagnostic procedures might be of help for the identification of the causative pathogen in infected patients. The concept of an unbiased sequence analysis of circulating cell-free DNA (cfDNA) from plasma samples of septic patients by next-generation sequencing (NGS) has recently been identified to be a promising diagnostic platform for critically ill patients suffering from bloodstream infections. Although this new approach might be more sensitive and specific than culture-based state-of-the-art technologies, additional clinical trials are needed to exactly define the performance as well as clinical value of a NGS-based approach. Next GeneSiS is a prospective, observational, noninterventional, multicenter study to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in patients with suspected or proven sepsis [according to recent sepsis definitions (sepsis-3)] by the use of the quantitative sepsis indicating quantifier (SIQ) score in comparison to standard (culture-based) microbiological diagnostics. The clinical value of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients' management based on NGS results. Further subgroup analyses will focus on the clinical value especially for patients suffering from a failure of empiric treatment within the first 3 days after onset [as assessed by death of the patient or lack of improvement of the patient's clinical condition (in terms of an inadequate decrease of SOFA-score) or

  8. Does psychological status influence clinical outcomes in patients with inflammatory bowel disease (IBD and other chronic gastroenterological diseases: An observational cohort prospective study

    Directory of Open Access Journals (Sweden)

    Wilson Ian G

    2008-06-01

    Full Text Available Abstract Background Whether there is a temporal relationship between psychological problems and clinical outcomes in patients with diseases of the digestive tract has not been widely researched. Thus, our aims were 1 To observe and compare prospectively clinical outcomes in relation to psychological co-morbidity in patients with inflammatory bowel disease (IBD, irritable bowel syndrome (IBS and chronic hepatitis C (HCV and, 2 To test the hypothesis that patients with psychological co-morbidities are less likely to have a satisfactory response to standard treatment at 12 months. Methods Overall, 139 patients were enrolled in this observational cohort prospective study. Over the ensuing year, physical and psychological measures were made at baseline and after 12 months (HADS, SCL90, SF-12 and disease activity measures. A logistic regression was conducted to observe any relationship between baseline characteristics and patients' clinical outcomes after 12 months. Results Overall, there was no relationship between psychological status and quality of life at baseline and relapse at 12 months (p > 0.05. However, patients with inactive disease at baseline were at lower risk of relapse after 12 months (OR = 0.046, CI: 0.012–0.178. No significant relationship was found between psychological problems such as depression/anxiety and a total number of relapses in the IBD group. However, interestingly, patients with an active disease at baseline tended to have a greater number of relapses (OR = 3.07, CI: 1.650–5.738 and CD participants were found at lower risk of relapse than UC participants (OR = 0.382, CI: 0.198–0.736. Conclusion In contrast to previous investigations, this study suggests that there is no temporal relationship between psychological problems at baseline and clinical outcomes over time. Longer and larger prospective studies are needed to better understand this result.

  9. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study.

    Science.gov (United States)

    Penaloza, Andrea; Soulié, Caroline; Moumneh, Thomas; Delmez, Quentin; Ghuysen, Alexandre; El Kouri, Dominique; Brice, Christian; Marjanovic, Nicolas S; Bouget, Jacques; Moustafa, Fares; Trinh-Duc, Albert; Le Gall, Catherine; Imsaad, Lionel; Chrétien, Jean-Marie; Gable, Béatrice; Girard, Philippe; Sanchez, Olivier; Schmidt, Jeannot; Le Gal, Grégoire; Meyer, Guy; Delvau, Nicolas; Roy, Pierre-Marie

    2017-12-01

    The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the predictive value of negative PERC to rule out pulmonary embolism among European patients with low implicit clinical probability. We did a multicentre, prospective, observational study in 12 emergency departments in France and Belgium. We included consecutive patients aged 18 years or older with suspected pulmonary embolism. Patients were excluded if they had already been hospitalised for more than 2 days, had curative anticoagulant therapy in progress for more than 48 h, or had a diagnosis of thromboembolic disease documented before admission to emergency department. Physicians completed a standardised case report form comprising implicit clinical probability assessment (low, moderate, or high) and a list of risk factors including criteria of the PERC rule. They were asked to follow international recommendations for diagnostic strategy, masked to PERC assessment. The primary endpoint was the proportion of patients with low implicit clinical probability and negative PERC who had venous thromboembolic events, diagnosed during initial diagnostic work-up or during 3-month follow-up, as externally adjudicated by an independent committee masked to the PERC and clinical probability assessment. The upper limit of the 95% CI around the 3-month thromboembolic risk was set at 3%. We did all analyses by intention to treat, including all patients with complete follow-up. This trial is registered with ClinicalTrials.gov, number NCT02360540. Between May 1, 2015, and April 30, 2016, 1773 consecutive patients with suspected pulmonary embolism were prospectively assessed for inclusion, of whom 1757 were included. 1052 (60%) patients were classed as having low clinical probability

  10. Clinical observations associated with proven and unproven cases in the ESCRS study of prophylaxis of postoperative endophthalmitis after cataract surgery.

    LENUS (Irish Health Repository)

    Barry, Peter

    2012-02-01

    PURPOSE: To describe cases of postoperative endophthalmitis in the European Society of Cataract & Refractive Surgeons (ESCRS) study of the prophylaxis of endophthalmitis, compare characteristics of unproven cases and cases proven by culture or polymerase chain reaction, and compare the characteristics with those in other reported series. SETTING: Twenty-four ophthalmology units in Austria, Belgium, Germany, Italy, Poland, Portugal, Spain, Turkey, and the United Kingdom. METHODS: Univariable and multivariable logistic regression models were used to analyze data for statistical association of signs and symptoms in cases with proven or unproven endophthalmitis. Specific data describing characteristics of the cases were compared between the 2 types of cases. RESULTS: Data from 29 endophthalmitis cases were analyzed. Swollen lids and pain were statistically associated with proven cases of endophthalmitis on univariable regression analysis. Multivariable analysis indicated that swollen lids and an opaque vitreous were associated with proven cases. Five cases of endophthalmitis occurred in the cefuroxime-treated groups. No case of streptococcal infection occurred in the cefuroxime-treated groups. However, cases of infection due to streptococci showed striking differences in visual acuity and were associated with earlier onset. Characteristics in the 29 cases parallel results in previous studies, such as the Endophthalmitis Vitrectomy Study, although the addition of a control group in the ESCRS study elicited additional findings. CONCLUSION: Swollen lids, pain, and an opaque vitreous were statistically associated with proven endophthalmitis cases in the ESCRS study.

  11. Assessment of function and clinical utility of alcohol and other drug web sites: An observational, qualitative study

    Directory of Open Access Journals (Sweden)

    Drennan Judy

    2011-05-01

    Full Text Available Abstract Background The increasing popularity and use of the internet makes it an attractive option for providing health information and treatment, including alcohol/other drug use. There is limited research examining how people identify and access information about alcohol or other drug (AOD use online, or how they assess the usefulness of the information presented. This study examined the strategies that individuals used to identify and navigate a range of AOD websites, along with the attitudes concerning presentation and content. Methods Members of the general community in Brisbane and Roma (Queensland, Australia were invited to participate in a 30-minute search of the internet for sites related to AOD use, followed by a focus group discussion. Fifty one subjects participated in the study across nine focus groups. Results Participants spent a maximum of 6.5 minutes on any one website, and less if the user was under 25 years of age. Time spent was as little as 2 minutes if the website was not the first accessed. Participants recommended that AOD-related websites should have an engaging home or index page, which quickly and accurately portrayed the site's objectives, and provided clear site navigation options. Website content should clearly match the title and description of the site that is used by internet search engines. Participants supported the development of a portal for AOD websites, suggesting that it would greatly facilitate access and navigation. Treatment programs delivered online were initially viewed with caution. This appeared to be due to limited understanding of what constituted online treatment, including its potential efficacy. Conclusions A range of recommendations arise from this study regarding the design and development of websites, particularly those related to AOD use. These include prudent use of text and information on any one webpage, the use of graphics and colours, and clear, uncluttered navigation options

  12. Clinical Risk Scoring Models for Prediction of Acute Kidney Injury after Living Donor Liver Transplantation: A Retrospective Observational Study.

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    Mi Hye Park

    Full Text Available Acute kidney injury (AKI is a frequent complication of liver transplantation and is associated with increased mortality. We identified the incidence and modifiable risk factors for AKI after living-donor liver transplantation (LDLT and constructed risk scoring models for AKI prediction. We retrospectively reviewed 538 cases of LDLT. Multivariate logistic regression analysis was used to evaluate risk factors for the prediction of AKI as defined by the RIFLE criteria (RIFLE = risk, injury, failure, loss, end stage. Three risk scoring models were developed in the retrospective cohort by including all variables that were significant in univariate analysis, or variables that were significant in multivariate analysis by backward or forward stepwise variable selection. The risk models were validated by way of cross-validation. The incidence of AKI was 27.3% (147/538 and 6.3% (34/538 required postoperative renal replacement therapy. Independent risk factors for AKI by multivariate analysis of forward stepwise variable selection included: body-mass index >27.5 kg/m2 [odds ratio (OR 2.46, 95% confidence interval (CI 1.32-4.55], serum albumin 20 (OR 2.01, 95%CI 1.17-3.44, operation time >600 min (OR 1.81, 95%CI 1.07-3.06, warm ischemic time >40 min (OR 2.61, 95%CI 1.55-4.38, postreperfusion syndrome (OR 2.96, 95%CI 1.55-4.38, mean blood glucose during the day of surgery >150 mg/dl (OR 1.66, 95%CI 1.01-2.70, cryoprecipitate > 6 units (OR 4.96, 95%CI 2.84-8.64, blood loss/body weight >60 ml/kg (OR 4.05, 95%CI 2.28-7.21, and calcineurin inhibitor use without combined mycophenolate mofetil (OR 1.87, 95%CI 1.14-3.06. Our risk models performed better than did a previously reported score by Utsumi et al. in our study cohort. Doses of calcineurin inhibitor should be reduced by combined use of mycophenolate mofetil to decrease postoperative AKI. Prospective randomized trials are required to address whether artificial modification of hypoalbuminemia, hyperglycemia

  13. Identification of new biosignatures for clinical outcomes in stable coronary artery disease - The study protocol and initial observations of a prospective follow-up study in Taiwan.

    Science.gov (United States)

    Leu, Hsin-Bang; Yin, Wei-Hsian; Tseng, Wei-Kung; Wu, Yen-Wen; Lin, Tsung-Hsien; Yeh, Hung-I; Chang, Kuan-Cheng; Wang, Ji-Hung; Wu, Chau-Chung; Chen, Jaw-Wen

    2017-01-28

    Either classic or novel biomarkers have not been well investigated for clinical outcomes of coronary artery disease (CAD) in Asian people especially ethnic Chinese. We reported here a prospective national-based follow-up study that aims to elucidate the clinical profiles and to identify the new biosignatures (especially the non-lipid profile and inflammatory biomakers) for future clinical outcomes in a sizable cohort of stable CAD patients in Taiwan. A total of 2500 CAD patients under stable condition after successful percutaneous coronary intervention will be enrolled for clinical data collection and blood/urine sampling in northern, southern, western, or eastern part of Taiwan between 2012 and 2017. They will be regularly followed up at least annually for 5 years to assess all cause deaths, hard clinical events (including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke), and total cardiovascular events (including hard events, unplanned revascularization procedures, unplanned hospitalization for refractory or unstable angina, and for other causes such as stroke, transient ischemic attack, heart failure, or peripheral arterial occlusive disease). The classic and newly defined biosignatures will be compared in patients with and without clinical events during follow-up. The novel biomarkers will be identified via metabolomics analyses. Additionally, psychological personality and lifestyle data will be incorporated to explore the new dimensional views of the complex mechanisms of the disease. Till December 2014, the initial 1663 patients have been successfully enrolled. Among them, 85.93% are male; 36.22% have type 2 diabetes; 64.82% have hypertension; 56.04% are smokers and 20.44% have a family history of CAD. Their lipid profiles are under contemporary medical control with a mean plasma total cholesterol level of 163.51 ± 36.99 mg/dL and a mean low-density lipoprotein cholesterol level of 95.21 ± 29.98 mg/dL. This nationwide study

  14. Safety Outcomes and Near-Adult Height Gain of Growth Hormone-Treated Children with SHOX Deficiency: Data from an Observational Study and a Clinical Trial.

    Science.gov (United States)

    Benabbad, Imane; Rosilio, Myriam; Child, Christopher J; Carel, Jean-Claude; Ross, Judith L; Deal, Cheri L; Drop, Stenvert L S; Zimmermann, Alan G; Jia, Nan; Quigley, Charmian A; Blum, Werner F

    2017-01-01

    To assess auxological and safety data for growth hormone (GH)-treated children with SHOX deficiency. Data were examined for GH-treated SHOX-deficient children (n = 521) from the observational Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS). For patients with near-adult height information, GeNeSIS results (n = 90) were compared with a clinical trial (n = 28) of SHOX-deficient patients. Near-adult height was expressed as standard deviation score (SDS) for chronological age, potentially increasing the observed effect of treatment. Most SHOX-deficient patients in GeNeSIS had diagnoses of Leri-Weill syndrome (n = 292) or non-syndromic short stature (n = 228). For GeNeSIS patients with near-adult height data, mean age at GH treatment start was 11.0 years, treatment duration 4.4 years, and height SDS gain 0.83 (95% confidence interval 0.49-1.17). Respective ages, GH treatment durations and height SDS gains for GeNeSIS patients prepubertal at baseline (n = 42) were 9.2 years, 6.0 years and 1.19 (0.76-1.62), and for the clinical trial cohort they were 9.2 years, 6.0 years and 1.25 (0.92-1.58). No new GH-related safety concerns were identified. Patients with SHOX deficiency who had started GH treatment before puberty in routine clinical practice had a similar height gain to that of patients in the clinical trial on which approval for the indication was based, with no new safety concerns. © 2016 The Author(s) Published by S. Karger AG, Basel.

  15. Long-term effect of galantamine on cognitive function in patients with Alzheimer’s disease versus a simulated disease trajectory: an observational study in the clinical setting

    Directory of Open Access Journals (Sweden)

    Nakagawa R

    2017-04-01

    Full Text Available Ryoko Nakagawa,1 Takashi Ohnishi,1 Hisanori Kobayashi,1 Toshio Yamaoka,2 Tsutomu Yajima,3 Ai Tanimura,4 Toshiya Kato,4 Kazutake Yoshizawa1 1Evidence Generation Department, Medical Affairs Division, 2Clinical Data Management Department, R&D Division, 3Biostatistics Department, Quantitative Science Division, 4Drug Surveillance Department, R&D Division, Janssen Pharmaceutical K.K., Tokyo, Japan Background: Long-term maintenance of cognitive function is an important goal of treatment for Alzheimer’s disease (AD, but evidence about the long-term efficacy of cholinesterase inhibitors is sparse. To evaluate the long-term efficacy and safety of galantamine for AD in routine clinical practice, we conducted a 72-week post-marketing surveillance study. The effect of galantamine on cognitive function was estimated in comparison with a simulated disease trajectory. Patients and methods: Patients with mild-to-moderate AD received flexible dosing of galantamine (16–24 mg/day during this study. Cognitive function was assessed by the mini mental state examination (MMSE and the clinical status was determined by the Clinical Global Impression-Improvement (CGI-I. Changes of the MMSE score without treatment were estimated in each patient using Mendiondo’s model. Generalized linear mixed model analysis was performed to compare the simulated MMSE scores with the actual scores. Results: Of the 661 patients who were enrolled, 642 were evaluable for safety and 554 were assessed for efficacy. The discontinuation rate was 46.73%. Cognitive decline indicated by the mean change of actual MMSE scores was significantly smaller than the simulated decline. Individual analysis demonstrated that >70% of patients had better actual MMSE scores than their simulated scores. Significant improvement of CGI-I was also observed during the observation period. Adverse events occurred in 28.5% of patients and were serious in 8.41%. The reported events generally corresponded with the

  16. Predictive value of clinical and laboratory features for the main febrile diseases in children living in Tanzania: A prospective observational study.

    Directory of Open Access Journals (Sweden)

    Olga De Santis

    Full Text Available To construct evidence-based guidelines for management of febrile illness, it is essential to identify clinical predictors for the main causes of fever, either to diagnose the disease when no laboratory test is available or to better target testing when a test is available. The objective was to investigate clinical predictors of several diseases in a cohort of febrile children attending outpatient clinics in Tanzania, whose diagnoses have been established after extensive clinical and laboratory workup.From April to December 2008, 1005 consecutive children aged 2 months to 10 years with temperature ≥38°C attending two outpatient clinics in Dar es Salaam were included. Demographic characteristics, symptoms and signs, comorbidities, full blood count and liver enzyme level were investigated by bi- and multi-variate analyses (Chan, et al., 2008. To evaluate accuracy of combined predictors to construct algorithms, classification and regression tree (CART analyses were also performed.62 variables were studied. Between 4 and 15 significant predictors to rule in (aLR+>1 or rule out (aLR+3 days (45%,83%; viral disease: runny nose, cough and age <2 years (68%,76%.A better understanding of the relative performance of these predictors might be of great help for clinicians to be able to better decide when to test, treat, refer or simply observe a sick child, in order to decrease morbidity and mortality, but also to avoid unnecessary antimicrobial prescription. These predictors have been used to construct a new algorithm for the management of childhood illnesses called ALMANACH.

  17. Excess Mortality in Patients with Multiple Sclerosis Starts at 20 Years from Clinical Onset: Data from a Large-Scale French Observational Study.

    Directory of Open Access Journals (Sweden)

    Emmanuelle Leray

    Full Text Available Recent studies in multiple sclerosis (MS showed longer survival times from clinical onset than older hospital-based series. However estimated median time ranges widely, from 24 to 45 years, which makes huge difference for patients as this neurological disease mainly starts around age 20 to 40. Precise and up-to-date reference data about mortality in MS are crucial for patients and neurologists, but unavailable yet in France.Estimate survival in MS patients and compare mortality with that of the French general population.We conducted a multicenter observational study involving clinical longitudinal data from 30,413 eligible patients, linked to the national deaths register. Inclusion criteria were definite MS diagnosis and clinical onset prior to January, 1st 2009 in order to get a minimum of 1-year disease duration.After removing between-center duplicates and applying inclusion criteria, the final population comprised 27,603 MS patients (F/M sex ratio 2.5, mean age at onset 33.0 years, 85.5% relapsing onset. During the follow-up period (mean 15.2 +/- 10.3 years, 1569 deaths (5.7% were identified; half related to MS. Death rates were significantly higher in men, patients with later clinical onset, and in progressive MS. Overall excess mortality compared with the general population was moderate (Standardized Mortality Ratio 1.48, 95% confidence interval [1.41-1.55], but increased considerably after 20 years of disease (2.20 [2.10-2.31].This study revealed a moderate decrease in life expectancy in MS patients, and showed that the risk of dying is strongly correlated to disease duration and disability, highlighting the need for early actions that can slow disability progression.

  18. Excess Mortality in Patients with Multiple Sclerosis Starts at 20 Years from Clinical Onset: Data from a Large-Scale French Observational Study.

    Science.gov (United States)

    Leray, Emmanuelle; Vukusic, Sandra; Debouverie, Marc; Clanet, Michel; Brochet, Bruno; de Sèze, Jérôme; Zéphir, Hélène; Defer, Gilles; Lebrun-Frenay, Christine; Moreau, Thibault; Clavelou, Pierre; Pelletier, Jean; Berger, Eric; Cabre, Philippe; Camdessanché, Jean-Philippe; Kalson-Ray, Shoshannah; Confavreux, Christian; Edan, Gilles

    2015-01-01

    Recent studies in multiple sclerosis (MS) showed longer survival times from clinical onset than older hospital-based series. However estimated median time ranges widely, from 24 to 45 years, which makes huge difference for patients as this neurological disease mainly starts around age 20 to 40. Precise and up-to-date reference data about mortality in MS are crucial for patients and neurologists, but unavailable yet in France. Estimate survival in MS patients and compare mortality with that of the French general population. We conducted a multicenter observational study involving clinical longitudinal data from 30,413 eligible patients, linked to the national deaths register. Inclusion criteria were definite MS diagnosis and clinical onset prior to January, 1st 2009 in order to get a minimum of 1-year disease duration. After removing between-center duplicates and applying inclusion criteria, the final population comprised 27,603 MS patients (F/M sex ratio 2.5, mean age at onset 33.0 years, 85.5% relapsing onset). During the follow-up period (mean 15.2 +/- 10.3 years), 1569 deaths (5.7%) were identified; half related to MS. Death rates were significantly higher in men, patients with later clinical onset, and in progressive MS. Overall excess mortality compared with the general population was moderate (Standardized Mortality Ratio 1.48, 95% confidence interval [1.41-1.55]), but increased considerably after 20 years of disease (2.20 [2.10-2.31]). This study revealed a moderate decrease in life expectancy in MS patients, and showed that the risk of dying is strongly correlated to disease duration and disability, highlighting the need for early actions that can slow disability progression.

  19. Non-interventional (observational study of application of the tamsulosin (Proflosin® in patients with benign prostatic hyperplasia in routine clinical practice

    Directory of Open Access Journals (Sweden)

    L. G. Spivak

    2015-02-01

    Full Text Available The problem of therapy of benign prostatic hyperplasia has not lost its relevance today due to the high prevalence rate of this pathologyamong the male population. The article provides the results of non-interventional (observational study of application of the tamsulosin(Proflosin® drug or combined therapy with tamsulosin (Proflosin® + Serenoa repens (Prostamol® Uno of patients with benign prostatic hyperplasia in routine clinical practice. 1,000 practicing urology experts from 100 cities and towns of Russia took part in the study as well as 23 492 patients with the established diagnosis of benign prostatic hyperplasia, which were prescribed with tamsulosin (Proflosin® monotherapy or combined therapy with tamsulosin (Proflosin® + Serenoa repens (Prostamol® Uno in conditions of outpatient clinical practice. As a result of the study, improvement of the life standard and subjective symptoms were stated with patients with the absence of significant side effects directly associated with intake of the drug studies.

  20. Non-interventional (observational study of application of the tamsulosin (Proflosin® in patients with benign prostatic hyperplasia in routine clinical practice

    Directory of Open Access Journals (Sweden)

    L. G. Spivak

    2014-01-01

    Full Text Available The problem of therapy of benign prostatic hyperplasia has not lost its relevance today due to the high prevalence rate of this pathologyamong the male population. The article provides the results of non-interventional (observational study of application of the tamsulosin(Proflosin® drug or combined therapy with tamsulosin (Proflosin® + Serenoa repens (Prostamol® Uno of patients with benign prostatic hyperplasia in routine clinical practice. 1,000 practicing urology experts from 100 cities and towns of Russia took part in the study as well as 23 492 patients with the established diagnosis of benign prostatic hyperplasia, which were prescribed with tamsulosin (Proflosin® monotherapy or combined therapy with tamsulosin (Proflosin® + Serenoa repens (Prostamol® Uno in conditions of outpatient clinical practice. As a result of the study, improvement of the life standard and subjective symptoms were stated with patients with the absence of significant side effects directly associated with intake of the drug studies.

  1. Long-term response to mood stabilizer treatment and its clinical correlates in patients with bipolar disorders: a retrospective observational study.

    Science.gov (United States)

    Ahn, Sung Woo; Baek, Ji Hyun; Yang, So-Yung; Kim, Yongkang; Cho, Youngah; Choi, Yujin; Lee, Kounseok; Park, Taesung; Hong, Kyung Sue

    2017-12-01

    The efficacy and utility of long-term prophylactic treatment in patients with bipolar disorders (BDs) have not been fully explored. This study aims to estimate the long-term clinical response of patients with BDs to mood stabilizer treatment and to identify the clinical factors associated with that response. The study subjects consisted of 80 patients with bipolar I or bipolar II disorder who had been receiving treatment with lithium and/or valproate for more than 2 years at a single bipolar disorder clinic. The long-term response to the best treatment option based on treatment algorithms was evaluated using the Alda scale. Clinical characteristics were evaluated on a lifetime basis. Patients were classified into two response groups based on frequentist mixture analysis using the total Alda scale score. Thirty-four percent of the patients were good responders, with a total Alda score of 5 or higher. The treatment response rate did not differ between the lithium and valproate groups, but lithium and valproate combination therapy was associated with poorer response. The number of previous mixed episodes was associated with a worse response (p = 0.026). Of individual symptoms, delusions during manic episodes (p = 0.008) and increased appetite (p = 0.035) during depressive episodes were more common in moderate/poor responders than in good responders. Co-morbid anxiety disorders were more frequently observed in the moderate/poor response group (p = 0.008). Psychotic, mixed, and atypical features of BDs were found to be correlated with long-term treatment outcomes. Lithium and valproate showed similar efficacy but moderate/poor responders preferred to use polypharmacy.

  2. Treatment compliance or medication adherence in children and adolescents on ADHD medication in clinical practice: results from the COMPLY observational study.

    Science.gov (United States)

    Wehmeier, Peter M; Dittmann, Ralf W; Banaschewski, Tobias

    2015-06-01

    Although the efficacy and tolerability of ADHD medications have been investigated fairly extensively, there are very few data comparing the different types of medication (e.g. psychostimulants, non-stimulants) in terms of medication adherence. The primary research objective of the COMPLY observational study was to evaluate medication adherence (i.e. compliance) over 1 year in children and adolescents with ADHD in a routine clinical setting. COMPLY was a prospective 12-month, observational, open-label study that included children and adolescents, aged 6-17 years, with ADHD. Medication adherence (i.e. compliance) was measured using the Pediatric Compliance Self-Rating (PCSR) instrument and using items 1-4 of the Medication Adherence Rating Scale (MARS). A total of 504 patients were enrolled. At baseline, 252 patients (50.0 %) were prescribed non-stimulant (atomoxetine) medication and 247 patients (49.0 %) were prescribed psychostimulant medication. Both types of medication were prescribed concomitantly in five patients (1.0 %). After 12 months, 123 patients (48.8 %) were taking atomoxetine and 176 patients (71.3 %) were taking psychostimulants. Adherence (PCSR score ≥ 5) was present in both groups (atomoxetine: 67.5 %; psychostimulant: 74.2 %) throughout the observation period. MARS scores declined over time in both groups (atomoxetine: from 3.7 to 2.9; psychostimulant: from 3.6 to 3.1), indicating a deterioration in adherence. There was no statistically significant difference in terms of medication adherence between the two groups.

  3. A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

    Directory of Open Access Journals (Sweden)

    Lipsky Benjamin A

    2012-09-01

    Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

  4. NEUROSYPHILIS IN THERAPEUTIC PRACTICE: CLINICAL OBSERVATION

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    N. A. Shostak

    2017-01-01

    Full Text Available Objective: to describe a clinical case of neurosyphilis diagnosed in a therapeutic inpatient facility.Materials and methods. Female patient T., 61, was hospitalized in the therapeutic department of a general hospital with referral diagnosis of “Stage II hypertensive heart disease, risk 4. Hypertensive crisis of 03.12.2015” with complaints of general fatigue, episodes of transient memory loss with full recovery, unstable blood pressure level. The patient was examined: She underwent treponemal and nontreponemal serological tests for antibodies against Treponema рallidum, hepatitis, human immunodeficiency virus; electrocardiogram; angiography of carotid and vertebral arteries; magnetic resonance imaging (MRI  of the brain with contrast; serological and microscopic examinations of the cerebrospinal fluid (CSF.Results. The patient»s medical history described episodes of transient global amnesia with full memory recovery, more frequent in the last year; arterial hypertension; chronic urinary tract infection; and chronic cholecystitis with frequent courses of antibacterial therapy (ceftriaxone. Since 1986, a positive serological reaction for syphilis was observed (Wassermann reaction (WR +++ due to a history of primary syphilis. Considering reliable history of syphilis, positive serum confirmation tests for syphilis (nontreponemal: rapid plasma reagin test 3+; treponemal: passive hemagglutination reaction 4+, antibodies against T. pallidum (total – present, history of neuropsychological symptoms (transient amnesia and acute neurological symptoms before hospitalization (transient ischemic attack, brain MRI data (2 lesions of cerebral circulation disorders of ischemic type in the cortical branches of left and right mesencephalic arteries, a diagnosis of neurosyphilis was proposed, and lumbar puncture was performed for confirmation. Inflammatory characteristics of the CSF (cytosis 19/3, neutrophilia up to 12 cells, insignificant lymphocytosis up

  5. The Power of Flash Mob Research: Conducting a Nationwide Observational Clinical Study on Capillary Refill Time in a Single Day.

    Science.gov (United States)

    Alsma, Jelmer; van Saase, Jan L C M; Nanayakkara, Prabath W B; Schouten, W E M Ineke; Baten, Anique; Bauer, Martijn P; Holleman, Frits; Ligtenberg, Jack J M; Stassen, Patricia M; Kaasjager, Karin H A H; Haak, Harm R; Bosch, Frank H; Schuit, Stephanie C E

    2017-05-01

    Capillary refill time (CRT) is a clinical test used to evaluate the circulatory status of patients; various methods are available to assess CRT. Conventional clinical research often demands large numbers of patients, making it costly, labor-intensive, and time-consuming. We studied the interobserver agreement on CRT in a nationwide study by using a novel method of research called flash mob research (FMR). Physicians in the Netherlands were recruited by using word-of-mouth referrals, conventional media, and social media to participate in a nationwide, single-day, "nine-to-five," multicenter, cross-sectional, observational study to evaluate CRT. Patients aged ≥ 18 years presenting to the ED or who were hospitalized were eligible for inclusion. CRT was measured independently (by two investigators) at the patient's sternum and distal phalanx after application of pressure for 5 s (5s) and 15 s (15s). On October 29, 2014, a total of 458 investigators in 38 Dutch hospitals enrolled 1,734 patients. The mean CRT measured at the distal phalanx were 2.3 s (5s, SD 1.1) and 2.4 s (15s, SD 1.3). The mean CRT measured at the sternum was 2.6 s (5s, SD 1.1) and 2.7 s (15s, SD 1.1). Interobserver agreement was higher for the distal phalanx (κ value, 0.40) than for the sternum (κ value, 0.30). Interobserver agreement on CRT is, at best, moderate. CRT measured at the distal phalanx yielded higher interobserver agreement compared with sternal CRT measurements. FMR proved a valuable instrument to investigate a relatively simple clinical question in an inexpensive, quick, and reliable manner. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  6. Associations between pituitary imaging abnormalities and clinical and biochemical phenotypes in children with congenital growth hormone deficiency: data from an international observational study.

    Science.gov (United States)

    Deal, Cheri; Hasselmann, Caroline; Pfäffle, Roland W; Zimmermann, Alan G; Quigley, Charmian A; Child, Christopher J; Shavrikova, Elena P; Cutler, Gordon B; Blum, Werner F

    2013-01-01

    Magnetic resonance imaging (MRI) is used to investigate the etiology of growth hormone deficiency (GHD). This study examined relationships between MRI findings and clinical/hormonal phenotypes in children with GHD in the observational Genetics and Neuroendocrinology of Short Stature International Study, GeNeSIS. Clinical presentation, hormonal status and first-year GH response were compared between patients with pituitary imaging abnormalities (n = 1,071), patients with mutations in genes involved in pituitary development/GH secretion (n = 120) and patients with idiopathic GHD (n = 7,039). Patients with hypothalamic-pituitary abnormalities had more severe phenotypes than patients with idiopathic GHD. Additional hormonal deficiencies were found in 35% of patients with structural abnormalities (thyroid-stimulating hormone > adrenocorticotropic hormone > luteinizing hormone/follicle-stimulating hormone > antidiuretic hormone), most frequently in patients with septo-optic dysplasia (SOD). Patients with the triad [ectopic posterior pituitary (EPP), pituitary aplasia/hypoplasia and stalk defects] had a more severe phenotype and better response to GH treatment than patients with isolated abnormalities. The sex ratio was approximately equal for patients with SOD, but there was a significantly higher proportion of males (approximately 70%) in the EPP, pituitary hypoplasia, stalk defects, and triad categories. This large, international database demonstrates the value of classification of GH-deficient patients by the presence and type of hypothalamic-pituitary imaging abnormalities. This information may assist family counseling and patient management. Copyright © 2013 S. Karger AG, Basel.

  7. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice.

    Science.gov (United States)

    Hwang, You-Cheol; Kim, Ari; Jo, Euna; Yang, Yeoree; Cho, Jae-Hyoung; Lee, Byung-Wan

    2017-10-25

    Randomized clinical trials have shown the efficacy and safety of short-acting exenatide in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to investigate the effectiveness and safety of exenatide twice a day in Korean patients with T2DM who are suboptimally controlled with oral hypoglycemic agents. This study was a post hoc analysis of multi-center (71 centers), prospective, observational, single-arm, post-marketing study of short-acting exenatide 5 to 10 μg twice a day from March 2008 to March 2014 and analyzed those who finished the follow-up over 20 weeks of medication. Changes of hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and body weight values before and after exenatide treatment were analyzed. Adverse events and adverse drug reactions were estimated in patients who were treated with exenatide at least once and for whom follow-up for safety has been completed. After 20 weeks treatment with exenatide, mean HbA1c and body weight were significantly reduced from 8.4% to 7.7% and from 83.4 kg to 80.2 kg, respectively (both p levels showed an independent association with a greater reduction in glucose level. In addition, short duration of diabetes less than 5 years was an independent predictor for the improvement in glucose level. The majority of study subjects showed a reduction in both body weight and glucose level (63.3%) after exenatide treatment. In terms of safety profile, exenatide treatment was generally well-tolerated and the incidence of severe adverse event was rare (0.8%). The gastrointestinal side effects were most common and hypoglycemia was reported in 1.7% of subjects. In real clinical practice, 20 weeks treatment with short-acting exenatide was well tolerated and showed a significant body weight and glucose reduction in Korean patients with T2D who are suboptimally controlled with oral hypoglycemic agents. ClinicalTirals.gov , number NCT02090673 , registered 14 February 2008.

  8. Effect of incident nocturnal home hemodialysis versus incident continuous ambulatory peritoneal dialysis on employment rate, clinical, and laboratory outcomes: A 1-year retrospective observation study.

    Science.gov (United States)

    Li, John Wing; Wong, Joseph Ho Sing; Chak, Wai Leung; Chau, Ka Foon

    2017-10-18

    While studies demonstrated favorable outcomes of nocturnal home hemodialysis (NHHD), direct comparison on employment rate, clinical and laboratory outcomes between the NHHD and continuous ambulatory peritoneal dialysis (CAPD) had not been previously performed. A 1-year retrospective observation study was performed in 20 incidents alternate night NHHD and 81 incident CAPD patients of Chinese ethnicity, who were sex, diabetic status, and Charlson comorbidity index matched, but not age due to our center's age limit for NHHD enrollment. The primary outcome was the difference in employment rate at 1 year. Secondary outcomes included differences in clinical parameters (weight, blood pressure, number of antihypertensive medication, dosage of phosphate binders, and erythropoietin stimulating agent) and laboratory parameters (residual renal function, mineral metabolic markers, hemoglobin). NHHD subjects were 5 years younger than CAPD patients, and they had higher employment rate (80% vs. 33.3%, P < 0.01) at 1 year, with age-adjusted odds ratio for employment was 6.10 (95% confidence interval 1.77-20.99, P = 0.04). They consumed less aluminum-based phosphate binder (0 vs. 1800 mg, P < 0.01), but showed no significant disparities in other clinical parameters. Residual renal function in both groups declined comparably, nonetheless NHHD group had lower serum phosphate (1.37 vs. 1.71 mmol/L, P = 0.01) and calcium phosphate product (3.13 vs. 4.12 mmol(2) /L(2) , P < 0.01), with similar hemoglobin levels. NHHD appeared to offer higher employment rate, lower dosage of aluminum-based phosphate binder and mineral metabolic markers at 1 year compared with CAPD in Hong Kong. © 2017 International Society for Hemodialysis.

  9. Implications of Entropy and Surgical Pleth Index-guided general anaesthesia on clinical outcomes in critically ill polytrauma patients. A prospective observational non-randomized single centre study.

    Science.gov (United States)

    Rogobete, Alexandru Florin; Sandesc, Dorel; Cradigati, Carmen Alina; Sarandan, Mirela; Papurica, Marius; Popovici, Sonia Elena; Vernic, Corina; Bedreag, Ovidiu Horea

    2017-08-30

    Being highly unstable, the critically ill polytrauma patient represents a challenge for the anaesthesia team. The aim of this study was to compare the Entropy and Surgical Pleth Index (SPI)-guided general anaesthesia with standard haemodynamic monitoring methods used in the critically ill polytrauma patients and to evaluate the incidence of hemodynamic events, as well as the opioid and vasopressor demand. 72 patients were included in this prospective observational study, divided in two groups, the ESPI Group (N = 37, patients that benefited from Entropy and SPI monitoring) and the STDR Group (N = 35 patients that benefited from standard hemodynamic monitoring). In the ESPI Group general anaesthesia was modulated in order to maintain the Entropy levels between 40 and 60. Analgesia control was achieved by maintaining the SPI levels between 20 and 50. In the STDR Group hypnosis and analgesia were maintained using the standard criteria based on hemodynamic changes. ClinicalTrials.gov identifier NCT03095430. The incidence of hypotension episodes was significantly lower in the ESPI Group (N = 3), compared to the STDR Group (N = 71) (p < 0.05). Moreover, the Fentanyl demand was significantly lower in the ESPI Group (p < 0.0001, difference between means 5.000 ± 0.038, 95% confidence interval 4.9250-5.0750), as well as vasopressor medication demand (p < 0.0001, difference between means 0.960 ± 0.063, 95% confidence interval 0.8.334-1.0866). The implementation of multimodal monitoring in the critically ill polytrauma patient brings substantial benefits both to the intraoperative clinical status and to the clinical outcome of these patients by reducing the incidence of anesthesia-related complications.

  10. Patient and carer experiences of clinical uncertainty and deterioration, in the face of limited reversibility: A comparative observational study of the AMBER care bundle.

    Science.gov (United States)

    Bristowe, Katherine; Carey, Irene; Hopper, Adrian; Shouls, Susanna; Prentice, Wendy; Caulkin, Ruth; Higginson, Irene J; Koffman, Jonathan

    2015-10-01

    Clinical uncertainty is emotionally challenging for patients and carers and creates additional pressures for those clinicians in acute hospitals. The AMBER care bundle was designed to improve care for patients identified as clinically unstable, deteriorating, with limited reversibility and at risk of dying in the next 1-2 months. To examine the experience of care supported by the AMBER care bundle compared to standard care in the context of clinical uncertainty, deterioration and limited reversibility. A comparative observational mixed-methods study using semi-structured qualitative interviews and a followback survey. Three large London acute tertiary National Health Service hospitals. Nineteen interviews with 23 patients and carers (10 supported by AMBER care bundle and 9 standard care). Surveys completed by next of kin of 95 deceased patients (59 AMBER care bundle and 36 standard care). The AMBER care bundle was associated with increased frequency of discussions about prognosis between clinicians and patients (χ(2) = 4.09, p = 0.04), higher awareness of their prognosis by patients (χ(2) = 4.29, p = 0.04) and lower clarity in the information received about their condition (χ(2) = 6.26, p = 0.04). Although the consistency and quality of communication were not different between the two groups, those supported by the AMBER care bundle described more unresolved concerns about caring for someone at home. Awareness of prognosis appears to be higher among patients supported by the AMBER care bundle, but in this small study this was not translated into higher quality communication, and information was judged less easy to understand. Adequately powered comparative evaluation is urgently needed. © The Author(s) 2015.

  11. Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study.

    Science.gov (United States)

    Landmesser, Ulf; Schmidt, Boris; Nielsen-Kudsk, Jens Erik; Lam, Simon Cheung Chi; Park, Jai-Wun; Tarantini, Giuseppe; Cruz-Gonzalez, Ignacio; Geist, Volker; Della Bella, Paolo; Colombo, Antonio; Zeus, Tobias; Omran, Heyder; Piorkowski, Christopher; Lund, Juha; Tondo, Claudio; Hildick-Smith, David

    2017-09-20

    The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study. This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis. This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

  12. Mammographic breast density and risk of breast cancer in women with atypical hyperplasia: an observational cohort study from the Mayo Clinic Benign Breast Disease (BBD) cohort.

    Science.gov (United States)

    Vierkant, Robert A; Degnim, Amy C; Radisky, Derek C; Visscher, Daniel W; Heinzen, Ethan P; Frank, Ryan D; Winham, Stacey J; Frost, Marlene H; Scott, Christopher G; Jensen, Matthew R; Ghosh, Karthik; Manduca, Armando; Brandt, Kathleen R; Whaley, Dana H; Hartmann, Lynn C; Vachon, Celine M

    2017-01-31

    Atypical hyperplasia (AH) and mammographic breast density (MBD) are established risk factors for breast cancer (BC), but their joint contributions are not well understood. We examine associations of MBD and BC by histologic impression, including AH, in a subcohort of women from the Mayo Clinic Benign Breast Disease Cohort. Women with a diagnosis of BBD and mammogram between 1985 and 2001 were eligible. Histologic impression was assessed via pathology review and coded as non-proliferative disease (NP), proliferative disease without atypia (PDWA) and AH. MBD was assessed clinically using parenchymal pattern (PP) or BI-RADS criteria and categorized as low, moderate or high. Percent density (PD) was also available for a subset of women. BC and clinical information were obtained by questionnaires, medical records and the Mayo Clinic Tumor Registry. Women were followed from date of benign biopsy to BC, death or last contact. Standardized incidence ratios (SIRs) compared the observed number of BCs to expected counts. Cox regression estimated multivariate-adjusted MBD hazard ratios. Of the 6271 women included in the study, 1132 (18.0%) had low MBD, 2921 (46.6%) had moderate MBD, and 2218 (35.4%) had high MBD. A total of 3532 women (56.3%) had NP, 2269 (36.2%) had PDWA and 470 (7.5%) had AH. Over a median follow-up of 14.3 years, 528 BCs were observed. The association of MBD and BC risk differed by histologic impression (p-interaction = 0.03), such that there was a strong MBD and BC association among NP (p women were not significant within subsets defined by type of MBD measure (PP vs. BI-RADS), age at biopsy, number of foci of AH, type of AH (lobular vs. ductal) and body mass index, and after adjustment for potential confounding variables. Women with atypia who also had high PD (>50%) demonstrated marginal evidence of increased BC risk (SIR 4.98), but results were not statistically significant. We found no evidence of an association between MBD and subsequent BC

  13. Clinical and radiological observations in the spondylolysis

    Energy Technology Data Exchange (ETDEWEB)

    Sol, Chang Hyo; Kim, Dong Woon; Kim, Byung Soo [Busan National University College of Medicine, Pusan (Korea, Republic of)

    1980-06-15

    The spondylolysis is a defective ossification in the pars interarticularis of the neural arches without displacement of the vertebral body and it sometimes confuses with other spinal lesions complaining of low back pain. The authors analyzed with clinical observations in 88 cases of spondylolysis diagnosed radiologically at B.N.U.H. from January 1977 to August 1978. The results obtained as follows: 1. Among 88 cases of the spondylolysis, the highest incidence of the age was second decade in 55.7%, and the sex ratio was 4.2 to 1 in male to female. 2. The prominent symptoms were a low back pain in 71.6%, the radiating pain with the low backache in 27.3% and the paresis of low extremities in 1.2%. 3. The frequent sites of the involvement were fifth lumbar vertebra in 83.6%, fourth lumbar vertebra in 9.8%, third lumbar vertebra in 5.5%, first lumbar vertebra in 1.1% and second lumbar vertebra in zero. 4. Bilateral lesions were in 68.2% and unilateral lesion was 20.9% in the right side and 10.9% in the left. 5. The combined abnormal findings of the spine were spondylitis in 36.1%, suspicious H.N.P. in 27.8%, spondylolisthesis in 25.0%, spina bifida in 8.3% and lumbarization in 2.8% in that order. 6. The cause of spondylolysis are still uncertain, but we are experienced 9 cases (10.3%) in the definite history of the trauma.

  14. Effectiveness and safety of varenicline as an aid to smoking cessation: results of an inter-Asian observational study in real-world clinical practice.

    Science.gov (United States)

    Wang, C; Cho, B; Xiao, D; Wajsbrot, D; Park, P W

    2013-05-01

    To evaluate the effectiveness and safety of varenicline for smoking cessation among Asian adult smokers in real-world clinical practice. A multicentre, prospective, non-comparative, observational study conducted in China, India, Philippines and Korea. Adult smokers, willing to make a quit attempt, who reached a joint decision with the investigators to take varenicline received 1 mg twice daily (after 1-week titration) for 12 weeks. No exclusion criteria were specified. Effectiveness evaluations included smoking abstinence status for the 7-day period before the Week 12 visit and the last observed study visit, determined by verbal reporting using a nicotine use inventory and carbon monoxide levels if part of usual practice (end of study only). The safety profile of varenicline was also assessed. Of 1377 subjects enrolled in the study, 1373 (99.7%) received varenicline and were evaluated for safety and effectiveness. Overall, 46.4% [95% confidence interval (CI): 43.73-49.07] of subjects successfully quit smoking by the end of the treatment phase at Week 12. When analysed by country, 57.1% (95% CI: 53.55-60.65) of subjects from China, 52.8% (95% CI: 45.21-60.25) of subjects from India, 51.0% (95% CI: 36.60-65.25) of subjects from Philippines and 20.3% (95% CI: 16.29-24.73) of subjects from Korea had quit smoking at Week 12. The most commonly reported treatment-related adverse event was nausea (11.5%). This study demonstrates the effectiveness and acceptable safety profile of varenicline for smoking cessation in a real-world setting among Asian populations, with results consistent with those of varenicline randomised controlled trials. © 2013 Blackwell Publishing Ltd.

  15. Impact of omalizumab on treatment of severe allergic asthma in UK clinical practice: a UK multicentre observational study (the APEX II study).

    Science.gov (United States)

    Niven, Robert M; Saralaya, Dinesh; Chaudhuri, Rekha; Masoli, Matthew; Clifton, Ian; Mansur, Adel H; Hacking, Victoria; McLain-Smith, Susan; Menzies-Gow, Andrew

    2016-08-09

    To describe the impact of omalizumab on asthma management in patients treated as part of normal clinical practice in the UK National Health Service (NHS). A non-interventional, mixed methodology study, combining retrospective and prospective data collection for 12 months pre-omalizumab and post-omalizumab initiation, respectively. Data were collected in 22 UK NHS centres, including specialist centres and district general hospitals in the UK. 258 adult patients (aged ≥16 years; 65% women) with severe persistent allergic asthma treated with omalizumab were recruited, of whom 218 (84.5%) completed the study. The primary outcome measure was change in mean daily dose of oral corticosteroids (OCS) between the 12-month pre-omalizumab and post-omalizumab initiation periods. A priori secondary outcome measures included response to treatment, changes in OCS dosing, asthma exacerbations, lung function, employment/education, patient-reported outcomes and hospital resource utilisation. The response rate to omalizumab at 16 weeks was 82.4%. Comparing pre-omalizumab and post-omalizumab periods, the mean (95% CIs) daily dose of OCS decreased by 1.61 (-2.41 to -0.80) mg/patient/day (plung function, assessed by percentage of forced expiratory volume in 1 s, improved by 4.5 (2.7 to 6.3)% at 16 weeks (p<0.001; maintained at 12 months) and patient quality of life (Asthma Quality of Life Questionnaire) improved by 1.38 (1.18 to 1.58) points at 16 weeks (p<0.001, maintained at 12 months). 21/162 patients with complete employment data gained employment and 6 patients lost employment in the 12-month post-omalizumab period. The mean number of A&E visits, inpatient hospitalisations, outpatient visits (excluding for omalizumab) and number of bed days/patient decreased significantly (p<0.001) in the 12-month post-omalizumab period. These data support the beneficial effects of omalizumab on asthma-related outcomes, quality of life and resource utilisation in unselected

  16. Rationale, design, and cohort enrolment of a prospective observational study of the clinical performance of the new contraceptive implant (Femplant in Pakistan

    Directory of Open Access Journals (Sweden)

    Azmat SK

    2014-05-01

    Full Text Available Syed Khurram Azmat,1 Waqas Hameed,1 Anja Lendvay,2 Babar Tasneem Shaikh,3 Ghulam Mustafa,1 Muhammad Ahmed Siddiqui,1 Sajid Brohi,1 Asif Karim,1 Muhammad Ishaque,1 Wajahat Hussain,1 Mohsina Bilgrami,1 Paul J Feldblum2 1Research, Monitoring and Evaluation Department, Marie Stopes Society, Karachi, Pakistan; 2FHI 360, Durham, NC, USA; 3Health Services Academy, Islamabad, Pakistan Introduction: The use of hormonal implants has gained positive traction in family planning programs in recent times. Compared to other popular methods, such as long-term reversible intrauterine devices, the use of hormonal implants as a family planning method has distinct advantages in terms of long-term efficiency and better user compliance and availability. This paper presents a study protocol to document and evaluate the efficacy, safety, and acceptability of Femplant (contraceptive implant in Pakistan during the first year of its use among married women of reproductive age (18–44 years at clinics in two provinces of Pakistan (Sindh and Punjab. Materials and methods: A total of 724 married women were enrolled in a noncomparative prospective observational study. The study involved six government clinics from the Population Welfare Department in Sindh Province and 13 clinics run by the Marie Stopes Society (a local nongovernmental organization in both provinces. The participation of women was subject to voluntary acceptance and medical eligibility. All respondents were interviewed at baseline and subsequently at each scheduled visit during the study period. Side effects, complications and adverse events, if any, were recorded for every participant at each visit to the facility. Discussion: Over the next 5-year period (2013–2018, 27 million hormonal implants will be made available in lower- to middle-income countries by international donors and agencies. The evidence generated from this study will identify factors affecting the acceptability and satisfaction of end

  17. The presence of nonthoracic distracting injuries does not affect the initial clinical examination of the cervical spine in evaluable blunt trauma patients: a prospective observational study.

    Science.gov (United States)

    Konstantinidis, Agathoklis; Plurad, David; Barmparas, Galinos; Inaba, Kenji; Lam, Lydia; Bukur, Marko; Branco, Bernardino C; Demetriades, Demetrios

    2011-09-01

    A distracting injury mandates cervical spine (c-spine) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine. The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the standard clinical examination of the c-spine. This is a prospective observational study conducted at a Level I Trauma Center from January 1, 2008, to December 31, 2009. After institutional review board approval, all evaluable (Glasgow Coma Scale score ≥13) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled. A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed. Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management. During the study period, 101 evaluable patients sustained a c-spine injury. Distracting injuries were present in 88 patients (87.1%). The most common was rib fracture (21.6%), followed by lower extremity fracture (20.5%) and upper extremity fracture (12.5%). Only four (4.0%) patients had no pain or tenderness on the initial examination of the c-spine. All four patients had bruising and tenderness to the upper anterior chest. None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization. C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. Further definition of distracting injuries is mandated to avoid unnecessary utilization of resources and to reduce the imaging burden associated with the evaluation of the c-spine.

  18. Canine trypanosomosis: Clinical observations and morphological ...

    African Journals Online (AJOL)

    Clinical and pathological aspects of canine trypanosomosis were determined in naturally infected dogs presented to the Veterinary Teaching Hospital, Federal University of Agriculture, Abeokuta, at different times between 2012 and 2013. The breeds, sexes, ages and body weights of the dogs were recorded. Clinical signs ...

  19. First Real-World Insights into Belimumab Use and Outcomes in Routine Clinical Care of Systemic Lupus Erythematosus in Germany: Results from the OBSErve Germany Study.

    Science.gov (United States)

    Schwarting, Andreas; Schroeder, Johann O; Alexander, Tobias; Schmalzing, Marc; Fiehn, Christoph; Specker, Christof; Perna, Alessandra; Cholmakow-Bodechtel, Constanze; Koscielny, Volker B; Carnarius, Heike

    2016-12-01

    OBSErve Germany was the first observational study of belimumab as add-on treatment for systemic lupus erythematosus (SLE) in routine clinical care in Germany, retrospectively collecting data from 102 SLE patients, 6 months before and after belimumab initiation. Most patients had moderate or severe SLE and several SLE manifestations. After 6 months of belimumab treatment, 78% of patients showed an improvement in overall disease activity of at least 20% in their physician's judgment and for 42% of patients the improvement was at least 50%. Similar results were observed for the most common manifestations: arthritis, fatigue, rash, alopecia, increased anti-dsDNA antibody levels, and low complement. The SLE Disease Activity Index (SLEDAI/SELENA-SLEDAI) decreased from 10.6 to 5.6 (n = 65), with other indices also showing improvement. A notable dose reduction was seen for concomitant oral corticosteroids, from 13.7 to 7.6 mg/day overall (n = 91), and from 17.5 to 8.6 mg/day in patients with a high corticosteroid dose at belimumab initiation (≥7.5 mg; n = 63). Six patients discontinued belimumab therapy within 6 months. Overall, belimumab showed promising results for SLE patients in real-world settings. After 6 months of belimumab treatment, disease activity and corticosteroid use were reduced. The discontinuation rate was low and belimumab appeared to be well tolerated. Funding GlaxoSmithKline UK.

  20. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Children & Clinical Studies NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  2. An observation study of the clinical evaluation of symptom relief and side effects associated with taking ulipristal acetate (esmya) including its effect on pre-menstrual syndrome.

    Science.gov (United States)

    Chen, Bee F; Powell, Martin C; O'Beirne, Courtney

    2017-07-01

    This was an observational study investigating the efficacy and side effects associated with ulipristal acetate (UPA), a progesterone receptor modulator, and the possible benefits to women who have co-existing pre-menstrual syndrome (PMS). 80 women returned a questionnaire on the bleeding, menstrual pain and side effects, and changes on PMS were recorded. 67 women (84%) showed improvement in their menses. 54 women (67%) became amenorrhoeic. Of those, 67% were within 10 days of commencing UPA. Menses returned in 33 amenorrhoeic women within 4 weeks of stopping UPA. 58 women (70%) reported an improvement in their pain score but 41 women had a return of their pain after stopping UPA. The majority of the women had no or infrequent side effects. 80% had demonstrable improvement in their PMS symptoms. UPA is effective in controlling symptoms due to uterine fibroids with infrequent side effects. Our data also showed new evidence of a concurrent dramatic improvement in PMS in these women. Impact statement The observational study explored the drug profile of ulipristal acetate (UPA), a selective progesterone receptor modulator, which has been licenced as pre-treatment for surgical therapies of fibroids since 2012. We aimed to investigate the efficiency and side effects of UPA. Since the introduction of UPA in clinical practice, there has yet to be a study looking at the drug profile outside a research setting. We have also decided to investigate the effect of UPA on pre-menstrual syndrome (PMS) in this group of women with symptomatic fibroids. As such this case report should be of interest to a broad readership including those interested in the medical management of symptomatic fibroids.

  3. Post-Irradiation Bladder Syndrome After Radiotherapy of Malignant Neoplasm of Small Pelvis Organs: An Observational, Non-Interventional Clinical Study Assessing VESIcare®/Solifenacin Treatment Results.

    Science.gov (United States)

    Jaszczyński, Janusz; Kojs, Zbigniew; Stelmach, Andrzej; Wohadło, Łukasz; Łuczyńska, Elzbieta; Heinze, Sylwia; Rys, Janusz; Jakubowicz, Jerzy; Chłosta, Piotr

    2016-07-30

    BACKGROUND Radiotherapy is explicitly indicated as one of the excluding factors in diagnosing overactive bladder syndrome (OAB). Nevertheless, symptoms of OAB such as urgent episodes, incontinence, pollakiuria, and nocturia, which are consequences of irradiation, led us to test the effectiveness of VESIcare®/Solifenacin in patients demonstrating these symptoms after radiation therapy of small pelvis organs due to malignant neoplasm. MATERIAL AND METHODS We conducted an observatory clinical study including 300 consecutive patients with symptoms of post-irradiation bladder; 271 of those patients completed the study. The observation time was 6 months and consisted of 3 consecutive visits taking place at 12-week intervals. We used VESIcare® at a dose of 5 mg a day. Every sixth patient was examined urodynamically at the beginning and at the end of the observation period, with an inflow speed of 50 ml/s. RESULTS We noticed improvement and decline in the average number of episodes a day in the following parameters: number of micturitions a day (-36%, P<0.01), nocturia (-50%, P<0.01), urgent episodes (-41%, P<0.03), and episodes of incontinence (-43%, P<0.01). The patients' quality of life improved. The average maximal cystometric volume increased by 34 ml (21%, p<0.01), average bladder volume of "first desire" increased by 42 ml (49%, P<0.01), and average detrusor muscle pressure at maximal cystometric volume diminished by 9 cmH2O (-36%, P<0.03). CONCLUSIONS The substance is well-tolerated. Solifenacin administered long-term to patients with symptoms of OAB after radiotherapy of a malignant neoplasm of the small pelvis organs has a daily impact in decreasing number of urgent episodes, incontinence, pollakiuria, and nocturia.

  4. [Study of the factors motivating refusal of women to participate to a randomized clinical trial in gynecological surgery. Retrospective observational bicentric study].

    Science.gov (United States)

    Nguyen-Xuan, H-T; Thiollier, G; Ruault, O; Fauconnier, A; Lucot, J-P; Bader, G

    2016-11-01

    Randomized controlled trials (RCT) in surgery are often subject to difficulties inherent in the study design and recruitment of patients. Women's participation rate to RCTs in surgery is relatively low and varies from 30 to 70%. These recruitment problems might induce a weak scientific value and even stop the study. Thus, optimizing recruitment is a challenge for surgical research. In contemporary literature, we lack data on motivations and profile of women who refuse to participate in a RCT in surgery. To explore the potentially influential factors affecting women's decision to decline participation in PROSPERE trial, comparing laparoscopic sacrocolpopexy (LSCP) to vaginal mesh for cystocele repair. Retrospective, observational, qualitative, bicentric study conducted in the department of gynecology of Poissy and Lille hospitals. Patients included were those who refused to participate to PROSPERE trial in both centers. Factors of non-participation in the trial were recorded at the time of the first visit. A control group consisted of women who agreed to participate in the trial was also analyzed. In both centers, 139 were eligible to participate in the trial but 35 of them (25%) refused. Thirty-two women agreed to declare their refusal motivations. Vaginal mesh was finally performed in 18 (56,2%) patients and LSCP in 14 patients (43,8%). The control group consisted of 20 women, including 9 operated by vaginal mesh and 11 by LSCP. Patient's characteristics were similar in the both groups. Most influencing factor in refusal for participation was "previous choice of technique" in 50% cases (16/32), followed by "geographical remoteness and difficulties for additional visits" in 40.6% cases (13/32), and finally by "do not accept the concept of randomization" in 21.8% cases (7/32). The most influencing factor in women's acceptance was interest in helping others by "supporting medical research" in 100% cases (20/20), followed by "potential personal benefits and close

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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  7. Clinical Outcomes Following a Switch from Remicade® to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study.

    Science.gov (United States)

    Smits, Lisa J T; Derikx, Lauranne A A P; de Jong, Dirk J; Boshuizen, Ronald S; van Esch, Aura A J; Drenth, Joost P H; Hoentjen, Frank

    2016-11-01

    The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients. Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study. Primary endpoint was change in Harvey-Bradshaw Index for Crohn's disease [CD] and Simple Clinical Colitis Activity Index for ulcerative colitis [UC] at week 16. We measured C-reactive protein [CRP], faecal calprotectin [FCP], infliximab trough level [TL] and anti-drug antibodies [ADAs] and documented adverse events. Our cohort consisted of 83 patients (28 males, 57 CD, 24 UC, 2 IBD-unclassified [IBD-U]). The median age was 36 years, range 18-79. Median change in disease activity was 0 [range -23 to +7] for CD and 0 [range -3 to +6] for UC/IBD-U. Median CRP and FCP levels did not change significantly during follow-up. Median TL increased from 3.5 µg/ml [range 0-18] to 4.2 µg/ml [range 0-21] at week 16 [p = 0.010]. Two patients developed a new detectable ADA response during follow-up and five patients discontinued CT-P13. No serious adverse events occurred. We demonstrated that switching from Remicade® to CT-P13 in a real-life cohort of IBD patients did not have a significant impact on short-term clinical outcomes. These results suggest that switching from Remicade® to CT-P13 for the treatment of IBD is feasible. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  8. Can clinical observation differentiate individuals with and without scapular dyskinesis?

    Science.gov (United States)

    Miachiro, Newton Y; Camarini, Paula M F; Tucci, Helga T; McQuade, Kevin J; Oliveira, Anamaria S

    2014-01-01

    Altered scapular rotation and position have been named scapular dyskinesis. Visual dynamic assessment could be applied to classify this alteration based on the clinical observation of the winging of the inferior medial scapular border (Type I) or of the prominence of the entire medial border (Type II), or by the excessive superior translation of the scapula (Type III). The aim of this study was to determine if there were differences in scapular rotations (Type I and II) and position (Type III) between a group of subjects with scapular dyskinesis, diagnosed by the clinical observation of an expert physical therapist, using a group of healthy individuals (Type IV). Twenty-six asymptomatic subjects volunteered for this study. After a fatigue protocol for the periscapular muscles, the dynamic scapular dyskinesis tests were conducted to visually classify each scapula into one of the four categories (Type IV dyskinesis-free). The kinematic variables studied were the differences between the maximum rotational dysfunctions and the minimum value that represented both normal function and a small dysfunctional movement. Only scapular anterior tilt was significantly greater in the type I dyskinesis group (clinical observation of the posterior projection of the inferior angle of the scapula) when compared to the scapular dyskinesis-free group (p=0.037 scapular and p=0.001 sagittal plane). Clinical observation was considered appropriate only in the diagnoses of dyskinesis type I. Considering the lower prevalence and sample sizes for types II and III, further studies are necessary to validate the clinical observation as a tool to diagnose scapular dyskinesis.

  9. Course of serum amyloid A (SAA) plasma concentrations in horses undergoing surgery for injuries penetrating synovial structures, an observational clinical study.

    Science.gov (United States)

    Haltmayer, Eva; Schwendenwein, Ilse; Licka, Theresia F

    2017-05-22

    Injuries penetrating synovial structures are common in equine practice and often result in septic synovitis. Significantly increased plasma levels of serum amyloid A (SAA) have been found in various infectious conditions in horses including wounds and septic arthritis. Plasma SAA levels were found to decrease rapidly once the infectious stimulus was eliminated. The purpose of the current study was to investigate the usefulness of serial measurements of plasma SAA as a monitoring tool for the response to treatment of horses presented with injuries penetrating synovial structures. In the current study plasma SAA concentrations were measured every 48 hours (h) during the course of treatment. A total of 19 horses with a wound penetrating a synovial structure were included in the current study. Horses in Group 1 (n = 12) (injuries older than 24 h) only needed one surgical intervention. Patients in this group had significantly lower median plasma SAA levels (P = 0.001) between 48 h (median 776 mg/L) and 96 h (median 202 mg/L) after surgery. A significant decrease (P = 0.004) in plasma SAA levels was also observed between 96 h after surgery (median 270 mg/L) and 6 days (d) after surgery (median 3 mg/L). Four horses (Group 2) required more than one surgical intervention. In contrast to Group 1 patients in Group 2 had either very high initial plasma concentrations (3378 mg/L), an increase or persistently high concentrations of plasma SAA after the first surgery (median 2525 mg/L). A small group of patients (n = 3) (Group 3) were admitted less than 24 h after sustaining a wound. In this group low SAA values at admission (median 23 mg/L) and peak concentrations at 48 h after surgery (median 1016 mg/L) were observed followed by a decrease in plasma SAA concentration over time. A decrease in plasma SAA concentrations between two consecutive time points could be associated with positive response to treatment in the current study. Therefore, serial

  10. Safety of Adding Oats to a Gluten-Free Diet for Patients With Celiac Disease: Systematic Review and Meta-analysis of Clinical and Observational Studies.

    Science.gov (United States)

    Pinto-Sánchez, María Inés; Causada-Calo, Natalia; Bercik, Premysl; Ford, Alexander C; Murray, Joseph A; Armstrong, David; Semrad, Carol; Kupfer, Sonia S; Alaedini, Armin; Moayyedi, Paul; Leffler, Daniel A; Verdú, Elena F; Green, Peter

    2017-08-01

    Patients with celiac disease should maintain a gluten-free diet (GFD), excluding wheat, rye, and barley. Oats might increase the nutritional value of a GFD, but their inclusion is controversial. We performed a systematic review and meta-analysis to evaluate the safety of oats as part of a GFD in patients with celiac disease. We searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases for clinical trials and observational studies of the effects of including oats in GFD of patients with celiac disease. The studies reported patients' symptoms, results from serology tests, and findings from histologic analyses. We used the GRADE approach to assess the quality of evidence. We identified 433 studies; 28 were eligible for analysis. Of these, 6 were randomized and 2 were not randomized controlled trials comprising a total of 661 patients-the remaining studies were observational. All randomized controlled trials used pure/uncontaminated oats. Oat consumption for 12 months did not affect symptoms (standardized mean difference: reduction in symptom scores in patients who did and did not consume oats, -0.22; 95% CI, -0.56 to 0.13; P = .22), histologic scores (relative risk for histologic findings in patients who consumed oats, 0.24; 95% CI, 0.01-4.8; P = .35), intraepithelial lymphocyte counts (standardized mean difference, 0.21; 95% CI, reduction of 1.44 to increase in 1.86), or results from serologic tests. Subgroup analyses of adults vs children did not reveal differences. The overall quality of evidence was low. In a systematic review and meta-analysis, we found no evidence that addition of oats to a GFD affects symptoms, histology, immunity, or serologic features of patients with celiac disease. However, there were few studies for many endpoints, as well as limited geographic distribution and low quality of evidence. Rigorous double-blind, placebo-controlled, randomized controlled trials, using commonly available oats sourced from

  11. Food assistance is associated with improved body mass index, food security and attendance at clinic in an HIV program in central Haiti: a prospective observational cohort study

    Directory of Open Access Journals (Sweden)

    Ivers Louise C

    2010-08-01

    Full Text Available Abstract Background Few data are available to guide programmatic solutions to the overlapping problems of undernutrition and HIV infection. We evaluated the impact of food assistance on patient outcomes in a comprehensive HIV program in central Haiti in a prospective observational cohort study. Methods Adults with HIV infection were eligible for monthly food rations if they had any one of: tuberculosis, body mass index (BMI 2, CD4 cell count 3 (in the prior 3 months or severe socio-economic conditions. A total of 600 individuals (300 eligible and 300 ineligible for food assistance were interviewed before rations were distributed, at 6 months and at 12 months. Data collected included demographics, BMI and food insecurity score (range 0 - 20. Results At 6- and 12-month time-points, 488 and 340 subjects were eligible for analysis. Multivariable analysis demonstrated that at 6 months, food security significantly improved in those who received food assistance versus who did not (-3.55 vs -0.16; P Conclusions Food assistance was associated with improved food security, increased BMI, and improved adherence to clinic visits at 6 and 12 months among people living with HIV in Haiti and should be part of routine care where HIV and food insecurity overlap.

  12. Persistence and Adherence with Mirabegron versus Antimuscarinic Agents in Patients with Overactive Bladder: A Retrospective Observational Study in UK Clinical Practice.

    Science.gov (United States)

    Chapple, Christopher R; Nazir, Jameel; Hakimi, Zalmai; Bowditch, Sally; Fatoye, Francis; Guelfucci, Florent; Khemiri, Amine; Siddiqui, Emad; Wagg, Adrian

    2017-09-01

    Persistence with antimuscarinic therapy in overactive bladder (OAB) is poor, but may be different for mirabegron, a β3-adrenoceptor agonist with a different adverse event profile. To compare persistence and adherence with mirabegron versus tolterodine extended release (ER) and other antimuscarinics in routine clinical practice over a 12-mo period. Retrospective, longitudinal, observational study of anonymised data from the UK Clinical Practice Research Datalink GOLD database. Eligibility: age ≥18 yr, ≥1 prescription for target OAB drug (between May 1, 2013 and June 29, 2014), and 12-mo continuous enrolment before and after the index prescription date. Mirabegron, darifenacin, fesoterodine, flavoxate, oxybutynin ER or immediate-release (IR), propiverine, solifenacin, tolterodine ER or IR, and trospium chloride. The primary endpoint was persistence (time to discontinuation). Secondary endpoints included 12-mo persistence rates and adherence (assessed using medication possession ratio, MPR). Cox proportional-hazards regression models and logistic regression models adjusted for potential confounding factors were used to compare cohorts. Analyses were repeated after 1:1 matching. The study population included 21996 eligible patients. In the unmatched analysis, the median time-to-discontinuation was significantly longer for mirabegron (169 d, interquartile range [IQR] 41-not reached) compared to tolterodine ER (56 d, IQR 28-254; adjusted hazard ratio [HR] 1.55, 95% confidence interval 1.41-1.71; p<0.0001) and other antimuscarinics (range 30-78 d; adjusted HR range 1.24-2.26, p<0.0001 for all comparisons). The 12-mo persistence rates and MPR were also significantly greater with mirabegron than with all the antimuscarinics. Limitations include the retrospective design, use of prescription records to estimate outcomes, and inability to capture reasons for discontinuation. Persistence and adherence were statistically significantly greater with mirabegron than with

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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  14. Evidence-based obstetrics in four hospitals in China: An observational study to explore clinical practice, women's preferences and provider's views

    Directory of Open Access Journals (Sweden)

    Liang Ji

    2001-05-01

    Full Text Available Abstract Background Evidence-based obstetric care is widely promoted in developing countries, but the success of implementation is not known. Using selected childbirth care procedures in four hospitals in Shanghai, we compared practice against evidence-based information, and explored user and provider views about each procedure. Methods Observational study. Using the Cochrane Library, we identified six procedures that should be avoided as routine and two that should be encouraged. Procedure rate determined by exit interviews with women, verified using hospital notes. Views of women and providers explored with in depth interviews. The study sites were three hospitals in Shanghai and one in neighbouring province of Jiangsu. 150 women at each centre for procedure rate, and 48 in-depth interviews with women and providers. Results Vaginal births were 50% (303/599 of the total. Of the six practices where evidence suggests they should be avoided as routine, three were performed with rates above 70%: pubic shaving (3 hospitals, rectal examination (3 hospitals, and episiotomy (3 hospitals. Most women delivered lying down, pain relief was rarely given, and only in the urban district hospital did women routinely have a companion. Most women wanted support or companionship during labour and to be given pain relief; but current practice is insufficient to meet women's needs. Conclusion Obstetric practice is not following best available evidence in the hospitals studied. There is a need to adjust hospital policy to support the use of interventions proven to be of benefit to women during childbirth, and develop approaches that ensure clinical practice changes.

  15. Implementation of continuous renal replacement therapy with regional citrate anticoagulation on a surgical and trauma intensive care unit: impact on clinical and economic aspects-an observational study.

    Science.gov (United States)

    Hafner, Sebastian; Stahl, Wolfgang; Fels, Theresa; Träger, Karl; Georgieff, Michael; Wepler, Martin

    2015-01-01

    Regional citrate anticoagulation (RCA) is being increasingly used during continuous renal replacement therapy (CRRT) in intensive care units as an alternative to systemic heparin anticoagulation. However, due to its availability in a variety of solutions and dialysis systems, RCA is still considered a complex intervention, possibly leading to confusion and pitfalls in everyday practice. We therefore tested retrospectively if the introduction of RCA as a new anticoagulation strategy for CRRT was feasible and had not negatively impacted efficacy, safety, metabolic stability, filter lifetime, and cost-effectiveness compared to well-established systemic heparin. This observational, retrospective study was performed on a non-cardiac surgical and trauma intensive care unit (ICU) in a university hospital. All charts of patients receiving one of the CRRT techniques from May 2006 to April 2010 were reviewed. The first 60 consecutive patients receiving CRRT with regional citrate anticoagulation after its implementation in February 2008 (continuous veno-venous haemodialysis, Multifiltrate® with integrated CiCa® system, AV 1000 S® filter, n = 60) were included in the study. The last 50 consecutive patients with systemic heparin anticoagulation therapy (continuous veno-venous haemodiafiltration, PRISMAFLEX®, AN69® filter, n = 50), treated immediately before the introduction of RCA, were used as a historic control group. Both treatment modalities were effective in terms of uraemia control. Patients in the citrate group presented with significantly higher pH levels, lower ionized calcium levels, and higher sodium levels compared with the heparin treated group, however, without notable adverse clinical events. Interestingly, mean circuit lifetime was significantly longer in the citrate group (48.6 ± 24.2 h vs. 18.8 ± 13.5 h; p parameters, i.e. different filters, modes of dialysis, and flow parameters not having been standardized, we were unable to draw a

  16. Toxoplasmosis: A history of clinical observations.

    Science.gov (United States)

    Weiss, Louis M; Dubey, Jitender P

    2009-07-01

    It has been 100 years since Toxoplasma gondii was initially described in Tunis by Nicolle and Manceaux (1908) in the tissues of the gundi (Ctenodoactylus gundi) and in Brazil by Splendore (1908) in the tissues of a rabbit. Toxoplasma gondii is a ubiquitous, Apicomplexan parasite of warm-blooded animals that can cause several clinical syndromes including encephalitis, chorioretinitis, congenital infection and neonatal mortality. Fifteen years after the description of T. gondii by Nicolle and Manceaux a fatal case of toxoplasmosis in a child was reported by Janků. In 1939 Wolf, Cowen and Paige were the first to conclusively identify T. gondii as a cause of human disease. This review examines the clinical manifestations of infection with T. gondii and the history of the discovery of these manifestations.

  17. Direct observation of clinical practice in emergency medicine education.

    Science.gov (United States)

    Craig, Simon

    2011-01-01

    This review aims to summarize the current literature on the effects of direct, clinical observation of residents in emergency departments (EDs) on learners, patients, and departmental functioning. A systematic literature search was conducted in Medline and ERIC, covering the years 1980-2009. Keywords were used to identify postgraduate medical staff working in the ED; direct observation of these trainees by supervising staff; and reports of outcomes relating to Kirkpatrick's levels of reaction, learning, behavior, and institutional change. From an initial 11,433 abstracts and titles, 193 full-text articles were retrieved for further study. Application of inclusion and exclusion criteria yielded seven that were relevant to the topic. These studies comprised a range of methods--descriptive, qualitative evaluation, cohort studies, and a cross-sectional survey. Learner reaction was very enthusiastic. Positive changes in behavior due to feedback provided during direct observation were suggested by two studies. A single study evaluated trainee's perceptions on patient outcomes and noted that thorough assessments and improved management decisions may be at the expense of slower throughput of patients and diversion of senior staff from direct patient care. Three studies noted the resource-intensive nature of direct observation. Direct observation of clinical practice may be useful in ED education; however, further research is required to evaluate its effects. © 2010 by the Society for Academic Emergency Medicine.

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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  1. An observational European study on clinical outcomes associated with current management strategies for non-variceal upper gastrointestinal bleeding (ENERGIB-Turkey).

    Science.gov (United States)

    Mungan, Zeynel

    2012-01-01

    This observational, retrospective cohort study assessed outcomes of the current management strategies for nonvariceal upper gastrointestinal bleeding in several European countries (Belgium, Greece, Italy, Norway, Portugal, Spain, and Turkey) (NCT00797641; ENERGIB). Turkey contributed 23 sites to this study. Adult patients (≥18 years old) consecutively admitted to hospital and who underwent endoscopy for overt non-variceal upper gastrointestinal bleeding (hematemesis, melena or hematochezia, with other clinical/laboratory evidence of acute upper GI blood loss) were included in the study. Data were collected from patient medical records regarding bleeding continuation, re-bleeding, pharmacological treatment, surgery, and mortality during a 30-day follow-up period. A total of 423 patients (67.4% men; mean age: 57.8 ± 18.9 years) were enrolled in the Turkish study centers, of whom 96.2% were admitted to hospital with acute non-variceal upper gastrointestinal bleeding. At admission, the most common symptom was melena (76.1%); 28.6% of patients were taking aspirin, 19.9% were on non-steroidal anti-inflammatory drugs, and 7.3% were on proton pump inhibitors. The most common diagnoses were duodenal (45.2%) and gastric (27.7%) ulcers and gastritis/gastric erosions (26.2%). Patients were most often managed in general medical wards (45.4%). A gastrointestinal team was in charge of treatment in 64.8% of cases. Therapeutic procedures were performed in 32.4% of patients during endoscopy. After the endoscopy, most patients (94.6%) received proton pump inhibitors. Mean (SD) hospital stay was 5.36 ± 4.91 days. The cumulative proportions of continued bleeding/re-bleeding, complications and mortality within 30 days of the non-variceal upper gastrointestinal bleeding episode were 9.0%, 5.7% and 2.8%, respectively. In the Turkish sub-group of patients, the significant risk factors for bleeding continuation or re-bleeding were age >65 years, presentation with hematemesis or shock

  2. Medication safety research by observational study design.

    Science.gov (United States)

    Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

    2016-06-01

    Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

  3. A Prospective, Observational Study to Determine the Prevalence and Clinical Profile of Patients of Hypertensive Crisis in a Tertiary Care Hospital.

    Science.gov (United States)

    Salagre, Santosh B; Itolikar, Shobha M; Gedam, Kapil

    2017-06-01

    Hypertension can present in crisis form as 'hypertensive urgency'(HU) or as 'hypertensive emergency' (HE). Both the conditions are associated with significant morbidity and mortality. To evaluate the clinical characteristics, course of illness, end-organ damage and survival outcome in patients with hypertensive crisis. This prospective observational year-long study was conducted after due ethical considerations on 120 adult non-pregnant patients who presented with blood pressure of >180/120 mm Hg in the emergency medical services of a tertiary care hospital. The available data was statistically analyzed using the t-test for continuous variables and chi-square test for categorical variables. Sixty two (51.67%) patients presented with hypertensive urgency and fifty eight (48.33%) with hypertensive emergency. Together they constituted 0.59% of total medical admissions and 18.04% of ICU admissions. Mean age of patients was 48.34 years and 52.48 years in HU and HE groups respectively. Headache (49.2%) and giddiness (43.3%) were the common presenting symptoms. Focal neurological deficit (p=0.001), psychomotor agitation (p=0.024), visual disturbances (p=0.048), oliguria (p=0.036) were noted significantly in patients with HE. Systolic and diastolic blood pressures were significantly elevated (p=0.001) in HE as compared to HU. Circadian peaks were noted between 2pm - 4 pm followed by 2am - 4 am and circannual peaks were noted in hot and humid months of May and October. Occurrence of HE was significantly linked with male gender (p=0.037), alcoholism (phypertensive emergencies (p=0.021), smoking (p=0.05), dyslipidemia(p=0.002), diabetes mellitus(p=0.003), cardiovascular (p=0.002) and cerebrovascular involvement(p=0.015). This study showcases the characteristic features of hypertensive crises in Indian subjects, thus allowing us a better understanding of the natural history of this medical emergency.

  4. Quantifying the clinical relevance of a laboratory observer performance paradigm.

    Science.gov (United States)

    Chakraborty, D P; Haygood, T M; Ryan, J; Marom, E M; Evanoff, M; McEntee, M F; Brennan, P C

    2012-09-01

    Laboratory observer performance measurements, receiver operating characteristic (ROC) and free-response ROC (FROC) differ from actual clinical interpretations in several respects, which could compromise their clinical relevance. The objective of this study was to develop a method for quantifying the clinical relevance of a laboratory paradigm and apply it to compare the ROC and FROC paradigms in a nodule detection task. The original prospective interpretations of 80 digital chest radiographs were classified by the truth panel as correct (C=1) or incorrect (C=0), depending on correlation with additional imaging, and the average of C was interpreted as the clinical figure of merit. FROC data were acquired for 21 radiologists and ROC data were inferred using the highest ratings. The areas under the ROC and alternative FROC curves were used as laboratory figures of merit. Bootstrap analysis was conducted to estimate conventional agreement measures between laboratory and clinical figures of merit. Also computed was a pseudovalue-based image-level correctness measure of the laboratory interpretations, whose association with C as measured by the area (rAUC) under an appropriately defined relevance ROC curve, is as a measure of the clinical relevance of a laboratory paradigm. Low correlations (e.g. κ=0.244) and near chance level rAUC values (e.g. 0.598), attributable to differences between the clinical and laboratory paradigms, were observed. The absolute width of the confidence interval was 0.38 for the interparadigm differences of the conventional measures and 0.14 for the difference of the rAUCs. The rAUC measure was consistent with the traditional measures but was more sensitive to the differences in clinical relevance. A new relevance ROC method for quantifying the clinical relevance of a laboratory paradigm is proposed.

  5. Validation of a clinical screening instrument for tumour predisposition syndromes in patients with childhood cancer (TuPS): protocol for a prospective, observational, multicentre study.

    Science.gov (United States)

    Postema, Floor A M; Hopman, Saskia M J; de Borgie, Corianne A J M; Hammond, Peter; Hennekam, Raoul C; Merks, Johannes H M; Aalfs, Cora M; Anninga, Jakob K; Berger, Lieke Pv; Bleeker, Fonnet E; de Bont, Eveline Sjm; de Borgie, Corianne Ajm; Dommering, Charlotte J; van Eijkelenburg, Natasha Ka; Hammond, Peter; Hennekam, Raoul C; van den Heuvel-Eibrink, Marry M; Hopman, Saskia Mj; Jongmans, Marjolijn Cj; Kors, Wijnanda A; Letteboer, Tom Gw; Loeffen, Jan Lcm; Merks, Johannes Hm; Olderode-Berends, Maran Jw; Postema, Floor Am; Wagner, Anja

    2017-01-20

    Recognising a tumour predisposition syndrome (TPS) in patients with childhood cancer is of significant clinical relevance, as it affects treatment, prognosis and facilitates genetic counselling. Previous studies revealed that only half of the known TPSs are recognised during standard paediatric cancer care. In current medical practice it is impossible to refer every patient with childhood cancer to a clinical geneticist, due to limited capacity for routine genetic consultation. Therefore, we have developed a screening instrument to identify patients with childhood cancer with a high probability of having a TPS. The aim of this study is to validate the clinical screening instrument for TPS in patients with childhood cancer. This study is a prospective nationwide cohort study including all newly diagnosed patients with childhood cancer in the Netherlands. The screening instrument consists of a checklist, two- and three-dimensional photographic series of the patient. 2 independent clinical geneticists will assess the content of the screening instrument. If a TPS is suspected based on the instrument data and thus further evaluation is indicated, the patient will be invited for full genetic consultation. A negative control group consists of 20% of the patients in whom a TPS is not suspected based on the instrument; they will be randomly invited for full genetic consultation. Primary outcome measurement will be sensitivity of the instrument. The Medical Ethical Committee of the Academic Medical Centre stated that the Medical Research Involving Human Subjects Act does not apply to this study and that official approval of this study by the Committee was not required. The results will be offered for publication in peer-reviewed journals and presented at International Conferences on Oncology and Clinical Genetics. The clinical data gathered in this study will be available for all participating centres. NTR5605. Published by the BMJ Publishing Group Limited. For permission to

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  7. Analysis of the relationship between periodontal disease and atherosclerosis within a local clinical system: a cross-sectional observational pilot study.

    Science.gov (United States)

    Kudo, Chieko; Shin, Wee Soo; Minabe, Masato; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Sasaki, Nobuhiro; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Maeda, Hiroshi; Takashiba, Shogo

    2015-09-01

    It has been revealed that atherosclerosis and periodontal disease may have a common mechanism of "chronic inflammation". Several reports have indicated that periodontal infection is related to atherosclerosis, but none have yet reported such an investigation through the cooperation of local clinics. This study was performed in local Japanese clinics to examine the relationship between periodontal disease and atherosclerosis under collaborative medical and dental care. A pilot multicenter cross-sectional study was conducted on 37 medical patients with lifestyle-related diseases under consultation in participating medical clinics, and 79 periodontal patients not undergoing medical treatment but who were seen by participating dental clinics. Systemic examination and periodontal examination were performed at baseline, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed. There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis. Plasma IgG titer to Porphyromonas gingivalis may be useful as the clinical risk marker for atherosclerosis related to periodontal disease. Moreover, the application of the blood examination as a medical check may lead to the development of collaborative medical and dental care within the local medical clinical system for the purpose of preventing the lifestyle-related disease.

  8. Three-Vessel Assessment of Coronary Microvascular Dysfunction in Patients With Clinical Suspicion of Ischemia: Prospective Observational Study With the Index of Microcirculatory Resistance.

    Science.gov (United States)

    Kobayashi, Yuhei; Lee, Joo Myung; Fearon, William F; Lee, Jang Hoon; Nishi, Takeshi; Choi, Dong-Hyun; Zimmermann, Frederik M; Jung, Ji-Hyun; Lee, Hyun-Jung; Doh, Joon-Hyung; Nam, Chang-Wook; Shin, Eun-Seok; Koo, Bon-Kwon

    2017-11-01

    Difficulty directly visualizing the coronary microvasculature as opposed to the epicardial coronary artery makes its assessment challenging. The goal of this study is to measure the index of microcirculatory resistance (IMR) in all 3 major coronary vessels to identify the clinical and angiographic predictors of an abnormal IMR. Ninety-three patients who underwent coronary physiological assessment in all 3 major coronary vessels were prospectively enrolled (59.8±9.4 years with 77.4% men). IMR was corrected using Yong's formula and coronary microvascular dysfunction (CMD) was defined using vessel-specific cutoffs. A global IMR was calculated as the sum of the IMR in all 3 major epicardial vessels. Angiographic epicardial disease severity was assessed with vessel-specific and overall SYNTAX score. Median IMR and fractional flow reserve was 17.2 (Q1-Q3: 13.3-22.9) and 0.92 (0.85-0.97). The majority of patients (59.1%) had no CMD, 23.7% had 1-vessel CMD, 14.0% had 2-vessel CMD, and 3.2% had 3-vessel CMD. CMD was observed at a similar rate in the territories supplied by all 3 major coronary vessels (left anterior descending coronary artery 28.0%, left circumflex artery 19.4%, and right coronary artery 23.7%; P =0.39). Fractional flow reserve had a weak, positive correlation with IMR (ρ=0.16; P CMD. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01621438. © 2017 American Heart Association, Inc.

  9. Prevention of poststroke cognitive decline: ASPIS--a multicenter, randomized, observer-blind, parallel group clinical trial to evaluate multiple lifestyle interventions--study design and baseline characteristics.

    Science.gov (United States)

    Brainin, Michael; Matz, Karl; Nemec, Matthias; Teuschl, Yvonne; Dachenhausen, Alexandra; Asenbaum-Nan, Susanne; Bancher, Christian; Kepplinger, Berthold; Oberndorfer, Stefan; Pinter, Michaela; Schnider, Peter; Tuomilehto, Jaakko

    2015-06-01

    Cognitive impairment after stroke is a considerable burden to patients and their caregivers and occurs in one-third of stroke survivors. No strategy to prevent cognitive decline after stroke exists thus far. Established vascular risk factors have been associated with cognitive decline and may be a target for therapeutic interventions in stroke survivors. To test whether intensive multifactorial non-pharmacologic interventions based on lifestyle modification can reduce the risk of cognitive decline in patients who recently suffered ischemic stroke. A randomized, controlled, multicenter, observer-blind trial was designed. The reference group obtains stroke care according to standard guidelines. The intervention group additionally receives intensive control and motivation for better compliance with prescribed evidence-based medication, regular blood pressure measurements, healthy diet, regular physical activity and cognitive training. Primary outcomes are the rate of cognitive decline at 24 months, assessed by a neuropsychological test battery and the cognitive subscale of the Alzheimer's Disease Assessment Scale. 202 patients (29% women), aged 62 ± 9 years, were recruited during 2010 to 2012. Stroke related impairment at inclusion was low (mean National Institutes of Health Stroke Scale: 1.9±1.8, median modified Rankin Scale: 1 (0-1)). At baseline, groups did not differ significantly in demographic, clinical or lifestyle characteristics. The recruitment was successful and the groups are balanced regarding potential confounding variables. The study will provide essential data about the feasibility and efficacy of lifestyle intervention after stroke in order to develop a new approach to prevent cognitive decline in patients with mild ischemic stroke. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  10. Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

    Science.gov (United States)

    Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

    2017-12-22

    The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Trials Clinical Trial Websites Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and ...

  12. Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human-Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans.

    Science.gov (United States)

    Goda, Keisuke; Kobayashi, Akio; Takahashi, Akemi; Takahashi, Tadakazu; Saito, Kosuke; Maekawa, Keiko; Saito, Yoshiro; Sugai, Shoichiro

    2017-04-12

    In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury (DILI) in humans. We conducted in vivo and in vitro exploratory studies for this purpose. In vivo lipidomics analysis was conducted to investigate the relationships between alteration of the hepatic lipids and mitochondrial dysfunction. In the liver of rats treated with compound X, triglycerides containing long-chain fatty acids, which are the main energy source of the mitochondria, accumulated. Accumulation of these triglycerides was considered to be related to the inhibition of mitochondrial respiration based on the results of in vitro mitochondria toxicity studies. In conclusion, fatty change of the hepatocytes (steatosis) in non-clinical toxicity studies of drug candidates can be regarded as a critical finding for the estimation of their potential risk to induce DILI in humans when the fatty change is induced by mitochondrial dysfunction.

  13. Direct observation and focused feedback for clinical skills training.

    Science.gov (United States)

    Singh, Tejinder; Kundra, Shaveta; Gupta, Piyush

    2014-09-01

    Direct observation of the medical trainee by an expert assessor and providing authentic feedback is considered an important tool for development of clinical and procedural skills. Mini-clinical evaluation exercise and Direct Observation of Procedural Skills are two important tools to observe the trainee during a clinical encounter or during a procedure, make an expert standardized (though subjective) observation, and use it to provide developmental feedback. Both can be easily integrated into routine work of clinical departments, and both provide a reliable assessment if 6-8 such encounters are used.

  14. Outbreak of brainstem encephalitis associated with enterovirus-A71 in Catalonia, Spain (2016): a clinical observational study in a children's reference centre in Catalonia.

    Science.gov (United States)

    Casas-Alba, D; de Sevilla, M F; Valero-Rello, A; Fortuny, C; García-García, J-J; Ortez, C; Muchart, J; Armangué, T; Jordan, I; Luaces, C; Barrabeig, I; González-Sanz, R; Cabrerizo, M; Muñoz-Almagro, C; Launes, C

    2017-11-01

    To describe the characteristics of an outbreak of brainstem encephalitis and encephalomyelitis related to enterovirus (EV) infection in Catalonia (Spain), a setting in which these manifestations were uncommon. Clinical and microbiological data were analysed from patients with neurological symptoms associated with EV detection admitted to a reference paediatric hospital between April and June 2016. Fifty-seven patients were included. Median age was 27.7 months (p25-p75 17.1-37.6). Forty-one (72%) were diagnosed with brainstem encephalitis, seven (12%) with aseptic meningitis, six (11%) with encephalitis, and three (5%) with encephalomyelitis (two out of three with cardiopulmonary failure). Fever, lethargy, and myoclonic jerks were the most common symptoms. Age younger than 12 months, higher white-blood-cell count, and higher procalcitonin levels were associated with cardiopulmonary failure. Using a PAN-EV real-time PCR, EV was detected in faeces and/or nasopharyngeal aspirate in all the patients, but it was found in cerebrospinal fluid only in patients with aseptic meningitis. EV was genotyped in 47 out of 57 and EV-A71 was identified in 40 out of 47, being the only EV type found in patients with brainstem symptoms. Most of the detected EV-A71 strains were subgenogroup C1. Intravenous immunoglobulins were used in 34 patients. Eight cases (14%) were admitted to the intensive care unit. All the patients but three, those with encephalomyelitis, showed a good clinical course and had no significant sequelae. No deaths occurred. The 2016 outbreak of brainstem encephalitis in Catalonia was associated with EV-A71 subgenogroup C1. Despite the clinical manifestations of serious disease, a favourable outcome was observed in the majority of patients. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or device is ... Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or device is ...

  16. New analysis tools for observational studies.

    Science.gov (United States)

    Landewé, R B M

    2015-03-01

    Observational studies, which are very common in rheumatology, usually follow a selected group of patients for a predetermined period of time, or infinitely, with regard to a certain outcome. Such an outcome could be a "score" reflecting an important aspect of the disease (e.g., a disease activity score), or an "event" (e.g., myocardial infarction). Rather than investigating the efficacy of a particular treatment, observational studies serve to investigate clinical associations between different (outcome) variables. Confounding, which may spuriously inflate or reduce the magnitude of a particular association, is an inherent risk in observational studies. The modern analytical approach of an observational study depends on the study question, the study design, and on how the outcome of interest has been assessed. The current article discusses several aspects of the analytical approach and requirements of the database. The focus is on longitudinal analysis, subgroup analysis, and adjustment for confounding. It is concluded that the appropriate analysis of an observational study should be a close collaboration between the clinical researcher with sufficient epidemiological knowledge and the expert statistician with sufficient interest in clinical questions.

  17. Comparison of the ultra-low-dose Veo algorithm with the gold standard filtered back projection for detecting pulmonary asbestos-related conditions: a clinical observational study.

    Science.gov (United States)

    Tekath, Marielle; Dutheil, Frédéric; Bellini, Romain; Roche, Antoine; Pereira, Bruno; Naughton, Geraldine; Chamoux, Alain; Michel, Jean-Luc

    2014-05-30

    Radiation delivered during CT is a major concern, especially for individuals undergoing repeated screening. We aimed to compare a new ultra-low-dose algorithm called Veo with the gold standard filtered back projection (FBP) for detecting pulmonary asbestos-related conditions. University Hospital CHU G. Montpied, Clermont-Ferrand, France Asbestos-exposed workers were recruited following referral to screening for asbestos-related conditions. Two acquisitions were performed on a 64-slice CT: the gold standard FBP followed by Veo reconstruction. Two radiologists independently assessed asbestos-related abnormalities, pulmonary nodules, radiation doses and image quality (noise). We included 27 asbestos-exposed workers (63.3±6.5 years with 11.9±9.7 years of asbestos exposure). We observed 297 pleural plaques in 20 participants (74%). All patients (100%) had pulmonary nodules, totalling 167 nodules. Detection rates did not differ for pleural plaques (Veo 87% vs FBP 97%, NS), pleural thickening (100% for both) and pulmonary nodules (80% for both). Interstitial abnormalities were depicted less frequently with Veo than FBP. False negative and false positive did not exceed 2.7%. Compared with FBP, Veo decreased the radiation dose up to 87% (Veo 0.23±0.07 vs FBP 1.83±0.88 mSv, p<0.001). The objective image noise also decreased with Veo as much as 23% and signal-to-noise ratio increased up to 33%. A low-dose CT with Veo reconstruction substantially reduced radiation. Veo compared favourably with FBP in detecting pleural plaques, pleural thickening and pulmonary nodules. These results should be confirmed on a larger sample size before the use of Veo in clinical routine practice in asbestos-related conditions, especially regarding the low prevalence of interstitial abnormalities in this study. NCT01955018. 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.

  18. A single center observational study on emergency department clinician non-adherence to clinical practice guidelines for treatment of uncomplicated urinary tract infections.

    Science.gov (United States)

    Zatorski, Catherine; Zocchi, Mark; Cosgrove, Sara E; Rand, Cynthia; Brooks, Gillian; May, Larissa

    2016-11-04

    The Emergency Department (ED) is a frequent site of antibiotic use; poor adherence with evidence-based guidelines and broad-spectrum antibiotic overuse is common. Our objective was to determine rates and predictors of inappropriate antimicrobial use in patients with uncomplicated urinary tract infections (UTI) compared to the 2010 International Clinical Practice Guidelines (ICPG). A single center, prospective, observational study of patients with uncomplicated UTI presenting to an urban ED between September 2012 and February 2014 that examined ED physician adherence to ICPG when treating uncomplicated UTIs. Clinician-directed antibiotic treatment was compared to the ICPG using a standardized case definition for non-adherence. Binomial confidence intervals and student's t-tests were performed to evaluate differences in demographic characteristics and management between patients with pyelonephritis versus cystitis. Regression models were used to analyze the significance of various predictors to non-adherent treatment. 103 cases met the inclusion and exclusion criteria, with 63.1 % receiving non-adherent treatment, most commonly use of a fluoroquinolone (FQ) in cases with cystitis (97.6 %). In cases with pyelonephritis, inappropriate antibiotic choice (39.1 %) and no initial IV antibiotic for pyelonephritis (39.1 %) where recommended were the most common characterizations of non-adherence. Overall, cases of cystitis were no more/less likely to receive non-adherent treatment than cases of pyelonephritis (OR 0.9, 95 % confidence interval 0.4-2.2, P = 0.90). In multivariable analysis, patients more likely to receive non-adherent treatment included those without a recent history of a UTI (OR 3.8, 95 % CI 1.3-11.4, P = 0.02) and cystitis cases with back or abdominal pain only (OR 11.4, 95 % CI 2.1-63.0, P = 0.01). Patients with cystitis with back or abdominal pain only were most likely to receive non-adherent treatment, potentially suggesting diagnostic

  19. Evaluation of functional rehabilitation physiotherapy protocol in the postoperative patients with anterior cruciate ligament reconstruction through clinical prognosis: an observational prospective study.

    Science.gov (United States)

    do Carmo Almeida, Tabata Cristina; de Alcantara Sousa, Luiz Vinicius; de Melo Lucena, Diego Monteiro; Dos Santos Figueiredo, Francisco Winter; Valenti, Vitor Engrácia; da Silva Paiva, Laércio; de Abreu, Luiz Carlos; Adami, Fernando

    2016-09-23

    The aim of the study was to evaluate the evolution of patients subject to physical treatment based on guidelines of functional rehabilitation after surgery anterior cruciate ligament reconstruction. This is a prospective study of 177 patients with anterior cruciate ligament injury, who underwent surgery and physical therapy guideline conducted in an orthopedic clinic in São Paulo, southeastern Brazil. The clinical evolution of patients was made according to Lysholm and IKDC questionnaire on the 1st day after surgery with 30, 90 and 180 days of treatment. There was statistically significant increase in the gross values of Lysholm and IKDC questionnaires during the treatment (p postoperative anterior cruciate ligament.

  20. Is social support associated with improved clinical outcomes in geriatric lung cancer patients? Observations from North Central Cancer Treatment Group Studies N9921 and N0222

    OpenAIRE

    Jatoi, Aminah; Hillman, Shauna L; Ziegler, Katie L Allen; Stella, Philip J.; Soori, Gamini S.; Rowland, Kendrith M.

    2009-01-01

    Background: Social support is defined as a network of family/friends who provide practical and emotional help. A sizable literature describes a direct relationship between social support and improved cancer clinical outcomes. This study explored the extent of social support and its potential association with survival and adverse events in geriatric lung cancer patients. Methods: One hundred thirteen patients, who were aged 65 years or older, had incurable cancer, and were enrolled in one of t...

  1. Excess Mortality in Patients with Multiple Sclerosis Starts at 20 Years from Clinical Onset: Data from a Large-Scale French Observational Study

    OpenAIRE

    Emmanuelle Leray; Sandra Vukusic; Marc Debouverie; Michel Clanet; Bruno Brochet; Jérôme de Sèze; Hélène Zéphir; Gilles Defer; Christine Lebrun-Frenay; Thibault Moreau; Pierre Clavelou; Jean Pelletier; Eric Berger; Philippe Cabre; Jean-Philippe Camdessanché

    2015-01-01

    International audience; Background :Recent studies in multiple sclerosis (MS) showed longer survival times from clinical onset than older hospital-based series. However estimated median time ranges widely, from 24 to 45 years, which makes huge difference for patients as this neurological disease mainly starts around age 20 to 40. Precise and up-to-date reference data about mortality in MS are crucial for patients and neurologists, but unavailable yet in France. Objectives :Estimate survival i...

  2. A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study

    Directory of Open Access Journals (Sweden)

    Sergio Pagliarini

    2014-01-01

    Full Text Available Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC in effect during the study. Key outcome measures were incidence of selected adverse events (AEs, treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%–1.9%. Patients received 6.2 (mean injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, –1.3 letters may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated.

  3. Clinical Manifestations and Myositis-Specific Autoantibodies Associated with Physical Dysfunction after Treatment in Polymyositis and Dermatomyositis: An Observational Study of Physical Dysfunction with Myositis in Japan

    Directory of Open Access Journals (Sweden)

    Hidenaga Kawasumi

    2016-01-01

    Full Text Available Objective. The physical function of PM/DM patients after remission induction therapy remains unknown adequately. The aim of our study was to evaluate the present status of physical dysfunction and to clarify the clinical manifestations and myositis-specific autoantibodies (MSAs associated with physical dysfunction after treatment in PM/DM. Methods. We obtained clinical data including the age at disease onset, gender, disease duration, laboratory data prior to initial treatment, and the specific treatment administered. We evaluated disease activity and physical dysfunction after treatment using the core set provided by the International Myositis Assessment and Clinical Studies Group. Results. 57% of the 77 enrolled patients with PM/DM had troubles in daily living after treatment. At the enrolment, disease activity evaluated by physicians was only revealed in 20% of patients. In a multivariate analysis, the age at disease onset, female gender, and CK levels before treatment were significantly associated with the severity of physical dysfunction after treatment. Anti-SRP positivity was associated with more severe physical dysfunction after treatment than anti-ARS or anti-MDA5. Conclusions. Half of the PM/DM patients showed physical dysfunction after treatment. Age at disease onset, gender, CK level before treatment, and anti-SRP were significant predictors associated with physical dysfunction after treatment in PM/DM.

  4. A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients

    NARCIS (Netherlands)

    Tijssen, M.P.W.; Cingel, R.E. van; Visser, E de; Nijhuis-Van der Sanden, M.W.G.

    2016-01-01

    OBJECTIVES: To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. DESIGN: Observational cohort study. SETTING: Sports medical center. PARTICIPANTS: 37 recreational athletes (21

  5. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

    Science.gov (United States)

    Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

    2014-04-01

    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

  6. Robot-assisted end-effector-based gait training in chronic stroke patients: A multicentric uncontrolled observational retrospective clinical study.

    Science.gov (United States)

    Mazzoleni, Stefano; Focacci, Antonella; Franceschini, Marco; Waldner, Andreas; Spagnuolo, Chiara; Battini, Elena; Bonaiuti, Donatella

    2017-01-01

    Until now studies report inconclusive results as regards the effectiveness of exclusive use of robot-assisted training and clinical indications in stroke patients. To evaluate if the only robot-assisted end-effector-based gait training can be feasible in chronic stroke subjects in terms of gait recovery. Five rehabilitation centers participated and one hundred chronic post-stroke patients were recruited. Patients underwent a robot-assisted end-effector-based gait training as only rehabilitation treatment.6 Minute Walk Test, 10 Meter Walk Test, Timed Up and Go test, Modified Ashworth Scale, Motricity Index, Functional Ambulation Classification (FAC) and Walking Handicap Scale were used as outcome clinical measure. Patients were divided into two groups: those assessed as FAC robot-assisted end-effector-based gait training showed significant improvements in global motor performances, gait endurance, balance and coordination, lower limbs strength and even spasticity.

  7. A comparative clinical study of the efficacy of subepithelial connective tissue graft and acellular dermal matrix graft in root coverage: 6-month follow-up observation.

    Science.gov (United States)

    Thomas, Libby John; Emmadi, Pamela; Thyagarajan, Ramakrishnan; Namasivayam, Ambalavanan

    2013-07-01

    The purpose of this study was to compare the clinical efficacy of subepithelial connective tissue graft and acellular dermal matrix graft associated with coronally repositioned flap in the treatment of Miller's class I and II gingival recession, 6 months postoperatively. Ten patients with bilateral Miller's class I or class II gingival recession were randomly divided into two groups using a split-mouth study design. Group I (10 sites) was treated with subepithelial connective tissue graft along with coronally repositioned flap and Group II (10 sites) treated with acellular dermal matrix graft along with coronally repositioned flap. Clinical parameters like recession height and width, probing pocket depth, clinical attachment level, and width of keratinized gingiva were evaluated at baseline, 90(th) day, and 180(th) day for both groups. The percentage of root coverage was calculated based on the comparison of the recession height from 0 to 180(th) day in both Groups I and II. Intragroup parameters at different time points were measured using the Wilcoxon signed rank test and Mann-Whitney U test was employed to analyze the differences between test and control groups. There was no statistically significant difference in recession height and width, gain in CAL, and increase in the width of keratinized gingiva between the two groups on the 180(th) day. Both procedures showed clinically and statistically significant root coverage (Group I 96%, Group II 89.1%) on the 180(th) day. The results indicate that coverage of denuded root with both subepithelial connective tissue autograft and acellular dermal matrix allograft are very predictable procedures, which were stable for 6 months postoperatively.

  8. Potatoes and risk of obesity, type 2 diabetes, and cardiovascular disease in apparently healthy adults: a systematic review of clinical intervention and observational studies.

    Science.gov (United States)

    Borch, Daniel; Juul-Hindsgaul, Nicole; Veller, Mette; Astrup, Arne; Jaskolowski, Jörn; Raben, Anne

    2016-08-01

    Potatoes have been related to increased risks of obesity, type 2 diabetes (T2D), and cardiovascular disease (CVD) mainly because of their high glycemic index. We conducted a systematic review to evaluate the relation between intake of potatoes and risks of obesity, T2D, and CVD in apparently healthy adults. MEDLINE, Embase, the Web of Science, and the Cochrane Central Register of Controlled Trials were searched for intervention and prospective observational studies that investigated adults without any known illnesses at baseline, recorded intake of potatoes, and measured adiposity (body weight, body mass index, or waist circumference), cases of T2D, cases of cardiovascular events, or risk markers thereof. In total, 13 studies were deemed eligible; 5 studies were related to obesity, 7 studies were related to T2D, and one study was related to CVD. Only observational studies were identified; there were 3 studies with moderate, 9 studies with serious, and one study with critical risk of bias. The association between potatoes (not including french fries) and adiposity was neutral in 2 studies and was positive in 2 studies. French fries were positively associated with adiposity in 3 of 3 studies. For T2D, 2 studies showed a positive association, whereas 5 studies showed no or a negative association with intake of potatoes and T2D. French fries were positively associated with T2D in 3 of 3 studies that distinguished this relation. For CVD, no association was observed. The identified studies do not provide convincing evidence to suggest an association between intake of potatoes and risks of obesity, T2D, or CVD. French fries may be associated with increased risks of obesity and T2D although confounding may be present. In this systematic review, only observational studies were identified. These findings underline the need for long-term randomized controlled trials. This trial was registered at the PROSPERO International prospective register of systematic reviews (www

  9. Clinical Nursing Records Study

    Science.gov (United States)

    1991-08-01

    effectiveness codes can be used for all controlled substances as well as PRN medications other than controlled substances, e.g., milk of magnesia...7C 270 7.,TAL 1 C,.. .C 1c((.C Uht [- IF MISSING UBSF’VATILNS 576 1-26 Table 27 CLINICAL NURSING RECORDS STUDY "OVERPRINTING THE NURSING DIAGNOSES ONTO

  10. Mediterranean diet or extended fasting's influence on changing the intestinal microflora, immunoglobulin A secretion and clinical outcome in patients with rheumatoid arthritis and fibromyalgia: an observational study

    Directory of Open Access Journals (Sweden)

    Schwickert Myriam

    2005-12-01

    Full Text Available Abstract Background Alterations in the intestinal bacterial flora are believed to be contributing factors to many chronic inflammatory and degenerative diseases including rheumatic diseases. While microbiological fecal culture analysis is now increasingly used, little is known about the relationship of changes in intestinal flora, dietary patterns and clinical outcome in specific diseases. To clarify the role of microbiological culture analysis we aimed to evaluate whether in patients with rheumatoid arthritis (RA or fibromyalgia (FM a Mediterranean diet or an 8-day fasting period are associated with changes in fecal flora and whether changes in fecal flora are associated with clinical outcome. Methods During a two-months-period 51 consecutive patients from an Integrative Medicine hospital department with an established diagnosis of RA (n = 16 or FM (n = 35 were included in the study. According to predefined clinical criteria and the subjects' choice the patients received a mostly vegetarian Mediterranean diet (n = 21; mean age 50.9 +/-13.3 y or participated in an intermittent modified 8-day fasting therapy (n = 30; mean age 53.7 +/- 9.4 y. Quantitative aerob and anaerob bacterial flora, stool pH and concentrations of secretory immunoglobulin A (sIgA were analysed from stool samples at the beginning, at the end of the 2-week hospital stay and at a 3-months follow-up. Clinical outcome was assessed with the DAS 28 for RA patients and with a disease severity rating scale in FM patients. Results We found no significant changes in the fecal bacterial counts following the two dietary interventions within and between groups, nor were significant differences found in the analysis of sIgA and stool ph. Clinical improvement at the end of the hospital stay tended to be greater in fasting vs. non-fasting patients with RA (p = 0.09. Clinical outcome was not related to alterations in the intestinal flora. Conclusion Neither Mediterranean diet nor fasting

  11. To what extent does the Health Professions Admission Test-Ireland predict performance in early undergraduate tests of communication and clinical skills? An observational cohort study.

    Science.gov (United States)

    Kelly, Maureen E; Regan, Daniel; Dunne, Fidelma; Henn, Patrick; Newell, John; O'Flynn, Siun

    2013-05-10

    Internationally, tests of general mental ability are used in the selection of medical students. Examples include the Medical College Admission Test, Undergraduate Medicine and Health Sciences Admission Test and the UK Clinical Aptitude Test. The most widely used measure of their efficacy is predictive validity.A new tool, the Health Professions Admission Test- Ireland (HPAT-Ireland), was introduced in 2009. Traditionally, selection to Irish undergraduate medical schools relied on academic achievement. Since 2009, Irish and EU applicants are selected on a combination of their secondary school academic record (measured predominately by the Leaving Certificate Examination) and HPAT-Ireland score. This is the first study to report on the predictive validity of the HPAT-Ireland for early undergraduate assessments of communication and clinical skills. Students enrolled at two Irish medical schools in 2009 were followed up for two years. Data collected were gender, HPAT-Ireland total and subsection scores; Leaving Certificate Examination plus HPAT-Ireland combined score, Year 1 Objective Structured Clinical Examination (OSCE) scores (Total score, communication and clinical subtest scores), Year 1 Multiple Choice Questions and Year 2 OSCE and subset scores. We report descriptive statistics, Pearson correlation coefficients and Multiple linear regression models. Data were available for 312 students. In Year 1 none of the selection criteria were significantly related to student OSCE performance. The Leaving Certificate Examination and Leaving Certificate plus HPAT-Ireland combined scores correlated with MCQ marks.In Year 2 a series of significant correlations emerged between the HPAT-Ireland and subsections thereof with OSCE Communication Z-scores; OSCE Clinical Z-scores; and Total OSCE Z-scores. However on multiple regression only the relationship between Total OSCE Score and the Total HPAT-Ireland score remained significant; albeit the predictive power was modest. We found

  12. To what extent does the Health Professions Admission Test-Ireland predict performance in early undergraduate tests of communication and clinical skills? – An observational cohort study

    Science.gov (United States)

    2013-01-01

    Background Internationally, tests of general mental ability are used in the selection of medical students. Examples include the Medical College Admission Test, Undergraduate Medicine and Health Sciences Admission Test and the UK Clinical Aptitude Test. The most widely used measure of their efficacy is predictive validity. A new tool, the Health Professions Admission Test- Ireland (HPAT-Ireland), was introduced in 2009. Traditionally, selection to Irish undergraduate medical schools relied on academic achievement. Since 2009, Irish and EU applicants are selected on a combination of their secondary school academic record (measured predominately by the Leaving Certificate Examination) and HPAT-Ireland score. This is the first study to report on the predictive validity of the HPAT-Ireland for early undergraduate assessments of communication and clinical skills. Method Students enrolled at two Irish medical schools in 2009 were followed up for two years. Data collected were gender, HPAT-Ireland total and subsection scores; Leaving Certificate Examination plus HPAT-Ireland combined score, Year 1 Objective Structured Clinical Examination (OSCE) scores (Total score, communication and clinical subtest scores), Year 1 Multiple Choice Questions and Year 2 OSCE and subset scores. We report descriptive statistics, Pearson correlation coefficients and Multiple linear regression models. Results Data were available for 312 students. In Year 1 none of the selection criteria were significantly related to student OSCE performance. The Leaving Certificate Examination and Leaving Certificate plus HPAT-Ireland combined scores correlated with MCQ marks. In Year 2 a series of significant correlations emerged between the HPAT-Ireland and subsections thereof with OSCE Communication Z-scores; OSCE Clinical Z-scores; and Total OSCE Z-scores. However on multiple regression only the relationship between Total OSCE Score and the Total HPAT-Ireland score remained significant; albeit the

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & Clinical Studies NHLBI Trials Clinical Trial Websites News & ...

  14. The clinical utility of the urine-based lateral flow lipoarabinomannan assay in HIV-infected adults in Myanmar: an observational study.

    Science.gov (United States)

    Thit, Swe Swe; Aung, Ne Myo; Htet, Zaw Win; Boyd, Mark A; Saw, Htin Aung; Anstey, Nicholas M; Kyi, Tint Tint; Cooper, David A; Kyi, Mar Mar; Hanson, Josh

    2017-08-04

    The use of the point-of-care lateral flow lipoarabinomannan (LF-LAM) test may expedite tuberculosis (TB) diagnosis in HIV-positive patients. However, the test's clinical utility is poorly defined outside sub-Saharan Africa. The study enrolled consecutive HIV-positive adults at a tertiary referral hospital in Yangon, Myanmar. On enrolment, patients had a LF-LAM test performed according to the manufacturer's instructions. Clinicians managing the patients were unaware of the LF-LAM result, which was correlated with the patient's clinical course over the ensuing 6 months. The study enrolled 54 inpatients and 463 outpatients between July 1 and December 31, 2015. On enrolment, the patients' median (interquartile range) CD4 T-cell count was 270 (128-443) cells/mm 3 . The baseline LF-LAM test was positive in 201/517 (39%). TB was confirmed microbiologically during follow-up in 54/517 (10%), with rifampicin resistance present in 8/54 (15%). In the study's resource-limited setting, extrapulmonary testing for TB was not possible, but after 6 months, 97/201 (48%) with a positive LF-LAM test on enrolment had neither died, required hospitalisation, received a TB diagnosis or received empirical anti-TB therapy, suggesting a high rate of false-positive results. Of the 97 false-positive tests, 89 (92%) were grade 1 positive, suggesting poor test specificity using this cut-off. Only 21/517 (4%) patients were inpatients with TB symptoms and a CD4 T-cell count of < 100 cells/mm 3 . Five (24%) of these 21 died, three of whom had a positive LF-LAM test on enrolment. However, all three received anti-TB therapy before death - two after diagnosis with Xpert MTB/RIF testing, while the other received empirical treatment. It is unlikely that knowledge of the baseline LF-LAM result would have averted any of the study's other 11 deaths; eight had a negative test, and of the three patients with a positive test, two received anti-TB therapy before death, while one died from laboratory

  15. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study.

    Science.gov (United States)

    Wittenmeier, Eva; Bellosevich, Sophia; Mauff, Susanne; Schmidtmann, Irene; Eli, Michael; Pestel, Gunther; Noppens, Ruediger R

    2015-10-01

    Collecting a blood sample is usually necessary to measure hemoglobin levels in children. Especially in small children, noninvasively measuring the hemoglobin level could be extraordinarily helpful, but its precision and accuracy in the clinical environment remain unclear. In this study, noninvasive hemoglobin measurement and blood gas analysis were compared to hemoglobin measurement in a clinical laboratory. In 60 healthy preoperative children (0.2-7.6 years old), hemoglobin was measured using a noninvasive method (SpHb; Radical-7 Pulse Co-Oximeter), a blood gas analyzer (clinical standard, BGAHb; ABL 800 Flex), and a laboratory hematology analyzer (reference method, labHb; Siemens Advia). Agreement between the results was assessed by Bland-Altman analysis and by determining the percentage of outliers. Sixty SpHb measurements, 60 labHb measurements, and 59 BGAHb measurements were evaluated. In 38% of the children, the location of the SpHb sensor had to be changed more than twice for the signal quality to be sufficient. The bias/limits of agreement between SpHb and labHb were -0.65/-3.4 to 2.1 g·dl(-1) . Forty-four percent of the SpHb values differed from the reference value by more than 1 g·dl(-1) . Age, difficulty of measurement, and the perfusion index (PI) had no influence on the accuracy of SpHb. The bias/limits of agreement between BGAHb and labHb were 1.14/-1.6 to 3.9 g·dl(-1) . Furthermore, 66% of the BGAHb values differed from the reference values by more than 1 g·dl(-1) . The absolute mean difference between SpHb and labHb (1.1 g·dl(-1) ) was smaller than the absolute mean difference between BGAHb and labHb (1.5 g·dl(-1) /P = 0.024). Noninvasive measurement of hemoglobin agrees more with the reference method than the measurement of hemoglobin using a blood gas analyzer. However, both methods can show clinically relevant differences from the reference method (ClinicalTrials.gov: NCT01693016). © 2015 John Wiley & Sons Ltd.

  16. Ultrasound measurement of joint cartilage thickness in large and small joints in healthy children: a clinical pilot study assessing observer variability

    Directory of Open Access Journals (Sweden)

    Pfeiffer-Jensen Mogens

    2007-04-01

    Full Text Available Abstract Background Loss of joint cartilage is a feature of destructive disease in JIA. The cartilage of most joints can be visualized with ultrasonography (US. Our present study focuses on discriminant validity of US in children. We studied reproducibility between and within a skilled and a non-skilled investigator of US assessment of cartilage thickness in small and large joints in healthy children. Methods and results In 11 healthy children (5 girls/6 boys, aged 9.6 years (9.3–10 years, 110 joints were examined. Cartilage thickness of the right and left hip, knee, ankle, 2nd metacarpophalangeal (MCP, and 2nd proximal interphalangeal (PIP joint independently. The joints were examined twice, two days apart by a skilled and a non-skilled investigator. Mean cartilage thickness in the five joints was: hip 2.59 ± 0.41, knee 3.67 ± 0.64, ankle 1.08 ± 0.31, MCP 1.52 ± 0.27 and PIP 0.73 ± 0.15 mm. We found the same mean differences in CTh of 0.6 mm in the inter-observer part with regard of the PIP joint. Within investigators (intra-observer, the smallest mean difference of CTh was found in the MCP joint with -0.004 (skilled and 0.013 mm (non-skilled. Conclusion We found the level of agreement between observers within a 95% Confidence Interval in assessment of cartilage thickness in hip-, knee-, ankle-, MCP-, and PIP joints in healthy children. Observer variability seems not to relate to joint size but to the positioning of the joints and the transducer. These factors seem to be of major importance for reproducible US measurements. The smallest difference in measurement of cartilage thickness between observers was found in the PIP joint, and within observers in the MCP joint and it seems that using EULAR standard US guidelines is feasible for a pediatric setting. The use of US in children is promising. Studies on larger groups of children are needed to confirm the validation and variability of US in children as well as determining the smallest

  17. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study.

    Science.gov (United States)

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T P; Chandra, Akhilesh; Singh, O P

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF.

  18. Human reliability analysis (HRA) techniques and observational clinical HRA.

    Science.gov (United States)

    Cuschieri, Alfred; Tang, B

    2010-01-01

    This review explains the nature of human reliability analysis (HRA) methods developed and used for predicting safety in high-risk human activities. HRA techniques have evolved over the years and have become less subjective as a result of inclusion of (i) cognitive factors in the man-machine interface and (ii) high and low dependency levels between human failure events (HFEs). All however remain probabilistic in the assessment of safety. In the translation of these techniques, developed for assessment of safety of high-risk industries (nuclear, aerospace etc.) where catastrophic failures from the man-machine complex interface are fortunately rare, to the clinical operative surgery (with its high incidence of human errors), the system loses subjectivity since the documentation of HFEs can be assessed and studied prospectively on the basis of an objective data capture of errors enacted during a defined clinical activity. The observational clinical-HRA (OC-HRA) was developed specifically for this purpose, initially for laparoscopic general surgery. It has however been used by other surgical specialties. OC-HRA has the additional merit of objective determination of the proficiency of a surgeon in executing specific interventions and is adaptable to the evaluation of safety and proficiency in clinical activities within the preoperative and postoperative periods.

  19. An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation

    Directory of Open Access Journals (Sweden)

    Konrad Futyma

    2015-01-01

    Full Text Available The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management.

  20. Cultivating cohort studies for observational translational research.

    Science.gov (United States)

    Ransohoff, David F

    2013-04-01

    "Discovery" research about molecular markers for diagnosis, prognosis, or prediction of response to therapy has frequently produced results that were not reproducible in subsequent studies. What are the reasons, and can observational cohorts be cultivated to provide strong and reliable answers to those questions? Experimental Selected examples are used to illustrate: (i) what features of research design provide strength and reliability in observational studies about markers of diagnosis, prognosis, and response to therapy? (ii) How can those design features be cultivated in existing observational cohorts, for example, within randomized controlled clinical trial (RCT), other existing observational research studies, or practice settings like health maintenance organization (HMOs)? Examples include a study of RNA expression profiles of tumor tissue to predict prognosis of breast cancer, a study of serum proteomics profiles to diagnose ovarian cancer, and a study of stool-based DNA assays to screen for colon cancer. Strengths and weaknesses of observational study design features are discussed, along with lessons about how features that help assure strength might be "cultivated" in the future. By considering these examples and others, it may be possible to develop a process of "cultivating cohorts" in ongoing RCTs, observational cohort studies, and practice settings like HMOs that have strong features of study design. Such an effort could produce sources of data and specimens to reliably answer questions about the use of molecular markers in diagnosis, prognosis, and response to therapy.

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Back To Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical ... is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies that explore whether ...

  2. Efficacy and Safety of Intravenous Ferric Carboxymaltose in Geriatric Inpatients at a German Tertiary University Teaching Hospital: A Retrospective Observational Cohort Study of Clinical Practice

    Directory of Open Access Journals (Sweden)

    Matthias Bach

    2015-01-01

    Full Text Available Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject in patients aged >75 years with iron deficiency anaemia (IDA. Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65–101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m/<12.0 g/dL (f in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8% received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1–3 infusions. 18 patients (47% fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge. AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%. AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years.

  3. Use of Implant-Derived Minimally Invasive Sinus Floor Elevation: A Multicenter Clinical Observational Study With 12- to 65-Month Follow-Up.

    Science.gov (United States)

    Mijiritsky, Eitan; Barbu, Horia; Lorean, Adi; Shohat, Izhar; Danza, Matteo; Levin, Liran

    2016-08-01

    The aim of this study is to evaluate the performance of implant-derived minimally invasive sinus floor elevation. A multicenter retrospective study was performed in 5 dental clinics. Patients requiring sinus augmentation for single implant placement were recorded and followed up. The dental implant used in this trial was a self-tapping endosseous dental implant that contains an internal channel to allow the introduction of liquids through the implant body into the maxillary sinus; those liquids include saline and a flowable bone grafting material. Overall, 37 implants were installed in 37 patients. The age range of the patients was 37-75 years (mean: 51.2 years). The average residual bone height prior to the procedure was 5.24 ± 1 mm. Of all cases, 25 implants replaced the maxillary first molar and 12 replaced the maxillary second premolar. All surgeries were uneventful with no apparent perforation of the sinus membrane. The mean follow-up time was 24.81 ± 13 months ranging from 12 to 65 months. All implants integrated and showed stable marginal bone level. No adverse events were recorded during the follow-up period. The presented method for transcrestal sinus floor elevation procedure can be accomplished using a specially designed dental implant. Further long-term studies are warranted to reaffirm the results of this study.

  4. Clinical characteristics of Q fever and etiology of community-acquired pneumonia in a tropical region of southern Taiwan: a prospective observational study.

    Directory of Open Access Journals (Sweden)

    Chung-Hsu Lai

    Full Text Available The clinical characteristics of Q fever are poorly identified in the tropics. Fever with pneumonia or hepatitis are the dominant presentations of acute Q fever, which exhibits geographic variability. In southern Taiwan, which is located in a tropical region, the role of Q fever in community-acquired pneumonia (CAP has never been investigated.During the study period, May 2012 to April 2013, 166 cases of adult CAP and 15 cases of acute Q fever were prospectively investigated. Cultures of clinical specimens, urine antigen tests for Streptococcus pneumoniae and Legionella pneumophila, and paired serologic assessments for Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Q fever (Coxiella burnetii were used for identifying pathogens associated with CAP. From April 2004 to April 2013 (the pre-study period, 122 cases of acute Q fever were also included retrospectively for analysis. The geographic distribution of Q fever and CAP cases was similar. Q fever cases were identified in warmer seasons and younger ages than CAP. Based on multivariate analysis, male gender, chills, thrombocytopenia, and elevated liver enzymes were independent characteristics associated with Q fever. In patients with Q fever, 95% and 13.5% of cases presented with hepatitis and pneumonia, respectively. Twelve (7.2% cases of CAP were seropositive for C. burnetii antibodies, but none of them had acute Q fever. Among CAP cases, 22.9% had a CURB-65 score ≧2, and 45.8% had identifiable pathogens. Haemophilus parainfluenzae (14.5%, S. pneumoniae (6.6%, Pseudomonas aeruginosa (4.8%, and Klebsiella pneumoniae (3.0% were the most common pathogens identified by cultures or urine antigen tests. Moreover, M. pneumoniae, C. pneumoniae, and co-infection with 2 pathogens accounted for 9.0%, 7.8%, and 1.8%, respectively.In southern Taiwan, Q fever is an endemic disease with hepatitis as the major presentation and is not a common etiology of CAP.

  5. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE)

    NARCIS (Netherlands)

    Simundic, Ana-Maria; Church, Stephen; Cornes, Michael P.; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Nikolac, Nora; van Dongen-Lases, Edmee; Eker, Pinar; Kovalevskaya, Svjetlana; Kristensen, Gunn B. B.; Sprongl, Ludek; Sumarac, Zorica

    2015-01-01

    Abstract Background: An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. Methods: A structured

  6. Laparoscopic cholecystectomy: day-care versus clinical observation

    NARCIS (Netherlands)

    Keulemans, Y.; Eshuis, J.; de Haes, H.; de Wit, L. T.; Gouma, D. J.

    1998-01-01

    OBJECTIVE: To determine the feasibility and desirability of laparoscopic cholecystectomy (LC) in day-care versus LC with clinical observation. SUMMARY BACKGROUND DATA: Laparoscopic cholecystectomy has been performed regularly as outpatient surgery in patients with uncomplicated gallstone disease in

  7. Beta-blocker Therapy and Clinical Outcomes in Patients with Moderate COPD and Heightened Cardiovascular Risk: An Observational Sub-study of SUMMIT.

    Science.gov (United States)

    Dransfield, Mark T; McAllister, David A; Anderson, Julie A; Brook, Robert D; Calverley, Peter M A; Celli, Bartolome R; Crim, Courtney; Gallot, Natacha; Martinez, Fernando J; Scanlon, Paul D; Yates, Julie; Vestbo, Jørgen; Newby, David E

    2018-02-06

    Cardiovascular disease is a common comorbidity in patients with chronic obstructive pulmonary disease (COPD). Although beta-blockers can be used safely in COPD, concerns remain regarding safety and efficacy interactions in patients using concomitant inhaled long-acting beta-agonists. To compare the differential effects of long-acting beta agonist or inhaled corticosteroid use on clinical outcomes in patients with heightened cardiovascular risk treated and not treated with beta-blockers. We examined data from 16,485 participants in the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) who were randomized to once daily inhaled fluticasone furoate (FF), vilanterol (VI), their combination (FF/VI), or placebo and examined the associations between treatment allocation and lung function, COPD exacerbations, cardiovascular events, and all-cause mortality stratified by baseline beta-blocker therapy. Baseline beta-blocker therapy was used by 31% (n=5,159) of SUMMIT participants. There was no evidence of an interaction between baseline beta-blocker therapy and the association between inhaled treatments and FEV1 at 3 months (p=0.27), 6 months (p=0.14), or 12 months (p=0.33). The placebo-adjusted mean difference in post-bronchodilator FEV1 at 3 months in the VI alone group was 58 mL [95% confidence interval (CI) 38, 78] in those taking baseline beta-blocker therapy, and 51 mL [95%CI 38, 65], in those not taking baseline beta-blocker therapy. The placebo-adjusted mean difference in post-bronchodilator FEV1 at 3 months in the FF/VI group was 85 mL [95%CI 65, 105] in those taking baseline beta-blocker therapy, and 68 mL [95%CI 54, 82] in those not taking baseline beta-blocker therapy. Overall, there was no evidence of interactions by randomized treatment, including VI alone or in combination with FF, for COPD exacerbations (p=0.18), cardiovascular composite events (p=0.33), and all-cause mortality (p=0.41). There is no evidence to suggest that baseline beta

  8. Investigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a prospective observational study in Australia.

    Science.gov (United States)

    Delaney, Lori J; Currie, Marian J; Huang, Hsin-Chia Carol; Litton, Edward; Wibrow, Bradley; Lopez, Violeta; Haren, Frank Van

    2018-01-21

    Sleep is a state of quiescence that facilitates the significant restorative processes that enhance individuals' physiological and psychological well-being. Patients admitted to the intensive care unit (ICU) experience substantial sleep disturbance. Despite the biological importance of sleep, sleep monitoring does not form part of standard clinical care for critically ill patients. There exists an unmet need to assess the feasibility and accuracy of a range of sleep assessment techniques that have the potential to allow widespread implementation of sleep monitoring in the ICU. The coprimary outcome measures of this study are to: determine the accuracy and feasibility of motion accelerometer monitoring (ie, actigraphy) and subjective assessments of sleep (nursing-based observations and patient self-reports) to the gold standard of sleep monitoring (ie, polysomnography) in evaluating sleep continuity and disturbance. The secondary outcome measures of the study will include: (1) the association between sleep disturbance and environmental factors (eg, noise, light and clinical interactions) and (2) to describe the sleep architecture of intensive care patients. A prospective, single centre observational design with a within subjects' assessment of sleep monitoring techniques. The sample will comprise 80 adults (aged 18 years or more) inclusive of ventilated and non-ventilated patients, admitted to a tertiary ICU with a Richmond Agitation-Sedation Scale score between +2 (agitated) and -3 (moderate sedation) and an anticipated length of stay >24 hours. Patients' sleep quality, total sleep time and sleep fragmentations will be continuously monitored for 24 hours using polysomnography and actigraphy. Behavioural assessments (nursing observations) and patients' self-reports of sleep quality will be assessed during the 24-hour period using the Richards-Campbell Sleep Questionnaire, subjective sleepiness evaluated via the Karolinska Sleepiness Scale, along with a

  9. Interhospital transfer due to failed prehospital diagnosis for primary percutaneous coronary intervention: an observational study on incidence, predictors, and clinical impact

    Science.gov (United States)

    Gu, Youlan L; Nijsten, Maarten W; de Vos, Ronald; Nieuwland, Wybe; Zijlstra, Felix; Hillege, Hans L; van der Horst, Iwan C; de Smet, Bart JGL

    2013-01-01

    Background: For patients with ST-elevation myocardial infarction (STEMI), guidelines recommend prehospital triage and direct referral to a percutaneous coronary intervention (PCI)-capable centre in order to minimize ischemic time. However, few have studied failed prehospital diagnosis. We assessed the incidence, predictors, and clinical impact of interhospital transfer for primary PCI after initial referral to a non-PCI-capable centre due to a failed prehospital STEMI diagnosis. Methods: We studied 846 consecutive STEMI patients undergoing primary PCI between January 2008 and January 2010. Results: We found that 609 patients (72%) were directly admitted through prehospital triage and 127 patients (15%) required interhospital transfer after failed prehospital diagnosis. Median first medical contact to treatment time was 88 min in the prehospital diagnosis group and 155 min in the interhospital transfer group (pprehospital diagnosis occurred in 15% of STEMI patients undergoing primary PCI. Interhospital transfer was a major predictor of ischemic time and 1-year mortality was significantly higher. Continuing efforts to optimize prehospital triage are warranted, especially among patients at higher risk of failed prehospital diagnosis. PMID:24222827

  10. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    Directory of Open Access Journals (Sweden)

    Adit Srivastava

    2015-01-01

    Full Text Available The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base for the treatment of oral submucous fibrosis (OSMF. Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF.

  11. [A retrospective, observational and multicentre study on patients with hyperactive bladder on treatment with mirabegron and oxybutinine under usual clinical practice conditions].

    Science.gov (United States)

    Sicras-Mainar, A; Navarro-Artieda, R; Ruiz-Torrejón, A; Saez, M; Coll-de Tuero, G; Sánchez, L

    To evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. An observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of P<.05. Of the total of1,277 patients included in the study, 42.9% were on oxybutynin and 57.1% mirabegron. The mean age was 69.3 years and 53.2% were female. Demographic characteristics and morbidity were similar between the drugs and had a similar persistence (35.0% oxybutynin vs. 32.2% mirabegron, P=.294), although their costs were lower (1,151.2 vs. €1,809.6, P<.001). The biggest differences were observed in the price of medication (279.2 vs. €692.3, P<.001; a variation of: -€413.1); and adverse events (9.7 vs. 4.9%, P<.001). Patients treated with oxybutynin vs. mirabegron for overactive bladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Clinical factors associated with intracranial complications after pediatric traumatic head injury: an observational study of children submitted to a neurosurgical referral unit

    DEFF Research Database (Denmark)

    Åstrand, Ramona Alice; Undén, Johan; Hesselgard, Karin

    2010-01-01

    Clinically validated guidelines for the management of head injury in children do not exist, and the treatment is often based upon adult management routines. In order to examine the safety of this procedure, an analysis of clinical factors associated with complications after pediatric head injury...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Home / Health Topics / < Back To About Clinical Trials / NHLBI Clinical Trials NHLBI Clinical Trials These NHLBI-sponsored research studies are for patients who have heart, lung, ...

  16. Assessing the connection between organophosphate pesticide poisoning and mental health: A comparison of neuropsychological symptoms from clinical observations, animal models and epidemiological studies.

    Science.gov (United States)

    Stallones, Lorann; Beseler, Cheryl L

    2016-01-01

    Psychiatry and psychology are beginning to recognize the importance of lead, mercury and heavy metals as causal partners in the development of mental disorders. Further, mental health researchers and clinicians are embracing the idea that the combined effects of genetics and environmental exposures can result in perturbations in brain neurochemistry leading to psychiatric disorders. The purpose of this review is to examine the biological foundations for the epidemiological observations previously identified by reviewing the toxicology literature and relating it to epidemiological studies addressing the role of poisoning with organophosphate pesticides (OPs) in neurobehavioral and neuropsychological disorders. The goal of this review is to raise awareness in the mental health community about the possibility that affective disorders might be the result of contributions from environmental and occupational pesticide poisoning. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Medical students trained in communication skills show a decline in patient-centred attitudes: an observational study comparing two cohorts during clinical clerkships.

    Science.gov (United States)

    Bombeke, Katrien; Van Roosbroeck, Sofie; De Winter, Benedicte; Debaene, Luc; Schol, Sandrina; Van Hal, Guido; Van Royen, Paul

    2011-09-01

    Literature indicates a decline in patient-centredness in medical students, especially during clinical clerkships. We examined the impact of preclinical communication skills training (CST) on students' development of patient-centred attitudes and attitudes toward CST during clerkships. We prospectively compared two cohorts before and after clerkships: one cohort (n=48) had not received CST, whereas the other (n=37) had received a five-year CST. We assessed the impact using five validated questionnaires. Communication trained students slightly but significantly declined in patient-centred attitudes (3/4 scales) and attitudes toward CST during clerkships, whereas the scores of the untrained students remained stable (5/5 scales). Both cohorts did not differ in attitudes before clerkships. In the trained cohort, males mostly showed a sharper decline than females. In the total group (n=85), females demonstrated higher attitude scores toward CST, and in 1/4 scales measuring patient-centred attitudes. This cohort study suggests that CST might make students more vulnerable to decline in attitude scores during clerkships. These remarkable findings, contrary to what educators would expect to result from their efforts, challenge medical education to address the new questions that are raised about the validity of the questionnaires, the impact of CST and the learning processes involved in the development of patient-centredness. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  18. Comparative observational study on the clinical presentation, intracranial volume measurements, and intracranial pressure scores in patients with either Chiari malformation Type I or idiopathic intracranial hypertension.

    Science.gov (United States)

    Frič, Radek; Eide, Per Kristian

    2017-04-01

    OBJECTIVE Several lines of evidence suggest common pathophysiological mechanisms in Chiari malformation Type I (CMI) and idiopathic intracranial hypertension (IIH). It has been hypothesized that tonsillar ectopy, a typical finding in CMI, is the result of elevated intracranial pressure (ICP) combined with a developmentally small posterior cranial fossa (PCF). To explore this hypothesis, the authors specifically investigated whether ICP is comparable in CMI and IIH and whether intracranial volumes (ICVs) are different in patients with CMI and IIH, which could explain the tonsillar ectopy in CMI. The authors also examined whether the symptom profile is comparable in these 2 patient groups. METHODS The authors identified all CMI and IIH patients who had undergone overnight diagnostic ICP monitoring during the period from 2002 to 2014 and reviewed their clinical records and radiological examinations. Ventricular CSF volume (VV), PCF volume (PCFV), and total ICV were calculated from initial MRI studies by using volumetric software. The static and pulsatile ICP scores during overnight monitoring were analyzed. Furthermore, the authors included a reference (REF) group consisting of patients who had undergone ICP monitoring due to suspected idiopathic normal-pressure hydrocephalus or chronic daily headache and showed normal pressure values. RESULTS Sixty-six patients with CMI and 41 with IIH were identified, with comparable demographics noted in both groups. The occurrence of some symptoms (headache, nausea, and/or vomiting) was comparable between the cohorts. Dizziness and gait ataxia were significantly more common in patients with CMI, whereas visual symptoms, diplopia, and tinnitus were significantly more frequent in patients with IIH. The cranial volume measurements (VV, PCFV, and ICV) of the CMI and IIH patients were similar. Notably, 7.3% of the IIH patients had tonsillar descent qualifying for diagnosis of CMI (that is, > 5 mm). The extent of tonsillar ectopy was

  19. A mechanistic PK/PD model for two anti-IL13 antibodies explains the difference in total IL-13 accumulation observed in clinical studies.

    Science.gov (United States)

    Tiwari, Abhinav; Kasaian, Marion; Heatherington, Anne C; Jones, Hannah M; Hua, Fei

    2016-07-01

    IMA-638 and IMA-026 are humanized IgG1 monoclonal antibodies (mAbs) that target non-overlapping epitopes of IL-13. Separate first-in-human single ascending dose studies were conducted for each mAb. These studies had similar study designs, but mild to moderate asthmatics were recruited for the IMA-638 study and healthy subjects were recruited for the IMA-026 study. IMA-638 and IMA-026 showed similar pharmacokinetic (PK) profiles, but very different total IL-13 (free and drug bound IL-13) profiles; free IL13 was not measured. IMA-026 treatment induced a dose-dependent accumulation of total IL-13, while IMA-638 treatment led to a much smaller accumulation without any clear dose-response. To understand the differences between the two total IL-13 profiles and to predict the free IL-13 profiles for each mAb treatment, a mechanistic PK/pharmacodynamic model was developed. PK-related parameters were first fit to the mean PK profiles of each mAb separately; thereafter, the target-related parameters were fit to both total IL-13 profiles simultaneously. The IL-13 degradation rate was assumed to be the same for asthma patients and healthy subjects. The model suggests that an approximately 100× faster elimination of IL-13-IMA-638 complex than IL-13-IMA-026 complex could be responsible for the differences observed in total IL-13 profiles for the two mAbs. Furthermore, the model predicts that IMA-638 administration results in greater and more prolonged free IL-13 inhibition than equivalent dosing of IMA-026 despite similar binding KD and PK profile. In conclusion, joint modeling of two similar molecules provided mechanistic insight that the elimination rate of mAb-target complex can regulate the degree of free target inhibition.

  20. A clinical observational study on patient-reported outcomes, hip functional performance and return to sports activities in hip arthroscopy patients.

    Science.gov (United States)

    Tijssen, Marsha; van Cingel, Robert; de Visser, Enrico; Nijhuis-van der Sanden, Maria

    2016-07-01

    To describe data of short- and midterm results of hip arthroscopy patients based on patient-reported hip function, hip functional performance and return to sports activities. Observational cohort study. Sports medical center. 37 recreational athletes (21 men) at least six months after finishing rehabilitation for hip arthroscopy. International Hip Outcome Tool 33 (IHOT-33), Pain Visual Analogue Scale (VAS), Global Perceived Effect Scale (GPE), sports questionnaires and hip functional performance tests. At a mean follow-up time of 2.3 years, 81% of participants reported improvement on the GPE and 84% returned to sports activities. The mean IHOT-33 score was 69.3; the mean VAS score was 35.0. Range of motion (ROM) and strength were within the 90% Limb Symmetry Index (LSI) limit, except for hip internal rotation ROM. A full recovery of hip functional performance, as measured with balance and hop tests, was established based on the 90% LSI limit. The overall short- and midterm results of these follow-up data show good recovery of hip arthroscopy patients on patient-reported outcomes, functional performance and return to sports activities. The functional performance tests used in this study seem adequate for measuring recovery in hip arthroscopy patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These ... Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept medicines and treatments based on what is known to ...

  4. The effect of attitude to risk on decisions made by nurses using computerised decision support software in telephone clinical assessment: an observational study

    Science.gov (United States)

    O'Cathain, Alicia; Munro, James; Armstrong, Iain; O'Donnell, Catherine; Heaney, David

    2007-01-01

    Background There is variation in the decisions made by telephone assessment nurses using computerised decision support software (CDSS). Variation in nurses' attitudes to risk has been identified as a possible explanatory factor. This study was undertaken to explore the effect of nurses' attitudes to risk on the decisions they make when using CDSS. The setting was NHS 24 which is a nationwide telephone assessment service in Scotland in which nurses assess health problems, mainly on behalf of out-of-hours general practice, and triage calls to self care, a service at a later date, or immediate contact with a service. Methods All NHS 24 nurses were asked to complete a questionnaire about their background and attitudes to risk. Routine data on the decisions made by these nurses was obtained for a six month period in 2005. Multilevel modelling was used to measure the effect of nurses' risk attitudes on the proportion of calls they sent to self care rather than to services. Results The response rate to the questionnaire was 57% (265/464). 231,112 calls were matched to 211 of these nurses. 16% (36,342/231,112) of calls were sent to self care, varying three fold between the top and bottom deciles of nurses. Fifteen risk attitude variables were tested, including items on attitudes to risk in clinical decision-making. Attitudes to risk varied greatly between nurses, for example 27% (71/262) of nurses strongly agreed that an NHS 24 nurse "must not take any risks with physical illness" while 17% (45/262) disagreed. After case-mix adjustment, there was some evidence that nurses' attitudes to risk affected decisions but this was inconsistent and unconvincing. Conclusion Much of the variation in decision-making by nurses using CDSS remained unexplained. There was no convincing evidence that nurses' attitudes to risk affected the decisions made. This may have been due to the limitations of the instrument used to measure risk attitude. PMID:18047658

  5. Clinical outcomes and prognostic factors of empirical antifungal therapy with itraconazole in the patients with hematological malignancies: a prospective multicenter observational study in Korea.

    Science.gov (United States)

    Kim, Jin Seok; Cheong, June-Won; Shin, Ho Jin; Lee, Jong Wook; Lee, Je-Hwan; Yang, Deok-Hwan; Lee, Won Sik; Kim, Hawk; Park, Joon Seong; Kim, Sung-Hyun; Kim, Yang Soo; Kwak, Jae-Yong; Chae, Yee Soo; Park, Jinny; Do, Young Rok; Min, Yoo Hong

    2014-01-01

    To identify prognostic factors for the outcomes of empirical antifungal therapy, we performed a multicenter, prospective, observational study in immunocompromised patients with hematological malignancies. Three hundred seventy-six patients (median age of 48) who had neutropenic fever and who received intravenous (IV) itraconazole as an empirical antifungal therapy for 3 or more days were analyzed. The patients with possible or probable categories of invasive fungal disease (IFD) were enrolled. The overall success rate was 51.3% (196/376). Age >50 years, underlying lung disease (co-morbidity), poor performance status [Eastern Cooperative Oncology Group (ECOG) ≥2], radiologic evidence of IFD, longer duration of baseline neutropenic fever (≥4 days), no antifungal prophylaxis or prophylactic use of antifungal agents other than itraconazole, and high tumor burden were associated with decreased success rate in univariate analysis. In multivariate analysis, age >50 years (p=0.009) and poor ECOG performance status (p=0.005) were significantly associated with poor outcomes of empirical antifungal therapy. Twenty-two patients (5.9%) discontinued itraconazole therapy due to toxicity. We concluded that empirical antifungal therapy with IV itraconazole in immunocompromised patients is effective and safe. Additionally, age over 50 years and poor performance status were poor prognostic factors for the outcomes of empirical antifungal therapy with IV itraconazole.

  6. Clinical Outcomes Following a Switch from Remicade(R) to the Biosimilar CT-P13 in Inflammatory Bowel Disease Patients: A Prospective Observational Cohort Study

    NARCIS (Netherlands)

    Smits, L.J.T.; Derikx, L.A.; Jong, D.J. de; Boshuizen, R.S.; Esch, A.A.J. van; Drenth, J.P.H.; Hoentjen, F.

    2016-01-01

    BACKGROUND AND AIMS: The biosimilar of Remicade(R), CT-P13, recently entered the European market. Clinical data on switching from Remicade(R) to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to accept ... treatments, drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help ... clinical trials is research, so the studies follow strict scientific standards. These standards protect patients and help ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

  10. Mitral regurgitation recovery and atrial reverse remodeling following pulmonary vein isolation procedure in patients with atrial fibrillation: a clinical observation proof-of-concept cardiac MRI study.

    Science.gov (United States)

    Reddy, Sahadev T; Belden, William; Doyle, Mark; Thompson, Diane V; Williams, Ronald; Yamrozik, June; Shah, Moneal; Biederman, Robert W W

    2013-09-01

    Reverse remodeling of the left atrium (LA) following successful pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF) has been well documented. However, mitral regurgitation (MR) recovery after successful PVI has never been demonstrated systematically. The objective of our study was to retrospectively analyze the effectiveness of PVI in patients with AF on recovery of MR using cardiac magnetic resonance (CMR) imaging. Prior to PVI, patients underwent a clinically indicated CMR imaging. Post-PVI (6 ± 2 months), patients underwent a follow-up MRI and were classified into two groups-responders (R) and non-responders (NR) to PVI-as assessed by cessation of AF at the end of the prespecified 6-month (14-day "P" sensitive event monitor defined) follow-up period. Furthermore, CMR was used to evaluate the severity of MR (0 to 4+) and to relate changes in MR to LA volumes as well as mitral apparatus geometry. Patients who had mild and higher MR (2+) on baseline CMR and had a post-PVI CMR were selected for final analysis. Out of the consecutive 122 patients with AF who underwent PVI, 74 patients that had mitral regurgitation on initial CMR were included in the study. Of these74 patients with AF with MR, 52 (70 %) were classified as R and 22 (30 %) were classified as NR. Baseline demographics were similar between the groups. In the subgroup with mild to severe MR, pre vs. post in the R group MR severity significantly improved (mean = 2.3, median = 2.0 vs. mean = 1.0, median = 1.0, p < 0.0001) and was matched by favorable reverse remodeling of the mitral apparatus geometry (annulus = 35 ± 4 vs. 33 ± 3 mm, p < 0.002; tenting area = 175 ± 56 vs.137 ± 37 mm(2), p < 0.003; tenting height = 8 ± 2 vs.7 ± 2 mm, p < 0.02; and tenting angle = 129 ± 10° vs. 131 ± 11°, p = 0.1). However, in the NR subgroup, MR failed to improve (mean = 2.2, median = 2.0 vs

  11. ABDOMINAL TRAUMA- CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Vanaja Ratnakumari Billa

    2017-08-01

    Full Text Available BACKGROUND In the recent times there has been increased incidence of abdominal trauma cases due to several causes. Quick and prompt intervention is needed to decrease the mortality of the patients. So we conducted a study to assess the cause and the management of abdominal trauma cases in our institution. The aim of this study was to know the incidence of blunt and penetrating injuries and their causes, age and sex incidence, importance of various investigations, mode of treatment offered and post-operative complications. To study the cause of death and evolve better management. MATERIALS AND METHODS The present study comprises of patients admitted to and operated in various surgical units in the Department of Surgery at Government General Hospital, attached to Guntur Medical College Guntur, from August 2014 to October 2016. RESULTS Increase incidence seen in age group 20-29 years (30%. Male predominance 77.5%. Mechanism of injury–road traffic accidents 65%. Isolated organ injury–colon and rectum 40%. Other associated injuries–chest injuries with rib fractures 7.5%. Complications–wound infection 17.5%. Duration of hospital stay 8–14 days. Bowel injury management–closure of perforation 84.6%. Resection anastomosis 15.38%. CONCLUSION Thorough clinical examination, diagnostic paracentesis, plain X-ray erect abdomen and ultrasound proved to be very helpful in the diagnosis of intra-abdominal injuries. Spleen is the commonest organ involved in blunt trauma and colon is the commonly injured organ in penetrating abdominal trauma, many patients have associated extremity and axial skeleton injuries. With advances in diagnosis and intensive care technologies, most patients of solid visceral injuries with hemodynamic stability can be managed conservatively. Surgical site infection is the most common complication following surgery. The mortality is high; reason might be patient reaching the hospital late, high incidence of postoperative septic

  12. Anatomical, Clinical and Electrical Observations in Piriformis Syndrome

    Directory of Open Access Journals (Sweden)

    Assoum Hani A

    2010-01-01

    Full Text Available Abstract Background We provided clinical and electrical descriptions of the piriformis syndrome, contributing to better understanding of the pathogenesis and further diagnostic criteria. Methods Between 3550 patients complaining of sciatica, we concluded 26 cases of piriformis syndrome, 15 females, 11 males, mean age 35.37 year-old. We operated 9 patients, 2 to 19 years after the onset of symptoms, 5 had piriformis steroids injection. A dorsolumbar MRI were performed in all cases and a pelvic MRI in 7 patients. The electro-diagnostic test was performed in 13 cases, between them the H reflex of the peroneal nerve was tested 7 times. Results After a followup 1 to 11 years, for the 17 non operated patients, 3 patients responded to conservative treatment. 6 of the operated had an excellent result, 2 residual minor pain and one failed. 3 new anatomical observations were described with atypical compression of the sciatic nerve by the piriformis muscle. Conclusion While the H reflex test of the tibial nerve did not give common satisfaction in the literature for diagnosis, the H reflex of the peroneal nerve should be given more importance, because it demonstrated in our study more specific sign, with six clinical criteria it contributed to improve the method of diagnosis. The cause of this particular syndrome does not only depend on the relation sciatic nerve-piriformis muscle, but the environmental conditions should be considered with the series of the anatomical anomalies to explain the real cause of this pain.

  13. [Polymyalgia rheumatica--clinical observations on 90 patients].

    Science.gov (United States)

    Günther, R; Tischler, H; Herold, M

    1985-01-01

    The clinical and laboratory data recorded during a several month study of 90 patients with polymyalgia rheumatica are presented. Especially with elderly women who lack other symptoms it should be borne in mind that muscular and articular pain in the scapular and pelvic regions together with an excessive increase in the blood sedimentation rate--more than 100 mm during the first hour are frequent--may indicate this disease. It is often accompanied by an arteritis of the temporal vessels (giant cell arteritis), which increases the danger of uni- or bilateral loss of sight. In our case material unilateral loss of sight occurred in 3% of the patients, bilateral loss of sight was not observed. A general disturbance in the patients well-being, occasional attacks of fever, non-specific signs of inflammation in the haematological findings and symptomatic anaemia mask the clinical picture and make diagnosis difficult. Initial high doses of cortisonoid and following long-term therapy make all signs and symptoms disappear. The disease can last for several years. The prognosis is favourable. The cause is still unknown.

  14. Clinical aspects of pulmonary radioactivity observed in radiocolloid liver scintigraphy

    Energy Technology Data Exchange (ETDEWEB)

    So, Young; Lee, Kang Wook; Lee, Heon Young; Lee, Won Woo [College of Medicine, Chungnam National Univ., Taejon (Korea, Republic of)

    2002-06-01

    We studied clinical aspects and courses of patients with pulmonary radioactivity on liver scintigraphy and speculated the mechanism of pulmonary uptake of radiocolloids. Forty-nine patients with pulmonary radioactivity were classified into 5 diseases groups-liver disease, infection, cancer, ischemic necrosis of liver, etc.- and their presence of absence of chronic liver disease (CLD), Child-Pugh class, serum levels of AST and ALT, results of follow-up liver scintigraphy and clinical course were checked. Of total 49 patients 25 had CLD; there were 23 liver disease patients, 16 infection patients, 7 advanced cancer patients, 2 ischemic necrosis of liver patients, and 1 hemolytic anemia patient. Reversible rise of serum levels of AST and ALT was observed in all patients with liver disease and ischemic necrosis of liver; on one-way ANOVA, these rise were statistically significant (p<0.01). Serum level of ALT of liver disease group patients without CLD was significantly higher than that of infection group patients without CLD (p<0.05). Among 17 patients who underwent follow-up liver scintigraphy, 13 showed no pulmonary radioactivity. Total 12 patients died during follow-up and most of them were terminal cancer patients or CLD patients of Child-Pugh class C. Pulmonary radioactivity of radiocolloid liver scintigraphy could be attributed to the mobilization of reticuloendothelial system (RES) cells by the activation of RES cells in severe infection and terminal cancer, and also by the extensive liver desctruction in liver diseases.

  15. Curso clínico da anemia hemolítica auto-imune: um estudo descritivo Clinical course of autoimmune hemolytic anemia: an observational study

    Directory of Open Access Journals (Sweden)

    Maria Christina L. A. Oliveira

    2006-02-01

    Full Text Available OBJETIVO: A anemia hemolítica auto-imune é caracterizada pela produção de auto-anticorpos contra antígenos de superfície das hemácias. O objetivo do estudo foi identificar as características clínicas, imunológicas e evolutivas dos pacientes com anemia hemolítica auto-imune acompanhados no serviço de hematologia pediátrica do HC-UFMG e no Hemocentro de Belo Horizonte. MÉTODOS: Foram avaliadas 17 crianças menores de 15 anos, diagnosticadas entre 1988 e 2003. O diagnóstico de anemia hemolítica auto-imune foi baseado no quadro de hemólise adquirida e confirmado por meio do teste de Coombs direto poliespecífico. Os dados clínicos, demográficos, laboratoriais e referentes à evolução dos pacientes foram obtidos retrospectivamente nos prontuários médicos. RESULTADOS: A mediana de idade ao diagnóstico foi de 10,5 meses. O teste de Coombs direto poliespecífico foi positivo em 13 pacientes e negativo em quatro. Em 14 pacientes, foi realizado o teste de Coombs direto monoespecífico. Nestes, a classe de anticorpo mais freqüente foi IgG (cinco pacientes, seguida pela IgM em dois. Em 13 (76% pacientes, a anemia foi considerada grave, o que tornou necessária a hemotransfusão. Em quatro pacientes, foi identificada uma doença de base: lúpus eritematoso sistêmico, linfoma de Hodgkin, hepatite auto-imune e histiocitose de células de Langerhans. Os demais casos foram considerados como primários. A mediana de seguimento foi de 11 meses (5 a 23 meses. Ocorreram três óbitos, sendo dois após esplenectomia e um pela doença de base. CONCLUSÃO: A anemia hemolítica auto-imune é rara em crianças e adolescentes. Apesar de apresentar resposta ao corticóide e imunoglobulina, casos fatais têm sido relatados. O prognóstico é pior na presença de uma doença crônica de base.OBJECTIVE: Autoimmune hemolytic anemia is characterized by the production of autoantibodies against erythrocyte membrane antigens. This study was carried out to

  16. Clinical, Serological, and Molecular Observations from a Case Series Study during the Asian Lineage Zika Virus Outbreak in Grenada during 2016

    Directory of Open Access Journals (Sweden)

    Marco Brenciaglia

    2018-01-01

    Full Text Available This paper describes the spatial and temporal distribution of cases, demographic characteristics of patients, and clinical manifestations of Zika virus (ZIKV during the 2016 outbreak in Grenada. The first reported case was recorded in St. Andrew Parish in April, and the last reported case was seen in November, with peak transmission occurring in the last week of June, based on test results. Data were collected from a total of 514 patients, of whom 207 (40% tested positive for ZIKV. No evidence was found that testing positive for ZIKV infection was related to age, gender, or pregnancy status. Clinical presentation with rash (OR = 2.4, 95% CI = 1.5 to 3.7 or with lymphadenopathy (OR = 1.7, 95% CI = 1.0 to 2.9 were the only reported symptoms consistent with testing positive for ZIKV infection. During the Zika outbreak, the infection rate was 20 clinical cases per 10,000 in the population compared to 41 cases per 10,000 during the chikungunya outbreak in Grenada in 2014 and 17 cases per 10,000 during the dengue outbreak in 2001-2002. Even though the country has employed vector control programs, with no apparent decrease in infection rates, it appears that new abatement approaches are needed to minimize morbidity in future arbovirus outbreaks.

  17. Validation of Clinical Observations of Mastication in Persons with ALS.

    Science.gov (United States)

    Simione, Meg; Wilson, Erin M; Yunusova, Yana; Green, Jordan R

    2016-06-01

    Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

  18. Clinical Studies with Epothilones

    Science.gov (United States)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  19. The clinical and radiological observation of congenital syphilis

    Energy Technology Data Exchange (ETDEWEB)

    Nah, Byung Sik; Chung, Ung Ki [Chonnam National University College of Medicine, Kwangju (Korea, Republic of)

    1983-03-15

    Congenital syphilis is transmitted through the placenta by the infected mother after 16 weeks of gestation. Since the incidence of syphilis is again on the increase, syphilis remains at the present time a public problem of major and increasing proportions. Recently, congenital syphilis has different formas of presentation. The authors observed clinically and radiologically 27 cases of congenital syphilis in the neonates and infants treated at the pediatric ward of Chonnam National University Hospital from Jan. 1977 to Mar. 1982. The results are as follows: 1. The number of observed patients was 27 cases, 22 cases in male, 5 cases in female. 2. Onset of first clinical symptoms and signs was within the 4th week life in 14 cases (52%), 1-2 months in 6 cases (22%), 2-3 months in 4 cases (15%), 3-4 months in 3 cases (11%). All cases was within 6 months. 3. The order of the frequency of common clinical manifestations was hepatomegaly (96%), splenomegaly (78%), skin lesion (63%), anemia (63%), nasal snuffle (56%). 4. Of 11 cases with known birth weight, 10 cases were low birth weight. 5. The serologic test (VDRL slide test) of 27 tested caes revealed reactive response in 26 cases, non-reactive response in 1 case, and that of syphilitic mothers except one revealed reactive in 23 cases, non- reactive in 3 cases. 6. Roentgenographic syphilitic bony changes were detected in 26 cases (96%), of 27 studied cases, osteochondritis was present in 24 cases (89%), periostitis in 21 case (78%), osteomyelitis in 11 cases (41%). 7. The most common sites affected were as follows. Radius and ulna were the most frequently affected, the next were in order of tibia and fibula. Considering osteochondiritis only, the distal end of radius and ulna (78% respectively) and proximal end of tibra (67%) were the most frequently affected sites, the proximal end of femur (33%) was least frequently affected site. 8. On chest films of 27 case, osseous changes (mainly periostitis) of clavicle were noted

  20. Prothrombin time is predictive of low plasma prothrombin concentration and clinical outcome in patients with trauma hemorrhage: analyses of prospective observational cohort studies.

    Science.gov (United States)

    Balendran, Clare A; Lövgren, Ann; Hansson, Kenny M; Nelander, Karin; Olsson, Marita; Johansson, Karin J; Brohi, Karim; Fries, Dietmar; Berggren, Anders

    2017-03-14

    Fibrinogen and prothrombin have been suggested to become rate limiting in trauma associated coagulopathy. Administration of fibrinogen is now recommended, however, the importance of prothrombin to patient outcome is unknown. We have utilized two trauma patient databases (database 1 n = 358 and database 2 n = 331) to investigate the relationship of plasma prothrombin concentration on clinical outcome and coagulation status. Database 1 has been used to assess the relationship of plasma prothrombin to administered packed red blood cells (PRBC), clinical outcome and coagulation biomarkers (Prothrombin Time (PT), ROTEM EXTEM Coagulation Time (CT) and Maximum Clot Firmness (MCF)). ROC analyses have been performed to investigate the ability of admission coagulation biomarkers to predict low prothrombin concentration (database 1), massive transfusion and 24 h mortality (database 1 and 2). The importance of prothrombin was further investigated in vitro by PT and ROTEM assays in the presence of a prothrombin neutralizing monoclonal antibody and following step-wise dilution. Patients who survived the first 24 h had higher admission prothrombin levels compared to those who died (94 vs.67 IU/dL). Patients with lower transfusion requirements within the first 24 h (≤10 units of PRBCs) also had higher admission prothrombin levels compared to patients with massive transfusion demands (>10 units of PRBCs) (95 vs.62 IU/dL). Admission PT, in comparison to admission ROTEM EXTEM CT and MCF, was found to be a better predictor of prothrombin concentration <60 IU/dL (AUC 0.94 in database 1), of massive transfusion (AUC 0.92 and 0.81 in database 1 and 2 respectively) and 24 h mortality (AUC 0.90 and 0.78 in database 1 and 2, respectively). In vitro experiments supported a critical role for prothrombin in coagulation and demonstrated that PT and ROTEM EXTEM CT are sensitive methods to measure low prothrombin concentration. Our analyses suggest that prothrombin concentration

  1. The clinical utility of tuberculin skin test and interferon-γ release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Lee Sei Won

    2011-04-01

    Full Text Available Abstract Background The roles of the tuberculin skin test (TST and QuantiFERON®-TB Gold In-Tube assay (QFT-IT in the diagnosis of active tuberculosis (TB are not clear in young adults. We evaluated the diagnostic accuracy of the TST and QFT-IT in smear-negative TB among young adults with no underlying disease. Methods We prospectively enrolled 166 young participants 20-29 years of age with suspected active TB in a military hospital of South Korea. The TST and QFT-IT were performed for all participants. Results Of the 143 patients included in the analysis, active TB was diagnosed in 100 (69.9%. There were 141 male patients, none of whom had immunosuppressive disease. The sensitivity, specificity, positive predictive value (PPV, and negative predictive value (NPV of TST were 94% (95% CI, 87-98%, 88% (95% CI, 74-96%, 95% (95% CI, 88-98%, and 86% (95% CI, 72-94%, respectively. The sensitivity, specificity, PPV, and NPV of the QFT-IT were 93% (95% CI, 86-97%, 95% (95% CI, 81-99%, 98% (95% CI, 92-99%, and 84% (95% CI, 69-93%, respectively. No significant differences were found between the TST and QFT-IT in any statistic. Conclusions Both the TST and QFT-IT showed high sensitivity and specificity in differentiating active TB from other diseases. The diagnostic accuracy of these two tests did not differ significantly when applied to this clinical population of young, immunocompetent adults in whom neonatal BCG vaccination was common, there was no history of previous TB and in whom suspicion of TB was high. Trial registration ClinicalTrials.gov: NCT00982969

  2. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and ... drugs, and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical ...

  4. Mucoceles of minor salivary glands in children. Own clinical observations.

    Science.gov (United States)

    Lewandowski, Bogumił; Brodowski, Robert; Pakla, Paweł; Makara, Aleksander; Stopyra, Wojciech; Startek, Bartek

    Mucoceles are benign lesions associated with the pathology of the oral mucosa of minor salivary glands. Two types of cysts are distinguished depending on their pathogenesis. Most often they occur as a result of mechanical trauma and mucus extravasation into tissues or obstruction of the gland ducts. The aim of the study was to present our own experiences regarding mucoceles of minor salivary glands in the oral cavity taking into account how frequently the individual types of cysts occur in children. The research was carried out based on medical files from the years 2005-2015. These were: medical case records, operating books and the medical registry of patients treated at the Clinic of Maxillofacial Surgery, Frederic Chopin Clinical Regional Hospital in Rzeszow. In that period 64 children and teenagers, 28 girls and 36 boys were treated. What was considered was the age and gender of the patients, the reason for their appointment with a doctor, the location, size and histopathological type of the cysts, as well as the course and results of the diagnostic and therapeutic process. In the group analyzed, the reasons for referral to the Clinic were: in 25 patients accidental ascertainment of a non-symptomatic tumor in the oral cavity during examination by a dentist, pediatrician or laryngologist which had not caused any discomfort to the children; in 13 patients concern had been raised by a gradually increasing tumor; in 18 cases there was an increased tissue tension surrounding the tumor, while in 3 children red oedema was observed in the oral cavity (suspicion of abscess). The most frequent mucocele location was the lower lip (34 children). The most frequent size was 2.1-3 cm (28 children). The most frequent histological type was MEP. All the patients were treated at the Clinic in the one-day surgery mode, with good outcome. Mucocele ascertainment in children's oral cavity could be made accidentally in routine pediatric examination, therefore it is necessary to extend

  5. Integrating clinical and genetic observations in facioscapulohumeral muscular dystrophy

    NARCIS (Netherlands)

    Mul, K.; Boogaard, M.L. van den; Maarel, S.M. van der; Engelen, B.G.M. van

    2016-01-01

    PURPOSE OF REVIEW: This review gives an overview of the currently known key clinical and (epi)genetic aspects of facioscapulohumeral muscular dystrophy (FSHD) and provides perspectives to facilitate future research. RECENT FINDINGS: Clinically, imaging studies have contributed to a detailed

  6. Evaluation of functional rehabilitation physiotherapy protocol in the postoperative patients with anterior cruciate ligament reconstruction through clinical prognosis: an observational prospective study

    OpenAIRE

    do Carmo Almeida, Tabata Cristina; de Alcantara Sousa, Luiz Vinicius; de Melo Lucena, Diego Monteiro; dos Santos Figueiredo, Francisco Winter; Valenti, Vitor Engr?cia; da Silva Paiva, La?rcio; de Abreu, Luiz Carlos; Adami, Fernando

    2016-01-01

    Abstract Background The aim of the study was to evaluate the evolution of patients subject to physical treatment based on guidelines of functional rehabilitation after surgery anterior cruciate ligament reconstruction. Methods This is a prospective study of 177 patients with anterior cruciate ligament injury, who underwent surgery and physical therapy guideline con...

  7. Liver support by extracorporeal blood purification: a clinical observation.

    Science.gov (United States)

    Stange, J; Mitzner, S R; Klammt, S; Freytag, J; Peszynski, P; Loock, J; Hickstein, H; Korten, G; Schmidt, R; Hentschel, J; Schulz, M; Löhr, M; Liebe, S; Schareck, W; Hopt, U T

    2000-09-01

    Liver failure associated with excretory insufficiency and jaundice results in an endogenous accumulation of toxins involved in the impairment of cardiovascular, kidney, and cerebral function. Moreover, these toxins have been shown to damage the liver itself by inducing hepatocellular apoptosis and necrosis, thus creating a vicious cycle of the disease. We report a retrospective cohort study of 26 patients with acute or chronic liver failure with intrahepatic cholestasis (bilirubin level > 20 mg/dL) who underwent a new extracorporeal blood purification treatment. A synthetic hydrophilic/hydrophobic domain-presenting semipermeable membrane (pore size MARS]). Bile acid and bilirubin levels, representing the previously described toxins, were reduced by 16% to 53% and 10% to 90% of the initial concentration by a single treatment of 6 to 8 hours, respectively. Toxicity testing of patient plasma onto primary rat hepatocytes by live/dead fluorescence microscopy showed cell-damaging effects of jaundiced plasma that were not observed after treatment. Patients with a worsening of Child-Turcotte-Pugh (CTP) index before the treatments showed a significant improvement of this index during a period of 2 to 14 single treatments with an average of 14 days. After withdrawal of MARS treatment, this improvement was sustained in all long-term survivors. Ten patients represented a clinical status equivalent to the United Network for Organ Sharing (UNOS) status 2b (group A1), and all survived. Sixteen patients represented a clinical status equivalent to UNOS status 2a, and 7 of these patients survived (group A2), whereas 9 patients (group B) died. We conclude that in acute excretory failure caused by a chronic liver disease, this treatment provides a therapy option to remove toxins involved in multiorgan dysfunction secondary to liver failure.

  8. AN OBSERVATIONAL CLINICAL STUDY OF ASSESSING THE UTILITY OF PSS (POISON SEVERITY SCORE AND GCS (GLASGOW COMA SCALE SCORING SYSTEMS IN PREDICTING SEVERITY AND CLINICAL OUTCOMES IN OP POISONING

    Directory of Open Access Journals (Sweden)

    S. Chandrasekhar

    2017-05-01

    Full Text Available BACKGROUND Organophosphorus compound poisoning is the most common poisonings in India because of easy availability often requiring ICU care and ventilator support. Clinical research has indicated that respiratory failure is the most important cause of death due to organophosphorus poisoning. It results in respiratory muscle weakness, pulmonary oedema, respiratory depression, increased secretions and bronchospasm. These complications and death can be prevented with timely institution of ventilator support. MATERIALS AND METHODS Hundred consecutive patients admitted with a history of organophosphorus poisoning at Kurnool Medical College, Kurnool, were taken for study after considering the inclusion and exclusion criteria. Detailed history, confirmation of poisoning, examination and other than routine investigations, serum pseudocholinesterase and arterial blood gas analysis was done. The severity and clinical outcomes in OP poisoning is graded by PSS (poison severity score and GCS (Glasgow coma scale scoring systems. RESULTS This study was conducted in 100 patients with male preponderance. Majority of poisoning occurred in 21-30 age group (n=5. Most common compound consumed in our study was methyl parathion and least common was phosphoran. Slightly more than half of the patients consumed less than 50 mL of poison. 21 patients consumed between 50 to 100 mL. Distribution of poison severity score of patients studied showed 45 cases of grade 1 poisoning. 26 cases of grade 2 poisoning, 23 cases of grade 3 poisoning and 6 cases of grade 4 poisoning (death within first 24 hours. Distribution of GCS score of patients studied GCS scores were <10 in 25 patients at admission and 24 patients after 24 hours. GCS scores were ≥10 in 75 patients at admission and 76 patients after 24 hours. Poison severity score is not prognostic, but merely defines severity of OP poisoning at a given time. CONCLUSION Both Glasgow coma scale and poison severity scoring systems

  9. Evaluation of functional rehabilitation physiotherapy protocol in the postoperative patients with anterior cruciate ligament reconstruction through clinical prognosis: an observational prospective study

    National Research Council Canada - National Science Library

    do Carmo Almeida, Tabata Cristina; de Alcantara Sousa, Luiz Vinicius; de Melo Lucena, Diego Monteiro; dos Santos Figueiredo, Francisco Winter; Valenti, Vitor Engrácia; da Silva Paiva, Laércio; de Abreu, Luiz Carlos; Adami, Fernando

    2016-01-01

      Background The aim of the study was to evaluate the evolution of patients subject to physical treatment based on guidelines of functional rehabilitation after surgery anterior cruciate ligament reconstruction...

  10. Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain

    National Research Council Canada - National Science Library

    Xia, Ting; Wilder, David G; Gudavalli, Maruti R; DeVocht, James W; Vining, Robert D; Pohlman, Katherine A; Kawchuk, Gregory N; Long, Cynthia R; Goertz, Christine M

    2014-01-01

    .... The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... These phases have different purposes and help researchers answer different questions. For example, phase I clinical trials test new ... importance of children in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional ...

  12. Digital breast tomosynthesis: a pilot observer study.

    Science.gov (United States)

    Good, Walter F; Abrams, Gordon S; Catullo, Victor J; Chough, Denise M; Ganott, Marie A; Hakim, Christiane M; Gur, David

    2008-04-01

    The objective of our study was to assess ergonomic and diagnostic performance-related issues associated with the interpretation of digital breast tomosynthesis-generated examinations. Thirty selected cases were read under three different display conditions by nine experienced radiologists in a fully crossed, mode-balanced observer performance study. The reading modes included full-field digital mammography (FFDM) alone, the 11 low-dose projections acquired for the reconstruction of tomosynthesis images, and the reconstructed digital breast tomosynthesis examination. Observers rated cases under the free-response receiver operating characteristic, as well as a screening paradigm, and provided subjective assessments of the relative diagnostic value of the two digital breast tomosynthesis-based image sets as compared with FFDM. The time to review and diagnose each case was also evaluated. Observer performance measures were not statistically significant (p > 0.05) primarily because of the small sample size in this pilot study, suggesting that showing significant improvements in diagnosis, if any, will require a larger study. Several radiologists did perceive the digital breast tomosynthesis image set and the projection series to be better than FFDM (p < 0.05) for diagnosing this specific case set. The time to review, interpret, and rate the examinations was significantly different for the techniques in question (p < 0.05). Tomosynthesis-based breast imaging may have great potential, but much work is needed before its optimal role in the clinical environment is known.

  13. Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial

    Directory of Open Access Journals (Sweden)

    Hengwei Jin

    2017-09-01

    Discussion: The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

  14. More co-morbid depression in patients with Type 2 diabetes with multiple complications. An observational study at a specialized outpatient clinic

    NARCIS (Netherlands)

    van Steenbergen-Weijenburg, K.M.; van Puffelen, A.L.; Horn, E.K.; v.d. Nuyen, J.; van Dam, P.S.; van Benthem, T.B.; Beekman, A.T.F.; Rutten, F.F.H.; Hakkaart-van Roijen, L.; van der Feltz-Cornelis, C.

    2011-01-01

    Aims: The impact of depression on patients with chronic medical illnesses such as diabetes is well documented. Depression is relatively common in diabetes patients with diabetes-related complications and they are more likely to be referred to specialized outpatient facilities. Only a few studies

  15. Transfusion burden in non-dialysis chronic kidney disease patients with persistent anemia treated in routine clinical practice: a retrospective observational study

    Directory of Open Access Journals (Sweden)

    Fox Kathleen M

    2012-01-01

    Full Text Available Abstract Background Transfusion patterns are not well characterized in non-dialysis (ND chronic kidney disease (CKD patients. This study describes the proportion of patients transfused, units of blood transfused and trigger-hemoglobin (Hb levels for transfusions in severe anemic, ND-CKD patients in routine practice. Methods A retrospective cohort study of electronic medical record data from the Henry Ford Health System identified 374 adult, ND-CKD patients with severe anemia (Hb Results At least 1 transfusion (mean of 2 units; range, 1-4 was administered to 20% (75/374 of ND-CKD patients with mean (± SD follow-up of 459 (± 427 days. The mean (± SD Hb level closest and prior to a transfusion was 8.8 (± 1.5 g/dL. Patients who were hospitalized in the 6 months prior to their first anemia diagnosis were 6.3 times more likely to receive a blood transfusion than patients who were not hospitalized (p Conclusions Transfusions were prevalent and the trigger hemoglobin concentration was approximately 9 g/dL among ND-CKD patients with anemia. To reduce the transfusion burden, clinicians should consider other anemia treatments including ESA therapy.

  16. UFOs: Observations, Studies and Extrapolations

    CERN Document Server

    Baer, T; Barnes, M J; Bartmann, W; Bracco, C; Carlier, E; Cerutti, F; Dehning, B; Ducimetière, L; Ferrari, A; Ferro-Luzzi, M; Garrel, N; Gerardin, A; Goddard, B; Holzer, E B; Jackson, S; Jimenez, J M; Kain, V; Zimmermann, F; Lechner, A; Mertens, V; Misiowiec, M; Nebot Del Busto, E; Morón Ballester, R; Norderhaug Drosdal, L; Nordt, A; Papotti, G; Redaelli, S; Uythoven, J; Velghe, B; Vlachoudis, V; Wenninger, J; Zamantzas, C; Zerlauth, M; Fuster Martinez, N

    2012-01-01

    UFOs (“ Unidentified Falling Objects”) could be one of the major performance limitations for nominal LHC operation. Therefore, in 2011, the diagnostics for UFO events were significantly improved, dedicated experiments and measurements in the LHC and in the laboratory were made and complemented by FLUKA simulations and theoretical studies. The state of knowledge is summarized and extrapolations for LHC operation in 2012 and beyond are presented. Mitigation strategies are proposed and related tests and measures for 2012 are specified.

  17. The role of unfractionated heparin for the antiaggregatory effect of aspirin in patients undergoing carotid endarterectomy: Results of an observational clinical study.

    Science.gov (United States)

    Brenner, Thorsten; Schmitt, Felix Cf; Demirel, Serdar; Salgado, Eduardo; Celi de la Torre, Juan Antonio; Göring, Martin; Bruckner, Thomas; Böckler, Dittmar; Weigand, Markus A; Hofer, Stefan; Attigah, Nicolas

    2017-02-01

    The aims of the present study were to examine the influence of a low-dose unfractionated heparin regime on platelet aggregation and to additionally assess the prevalence of primary aspirin resistance in patients undergoing carotid endarterectomy. Therefore, 50 patients undergoing carotid endarterectomy were enrolled. A bolus of 3000 IU unfractionated heparin was administered 2 min before carotid cross-clamping additionally to standard antiaggregatory therapy. Haemostaseological point of care testing was performed twice, prior to surgery and 10 min after unfractionated heparin administration by the use of aggregometric and viscoelastic point of care testing. Following unfractionated heparin administration, the activated partial thromboplastin time increased significantly and clotting time in viscoelastic INTEM test was shown to be significantly prolonged. In contrast, the antiaggregatory effect of aspirin was not diminished in aggregometric ASPI test. A low-dose unfractionated heparin regime during carotid endarterectomy was therefore considered to be safe, without diminishing the antiplatelet effect of aspirin. Moreover, aggregometric point of care testing was identified to be a suitable tool for the identification of patients with primary aspirin resistance ( n = 3).

  18. Observation on clinical effects of comprehensive treatment for blepharospasm

    Directory of Open Access Journals (Sweden)

    Qi-Ling Peng

    2016-07-01

    Full Text Available AIM: To observe the effect of compound anisodine injection combined with yi-qi-tong-luo acupuncture, hot compress and massage for blepharospasm. METHODS: Selected in our hospital, 60 cases(78 eyeswith blepharospasm were randomly divided into two groups, 30 cases 39 eyes in each group. The observation group were treated with compound anisodine injection combined with yi-qi-tong-luo acupuncture treatment, and supplemented by hot compress and massage, while the control group only with compound anisodine injection. We compared the treatment effect of the two groups. RESULTS: In the observation group, 38 eyes were clinically effective, 1 eye was invalid, 35 eyes marked, the total effective rate was 97%, the markedly effective rate was 90%; in control group, 32 eyes were the clinically effective, 7 eyes invalid, 23 eyes marked, the total effective rate was 82%, the markedly effective rate was 59%; the total effective rate and markedly effective rate of observation group were higher than those of the control group with statistical difference(PPCONCLUSION: The compound anisodine injection combined with yi-qi-tong-luo acupuncture, hot compress and massage for blepharospasm, can significantly improve the efficiency of treatment, with higher effective rate and lower recurrence rate, compared with using compound anisodine alone.

  19. Clinical observation of intravitreal injection of Conbercept treating diabetic macularedema

    Directory of Open Access Journals (Sweden)

    Li Jiang

    2017-06-01

    Full Text Available AIM: To observe the clinical efficiency of intravitreal conbercept on diabetic macular edema(DME. METHODS: This was a single arm, open-babel prospective study. Twenty eyes from 20 patients(12 males and 8 femaleswith DME diagnosed by fundus fluorescein angiography(FFAand optical coherence tomography(OCTwere enrolled. Before the injection, best-corrected visual acuity(BCVAof early treatment of diabetic retinopathy study(ETDRS, non-contact tonometer, ophthalmoscope, fundus photography, fundus fluoresein angiograph(FFA, and OCT were examined. All affected eyes were treated with intravitreal conbercept 0.05mL(10mg/mL. Patients were followed up for 6 to 11mo, with a mean duration of 8.55±1.96mo. Post-treatment BCVA, CMT, leakage of macular edema and complications were compared with baseline using repeat analysis. RESULTS: The initial average visual acuity(ETDRS letterswere 43.35±17.45, range from 9 to 70. The initial average central macular thickness(CMTwas 576.30±167.92μm, range from 337 to 987μm. The mean BCVA showed significant improvement during 1, 3, 6mo post-treatment and the latest follow up, with a mean increase of 11.2±5.9, 13.8±7.9, 15.7±6.8 and 14.7±8.6, respectively(PPPPCONCLUSION: Intravitreal conbercept significantly improve visual acuity and macular edema exudation.

  20. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... NHLBI study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that ... trials is a high priority for clinical researchers. Each trial has scientific ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... or they may even answer the NIH study's research question. Scientific oversight informs decisions about a trial while ... in clinical studies and get answers to common questions. NIH Clinical Research Trials and You Get additional guidance on participating ...

  2. Noninterventional studies of depot formulations of LHRH analogues for prostate cancer in routine clinical practice. The launch of an observational program to assess the use of Eligard 45 mg in Russia

    Directory of Open Access Journals (Sweden)

    V. B. Matveev

    2015-03-01

    Full Text Available Open-label observational studies can objectively assess treatment in routine clinical practice, which is important from both the scientific and pharmacoeconomical points of view. In 2013, a multicenter open-label prospective observational EQUILIBRIUM study was initiated to describe the Russian experience with Eligard 45 mg used to treat disseminated prostate cancer (PC in routine clinical practice. A total of 623 patients who had different stages of PC and had been previously treated for this condition were included in the program. The mean age of the patients was 68.9±8.55 years; their mean level of prostate-specific antigen was equal to 42.2 ng/ml and that of testosterone was 89 ng/dl. At the same time, pretreatment testosterone concentrations were measured in only one third of the patients. When included in the program, the patients had a rather high quality of life as evidenced by the EQ-5D-5L questionnaire: its mean index was 0.84±0.18 scores (complete well-being was taken as 1; the mean visual analogue scale health status scores were 75.15±16.5 mm (0, worst health; 100, best health. During the study, most patients received hormone therapy with Eligard 45 for locally advanced PC and distant metastases were detectable in only 15.89 % of the patients. 

  3. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... help produce reliable study results. Clinical trials are one of the final stages of a long and ... trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of lowering ...

  4. [Surgical treatment of experimental liver injuries in dogs with special evaluation of Polish-made cyanoacrylic glue. I. Clinical observations, morphological and biochemical studies of blood and autopsy studies].

    Science.gov (United States)

    Studnicki, W

    1979-01-01

    Liver wounds were experimentally induced in dogs. The wounds were dressed with catgut suture, suture and fibrinous sponge and ester n-butyl alfa-cyanoacrylic acid in aerosol form obtained laboratorially at the Institute of Organic Chemistry--Polish Academy of Sciences in Warsaw. The basis for evaluation were clinical observations of the operated animals, morphological and biochemical examination of blood and dissection. It was found that the best results were achieved with the surgical glue. Application of this monomer in aerosol form to join and dress liver wounds helps to close them tightly in a short time and obtain full hemostasis and stop bile leaking.

  5. Clinical disorders observed in a beagle breeding colony.

    Science.gov (United States)

    Fukuda, S; Iida, H; Oghiso, Y; Matsuoka, O

    1985-01-01

    Disorders in a beagle breeding colony were discussed, based on 472 clinical charts made in 1974-1983. In 201 neonates less than a week old, hypothermia associated with pneumonia was mostly seen. In 31 puppies from one week to two months old and in 46 young dogs from two months to a year old, pneumonia, canine parvovirus infection, dermal abscess and dermatosis were mostly found. In 91 dogs aged from one to five, trauma, intervertebral disc protrusion, dermal abscess, dystocia, claudication and otohematoma were frequently noted. In 103 animals over five years old, intervertebral disc protrusion, tumors, abscess, trauma and otohematoma were observed most often.

  6. Clinical observations during virtual reality therapy for specific phobias.

    Science.gov (United States)

    Wiederhold, B K; Wiederhold, M D

    1999-01-01

    Virtual environments offer a new method of providing exposure therapy to patients with specific phobias. Although the stimuli (three-dimensional computer simulations) is new, the method of systematically desensitizing the patient to phobic stimuli until habituation occurs is a concept that was formally introduced by Joseph Wolpe over 40 years ago. Our article discusses some of the clinical observations that have been made during nearly 500 virtual reality exposure therapy sessions with patients and research participants who have come to our center in the past 15 months with a fear of flying or driving.

  7. Prognosis in hypertrophic cardiomyopathy observed in a large clinic population

    NARCIS (Netherlands)

    M.J.M. Kofflard (Marcel); D.J. Waldstein; J. Vos (Jeroen); F.J. ten Cate (Folkert)

    1993-01-01

    textabstractOverall annual cardiac mortality in hypertrophic cardiomyopathy (HC) has been reported to be between 2 and 4%, although these numbers are primarily from retrospective studies of patients referred to large research institutions. A clinic population of 113 patients with HC was

  8. Observer bias in randomized clinical trials with measurement scale outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2013-01-01

    conducted a systematic review of randomized clinical trials with both blinded and nonblinded assessment of the same measurement scale outcome. We searched PubMed, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press and Google Scholar for relevant studies. Two...

  9. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    : PubMed, Embase, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press, and Google Scholar. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. RESULTS: We included 21 trials in the main...

  10. Liraglutide effect and action in diabetes-In (LEAD-In: A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India

    Directory of Open Access Journals (Sweden)

    Subhash Kumar Wangnoo

    2016-01-01

    Full Text Available Background: This 26-week, open-label observational study assessed the incidence and type of adverse events (AEs associated with liraglutide use according to the standard clinical practice settings and the local label in India. Materials and Methods: A total of 1416 adults with type 2 diabetes (T2D treated with liraglutide in 125 sites across India were included in the study. Participants were newly diagnosed or already receiving antidiabetic medications. Safety and efficacy data were collected at baseline and at approximately weeks 13 and 26. The primary outcome was incidence and type of AEs while using liraglutide, with events classified by Medical Dictionary for Regulatory Activities system organ class and preferred term. The secondary objective was to assess other clinical parameters related to effective T2D management. Results: Twenty AEs, predominately gastrointestinal, were reported in 1.3% of the study population in scheduled visits up to week 26. No serious AEs, including death, were reported. Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 0.4%. Glycated hemoglobin was reduced from baseline (8.8 ± 1.3% to week 26 by 1.6 ± 1.1% (P < 0.0001; significant improvements in fasting blood glucose, and 2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner were also observed. Mean body weight decreased by 8.1 ± 6.5 kg from baseline (92.5 ± 14.6 kg; P< 0.0001. Conclusions: From the number of AEs reported, it is suggested that liraglutide was well tolerated in subjects with T2D treated under standard clinical practice conditions in India. Liraglutide was effective, and no new safety concerns were identified.

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... and Clinical Studies Learn about the importance of children in clinical ... America's research hospital, located on the NIH campus in Bethesda, Maryland. ...

  12. Using systematically observed clinical encounters (SOCEs to assess medical students’ skills in clinical settings

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    George R Bergus

    2010-11-01

    Full Text Available George R Bergus1–3, Jerold C Woodhead4, Clarence D Kreiter2,51Performance Based Assessment Program, Office of Student Affairs and Curriculum, 2Department of Family Medicine, 3Department of Psychiatry, 4Department of Pediatrics, 5Office of Consultation and Research in Medical Education, Roy J and Lucille A Carver College of Medicine, The University of Iowa, Iowa City, IA, USAIntroduction: The Objective Structured Clinical Examination (OSCE is widely used to assess the clinical performance of medical students. However, concerns related to cost, availability, and validity, have led educators to investigate alternatives to the OSCE. Some alternatives involve assessing students while they provide care to patients – the mini-CEX (mini-Clinical Evaluation Exercise and the Long Case are examples. We investigated the psychometrics of systematically observed clinical encounters (SOCEs, in which physicians are supplemented by lay trained observers, as a means of assessing the clinical performances of medical students.Methods: During the pediatrics clerkship at the University of Iowa, trained lay observers assessed the communication skills of third-year medical students using a communication checklist while the students interviewed and examined pediatric patients. Students then verbally presented their findings to faculty, who assessed students’ clinical skills using a standardized form. The reliability of the combined communication and clinical skills scores was calculated using generalizability theory.Results: Fifty-one medical students completed 199 observed patient encounters. The mean combined clinical and communication skills score (out of a maximum 45 points was 40.8 (standard deviation 3.3. The calculated reliability of the SOCE scores, using generalizability theory, from 10 observed patient encounters was 0.81. Students reported receiving helpful feedback from faculty after 97% of their observed clinical encounters.Conclusion: The SOCE can

  13. Assessing observational studies of medical treatments

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    Butani Yogita

    2005-09-01

    Full Text Available Abstract Background Previous studies have assessed the validity of the observational study design by comparing results of studies using this design to results from randomized controlled trials. The present study examined design features of observational studies that could have influenced these comparisons. Methods To find at least 4 observational studies that evaluated the same treatment, we reviewed meta-analyses comparing observational studies and randomized controlled trials for the assessment of medical treatments. Details critical for interpretation of these studies were abstracted and analyzed qualitatively. Results Individual articles reviewed included 61 observational studies that assessed 10 treatment comparisons evaluated in two studies comparing randomized controlled trials and observational studies. The majority of studies did not report the following information: details of primary and ancillary treatments, outcome definitions, length of follow-up, inclusion/exclusion criteria, patient characteristics relevant to prognosis or treatment response, or assessment of possible confounding. When information was reported, variations in treatment specifics, outcome definition or confounding were identified as possible causes of differences between observational studies and randomized controlled trials, and of heterogeneity in observational studies. Conclusion Reporting of observational studies of medical treatments was often inadequate to compare study designs or allow other meaningful interpretation of results. All observational studies should report details of treatment, outcome assessment, patient characteristics, and confounding assessment.

  14. Assigning ethical weights to clinical signs observed during toxicity testing.

    Science.gov (United States)

    Ringblom, Joakim; Törnqvist, Elin; Hansson, Sven Ove; Rudén, Christina; Öberg, Mattias

    2017-01-01

    Reducing the number of laboratory animals used and refining experimental procedures to enhance animal welfare are fundamental questions to be considered in connection with animal experimentation. Here, we explored the use of cardinal ethical weights for clinical signs and symptoms in rodents by conducting trade-off interviews with members of Swedish Animal Ethics Committees in order to derive such weights for nine typical clinical signs of toxicity. The participants interviewed represent researchers, politically nominated political nominees and representatives of animal welfare organizations. We observed no statistically significant differences between these groups with respect to the magnitude of the ethical weights assigned, though the political nominees tended to assign lower weights. Overall, hunched posture was considered the most severe clinical sign and body weight loss the least severe. The ethical weights assigned varied considerably between individuals, from zero to infinite value, indicating discrepancies in prioritization of reduction and refinement. Cardinal ethical weights may be utilized to include both animal welfare refinement and reduction of animal use in designing as well as in retrospective assessment of animal experiments. Such weights may also be used to estimate ethical costs of animal experiments.

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... these studies should be done. Patient Rights Informed Consent Informed consent is the process of giving clinical trial participants ... part and during the course of the trial. Informed consent includes details about the treatments and tests you ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... define health across the lifespan and will be part of a control group in future studies of ... boys and girls. Visit the Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial ( ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  1. Clinical Utility of Epstein-Barr Virus Viral Load Monitoring and Risk Factors for Posttransplant Lymphoproliferative Disorders After Kidney Transplantation: A Single-Center, 10-Year Observational Cohort Study

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    Erica Franceschini, MD

    2017-07-01

    Conclusions. Our results suggest that the keystone of PTLD diagnosis is the clinical suspicion. Our study suggests that, in line with guidelines, EBV-VL assays may be avoided in low-risk patients in the absence of a strong clinical PTLD suspicion without increasing patients' risk of developing PTLD. This represents a safe and cost-saving clinical strategy for our center.

  2. Influence of treatment with alendronate on the speed of sound, an ultrasound parameter, of the calcaneus in postmenopausal Japanese women with osteoporosis: a clinical practice-based observational study

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    Iwamoto J

    2012-06-01

    Full Text Available Jun Iwamoto,1 Tetsuya Takada,2 Yoshihiro Sato,3 Hideo Matsumoto11Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, 2Department of Internal Medicine, Hiyoshi Medical Clinic, Kanagawa, 3Department of Neurology, Mitate Hospital, Fukuoka, JapanPurpose: The influence of alendronate (ALN treatment on the quantitative ultrasound parameters of the calcaneus remains to be established in Japanese patients. The aim of the present clinical practice-based observational study was to examine the influence of ALN treatment for 1 year on the speed of sound (SOS of the calcaneus and bone turnover markers in postmenopausal Japanese women with osteoporosis.Patients and methods: Forty-five postmenopausal Japanese women with osteoporosis who had received treatment with ALN for more than 1 year were enrolled in the study. The SOS and bone turnover markers were monitored over 1 year of ALN treatment.Results: The urinary levels of cross-linked N-terminal telopeptides of type I collagen and serum levels of alkaline phosphatase decreased significantly from the baseline values (–44.9% at 3 months and –22.2% at 12 months, respectively. The SOS increased modestly, but significantly, from the baseline value (0.6% at both 6 and 12 months. The percentage decrease in the urinary levels of cross-linked N-terminal telopeptides of type I collagen at 3 months was significantly correlated with the percentage increase in the SOS only at 6 months (correlation coefficient, 0.299.Conclusion: The present study confirmed that ALN treatment suppressed bone turnover, producing a clinically significant increase in the SOS of the calcaneus in postmenopausal Japanese women with osteoporosis.Keywords: postmenopausal osteoporosis, quantitative ultrasound (QUS, SOS, bone turnover, biochemical markers

  3. Laparoscopic anterior pelvic exenteration with sigmoid colon resection (clinical observation

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    A. O. Rasulov

    2017-01-01

    Full Text Available The clinical observation demonstrates a successful surgical treatment of a 61-year-old female patient K. (body mass index 38.4 diagnosed with locally advanced sigmoid colon cancer protruded into the bladder and uterus (сT4bN2M0 with formation of a colovesical fistula. The patient underwent surgical treatment in the form of laparoscopic resection of the sigmoid colon and supralevator anterior pelvic exenteration with formation of a Bricker conduit. Intraoperative blood loss was 200 ml. Postoperative period was smooth, with fast track rehabilitation; the patient was discharged on day 9. Considering cancer stage, the patient received XELOX as adjuvant chemotherapy for 6 months after the surgery. During a year of follow-up, no signs of disease progression were evident. The patient is fully socially rehabilitated.  

  4. Clinical observation of modified hydroxyapatite implant in scleral shell

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    Qing-Wei Du

    2014-10-01

    Full Text Available AIM: To evaluate the clinical effects of modified hydroxyapatite implant in scleral shell.METHODS:Thirty-four cases were performed eye evisceration, autogenous sclera shell anterior and posterior petaloid shape with posterior sclera fenestration, hydroxyapatite artificial eyeballs were implanted at stage I, and conjunctival wound, orbital activity and other complications were observed after surgery.RESULTS: The follow-up was 6~12mo. There was no patients with implant exposure, sclera dissolution, conjunctival wound dehiscence, conjunctival sac constriction noted. All the patients got good activity of artificial globe, and the active range of side motion of the HA was 10°~15°.The artificial eyes looked symmetrical, and the eyes socket were full.CONCLUSION: The modified hydroxyapatite implant in scleral shell can maintain the normal anatomy of the orbital tissue, and also can get full eyes socket and good activity, It was an easy and simple surgery which could obtain satisfactory clinical effect and less complications.

  5. Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

    Science.gov (United States)

    Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

    2017-06-01

    ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

  6. Cutaneous anthrax of the hand: Some clinical observations

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    Tuncali Dogan

    2004-01-01

    Full Text Available CONTEXT: Anthrax is a very rare disease in Europe and the United States. AIM: A case of cutaneous anthrax of the hand with a wide skin defect is presented and some clinical observations highlighted. CASE REPORT: A 56-year-old male patient with cutaneous anthrax attended our infectious diseases department with a swelling up to the upper arm. An urgent fasciotomy was undertaken with a diagnosis of compartment syndrome. A black eschar had formed on the dorsal surface of the hand. A superficial tangential escharectomy was performed. RESULTS: Viable fibrous tissue, about 4 to 5 mm in thickness over the extensor tendons, was found under the eschar. At the postoperative 2-year follow-up, remarkable healing was observed via skin grafting. CONCLUSIONS: Hand surgeons should be cautious against the compartment syndrome that may accompany cutaneous anthrax of the hand. A consistent viable fibrous tissue can be found below the eschar. The mechanism for the involvement of the hand dorsum needs further concern.

  7. Using video observation to gain insight into complex clinical work practices.

    Science.gov (United States)

    Hostgaard, Anna Marie Balling; Bertelsen, Pernille

    2012-01-01

    Experience shows that the precondition for development of successful health-information-technologies (HIT) is a thorough insight into clinical work practices. In contemporary clinical work practices, clinical work and health information technology are closely integrated. Research within Virtual Centre for Health Informatics at Aalborg University, Denmark have during recent years focused on video observation to supplementing traditional ethnographical research methods in providing insight into complex clinical work practices. The objective of this paper is to argue for the potentials of the video observation method to inform and to improve HIT development compared to traditional ethnographic methods. Based on several studies conducted within the healthcare sector, we find, that the video observation method is superior to other ethnographical research methods when it comes to rapidly disclosing the complexity in clinical sociomaterial work practices. We also find that the video techniques used in the healthcare context allows us to revisit the field of observation through the data, to broaden our initial focus and to share data with both the clinical staff involved and other researchers. Hence, it provides us a more in depth insight in the complex clinical sociomaterial work practices than when observing by the use of pen and paper.

  8. Clinical evaluation of 860 anterior and posterior lithium disilicate restorations: retrospective study with a mean follow-up of 3 years and a maximum observational period of 6 years.

    Science.gov (United States)

    Fabbri, Giacomo; Zarone, Fernando; Dellificorelli, Gianluca; Cannistraro, Giorgio; De Lorenzi, Marco; Mosca, Alberto; Sorrentino, Roberto

    2014-01-01

    This study aimed to assess the clinical performance of lithium disilicate restorations supported by natural teeth or implants. Eight hundred sixty lithium disilicate adhesive restorations, including crowns on natural teeth and implant abutments, veneers, and onlays, were made in 312 patients. Parafunctional patients were included, but subjects with uncontrolled periodontitis and gingival inflammation were excluded. Veneers up to 0.5 mm thick were luted with flowable composite resin or light curing cements, while dual-curing composite systems were used with veneers up to 0.8 mm thick. Onlays up to 2 mm in thickness were luted with flowable composite resins or dual-curing composite cements. Crowns up to 1 mm in thickness were cemented with self-adhesive or dual-curing resin cements. The observational period ranged from 12 to 72 months, with a mean follow-up of 3 years. The mechanical and esthetic outcomes of the restorations were evaluated according to the modified California Dental Association (CDA) criteria. Data were analyzed with descriptive statistics. Twenty-six mechanical complications were observed: 17 porcelain chippings, 5 fractures, and 4 losses of retention. Structural drawbacks occurred mainly in posterior segments, and monolithic restorations showed the lowest number of mechanical complications. The clinical ratings of the successful restorations, both monolithic and layered, were satisfactory according to the modified CDA criteria for color match, porcelain surface, and marginal integrity. The cumulative survival rates of lithium disilicate restorations ranged from 95.46% to 100%, while cumulative success rates ranged from 95.39% to 100%. All restorations recorded very high survival and success rates. The use of lithium disilicate restorations in fixed prosthodontics proved to be effective and reliable in the short- and medium-term.

  9. A large, multicentre, observational, post-marketing surveillance study of the 2:1 formulation of follitropin alfa and lutropin alfa in routine clinical practice for assisted reproductive technology.

    Science.gov (United States)

    Bühler, Klaus; Naether, Olaf G J; Bilger, Wilma

    2014-01-14

    Follicle-stimulating hormone (FSH) and luteinizing hormone (LH) both have a role to play in follicular development during the natural menstrual cycle. LH supplementation during controlled ovarian stimulation (COS) for assisted reproductive technology (ART) is used for patients with hypogonadotropic hypogonadism. However, the use of exogenous LH in COS in normogonadotropic women undergoing ART is the subject of debate. The aim of this study was to investigate characteristics of infertile women who received the 2:1 formulation of follitropin alfa and lutropin alfa (indicated for stimulation of follicular development in women with severe LH and FSH deficiency) in German clinical practice. A 3-year, multicentre, open-label, observational/non-interventional, post-marketing surveillance study of women (21-45 years) undergoing ART. Primary endpoint: reason for prescribing the 2:1 formulation of follitropin alfa and lutropin alfa. Secondary variables included: COS duration/dose; oocytes retrieved; fertilization; clinical pregnancy; ovarian hyperstimulation syndrome (OHSS). In total, 2220 cycles were assessed; at least one reason for prescribing the 2:1 formulation was given in 1834/2220 (82.6%) cycles. Most common reasons were: poor ovarian response (POR) (39.4%), low baseline LH (17.8%), and age (13.8%). COS: mean dose of the 2:1 formulation on first day, 183.1/91.5 IU; mean duration, 10.8 days. In 2173/2220 (97.9%) cycles, human chorionic gonadotrophin was administered. Oocyte pick-up (OPU) was attempted in 2108/2220 (95.0%) cycles; mean (standard deviation) 8.0 (5.4) oocytes retrieved/OPU cycle. Fertilization (≥1 oocyte fertilized) rates: in vitro fertilization (IVF), 391/439 (89.1%) cycles; intracytoplasmic sperm injection (ICSI)/IVF + ICSI, 1524/1613 (94.5%) cycles. Clinical pregnancy rate: all cycles, 25.9%; embryo transfer cycles, 31.3%. OHSS: hospitalization for OHSS, 8 (0.36%) cycles, Grade 2, 60 (2.7%), and Grade 3, 1 (0.05%). In German routine clinical

  10. Compliance of blood sampling procedures with the CLSI H3-A6 guidelines: An observational study by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PRE).

    Science.gov (United States)

    Simundic, Ana-Maria; Church, Stephen; Cornes, Michael P; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Nikolac, Nora; van Dongen-Lases, Edmee; Eker, Pinar; Kovalevskaya, Svjetlana; Kristensen, Gunn B B; Sprongl, Ludek; Sumarac, Zorica

    2015-08-01

    An observational study was conducted in 12 European countries by the European Federation of Clinical Chemistry and Laboratory Medicine Working Group for the Preanalytical Phase (EFLM WG-PRE) to assess the level of compliance with the CLSI H3-A6 guidelines. A structured checklist including 29 items was created to assess the compliance of European phlebotomy procedures with the CLSI H3-A6 guideline. A risk occurrence chart of individual phlebotomy steps was created from the observed error frequency and severity of harm of each guideline key issue. The severity of errors occurring during phlebotomy was graded using the risk occurrence chart. Twelve European countries participated with a median of 33 (18-36) audits per country, and a total of 336 audits. The median error rate for the total phlebotomy procedure was 26.9 % (10.6-43.8), indicating a low overall compliance with the recommended CLSI guideline. Patient identification and test tube labelling were identified as the key guideline issues with the highest combination of probability and potential risk of harm. Administrative staff did not adhere to patient identification procedures during phlebotomy, whereas physicians did not adhere to test tube labelling policy. The level of compliance of phlebotomy procedures with the CLSI H3-A6 guidelines in 12 European countries was found to be unacceptably low. The most critical steps in need of immediate attention in the investigated countries are patient identification and tube labelling.

  11. Ways of learning: Observational studies versus experiments

    Science.gov (United States)

    Shaffer, T.L.; Johnson, D.H.

    2008-01-01

    Manipulative experimentation that features random assignment of treatments, replication, and controls is an effective way to determine causal relationships. Wildlife ecologists, however, often must take a more passive approach to investigating causality. Their observational studies lack one or more of the 3 cornerstones of experimentation: controls, randomization, and replication. Although an observational study can be analyzed similarly to an experiment, one is less certain that the presumed treatment actually caused the observed response. Because the investigator does not actively manipulate the system, the chance that something other than the treatment caused the observed results is increased. We reviewed observational studies and contrasted them with experiments and, to a lesser extent, sample surveys. We identified features that distinguish each method of learning and illustrate or discuss some complications that may arise when analyzing results of observational studies. Findings from observational studies are prone to bias. Investigators can reduce the chance of reaching erroneous conclusions by formulating a priori hypotheses that can be pursued multiple ways and by evaluating the sensitivity of study conclusions to biases of various magnitudes. In the end, however, professional judgment that considers all available evidence is necessary to render a decision regarding causality based on observational studies.

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... purpose is to ensure that clinical trials are ethical and that the participants' rights are ... Safety Monitoring Board Every National Institutes of ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... children, more studies are needed focusing on children's health with the goal to ... education for parents, clinicians, researchers, children, and the general ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... known to work in adults. To improve clinical care of children, more studies are needed focusing on children's health with the goal to develop treatments, drugs, ... National Institutes of Health Department of Health and Human Services USA.gov

  15. Clinical observation on fibrin glue application during pterygium surgery

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    Qi-Feng Lei

    2015-02-01

    Full Text Available AIM:To observe the clinical results of pterygium excision combined with conjunctival autograft transplantation using fibrin glue.METHODS: A total of 60 patients(60 eyeswith primary nasal pterygium were randomly divided into two groups: the fibrin glue group(experimental group, 30 eyesand suture group(control group, 30 eyes. All patients underwent pterygium excision combined with conjunctival autograft transplantation. In the experimental group autograft was attached to sclera with fibrin glue while in control group 10-0 polyamide was used. The patients were followed up for 6mo. The time of operation, post operation comfort, complications and recurrence were evaluated. RESULTS:The average surgical time was 24.5±6.5min with fibrin glue group while 35.2±5.4min with suture group, with statistically significant difference between two groups(PPPCONCLUSION:It's a safe and effective way to attach conjunctival autograft during pterygium surgery by fibrin glue. It can reduce surgical time, postoperative complications and relieve postoperative discomfort.

  16. Usher syndrome in Denmark: mutation spectrum and some clinical observations.

    Science.gov (United States)

    Dad, Shzeena; Rendtorff, Nanna Dahl; Tranebjærg, Lisbeth; Grønskov, Karen; Karstensen, Helena Gásdal; Brox, Vigdis; Nilssen, Øivind; Roux, Anne-Françoise; Rosenberg, Thomas; Jensen, Hanne; Møller, Lisbeth Birk

    2016-09-01

    Usher syndrome (USH) is a genetically heterogeneous deafness-blindness syndrome, divided into three clinical subtypes: USH1, USH2 and USH3. Mutations in 21 out of 26 investigated Danish unrelated individuals with USH were identified, using a combination of molecular diagnostic methods. Before Next Generation Sequencing (NGS) became available mutations in nine individuals (1 USH1, 7 USH2, 1 USH3) were identified by Sanger sequencing of USH1C,USH2A or CLRN1 or by Arrayed Primer EXtension (APEX) method. Mutations in 12 individuals (7 USH1, 5 USH2) were found by targeted NGS of ten known USH genes. Five novel pathogenic variants were identified. We combined our data with previously published, and obtained an overview of the USH mutation spectrum in Denmark, including 100 unrelated individuals; 32 with USH1, 67 with USH2, and 1 with USH3. Macular edema was observed in 44 of 117 individuals. Olfactory function was tested in 12 individuals and found to be within normal range in all. Mutations that lead to USH1 were predominantly identified in MYO7A (75%), whereas all mutations in USH2 cases were identified in USH2A. The MYO7A mutation c.93C>A, p.(Cys31*) accounted for 33% of all USH1 mutations and the USH2A c.2299delG, p.(Glu767Serfs*21) variant accounted for 45% of all USH2 mutations in the Danish cohort.

  17. Clinical observation of glaucoma trabeculectomy with mitomycin C treatment

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    Shi Liu

    2014-12-01

    Full Text Available AIM:To explore the clinical outcome of trabeculectomy with mitomycin C(MMCon glaucoma. METHODS: A total of 57 patients(95 eyesof primary glaucoma were randomly divided into two groups, 31 patients(54 eyesin trabeculectomy with MMC(T+MMCgroup, which received trabeculectomy with 0.2mg/mL MMC in surgical sites, and 26 patients(41 eyesin trabeculectomy(Tgroup. The anterior chamber, bleb, intraocular pressure(IOPand complications were observed. The post-operative follow-up periods ranged between 4 and 6mo.RESULTS: The mean IOP was 11.24±3.73mmHg on 1d in group T+MMC. There was the significant difference compared with preoperative IOP(PP>0.05. At final follow-up, the IOP was significantly different between group T+MMC and group T(16.15±3.62mmHg vs 18.79±5.27mmHg, PPCONCLUSION: Trabeculectomy with MMC for glaucoma can effectively reduce postoperative scar formation of the filtration passage and lower the IOP to a target level with fewer complications.

  18. Clinical observation of transepithelial photorefractive keratectomy for myopia

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    Xiao-Ning Yang

    2013-10-01

    Full Text Available AIM: To assess the effectiveness and safety of transepithelial photorefractive keratectomy(TransPRKusing the AMARIS laser platform. METHODS: Eighty myopic cases(156 eyeswith or without astigmatism were treated by TransPRK. In all eyes, treatments were planned with Custom Ablation Manager Software and ablations performed with the SCHWIND AMARIS system. Clinical outcomes of visual acuity, manifest refraction, intraocular pressure, and corneal topography were observed and analyzed. The follow-up period was one year.RESULTS: All patients completed the 1-year follow-up. After one-year follow-up, 47 cases(92 eyes, 58.8%achieved an uncorrected distance visual acuity(UDVA≥1.0. Twenty cases(40 eyes, 25%was 0.8 and 13 cases(24 eyes, 16.3%was 0.6. Sixty-three cases(121 eyes, 78.8%were close to or above best corrected visual acuity(BCVA. Seventeen cases(34 eyes, 21.2%were slightly lower than BCVA 1 row or two. Nine cases(18 eyes, 11.3%got dry eye postoperatively. 16 cases(32 eyes, 20%complain of glare and poor night vision. CONCLUSION: The results show that TransPRK for myopia with or without astigmatism is safe and effective. The postoperative visual outcomes are stable.

  19. Clinical features of diabetes mellitus in Japan as observed in a hospital outpatient clinic

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    Wada, Sunao; Toda, Shintaro; Omori, Yoshiaki; Yamakido, Michio; Blackard, W.G.

    1963-04-18

    A university diabetes clinic in Japan was characterized by age at examination, age at onset, sex ratio, microangiopathies, atherosclerotic complications, weight, heredity, and diet. The findings in this clinic, along with those from other diabetes clinics in Japan, were compared with studies on Western diabetics. The similarities between the 2 diabetic populations far outnumbered the dissimilarities. However, diabetes mellitus in Japan is distinguished by infrequent occurrence of juvenile diabetes and ketosis, relative lack of atherosclerotic complications, and reversal of the sex ratio. 39 references, 7 tables.

  20. The diagnosis of urinary tract infections in young children (DUTY: protocol for a diagnostic and prospective observational study to derive and validate a clinical algorithm for the diagnosis of UTI in children presenting to primary care with an acute illness

    Directory of Open Access Journals (Sweden)

    Downing Harriet

    2012-07-01

    Full Text Available Abstract Background Urinary tract infection (UTI is common in children, and may cause serious illness and recurrent symptoms. However, obtaining a urine sample from young children in primary care is challenging and not feasible for large numbers. Evidence regarding the predictive value of symptoms, signs and urinalysis for UTI in young children is urgently needed to help primary care clinicians better identify children who should be investigated for UTI. This paper describes the protocol for the Diagnosis of Urinary Tract infection in Young children (DUTY study. The overall study aim is to derive and validate a cost-effective clinical algorithm for the diagnosis of UTI in children presenting to primary care acutely unwell. Methods/design DUTY is a multicentre, diagnostic and prospective observational study aiming to recruit at least 7,000 children aged before their fifth birthday, being assessed in primary care for any acute, non-traumatic, illness of ≤ 28 days duration. Urine samples will be obtained from eligible consented children, and data collected on medical history and presenting symptoms and signs. Urine samples will be dipstick tested in general practice and sent for microbiological analysis. All children with culture positive urines and a random sample of children with urine culture results in other, non-positive categories will be followed up to record symptom duration and healthcare resource use. A diagnostic algorithm will be constructed and validated and an economic evaluation conducted. The primary outcome will be a validated diagnostic algorithm using a reference standard of a pure/predominant growth of at least >103, but usually >105 CFU/mL of one, but no more than two uropathogens. We will use logistic regression to identify the clinical predictors (i.e. demographic, medical history, presenting signs and symptoms and urine dipstick analysis results most strongly associated with a positive urine culture result. We will

  1. Neurological complications ofLyme disease – clinical observations

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    Katarzyna Jastrzębska

    2014-12-01

    Full Text Available Lyme disease is a chronic, multiorgan disease caused by the spirochete Borrelia burgdorferi, which is transmitted by Ixodes ticks. Poland has medium to high rate of tick infection. Lyme disease incidence has been increasing in recent years, with the peak incidence recorded in the summer, especially in endemic areas. The risk of infection depends on the type of spirochete and the time it is present in the human skin. It is crucial to remove the parasite as soon as possible, not later than 24 hours after the spirochete enters the body. The infection usually occurs in three stages, although not all of them have to be present. A characteristic erythema migrans or, less common, lymphocytic lymphoma, may be observed in the first stage of the disease. General symptoms, such as myocarditis, arthritis or nervous system involvement, are developed in the second stage. In the late stage of the disease, serious irreversible complications of the nervous system, musculoskeletal system or the skin occur. The diagnosis of Lyme disease is based on a history of tick bite as well as on the presence of clinical symptoms confirmed by serological findings. The presence of erythema migrans is sufficient for diagnosis and treatment initiation, therefore laboratory diagnostics is not necessary in this case. Serological diagnostics is primarily based on ELISA testing, while the second step uses a Western blot test. Positive serology test in the absence of clinical symptoms or a positive medical history is insufficient for diagnosis and treatment initiation. The type of the antibiotic used as well as the route and duration of its administration depend on the stage of the disease and on the affected organ. The most common antimicrobials used in the treatment of Lyme disease include amoxicillin, doxycycline (over the age of 12 years and ceftriaxone.

  2. Clinical observation on Greeva Stambha (cervical spondylosis) Chikitsa.

    Science.gov (United States)

    Bharti; Katyal, Shveta; Kumar, Adarsh; Makhija, Renu; Devalla, Ramesh Babu

    2010-04-01

    Greeva Stambha (A Vataja Disorder) simulates cervical spondylosis, which is a chronic degenerative condition of the cervical spine. Keeping in view the increasing incidence of this problem in modern society with more of desk- workers; an observational study was conducted on 22 patients of Greeva stambha vis-a-vis cervical spondylosis selected from OPD/IPD of CRIA, Punjabi-Bagh, New-Delhi, satisfying the inclusion criteria. The Vatahara treatment viz. Maha Yogaraj Guggulu 500 mg BD, Panchguna tail for local use and Nadi sweda (Local steam with Dashmoola Kwatha) were given for seven days. The results were assessed on the basis of symptomatic improvement using visual analog scale.

  3. Asphyxia in the Newborn: Evaluating the Accuracy of ICD Coding, Clinical Diagnosis and Reimbursement: Observational Study at a Swiss Tertiary Care Center on Routinely Collected Health Data from 2012-2015.

    Science.gov (United States)

    Endrich, Olga; Rimle, Carole; Zwahlen, Marcel; Triep, Karen; Raio, Luigi; Nelle, Mathias

    2017-01-01

    The ICD-10 categories of the diagnosis "perinatal asphyxia" are defined by clinical signs and a 1-minute Apgar score value. However, the modern conception is more complex and considers metabolic values related to the clinical state. A lack of consistency between the former clinical and the latter encoded diagnosis poses questions over the validity of the data. Our aim was to establish a refined classification which is able to distinctly separate cases according to clinical criteria and financial resource consumption. The hypothesis of the study is that outdated ICD-10 definitions result in differences between the encoded diagnosis asphyxia and the medical diagnosis referring to the clinical context. Routinely collected health data (encoding and financial data) of the University Hospital of Bern were used. The study population was chosen by selected ICD codes, the encoded and the clinical diagnosis were analyzed and each case was reevaluated. The new method categorizes the diagnoses of perinatal asphyxia into the following groups: mild, moderate and severe asphyxia, metabolic acidosis and normal clinical findings. The differences of total costs per case were determined by using one-way analysis of variance. The study population included 622 cases (P20 "intrauterine hypoxia" 399, P21 "birth asphyxia" 233). By applying the new method, the diagnosis asphyxia could be ruled out with a high probability in 47% of cases and the variance of case related costs (one-way ANOVA: F (5, 616) = 55.84, p clinical practice, research and reimbursement.

  4. Clinical observation of phacoemulsification in patients with previous trabeculectomy

    Directory of Open Access Journals (Sweden)

    Li Li

    2013-09-01

    Full Text Available AIM: To observe the clinical effect of transparent corneal incision phacoemulsification in cataract patients who had undergone different kinds of glaucoma filtration surgeries.METHODS: Totally 43 cases(50 eyes, in which 23 patients with primary angle-closure glaucoma(group A, 26 eyesand 20 patients with primary open angle glaucoma(group B, 24 eyes, all had undergone glaucoma filtration surgery for more than 6 months. Visual acuity, intraocular pressure, slit lamp, gonioscope, corneal endothelial cell counts, etc., were done before surgery.And transparent corneal incision phacoemulsification combined with artificial lens implantation operation were preformed, postoperative follow-up of 3 to 12 months, visual acuity, intraocular pressure, corneal endothelial cell counts and vision field, etc. were observed and recorded.RESULTS: The visual acuity of 50 eyes(100%increased with different degree postoperatively, 41 eyes(82%with postoperative visual acuity ≥0.3; average preoperative intraocular pressure: group A 18.08±5.08mmHg(1mmHg=0.133kpa, group B 14.48±3.52mmHg; Postoperative follow-up average intraocular pressure: group A 13.65±3.51mmHg, group B 14.28±3.41 mmHg, intraocular pressure changed significantly pre and post-operation in group A(PP>0.05; Postoperative intraocular pressure of 1 eye in group A and 3 eyes in group B rose within three days post-operation, the intraocular pressure fluctuated between 21-33mmHg, with drug therapy and drug withdral when intraocular pressure epistrophy; Intraocular pressure was stable in the follow-up process.Corneal endothelial cell density: pre-operation group A was 2 293.57±352.24(cells/mm2, group B 2 658.14±458.69(cells/mm2, post- operation group A 2 175.95±379.16(cells/mm2, group B 2 442.97±477.30(cells/mm2, cell loss rate: 5.13% in group A, and 8.10% in group B. Postoperative visual acuity was related to vision field damage in patients, the more visual field damage, the longer the duration

  5. Study Designs in Clinical Research

    NARCIS (Netherlands)

    Noordzij, Marlies; Dekker, Friedo W.; Zoccali, Carmine; Jager, Kitty J.

    2009-01-01

    In nephrology research, both observational studies and randomized controlled trials (RCTs) are commonly applied. Clinicians using the evidence from epidemiological studies should be aware of the specific qualities and limitations of each study design. The purpose of the article is therefore to

  6. Can commonly prescribed drugs be repurposed for the prevention or treatment of Alzheimer's and other neurodegenerative diseases? Protocol for an observational cohort study in the UK Clinical Practice Research Datalink.

    Science.gov (United States)

    Walker, Venexia M; Davies, Neil M; Jones, Tim; Kehoe, Patrick G; Martin, Richard M

    2016-12-13

    Current treatments for Alzheimer's and other neurodegenerative diseases have only limited effectiveness meaning that there is an urgent need for new medications that could influence disease incidence and progression. We will investigate the potential of a selection of commonly prescribed drugs, as a more efficient and cost-effective method of identifying new drugs for the prevention or treatment of Alzheimer's disease, non-Alzheimer's disease dementias, Parkinson's disease and amyotrophic lateral sclerosis. Our research will focus on drugs used for the treatment of hypertension, hypercholesterolaemia and type 2 diabetes, all of which have previously been identified as potentially cerebroprotective and have variable levels of preclinical evidence that suggest they may have beneficial effects for various aspects of dementia pathology. We will conduct a hypothesis testing observational cohort study using data from the Clinical Practice Research Datalink (CPRD). Our analysis will consider four statistical methods, which have different approaches for modelling confounding. These are multivariable adjusted Cox regression; propensity matched regression; instrumental variable analysis and marginal structural models. We will also use an intention-to-treat analysis, whereby we will define all exposures based on the first prescription observed in the database so that the target parameter is comparable to that estimated by a randomised controlled trial. This protocol has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will publish the results of the study as open-access peer-reviewed publications and disseminate findings through national and international conferences as are appropriate. 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/.

  7. An observational study on oesophageal variceal endoscopic ...

    African Journals Online (AJOL)

    African Journal of Health Sciences ... The study site was the Centre for Clinical Research, Kenya Medical Research Institute (KEMRI). ... All the patients with portal hypertension and previous history of acute variceal blood who underwent endoscopic injection sclerotherapy between August 1998 and May 2001 in the ...

  8. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  9. The Alberta smoke plume observation study

    Directory of Open Access Journals (Sweden)

    K. Anderson

    2018-02-01

    Full Text Available A field project was conducted to observe and measure smoke plumes from wildland fires in Alberta. This study used handheld inclinometer measurements and photos taken at lookout towers in the province. Observations of 222 plumes were collected from 21 lookout towers over a 6-year period from 2010 to 2015. Observers reported the equilibrium and maximum plume heights based on the plumes' final levelling heights and the maximum lofting heights, respectively. Observations were tabulated at the end of each year and matched to reported fires. Fire sizes at assessment times and forest fuel types were reported by the province. Fire weather conditions were obtained from the Canadian Wildland Fire Information System (CWFIS. Assessed fire sizes were adjusted to the appropriate size at plume observation time using elliptical fire-growth projections. Though a logical method to collect plume observations in principle, many unanticipated issues were uncovered as the project developed. Instrument limitations and environmental conditions presented challenges to the investigators, whereas human error and the subjectivity of observations affected data quality. Despite these problems, the data set showed that responses to fire behaviour conditions were consistent with the physical processes leading to plume rise. The Alberta smoke plume observation study data can be found on the Canadian Wildland Fire Information System datamart (Natural Resources Canada, 2018 at http://cwfis.cfs.nrcan.gc.ca/datamart.

  10. Impact of matrix-assisted laser desorption ionization time-of-flight mass spectrometry on the clinical management of patients with Gram-negative bacteremia: a prospective observational study.

    Science.gov (United States)

    Clerc, Olivier; Prod'hom, Guy; Vogne, Christelle; Bizzini, Alain; Calandra, Thierry; Greub, Gilbert

    2013-04-01

    Early identification of pathogens from blood cultures using matrix-assisted laser desorption ionization time-of-flight (MALDI-TOF) mass spectrometry may optimize the choice of empirical antibiotic therapy in the setting of bloodstream infections. We aimed to assess the impact of this new technology on the use of antibiotic treatment in patients with gram-negative bacteremia. We conducted a prospective observational study from January to December 2010 to evaluate the sequential and separate impacts of Gram stain reporting and MALDI-TOF bacterial identification performed on blood culture pellets in patients with gram-negative bacteremia. The primary outcome was the impact of MALDI-TOF on empirical antibiotic choice. Among 202 episodes of gram-negative bacteremia, Gram stain reporting had an impact in 42 cases (20.8%). MALDI-TOF identification led to a modification of empirical therapy in 71 of all 202 cases (35.1%), and in 16 of 27 cases (59.3%) of monomicrobial bacteremia caused by AmpC-producing Enterobacteriaceae. The most frequently observed impact was an early appropriate broadening of the antibiotic spectrum in 31 of 71 cases (43.7%). In total, 143 of 165 episodes (86.7%) of monomicrobial bacteremia were correctly identified at genus level by MALDI-TOF. In a low prevalence area for extended spectrum betalactamases (ESBL) and multiresistant gram-negative bacteria, MALDI-TOF performed on blood culture pellets had an impact on the clinical management of 35.1% of all gram-negative bacteremia cases, demonstrating a greater impact than Gram stain reporting. Thus, MALDI-TOF could become a vital second step beside Gram stain in guiding the empirical treatment of patients with bloodstream infection.

  11. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for advancing medical knowledge and patient care. ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical Trials What Are Clinical Trials? Children & ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... criteria). For more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people ... clinical trials for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical Trials Protect Participants?" ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  19. Retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant Gram-negative bacteria (RESCUING).

    Science.gov (United States)

    Shaw, Evelyn; Addy, Ibironke; Stoddart, Margaret; Vank, Christiane; Grier, Sally; Wiegand, Irith; Leibovici, Leonard; Eliakim-Raz, Noa; Vallejo-Torres, Laura; Morris, Stephen; MacGowan, Alasdair; Carratalà, Jordi; Pujol, Miquel

    2016-07-29

    The emergence of multidrug resistant (MDR) Gram-negative bacteria (GNB), including carbapenemase-producing strains, has become a major therapeutic challenge. These MDR isolates are often involved in complicated urinary tract infection (cUTI), and are associated with poor clinical outcomes. The study has been designed to gain insight into the epidemiology, clinical management, outcome and healthcare cost of patients with cUTI, especially in countries with high prevalence of MDR GNB. This multinational and multicentre observational, retrospective study will identify cases from 1 January 2013 to 31 December 2014 in order to collect data on patients with cUTI as a cause of hospital admission, and patients who develop cUTI during their hospital stay. The primary end point will be treatment failure defined as the presence of any of the following criteria: (1) signs or symptoms of cUTI present at diagnosis that have not improved by days 5-7 with appropriate antibiotic therapy, (2) new cUTI-related symptoms that have developed within 30 days of diagnosis, (3) urine culture taken within 30 days of diagnosis, either during or after completion of therapy, that grows ≥10(4) colony-forming unit/mL of the original pathogen and (4) death irrespective of cause within 30 days of the cUTI diagnosis. 1000 patients afford a power of 0.83 (α=0.05) to detect an absolute difference of 10% in the treatment failure rate between MDR bacteria and other pathogens. This should allow for the introduction of about 20 independent risk factors (or their interaction) in a logistic regression model looking at risk factors for failure. Approval will be sought from all relevant Research Ethics Committees. Publication of this study will be considered as a joint publication by the participating investigator leads, and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). NCT02641015; Pre-results. Published by the BMJ Publishing Group Limited. For

  20. Clinical efficacy of β-lactam/β-lactamase inhibitor combinations for the treatment of bloodstream infection due to extended-spectrum β-lactamase-producing Enterobacteriaceae in haematological patients with neutropaenia: a study protocol for a retrospective observational study (BICAR).

    Science.gov (United States)

    Gudiol, C; Royo-Cebrecos, C; Tebe, C; Abdala, E; Akova, M; Álvarez, R; Maestro-de la Calle, G; Cano, A; Cervera, C; Clemente, W T; Martín-Dávila, P; Freifeld, A; Gómez, L; Gottlieb, T; Gurguí, M; Herrera, F; Manzur, A; Maschmeyer, G; Meije, Y; Montejo, M; Peghin, M; Rodríguez-Baño, J; Ruiz-Camps, I; Sukiennik, T C; Carratalà, J

    2017-01-23

    Bloodstream infection (BSI) due to extended-spectrum β-lactamase-producing Gram-negative bacilli (ESBL-GNB) is increasing at an alarming pace worldwide. Although β-lactam/β-lactamase inhibitor (BLBLI) combinations have been suggested as an alternative to carbapenems for the treatment of BSI due to these resistant organisms in the general population, their usefulness for the treatment of BSI due to ESBL-GNB in haematological patients with neutropaenia is yet to be elucidated. The aim of the BICAR study is to compare the efficacy of BLBLI combinations with that of carbapenems for the treatment of BSI due to an ESBL-GNB in this population. A multinational, multicentre, observational retrospective study. Episodes of BSI due to ESBL-GNB occurring in haematological patients and haematopoietic stem cell transplant recipients with neutropaenia from 1 January 2006 to 31 March 2015 will be analysed. The primary end point will be case-fatality rate within 30 days of onset of BSI. The secondary end points will be 7-day and 14-day case-fatality rates, microbiological failure, colonisation/infection by resistant bacteria, superinfection, intensive care unit admission and development of adverse events. The number of expected episodes of BSI due to ESBL-GNB in the participant centres will be 260 with a ratio of control to experimental participants of 2. The protocol of the study was approved at the first site by the Research Ethics Committee (REC) of Hospital Universitari de Bellvitge. Approval will be also sought from all relevant RECs. Any formal presentation or publication of data from this study will be considered as a joint publication by the participating investigators and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE). The study has been endorsed by the European Study Group for Bloodstream Infection and Sepsis (ESGBIS) and the European Study Group for Infections in Compromised Hosts (ESGICH). Published by the BMJ

  1. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting Summaries Technology Transfer Clinical ...

  2. Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

    Science.gov (United States)

    Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

    2010-01-01

    Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

  3. Large observer variation of clinical assessment of dyspnoeic wheezing children

    NARCIS (Netherlands)

    Bekhof, Jolita; Reimink, Roelien; Bartels, Ine-Marije; Eggink, Hendriekje; Brand, Paul L. P.

    Background In children with acute dyspnoea, the assessment of severity of dyspnoea and response to treatment is often performed by different professionals, implying that knowledge of the interobserver variation of this clinical assessment is important. Objective To determine intraobserver and

  4. Mastocytosis in Children: Literature Review and Own Clinical Observation

    National Research Council Canada - National Science Library

    N.V. Nagornaya; Ye.V. Bordyugova; A.P. Koval; A.V. Dubovaya

    2013-01-01

    The review of literature presents the data on neoplastic disease — mastocytosis. We provide the modern information of the etiopathogenesis, classification, clinical presentation, methods of diagnosis and treatment in children...

  5. Inter- and intra-observer agreement of non-reassuring cardiotocography analysis and subsequent clinical management

    NARCIS (Netherlands)

    Rhose, S.; Heinis, A.M.; Vandenbussche, F.P.; Drongelen, J. van; Dillen, J. van

    2014-01-01

    OBJECTIVE: To quantify inter- and intra-observer agreement of non-reassuring intrapartum cardiotocography (CTG) patterns and subsequent clinical management. DESIGN: Methodological study. SETTING: University Medical Center. POPULATION: CTG patterns of 79 women beyond 37 weeks of gestation with a

  6. Statistical challenges in observational cohort studies

    NARCIS (Netherlands)

    Hof, M.H.P.

    2015-01-01

    For over a century observational cohort studies have been used to study determinants of health and disease. Within a sample from the population, we can determine the relation between health outcomes (e.g. death) and a broad range of factors as genetic markers, environmental exposures, and lifestyle

  7. ANALYSIS OF OBSERVED BEHAVIORS DISPLAYED BY DEPRESSED-PATIENTS DURING A CLINICAL INTERVIEW - RELATIONSHIPS BETWEEN BEHAVIORAL-FACTORS AND CLINICAL CONCEPTS OF ACTIVATION

    NARCIS (Netherlands)

    BOUHUYS, AL; JANSEN, CJ; VANDENHOOFDAKKER, RH

    In 61 drug-free depressed patients, relationships were studied between observed behaviors and measures of common clinical concepts of activation. The behaviors were observed during a clinical interview and analyzed with ethological methods. Activation was assessed by means of self-ratings (Thayer,

  8. Methodology of clinical studies dealing with the treatment of envenomation

    OpenAIRE

    Chippaux, Jean-Philippe; Stock, R. P.; Massougbodji, A.

    2010-01-01

    A total of 142 clinical studies have been devoted to the treatment of envenomations, of which 115 address snake bites, 20 scorpion stings, and 8 other animals (one addresses both snake and spider envenomation). Antivenom use was studied in 118, of which 82 addressed efficacy, 43 evaluated safety, 23 studied dosage and 8 explored other issues. Besides anecdotal clinical reports, three classes of clinical studies are distinguished: (a) observational clinical studies (55 of the total) which anal...

  9. Asphyxia in the Newborn: Evaluating the Accuracy of ICD Coding, Clinical Diagnosis and Reimbursement: Observational Study at a Swiss Tertiary Care Center on Routinely Collected Health Data from 2012-2015.

    Directory of Open Access Journals (Sweden)

    Olga Endrich

    Full Text Available The ICD-10 categories of the diagnosis "perinatal asphyxia" are defined by clinical signs and a 1-minute Apgar score value. However, the modern conception is more complex and considers metabolic values related to the clinical state. A lack of consistency between the former clinical and the latter encoded diagnosis poses questions over the validity of the data. Our aim was to establish a refined classification which is able to distinctly separate cases according to clinical criteria and financial resource consumption. The hypothesis of the study is that outdated ICD-10 definitions result in differences between the encoded diagnosis asphyxia and the medical diagnosis referring to the clinical context.Routinely collected health data (encoding and financial data of the University Hospital of Bern were used. The study population was chosen by selected ICD codes, the encoded and the clinical diagnosis were analyzed and each case was reevaluated. The new method categorizes the diagnoses of perinatal asphyxia into the following groups: mild, moderate and severe asphyxia, metabolic acidosis and normal clinical findings. The differences of total costs per case were determined by using one-way analysis of variance.The study population included 622 cases (P20 "intrauterine hypoxia" 399, P21 "birth asphyxia" 233. By applying the new method, the diagnosis asphyxia could be ruled out with a high probability in 47% of cases and the variance of case related costs (one-way ANOVA: F (5, 616 = 55.84, p < 0.001, multiple R-squared = 0.312, p < 0.001 could be best explained. The classification of the severity of asphyxia could clearly be linked to the complexity of cases.The refined coding method provides clearly defined diagnoses groups and has the strongest effect on the distribution of costs. It improves the diagnosis accuracy of perinatal asphyxia concerning clinical practice, research and reimbursement.

  10. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

  11. Truth telling in medical practice: students' opinions versus their observations of attending physicians' clinical practice.

    Science.gov (United States)

    Tang, Woung-Ru; Fang, Ji-Tseng; Fang, Chun-Kai; Fujimori, Maiko

    2013-07-01

    Truth telling or transmitting bad news is a problem that all doctors must frequently face. The purpose of this cross-sectional study was to investigate if medical students' opinions of truth telling differed from their observations of attending physicians' actual clinical practice. The subjects were 275 medical clerks/interns at a medical center in northern Taiwan. Data were collected on medical students' opinions of truth telling, their observations of physicians' clinical practice, students' level of satisfaction with truth telling practiced by attending physicians, and cancer patients' distress level when they were told the truth. Students' truth-telling awareness was significantly higher than the clinical truth-telling practice of attending physicians (ptruth telling of attending physicians (mean ± SD=7.33 ± 1.74). However, our data also show that when cancer patients were informed of bad news, they all experienced medium to above average distress (5.93 ± 2.19). To develop the ability to tell the truth well, one must receive regular training in communication skills, including experienced attending physicians. This study found a significant difference between medical students' opinions on truth telling and attending physicians' actual clinical practice. More research is needed to objectively assess physicians' truth telling in clinical practice and to study the factors affecting the method of truth telling used by attending physicians in clinical practice. Copyright © 2012 John Wiley & Sons, Ltd.

  12. [Cluster headache. A clinical study].

    Science.gov (United States)

    Molins, A; Lafuente, A; Malagelada, A; Codina, A; Titus, F

    1991-03-01

    The personal experience with cluster headache in 108 patients is reported. Significant clinical findings included a clear male predominance, with a male/female prevalence ratio of 4.7/1, the persistent homolateral character of pain during the attacks, seen in 100% of cases, and the tendency to repeat the attacks on the same side (96%). The cluster headache predominated during spring and the painful crisis, in our experience, had a clear nocturnal predominance. Regarding the signs and symptoms accompanying pain, our series was similar to those in the international literature, except for a smaller prevalence of Horner's sign in our cases. The association with tenderness of the carotid territory ipsilateral to pain is reported here for the first time. The importance of a correct anamnesis of all parameters associated with pain is emphasized in the present study, as in many patients only a detailed investigation permits an adequate clinical definition.

  13. Schistosoma mattheei in the ox: clinical pathological observations.

    Science.gov (United States)

    Lawrence, J A

    1977-11-01

    Twenty-eight Friesian calves were infected between seven and 11 months of age with 5000 to 45,000 cercariae of Schistosoma mattheei. They developed anaemia, lymphopaenia and hypoalbuminaemia during the period of acute clinical illness after the infection became patent, and lymphocyte counts remained depressed after clinical recovery. Neutrophil counts rose and later fell before returning to normal. Eosinophilia and hypergammaglobulinaemia were marked during the period of recovery. The changes in haemoglobin, neutrophils and serum proteins were proportional to the level of infection. The eosinophil response was reduced in animals subjected to nutritional stress. The aetiology of the changes is discussed.

  14. Clinical outcomes of indirect composite restorations for grossly mutilated primary molars: a clinical observation.

    Science.gov (United States)

    Mittal, Neeti; Srivastava, Binita

    2015-01-01

    This study was conducted to report the clinical outcomes and the parental and child satisfaction of onlays for restoring mutilated primary molars. Twenty subjects, ages 3-8 years, with the presence of at least 1 mutilated primary molar (≥3 carious surfaces and a carious surface area ≥3/4 of the occlusal surface) were recruited. This study assessed the clinical success, gingival health, and parent/child satisfaction of 28 indirect composite onlays. The onlays showed a 100% retention rate at 12 months follow-up and a marginal integrity of 96.43%. High rates of satisfactory Alpha ratings for color stability (92.86%), surface texture (92.86%), and anatomic form (100%), coupled with significant improvements in gingival health of the restored teeth (P Indirect composite onlays successfully restored anatomic form and function of the grossly decayed primary molars--with shorter chairside times--while satisfying the esthetic demands of the young pediatric patients.

  15. A roadside study of observable driver distractions.

    Science.gov (United States)

    Sullman, Mark J M; Prat, Francesc; Tasci, Duygu Kuzu

    2015-01-01

    This study investigated the prevalence of observable distractions while driving and the effect of drivers' characteristics and time-related variables on their prevalence. Using roadside observation, 2 independent observers collected data at 4 randomly selected locations in St. Albans, UK. Of the 10,984 drivers observed, 16.8% were engaged in a secondary task, with talking to passengers being the most common distraction (8.8%), followed by smoking (1.9%) and talking on a hands-free mobile phone (1.7%). An additional 1.0% were observed talking on a handheld phone, and the rest of the distractions (e.g., texting, drinking) were recorded in less than 1% of the drivers observed. Gender-related differences were found for a number of different distractions (i.e., talking to passengers, drinking, and handheld mobile phone conversations), but age emerged as a significant predictor for most secondary tasks, including talking to passengers, smoking, hands-free mobile phone use, handheld mobile phone use, texting/keying numbers, drinking, and engagement in any type of distraction (all distractions combined). The overall pattern for age was that middle-aged and older drivers were less likely to be distracted than younger drivers. This work provides further evidence of the relatively high rate of distracted driving in the UK. The findings clearly indicate that younger drivers are more likely to drive distracted, which probably contributes to their higher crash rates.

  16. Using non-specialist observers in 4AFC human observer studies

    Science.gov (United States)

    Elangovan, Premkumar; Mackenzie, Alistair; Dance, David R.; Young, Kenneth C.; Wells, Kevin

    2017-03-01

    Virtual clinical trials (VCTs) are an emergent approach for rapid evaluation and comparison of various breast imaging technologies and techniques using computer-based modeling tools. Increasingly 4AFC (Four alternative forced choice) virtual clinical trials are used to compare detection performances of different breast imaging modalities. Most prior studies have used physicists and/or radiologists and physicists interchangeably. However, large scale use of statistically significant 4AFC observer studies is challenged by the individual time commitment and cost of such observers, often drawn from a limited local pool of specialists. This work aims to investigate whether non-specialist observers can be used to supplement such studies. A team of five specialist observers (medical physicists) and five non-specialists participated in a 4AFC study containing simulated 2D-mammography and DBT (digital breast tomosynthesis) images, produced using the OPTIMAM toolbox for VCTs. The images contained 4mm irregular solid masses and 4mm spherical targets at a range of contrast levels embedded in a realistic breast phantom background. There was no statistically significant difference between the detection performance of medical physicists and non-specialists (p>0.05). However, non-specialists took longer to complete the study than their physicist counterparts, which was statistically significant (pcontrast than 2D-mammography for both masses and spheres, and both groups found spheres easier to detect than irregular solid masses.

  17. Evaluating the Impact of Database Heterogeneity on Observational Study Results

    Science.gov (United States)

    Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

    2013-01-01

    Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Entire Site Health Topics News & Resources Intramural ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... screening tests to see which test produces the best results. Some companies and ... Clinical Trials Are Important Clinical trials are ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... it clear to whom a clinical trial's results apply. These criteria also are a safety measure. They ... a scientific and responsible way. The IRB also checks on results during the trial. All U.S. clinical ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines who is ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take ... clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  14. Sebaceous adenitis in the Akita: clinical observations, histopathology and heredity.

    Science.gov (United States)

    Reichler, I M; Hauser, B; Schiller, I; Dunstan, R W; Credille, K M; Binder, H; Glaus, T; Arnold, S

    2001-10-01

    Ninety-seven pure-bred Akitas were examined clinically and histologically for sebaceous adenitis. The diagnosis was established histologically in 23 Akitas by demonstrating an inflammatory reaction targeted against the sebaceous glands or a reduction in the number of glands. The clinical course of sebaceous adenitis in the Akita was similar to that seen in other breeds. The first skin lesions occurred mainly on the dorsal midline and ears. Compared with the Poodle, the age at first onset of the disease was more variable and the hair loss affected mainly the undercoat. The progression of sebaceous gland destruction varied between dogs and was not seen in all cases. Because bud-like sebaceous gland proliferation could be identified, it seems that regeneration of the sebaceous glands may occur. An autosomal recessive inheritance appears to be possible. Apart from a genetic background, immune-mediated factors possibly influence the onset and course of sebaceous adenitis.

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  16. Clinical observations on the use of honcrivine in the chemical ...

    African Journals Online (AJOL)

    Honcrivine did not provoke any inflammatory response nor was any allergic reaction observed. It is one of the oldest remedies known to mankind and is still useful and versatile today as it was 2000 years ago. It is a very effective chemicalwound debridant. Keywords: Chemical debridement, Acriflavine, honcrivine, honey ...

  17. Tumefactive demyelinating lesions as a first clinical event: Clinical, imaging, and follow-up observations.

    Science.gov (United States)

    Jeong, In Hye; Kim, Su-Hyun; Hyun, Jae-Won; Joung, AeRan; Cho, Hyo-Jin; Kim, Ho Jin

    2015-11-15

    Tumefactive demyelinating lesions (TDLs) are associated with a variety of demyelinating diseases in the central nervous system (CNS). However, there are no current guidelines describing how to classify and treat patients with this rare phenotype. Thus, the present study aimed to determine the long-term evolution and disease course of patients initially presenting with TDLs and to describe their clinical and radiographic characteristics. From the National Cancer Center registry of inflammatory diseases of the CNS, 31 patients initially presenting with TDLs with follow-up for at least 12 months were enrolled and their demographic, clinical, and radiographic characteristics were evaluated. The median follow-up duration was 37.6 months, during which time 11 patients were diagnosed with neuromyelitis optica spectrum disorder (NMOSD), seven with multiple sclerosis (MS), and 11 remained idiopathic; six did not experience any further clinical events (isolated demyelinating syndrome), and five patients experienced recurrent demyelinating events that were not consistent with either MS or NMOSD. Of the remaining two patients, one was diagnosed with hyperthyroidism-associated demyelination and one with tacrolimus-induced demyelination. The majority of TDLs evolve into MS or NMOSD. However, despite extensive diagnostic work-ups and long-term follow-ups, the etiology of TDLs was unknown for some patients. Copyright © 2015 Elsevier B.V. All rights reserved.

  18. Juvenile Behсet's Disease: Clinical Observation

    Directory of Open Access Journals (Sweden)

    Nikolai V. Sobotiuk

    2016-01-01

    Full Text Available Behcet's disease is a type of systemic vasculitis of unknown etiology characterized by recurrent erosive and ulcerative lesions of the mucous membrane in the mouth and genitals and pathological processes in the joints, central nervous system, and gastrointestinal tract. Polysystemic clinical manifestations, relatively rare occurrence, especially in childhood, and absence of pathognomonic laboratory signs make this disease difficult to verify. The diagnosis of Behcet's disease is especially complicated in cases where the intestinal symptoms are presented as initial or predominant manifestations of the disease, because they are often erroneously regarded as inflammatory bowel diseases. It should be added that the diagnosis of Behcet's disease is based on a set of classification/diagnostic signs that can develop for 5–6 years or more. The article presents a case of juvenile Behcet's disease demonstrating the complexity of the search for diagnosis. A brief literature review discusses the current view on the problem of diagnosis, pathogenesis, clinical presentation, and treatment of the disease in pediatric practice.

  19. Ozone Lidar Observations for Air Quality Studies

    Science.gov (United States)

    Wang, Lihua; Newchurch, Mike; Kuang, Shi; Burris, John F.; Huang, Guanyu; Pour-Biazar, Arastoo; Koshak, William; Follette-Cook, Melanie B.; Pickering, Kenneth E.; McGee, Thomas J.; hide

    2015-01-01

    Tropospheric ozone lidars are well suited to measuring the high spatio-temporal variability of this important trace gas. Furthermore, lidar measurements in conjunction with balloon soundings, aircraft, and satellite observations provide substantial information about a variety of atmospheric chemical and physical processes. Examples of processes elucidated by ozone-lidar measurements are presented, and modeling studies using WRF-Chem, RAQMS, and DALES/LES models illustrate our current understanding and shortcomings of these processes.

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting ...

  1. Nutritional clinical studies in dermatology.

    Science.gov (United States)

    Liakou, Aikaterini I; Theodorakis, Michael J; Melnik, Bodo C; Pappas, Apostolos; Zouboulis, Christos C

    2013-10-01

    Nutrition has long been associated with skin health, beauty, integrity and aging through multiple pathways and cofactors implicated in skin biology. The onset and clinical course of various common skin diseases, especially acne, psoriasis, atopic dermatitis, and hair loss, have been suggested to be critically affected by nutrition patterns and habits. The relationship between acne and diet, predominantly the role of high glycemic load diets and dairy consumption have recently gained increased interest. Abnormal nutritional conditions such as obesity or malnutrition often manifest themselves by specific cutaneous features and altered skin function. Skin photoprotection, rendered by various nutrients, is well documented and appropriate nutritional supplementation has been shown to exert beneficial effects upon impaired skin integrity, restore its appearance and promote skin health. It is our intention to provide a comprehensive review of the most recent information on the role of nutrition for common skin diseases and regulation of skin biology. Nutritional clinical studies in dermatology have been reviewed using the MedLine literature source and the terms "diet" or "nutrition" and "skin". The data on the relationship between nutrition and skin are until now controversial and much more work is needed to be done to clarify possible etiological correlations.

  2. Pancreatic cancer in obesity: epidemiology, clinical observations, and basic mechanisms.

    Science.gov (United States)

    Zyromski, Nicholas J; White, Patrick B

    2011-06-01

    Obesity, now a worldwide epidemic, causes myriad medical problems. One of the most significant obesity-related problems is the well-recognized relationship between obesity and various malignancies, including pancreatic cancer. Pancreatic cancer is a devastating disease--the annual death rate nearly approximates its incidence. While surgical extirpation provides the best chance at long term survival, systemic therapy is largely ineffective: even those patients undergoing successful operative resection have only approximately 20% 5-year survival. These poor outcomes are largely a consequence of poor understanding of tumor biology. Clearly, identification of novel treatment strategies is of paramount importance; investigation of pancreatic cancer biology from the novel aspect of obesity offers the potential to identify unique therapeutic targets. This manuscript reviews the epidemiology, clinical findings, and putative basic science mechanisms underlying obesity-related pancreatic cancer.

  3. Accuracy and inter-observer reliability of visual estimation compared to clinical goniometry of the elbow.

    Science.gov (United States)

    Blonna, Davide; Zarkadas, Peter C; Fitzsimmons, James S; O'Driscoll, Shawn W

    2012-07-01

    To test the hypothesis that visual estimation by a trained observer is as accurate and reliable as clinical goniometry for measuring elbow range of motion. Instrument validity and inter-observer reliability of visual estimation was evaluated on a consecutive series of 50 elbow contractures. Four observers with different levels of elbow experience first estimated extension and flexion of the contracted elbows and then measured them with a blinded goniometer. Instrument validity for visually-based goniometry was extremely high. ICC scores were 0.97 for both extension and flexion estimations. Systematic error was negligible (1°) with upper limits of agreement being 9° (95% CI: 7°-11°) and 8° (95% CI: 6°-10°), respectively, for extension and flexion. For the expert surgeon, 92% of the visual estimates were within 5° of the value obtained by clinical goniometry. Between experienced observers (elbow surgeon and physician assistant), the ICC's were very high-0.96 for extension and 0.93 for flexion. The systematic errors were low, from -1° to 1° with upper limit of agreement being 11° (95% CI: 8°-14°). However, agreement was poor between an inexperienced study coordinator and the others (ICC's: 0.51-0.38, systematic errors: 8°-18°, upper limit of agreement: 32°-40°). The accuracy of the visual estimations made by the experienced elbow surgeon was as good as the measurements taken with a goniometer by the physician assistant or the clinical fellow and better than those taken by an inexperienced study coordinator. The trained human eye is highly capable of accurately estimating the range of motion of the elbow, compared to conventional clinical goniometry, depending on the experience of the observer. Diagnostic study, Level II.

  4. Digital breast tomosynthesis: observer performance study.

    Science.gov (United States)

    Gur, David; Abrams, Gordon S; Chough, Denise M; Ganott, Marie A; Hakim, Christiane M; Perrin, Ronald L; Rathfon, Grace Y; Sumkin, Jules H; Zuley, Margarita L; Bandos, Andriy I

    2009-08-01

    The purpose of this study was to compare in a retrospective observer study the diagnostic performance of full-field digital mammography (FFDM) with that of digital breast tomosynthesis. Eight experienced radiologists interpreted images from 125 selected examinations, 35 with verified findings of cancer and 90 with no finding of cancer. The four display conditions included FFDM alone, 11 low-dose projections, reconstructed digital breast tomosynthesis images, and a combined display mode of FFDM and digital breast tomosynthesis images. Observers rated examinations using the screening BI-RADS rating scale and the free-response receiver operating characteristic paradigm. Observer performance levels were measured as the proportion of examinations prompting recall of patients for further diagnostic evaluation. The results were presented in terms of true-positive fraction and false-positive fraction. Performance levels were compared among the acquisitions and reading modes. Time to view and interpret an examination also was evaluated. Use of the combination of digital breast tomosynthesis and FFDM was associated with 30% reduction in recall rate for cancer-free examinations that would have led to recall if FFDM had been used alone (p digital breast tomosynthesis alone also tended to reduce recall rates, an average of 10%, although the observed decrease was not statistically significant (p = 0.09 for the participating radiologists). There was no convincing evidence that use of digital breast tomosynthesis alone or in combination with FFDM results in a substantial improvement in sensitivity. Use of digital breast tomosynthesis for breast imaging may result in a substantial decrease in recall rate.

  5. The NOAA Satellite Observing System Architecture Study

    Science.gov (United States)

    Volz, Stephen; Maier, Mark; Di Pietro, David

    2016-01-01

    NOAA is beginning a study, the NOAA Satellite Observing System Architecture (NSOSA) study, to plan for the future operational environmental satellite system that will follow GOES and JPSS, beginning about 2030. This is an opportunity to design a modern architecture with no pre-conceived notions regarding instruments, platforms, orbits, etc. The NSOSA study will develop and evaluate architecture alternatives to include partner and commercial alternatives that are likely to become available. The objectives will include both functional needs and strategic characteristics (e.g., flexibility, responsiveness, sustainability). Part of this study is the Space Platform Requirements Working Group (SPRWG), which is being commissioned by NESDIS. The SPRWG is charged to assess new or existing user needs and to provide relative priorities for observational needs in the context of the future architecture. SPRWG results will serve as input to the process for new foundational (Level 0 and Level 1) requirements for the next generation of NOAA satellites that follow the GOES-R, JPSS, DSCOVR, Jason-3, and COSMIC-2 missions.

  6. Clinical observation of ocular alkali burn by Breviscapinun

    Directory of Open Access Journals (Sweden)

    Yu-Lian Cai

    2014-07-01

    Full Text Available AIM: To find better ways of treating ocular alkali burn, and to reduce the suffering of patients and social burden.METHODS:Totally 100 patients were graded according to the degree of chemical burns to four major groups, each half were randomly divided into the control group and the treatment group. Control group underwent conventional treatment. In addition to conventional therapy, patients in each treatment group were also added a Breviscapine intravenous injection of 40mg daily. Corneal recovery time, changes in vision, degree of corneal opacity, number of corneal neovascularization and other complications were observed. Curative effects were analyzed statistically. RESULTS: There was no significant difference in level Ⅰ group between control group and treatment group(P>0.05; There were significantly different in level Ⅱ, Ⅲ and Ⅳ group(PPCONCLUSION: Breviscapine in the treatment of ocular alkali burns can shorten the course of treatment, reduce corneal scarring, and improve vision.

  7. Investigating common clinical presentations in first opinion small animal consultations using direct observation

    Science.gov (United States)

    Robinson, N. J.; Dean, R. S.; Cobb, M.; Brennan, M. L.

    2015-01-01

    Understanding more about the clinical presentations encountered in veterinary practice is vital in directing research towards areas relevant to practitioners. The aim of this study was to describe all problems discussed during a convenience sample of consultations using a direct observation method. A data collection tool was used to gather data by direct observation during small animal consultations at eight sentinel practices. Data were recorded for all presenting and non-presenting specific health problems discussed. A total of 1901 patients were presented with 3206 specific health problems discussed. Clinical presentation varied widely between species and between presenting and non-presenting problems. Skin lump, vomiting and inappetence were the most common clinical signs reported by the owner while overweight/obese, dental tartar and skin lump were the most common clinical examination findings. Skin was the most frequently affected body system overall followed by non-specific problems then the gastrointestinal system. Consultations are complex, with a diverse range of different clinical presentations seen. Considering the presenting problem only may give an inaccurate view of the veterinary caseload, as some common problems are rarely the reason for presentation. Understanding the common diagnoses made is the next step and will help to further focus questions for future research. PMID:25564472

  8. [Progressive degenerative aphasia: clinical and neuroradiological observations in 18 cases].

    Science.gov (United States)

    Robles, A; Vilariño, I; Sesar, A; Pardellas, H; Cacabelos, P; Noya, M

    1997-04-01

    In some types of degenerative dementia aphasia is the main disorder. In primary progressive aphasia. (PPA) atrophy is limited to the dominant peri-sylvan region. We present 18 cases of progressive aphasia of degenerative origin, with or without dementia. We describe the clinical and neuro-radiological findings in 3 patients with 'aphasic dementia and motor neuron disease (ADMND)', 7 with 'semantic dementia' (DS), and 4 with 'fronto-temporal dementia' with 'marked non-fluent aphasia' (AFTD). Criteria published in recent years were used. In patients with ADMND non-fluent aphasia progressed to global aphasia, with dementia occurring after 2-9 months, and death after an average of 17 months. In cases with SD, initial anomic aphasia progressed to transcortical sensory or global aphasia, and in patients with AFTD, Broca's aphasia or motor transcortical aphasia progressed to global aphasia. Seven of these patients had been initially diagnosed as having PPA and became demented after two years or more. In most of the cases the cognitive disorder had the characteristics of fronto-temporal dementia. All cases had cortical atrophy or asymmetrical cortical or cortico-subcortical atrophy. The 4 cases of non-fluent PPA were not demented after 21 months-6 years of illness, and showed perisylvan and left fronto-temporopolar atrophy. The PPA may correspond to the initial form of at least three varieties of dementia, usually the fronto-temporal type. Dementia occurs after two years or more, except in patients with motor neurone disease, when there is a latent period of less than one year.

  9. Clinical observation of two operation methods for neovascular glaucoma

    Directory of Open Access Journals (Sweden)

    Peng Zhang

    2013-11-01

    Full Text Available AIM: To evaluate the clinical effect of two different surgical treatments for neovascular glaucoma(NVG.METHODS: A total of 30 NVG inpatients(30 eyesat our hospital from April 2008 to December 2011 were reviewed. Patients were divided into two groups according to the different surgical treatments. In group A, 12 cases(12 eyeswere treated with Ahmed glaucoma valve(AGVimplantation and in group B, 18 cases(18 eyeswere treated with semiconductor diode laser photocoagulation transscleral cyclophotocoagulation(TSCPC. Intraocular pressure, visual acuity and complications were compared between two groups postoperatively.RESULTS: The postoperative IOP was significantly lower in each group(PPP>0.05in IOP 1 month after surgery. Visual acuity: in group A, the visual acuity was improved in 3 eyes, unchanged in 7 eyes and worsened in 2 eyes.; in group B, the visual acuity was improved in 3 eyes, unchanged in 12 eyes and worsened in 3 eyes. Postoperative complications: in group A, eyeball pain and corneal edema were found in 5 cases(41.7%, shallow anterior chamber in 3 cases(25%, anterior chamber fibroid exudation in 2 cases(16.7%, hyphema in 3 cases(25%; in group B, eyeball pain atearly stage after surgery were found in 10 cases(55.6% , corneal edema in 11 cases(61.1%, anterior chamber fibroid exudation in 5 cases(27.8%, hyphema in 6 cases(33.3%.CONCLUSION: AGV implantation and TSCPC are both effective surgical treatment methods for NVG. AGV implantation is a filtration surgery, which is relatively safe. TSCPC is more economical and suitable for glaucoma of advanced or absolute stage.

  10. Analysis of double reading in an observer study

    Science.gov (United States)

    Jiang, Yulei

    2009-02-01

    Previously we showed based on theoretical analysis that it is possible to attain greater diagnostic performance from appropriately combining the diagnostic opinions of two or more equally skilled readers. Such gain in performance is available from combining the readers' "latent decision variables" that are accessible through ROC analysis, but is generally ambiguous at best if the readers' binary decisions with regard to clinical actions (e.g., recall vs. annual screening mammogram) are combined. We now analyze the data of an observer study. In this observer study, ten radiologists interpreted 104 cases of mammograms containing clustered microcalcifications in a diagnostic-study setting to decide whether to recommend biopsy. They also reported diagnostic confidence on a quasi-continuous scale that the calcifications indicated malignancy. A previous analysis showed that combining the radiologists' binary decisions (biopsy vs. no biopsy) would change both sensitivity and specificity generally along the radiologists' single-reading, average, ROC curve but would not increase the diagnostic performance. Combining two radiologists' "latent decision variables" resulted in small increases in the ROC curves consistent with the theoretical predictions. However, the shapes of the single-reading ROC curves were inconsistent with the expectation of the clinical diagnostic-study setting because all benign cases in the observer study were difficult-to-diagnose cases (all cases clinically biopsied). The double-reading results would have been different, and gains in diagnostic performance possible, if the ROC curve shape more accurately resembled that of clinical practice. There is need to estimate the ROC curve of clinical practice.

  11. Reversal of dental fluorosis: A clinical study.

    Science.gov (United States)

    Mehta, Dhaval N; Shah, Jigna

    2013-01-01

    This study was conducted to evaluate the clinical reversal of dental fluorosis with various combinations of calcium, vitamin D3, and ascorbic acid, along with changes in levels of certain biochemical parameters concerned with dental fluorosis. The role of fluoride level of drinking water in the etiology of dental fluorosis and the prevalence of dental fluorosis in both dentitions and teeth were also assessed. A total number of 50 patients with clinical features of dental fluorosis without trauma and any adverse habits were selected. Of these, in 30 co-operative patients, estimation of water fluoride level and pretreatment and post-treatment serum and urine fluoride levels were done with ion selective electrode method. The selected 30 patients were divided into three groups, that is, group A, group B, and group C, and were given various combinations of medications like calcium with vitamin D3 supplements, ascorbic acid with vitamin D3 supplements, and chlorhexidine mouthwash (placebo) for three months, respectively. These 30 patients were assessed for any change in the clinical grading of dental fluorosis. No change in clinical grading of dental fluorosis was noted. Considerable reduction in serum and urine fluoride levels was noted in both group A and group B patients. Dental fluorosis was noted in permanent teeth more commonly than deciduous teeth, and permanent maxillary central incisors had the highest prevalence rate. This study comprises only 30 patients with three months of follow-up. So, this sample of patients and duration of follow-up period are conclusive to observe changes in biochemical parameters but not sufficient to observe changes in clinical grading.

  12. Extrasolar planet observational studies: the Italian contribution.

    Science.gov (United States)

    Gratton, R.; Desidera, S.; Claudi, R.

    We review the Italian contribution to observationals studies of extrasolar planets. Various techniques are used, including high precision radial velocities, transits, time delays, and direct imaging. Italian groups participate to some of the most interesting projects of the next decade, including imaging, photometry and astrometry. We will focus our attention on a few of these projects, including results obtained with SARG at TNG, those expected from OmegaTrans at VST, SPHERE at VLT and EPICS at E-ELT, with the PLATO satellite, and with GAIA.

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI Entire Site Health Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

    Medline Plus

    Full Text Available ... companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... find out whether a new approach causes any harm. In later phases of clinical trials, researchers learn ... patient outcomes; offers no benefit; or causes unexpected harm All of these results are important because they ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... addition, the NIH requires DSMBs for some earlier phase trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ...

  1. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... review data from a clinical trial for safety problems or differences in results among different groups. The ...

  2. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... look at the best age and frequency for doing screening tests, such as mammography; and compare two ... available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" ...

  3. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  4. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  5. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, ... or other factors not related to the protocol affect the trial's results. Comparison Groups In most clinical ...

  6. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  7. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  8. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Health Topics Education & Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and ...

  9. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  10. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... boys and girls. Visit the Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial ( ... financial incentives for healthy food purchases can help employees at Massachusetts General Hospital (MGH) prevent weight gain, ...

  11. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  12. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education ... Funding Training & Career Development Division of Intramural ...

  13. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Awareness Resources Contact The Health Information Center Health Professionals Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural Research Research Resources Research Meeting ...

  14. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Topics News & Resources Intramural Research Public Health Topics Education & Awareness Resources Contact The Health Information Center Health ... Systematic Evidence Reviews & Clinical Practice Guidelines Resources Continuing Education Researchers Funding Training & Career Development Division of Intramural ...

  15. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... works well in the lab or animals doesn't always work well in people. Thus, research in ... Clinical research is done only if doctors don't know whether a new approach works well in ...

  16. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... to the protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. ... Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs and ...

  17. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

  18. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... purpose is to ensure that clinical trials are ethical and that the participants' rights are protected. The ... Privacy Policy Freedom of Information Act (FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding ...

  19. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

  20. Children and Clinical Studies: Why Clinical Studies Are Important

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...