A prospective observational study of ICU patient position and frequency of turning.

Science.gov (United States)

Goldhill, D R; Badacsonyi, A; Goldhill, A A; Waldmann, C

2008-05-01

Positioning and turning critically ill patients may be beneficial but there are little data on current practice. We prospectively recorded patient position every hour over two separate days in 40 British intensive care units and analysed 393 sets of observation. Five patients were prone at any time and 3.8% (day 1) and 5% (day 2) were on rotating beds. Patients were on their back for 46.1% of observations, turned left for 28.4% and right for 25.5%, and head up for 97.4%. A turn was defined as a change between on back, turned left or turned right. The average time (SD) between turns was 4.85 (3.3) h. There was no significant association between the average time between turns and age, weight, height, gender, respiratory diagnosis, intubated and ventilated, sedation score, day of week or nurse:patient ratio. There was a significant difference between hospitals in the frequency with which patients were turned.

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

DEFF Research Database (Denmark)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela

2013-01-01

OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...... and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. RESULTS: The risk score...

Decannulation and Functional Outcome After Tracheostomy in Patients with Severe Stroke (DECAST): A Prospective Observational Study.

Science.gov (United States)

Schneider, Hauke; Hertel, Franziska; Kuhn, Matthias; Ragaller, Maximilian; Gottschlich, Birgit; Trabitzsch, Anne; Dengl, Markus; Neudert, Marcus; Reichmann, Heinz; Wöpking, Sigrid

2017-08-01

Tracheostomy is performed in ventilated stroke patients affected by persisting severe dysphagia, reduced level of consciousness, or prolonged mechanical ventilation. The study aim was to determine the frequency and predictors of successful decannulation and long-term functional outcome in tracheotomized stroke patients. A prospective single-center observational study recruited ventilated patients with ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage. Follow-up visits were performed at hospital discharge, 3, and 12 months. Competing risk analyses were performed to identify predictors of decannulation. We included 53 ventilated stroke patients who had tracheostomy. One year after tracheostomy, 19 patients were decannulated (median [IQR] time to decannulation 74 [58-117] days), 13 patients were permanently cannulated, and 21 patients died without prior removal of the cannula. Independent predictors for decannulation in our cohort were patient age (HR 0.95 [95% CI: 0.92-0.99] per one year increase, p = 0.003) and absence of sepsis (HR 4.44 [95% CI: 1.33-14.80], p = 0.008). Compared to surviving patients without cannula removal, decannulated patients had an improved functional outcome after one year (median modified Rankin Scale score 4 vs. 5 [p tracheostomy and was associated with better functional outcome compared to patients without decannulation. Further prospective studies with larger sample sizes are needed to confirm our results.

Prospective Observations of Discomfort, Pain, and Dyspnea in Nursing Home Residents With Dementia and Pneumonia

NARCIS (Netherlands)

Maaden, T. van der; Steen, J.T. van der; Vet, H.C. de; Hertogh, C.M.; Koopmans, R.T.

2016-01-01

OBJECTIVES: To describe observations of suffering in patients with dementia from the diagnosis of pneumonia until cure or death. DESIGN: Prospective observational study between January 2012 and May 2014. SETTING: Dutch nursing homes (32). PARTICIPANTS: Nursing home patients with dementia and

Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

Directory of Open Access Journals (Sweden)

Pascal H Colson

Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

Science.gov (United States)

Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

2016-01-01

To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands

NARCIS (Netherlands)

Jong, L.A.W.; Harmark, L.; Puijenbroek, E. van

2016-01-01

PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective : a prospective, observational cohort study in the Netherlands

NARCIS (Netherlands)

de Jong, Loek; Härmark, Linda; van Puijenbroek, Eugène

2016-01-01

PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

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.

A prospective observational study of skin to subarachnoid space depth in the Indian population

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Smita Prakash

2014-01-01

Full Text Available Background and Aims: A pre-puncture estimate of skin to subarachnoid space depth (SSD may guide spinal needle placement and reduce complications associated with lumbar puncture. Our aim was to determine (1 The SSD in Indian males, females, parturients and the overall population; (2 To derive formulae for predicting SSD and (3 To determine which previously suggested formula best suited our population. Methods: In this prospective, observational study, 800 adult Indian patients undergoing surgery under spinal anaesthesia were divided into three groups: Males (Group M, females (Group F and parturients (Group PF. SSD was measured after lumbar puncture. The relationship between SSD and patient characteristics was studied and statistical models were used to derive formula for predicting SSD. Statistical analysis included One-way ANOVA with post hoc analysis, forward stepwise multivariate regression analysis and paired t-tests. Results: Mean SSD was 4.71 ± 0.70 cm in the overall population. SSD in adult males (4.81 ± 0.68 cm was significantly longer than that observed in females (4.55 ± 0.66 cm but was comparable with SSD in parturients (4.73 ± 0.73 cm. Formula for predicting SSD in the overall population was 2.71 + 0.09 × Body Mass Index (BMI. Stocker′s formula when applied correlated best with the observed SSD. Formulae were derived for the three groups. Conclusions: We found gender-based differences in SSD, with SSD in males being significantly greater than that observed in the female population. SSD correlated with BMI in the parturient and the overall population. Amongst the previously proposed formulae, Stocker′s formula was most accurate in predicting SSD in our population.

Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

LENUS (Irish Health Repository)

Unterscheider, Julia

2013-04-01

The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.

Science.gov (United States)

Frantz, Robert P; Schilz, Robert J; Chakinala, Murali M; Badesch, David B; Frost, Adaani E; McLaughlin, Vallerie V; Barst, Robyn J; Rosenberg, Daniel M; Miller, Dave P; Hartline, Brian K; Benton, Wade W; Farber, Harrison W

2015-02-01

Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study

Science.gov (United States)

2014-01-01

Introduction Severe infections in intensive care patients show high morbidity and mortality rates. Linezolid is an antimicrobial drug frequently used in critically ill patients. Recent data indicates that there might be high variability of linezolid serum concentrations in intensive care patients receiving standard doses. This study was aimed to evaluate whether standard dosing of linezolid leads to therapeutic serum concentrations in critically ill patients. Methods In this prospective observational study, 30 critically ill adult patients with suspected infections received standard dosing of 600 mg linezolid intravenously twice a day. Over 4 days, multiple serum samples were obtained from each patient, in order to determine the linezolid concentrations by liquid chromatography tandem mass spectrometry. Results A high variability of serum linezolid concentrations was observed (range of area under the linezolid concentration time curve over 24 hours (AUC24) 50.1 to 453.9 mg/L, median 143.3 mg*h/L; range of trough concentrations (Cmin) linezolid concentrations over 24 hours and at single time points (defined according to the literature as AUC24  400 mg*h/L and Cmin > 10 mg/L) were observed for 7 of the patients. Conclusions A high variability of linezolid serum concentrations with a substantial percentage of potentially subtherapeutic levels was observed in intensive care patients. The findings suggest that therapeutic drug monitoring of linezolid might be helpful for adequate dosing of linezolid in critically ill patients. Trial registration Clinicaltrials.gov NCT01793012. Registered 24 January 2013. PMID:25011656

In infectious endocarditis patients mortality is highly related to kidney function at time of diagnosis: a prospective observational cohort study of 231 cases

DEFF Research Database (Denmark)

Buchholtz, Kristine; Larsen, Carsten T; Hassager, Christian

2009-01-01

function at the time of admittance. METHODS: In a prospective observational cohort study data from 235 consecutive IE patients were collected at 2 tertiary heart centres in Copenhagen. Kidney function was evaluated as Estimated Endogenous Creatinine Clearance (EECC) calculated at the time of admission...

Safety and Effectiveness of Vibration Massage by Deep Oscillations: A Prospective Observational Study

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Karin Kraft

2013-01-01

Full Text Available The objective of this study is to assess the safety of treatment with vibration massage using a deep oscillation device and the effects on symptom severity and quality of life in patients with primary fibromyalgia syndrome (FMS. Outpatients with FMS performed an observational prospective study with visits 2–4 weeks after the last treatment (control and after further 2 months (follow-up. Patients were treated with 10 sessions of 45 min deep oscillation massage, 2/week. Primary outcome parameters were safety and tolerability (5-level Likert scale (1 = very good (after each treatment session and at control visit. Secondary outcome parameters were symptom severity (Fibromyalgia Impact Questionnaire (FIQ, pain and quality of life (SF-36. Seventy patients (97.1% females were included. At control visit, 41 patients (58.6% reported 63 mild and short-lasting adverse events, mainly worsening of prevalent symptoms such as pain and fatigue. Tolerability was rated as 1.8 (95% confidence interval: 1.53; 2.07. Symptoms and quality of life were significantly improved at both control and follow-up visits (at least P<0.01. In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather sustained.

THE PROSPECTIVE OBSERVATIONAL STUDY ON CUTANEOUS ADVERSE DRUG REACTIONS TO CHEMOTHERAPY

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Prakash Mani

2016-07-01

Full Text Available INTRODUCTION There are a wide spectrum of adverse cutaneous drug reactions (ACDRs varying from transient maculopapular rash to fatal toxic epidermal necrolysis (TEN. With the advent of newer and targeted therapy in the field of dermatology, the pattern of cutaneous adverse drug eruptions and the drugs responsible for them keep changing every year. Hence, this study was undertaken to ascertain the clinical spectrum of ACDRs and the causative drugs, in a tertiary care centre in South India. MATERIALS AND METHODS This study was a prospective, observational study conducted in Department of Medical Oncology, Government Rajaji Hospital, Madurai Medical College, Madurai during the period of March 2015 - August 2015 (6 months. Severity of the reaction was assessed using CTCAE (Common Terminology Criteria for Adverse Events scale version 4.1. Causality of the drug was assessed using Naranjo Causality Assessment Scale. The scale was calculated first for the regimen and then for individual drugs separately. The adverse events with score of 6 or more (probable and definite adverse events were taken for the study. RESULTS AND CONCLUSION The overall incidence of ACDRs found in this study was 85%. Alopecia was the commonest ACDR occurring in 51.6% of patients. Nail pigmentation and supravenous pigmentation were the next common ACDRs, recorded in 35% and 16% of patients respectively. Imatinib caused generalised hypopigmentation in 40% of patients. Bleomycin induced, flagellate erythema and pigmentation in 17% of patients and stomatitis was seen in 11% of patients. Acneiform eruptions were recorded with erlotinib and gefitinib therapy. Supravenous pigmentation was common with 5-fluorouracil and docetaxel, occurring in 53% & 48% respectively. Newer targeted therapies like EGFR (Epidermal growth factor receptor inhibitors recorded low incidence of ACDRs like alopecia as against conventional antineoplastic agents. The cancer chemotherapeutic drugs are associated

Incidence of cervical cancer after several negative smear results by age 50: prospective observational study

DEFF Research Database (Denmark)

Rebolj, Matejka; van Ballegooijen, Marjolein; Lynge, Elsebeth

2009-01-01

/100,000 (95% confidence interval 33 to 51) in the younger group and 36/100,000 (24 to 52) in the older group (P=0.48). The cumulative incidence rate of cervical intraepithelial neoplasia grade I+ was twice as high in the younger than in the older group (Pcervical cancer......OBJECTIVE: To determine the incidence of cervical cancer after several negative cervical smear tests at different ages. DESIGN: Prospective observational study of incidence of cervical cancer after the third consecutive negative result based on individual level data in a national registry...... of histopathology and cytopathology (PALGA). SETTING: Netherlands, national data. Population 218,847 women aged 45-54 and 445,382 aged 30-44 at the time of the third negative smear test. MAIN OUTCOME MEASURES: 10 year cumulative incidence of interval cervical cancer. RESULTS: 105 women developed cervical cancer...

Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study.

Science.gov (United States)

Boselli, E; Bouvet, L; Bégou, G; Dabouz, R; Davidson, J; Deloste, J-Y; Rahali, N; Zadam, A; Allaouchiche, B

2014-04-01

The analgesia/nociception index (ANI) is derived from heart rate variability, ranging from 0 (maximal nociception) to 100 (maximal analgesia), to reflect the analgesia/nociception balance during general anaesthesia. This should be correlated with immediate postoperative pain in the post-anaesthesia care unit (PACU). The aim of this study was to evaluate the performance of ANI measured at arousal from general anaesthesia to predict immediate postoperative pain on arrival in PACU. Two hundred patients undergoing ear, nose, and throat or lower limb orthopaedic surgery with general anaesthesia using an inhalational agent and remifentanil were included in this prospective observational study. The ANI was measured immediately before tracheal extubation and pain intensity was assessed within 10 min of arrival in PACU using a 0-10 numerical rating scale (NRS). The relationship between ANI and NRS was assessed using linear regression. A receiver-operating characteristic (ROC) curve was used to evaluate the performance of ANI to predict NRS>3. A negative linear relationship was observed between ANI immediately before extubation and NRS on arrival in PACU. Using a threshold of 3 were both 86% with 92% negative predictive value, corresponding to an area under the ROC curve of 0.89. The measurement of ANI immediately before extubation after inhalation-remifentanil anaesthesia was significantly associated with pain intensity on arrival in PACU. The performance of ANI for the prediction of immediate postoperative pain is good and may assist physicians in optimizing acute pain management. ClinicalTrials.gov NCT01796249.

Endothelial Nitric Oxide Pathways in the Pathophysiology of Dengue: A Prospective Observational Study.

Science.gov (United States)

Yacoub, Sophie; Lam, Phung Khanh; Huynh, Trieu Trung; Nguyen Ho, Hong Hanh; Dong Thi, Hoai Tam; Van, Nguyen Thu; Lien, Le Thi; Ha, Quyen Nguyen Than; Le, Duyen Huynh Thi; Mongkolspaya, Juthathip; Culshaw, Abigail; Yeo, Tsin Wen; Wertheim, Heiman; Simmons, Cameron; Screaton, Gavin; Wills, Bridget

2017-10-16

Dengue can cause increased vascular permeability that may lead to hypovolemic shock. Endothelial dysfunction may underlie this; however, the association of endothelial nitric oxide (NO) pathways with disease severity is unknown. We performed a prospective observational study in 2 Vietnamese hospitals, assessing patients presenting early (dengue. The reactive hyperemic index (RHI), which measures endothelium-dependent vasodilation and is a surrogate marker of endothelial function and NO bioavailability, was evaluated using peripheral artery tonometry (EndoPAT), and plasma levels of l-arginine, arginase-1, and asymmetric dimethylarginine were measured at serial time-points. The main outcome of interest was plasma leakage severity. Three hundred fourteen patients were enrolled; median age of the participants was 21(interquartile range, 13-30) years. No difference was found in the endothelial parameters between dengue and other febrile illness. Considering dengue patients, the RHI was significantly lower for patients with severe plasma leakage compared to those with no leakage (1.46 vs 2.00; P dengue illness and correlates with hypoargininemia and high arginase-1 levels. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Perceived job insecurity, unemployment and depressive symptoms: a systematic review and meta-analysis of prospective observational studies.

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Kim, T J; von dem Knesebeck, O

2016-05-01

It was shown that both job insecurity and unemployment are strongly and consistently associated with depressive symptoms. It is, however, less clear whether perceived job insecurity and unemployment constitute a comparable risk for the onset of depressive symptoms. A meta-analysis was conducted to explore this issue. In December 2014, relevant records were identified through the databases MEDLINE, Embase and PsychINFO. Articles were included if they had been published in the last 10 years and contained a quantitative analysis on the prospective link between job insecurity and unemployment with depressive symptoms. In 20 cohort studies within 15 articles, job insecurity and unemployment were significantly related to a higher risk of depressive symptoms, with the odds ratio (OR) being modestly higher for job insecurity (1.29, 95% CI 1.06-1.57) than for unemployment (1.19, 95% CI 1.11-1.28). Sensitivity analyses revealed that the effects were strongest in studies that examined younger respondents (unemployment ORs were higher in shorter time lags (under 1 year), while ORs for job insecurity were increased in longer exposure-outcome intervals (3-4 years). Specifically for unemployment, ORs were highest in studies that did not control for potential health selection effects and that ascertained enduring unemployment. A statistically significant publication bias was found for studies on unemployment, but not for job insecurity. The analyses revealed that both perceived job insecurity and unemployment constitute significant risks of increased depressive symptoms in prospective observational studies. By comparing both stressors, job insecurity can pose a comparable (and even modestly increased) risk of subsequent depressive symptoms.

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

Science.gov (United States)

Abrams, Donald I; Dolor, Rowena; Roberts, Rhonda; Pechura, Constance; Dusek, Jeffery; Amoils, Sandi; Amoils, Steven; Barrows, Kevin; Edman, Joel S; Frye, Joyce; Guarneri, Erminia; Kligler, Ben; Monti, Daniel; Spar, Myles; Wolever, Ruth Q

2013-06-24

Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. ClinicalTrials.gov, NCT01186341.

Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in 1130 children: results of an European prospective multicenter observational postauthorization safety study (PASS)

NARCIS (Netherlands)

Sümpelmann, Robert; Kretz, Franz-Josef; Luntzer, Robert; de Leeuw, Thomas G.; Mixa, Vladimir; Gäbler, Ralf; Eich, Christoph; Hollmann, Markus W.; Osthaus, Wilhelm A.

2012-01-01

Introduction: Third-generation hydroxyethyl starch (HES) is now approved also for the use in children, but safety studies including large numbers of pediatric patients are still missing. Therefore, we performed an European multicentric prospective observational postauthorization safety study (PASS)

CRRTnet: a prospective, multi-national, observational study of continuous renal replacement therapy practices.

Science.gov (United States)

Heung, Michael; Bagshaw, Sean M; House, Andrew A; Juncos, Luis A; Piazza, Robin; Goldstein, Stuart L

2017-07-06

Continuous renal replacement therapy (CRRT) is the recommended modality of dialysis for critically ill patients with hemodynamic instability. Yet there remains significant variability in how CRRT is prescribed and delivered, and limited evidence-basis to guide practice. This is a prospective, multi-center observational study of patients undergoing CRRT. Initial enrollment phase will occur at 4 academic medical centers in North America over 5 years, with a target enrollment of 2000 patients. All adult patients (18-89 years of age) receiving CRRT will be eligible for inclusion; patients who undergo CRRT for less than 24 h will be excluded from analysis. Data collection will include patient characteristics at baseline and at time of CRRT initiation; details of CRRT prescription and delivery, including machine-generated treatment data; and patient outcomes. The goal of this study is to establish a large comprehensive registry of critically ill adults receiving CRRT. Specific aims include describing variations in CRRT prescription and delivery across quality domains; validating quality measures for CRRT care by correlating processes and outcomes; and establishing a large registry for use in quality improvement and benchmarking efforts. For initial analyses, some particular areas of interest are anticoagulation protocols; approach to fluid overload; CRRT-related workload; and patient safety. Registered on ClinicalTrials.gov 1/10/2014: NCT02034448.

Respiratory Viruses in Invasively Ventilated Critically Ill Patients-A Prospective Multicenter Observational Study.

Science.gov (United States)

van Someren Gréve, Frank; Juffermans, Nicole P; Bos, Lieuwe D J; Binnekade, Jan M; Braber, Annemarije; Cremer, Olaf L; de Jonge, Evert; Molenkamp, Richard; Ong, David S Y; Rebers, Sjoerd P H; Spoelstra-de Man, Angelique M E; van der Sluijs, Koenraad F; Spronk, Peter E; Verheul, Kirsten D; de Waard, Monique C; de Wilde, Rob B P; Winters, Tineke; de Jong, Menno D; Schultz, Marcus J

2018-01-01

The presence of respiratory viruses and the association with outcomes were assessed in invasively ventilated ICU patients, stratified by admission diagnosis. Prospective observational study. Five ICUs in the Netherlands. Between September 1, 2013, and April 30, 2014, 1,407 acutely admitted and invasively ventilated patients were included. None. Nasopharyngeal swabs and tracheobronchial aspirates were collected upon intubation and tested for 14 respiratory viruses. Out of 1,407 patients, 156 were admitted because of a severe acute respiratory infection and 1,251 for other reasons (non-severe acute respiratory infection). Respiratory viruses were detected in 28.8% of severe acute respiratory infection patients and 17.0% in non-severe acute respiratory infection (p < 0.001). In one third, viruses were exclusively detected in tracheobronchial aspirates. Rhinovirus and human metapneumovirus were more prevalent in severe acute respiratory infection patients (9.6% and 2.6% vs 4.5 and 0.2%; p = 0.006 and p < 0.001). In both groups, there were no associations between the presence of viruses and the number of ICU-free days at day 28, crude mortality, and mortality in multivariate regression analyses. Respiratory viruses are frequently detected in acutely admitted and invasively ventilated patients. Rhinovirus and human metapneumovirus are more frequently found in severe acute respiratory infection patients. Detection of respiratory viruses is not associated with worse clinically relevant outcomes in the studied cohort of patients.

Effects of Ramadan fasting on moderate to severe chronic kidney disease. A prospective observational study.

Science.gov (United States)

Bakhit, Amaar A; Kurdi, Amr M; Wadera, Junaid J; Alsuwaida, Abdulkareem O

2017-01-01

To examin the effect of Ramadan fasting on worsening of renal function (WRF). Method: This was a single-arm prospective observational study including 65 patients with stage 3 or higher chronic kidney disease (CKD). By definition, WRF was considered to have occurred when serum creatinine levels increased by 0.3 mg/dL (26.5 µmol/l) from baseline during or within 3 months after Ramadan. The study was conducted in the Nephrology Clinic of King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia during the month of Ramadan 1436 AH (Hijiri), which corresponded to June 18-July 17, 2015.  Results: This study included 65 adults with a mean age of 53 years. Overall, 33% of patients developed WRF. In the multivariate analysis, more advanced CKD stage, higher baseline systolic blood pressure and younger age were independently associated with WRF. Underlying cause of CKD, use of diuretics, use of renin angiotensin blockers, gender, and smoking status were not associated with WRF.  Conclusion: In patients with stage 3 or higher CKD, Ramadan fasting during the summer months was associated with worsening of renal function. Clinicians need to warn CKD patients against Ramadan fasting.

Opportunities for in-depth compositional studies of comets: Summary from semester 2017A observations and prospects for a 2018 observing campaign

Science.gov (United States)

DiSanti, Michael A.; Dello Russo, Neil; Bonev, Boncho P.; Gibb, Erika L.; Roth, Nathan; Vervack, Ronald J.; McKay, Adam J.; Kawakita, Hideyo; Cochran, Anita L.

2017-10-01

The period from late 2016 to mid 2017 provided unusually rich observational opportunities for compositional studies of comets using ground-based IR and optical spectroscopy. Three ecliptic comets - Jupiter-family comet (JFC) 45P/Honda-Mrkos-Pajdusakova, JFC 41P/Tuttle-Giacobini-Kresak, and 2P/Encke - as well as two moderately bright nearly istotropic comets from the Oort cloud (C/2015 ER61 PanSTARRS and C/2015 V2 Johnson) experienced highly favorable appritions.In the IR, very long on-source integration times were accumulated on all targets, primarily with the powerful new high-resolution, cross-dispersed iSHELL spectrograph at the IRTF (Rayner et al. 2016 SPIE 9908:1) but also with NIRSPEC at Keck II. This enabled accurate production rates and abundance ratios for 8-10 native ices, and spatially resolved studies of coma physics (H2O rotational temperatures and column abundances). The recent availability of iSHELL coupled with the daytime observing capability at the IRTF has opened a powerful window for conducting detailed compositional studies of comets over a range of heliocentric distances (Rh), particularly at small Rh where studies are relatively sparse. Our campaign provided detections of (or stringent abundance limits for) hyper-volatiles CO and CH4, which are severely lacking in compositional studies of JFCs.For all of these targets, optical spectra measured photo-dissociation product species using the Tull Coude spectrograph at McDonald Observatory, and ARCES at Apache Point Observatory. When possible optical and IR observations were obtained contemporaneously, with the goal of addressing potential parent-product relationships.We summarize our campaign and highlight related presentations. Prospects for investigations during the upcoming favorable apparitions of JFCs 21P/Giacobini-Zinner and 46P/Wirtanen will also be discussed, along with increased capabilities for serial studies (i.e., measurements at multiple Rh) of newly discovered (Oort cloud) comets

Neoadjuvant conformal chemoradiation with induction chemotherapy for rectal adenocarcinoma. A prospective observational study.

Science.gov (United States)

Fekete, Zsolt; Muntean, Alina-Simona; Hica, Ştefan; Rancea, Alin; Resiga, Liliana; Csutak, Csaba; Todor, Nicolae; Nagy, Viorica Magdalena

2014-06-01

The purpose of this prospective observational study was to evaluate the rate and the prognostic factors for down-staging and complete response for rectal adenocarcinoma after induction chemotherapy and neoadjuvant chemoradiation followed by surgery, and to analyze the rate of sphincter-saving surgery. We included from March 2011 to October 2013 a number of 88 patients hospitalized with locally advanced rectal adenocarcinoma in the Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj. The treatment schedule included 2-4 cycles of Oxaliplatin plus a fluoropyrimidine followed by concomitant chemoradiation with a dose of 50 Gy in 25 fractions combined with a fluoropyrimidine monotherapy. The rate of T down-staging was 49.4% (40/81 evaluable patients). Independent prognostic factors for T down-staging were: age >57 years (p5 cm (p35 days (p5 cm (p=0.03). Sixty-eight patients (79.1%) underwent radical surgery and among them 35 patients (51.5 %) had a sphincter saving procedure. Induction chemotherapy with neoadjuvant chemoradiation produced important down-staging in rectal adenocarcinoma. Independent prognostic factors for T down-staging were: age, cN0, distance from anal verge, initial CEA, the number of Oxaliplatin cycles and duration of radiotherapy; for complete response: cT2, initial tumor size and distance from the anal verge.

Tea consumption and risk of cardiovascular outcomes and total mortality: a systematic review and meta-analysis of prospective observational studies

International Nuclear Information System (INIS)

Zhang, Chi; Qin, Ying-Yi; Wei, Xin; Yu, Fei-Fei; Zhou, Yu-Hao; He, Jia

2015-01-01

Studies that investigated the association between tea consumption and the risk of major cardiovascular events have reported inconsistent results. We conducted a meta-analysis of prospective observational studies in order to summarize the evidence regarding the association between tea consumption and major cardiovascular outcomes or total mortality. In July 2014, we performed electronic searches in PubMed, EmBase, and the Cochrane Library, followed by manual searches of reference lists from the resulting articles to identify other relevant studies. Prospective observational studies that reported effect estimates, with 95 % confidence intervals (CIs), for coronary heart disease (CHD), stroke, cardiac death, stroke death, or total mortality for more than two dosages of tea consumption were included. A random-effects meta-analysis was performed to determine the risk of major cardiovascular outcomes associated with an increase in tea consumption by 3 cups per day. Of the 736 citations identified from database searches, we included 22 prospective studies from 24 articles reporting data on 856,206 individuals, and including 8,459 cases of CHD, 10,572 of stroke, 5,798 cardiac deaths, 2,350 stroke deaths, and 13,722 total deaths. Overall, an increase in tea consumption by 3 cups per day was associated with a reduced risk of CHD (relative risk [RR], 0.73; 95 % CI: 0.53–0.99; P = 0.045), cardiac death (RR, 0.74; 95 % CI: 0.63–0.86; P < 0.001), stroke (RR, 0.82; 95 % CI: 0.73–0.92; P = 0.001), total mortality (RR, 0.76; 95 % CI: 0.63–0.91; P = 0.003), cerebral infarction (RR, 0.84; 95 % CI: 0.72–0.98; P = 0.023), and intracerebral hemorrhage (RR, 0.79; 95 % CI: 0.72–0.87; P < 0.001), but had little or no effect on stroke mortality (RR, 0.93; 95 % CI: 0.83–1.05; P = 0.260). The findings from this meta-analysis indicate that increased tea consumption is associated with a reduced risk of CHD, cardiac death, stroke, cerebral infarction, and

Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

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Rocco Totaro

2015-01-01

Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

Forest biomass observation: current state and prospective

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D. G. Schepaschenko

2017-08-01

Full Text Available With this article, we provide an overview of the methods, instruments and initiatives for forest biomass observation at global scale. We focus on the freely available information, provided by both remote and in-situ observations. The advantages and limitation of various space borne methods, including optical, radar (C, L and P band and LiDAR, as well as respective instruments available on the orbit (MODIS, Proba-V, Landsat, Sentinel-1, Sentinel-2 , ALOS PALSAR, Envisat ASAR or expecting (BIOMASS, GEDI, NISAR, SAOCOM-CS are discussed. We emphasize the role of in-situ methods in the development of a biomass models, providing calibration and validation of remote sensing data. We focus on freely available forest biomass maps, databases and empirical models. We describe the functionality of Biomass.Geo-Wiki.org portal, which provides access to a collection of global and regional biomass maps in full resolution with unified legend and units overplayed with high-resolution imagery. The Forest-Observation-System.net is announced as an international cooperation to establish a global in-situ forest biomass database to support earth observation and to encourage investment in relevant field-based observations and science. Prospects of unmanned aerial vehicles in the forest inventory are briefly discussed. The work was partly supported by ESA IFBN project (contract 4000114425/15/NL/FF/gp.

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

Science.gov (United States)

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

2012-01-01

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

[Changes in quality of life and work function during phase prophylactic lamotrigine treatment in bipolar patients: 6 month, prospective, observational study].

Science.gov (United States)

Gonda, Xenia; Kalman, Janos; Dome, Peter; Rihmer, Zoltan

2016-03-01

Bipolar disorder is a lifelong illness requiring lifelong pharmacotherapy. Therefore besides symptomatic remission, achievement of full work-related functioning and restoration of quality of life is a priority during successful treatment. The present prospective, observational, non-intervention study focused on investigating the effect of lamotrigine therapy on the quality of life and work-related function of bipolar patients in outpatient care. 969 bipolar or schizoaffective outpatients participated in the study who previously did not receive lamotrigine therapy. Our present phase-prophylactic study was a prospective, observational, non-intervention study with a six-month follow-up. Evaluations took place at baseline and at months 1, 2, 3 and 6. Patients were followed with a Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). Changes in work-related function was evaluated using Social Adjustment Scale (SAS), while quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale. SAS scoreds showed a consistent decrease in the overall sample and in all CGI-S initial groups reflecting the improvement of work-related function during the six months of the follow-up. Q-LES-Q values in the whole sample and in all initial CGI-S groups showed a steady increase indicating a continuous increase in quality of life during the study. Our results indicate that during long-term prophylactic lamotrigine therapy the work function and quality of life of bipolar patients shows a significant improvement, therefore lamotrigine provides a possibility for full functional remission and restoration of quality of life.

Implementation of a mechanical CPR device in a physician staffed HEMS - a prospective observational study.

Science.gov (United States)

Rauch, Simon; Strapazzon, Giacomo; Brodmann, Monika; Fop, Ernst; Masoner, Christian; Rauch, Lydia; Forti, Alessandro; Pietsch, Urs; Mair, Peter; Brugger, Hermann

2018-04-28

In this prospective, observational study we describe the incidence and characteristics of out of hospital cardiac arrest (OHCA) cases who received mechanical CPR, after the implementation of a mechanical CPR device (LUCAS 2; Physio Control, Redmond, WA, USA) in a physician staffed helicopter emergency medical service (HEMS) in South Tyrol, Italy. During the study period (06/2013-04/2016), 525 OHCA cases were registered by the dispatch centre, 271 (51.6%) were assisted by HEMS. LUCAS 2 was applied in 18 (6.6%) of all HEMS-assisted OHCA patients; ten were treated with LUCAS 2 at the scene only, and eight were transported to hospital with ongoing CPR. Two (11.1%) of the 18 patients survived long term with full neurologic recovery. In seven of eight patients transferred to hospital with ongoing CPR, CPR was ceased in the emergency room without further intervention. Retrospectively, all HEMS-assisted OHCA cases were screened for proposed indication criteria for prolonged CPR. Thirteen patients fulfilled these criteria, but only two of them were transported to hospital. Based on these results, we propose a standard operating procedure for HEMS-assisted patients with refractory OHCA in a region without hospitals with ECLS capacity.

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

Science.gov (United States)

Kim, Kwan-Ii; Jo, Junyoung

2018-01-01

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

Real-time ultrasound-guided spinal anaesthesia: a prospective observational study of a new approach.

LENUS (Irish Health Repository)

Conroy, P H

2013-01-01

Identification of the subarachnoid space has traditionally been achieved by either a blind landmark-guided approach or using prepuncture ultrasound assistance. To assess the feasibility of performing spinal anaesthesia under real-time ultrasound guidance in routine clinical practice we conducted a single center prospective observational study among patients undergoing lower limb orthopaedic surgery. A spinal needle was inserted unassisted within the ultrasound transducer imaging plane using a paramedian approach (i.e., the operator held the transducer in one hand and the spinal needle in the other). The primary outcome measure was the success rate of CSF acquisition under real-time ultrasound guidance with CSF being located in 97 out of 100 consecutive patients within median three needle passes (IQR 1-6). CSF was not acquired in three patients. Subsequent attempts combining landmark palpation and pre-puncture ultrasound scanning resulted in successful spinal anaesthesia in two of these patients with the third patient requiring general anaesthesia. Median time from spinal needle insertion until intrathecal injection completion was 1.2 minutes (IQR 0.83-4.1) demonstrating the feasibility of this technique in routine clinical practice.

A PROSPECTIVE OBSERVATIONAL STUDY OF SHORT TERM MORBIDITY PATTERN IN PRETERM NEWBORNS DELIVERED IN A TERTIARY CARE HOSPITAL

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Harsha

2015-08-01

Full Text Available OBJECTIVE: To study the short term morbidity pattern in preterm new born babies delivered in a tertiary care hospital with level III neonatal intensive care unit (NICU. MATERIAL AND METHODS: A prospective observational study was conducted in a level III NICU betwee n November 2009 to July 2010 at Grant medical college and JJ Group of hospitals, Mumbai. All the in born preterm babies were assessed for morbidity pattern from the time of admission till discharge or death. RESULT: 156 preterm babies were included in the study. 83(54.21% were male and 73(46.79% were female. The major morbidities observed in the preterm neonates were hyperbilirubinemia in 50.54%, Respiratory distress syndrome (RDS in25.64% and severe birth asphyxia in13.46%. Other common morbidities seen were retinopathy of prematurity in 12.17%, apnoea in 11.54% and anaemia in 10.9%. Preterm neonates also had in 9.62% culture proven sepsis, in 8.33% hypoglycaemia, in 7.05% Intraventricular haemorrhage (IVH and in 6.41% various congenital anomalies. CONCL USION: Hyperbilirubinemia, respiratory distress syndrome and severe birth asphyxia are major preterm morbidity

Profiling sirolimus-induced inflammatory syndrome: a prospective tricentric observational study.

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Fanny Buron

Full Text Available BACKGROUND: The use of the immunosuppressant sirolimus in kidney transplantation has been made problematic by the frequent occurrence of various side effects, including paradoxical inflammatory manifestations, the pathophysiology of which has remained elusive. METHODS: 30 kidney transplant recipients that required a switch from calcineurin inhibitor to sirolimus-based immunosuppression, were prospectively followed for 3 months. Inflammatory symptoms were quantified by the patients using visual analogue scales and serum samples were collected before, 15, 30, and 90 days after the switch. RESULTS: 66% of patients reported at least 1 inflammatory symptom, cutaneo-mucosal manifestations being the most frequent. Inflammatory symptoms were characterized by their lability and stochastic nature, each patient exhibiting a unique clinical presentation. The biochemical profile was more uniform with a drop of hemoglobin and a concomitant rise of inflammatory acute phase proteins, which peaked in the serum 1 month after the switch. Analyzing the impact of sirolimus introduction on cytokine microenvironment, we observed an increase of IL6 and TNFα without compensation of the negative feedback loops dependent on IL10 and soluble TNF receptors. IL6 and TNFα changes correlated with the intensity of biochemical and clinical inflammatory manifestations in a linear regression model. CONCLUSIONS: Sirolimus triggers a destabilization of the inflammatory cytokine balance in transplanted patients that promotes a paradoxical inflammatory response with mild stochastic clinical symptoms in the weeks following drug introduction. This pathophysiologic mechanism unifies the various individual inflammatory side effects recurrently reported with sirolimus suggesting that they should be considered as a single syndromic entity.

Auditive stimulation therapy as an intervention in subacute and chronic tinnitus: a prospective observational study.

Science.gov (United States)

Kusatz, Martin; Ostermann, Thomas; Aldridge, David

2005-01-01

Tinnitus is a noise, a ringing, or a roaring sound in the affected ear and is becoming an increasingly serious problem for health care systems. Integrative treatment concepts are currently regarded as promising therapeutic approaches for managing tinnitus. The aim of this study was to present the results of auditive stimulation therapy, a program of music therapy developed specifically for tinnitus treatment. We collected data on outpatient treatment results from 155 tinnitus patients and evaluated them in a prospective observational study with three defined times of measurement (start, end, and 6 months after the end of treatment). Apart from anamnestic data and subjective evaluation of treatment, the major outcome parameter was the score of the tinnitus questionnaire. To evaluate effectiveness of the therapy, we calculated effect sizes (according to Cohen). Fifty-one percent of the patients were male, and the mean patient age was 49 years. Of the 155 patients, 137 (88%) were capable of gainful employment, which means that they fell in the age range between 18 and 65 years. The duration of tinnitus was more than 6 months for 80% of patients, and 43% had been suffering from tinnitus for more than 3 years. In general, all subscales of the tinnitus questionnaire showed highly significant changes (t-test, p observe a reduction to the level prior to treatment. The values for the effect sizes mostly ranged between medium (> 0.5) and high (> 0.8). Closer investigations indicated that a combination of music therapy and psychological training rendered the best effect sizes. This study demonstrated that music therapy is an effective integrated treatment approach and offers a way to make progress in tinnitus treatment.

Incidence and risk factors for delirium development in ICU patients - a prospective observational study.

Science.gov (United States)

Kanova, Marcela; Sklienka, Peter; Roman, Kula; Burda, Michal; Janoutova, Jana

2017-06-01

Delirium is an acute brain dysfunction and a frequent complication in critically ill patients. When present it significantly worsens the prognosis of patients. The aim of this study was to evaluate the incidence of delirium and risk factors for delirium in a mixed group of trauma, medical and surgical ICU patients. A prospective observational study was conducted in one of the six-bed Intensive Care Units of the University Hospital Ostrava in the Czech Republic during a 12-month period. We evaluated the incidence of delirium and its predisposing and precipitating risk factors. All patients were assessed daily using the Confusion Assessment Method for the ICU (CAM-ICU). Of the total of 332 patients with a median APACHE II (the Acute Physiology and Chronic Health Evaluation) score of 12, who were evaluated for delirium, 48 could not be assessed using CAM-ICU (47 due to prolonged coma, 1 due to language barriers). The incidence of delirium was 26.1%, with trauma and medical patients being more likely to develop delirium than surgical patients. Risk of delirium was significantly associated with age ≥ 65 years, and alcohol abuse in their anamnesis, with APACHE II score on admission, and with the use of sedatives and/or vasopressors. Delirious patients who remained in the ICU for a prolonged period showed a greater need for ventilator support and had a greater ICU-mortality.

Relative associations between depression and anxiety on adverse cardiovascular events: does a history of coronary artery disease matter? A prospective observational study

OpenAIRE

Pelletier, Roxanne; Bacon, Simon L; Arsenault, Andr?; Dupuis, Jocelyn; Laurin, Catherine; Blais, Lucie; Lavoie, Kim L

2015-01-01

Objectives To assess whether depression and anxiety increase the risk of mortality and major adverse cardiovascular events (MACE), among patients with and without coronary artery disease (CAD). Design and setting, and patients DECADE (Depression Effects on Coronary Artery Disease Events) is a prospective observational study of 2390 patients referred at the Montreal Heart Institute. Patients were followed for 8.8?years, between 1998 and 2009. Depression and anxiety were assessed using a psychi...

Accumulation of advanced glycation end (AGEs products in intensive care patients: an observational, prospective study

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Rommes Johannes H

2010-05-01

Full Text Available Abstract Background Oxidative stress plays an important role in the course and eventual outcome in a majority of patients admitted to the intensive care unit (ICU. Markers to estimate oxidative stress are not readily available in a clinical setting. AGEs accumulation has been merely described in chronic conditions, but can also occur acutely due to oxidative stress. Since AGEs have emerged to be stable end products, these can be a marker of oxidative stress. Skin autofluorescence (AF is a validated marker of tissue content of AGEs. We hypothesized that AGEs accumulate acutely in ICU patients. Methods We performed an observational prospective study in a medical surgical ICU in a university affiliated teaching hospital. All consecutively admitted ICU patients in a 2 month period were included. Skin AF was measured using an AGE reader in 35 consecutive ICU patients > 18 yrs. As a comparison, historical data of a control group (n = 231 were used. These were also used to calculate age-adjusted AF-levels (AFadj. Values are expressed as median and interquartile range [P25-P75]. Differences between groups were tested by non parametric tests. P Results AFadj values were higher in ICU patients (0.33 [0.00 - 0.68] than in controls (-0.07 [-0.29 - 0.24]; P adj were observed between acute or planned admissions, or presence of sepsis, nor was skin AFadj related to severity of disease as estimated by APACHE-II score, length of ICU, hospital stay or mortality. Conclusion Acute AGE accumulation in ICU patients was shown in this study, although group size was small. This can possibly reflect oxidative stress in ICU patients. Further studies should reveal whether AGE-accumulation will be a useful parameter in ICU patients and whether skin AF has a predictive value for outcome, which was not shown in this small study.

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

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Abdullah Cüneyt Hocagil

2018-03-01

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

Using observational data to inform the design of a prospective effectiveness study for a novel insulin delivery device

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Grabner M

2013-09-01

Full Text Available Michael Grabner,1 Yong Chen,2 Matthew Nguyen,3 Scott D Abbott,3 Ralph Quimbo1 1HealthCore, Inc., Wilmington, DE, USA; 2Merck and Co., Inc., Whitehouse Station, NJ, USA; 3Valeritas, Inc., Bridgewater, NJ, USA Objective: To inform the design and assess the feasibility of a prospective effectiveness study evaluating an insulin delivery device for patients with diabetes mellitus to be conducted within the membership of a large US commercial insurer. Methods: Providers who issued ≥1 insulin prescription between January 1, 2011 and September 30, 2011 were selected from administrative claims contained in the HealthCore Integrated Research DatabaseSM. Adult diabetes patients with visits to these providers were identified. Providers were dichotomized into high- [HVPs] and low-volume providers [LVPs] based on median number of diabetes patients per provider. Results: We identified 15,349 HVPs and 15,313 LVPs (median number of patients = 14. Most HVPs were located in the Midwest (6,291 [41.0%] and South (5,092 [33.2%], while LVPs were evenly distributed across regions. Over 80% (12,769 of HVPs practiced family or internal medicine; 6.4% (989 were endocrinologists. HVPs prescribed insulin to an average of 25% of patients. Patients of HVPs (522,527 had similar characteristics as patients of LVPs (80,669, except for geographical dispersion, which followed that of providers. Approximately 65% of patients were aged 21-64 years and 97% had type 2 diabetes. Among patients with ≥1 available HbA1C result during 2011 (103,992, 48.3% (50,193 had an average HbA1C ≥7.0%. Among patients initiating insulin, 79.6% (22,205 had an average HbA1C ≥7.0%. Conclusion: The observed provider and patient populations support the feasibility of the prospective study. Sampling of patients from HVPs is efficient while minimizing bias as patient characteristics are similar to those from LVPs. The study also highlights unmet needs for improved glycemic control since approximately

The relationship between serum ammonia level and neurologic complications in patients with acute glufosinate ammonium poisoning: A prospective observational study.

Science.gov (United States)

Cha, Y S; Kim, H; Lee, Y; Choi, E H; Kim, H I; Kim, O H; Cha, K-C; Lee, K H; Hwang, S O

2018-06-01

Glufosinate ammonium poisoning can cause neurological complications even after a symptom-free period. We prospectively investigated the predictors of neurologic complications in acute glufosinate ammonium poisoning and the change of serum ammonia level as a predictor of patient's presence and recovery of neurologic complication. This prospective observational study collected data from consecutive patients diagnosed with acute glufosinate ammonium poisoning between September 2014 and June 2016. Serum ammonia was serially measured. The patients were divided into two groups: the neurologic complication group and the nonneurologic complication group. We also defined 25 other insecticide- or herbicide-poisoned patients as controls. The neurologic complication group included 18 patients (72.0%). The latency period for neurologic complications was within 48-h postingestion. The peak ammonia level was statistically higher in the neurologic complication group than in the control group ( p glufosinate ammonium poisoning, serial serum ammonia level measurements are needed and a serum peak ammonia level greater than 90 μg/dL is a predictor of neurologic complications. Also, it is important to treat the hyperammonemia in acute glufosinate ammonium poisoning.

A prospective observational longitudinal study of new-onset seizures and newly diagnosed epilepsy in dogs

DEFF Research Database (Denmark)

Fredsø, N; Toft, Nils; Sabers, A.

2017-01-01

Seizures are common in dogs and can be caused by non-epileptic conditions or epilepsy. The clinical course of newly diagnosed epilepsy is sparsely documented. The objective of this study was to prospectively investigate causes for seizures (epileptic and non-epileptic) in a cohort of dogs with ne...

Pain in neurosurgically treated patients: A prospective observational study

NARCIS (Netherlands)

M. Klimek (Markus); J.F. Ubben (Johannes); J. Ammann (Jan); K. Borner (Katy); J. Klein (Jan); S.J.C. Verbrugge (Serge)

2006-01-01

textabstractObject. This is the first observational study to compare perioperative pain character and intensity in patients undergoing different types of elective neurosurgical procedures. Methods. A structured questionnaire was used to inquire about pain intensity, character, and management during

Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

Science.gov (United States)

Kleine-Brueggeney, Maren; Gottfried, Anne; Nabecker, Sabine; Greif, Robert; Book, Malte; Theiler, Lorenz

2017-09-02

Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH 2 O ± 10%. None of the SGA showed a mean airway leak pressure of 20 cmH 2 O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH 2 O, Air-Q® 15.9 (3.2) cmH 2 O, Ambu® Aura-i™ 17.3 (3.7) cmH 2 O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™,

Coagulation Profile in Patients with Different Etiologies for Cushing Syndrome: A Prospective Observational Study.

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Tirosh, Amit; Lodish, Maya; Lyssikatos, Charalampos; Belyavskaya, Elena; Feelders, Richard A; Stratakis, Constantine A

2017-05-01

Previous studies reported a higher prevalence of venous-thromboembolic events among patients with Cushing disease (CD) compared to those with ACTH-independent Cushing syndrome (CS) from adrenal sources. The objective of the current study was to evaluate the coagulation profile of patients with CS from different etiologies. A prospective observational study was conducted at a clinical research center. The study included adult patients admitted for evaluation of suspected CS (n=85), that were divided into 3 groups: CD (n=22), ACTH-independent CS from an adrenal tumor/hyperplasia (adrenal CS, n=21), and a control group consisting of subjects with negative screening for CS (rule-out CS, n=42). Coagulation profiles were drawn before and 8.5±4.3 months after surgery (trans-sphenoidal or adrenalectomy, n=18), and included fibrinogen, Factor VIII (FVIII), von Willebrand factor antigen (vWF:Ag), plasminogen activator inhibitor-1 (PAI-1), antithrombin III (ATIII), Protein C (PC), Protein S (PS), α2-antiplasmin (α2AP), and aPTT measurements. Patients with CD had higher baseline mean cortisol levels, ATIII activity and vWF:Ag levels compared with adrenal CS. Differences in ATIII activity and vWF:Ag levels remained even after controlling for BMI, and ATIII after also controlling for 24-h urinary free cortisol collections. Our study showed for the first time the differences in coagulation profiles between various etiologies of CS. We assume that the higher cortisol burden among CD patients may explain the differences found in the coagulation profile as well as the higher risk for VTE compared with primary adrenal CS patients. © Georg Thieme Verlag KG Stuttgart · New York.

Levonorgestrel used for emergency contraception during lactation-a prospective observational cohort study on maternal and infant safety.

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Polakow-Farkash, Sharon; Gilad, Oded; Merlob, Paul; Stahl, Bracha; Yogev, Yariv; Klinger, Gil

2013-02-01

To identify possible effects of levonorgestrel used as an emergency contraceptive during breastfeeding on mothers and their infants. A prospective observational cohort study of all women who contacted the Teratology Information Service between January, 2005 and January, 2010. Breastfeeding women who used levonorgestrel as an emergency contraceptive (study group) were compared to breastfeeding women who used either ethynodiol diacetate or desogestrel (control group). Women were followed for 6-24 months. Main outcome measures were adverse maternal and infant effects and continuation of breastfeeding. We followed 71 of 128 study group women and 72 of 100 control group women. Maternal adverse effects were mainly vaginal bleeding, which was less frequent in the study vs. control group (16 of 71 vs. 27 of 72, p = 0.068). Decreased lactation was uncommon and similar in both groups. Breastfeeding was reinitiated within less than 8 h in 75% of the levonorgestrel group women. Adverse infant effects were rare (0 of 72 infants vs. 2 of 72 infants, p = 0.5 in the study vs. control group). Our findings support the safety of using levonorgestrel as an emergency contraceptive during lactation without the need for withholding breastfeeding.

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

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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.

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

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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 (Ppilates. 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.

The health and healthcare impact of providing insurance coverage to uninsured children: A prospective observational study

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Glenn Flores

2017-05-01

Full Text Available Abstract Background Of the 4.8 million uninsured children in America, 62–72% are eligible for but not enrolled in Medicaid or CHIP. Not enough is known, however, about the impact of health insurance on outcomes and costs for previously uninsured children, which has never been examined prospectively. Methods This prospective observational study of uninsured Medicaid/CHIP-eligible minority children compared children obtaining coverage vs. those remaining uninsured. Subjects were recruited at 97 community sites, and 11 outcomes monitored monthly for 1 year. Results In this sample of 237 children, those obtaining coverage were significantly (P 6 months at baseline were associated with remaining uninsured for the entire year. In multivariable analysis, children who had been uninsured for >6 months at baseline (odds ratio [OR], 3.8; 95% confidence interval [CI], 1.4–10.3 and African-American children (OR, 2.8; 95% CI, 1.1–7.3 had significantly higher odds of remaining uninsured for the entire year. Insurance saved $2886/insured child/year, with mean healthcare costs = $5155/uninsured vs. $2269/insured child (P = .04. Conclusions Providing health insurance to Medicaid/CHIP-eligible uninsured children improves health, healthcare access and quality, and parental satisfaction; reduces unmet needs and out-of-pocket costs; and saves $2886/insured child/year. African-American children and those who have been uninsured for >6 months are at greatest risk for remaining uninsured. Extrapolation of the savings realized by insuring uninsured, Medicaid/CHIP-eligible children suggests that America potentially could save $8.7–$10.1 billion annually by providing health insurance to all Medicaid/CHIP-eligible uninsured children.

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

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Kasch, Helge; Kongsted, Alice; Qerama, Erisela; Bach, Flemming W; Bendix, Tom; Jensen, Troels Staehelin

2013-01-01

Objectives An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. Design The design was an observational prospective study of risk factors embedded in a randomised controlled study. Setting Acute whiplash patients from units, general practitioners in four Danish counties were referred to two research centres. Participants During a 2-year inclusion period, acute consecutive whiplash-injured (age 18–70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I–III, symptoms within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. Results The risk score and number of sick-listing days were related (Kruskal-Wallis, pwhiplash. Neck-mobility was a strong predictor in this study; however, it was a more inconsistent predictor in other studies. Conclusions Application of the risk assessment score and use of the risk strata system may be beneficial in future studies and may be considered as a valuable tool to assess return-to-work following injuries; however, further studies are needed. PMID:23370009

Postmenopausal vulvovaginal atrophy (VVA) is positively improved by topical hyaluronic acid application. A prospective, observational study.

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Origoni, M; Cimmino, C; Carminati, G; Iachini, E; Stefani, C; Girardelli, S; Salvatore, S; Candiani, M

2016-10-01

To evaluate the effectiveness of a topical vaginal preparation containing hyaluronic acid in controlling signs and symptoms correlated with postmenopausal vulvovaginal atrophy (VVA). A prospective, observational study has been performed at the Obstetrics and Gynecology Department of the Vita Salute San Raffaele University of Milan, Italy. Forty-six (46) consecutive postmenopausal women complaining of genital discomfort due to postmenopausal estrogen lack have been enrolled. All patients have been investigated by the use of the Vaginal Health Index (VHI) and of a Visual Analogic Scale (VAS) of symptoms at baseline and one month after the end of the study. The treatment protocol consisted of the administration of a hyaluronic acid-based liquid preparation for vaginal use (Justgin®, Just Pharma, Rome, Italy) three times a week, for a total of 8 weeks. Statistical analysis of VHI and VAS scores has been performed by the use of the Wilcoxon signed-rank test for repeated values, assuming a p-value Hyaluronic acid topical approach with a liquid preparation for vaginal use (Justgin®, Just Pharma, Roma, Italy) to control signs and symptoms of vulvovaginal atrophy (VVA) in postmenopausal women demonstrated significant effectiveness both in terms of objective and subjective improvement.

Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

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Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

2015-01-01

Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

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Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

2017-03-01

Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; Poverdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Effects of Ramadan fasting on cardiovascular risk factors: a prospective observational study

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Nematy Mohsen

2012-09-01

Full Text Available Abstract Background Previous research has shown that Ramadan fasting has beneficial effects on cardiovascular risk factors, however there are controversies. In the present study, the effect of Ramadan fasting on cardiovascular risk factors has been investigated. Method This is a prospective observational study that was carried out in a group of patients with at least one cardiovascular risk factor (including history of documented previous history of either coronary artery disease (CAD, metabolic syndrome or cerebro-vascular disease in past 10 y. Eighty two volunteers including 38 male and 44 female, aged 29–70 y, mean 54.0 ± 10 y, with a previous history of either coronary artery disease, metabolic syndrome or cerebro-vascular disease were recruited. Subjects attended the metabolic unit after at least 10 h fasting, before and after Ramadan who were been fasting for at least 10 days. A fasting blood sample was obtained, blood pressure was measured and body mass index (BMI was calculated. Lipids profile, fasting blood sugar (FBS and insulin, homocysteine (hcy, high-sensitivity C-reactive protein (hs-CRP and complete blood count (CBC were analyzed on all blood samples. Results A significant improvement in 10 years coronary heart disease risk (based on Framingham risk score was found (13.0 ± 8 before Ramadan and 10.8 ±7 after Ramadan, P 0.001, t test.There was a significant higher HDL-c, WBC, RBC and platelet count (PLT, and lower plasma cholesterol, triglycerides, LDL-c, VLDL-c, systolic blood pressure, body mass index and waist circumference after Ramadan (P 0.05, t test. The changes in FBS, insulin,Homeostasis Model Assessment Insulin Resistance (HOMA-IR, hcy, hs-CRP and diastolic blood pressure before and after Ramadan were not significant (P >0.05, t test. Conclusions This study shows a significant improvement in 10 years coronary heart disease risk score and other cardiovascular risk factors such as lipids profile

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

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Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

Predictors of stress among parents in pediatric intensive care unit: a prospective observational study.

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Aamir, Mohd; Mittal, Kundan; Kaushik, Jaya Shankar; Kashyap, Haripal; Kaur, Gurpreet

2014-11-01

To determine the sociodemographic and clinical factors leading to stress among parents whose children are admitted in pediatric intensive care unit (PICU). A prospective observational study was conducted in PICU of a tertiary care hospital of north India. Parents of children admitted to PICU for at least 48 h duration were eligible for participation. At the end of 48 h, parental stress was assessed using parental stress scale (PSS:PICU) questionnaire which was administered to the parents. Baseline demographic and clinical parameters of children admitted to PICU were recorded. The parental stress was compared with demographic and clinical characteristics of children using appropriate statistical methods. A total of 49 parents were finally eligible for participation. Mean (SD) parental stress scores was highest in domains of procedures [1.52 (0.66)] and behavior and emotional [1.32 (0.42)] subscales. Mean (SD) total parental stress score among intubated children [1.31 (0.25)] was significantly more than among non intubated children [0.97 (0.26)] (p parental stress score were comparable in terms of gender (p = 0.15) and socioeconomic status (p = 0.32). On subscale analysis, it was found that professional communication is a significant stressor in age groups 0-12 mo [0.61(0.41)] (p = 0.02). It was observed that parents of intubated children were significantly stressed by the physical appearance of their children (p parental role (p = 0.002). Total parental stress score had a positive correlation with PRISM score (r = 0.308). Indian parents are stressed maximally with environment of PICU. Factor leading to parental stress was intubation status of the child and was not affected by gender or socio demographic profile of the parents.

High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study.

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Appelt, Ane L; Pløen, John; Harling, Henrik; Jensen, Frank S; Jensen, Lars H; Jørgensen, Jens C R; Lindebjerg, Jan; Rafaelsen, Søren R; Jakobsen, Anders

2015-08-01

Abdominoperineal resection is the standard treatment for patients with distal T2 or T3 rectal cancers; however, the procedure is extensive and mutilating, and alternative treatment strategies are being investigated. We did a prospective observational trial to assess whether high-dose radiotherapy with concomitant chemotherapy followed by observation (watchful waiting) was successful for non-surgical management of low rectal cancer. Patients with primary, resectable, T2 or T3, N0-N1 adenocarcinoma in the lower 6 cm of the rectum were given chemoradiotherapy (60 Gy in 30 fractions to tumour, 50 Gy in 30 fractions to elective lymph node volumes, 5 Gy endorectal brachytherapy boost, and oral tegafur-uracil 300 mg/m(2)) every weekday for 6 weeks. Endoscopies and biopsies of the tumour were done at baseline, throughout the course of treatment (weeks 2, 4, and 6), and 6 weeks after the end of treatment. We allocated patients with complete clinical tumour regression, negative tumour site biopsies, and no nodal or distant metastases on CT and MRI 6 weeks after treatment to the observation group (watchful waiting). We referred all other patients to standard surgery. Patients under observation were followed up closely with endoscopies and selected-site biopsies, with surgical resection given for local recurrence. The primary endpoint was local tumour recurrence 1 year after allocation to the observation group. This study is registered with ClinicalTrials.gov, number NCT00952926. Enrolment is closed, but follow-up continues for secondary endpoints. Between Oct 20, 2009, and Dec 23, 2013, we enrolled 55 patients. Patients were recruited from three surgical units throughout Denmark and treated in one tertiary cancer centre (Vejle Hospital, Vejle, Denmark). Of 51 patients who were eligible, 40 had clinical complete response and were allocated to observation. Median follow-up for local recurrence in the observation group was 23·9 months (IQR 15·3-31·0). Local recurrence in the

Risk factors associated with early reintubation in trauma patients: a prospective observational study.

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Brown, Carlos V R; Daigle, Jacob B; Foulkrod, Kelli H; Brouillette, Brandee; Clark, Adam; Czysz, Clea; Martinez, Marnie; Cooper, Hassie

2011-07-01

After mechanical ventilation, extubation failure is associated with poor outcomes and prolonged hospital and intensive care unit (ICU) stays. We hypothesize that specific and unique risk factors exist for failed extubation in trauma patients. The purpose of this study was to identify the risk factors in trauma patients. We performed an 18-month (January 2008-June 2009) prospective, cohort study of all adult (8 years or older) trauma patients admitted to the ICU who required mechanical ventilation. Failure of extubation was defined as reintubation within 24 hours of extubation. Patients who failed extubation (failed group) were compared with those who were successfully extubated (successful group) to identify independent risk factors for failed extubation. A total of 276 patients were 38 years old, 76% male, 84% sustained blunt trauma, with an mean Injury Severity Score = 21, Glasgow Coma Scale (GCS) score = 7, and systolic blood pressure = 125 mm Hg. Indications for initial intubation included airway (4%), breathing (13%), circulation (2%), and neurologic disability (81%). A total of 17 patients (6%) failed extubation and failures occurred a mean of 15 hours after extubation. Independent risk factors to fail extubation included spine fracture, airway intubation, GCS at extubation, and delirium tremens. Patients who failed extubation spent more days in the ICU (11 vs. 6, p = 0.006) and hospital (19 vs. 11, p = 0.002). Mortality was 6% (n = 1) in the failed group and 0.4% (n = 1) in the successful extubation group. Independent risk factors for trauma patients to fail extubation include spine fracture, initial intubation for airway, GCS at extubation, and delirium tremens. Trauma patients with these four risk factors should be observed for 24 hours after extubation, because the mean time to failure was 15 hours. In addition, increased complications, extended need for mechanical ventilation, and prolonged ICU and hospital stays should be expected for trauma patients

Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

NARCIS (Netherlands)

Madsen, M.B.; Skrede, S.; Bruun, T.; Arnell, P.; Rosén, A.; Nekludov, M.; Karlsson, Y.; Bergey, F.; Saccenti, E.; Martins dos Santos, V.A.P.; Perner, A.; Norrby-Teglund, A.; Hyldegaard, O.

2018-01-01

Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating

The Gambian Bone and Muscle Ageing Study: Baseline Data from a Prospective Observational African Sub-Saharan Study

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Ayse Zengin

2017-08-01

Full Text Available The Gambian Bone and Muscle Ageing Study is a prospective observational study investigating bone and muscle ageing in men and women from a poor, subsistence farming community of The Gambia, West Africa. Musculoskeletal diseases, including osteoporosis and sarcopenia, form a major part of the current global non-communicable disease burden. By 2050, the vast majority of the world’s ageing population will live in low- and middle-income countries with an estimated two-fold rise in osteoporotic fracture. The study design was to characterise change in bone and muscle outcomes and to identify possible preventative strategies for fracture and sarcopenia in the increasing ageing population. Men and women aged ≥40 years from the Kiang West region of The Gambia were recruited with stratified sampling by sex and age. Baseline measurements were completed in 488 participants in 2012 who were randomly assigned to follow-up between 1.5 and 2 years later. Follow-up measurements were performed on 465 participants approximately 1.7 years after baseline measurements. The data set comprises a wide range of measurements on bone, muscle strength, anthropometry, biochemistry, and dietary intake. Questionnaires were used to obtain information on health, lifestyle, musculoskeletal pain, and reproductive status. Baseline cross-sectional data show preliminary evidence for bone mineral density and muscle loss with age. Men had greater negative differences in total body lean mass with age than women following adjustments for body size. From peripheral quantitative computed tomography scans, greater negative associations between bone outcomes and age at the radius and tibia were shown in women than in men. Ultimately, the findings from The Gambian Bone and Muscle Ageing Study will contribute to the understanding of musculoskeletal health in a transitioning population and better characterise fracture and sarcopenia incidence in The Gambia with an aim to the

A prospective observational study of pigmented naevi changes in psoriasis patients on biologic therapy.

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Choi, Seohee Deanne; D'Souza, Mario I; Menzies, Scott W; Weninger, Wolfgang

2018-05-23

Patients on biologic therapy are thought to be at increased risk of developing non-melanoma skin cancers and melanomas. It is unknown whether biologic therapy alters the natural history of melanocytic naevi. Therefore, a prospective observational study was conducted to determine whether psoriasis patients on biologic therapy develop changes in naevi. Clinical and dermoscopic assessment of all melanocytic naevi was performed in 45 psoriasis patients on biologic therapy versus a control cohort of 43 subjects, using sequential digital dermoscopic imaging and total body photography. The mean follow-up period was 1.5 years. The study and control patients had comparable age, gender, previous and family history of non-melanoma skin cancers and melanomas, as well as previous sun exposure and total number of naevi. The number of naevi with major dermoscopic changes was 3% in the study and 1.9% in the control group, with an adjusted incidence rate ratio of 1.45 (95% confidence interval 0.90-2.33; P = 0.125). The rate of minor changes was 15.9% in the study group versus 19.4% in the control (adjusted incidence rate ratio 0.77, 95% confidence interval 0.57-1.08; P = 0.14). There were six new dysplastic naevi in 4/45 biologic patients and four in 4/43 controls; however, the difference was not significant (relative risk 0.96, 95% confidence interval -0.12 to 0.12; P = 0.95). There were no melanomas in either group. Over a mean follow-up period of 1.5 years there was no evidence of significantly different changes in naevi or development of new dysplastic naevi in psoriasis patients on biologic treatment compared to controls. © 2018 The Australasian College of Dermatologists.

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

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Schwenn Oliver

2010-09-01

Full Text Available Abstract Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP, visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population, the primary reasons for switching were inadequate IOP reduction (78.2% and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible. In all, 1317 (56.3% subjects completed the study, and 1028 (44.0% were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up.

Postural and Balance Disorders in Patients with Parkinson’s Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

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Andrea Santamato

2015-01-01

Full Text Available Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson’s disease (PD to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

Prospects for SODART observations of nearby clusters of galaxies

DEFF Research Database (Denmark)

Pedersen, Kenneth; Westergaard, Niels Jørgen Stenfeldt

1998-01-01

Using the current best understanding of the SODART mirror system, the Bragg panel and of the LEPC/HEPC responses [1] we have studied the feasibility and prospects for SODART studies of nearby clusters of galaxies. From simulated HEPC data of the cluster Abell 2256, we demonstrate that SODART...

Pharmacotherapy of elderly patients in everyday anthroposophic medical practice: a prospective, multicenter observational study

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Bockelbrink Angelina

2010-07-01

Full Text Available Abstract Background Pharmacotherapy in the older adult is a complex field involving several different medical professionals. The evidence base for pharmacotherapy in elderly patients in primary care relies on only a few clinical trials, thus documentation must be improved, particularly in the field of complementary and alternative medicine (CAM like phytotherapy, homoeopathy, and anthroposophic medicine. This study describes diagnoses and therapies observed in elderly patients treated with anthroposophic medicine in usual care. Methods Twenty-nine primary care physicians in Germany participated in this prospective, multicenter observational study on prescribing patterns. Prescriptions and diagnoses were reported for each consecutive patient. Data were included if patients were at least 60 years of age. Multiple logistic regression analysis was used to determine factors associated with anthroposophic prescriptions. Results In 2005, a total of 12 314 prescriptions for 3076 patients (68.1% female were included. The most frequent diagnoses were hypertension (11.1%, breast cancer (3.5%, and heart failure (3.0%. In total, 30.5% of the prescriptions were classified as CAM remedies alone, 54.4% as conventional pharmaceuticals alone, and 15.1% as a combination of both. CAM remedies accounted for 41.7% of all medications prescribed (35.5% anthroposophic. The adjusted odds ratio (AOR for receiving an anthroposophic remedy was significantly higher for the first consultation (AOR = 1.65; CI: 1.52-1.79, treatment by an internist (AOR = 1.49; CI: 1.40-1.58, female patients (AOR = 1.35; CI: 1.27-1.43, cancer (AOR = 4.54; CI: 4.12-4.99, arthropathies (AOR = 1.36; CI: 1.19-1.55, or dorsopathies (AOR = 1.34; CI: 1.16-1.55 and it decreased with patient age (AOR = 0.97; CI: 0.97-0.98. The likelihood of being prescribed an anthroposophic remedy was especially low for patients with hypertensive diseases (AOR = 0.36; CI: 0.32-0.39, diabetes mellitus (AOR = 0.17; CI: 0

The Home Observation of Periconceptional Exposures (HOPE) study, a prospective cohort: aims, design, recruitment and compliance.

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Porucznik, Christina A; Cox, Kyley J; Schliep, Karen C; Wilkins, Diana G; Stanford, Joseph B

2016-06-08

To examine transient environmental exposures and their relationship with human fecundity, exposure assessment should occur optimally at the time of conception in both members of the couple. We performed an observational, prospective cohort study with biomonitoring in both members of a heterosexual couple trying to conceive. Couples collected urine, saliva, and semen specimens for up to two menstrual cycles on days corresponding to the time windows of fertilization, implantation, and early pregnancy, identified based on the woman's observations of her cervical fluid. Three hundred nine eligible couples were screened between 2011 and 2015, of which 183 enrolled. Eleven couples (6.0 %) withdrew or were lost to follow up. The most successful and cost effective recruiting strategies were word of mouth (40 % of participating couples), posters and flyers (37 %), and targeted Facebook advertising (13 %) with an overall investment of $37.35 spent on recruitment per couple. Both men and women collected ≥97.2 % of requested saliva samples, and men collected ≥89.9 % of requested semen samples. Within the periovulatory days (±3 days), there was at least one urine specimen collected by women in 97.1 % of cycles, and at least one by men in 91.7 % of cycles. Daily compliance with periovulatory urine specimens ranged from 66.5 to 92.4 % for women and from 55.7 to 75.0 % for men. Compliance was ≥88 % for questionnaire completion at specified time points. Couples planning to conceive can be recruited successfully for periconceptional monitoring, and will comply with intensive study protocols involving home collection of biospecimens and questionnaire data.

Risk factors for post-colorectal endoscopic submucosal dissection (ESD) coagulation syndrome: a multicenter, prospective, observational study

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Arimoto, Jun; Higurashi, Takuma; Kato, Shingo; Fuyuki, Akiko; Ohkubo, Hidenori; Nonaka, Takashi; Yamaguchi, Yoshikazu; Ashikari, Keiichi; Chiba, Hideyuki; Goto, Shungo; Taguri, Masataka; Sakaguchi, Takashi; Atsukawa, Kazuhiro; Nakajima, Atsushi

2018-01-01

Background and study aims  Colorectal cancer (CRC) is one of the most common neoplasms and endoscopic submucosal dissection (ESD) is an effective treatment for early-stage CRC. However, it has been observed that patients undergoing ESD often complain of pain, even if ESD has been successfully performed. Risk factors for such pain still remain unknown. The aim of this study was to explore the risk factors for post-colorectal ESD coagulation syndrome (PECS). Patients and methods  This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS. We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. Results  PECS occurred in 15/106 (14.2 %), and 10 were women ( P  = 0.01, OR: 7.74 [1.6 – 36.4]), 7 had lesions in the cecum ( P   90 min ( P  = 0.002, OR: 10.3 [2.4 – 44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47 % [7/15] vs. 2 % [2/91], P  PECS group.  Conclusions  Female gender, location of lesion in the cecum, and ESD operation time > 90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.  PMID:29527556

A Prospective Observational Study of Technical Difficulty With GlideScope-Guided Tracheal Intubation in Children.

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Zhang, Bin; Gurnaney, Harshad G; Stricker, Paul A; Galvez, Jorge A; Isserman, Rebecca S; Fiadjoe, John E

2018-05-09

The GlideScope Cobalt is one of the most commonly used videolaryngoscopes in pediatric anesthesia. Although visualization of the airway may be superior to direct laryngoscopy, users need to learn a new indirect way to insert the tracheal tube. Learning this indirect approach requires focused practice and instruction. Identifying the specific points during tube placement, during which clinicians struggle, would help with targeted education. We conducted this prospective observational study to determine the incidence and location of technical difficulties using the GlideScope, the success rates of various corrective maneuvers used, and the impact of technical difficulty on success rate. We conducted this observational study at our quaternary pediatric hospital between February 2014 and August 2014. We observed 200 GlideScope-guided intubations and documented key intubation-related outcomes. Inclusion criteria for patients were the number of advancement maneuvers required to intubate the trachea, the location where technical difficulty occurred, the types of maneuvers used to address difficulties, and the tracheal intubation success rate. We used a bias-corrected bootstrapping method with 300 replicates to determine the 95% confidence interval (CI) around the rate of difficulty with an intubation attempt. After excluding attempts by inexperienced clinicians, there were 225 attempts in 187 patients, 58% (131 of 225; bootstrap CI, 51.6%-64.6%]) of the attempts had technical difficulties. Technical difficulty was most likely to occur when inserting the tracheal tube between the plane of the arytenoid cartilages to just beyond the vocal cords: "zone 3." Clockwise rotation of the tube was the most common successful corrective maneuver in zone 3. The overall tracheal intubation success rate was 98% (CI, 95%-99%); however, the first attempt success rate was only 80% (CI, 74%-86%). Patients with technical difficulty had more attempts (median [interquartile range], 2 [1

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

NARCIS (Netherlands)

Caniglia, Ellen C.; Cain, Lauren E.; Sabin, Caroline A.; Robins, James M.; Logan, Roger; Abgrall, Sophie; Mugavero, Michael J.; Hernández-Díaz, Sonia; Meyer, Laurence; Seng, Remonie; Drozd, Daniel R.; Seage, George R.; Bonnet, Fabrice; Dabis, Francois; Moore, Richard D.; Reiss, Peter; van Sighem, Ard; Mathews, William C.; del Amo, Julia; Moreno, Santiago; Deeks, Steven G.; Muga, Roberto; Boswell, Stephen L.; Ferrer, Elena; Eron, Joseph J.; Napravnik, Sonia; Jose, Sophie; Phillips, Andrew; Justice, Amy C.; Tate, Janet P.; Gill, John; Pacheco, Antonio; Veloso, Valdilea G.; Bucher, Heiner C.; Egger, Matthias; Furrer, Hansjakob; Porter, Kholoud; Touloumi, Giota; Crane, Heidi; Miro, Jose M.; Sterne, Jonathan A.; Costagliola, Dominique; Saag, Michael; Hernán, Miguel A.

2017-01-01

Clinical guidelines vary with respect to the optimal monitoring frequency of HIV-positive individuals. We compared dynamic monitoring strategies based on time-varying CD4 cell counts in virologically suppressed HIV-positive individuals. In this observational study, we used data from prospective

Black cohosh (Cimicifuga racemosa) in tamoxifen-treated breast cancer patients with climacteric complaints - a prospective observational study.

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Rostock, Matthias; Fischer, Julia; Mumm, Andreas; Stammwitz, Ute; Saller, Reinhard; Bartsch, Hans Helge

2011-10-01

The antihormonal therapy of breast cancer patients with the antiestrogen tamoxifen often induces or aggravates menopausal complaints. As estrogen substitution is contraindicated, herbal alternatives, e.g. extracts of black cohosh are often used. A prospective observational study was carried out in 50 breast cancer patients with tamoxifen treatment. All patients had had surgery, most of them had undergone radiation therapy (87%) and approximately 50% had received chemotherapy. Every patient was treated with an isopropanolic extract of black cohosh (1-4 tablets, 2.5 mg) for 6 months. Patients recorded their complaints before therapy and after 1, 3, and 6 months of therapy using the menopause rating scale (MRS II). The reduction of the total MRS II score under black cohosh treatment from 17.6 to 13.6 was statistically significant. Hot flashes, sweating, sleep problems, and anxiety improved, whereas urogenital and musculoskeletal complaints did not change. In all, 22 patients reported adverse events, none of which were linked with the study medication; 90% reported the tolerability of the black cohosh extract as very good or good. Black cohosh extract seems to be a reasonable treatment approach in tamoxifen treated breast cancer patients with predominantly psychovegetative symptoms.

The Predictive Value of Integrated Pulmonary Index after Off-Pump Coronary Artery Bypass Grafting: A Prospective Observational Study

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Evgenia V. Fot

2017-08-01

Full Text Available BackgroundThe early warning scores may increase the safety of perioperative period. The objective of this study was to assess the diagnostic and predictive role of Integrated Pulmonary Index (IPI after off-pump coronary artery bypass grafting (OPCAB.Materials and MethodsForty adult patients undergoing elective OPCAB were enrolled into a single-center prospective observational study. We assessed respiratory function using IPI that includes oxygen saturation, end-tidal CO2, respiratory rate, and pulse rate. In addition, we evaluated blood gas analyses and hemodynamics, including ECG, invasive arterial pressure, and cardiac index. The measurements were performed after transfer to the intensive care unit, after spontaneous breathing trial and at 2, 6, 12, and 18 h after extubation.Results and DiscussionThe value of IPI registered during respiratory support correlated weakly with cardiac index (rho = 0.4; p = 0.04 and ScvO2 (rho = 0.4, p = 0.02. After extubation, IPI values decreased significantly, achieving a minimum by 18 h. The IPI value ≤9 at 6 h after extubation was a predictor of complicated early postoperative period (AUC = 0.71; p = 0.04 observed in 13 patients.ConclusionIn off-pump coronary surgery, the IPI decreases significantly after tracheal extubation and may predict postoperative complications.

Perfusion index as a predictor of hypotension following propofol induction - A prospective observational study

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Sripada G Mehandale

2017-01-01

Full Text Available Background and Aims: Hypotension during propofol induction is a common problem. Perfusion index (PI, an indicator of systemic vascular resistance, is said to be predictive of hypotension following subarachnoid block. We hypothesised that PI can predict hypotension following propofol induction and a cut-off value beyond which hypotension is more common can be determined. Methods: Fifty adults belonging to the American Society of Anesthesiologists' physical status I/II undergoing elective surgery under general anaesthesia were enrolled for this prospective, observational study. PI, heart rate, blood pressure (BP and oxygen saturation were recorded every minute from baseline to 10 min following induction of anaesthesia with a titrated dose of propofol, and after endotracheal intubation. Hypotension was defined as fall in systolic BP (SBP by >30% of baseline or mean arterial pressure (MAP to <60 mm Hg. Severe hypotension (MAP of <55 mm Hg was treated. Results: Within first 5-min after induction, the incidence of hypotension with SBP and MAP criteria was 30% and 42%, respectively, and that of severe hypotension, 22%. Baseline PI <1.05 predicted incidence of hypotension at 5 min with sensitivity 93%, specificity 71%, positive predictive value (PPV 68% and negative predictive value (NPV 98%. The area under the ROC curve (AUC was 0.816, 95% confidence interval (0.699–0.933, P < 0.001 Conclusion: Perfusion index could predict hypotension following propofol induction, especially before endotracheal intubation, and had a very high negative predictive value.

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

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Menz Hylton B

2011-09-01

Full Text Available Abstract Background Symptomatic osteoarthritis (OA affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. 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 and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only and three years (clinic attenders and survey participants, and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and

Medical care and organisation at the 2012 Roskilde Music Festival: a prospective observational study.

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Stagelund, S; Jans, Ø; Nielsen, K; Jans, H; Wildgaard, K

2014-10-01

Music festivals, with a mix of music, alcohol and camping at the festival site combined with low hygiene, have become an integral part of society and attracts large numbers of guests. Our study was performed in order to increase the very limited knowledge on health-care issues and organisation of major music festivals. Pre-defined illness and injury categories were constructed based on categories previously reported from music festivals. We prospectively recorded patient presentations to the Medical Health Care Organisation (MHCO) at the 2012 Roskilde Festival. During 10 days, more than 130,000 guests and volunteers attended the 2012 Roskilde Festival. Ten thousand six hundred thirty patient presentations were registered between the 30th of June and 9th of July 2012 by the MHCO. The majority of patient presentations, 6919, could be handled by first-aid volunteers with different levels of training. The remaining 3473 patient presentations were assessed to require further health-care competencies or additional resources such as prescriptions, medication or suturing. Two hundred thirty-eight patient presentations were triaged to a designated observation area. Two hundred sixty patients were referred to a local hospital, a general practitioner or a dentist. The overall patient presentation rate was 72/1000 attendees, and the transport-to-hospital rate was 1.8/1000 attendees. Our study demonstrates that illnesses and injuries are frequent, although mostly minor, in this normally low-risk population consisting of primarily young and healthy guests. However, comparison with other recent events was difficult as only limited data have been published from other music festivals. Future festivals should publish similar data. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Mechanical Ventilation and ARDS in the ED: A Multicenter, Observational, Prospective, Cross-sectional Study.

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Fuller, Brian M; Mohr, Nicholas M; Miller, Christopher N; Deitchman, Andrew R; Levine, Brian J; Castagno, Nicole; Hassebroek, Elizabeth C; Dhedhi, Adam; Scott-Wittenborn, Nicholas; Grace, Edward; Lehew, Courtney; Kollef, Marin H

2015-08-01

There are few data regarding mechanical ventilation and ARDS in the ED. This could be a vital arena for prevention and treatment. This study was a multicenter, observational, prospective, cohort study aimed at analyzing ventilation practices in the ED. The primary outcome was the incidence of ARDS after admission. Multivariable logistic regression was used to determine the predictors of ARDS. We analyzed 219 patients receiving mechanical ventilation to assess ED ventilation practices. Median tidal volume was 7.6 mL/kg predicted body weight (PBW) (interquartile range, 6.9-8.9), with a range of 4.3 to 12.2 mL/kg PBW. Lung-protective ventilation was used in 122 patients (55.7%). The incidence of ARDS after admission from the ED was 14.7%, with a mean onset of 2.3 days. Progression to ARDS was associated with higher illness severity and intubation in the prehospital environment or transferring facility. Of the 15 patients with ARDS in the ED (6.8%), lung-protective ventilation was used in seven (46.7%). Patients who progressed to ARDS experienced greater duration in organ failure and ICU length of stay and higher mortality. Lung-protective ventilation is infrequent in patients receiving mechanical ventilation in the ED, regardless of ARDS status. Progression to ARDS is common after admission, occurs early, and worsens outcome. Patient- and treatment-related factors present in the ED are associated with ARDS. Given the limited treatment options for ARDS, and the early onset after admission from the ED, measures to prevent onset and to mitigate severity should be instituted in the ED. ClinicalTrials.gov; No.: NCT01628523; URL: www.clinicaltrials.gov.

Quality of recovery after anaesthesia measured with QoR-40: a prospective observational study

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Luís Guimarães-Pereira

Full Text Available Abstract Background: QoR-40, a 40-item questionnaire on quality of recovery from anaesthesia, has been shown to measure health status after surgery. Our aim was to evaluate the incidence of poor quality of recovery in our Post Anaesthesia Care Unit and to compare their QoR-40 scores before surgery and 3 months later. Methods: A prospective observational study was conducted in adult patients consecutively admitted from 18 June to 12 July 2012. The follow-up period was 3 months. We exclude patients submitted to cardiac surgery, neurosurgery, obstetric surgery and with a mini-mental state examination test score lower than 25. The primary endpoint was quality of recovery measured with the validated Portuguese for Portugal version of the QoR-40 before surgery (T0, 24 h after surgery (T1 and 3 months after (T2. Results: A total of 114 patients completed the study. Mean QoR-40 score was 169 and patients with poor quality of recovery were identified if their QoR-40 score was lesser than 142. This occurred in 26 patients (24%. Global median scores for patients with poor quality of recovery were lower at T0 (121 vs. 184, p < 0.001, at T1 (120 vs. 177, p < 0.001 and at T2 (119 vs. 189, p < 0.001. Conclusion: Patients with poor quality of recovery had lower quality of life. This fact may allow earlier and more effective interventions, in order to improve quality of life after surgery. Beside its utility after surgery, QoR-40 may be important prior to surgery to identify patients who will develop a poor quality of recovery.

Sleep disorders in pregnancy and their association with pregnancy outcomes: a prospective observational study.

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Sharma, S K; Nehra, A; Sinha, S; Soneja, M; Sunesh, K; Sreenivas, V; Vedita, D

2016-03-01

Sleep disturbances such as insomnia, nocturnal awakenings, restless legs syndrome, habitual snoring, and excessive daytime sleepiness are frequent during pregnancy, and these have been linked to adverse maternal and fetal outcomes. A prospective observational study was performed in high-risk Indian pregnant women. We used modified Berlin questionnaire (MBQ), Pittsburgh sleep quality index (PSQI), International Restless Legs Syndrome Study Group 2011 criteria, and Epworth sleepiness scale to diagnose various sleep disorders, such as symptomatic OSA, poor sleep quality and insomnia, RLS, and excessive daytime sleepiness, respectively, in successive trimesters of pregnancy. Outcome variables of interest were development of gestational hypertension (GH), gestational diabetes mellitus (GDM), and cesarean delivery (CS); the Apgar scores; and low birth weight (LBW). The relationship between sleep disorders and outcomes was explored using logistic regression analysis. Outcome data were obtained in 209 deliveries. As compared to nonsnorers, women who reported snoring once, twice, and thrice or more had odds ratios for developing GH-4.0 (95 % CI 1.3-11.9), 1.5 (95 % CI 0.5-4.5), and 2.9 (95 % CI 1.0-8.2) and for undergoing CS-5.3 (95 % CI 1.7-16.3), 4.9 (95 % CI 1.8-13.1), and 5.1 (95 % CI 1.9-14.9), respectively. Pregnant women who were persistently positive on MBQ had increased odds for GH and CS. Snoring and high-risk MBQ in pregnant women are strong risk factors for GH and CS. In view of the significant morbidity and health care costs, simple screening of pregnant women with questionnaires such as MBQ may have clinical utility.

Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study.

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Steensma, David P; Abedi, Medrdad; Bejar, Rafael; Cogle, Christopher R; Foucar, Kathryn; Garcia-Manero, Guillermo; George, Tracy I; Grinblatt, David; Komrokji, Rami; Ma, Xiaomei; Maciejewski, Jaroslaw; Pollyea, Daniel A; Savona, Michael R; Scott, Bart; Sekeres, Mikkael A; Thompson, Michael A; Swern, Arlene S; Nifenecker, Melissa; Sugrue, Mary M; Erba, Harry

2016-08-19

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are myeloid neoplasms in which outgrowth of neoplastic clones disrupts normal hematopoiesis. Some patients with unexplained persistent cytopenias may not meet minimal diagnostic criteria for MDS but an alternate diagnosis is not apparent; the term idiopathic cytopenia of undetermined significance (ICUS) has been used to describe this state. MDS and AML occur primarily in older patients who are often treated outside the clinical trial setting. Consequently, our understanding of the patterns of diagnostic evaluation, management, and outcomes of these patients is limited. Furthermore, there are few natural history studies of ICUS. To better understand how patients who have MDS, ICUS, or AML are managed in the routine clinical setting, the Connect MDS/AML Disease Registry, a multicenter, prospective, observational cohort study of patients newly diagnosed with these conditions has been initiated. The Connect MDS/AML Disease Registry will capture diagnosis, risk assessment, treatment, and outcomes data for approximately 1500 newly diagnosed patients from approximately 150 community and academic sites in the United States in 4 cohorts: (1) lower-risk MDS (International Prognostic Scoring System [IPSS] low and intermediate-1 risk), with and without del(5q); (2) higher-risk MDS (IPSS intermediate-2 and high risk); (3) ICUS; and (4) AML in patients aged ≥ 55 years (excluding acute promyelocytic leukemia). Diagnosis will be confirmed by central review. Baseline patient characteristics, diagnostic patterns, treatment patterns, clinical outcomes, health economics outcomes, and patient-reported health-related quality of life will be entered into an electronic data capture system at enrollment and quarterly for 8 years. A tissue substudy to explore the relationship between karyotypes, molecular markers, and clinical outcomes will be conducted, and is optional for patients. The Connect MDS/AML Disease

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study.

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García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

2018-01-08

Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for

An open-label, prospective, observational study of the efficacy of bisphosphonate therapy for painful osteoid osteoma

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Bousson, Valerie; Parlier-Cuau, Caroline; Laredo, Jean-Denis [AP-HP, Hopital Lariboisiere, Service de Radiologie Osteo-Articulaire, Paris (France); Universite Paris Diderot, Sorbonne Paris Cite, Paris (France); Leturcq, Tifenn; Ea, Hang-Korng; Orcel, Philippe [AP-HP, Hopital Lariboisiere, Service de Rhumatologie, Paris (France); Universite Paris Diderot, Sorbonne Paris Cite, Paris (France); Hauger, Olivier [CHU Pellegrin Bordeaux, Service d' Imagerie Diagnostique et Therapeutique de l' Adulte, Bordeaux (France); Mehsen-Cetre, Nadia; Schaeverbeke, Thierry [CHU Pellegrin Bordeaux, Service de Rhumatologie, Bordeaux (France); Hamze, Bassam [AP-HP, Hopital Lariboisiere, Service de Radiologie Osteo-Articulaire, Paris (France)

2018-02-15

To assess the efficacy of bisphosphonate therapy on bone pain in patients with osteoid osteoma (OO) (main objective), and to describe bisphosphonate-induced changes in nidus mineralisation and regional bone-marrow oedema (BMO). A prospective, observational study was conducted from 2011 to 2014. Patients with risk factors for complications of percutaneous or surgical ablation or recurrence after ablation, were offered once monthly intravenous bisphosphonate treatment until significant pain alleviation was achieved. We included 23 patients. The first two patients received pamidronate and the next 21 zoledronic acid (mean, 2.95 infusions per patient). Bisphosphonate therapy was successful in 19 patients (83%), whose mean pain visual analogue scale score decreased by 76.7%; this pain-relieving effect persisted in 17 patients (74%) with a mean follow-up time of 36 months. Computed tomography (CT) demonstrated a mean nidus density increase of 177.7% (p = 0.001). By magnetic resonance imaging (MRI), mean decreases were 38.4% for BMO surface area and 30.3% for signal intensity (p = 0.001 and p = 0.000, respectively). In 17/23 patients with painful OO managed conservatively with bisphosphonates, long-term final success was achieved. Bisphosphonates may accelerate the spontaneous healing of OO. (orig.)

The South African Surgical Outcomes Study: A 7-day prospective ...

African Journals Online (AJOL)

To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at ...

Danish Observational Study of Eldercare work and musculoskeletal disorderS (DOSES): a prospective study at 20 nursing homes in Denmark

Science.gov (United States)

Karstad, Kristina; Jørgensen, Anette F B; Greiner, Birgit A; Burdorf, Alex; Søgaard, Karen; Rugulies, Reiner; Holtermann, Andreas

2018-01-01

Purpose Musculoskeletal disorders (MSDs), sickness absence and premature retirement are highly prevalent among eldercare workers. We conducted a prospective observational workplace study with the main purpose to investigate longitudinal associations between physical and psychosocial working conditions and occurrence of MSD and its consequences (pain-related interference with daily work activities and sickness absence) among Danish eldercare workers. Participants At 20 Danish nursing homes, a total of 941 eldercare workers employed in day and evening shifts were invited to the study. Of those, 553 participated in the baseline measurements, and 441 completed the total period of 12 months follow-up. Findings to date Data were collected from September 2013 to January 2016. Physical and psychosocial working conditions were assessed with multiple methods (observations, accelerometer measurements and work schedules), and multiple levels of information (nursing home, ward, resident and eldercare worker) were incorporated in the data collection. MSD and the consequences hereof were assessed monthly during a 1-year follow-up. Study participants and non-participants were comparable on most of the 27 sociodemographic, health and working condition characteristics at baseline. The exceptions were higher neck–shoulder pain intensity, less sickness absence, more exposure to negative behaviour from residents and a higher percentage of working day shifts and fewer evening shifts among participants compared with non-participants. Future plans The first publications will report on the associations of physical and psychosocial working conditions with occurrence of MSD and its consequences. In addition, the cohort gives the opportunity to investigate the importance of organisational, management and team factors for distribution of physical work demands and development of MSD among the workers. This will provide important knowledge for future workplace interventions to reduce MSD and

The safety of a novel early mobilization protocol conducted by ICU physicians: a prospective observational study

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Keibun Liu

2018-02-01

Full Text Available Abstract Background There are numerous barriers to early mobilization (EM in a resource-limited intensive care unit (ICU without a specialized team or an EM culture, regarding patient stability while critically ill or in the presence of medical devices. We hypothesized that ICU physicians can overcome these barriers. The aim of this study was to investigate the safety of EM according to the Maebashi EM protocol conducted by ICU physicians. Methods This was a single-center prospective observational study. All consecutive patients with an unplanned emergency admission were included in this study, according to the exclusion criteria. The observation period was from June 2015 to June 2016. Data regarding adverse events, medical devices in place during rehabilitation, protocol adherence, and rehabilitation outcomes were collected. The primary outcome was safety. Results A total of 232 consecutively enrolled patients underwent 587 rehabilitation sessions. Thirteen adverse events occurred (2.2%; 95% confidence interval, 1.2–3.8% and no specific treatment was needed. There were no instances of dislodgement or obstruction of medical devices, tubes, or lines. The incidence of adverse events associated with mechanical ventilation or extracorporeal membrane oxygenation (ECMO was 2.4 and 3.6%, respectively. Of 587 sessions, 387 (66% sessions were performed at the active rehabilitation level, including sitting out of the bed, active transfer to a chair, standing, marching, and ambulating. ICU physicians attended over 95% of these active rehabilitation sessions. Of all patients, 143 (62% got out of bed within 2 days (median 1.2 days; interquartile range 0.1–2.0. Conclusions EM according to the Maebashi EM protocol conducted by ICU physicians, without a specialized team or EM culture, was performed at a level of safety similar to previous studies performed by specialized teams, even with medical devices in place, including mechanical ventilation or ECMO

In-hospital resuscitation evaluated by in situ simulation: a prospective simulation study

DEFF Research Database (Denmark)

Mondrup, Frederik; Brabrand, Mikkel; Folkestad, Lars

2011-01-01

, and to examine differences in the resuscitation performance between the first responders and the cardiac arrest team. METHOD: S: A prospective observational study of 16 unannounced simulated cardiopulmonary arrest scenarios was conducted. The participants of the study involved all health care personel on duty...

Baseline Lower Urinary Tract Symptoms in Patients Enrolled in LURN: A Prospective, Observational Cohort Study.

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Cameron, Anne P; Lewicky-Gaupp, Christina; Smith, Abigail R; Helfand, Brian T; Gore, John L; Clemens, J Quentin; Yang, Claire C; Siddiqui, Nazema Y; Lai, H Henry; Griffith, James W; Andreev, Victor P; Liu, Gang; Weinfurt, Kevin; Amundsen, Cindy L; Bradley, Catherine S; Kusek, John W; Kirkali, Ziya

2018-04-01

We described and compared the frequency and type of lower urinary tract symptoms reported by men and women at the time that they were recruited from urology and urogynecology clinics into the Symptoms of Lower Urinary Tract Dysfunction Research Network multicenter, prospective, observational cohort study. At 6 research sites treatment seeking men and women were enrolled who reported any lower urinary tract symptoms at a frequency more than rarely during the last month on the LUTS (Lower Urinary Tract Symptoms) Tool. At baseline the study participants underwent a standardized clinical evaluation and completed validated questionnaires. Urological tests were performed, including pelvic/rectal examination, post-void residual urine measurement and urinalysis. A total of 545 women and 519 men were enrolled in the study. Mean ± SD age was 58.8 ± 14.1 years. At baseline nocturia, frequency and a sensation of incomplete emptying were similar in men and women but men experienced more voiding symptoms (90% vs 85%, p = 0.007) and women reported more urgency (85% vs 66%, p urinary incontinence than men (82% vs 51% p urinary incontinence, including post-void dribbling in 44% and urgency incontinence in 46%. Older participants had higher odds of reporting symptoms of nocturia and urgency. In this large, treatment seeking cohort of men and women lower urinary tract symptoms varied widely by gender and age. Men reported more voiding symptoms and nonstress or urgency urinary incontinence while women reported more incontinence overall and urgency. Older participants had greater odds of urgency and nocturia. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Acute Undifferentiated Febrile Illness in Rural Cambodia: A 3-Year Prospective Observational Study

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Mueller, Tara C.; Siv, Sovannaroth; Khim, Nimol; Kim, Saorin; Fleischmann, Erna; Ariey, Frédéric; Buchy, Philippe; Guillard, Bertrand; González, Iveth J.; Christophel, Eva-Maria; Abdur, Rashid; von Sonnenburg, Frank; Bell, David; Menard, Didier

2014-01-01

In the past decade, malaria control has been successfully implemented in Cambodia, leading to a substantial decrease in reported cases. Wide-spread use of malaria rapid diagnostic tests (RDTs) has revealed a large burden of malaria-negative fever cases, for which no clinical management guidelines exist at peripheral level health facilities. As a first step towards developing such guidelines, a 3-year cross-sectional prospective observational study was designed to investigate the causes of acute malaria-negative febrile illness in Cambodia. From January 2008 to December 2010, 1193 febrile patients and 282 non-febrile individuals were recruited from three health centers in eastern and western Cambodia. Malaria RDTs and routine clinical examination were performed on site by health center staff. Venous samples and nasopharyngeal throat swabs were collected and analysed by molecular diagnostic tests. Blood cultures and blood smears were also taken from all febrile individuals. Molecular testing was applied for malaria parasites, Leptospira, Rickettsia, O. tsutsugamushi, Dengue- and Influenza virus. At least one pathogen was identified in 73.3% (874/1193) of febrile patient samples. Most frequent pathogens detected were P. vivax (33.4%), P. falciparum (26.5%), pathogenic Leptospira (9.4%), Influenza viruses (8.9%), Dengue viruses (6.3%), O. tsutsugamushi (3.9%), Rickettsia (0.2%), and P. knowlesi (0.1%). In the control group, a potential pathogen was identified in 40.4%, most commonly malaria parasites and Leptospira. Clinic-based diagnosis of malaria RDT-negative cases was poorly predictive for pathogen and appropriate treatment. Additional investigations are needed to understand their impact on clinical disease and epidemiology, and the possible role of therapies such as doxycycline, since many of these pathogens were seen in non-febrile subjects. PMID:24755844

A Prospective Observational Survey on the Long-Term Effect of LDL Apheresis on Drug-Resistant Nephrotic Syndrome

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Eri Muso

2015-08-01

Full Text Available Background/Aims: LDL apheresis (LDL-A is used for drug-resistant nephrotic syndrome (NS as an alternative therapy to induce remission by improvement of hyperlipidemia. Several clinical studies have suggested the efficacy of LDL-A for refractory NS, but the level of evidence remains insufficient. A multicenter prospective study, POLARIS (Prospective Observational Survey on the Long-Term Effects of LDL Apheresis on Drug-Resistant Nephrotic Syndrome, was conducted to evaluate its clinical efficacy with high-level evidence. Methods: Patients with NS who showed resistance to primary medication for at least 4 weeks were prospectively recruited to the study and treated with LDL-A. The long-term outcome was evaluated based on the rate of remission of NS 2 years after treatment. Factors affecting the outcome were also examined. Results: A total of 58 refractory NS patients from 40 facilities were recruited and enrolled as subjects of the POLARIS study. Of the 44 subjects followed for 2 years, 21 (47.7% showed remission of NS based on a urinary protein (UP level Conclusions: Almost half of the cases of drug-resistant NS showed remission 2 years after LDL-A. Improvement of nephrotic parameters at termination of the LDL-A treatment was a predictor of a favorable outcome.

The mental wellbeing of current and retired professional cricketers: an observational prospective cohort study.

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Schuring, Nannet; Kerkhoffs, Gino; Gray, Janine; Gouttebarge, Vincent

2017-11-01

Scientific knowledge about symptoms of common mental disorders in professional cricket is non-existent. Consequently, the aims of the study were to determine the prevalence and the 6 months incidence of symptoms of common mental disorders (CMD: distress, anxiety/depression, sleep disturbance, adverse alcohol use) among current and former professional cricketers and to explore the association of potential stressors (significant injury, surgery, adverse life events, career dissatisfaction) and CMD. An observational prospective cohort study with a follow-up period of 6 months was conducted among current and former professional cricketers from South Africa. Using validated questionnaires to assess symptoms of common mental disorders as well as several stressors, an electronic questionnaire was set up and distributed by the South African Cricketers Association (SACA). A total of 116 participants enrolled at baseline (overall response rate of 33%) and 76 of those participants completed the 6 month follow-up (follow up rate of 66%). The prevalence of symptoms of CMD in current professional cricketers was 38% for distress, 38% for sleep disturbance, 37% for anxiety/depression and 26% for adverse alcohol use. Among former professional cricketers, baseline prevalence as was 26% for distress, 24% for anxiety/depression, 21% for sleep disturbance and 22% for adverse alcohol use. Career dissatisfaction led to an increased risk of distress, anxiety/depression and sleep disturbance in current professional cricketers. Surgeries and adverse life events led to an increase in reported symptoms of distress and anxiety/depression in current professional cricketers. It was concluded that symptoms of CMD are prevalent in both current and former professional cricketers and the association with surgery, adverse life events and cricket career dissatisfaction may provide some insight into possible mechanisms.

Quality of recovery after anaesthesia measured with QoR-40: a prospective observational study.

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Guimarães-Pereira, Luís; Costa, Maria; Sousa, Gabriela; Abelha, Fernando

2016-01-01

QoR-40, a 40-item questionnaire on quality of recovery from anaesthesia, has been shown to measure health status after surgery. Our aim was to evaluate the incidence of poor quality of recovery in our Post Anaesthesia Care Unit and to compare their QoR-40 scores before surgery and 3 months later. A prospective observational study was conducted in adult patients consecutively admitted from 18 June to 12 July 2012. The follow-up period was 3 months. We exclude patients submitted to cardiac surgery, neurosurgery, obstetric surgery and with a mini-mental state examination test score lower than 25. The primary endpoint was quality of recovery measured with the validated Portuguese for Portugal version of the QoR-40 before surgery (T0), 24h after surgery (T1) and 3 months after (T2). A total of 114 patients completed the study. Mean QoR-40 score was 169 and patients with poor quality of recovery were identified if their QoR-40 score was lesser than 142. This occurred in 26 patients (24%). Global median scores for patients with poor quality of recovery were lower at T0 (121 vs. 184, p<0.001), at T1 (120 vs. 177, p<0.001) and at T2 (119 vs. 189, p<0.001). Patients with poor quality of recovery had lower quality of life. This fact may allow earlier and more effective interventions, in order to improve quality of life after surgery. Beside its utility after surgery, QoR-40 may be important prior to surgery to identify patients who will develop a poor quality of recovery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

[Quality of recovery after anaesthesia measured with QoR-40: a prospective observational study].

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Guimarães-Pereira, Luís; Costa, Maria; Sousa, Gabriela; Abelha, Fernando

2016-01-01

QoR-40, a 40-item questionnaire on quality of recovery from anaesthesia, has been shown to measure health status after surgery. Our aim was to evaluate the incidence of poor quality of recovery in our Post Anaesthesia Care Unit and to compare their QoR-40 scores before surgery and 3 months later. A prospective observational study was conducted in adult patients consecutively admitted from 18 June to 12 July 2012. The follow-up period was 3 months. We exclude patients submitted to cardiac surgery, neurosurgery, obstetric surgery and with a mini-mental state examination test score lower than 25. The primary endpoint was quality of recovery measured with the validated Portuguese for Portugal version of the QoR-40 before surgery (T0), 24h after surgery (T1) and 3 months after (T2). A total of 114 patients completed the study. Mean QoR-40 score was 169 and patients with poor quality of recovery were identified if their QoR-40 score was lesser than 142. This occurred in 26 patients (24%). Global median scores for patients with poor quality of recovery were lower at T0 (121 vs. 184, p<0.001), at T1 (120 vs. 177, p<0.001) and at T2 (119 vs. 189, p<0.001). Patients with poor quality of recovery had lower quality of life. This fact may allow earlier and more effective interventions, in order to improve quality of life after surgery. Beside its utility after surgery, QoR-40 may be important prior to surgery to identify patients who will develop a poor quality of recovery. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Symptom clusters predict mortality among dialysis patients in Norway: a prospective observational cohort study.

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Amro, Amin; Waldum, Bård; von der Lippe, Nanna; Brekke, Fredrik Barth; Dammen, Toril; Miaskowski, Christine; Os, Ingrid

2015-01-01

Patients with end-stage renal disease on dialysis have reduced survival rates compared with the general population. Symptoms are frequent in dialysis patients, and a symptom cluster is defined as two or more related co-occurring symptoms. The aim of this study was to explore the associations between symptom clusters and mortality in dialysis patients. In a prospective observational cohort study of dialysis patients (n = 301), Kidney Disease and Quality of Life Short Form and Beck Depression Inventory questionnaires were administered. To generate symptom clusters, principal component analysis with varimax rotation was used on 11 kidney-specific self-reported physical symptoms. A Beck Depression Inventory score of 16 or greater was defined as clinically significant depressive symptoms. Physical and mental component summary scores were generated from Short Form-36. Multivariate Cox regression analysis was used for the survival analysis, Kaplan-Meier curves and log-rank statistics were applied to compare survival rates between the groups. Three different symptom clusters were identified; one included loading of several uremic symptoms. In multivariate analyses and after adjustment for health-related quality of life and depressive symptoms, the worst perceived quartile of the "uremic" symptom cluster independently predicted all-cause mortality (hazard ratio 2.47, 95% CI 1.44-4.22, P = 0.001) compared with the other quartiles during a follow-up period that ranged from four to 52 months. The two other symptom clusters ("neuromuscular" and "skin") or the individual symptoms did not predict mortality. Clustering of uremic symptoms predicted mortality. Assessing co-occurring symptoms rather than single symptoms may help to identify dialysis patients at high risk for mortality. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study).

Science.gov (United States)

Starling, Amaal J; Tepper, Stewart J; Marmura, Michael J; Shamim, Ejaz A; Robbins, Matthew S; Hindiyeh, Nada; Charles, Andrew C; Goadsby, Peter J; Lipton, Richard B; Silberstein, Stephen D; Gelfand, Amy A; Chiacchierini, Richard P; Dodick, David W

2018-05-01

Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a -2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (-0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of -2

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

Directory of Open Access Journals (Sweden)

Amelia Scott

Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

The MS@Work study: a 3-year prospective observational study on factors involved with work participation in patients with relapsing-remitting Multiple Sclerosis.

Science.gov (United States)

van der Hiele, Karin; van Gorp, Dennis A M; Heerings, Marco A P; van Lieshout, Irma; Jongen, Peter J; Reneman, Michiel F; van der Klink, Jac J L; Vosman, Frans; Middelkoop, Huub A M; Visser, Leo H

2015-08-12

Multiple Sclerosis (MS) is the most common cause of neurological disability in young and middle-aged adults. At this stage in life most people are in the midst of their working career. The majority of MS patients are unable to retain employment within 10 years from disease onset. Leading up to unemployment, many may experience a reduction in hours or work responsibilities and increased time missed from work. The MS@Work study examines various factors that may influence work participation in relapsing-remitting MS patients, including disease-related factors, the working environment and personal factors. The MS@Work study is a multicenter, 3-year prospective observational study on work participation in patients with relapsing-remitting MS. We aim to include 350 patients through 15-18 MS outpatient clinics in the Netherlands. Eligible participants are 18 years and older, and either currently employed or within three years since their last employment. At baseline and after 1, 2 and 3 years, the participants are asked to complete online questionnaires (including questions on work participation, work problems and accommodations, cognitive and physical ability, anxiety, depression, psychosocial stress, quality of life, fatigue, empathy, personality traits and coping strategies) and undergo cognitive and neurological examinations. After six months, patients are requested to only complete online questionnaires. Patient perspectives on maintaining and improving work participation and reasons to stop working are gathered through semi-structured interviews in a sub-group of patients. Prospective studies with long-term follow-up on work participation in MS are rare, or take into account a limited number of factors. The MS@Work study provides a 3-year follow-up on various factors that may influence work participation in patients with relapsing-remitting MS. We aim to identify factors that relate to job loss and to provide information about preventative measures for physicians

Childhood IQ and cardiovascular disease in adulthood: prospective observational study linking the Scottish Mental Survey 1932 and the Midspan studies

OpenAIRE

Hart, C.L.; Taylor, M.D.; Davey Smith, G.; Whalley, L.J.; Starr, J.M.; Hole, D.J.; Wilson, V.; Deary, I.J.

2004-01-01

This study investigated the influence of childhood IQ on the relationships between risk factors and cardiovascular disease (CVD), coronary heart disease (CHD) and stroke in adulthood. Participants were from the Midspan prospective cohort studies which were conducted on adults in Scotland in the 1970s. Data on risk factors were collected from a questionnaire and at a screening examination, and participants were followed up for 25 years for hospital admissions and mortality. 938 Midspan partici...

Analysis of home-based rehabilitation in patients with motor impairment in primary care: a prospective observational study.

Science.gov (United States)

Vega-Ramírez, Francisco Antonio; López-Liria, Remedios; Granados-Gámez, Genoveva; Aguilar-Parra, Jose Manuel; Padilla-Góngora, David

2017-07-14

The purpose of health and social policies is to encourage older people more longevity, remain free of disability and experience quality of life while living in their homes. The aim of this study was to describe the characteristics of 473 patients diagnosed with motor impairment in primary care, the objectives of home-based rehabilitation and its functional impact. This prospective observational study was conducted in the Almería Health District. The analysed variables included age, gender, secondary diagnosis, Barthel Index (BI), physiotherapeutic objectives and techniques, and number of sessions. The sample had a mean age of 83 years, and 59% were women. The assessed conditions with a high prevalence included osteoarticular pathology (55%), Alzheimer's disease (15.1%), cardiovascular disease (13.7%) and stroke (6.5%). The techniques applied mainly consisted of functional exercises (57.1%), caregiver education (13.8%), and technical assistance (5.7%). There were statistically significant differences (t = -15.79; p physiotherapy. Lower patient age was correlated with higher initial and final functional capacities in primary care. This study aimed to present a useful starting point for decision making among management and health administration regarding this population group by approaching the process from the reality of practice and in relation to the rehabilitation provided. ClinicalTrials.gov identifier: NCT02715245 ; Date of registration: 18 January 2016.

Association between painful physical symptoms and clinical outcomes in East Asian patients with major depressive disorder: a 3-month prospective observational study.

Science.gov (United States)

Ang, Q Q; Wing, Y K; He, Y; Sulaiman, A H; Chiu, N-Y; Shen, Y-C; Wang, G; Zhang, C; Lee, K-H; Singh, P; Granger, R E; Raskin, J; Dossenbach, M

2009-07-01

Reports from non-Asian populations indicate that painful physical symptoms (PPS) are associated with poorer clinical and functional outcomes in major depressive disorder (MDD). The purpose of this study is to report comparative changes in disease severity, treatment patterns and quality of life observed in East Asian patients with MDD, with and without PPS, as assessed prospectively over a 3-month observation period. This observational study enrolled 909 patients with MDD in psychiatric care settings in China, Hong Kong, Korea, Malaysia, Singapore and Taiwan. Patients were classified as PPS positive (PPS+) or negative (PPS-) based on mean modified Somatic Symptom Inventory scores of >or= 2 or Depression Rating Scale (HAMD(17)) determined depression severity; a visual analogue scale (VAS) determined pain severity; and the EuroQoL (EQ-5D) assessed well-being after 3 months observation. Of the 909 enrollees, 355/471 (75.4%) of PPS+ patients and 363/438 (82.9%) of PPS- patients completed the study (p = 0.006). PPS+ patients improved less than PPS- patients on depression, pain and quality of life measures during the study (HAMD(17) p < 0.001, CGI-S p < 0.001, VAS p = 0.008 and EQ-5D p = 0.004). Fewer PPS+ patients (46.5%) achieved remission compared with PPS- patients (69.4%, p < 0.001). As the presence of PPS is associated with poorer outcomes in East Asian MDD patients, clinical management should aim to address both the mental and PPS associated with MDD.

Dietary fibre in food and protection against colorectal cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC) : an observational study

NARCIS (Netherlands)

Bingham, SA; Day, NE; Luben, R; Ferrari, P; Slimani, N; Norat, T; Clavel-Chapelon, F; Kesse, E; Boeing, H; Tjonneland, A; Overvad, K; Martinez, C; Dorronsoro, M; Gonzalez, CA; Key, TJ; Trichopoulou, A; Naska, A; Vineis, P; Tumino, R; Krogh, [No Value; Bueno-de-Mesquita, HB; Peeters, PHM; Berglund, G; Hallmans, G; Lund, E; Skeie, G; Kaaks, R; Riboli, E

2003-01-01

Background Dietary fibre is thought to protect against colorectal cancer but this view has been challenged by recent prospective and intervention studies that showed no protective effect. Methods We prospectively examined the association between dietary fibre intake and incidence of colorectal

Comparison of outcomes between emergent-start and planned-start peritoneal dialysis in incident ESRD patients: a prospective observational study.

Science.gov (United States)

Li, Wen-Yi; Wang, Yi-Cheng; Hwang, Shang-Jyh; Lin, Shih-Hua; Wu, Kwan-Dun; Chen, Yung-Ming

2017-12-11

The clinical consequences of starting chronic peritoneal dialysis (PD) after emergent dialysis via a temporary hemodialysis (HD) catheter has rarely been evaluated within a full spectrum of treated end-stage renal disease (ESRD). We investigated the longer-term outcomes of patients undergoing emergent-start PD in comparison with that of other practices of PD or HD in a prospective cohort of new-onset ESRD. This was a 2-year prospective observational study. We enrolled 507 incident ESRD patients, among them 111 chose PD (43 planned-start, 68 emergent-start) and 396 chose HD (116 planned-start, 280 emergent-start) as the long-term dialysis modality. The logistic regression model was used to identify variables associated with emergent-start dialysis. The Kaplan-Meier survival analysis was used to determine patient survival and technique failure. The propensity score-adjusted Cox regression model was used to identify factors associated with patient outcomes. During the 2-year follow-up, we observed 5 (4.5%) deaths, 15 (13.5%) death-censored technique failures (transfer to HD) and 3 (2.7%) renal transplantations occurring in the PD population. Lack of predialysis education, lower predialysis estimated glomerular filtration rate and serum albumin were predictors of being assigned to emergent dialysis initiation. The emergent starters of PD displayed similar risks of patient survival, technique failure and overall hospitalization, compared with the planned-start counterparts. By contrast, the concurrent planned-start and emergent-start HD patients with an arteriovenous fistula or graft were protected from early overall death and access infection-related mortality, compared with the emergent HD starters using a central venous catheter. In late-referred chronic kidney disease patients who have initiated emergent dialysis via a temporary HD catheter, post-initiation PD can be a safe and effective long-term treatment option. Nevertheless, due to the potential complications

Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

Science.gov (United States)

Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

2015-09-01

The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

Computed Tomography Profile and its Utilization in Head Injury Patients in Emergency Department: A Prospective Observational Study

Directory of Open Access Journals (Sweden)

Archana Waganekar

2018-01-01

Full Text Available Context: Based on Glasgow Coma Scale (GCS, head injury can be classified as minor (GCS 13–15, moderate (GCS 9–12, and severe (GCS 3–8. There is a lot of controversy in the use of computed tomography (CT in head injury patients. Aims: This study was intended to estimate the rate of CT positivity in head injury patients and to define the criteria for doing CT in head injury patients. Settings and Design: This was a prospective observational study in the emergency department (ED over a 12-month period. Subjects and Methods: Study involved all head injury patients attending ED. Risk factors studied were a loss of consciousness (LOC, vomiting, seizures, ear bleed, nosebleed, external injuries, and alcohol intoxication. Statistical Analysis Used: Comparison of CT positivity with the patient's demographics and clinical characteristics was carried out using Chi-square. Results: A total of 1782 patients were included in this study. Overall CT positivity was 50.9%. In minor head injury (MHI, CT positivity rate was 38%. The study showed significant association of CT positivity with five variables: LOC >5 min, vomiting, seizures, ear bleed, and nosebleed. Conclusions: From the study, we recommend following: CT is indicated in all patients with moderate and severe head injury (GCS ≤12. Low threshold for taking CT is advisable in elderly and alcohol-intoxicated patients. In MHI, CT is indicated if any one of the following risk factors are present: LOC >5 min, history of vomiting, history of seizures, history of ear bleed, and history of nosebleed.

Protocol for the evaluation and validation of Qi Blood Yin Yang deficiency pattern questionnaire: prospective observational study.

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Kim, Jihye; Kim, Keun Ho

2015-12-01

The aim of this study is to validate the pattern identification standard of qi, blood, yin, and yang deficiency patterns diagnosis. The current study will investigate the usefulness of the Qi Blood Yin Yang deficiency pattern questionnaire as a diagnostic tool for qi, blood, yin, and yang deficiencies by assessing the agreement between the scores and a gold standard established by assessors. This protocol is for a single center, prospective, observational study. A total of 248 eligible patients with unexplained chronic fatigue will be assigned to four groups in a 1:1:1:1 ratio as the qi deficiency group, blood deficiency group, yin deficiency group, and yang deficiency group. The primary outcome will be measured using the score of the Qi Blood Yin Yang deficiency pattern questionnaire and the secondary outcomes will be measured using the fatigue severity scale, Korean-translated chalder fatigue scale, computerized tongue image analysis system, and three types of pattern identification questionnaires (cold-heat, food accumulation, and seven emotions patterns). The safety of the clinical study will be assessed after measurements at every visit. All statistical analysis will be performed using the R Statistics program. Statistics experts will analyze the relationship between clinical data using the Pearson's Chi-squared test and independent t -test. This study will provide reference data and good evidence that are applicable to future studies. Furthermore, the results of the present study are useful to improve the care of patients with unexplained chronic fatigue and unexplained chronic fatigue-related disorders.

Distress in suspected lung cancer patients following rapid and standard diagnostic programs: a prospective observational study.

Science.gov (United States)

Brocken, Pepijn; van der Heijden, Erik H F M; Oud, Karen T M; Bootsma, Gerben; Groen, Harry J M; Donders, A Rogier T; Dekhuijzen, P N Richard; Prins, Judith B

2015-04-01

Timeliness may influence emotional distress during the diagnostic phase of suspected lung cancer patients. We performed a prospective observational study to compare distress and quality of life (QoL) in two medical centres with a Rapid Outpatient Diagnostic Program (RODP) and two using conventional Stepwise Diagnostic Approach (SDA) on the basis of trained nurse-led care. Outpatients with radiological suspicion of lung cancer completed the Hospital Anxiety and Depression Scale (HADS), European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (QLQ-C30) and its 13-item Lung Cancer specific module (QLQ-LC13) upon first visit, 2 days later, thereafter weekly for 5 weeks and after 3 months. The 72 SDA patients and 121 RODP patients had a mean pre-diagnostic HADS-total score of 13.5 (SD 7.6); 63.4% had a score ≥10. Baseline QLQ-C30 global QoL was 61.6 (SD 22.7) exceeding reference values for lung cancer patients. Generalized least square models showed a significant centre by time interaction effect: during the first 6 weeks, HADS-total scores decreased in RODP patients (13.8-11.9) but sustained in SDA patients (13.1-13.6), whereas QoL showed no relevant changes. Times to diagnosis and discussion of therapy plan for RODP patients were 7 and 11 days shorter, respectively. Suspected lung cancer patients had high baseline distress levels. A decrease over time was found in RODP compared with SDA patients. QoL did not change relevantly. Albeit observational, these data indicate that patients experience less distress in rapid diagnostic programs than in stepwise diagnostic evaluation. Copyright © 2014 John Wiley & Sons, Ltd.

Therapy optimization in multiple sclerosis: a prospective observational study of therapy compliance and outcomes.

Science.gov (United States)

Coyle, Patricia K; Cohen, Bruce A; Leist, Thomas; Markowitz, Clyde; Oleen-Burkey, MerriKay; Schwartz, Marc; Tullman, Mark J; Zwibel, Howard

2014-03-13

Data sources for MS research are numerous but rarely provide an objective measure of drug therapy compliance coupled with patient-reported health outcomes. The objective of this paper is to describe the methods and baseline characteristics of the Therapy Optimization in MS (TOP MS) study designed to investigate the relationship between disease-modifying therapy compliance and health outcomes. TOP MS was designed as a prospective, observational, nationwide patient-focused study using an internet portal for data entry. The protocol was reviewed and approved by Sterling IRB. The study was registered with ClinicalTrials.gov. It captured structured survey data monthly from MS patients recruited by specialty pharmacies. Data collection included the clinical characteristics of MS such as MS relapses. Disability, quality of life and work productivity and activity impairment were assessed quarterly with well-validated scales. When events like severe fatigue or new or worsening depression were reported, feedback was provided to treating physicians. The therapy compliance measure was derived from pharmacy drug shipment records uploaded to the study database. The data presented in this paper use descriptive statistics. The TOP MS Study enrolled 2966 participants receiving their disease-modifying therapy (DMT) from specialty pharmacies. The mean age of the sample was 49 years, 80.4% were female, 89.9% were Caucasian and 55.7% were employed full or part time. Mean time since first symptoms was 11.5 years; mean duration since diagnosis was 9.5 years. Patient-reported EDSS was 3.5; 72.2% had a relapsing-remitting disease course. The most commonly reported symptoms at the time of enrollment were fatigue (74.7%), impaired coordination or balance (61.8%) and numbness and tingling (61.2%). Half of the sample was using glatiramer acetate and half was using beta-interferons. Demographic and clinical characteristics of the TOP MS sample at enrollment are consistent with other community

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.

Childhood mental ability and smoking cessation in adulthood: prospective observational study linking the Scottish Mental Survey 1932 and the Midspan studies

OpenAIRE

Taylor, M.D.; Hart, C.; Davey Smith, G.; Starr, J.M.; Hole, D.; Whalley, L.J.; Wilson, V.; Deary, I.J.

2003-01-01

The social and smoking data were from two of the Midspan prospective cohort studies conducted in the 1970s—the Collaborative study and the Renfrew/Paisley study. Participants completed a questionnaire and attended a physical examination. Occupational social class was coded according to the registrar general’s classification. The home address of the participants at the time of screening was retrospectively postcoded to allow deprivation category as defined by Carstairs and Morris to be ascerta...

Uranium project. Geochemistry prospection[Study of Uranium geochemical prospection in Uruguay]; Proyecto Uranio. Prospeccion geoquimica

Energy Technology Data Exchange (ETDEWEB)

Lambert, J

1983-07-01

Geochemistry studies the distribution of the chemicals elements in the terrestrial crust and its ways to migrate. The terminology used in this report is the following one: 1) Principles of the prospection geochemistry 2) Stages of the prospection geochemistry 3)utility of the prospection geochemistry 4) geochemistry of uranium 5) procedures used within the framework of uranium project 6) Average available 7) Selection of the zones of prospection geochemistry 8) Stages of the prospection, Sample preparation and analisis 9) Presentation of the results.

Evaluation of supportive care management outcomes in cancer chemotherapy: A prospective observational study in a tertiary care teaching hospital in South India

Directory of Open Access Journals (Sweden)

Reshma Susan Reji

2018-01-01

Full Text Available Aims: Evaluation of supportive care management of cancer patients experiencing drug-related problems (DRPs is a challenge because it might increase the cost due to additional therapy. The main objectives of this study were to estimate chemotherapy-associated drug-related hospital admissions in the department of medical oncology and to estimate the cost of managing chemotherapy-associated DRPs.Settings and Design: This study is a prospective observational study.Subjects and Methods: Patients with chemotherapy-related DRPs were prospectively identified from the patient's medical records. The contribution of DRPs and cost incurred due to each hospitalization was assessed.Statistical Analysis Used: Data were analyzed using SPSS® 20.0 version.Results: Out of 55 patients analyzed for DRPs, 25 (45.5% patients in the age group of 51–60 years experienced DRPs most frequently. Most commonly occurring DRP was adverse drug reactions 42 (76.4%, which were more frequent in females. DRPs were maximum with alkylating agents 15 (27.3% and the least with hormonal agents 1 (1.8%. The mean length of hospitalization was 9.6 ± 6.5 days. The total direct medical cost was Rs. 31,540 ± 42,476, of which medicine cost accounted for Rs. 16,550 ± 25,404, constituting a major share of the total medical costs.Conclusions: Pharmacists can provide better patient care by identifying and preventing DRPs and reducing drug-related morbidity and mortality.

Characteristics and outcomes of patients admitted to Spanish ICU: A prospective observational study from the ENVIN-HELICS registry (2006-2011).

Science.gov (United States)

Olaechea, P M; Álvarez-Lerma, F; Palomar, M; Gimeno, R; Gracia, M P; Mas, N; Rivas, R; Seijas, I; Nuvials, X; Catalán, M

2016-05-01

To describe the case-mix of patients admitted to intensive care units (ICUs) in Spain during the period 2006-2011 and to assess changes in ICU mortality according to severity level. Secondary analysis of data obtained from the ENVN-HELICS registry. Observational prospective study. Spanish ICU. Patients admitted for over 24h. None. Data for each of the participating hospitals and ICUs were recorded, as well as data that allowed to knowing the case-mix and the individual outcome of each patient. The study period was divided into two intervals, from 2006 to 2008 (period 1) and from 2009 to 2011 (period 2). Multilevel and multivariate models were used for the analysis of mortality and were performed in each stratum of severity level. The study population included 142,859 patients admitted to 188 adult ICUs. There was an increase in the mean age of the patients and in the percentage of patients >79 years (11.2% vs. 12.7%, P<0.001). Also, the mean APACHE II score increased from 14.35±8.29 to 14.72±8.43 (P<0.001). The crude overall intra-UCI mortality remained unchanged (11.4%) but adjusted mortality rate in patients with APACHE II score between 11 and 25 decreased modestly in recent years (12.3% vs. 11.6%, odds ratio=0.931, 95% CI 0.883-0.982; P=0.008). This study provides observational longitudinal data on case-mix of patients admitted to Spanish ICUs. A slight reduction in ICU mortality rate was observed among patients with intermediate severity level. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Factors associated with weaning practices in term infants: a prospective observational study in Ireland.

LENUS (Irish Health Repository)

Tarrant, R C

2010-11-01

The WHO (2001) recommends exclusive breast-feeding and delaying the introduction of solid foods to an infant\\'s diet until 6 months postpartum. However, in many countries, this recommendation is followed by few mothers, and earlier weaning onto solids is a commonly reported global practice. Therefore, this prospective, observational study aimed to assess compliance with the WHO recommendation and examine weaning practices, including the timing of weaning of infants, and to investigate the factors that predict weaning at ≤ 12 weeks. From an initial sample of 539 pregnant women recruited from the Coombe Women and Infants University Hospital, Dublin, 401 eligible mothers were followed up at 6 weeks and 6 months postpartum. Quantitative data were obtained on mothers\\' weaning practices using semi-structured questionnaires and a short dietary history of the infant\\'s usual diet at 6 months. Only one mother (0.2%) complied with the WHO recommendation to exclusively breastfeed up to 6 months. Ninety-one (22.6%) infants were prematurely weaned onto solids at ≤ 12 weeks with predictive factors after adjustment, including mothers\\' antenatal reporting that infants should be weaned onto solids at ≤ 12 weeks, formula feeding at 12 weeks and mothers\\' reporting of the maternal grandmother as the principal source of advice on infant feeding. Mothers who weaned their infants at ≤ 12 weeks were more likely to engage in other sub-optimal weaning practices, including the addition of non-recommended condiments to their infants\\' foods. Provision of professional advice and exploring antenatal maternal misperceptions are potential areas for targeted interventions to improve compliance with the recommended weaning practices.

Prospective multicenter observational study of 260 infants born to 259 opiate-dependent mothers on methadone or high-dose buprenophine substitution.

Science.gov (United States)

Lejeune, Claude; Simmat-Durand, Laurence; Gourarier, Laurent; Aubisson, Sandrine

2006-05-20

Specialized prenatal care and substitution programs improve the perinatal prognoses of pregnant drug-abusers and their infants. Although methadone is well documented, little is known about high-dose buprenorphine (HDB). This prospective, multicenter (n = 35) observational study included 259 women on maintenance during pregnancy: 39% on methadone and 61% on HDB. Major findings were: 46% of them received good prenatal care; 62% had peridural analgesia; 12.3% delivered prematurely (hydrochloride. No baby died. Newborns were discharged with their mothers (96%) or placed in foster care (4%). Comparing methadone with HDB, respectively, mean age at the maximum Lipsitz score was 81 h versus 66 h (P = 0.066). The perinatal medical and social prognoses for these 259 drug addicts and their infants appeared to be improved by specialized prenatal care and was similar for methadone or BHD substitution during pregnancy.

Early pushing urge in labour and midwifery practice: a prospective observational study at an Italian maternity hospital.

Science.gov (United States)

Borrelli, Sara E; Locatelli, Anna; Nespoli, Antonella

2013-08-01

to investigate the early pushing urge (EPU) incidence in one maternity unit and explore how it is managed by midwives. The relation to some obstetric outcomes was also observed but not analysed in depth. prospective observational study. Italian maternity hospital. 60 women (44 nullips and 16 multips) experiencing EPU during labour. the total EPU incidence percentage was 7.6%. The single midwives' incidences range had a very wide margin, noting an inverse proportion between the number of diagnoses of EPU and midwife's waiting time between urge to push and vaginal examination. Two care policies were adopted in relation to the phenomenon: the stop pushing technique (n=52/60) and the 'let the woman do what she feels' technique (n=8/60). In case of stop pushing techniques, midwives proposed several combined techniques (change of maternal position, blowing breath, vocalisation, use of the bath). The EPU diagnosis at less than 8cm of cervical dilatation was associated with more medical interventions. Maternal and neonatal outcomes were within the range of normal physiology. An association between the dilatation at EPU diagnosis and obstetric outcomes was observed, in particular the modality of childbirth and perineal outcomes. this paper contributes new knowledge to the body of literature around the EPU phenomenon during labour and midwifery practices adopted in response to it. Overall, it could be argued that EPU is a physiologic variation in labour if maternal and fetal conditions are good. Midwives might suggest techniques to woman to help her to stay with the pain, such as change of position, blowing breath, vocalisation and use of the bath. However, the impact of policies, guidelines and culture on midwifery practices of the specific setting are a limitation of the study because it is not representative of other similar maternity units. Thus, a larger scale work should be considered, including different units and settings. The optimal response to the phenomenon

Changes in Rotavirus Genotypes before and after Vaccine Introduction: a Multicenter, Prospective Observational Study in Three Areas of Japan.

Science.gov (United States)

Tanaka, Takaaki; Kamiya, Hajime; Asada, Kazutoyo; Suga, Shigeru; Ido, Masaru; Umemoto, Masakazu; Ouchi, Kazunobu; Ito, Hiroaki; Kuroki, Haruo; Nakano, Takashi; Taniguchi, Koki

2017-07-24

In Japan, monovalent and pentavalent rotavirus (RV) vaccines were approved in 2011 and 2012, respectively. To monitor changes in the RV genotypes before and after vaccine introduction, we performed a prospective observational study among children (＜ 5 years) with gastroenteritis who tested RV-positive on antigen rapid tests. Stool samples were collected from 3 different sites in Japan: Tsu City, Mie Prefecture; Kurashiki City, Okayama Prefecture; and Isumi City, Chiba Prefecture. RV genotypes were determined using reverse transcription-polymerase chain reaction. In Tsu City, G3P[8] was dominant (61.0-77.1%) before vaccine introduction, but decreased after introduction. Meanwhile, in an inverse proportion to the decrease in G3P[8], G1P[8] increased until the 2013/14 season, when a sudden predominance of G2P[4] (100%) occurred. A similar trend was observed in Kurashiki City in terms of the extent of reduction in G3P[8] and the emergence of G2P[4]. In Isumi City, G1P[8] was dominant (70.3%) before vaccine introduction, and G9P[8] became predominant (83.3%) in the 2013/14 season. To determine whether the genotype changes are attributable to vaccines or natural epidemiological changes, ongoing continuous monitoring of the RV genotypes is required.

A one-year prospective study of refractory status epilepticus in Modena, Italy.

Science.gov (United States)

Giovannini, Giada; Monti, Giulia; Polisi, Michela M; Mirandola, Laura; Marudi, Andrea; Pinelli, Giovanni; Valzania, Franco; Girardis, Massimo; Nichelli, Paolo F; Meletti, Stefano

2015-08-01

Refractory status epilepticus (RSE) is a particular critical condition characterized by seizures that continue despite the use of first- and second-line therapies and by high mortality. To date, only one prospective study investigated clinical features and prognostic factors in RSE. In this study, we performed a one-year prospective survey to identify clinical features, outcomes, and variables associated with the development of RSE in the adolescent and adult population of Modena, northern Italy. We observed 83 episodes of SE in 83 patients. In 31% of the cases, third-line therapy (anesthetic drug) was needed. Among this group, 14% resolved and were classified as RSE, while, in 17%, seizures recurred at withdrawal of anesthetics and were classified as super-RSE. The development of RSE/super-RSE was associated with a stuporous/comatose state at presentation and with the absence of a previous history of epilepsy. Refractory status epilepticus/super-refractory status epilepticus showed a worse outcome compared with responsive SE: 54% versus 21% for 30-day mortality; 19% versus 56% for a return to baseline condition. This prospective study confirms stupor/coma at onset as a relevant clinical factor associated with SE refractoriness. We observed a rate of RSE comparable with previous reports, with high mortality and morbidity. Mortality in the observed RSE was higher than in previous studies; this result is probably related to the low rate of a previous epilepsy history in our population that reflects a high incidence of acute symptomatic etiologies, especially the inclusion of patients with postanoxic SE who have a bad prognosis per se. This article is part of a Special Issue entitled "Status Epilepticus". Copyright © 2015 Elsevier Inc. All rights reserved.

Febrile urinary tract infection after pediatric kidney transplantation: a multicenter, prospective observational study.

Science.gov (United States)

Weigel, Friederike; Lemke, Anja; Tönshoff, Burkhard; Pape, Lars; Fehrenbach, Henry; Henn, Michael; Hoppe, Bernd; Jungraithmayr, Therese; Konrad, Martin; Laube, Guido; Pohl, Martin; Seeman, Tomáš; Staude, Hagen; Kemper, Markus J; John, Ulrike

2016-06-01

Febrile urinary tract infections (fUTIs) are common after kidney transplantation (KTx); however, prospective data in a multicenter pediatric cohort are lacking. We designed a prospective registry to record data on fUTI before and after pediatric KTx. Ninety-eight children (58 boys and 40 girls) ≤ 18 years from 14 mid-European centers received a kidney transplant and completed a 2-year follow-up. Posttransplant, 38.7% of patients had at least one fUTI compared with 21.4% before KTx (p = 0.002). Before KTx, fUTI was more frequent in patients with congenital anomalies of kidneys and urinary tract (CAKUT) vs. patients without (38% vs. 12%; p = 0.005). After KTx, fUTI were equally frequent in both groups (48.7% vs. 32.2%; p = 0.14). First fUTI posttransplant occurred earlier in boys compared with girls: median range 4 vs. 13.5 years (p = 0.002). Graft function worsened (p pediatric KTx, which is not restricted to patients with CAKUT; fUTIs have a negative impact on graft function during the infectious episode but not on 2-year graft outcome.

Facebook and body image concern in adolescent girls: A prospective study.

Science.gov (United States)

Tiggemann, Marika; Slater, Amy

2017-01-01

The primary aim of the study was to examine the relationship across time between Facebook use and body image concern in adolescent girls. A sample of 438 girls in the first two years (Years 8 and 9) of high school (aged 13-15 years) at Time 1 completed questionnaire measures of Facebook consumption and body image concerns, and again two years later (Time 2). Facebook involvement increased substantially over the two year time period. Body image concerns also increased. Number of Facebook friends was found to prospectively predict the observed increase in drive for thinness. On the other hand, internalization and body surveillance prospectively predicted the observed increase in number of Facebook friends. It was concluded that Facebook "friendships" represent a potent sociocultural force in the body image of adolescent girls. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2017; 50:80-83). © 2016 Wiley Periodicals, Inc.

Evaluating team-based inter-professional advanced life support training in intensive care-a prospective observational study.

Science.gov (United States)

Brewster, D J; Barrett, J A; Gherardin, E; O'Neill, J A; Sage, D; Hanlon, G

2017-01-01

Recent focus on national standards within Australian hospitals has prompted a focus on the training of our staff in advanced life support (ALS). Research in critical care nursing has questioned the traditional annual certification of ALS competence as the best method of delivering this training. Simulation and team-based training may provide better ALS education to intensive care unit (ICU) staff. Our new inter-professional team-based advanced life support program involved ICU staff in a large private metropolitan ICU. A prospective observational study using three standardised questionnaires and two multiple choice questionnaire assessments was conducted. Ninety-nine staff demonstrated a 17.8% (95% confidence interval 4.2-31, P =0.01) increase in overall ICU nursing attendance at training sessions. Questionnaire response rates were 93 (94%), 99 (100%) and 60 (61%) respectively; 51 (52%) staff returned all three. Criteria were assessed by scores from 0 to 10. Nurses reported improved satisfaction with the education program (9.4 to 7.1, P versus 7.9 and 8.2, P versus 7.4 and 7.8, P versus 8.1, P =0.04). The new program cost approximately an extra $16,500 in nursing salaries. We concluded that team-based, inter-professional ALS training produced statistically significant improvements in nursing attendance, satisfaction with ALS education, confidence and role understanding compared to traditional ALS training.

Rasagiline for sleep disorders in patients with Parkinson’s disease: a prospective observational study

Directory of Open Access Journals (Sweden)

Schettino C

2016-09-01

Full Text Available Carla Schettino,1,2,* Clemente Dato,1,2,* Guglielmo Capaldo,1,2 Simone Sampaolo,1,2 Giuseppe Di Iorio,1,2 Mariarosa AB Melone1,2 1Department of Medical, Surgical, Neurological, Metabolic Sciences, and Aging, 2Division of Neurology and InterUniversity Center for Research in Neurosciences, Second University of Naples, Naples, Italy *These authors contributed equally to this work Introduction: Rasagiline is a selective, irreversible monoamine oxidase B inhibitor that ameliorates the symptoms of Parkinson’s disease (PD by inhibiting striatal dopamine metabolism. There is also evidence that monoamine oxidase B inhibitors increase melatonin levels in the pineal gland and may have a beneficial effect on sleep disorders, which are a common feature in patients with PD.Methods: This single-center, prospective, observational, 12-week study compared the effect of combination therapy with levodopa 200–300 mg/d + rasagiline 1 mg/d (n=19 with levodopa 200–300 mg/d alone (n=19 in the treatment of sleep disorders in patients with idiopathic PD.Results: After 12 weeks’ treatment, mean sleep latency was significantly (P<0.001 lower and the improvement in sleep latency from baseline was significantly (P=0.001 greater in patients receiving levodopa + rasagiline than in patients receiving levodopa alone. Similarly, at the end of the study, the mean total sleep time was significantly (P=0.002 longer and the improvement from baseline in mean total sleep time was significantly (P=0.026 greater in patients receiving levodopa + rasagiline than levodopa alone. There were no significant differences between treatment groups for the mean number of awakenings reported at week 12 nor the change from baseline to week 12 in mean number of awakenings.Conclusion: Adding rasagiline to levodopa improved sleep outcomes and may be an appropriate option for patients with PD experiencing sleep disorders. Keywords: Parkinson’s disease, rasagiline, sleep disorders, Parkinson�

Returning to work after laparoscopic myomectomy: a prospective observational study.

Science.gov (United States)

Huff, Keren O; Aref-Adib, Mehrnoosh; Magama, Zwelihle; Vlachodimitropoulou, Evangelia K; Oliver, Reeba; Odejinmi, Funlayo

2018-01-01

Laparoscopic myomectomy offers women many benefits over conventional open surgery, including an expedited recovery and return to employment. Our study evaluates the time taken for women to return to work after laparoscopic myomectomy and identifies factors prolonging recovery to > 8 weeks. We prospectively evaluated 94 women undergoing laparoscopic myomectomy by a single surgeon between January 2012 and March 2015. Women had standardized preoperative counseling and completed a validated return to work questionnaire 3 months postoperatively via telephone, post or in clinic. In all, 71/94 (75.5%) women completed the questionnaire. Results were analyzed comparing women who returned to work in ≤ 8 weeks [43/71 (60.6%)] with those who returned > 8 weeks postoperatively [28/71 (39.4%)]. A higher proportion of Asian and Caucasian women returned to work in ≤ 8 weeks (24/29) compared with black African and Caribbean women (19/42) (p = 0.003). Mean number of fibroids removed (2.59 and 5.75, respectively) was the only significantly differing factor between the two groups (p = 0.004). There was a significant difference in body mass index (BMI) and time to return to normal activity between the ≤ 8-week and > 8-week groups (p = 0.027, p = 0.011, respectively). Logistic regression analysis demonstrated that BMI and time to return to normal activity were the only factors prolonging recovery to > 8 weeks (p = 0.039, p = 0.015, respectively). Time to return to normal activity and BMI significantly influenced the time taken for women to work after laparoscopic myomectomy. Further data would support clinicians in counseling women appropriately and optimizing their postoperative return to employment. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

Future prospects for studies in the VUV-SX region

International Nuclear Information System (INIS)

Tanaka, Kenichiro; Kitajima, Yoshinori

1989-09-01

This book carries papers presented at a workshop 'Future Prospects for Studies in the VUV-SX Region' held on March 22 and 23, 1989. The workshop focussed particularly on the promotion of research in the VUV and soft X-ray regions. Three sessions were held: Session 1 for studies in peripheral areas, Session 2 for theoretical studies, and Session 3 for recent developments. Session 1 covered five studies: 'Laser Spectroscopy: High-Resolution Observation of Highly Electronically Excited Gaseous Molecule', 'High-Resolution Electron Spectroscopy: Surface Phonon Spectroscopy', 'Experimental Study on Atoms and Molecules through Ion Trap', 'Basic Mechanism of Photo-Induced CVD', and 'Application of Circularly Polarized Light'. Session 2 covered five studies: 'Electronic State of High Tc Superconducting Oxide', 'Surface Condition and Electronic State', 'XES and XAS Study of Rare Earth Compound', 'Resonance Photoelectric Spectroscopy on Strongly Correlated Electronic System', and 'Circularly Polarized Light and Atomic Process in Soft X-Ray Region'. Session 3 covered six studies: 'Prospects of Application of Supercritical Liquid to Research on Physical Characteristics', 'Application of Orbit Radiation to Polarization Spectroscopy', 'XES Research for La Compounds', 'Characteristics of Ultra-Fine Particles', 'Surface Study by Angular-Resolution Photoelectric Spectroscopy', and 'EXAFS Study of Light Element'. (N.K.)

Social determinants of tuberculosis in Europe: a prospective ecological study.

Science.gov (United States)

Ploubidis, George B; Palmer, Melissa J; Blackmore, Charlotte; Lim, Tek-Ang; Manissero, Davide; Sandgren, Andreas; Semenza, Jan C

2012-10-01

Tuberculosis (TB) is considered to be a disease of poverty, since its incidence is exacerbated by socioeconomic factors, inconsistent or partial treatment practices, and immigration from endemic countries. A prospective country level study, using a comprehensive dataset of TB incidence and prevalence taken from countries within the World Health Organization (WHO) European region, was conducted. We employed quintile regression to investigate the prospective association between baseline (measured in 2000) and a nation's wealth, level of egalitarianism, migration rate, health-related lifestyle and social capital with TB incidence and prevalence over a 10-yr period (2000-2009). We found that ∼50% of TB variation is accounted for by a nation's wealth and level of egalitarianism. We observed a negative prospective association between logged gross domestic product and TB rates, and a positive prospective association between income inequality and TB. National income levels per capita and income inequality are important predictors for TB incidence and prevalence in the WHO European region. They account for 50% of country-level variation, indicating the importance of a combined absolute and relative socioeconomic disadvantage in the development of TB. These findings also provide a tool for forecasting potential fluctuations in the level of TB epidemics in the WHO European region, with respect to socioeconomic changes.

Danish Observational Study of Eldercare work and musculoskeletal disorderS (DOSES)

DEFF Research Database (Denmark)

Karstad, Kristina; Jørgensen, Anette F B; Greiner, Birgit A

2018-01-01

PURPOSE: Musculoskeletal disorders (MSDs), sickness absence and premature retirement are highly prevalent among eldercare workers. We conducted a prospective observational workplace study with the main purpose to investigate longitudinal associations between physical and psychosocial working cond...... and team factors for distribution of physical work demands and development of MSD among the workers. This will provide important knowledge for future workplace interventions to reduce MSD and sickness absence.......PURPOSE: Musculoskeletal disorders (MSDs), sickness absence and premature retirement are highly prevalent among eldercare workers. We conducted a prospective observational workplace study with the main purpose to investigate longitudinal associations between physical and psychosocial working...... conditions and occurrence of MSD and its consequences (pain-related interference with daily work activities and sickness absence) among Danish eldercare workers. PARTICIPANTS: At 20 Danish nursing homes, a total of 941 eldercare workers employed in day and evening shifts were invited to the study. Of those...

High Serum Adiponectin Level Is a Risk Factor for Anemia in Japanese Men: A Prospective Observational Study of 1,029 Japanese Subjects.

Directory of Open Access Journals (Sweden)

Kei Kohno

Full Text Available Erythroid abnormalities including anemia and polycythemia are often observed in the general clinical setting. Because recent studies reported that adiponectin negatively affects hematopoiesis, we performed a prospective observational study to assess the relationship between anemia and adiponectin, as well as other parameters, in 1029 Japanese subjects (477 men and 552 women 40 years of age and older. Body measurements, blood tests, and nutrition intake studies were performed at baseline, and 5 to 7 years later (follow-up. Hemoglobin (Hb and hematocrit (Hct levels in men with high serum adiponectin levels were lower at follow-up than at baseline. Multiple regression analysis showed that age, body mass index, adiponectin, and glutamic-pyruvic transaminase were significantly associated with erythroid-related variables (red blood cells, Hb, and Hct in both men and women (P <0.05. In a logistic regression analysis, adiponectin, fasting blood glucose, and β-natriuretic peptide were significant risk factors for anemia in men, and blood urea nitrogen and amylase were significant risk factors in women. Physical features and nutrient intake were not risk factors for anemia. Our study demonstrates, both clinically and epidemiologically, that a high serum adiponectin level decreases the amounts of erythroid-related variables and is a risk factor for anemia in Japanese men.

Blood transfusion in patients having caesarean section: a prospective multicentre observational study of practice in three Pakistan hospitals.

Science.gov (United States)

Ismail, S; Siddiqui, S; Shafiq, F; Ishaq, M; Khan, S

2014-08-01

Increasing awareness of the risks of blood transfusion has prompted examination of red cell transfusion practice in obstetrics. A six-month prospective observational study was performed to examine blood transfusion practices in patients undergoing caesarean delivery at three hospitals in Pakistan. In the three hospitals (two private, one public) 3438 caesarean deliveries were performed in the study period. Data were collected on patient demographics, indications for transfusion, ordering physicians, consent, associations with obstetric factors, estimated allowable blood loss, calculated blood loss, pre- and post-transfusion haemoglobin and discharge haemoglobin. A total number of 397 (11.5%) patients who underwent caesarean section received a blood transfusion. The highest transfusion rate of 16% was recorded in the public tertiary care hospital compared to 5% in the two private hospitals. Emergency caesarean delivery and multiparity were associated with blood transfusion (Ptransfusion in 98% of cases. In 343 (86%) patients, blood transfusion was given even when the haemoglobin was >7g/dL. The method for documenting the indication or consent for transfusion was not found in any of the three hospitals. Blood transfusion was prescribed more readily in the public hospital. Identification of a transfusion trigger and the development of institutional guidelines to reduce unnecessary transfusion are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

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

Science.gov (United States)

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

2012-01-01

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

The host response in critically ill sepsis patients on statin therapy: a prospective observational study.

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Wiewel, Maryse A; Scicluna, Brendon P; van Vught, Lonneke A; Hoogendijk, Arie J; Zwinderman, Aeilko H; Lutter, René; Horn, Janneke; Cremer, Olaf L; Bonten, Marc J; Schultz, Marcus J; van der Poll, Tom

2018-01-18

Statins can exert pleiotropic anti-inflammatory, vascular protective and anticoagulant effects, which in theory could improve the dysregulated host response during sepsis. We aimed to determine the association between prior statin use and host response characteristics in critically ill patients with sepsis. We performed a prospective observational study in 1060 patients admitted with sepsis to the mixed intensive care units (ICUs) of two hospitals in the Netherlands between January 2011 and July 2013. Of these, 351 patients (33%) were on statin therapy before admission. The host response was evaluated by measuring 23 biomarkers providing insight into key pathways implicated in sepsis pathogenesis and by analyzing whole-blood leukocyte transcriptomes in samples obtained within 24 h after ICU admission. To account for indication bias, a propensity score-matched cohort was created (N = 194 in both groups for protein biomarkers and N = 95 in both groups for gene expression analysis). Prior statin use was not associated with an altered mortality up to 90 days after admission (38.0 vs. 39.7% in the non-statin users in the propensity-matched analysis). Statin use did not modify systemic inflammatory responses, activation of the vascular endothelium or the coagulation system. The blood leukocyte genomic response, characterized by over-expression of genes involved in inflammatory and innate immune signaling pathways as well as under-expression of genes associated to T cell function, was not different between patients with and without prior statin use. Statin therapy is not associated with a modified host response in sepsis patients on admission to the ICU.

The elimination half-life of benzodiazepines and fall risk: two prospective observational studies.

Science.gov (United States)

de Vries, Oscar J; Peeters, Geeske; Elders, Petra; Sonnenberg, Caroline; Muller, Majon; Deeg, Dorly J H; Lips, Paul

2013-11-01

the STOPP criteria advise against the use of long-acting benzodiazepines (LBs). to study whether LBs are associated with a higher fall risk than short-acting benzodiazepines (SBs) (elimination half-life ≤ 10 h). we used base-line data and prospective fall follow-up from the Longitudinal Aging Study Amsterdam, a longitudinal cohort study including 1,509 community-dwelling older persons (Study 1) and from a separate fall prevention study with 564 older persons after a fall (Study 2). Time to the first fall after inclusion and number of falls in the first year after inclusion were the primary endpoints. both in Study 1 and Study 2 the use of SBs was associated with time to the first fall, hazard ratio (HR) 1.62 (95% CI: 1.03-2.56) and HR 1.64 (95% CI: 1.19-2.26),respectively. LBs were not significantly associated with time to first fall, HR 1.40 (0.85-2.31) and HR 1.08 (0.72-1.62). In both studies, the use of SBs was also associated with number of falls, odds ratio (OR) 1.28 (95% CI: 1.01-1.61) and OR 1.37 (95% CI: 1.10-1.70). LBs were not significantly associated with number of falls, OR 1.23 (0.96-1.57) and 1.10 (0.82-1.48). the use of SBs is not associated with a lower fall risk compared with LBs. The use of both SBs and LBs by old persons should be strongly discouraged.

Bystander first aid in trauma - prevalence and quality: a prospective observational study.

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Bakke, H K; Steinvik, T; Eidissen, S-I; Gilbert, M; Wisborg, T

2015-10-01

Bystander first aid and basic life support can likely improve victim survival in trauma. In contrast to bystander first aid and out-of-hospital cardiac arrest, little is known about the role of bystanders in trauma response. Our aim was to determine how frequently first aid is given to trauma victims by bystanders, the quality of this aid, the professional background of first-aid providers, and whether previous first-aid training affects aid quality. We conducted a prospective 18-month study in two mixed urban-rural Norwegian counties. The personnel on the first ambulance responding to trauma calls assessed and documented first aid performed by bystanders using a standard form. A total of 330 trauma calls were included, with bystanders present in 97% of cases. Securing an open airway was correctly performed for 76% of the 43 patients in need of this first-aid measure. Bleeding control was provided correctly for 81% of 63 patients for whom this measure was indicated, and prevention of hypothermia for 62% of 204 patients. Among the first-aid providers studied, 35% had some training in first aid. Bystanders with documented first-aid training gave better first aid than those where first-aid training status was unknown. A majority of the trauma patients studied received correct pre-hospital first aid, but still there is need for considerable improvement, particularly hypothermia prevention. Previous first-aid training seems to improve the quality of first aid provided. The effect on patient survival needs to be investigated. © 2015 The Authors. The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

The Eldicus prospective, observational study of triage decision making in European intensive care units. Part II: Intensive care benefit for the elderly

DEFF Research Database (Denmark)

Sprung, Charles L; Artigas, Antonio; Kesecioglu, Jozef

2012-01-01

on mortality and intensive care unit benefit, specifically for elderly patients. DESIGN:: Prospective, observational study of triage decisions from September 2003 until March 2005. SETTING:: Eleven intensive care units in seven European countries. PATIENTS:: All patients >18 yrs with an explicit request......RATIONALE:: Life and death triage decisions are made daily by intensive care unit physicians. Admission to an intensive care unit is denied when intensive care unit resources are constrained, especially for the elderly. OBJECTIVE:: To determine the effect of intensive care unit triage decisions...... care unit rejections than younger patients and have a higher mortality when admitted, the mortality benefit appears greater for the elderly. Physicians should consider changing their intensive care unit triage practices for the elderly....

Prospective Register Of patients undergoing repeated OFfice and Ambulatory Blood Pressure Monitoring (PROOF-ABPM): protocol for an observational cohort study.

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Sheppard, James P; Martin, Una; Gill, Paramjit; Stevens, Richard; McManus, Richard J

2016-10-31

The diagnosis and management of hypertension depends on accurate measurement of blood pressure (BP) in order to target antihypertensive treatment appropriately. Most BP measurements take place in a clinic setting, but it has long been recognised that readings taken out-of-office (via home or ambulatory monitoring) estimate true underlying BP more accurately. Recent studies have shown that the change in clinic BP over multiple readings is a significant predictor of the difference between clinic and out-of-office BP. Used in combination with patient characteristics, this change has been shown to accurately predict a patient's out-of-office BP level. The present study proposes to collect real-life BP data to prospectively validate this new prediction tool in routine clinical practice. A prospective, multicentre observational cohort design will be used, recruiting patients from primary and secondary care. All patients attending participating centres for ambulatory BP monitoring will be eligible to participate. Anonymised clinical data will be collected from all eligible patients, who will be invited to give informed consent to permit identifiable data to be collected for data linkage to external outcome registries. Descriptive statistics will be used to calculate the sensitivity, specificity, positive and negative predictive values of the out-of-office BP prediction tool. Area under the receiver operator characteristic curve statistics will be used to examine model performance. Ethical approval for this study has been obtained from the National Research. Ethics Service Committee South Central-Oxford A (reference; 15/SC/0184), and site-specific R&D approval has been acquired from the relevant NHS trusts. All findings will be presented at relevant conferences and published in peer-reviewed journals, on the study website and disseminated in lay and social media where appropriate. Published by the BMJ Publishing Group Limited. For permission to use (where not already

The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

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Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

2011-01-01

Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

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

Science.gov (United States)

Senesse, Pierre; Tadmouri, Abir; Culine, Stéphane; Dufour, Patrick R; Seys, Patrick; Radji, Abderraouf; Rotarski, Maciej; Balian, Axel; Chambrier, Cecile

2015-02-01

Patients with gastrointestinal cancer are at high risk for deterioration of nutrition. Home parenteral nutrition (HPN) could improve nutritional status and quality of life (QoL). The purpose of this study was 1) to evaluate the impact of HPN on QoL, 2) to assess changes in nutritional status, and 3) to assess proxy perception of patient well-being. We conducted a prospective, observational, and a multicenter study. Inclusion criteria were adult patients with gastrointestinal cancer, for whom HPN was indicated and prescribed for at least 14 days. The physician, the patient, and a family member completed questionnaires at inclusion and 28 days later. The QoL was assessed by the patients using the Functional Assessment of Cancer Therapy-General questionnaire, at inclusion and 28 days later. The study included 370 patients with gastrointestinal cancer. The HPN was indicated for cancer-related undernutrition in 89% of the patients and was used as a complement to oral intake in 84%. After 28 days of parenteral intake, global QoL was significantly increased (48.9 at inclusion vs. 50.3, P=0.007). The patients' weight improved significantly by 2.7% (Pnutrition risk screening also decreased significantly (3.2±1.1 vs. 2.8±1.3, P=0.003). HPN could provide benefit for malnourished patients with gastrointestinal cancer. However, randomized controlled studies are required to confirm this benefit and the safety profile. Copyright © 2015. Published by Elsevier Inc.

Fire Engine Support and On-scene Time in Prehospital Stroke Care - A Prospective Observational Study.

Science.gov (United States)

Puolakka, Tuukka; Väyrynen, Taneli; Erkkilä, Elja-Pekka; Kuisma, Markku

2016-06-01

Introduction On-scene time (OST) previously has been shown to be a significant component of Emergency Medical Services' (EMS') operational delay in acute stroke. Since stroke patients are managed routinely by two-person ambulance crews, increasing the number of personnel available on the scene is a possible method to improve their performance. Hypothesis Using fire engine crews to support ambulances on the scene in acute stroke is hypothesized to be associated with a shorter OST. All patients transported to hospital as thrombolysis candidates during a one-year study period were registered by the ambulance crews using a case report form that included patient characteristics and operational EMS data. Seventy-seven patients (41 [53%] male; mean age of 68.9 years [SD=15]; mean Glasgow Coma Score [GCS] of 15 points [IQR=14-15]) were eligible for the study. Forty-five cases were managed by ambulance and fire engine crews together and 32 by the ambulance crews alone. The median ambulance response time was seven minutes (IQR=5-10) and the fire engine response time was six minutes (IQR=5-8). The number of EMS personnel on the scene was six (IQR=5-7) and two (IQR=2-2), and the OST was 21 minutes (IQR=18-26) and 24 minutes (IQR=20-32; P =.073) for the groups, respectively. In a following regression analysis, using stroke as the dispatch code was the only variable associated with short (engine crews to support ambulances in acute stroke care was not associated with a shorter on-scene stay when compared to standard management by two-person ambulance crews alone. Using stroke as the dispatch code was the only variable that was associated independently with a short OST. Puolakka T , Väyrynen T , Erkkilä E-P , Kuisma M . Fire engine support and on-scene time in prehospital stroke care - a prospective observational study. Prehosp Disaster Med. 2016;31(3):278-281.

Telephone Encounters Predict Future High Financial Expenditures in Inflammatory Bowel Disease Patients: A 3-Year Prospective Observational Study.

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Click, Benjamin; Anderson, Alyce M; Ramos Rivers, Claudia; Koutroubakis, Ioannis E; Hashash, Jana G; Dunn, Michael A; Schwartz, Marc; Swoger, Jason; Barrie, Arthur; Szigethy, Eva; Regueiro, Miguel; Schoen, Robert E; Binion, David G

2018-04-01

Telephone activity is essential in management of complex chronic diseases including inflammatory bowel disease (IBD). Telephone encounters logged in the electronic medical record have recently been proposed as a surrogate marker of disease activity and impending health care utilization; however, the association between telephone calls and financial expenditures has not been evaluated. We performed a 3-year prospective observational study of telephone encounters logged at a tertiary referral IBD center. We analyzed patient demographics, disease characteristics, comorbidities, clinical activity, and health care financial charges by telephone encounter frequency. Eight hundred one patients met inclusion criteria (52.3% female; mean age, 44.1 y), accounted for 12,669 telephone encounters, and accrued $70,513,449 in charges over 3 years. High telephone encounter frequency was associated with female gender (P=0.003), anxiety/depression (Pfinancial charges the following year after controlling for demographic, utilization, and medication covariates. Increased telephone encounters are associated with significantly higher health care utilization and financial expenditures. Increased call frequency is predictive of future health care spending. Telephone encounters are a useful tool to identify patients at risk of clinical deterioration and large financial expense.

A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

Science.gov (United States)

van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

2015-03-01

The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC): a prospective, observational, multicenter study [NCT01283893

International Nuclear Information System (INIS)

Kim, Hyoung-Il; Hur, Hoon; Kim, Youn Nam; Lee, Hyuk-Joon; Kim, Min-Chan; Han, Sang-Uk; Hyung, Woo Jin

2014-01-01

Extended systemic lymphadenectomy (D2) is standard procedure for surgical treatment of advanced gastric cancer (AGC) although less extensive lymphadenectomy (D1) can be applied to early gastric cancer. Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC. However, the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station. This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy. This (KLASS-02-QC) is a prospective, observational, multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT, which is a prospective, randomized, clinical trial comparing laparoscopic and open gastrectomy for AGC. Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training, and the gastrectomy metrics of their primary hospitals. All surgeons must submit three laparoscopic and three open D2 gastrectomy videos, respectively. Each video will be allocated to five peer reviewers; thus each surgeon’s operations will be assessed by a total of 30 reviews. Based on blinded assessment of unedited videos by experts’ review, a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT. The primary outcome measure is each surgeon’s proficiency, as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy. We believe that our study for standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC) will guarantee successful implementation of the subsequent KLASS-02-RCT study. After making consensus on D2 lymphadenectomy, we developed evaluation criteria for completeness of D2

Extracorporeal cardiopulmonary resuscitation versus conventional cardiopulmonary resuscitation in adults with out-of-hospital cardiac arrest: a prospective observational study.

Science.gov (United States)

Sakamoto, Tetsuya; Morimura, Naoto; Nagao, Ken; Asai, Yasufumi; Yokota, Hiroyuki; Nara, Satoshi; Hase, Mamoru; Tahara, Yoshio; Atsumi, Takahiro

2014-06-01

A favorable neurological outcome is likely to be achieved in out-of-hospital cardiac arrest (OHCA) patients with ventricular fibrillation or pulseless ventricular tachycardia (VF/VT) on the initial electrocardiogram (ECG). However, in patients without pre-hospital restoration of spontaneous circulation despite the initial VF/VT, the outcome is extremely low by conventional cardiopulmonary resuscitation (CPR). Extracorporeal CPR (ECPR) may enhance cerebral blood flow and recovery of neurological function. We prospectively examined how ECPR for OHCA with VF/VT would affect neurological outcomes. The design of this trial was a prospective, observational study. We compared differences of outcome at 1 and 6 months after OHCA between ECPR group (26 hospitals) and non-ECPR group (20 hospitals). Primary endpoints were the rate of favorable outcomes defined by the Glasgow-Pittsburgh Cerebral Performance and Overall Performance Categories (CPC) 1 or 2 at 1 and 6 months after OHCA. Based on intention-to-treat analysis, CPC 1 or 2 were 12.3% (32/260) in the ECPR group and 1.5% (3/194) in the non-ECPR group at 1 month (P<0.0001), and 11.2% (29/260) and 2.6% (5/194) at 6 months (P=0.001), respectively. By per protocol analysis, CPC 1 or 2 were 13.7% (32/234) in the ECPR group and 1.9% (3/159) in the non-ECPR group at 1 month (P<0.0001), and 12.4% (29/234) and 3.1% (5/159) at 6 months (P=0.002), respectively. In OHCA patients with VF/VT on the initial ECG, a treatment bundle including ECPR, therapeutic hypothermia and IABP was associated with improved neurological outcome at 1 and 6 months after OHCA. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Socioeconomic status and transient ischaemic attack/stroke: a prospective observational study.

Science.gov (United States)

Kerr, Gillian D; Higgins, Peter; Walters, Matthew; Ghosh, Sandip K; Wright, Fiona; Langhorne, Peter; Stott, David J

2011-01-01

Lower socioeconomic status (SES) is associated with an increased risk of stroke but the mechanisms are unclear. We aimed to determine whether low-SES stroke/transient ischaemic attack (TIA) patients have a greater burden of vascular risk factors/co-morbidity and reduced health care access. We prospectively studied 467 consecutive stroke and TIA patients from 3 Scottish hospitals (outpatients and inpatients) during 2007/2008. We recorded vascular risk factors, stroke severity, co-morbidity measures, investigations and health service utilisation. SES was derived from postcodes using Scottish Neighbourhood Statistics and analysed in quartiles. TIA/stroke patients in the lowest SES quartile were younger (64 years, SD 14.1) than those in the highest quartile (72 years, SD 12.9; p p = 0.001) but there was no association with other vascular risk factors/co-morbidity. There was a trend for those with lower SES to have a more severe stroke [modified National Institutes of Health Stroke Scale score and interquartile range: 4 (2-6) vs. 3 (1-5); multivariate p = 0.05]. Lower SES groups were less likely to have neuro-imaging (82 vs. 90%; p = 0.036) or an electrocardiogram (72 vs. 87%; p = 0.003), but differences were no longer significant on multivariate analysis. However, there was equal access to stroke unit care. Low-SES TIA and stroke patients are younger and have a more severe deficit; an increased prevalence of smoking is likely to be a major contributor. We found equal access to stroke unit care for low-SES patients. Copyright © 2010 S. Karger AG, Basel.

The price of donation after cardiac death in liver transplantation : a prospective cost-effectiveness study

NARCIS (Netherlands)

van der Hilst, Christian S.; IJtsma, Alexander J. C.; Bottema, Jan T.; van Hoek, Bart; Dubbeld, Jeroen; Metselaar, Herold J.; Kazemier, Geert; van den Berg, Aad P.; Porte, Robert J.; Slooff, Maarten J. H.

This study aims to perform a detailed prospective observational multicenter cost-effectiveness study by comparing liver transplantations with Donation after Brain Death (DBD) and Donation after Cardiac Death (DCD) grafts. All liver transplantations in the three Dutch liver transplant centers between

A prospective observational longitudinal study of new-onset seizures and newly diagnosed epilepsy in dogs

DEFF Research Database (Denmark)

Fredsø, N; Toft, Nils; Sabers, A.

2017-01-01

Seizures are common in dogs and can be caused by non-epileptic conditions or epilepsy. The clinical course of newly diagnosed epilepsy is sparsely documented. The objective of this study was to prospectively investigate causes for seizures (epileptic and non-epileptic) in a cohort of dogs with new...... structural epilepsy. A non-epileptic cause for seizures was identified in 13 dogs and suspected in 10 dogs. Four dogs in which no cause for seizures was identified experienced only one seizure during the study. In dogs with idiopathic epilepsy 60% had their second epileptic seizure within three months...... seizures motivated early treatment. In a few dogs with a high seizure frequency owners declined treatment against the investigators advice. Epilepsy is the most likely diagnosis in dogs presenting with new-onset seizures. The course of idiopathic epilepsy is highly individual and might not necessarily...

Influence of Malnutrition on Adverse Outcome in Children with Confirmed or Probable Viral Encephalitis: A Prospective Observational Study

Directory of Open Access Journals (Sweden)

Priyanka Singh

2015-01-01

Full Text Available A prospective observational study was conducted in a tertiary care teaching hospital from August 2008 to August 2009 to explore the independent predictors of adverse outcome in the patients with confirmed/probable viral encephalitis. The primary outcome variable was the incidence of adverse outcomes defined as death or severe neurological deficit such as loss of speech, motor deficits, behavioural problems, blindness, and cognitive impairment. Patients with confirmed or probable viral encephalitis were classified into two groups based on their Z-score of weight-for-age as per WHO growth charts. Group I. Patients with confirmed or probable viral encephalitis with weight-for-age (W/A Z-scores below −2SD were classified as undernourished. Group II. Patients with confirmed or probable viral encephalitis were classified as having normal nutritional status (weight-for-age Z-score >−2SD. A total of 114 patients were classified as confirmed or probable viral encephalitis based on detailed investigations. On multivariate logistic regression, undernutrition (adjusted OR: 5.05; 95% CI: 1.92 to 13.44 and requirement of ventilation (adjusted OR: 6.75; 95% CI: 3.63 to 77.34 were independent predictors of adverse outcomes in these patients. Thus, the results from our study highlight that the association between undernutrition and adverse outcome could be extended to the patients with confirmed/probable viral encephalitis.

Results from a Prospective, International, Epidemiologic Study of Invasive Candidiasis in Children and Neonates

NARCIS (Netherlands)

Steinbach, W.J.; Roilides, E.; Berman, D.; Hoffman, J.A.; Groll, A.H.; Bin-Hussain, I.; Palazzi, D.L.; Castagnola, E.; Halasa, N.; Velegraki, A.; Dvorak, C.C.; Charkabarti, A.; Sung, L.; Danziger-Isakov, L.; Lachenauer, C.; Arrieta, A.; Knapp, K.; Abzug, M.J.; Ziebold, C.; Lehrnbecher, T.; Klingspor, L.; Warris, A.; Leckerman, K.; Martling, T.; Walsh, T.J.; Benjamin, D.K., Jr.; Zaoutis, T.E.; and the International Pediatric Fungal, N.

2012-01-01

BACKGROUND:: Candida species are the third most common cause of pediatric healthcareassociated bloodstream infection in the United States and Europe. To our knowledge, this report from the International Pediatric Fungal Network is the largest prospective, multi-center observational study dedicated

Moderate alcohol consumption lowers the risk of type 2 diabetes: a meta-analysis of prospective observational studies

OpenAIRE

Koppes, L.L.J.; Dekker, J.M.; Hendriks, H.F.J.; Bouter, L.M.; Heine, R.J.

2005-01-01

OBJECTIVE - This meta-analysis was undertaken to obtain insight regarding the shape and strength of the relationship between alcohol consumption and the risk of type 2 diabetes, the effects of adjustment for confounders, and the effect of modification by type 2 diabetes definition, sex, and BMI. RESEARCH DESIGN AND METHODS - The 15 original prospective cohort studies that were included comprise 11,959 incident cases of type 2 diabetes in 369,862 individuals who, on average, were followed for ...

Exoplanet Biosignatures: Observational Prospects

Science.gov (United States)

Angerhausen, Daniel; Deitrick, Russell; Domagal-Goldman, Shawn; Grenfell, John Lee; Hori, Yasunori; Kane, Stephen R.; Pallé, Enric; Rauer, Heike; Siegler, Nicholas; Stapelfeldt, Karl; Stevenson, Kevin B.

2018-01-01

Abstract Exoplanet hunting efforts have revealed the prevalence of exotic worlds with diverse properties, including Earth-sized bodies, which has fueled our endeavor to search for life beyond the Solar System. Accumulating experiences in astrophysical, chemical, and climatological characterization of uninhabitable planets are paving the way to characterization of potentially habitable planets. In this paper, we review our possibilities and limitations in characterizing temperate terrestrial planets with future observational capabilities through the 2030s and beyond, as a basis of a broad range of discussions on how to advance “astrobiology” with exoplanets. We discuss the observability of not only the proposed biosignature candidates themselves but also of more general planetary properties that provide circumstantial evidence, since the evaluation of any biosignature candidate relies on its context. Characterization of temperate Earth-sized planets in the coming years will focus on those around nearby late-type stars. The James Webb Space Telescope (JWST) and later 30-meter-class ground-based telescopes will empower their chemical investigations. Spectroscopic studies of potentially habitable planets around solar-type stars will likely require a designated spacecraft mission for direct imaging, leveraging technologies that are already being developed and tested as part of the Wide Field InfraRed Survey Telescope (WFIRST) mission. Successful initial characterization of a few nearby targets will be an important touchstone toward a more detailed scrutiny and a larger survey that are envisioned beyond 2030. The broad outlook this paper presents may help develop new observational techniques to detect relevant features as well as frameworks to diagnose planets based on the observables. Key Words: Exoplanets—Biosignatures—Characterization—Planetary atmospheres—Planetary surfaces. Astrobiology 18, 739–778. PMID:29938537

Congenital Critical Heart Defect Screening in a Health Area of the Community of Valencia (Spain: A Prospective Observational Study

Directory of Open Access Journals (Sweden)

Elena Cubells

2018-01-01

Full Text Available Despite the progress in the fetal echocardiographic detection of congenital critical heart defects and neonatal physical examination, a significant number of newborn infants are discharged and readmitted to the hospital in severe condition due to cardiac failure or collapse. The aim of this study was to assess the incidence of undetected critical congenital heart disease (CCHD by a pulse oximetry-screening program in the maternity wards of hospitals with Perinatal Services in a specific geographic area. This is a prospective observational study performed in in the health area corresponding to the city of Valencia. Eligible infants were consecutively admitted newborn infants in the maternities of the participating hospitals with negative fetal echocardiography after normal physical examination in the delivery room. All patients were screened following a specific pulse oximetry protocol before discharge. A total of 8856 newborn infants were screened. A total of three babies presented with severe congenital cardiac malformation and two babies presented with early onset sepsis. Sensitivity was 100% and specificity was 99.97%, with a positive predictive value of 60% and negative predictive value of 100%. Pulse oximetry screening programs in the early neonatal period constitute a valuable tool to avoid inadvertent hospital discharge of severe cardiac malformations and the subsequent life-threatening complications derived.

A Study on Chocolate Consumption in Prospective Teachers

Science.gov (United States)

Ozgen, Leyla

2016-01-01

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

Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

Science.gov (United States)

Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

2011-12-01

Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

A prospective observational study comparing a physiological scoring system with time-based discharge criteria in pediatric ambulatory surgical patients.

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Armstrong, James; Forrest, Helen; Crawford, Mark W

2015-10-01

Discharge criteria based on physiological scoring systems can be used in the postanesthesia care unit (PACU) to fast-track patients after ambulatory surgery; however, studies comparing physiological scoring systems with traditional time-based discharge criteria are lacking. The purpose of this study was to compare PACU discharge readiness times using physiological vs time-based discharge criteria in pediatric ambulatory surgical patients. We recorded physiological observations from consecutive American Society of Anesthesiologists physical status I-III patients aged 1-18 yr who were admitted to the PACU after undergoing ambulatory surgery in a tertiary academic pediatric hospital. The physiological score was a combination of the Aldrete and Chung systems. Scores were recorded every 15 min starting upon arrival in the PACU. Patients were considered fit for discharge once they attained a score ≥12 (maximum score, 14), provided no score was zero, with the time to achieve a score ≥12 defining the criteria-based discharge (CBD) time. Patients were discharged from the PACU when both the CBD and the existing time-based discharge (TBD) criteria were met. The CBD and TBD data were compared using Kaplan-Meier and log-rank analysis. Observations from 506 children are presented. Median (interquartile range [IQR]) age was 5.5 [2.8-9.9] yr. Median [IQR] CBD and TBD PACU discharge readiness times were 30 [15-45] min and 60 [45-60] min, respectively. Analysis of Kaplan-Meier curves indicated a significant difference in discharge times using the different criteria (hazard ratio, 5.43; 95% confidence interval, 4.51 to 6.53; P < 0.001). All patients were discharged home without incident. This prospective study suggests that discharge decisions based on physiological criteria have the potential for significantly speeding the transit of children through the PACU, thereby enhancing PACU efficiency and resource utilization.

Serum Lipids and Breast Cancer Risk: A Meta-Analysis of Prospective Cohort Studies.

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Haibo Ni

Full Text Available Epidemiologic studies exploring causal associations between serum lipids and breast cancer risk have reported contradictory results. We conducted a meta-analysis of prospective cohort studies to evaluate these associations.Relevant studies were identified by searching PubMed and EMBASE through April 2015. We included prospective cohort studies that reported relative risk (RR estimates with 95% confidence intervals (CIs for the associations of specific lipid components (i.e., total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], and triglycerides [TG] with breast cancer risk. Either a fixed- or a random-effects model was used to calculate pooled RRs.Fifteen prospective cohort studies involving 1,189,635 participants and 23,369 breast cancer cases were included in the meta-analysis. The pooled RRs of breast cancer for the highest versus lowest categories were 0.96 (95% CI: 0.86-1.07 for TC, 0.92 (95% CI: 0.73-1.16 for HDL-C, 0.90 (95% CI: 0.77-1.06 for LDL-C, and 0.93 (95% CI: 0.86-1.00 for TG. Notably, for HDL-C, a significant reduction of breast cancer risk was observed among postmenopausal women (RR = 0.77, 95% CI: 0.64-0.93 but not among premenopausal women. Similar trends of the associations were observed in the dose-response analysis.Our findings suggest that serum levels of TG but not TC and LDL-C may be inversely associated with breast cancer risk. Serum HDL-C may also protect against breast carcinogenesis among postmenopausal women.

Predictors of remission in the treatment of major depressive disorder: real-world evidence from a 6-month prospective observational study.

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Novick, Diego; Hong, Jihyung; Montgomery, William; Dueñas, Héctor; Gado, Magdy; Haro, Josep Maria

2015-01-01

This study examined potential predictors of remission among patients treated for major depressive disorder (MDD) in a naturalistic clinical setting, mostly in the Middle East, East Asia, and Mexico. Data for this post hoc analysis were taken from a 6-month prospective, noninterventional, observational study that involved 1,549 MDD patients without sexual dysfunction at baseline in 12 countries worldwide. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16). Depression-related pain was measured using the pain-related items of the Somatic Symptom Inventory. Remission was defined as a QIDS-SR16 score ≤5. Generalized estimating equation regression models were used to examine baseline factors associated with remission during follow-up. Being from East Asia (odds ratio [OR] 0.48 versus Mexico; Pdepression severity at baseline (OR 0.77, P=0.003, for Clinical Global Impression of Severity; OR 0.92, Pdepression (OR 0.78, P=0.030), and having any significant psychiatric and medical comorbidity at baseline (OR 0.60, Pdepression-related pain and outcomes of depression.

Comparison of propofol pharmacokinetic and pharmacodynamic models for awake craniotomy: A prospective observational study.

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Soehle, Martin; Wolf, Christina F; Priston, Melanie J; Neuloh, Georg; Bien, Christian G; Hoeft, Andreas; Ellerkmann, Richard K

2015-08-01

Anaesthesia for awake craniotomy aims for an unconscious patient at the beginning and end of surgery but a rapidly awakening and responsive patient during the awake period. Therefore, an accurate pharmacokinetic/pharmacodynamic (PK/PD) model for propofol is required to tailor depth of anaesthesia. To compare the predictive performances of the Marsh and the Schnider PK/PD models during awake craniotomy. A prospective observational study. Single university hospital from February 2009 to May 2010. Twelve patients undergoing elective awake craniotomy for resection of brain tumour or epileptogenic areas. Arterial blood samples were drawn at intervals and the propofol plasma concentration was determined. The prediction error, bias [median prediction error (MDPE)] and inaccuracy [median absolute prediction error (MDAPE)] of the Marsh and the Schnider models were calculated. The secondary endpoint was the prediction probability PK, by which changes in the propofol effect-site concentration (as derived from simultaneous PK/PD modelling) predicted changes in anaesthetic depth (measured by the bispectral index). The Marsh model was associated with a significantly (P = 0.05) higher inaccuracy (MDAPE 28.9 ± 12.0%) than the Schnider model (MDAPE 21.5 ± 7.7%) and tended to reach a higher bias (MDPE Marsh -11.7 ± 14.3%, MDPE Schnider -5.4 ± 20.7%, P = 0.09). MDAPE was outside of accepted limits in six (Marsh model) and two (Schnider model) of 12 patients. The prediction probability was comparable between the Marsh (PK 0.798 ± 0.056) and the Schnider model (PK 0.787 ± 0.055), but after adjusting the models to each individual patient, the Schnider model achieved significantly higher prediction probabilities (PK 0.807 ± 0.056, P = 0.05). When using the 'asleep-awake-asleep' anaesthetic technique during awake craniotomy, we advocate using the PK/PD model proposed by Schnider. Due to considerable interindividual variation, additional monitoring of anaesthetic depth is

Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis.

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Lenz, Philipp; Eckelskemper, Franziska; Erichsen, Thomas; Lankisch, Tim; Dechêne, Alexander; Lubritz, Gabriele; Lenze, Frank; Beyna, Torsten; Ullerich, Hansjörg; Schmedt, Andre; Domagk, Dirk

2014-09-14

To develop an algorithm to improve the diagnosis and treatment of patients with biliary candidiasis. We performed a prospective study of 127 patients who underwent endoscopic retrograde cholangiopancreatography, for various biliary disorders, at 3 tertiary referral centers in Germany from July 2011 through July 2012 (ClinicalTrials.gov: NCT01109550). Bile, buccal, and stool samples were collected. When indicated, endoscopic transpapillary bile duct biopsies were performed to clarify the etiology of bile duct strictures and to prove invasive fungal infections. Candida species were detected in 38 of the 127 bile samples (29.9%). By multivariate analysis patients' age and previous endoscopic sphincterotomy were independent risk factors for biliary candidiasis (P 7 d) (P = 0.089) tend to be at risk for biliary candidiasis. One patient was negative in mycological culture of bile fluid but invasive biliary candidiasis was diagnosed histologically. Of Candida subspecies detected, 36.7% were azole-resistant, such as C glabrata. Eight patients received anti-mycotic therapy, based on our algorithm. Of these, 3 had cancer with biliary tract involvement, 2 had secondary sclerosing cholangitis, 1 had retroperitoneal fibrosis, and 5 had septicemia. In all patients contamination was ruled out by smears of the endoscope channel. Gastroenterologists should be aware of frequent candida colonization in patients with cholangitis and biliary disorders. Our suggested algorithm facilitates the further clinical management.

Prospective observational multicenter study to define a diagnostic algorithm for biliary candidiasis

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Lenz, Philipp; Eckelskemper, Franziska; Erichsen, Thomas; Lankisch, Tim; Dechêne, Alexander; Lubritz, Gabriele; Lenze, Frank; Beyna, Torsten; Ullerich, Hansjörg; Schmedt, Andre; Domagk, Dirk

2014-01-01

AIM: To develop an algorithm to improve the diagnosis and treatment of patients with biliary candidiasis. METHODS: We performed a prospective study of 127 patients who underwent endoscopic retrograde cholangiopancreatography, for various biliary disorders, at 3 tertiary referral centers in Germany from July 2011 through July 2012 (ClinicalTrials.gov: NCT01109550). Bile, buccal, and stool samples were collected. When indicated, endoscopic transpapillary bile duct biopsies were performed to clarify the etiology of bile duct strictures and to prove invasive fungal infections. RESULTS: Candida species were detected in 38 of the 127 bile samples (29.9%). By multivariate analysis patients’ age and previous endoscopic sphincterotomy were independent risk factors for biliary candidiasis (P 7 d) (P = 0.089) tend to be at risk for biliary candidiasis. One patient was negative in mycological culture of bile fluid but invasive biliary candidiasis was diagnosed histologically. Of Candida subspecies detected, 36.7% were azole-resistant, such as C glabrata. Eight patients received anti-mycotic therapy, based on our algorithm. Of these, 3 had cancer with biliary tract involvement, 2 had secondary sclerosing cholangitis, 1 had retroperitoneal fibrosis, and 5 had septicemia. In all patients contamination was ruled out by smears of the endoscope channel. CONCLUSION: Gastroenterologists should be aware of frequent candida colonization in patients with cholangitis and biliary disorders. Our suggested algorithm facilitates the further clinical management. PMID:25232260

Physical Trauma Patients with Symptoms of an Acute and Posttraumatic Stress Disorder: Protocol for an Observational Prospective Cohort Study.

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Visser, Eva; Gosens, Taco; Den Oudsten, Brenda; De Vries, Jolanda

2018-03-29

underway. Data collection will be completed in November 2018. The first results will be expected in the first trimester of 2019. This is the first multi-method study in trauma patients that examines patients' experiences (qualitative design) as well as psychological disorders (observational prospective). This study will contribute to necessary information on psychological consequences after injury. Moreover, it provides knowledge about which patients to include in future psychological intervention research. Finally, awareness in clinicians about the psychological consequences can be created, so they are able to act more effectively to provide patient-oriented care. Netherlands Trial Registry NTR6258; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6258 (Archived by WebCite at http://www.webcitation.org/6xSCiO1bS). ©Eva Visser, Taco Gosens, Brenda Den Oudsten, Jolanda De Vries. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.03.2018.

Clinical characteristics of pneumonia in bedridden patients receiving home care: a 3-year prospective observational study.

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Ishida, Tadashi; Tachibana, Hiromasa; Ito, Akihiro; Ikeda, Satoshi; Furuta, Kenjiro; Nishiyama, Akihiro; Noyama, Maki; Tokioka, Fumiaki; Yoshioka, Hiroshige; Arita, Machiko

2015-08-01

The aim of the study was to describe the epidemiology, clinical features, antimicrobial treatment, and outcomes of bedridden pneumonia patients receiving home healthcare. A 3-year prospective observational study of poor performance status (PS) 3-4 patients receiving long-term home healthcare and hospitalized at a single center with pneumonia between October 2010 and September 2013 was conducted, and their clinical characteristics were compared with non-bedridden community-acquired pneumonia (CAP) patients. A total of 131 CAP patients with PS 3-4, and 400 CAP patients with PS 0-2 were evaluated. The PS 3-4 patients were older, and exhibited a higher frequency of underlying diseases. Aspiration was thought to be associated with pneumonia in 77.1% of the PS 3-4 patients. Streptococcus pneumoniae was the leading pathogen in both groups, whereas the frequency of streptococci and polymicrobial infections was higher in the PS 3-4 group. The incidence of multidrug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa was lower than in previous healthcare-associated pneumonia reports. The in-hospital mortality and recurrence rates were significantly higher in the PS 3-4 group than in the good PS group (17.6% vs. 6.0%, p < 0.001 and 15.3% vs. 7.5%, p = 0.008, respectively). The clinical characteristics of pneumonia in poor PS patients were similar to healthcare-associated pneumonia (HCAP), except for the frequency of drug-resistant pathogens. Hence, it might be beneficial to categorize pneumonia in home residents with poor PS separately from pneumonia in CAP patients who were previously healthy or experienced mild comorbidities. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

The Sydney Triage to Admission Risk Tool (START): A prospective validation study.

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Ebker-White, Anja A; Bein, Kendall J; Dinh, Michael M

2018-02-08

The present study aims to prospectively validate the Sydney Triage to Admission Risk Tool (START) to predict ED disposition. This was a prospective validation study at two metropolitan EDs in Sydney, Australia. Consecutive triage encounters were observed by a trained researcher and START scores calculated. The primary outcome was patient disposition (discharge or inpatient admission) from the ED. Multivariable logistic regression was used to estimate area under curve of receiver operator characteristic (AUC ROC) for START scores as well as START score in combination with other variables such as frailty, general practitioner referral, overcrowding and major medical comorbidities. There were 894 patients analysed during the study period. The START score when applied to the data had AUC ROC of 0.80 (95% CI 0.77-0.83). The inclusion of other clinical variables identified at triage did not improve the overall performance of the model with an AUC ROC of 0.81 (95% CI 0.78-0.84) in the present study. The overall performance of the START tool with respect to model discrimination and accuracy has been prospectively validated. Further clinical trials are required to test the clinical effectiveness of the tool in improving patient flow and overall ED performance. © 2018 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

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

International Nuclear Information System (INIS)

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

2013-01-01

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

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

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

2013-03-15

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

Relationship between severe obesity and depth to the cricothyroid membrane in third-trimester non-labouring parturients: a prospective observational study.

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Gadd, K; Wills, K; Harle, R; Terblanche, N

2018-05-01

Severely obese parturients have increased 'cannot intubate, cannot oxygenate' risk during Caesarean section under general anaesthesia. Front-of-neck access (FONA) at the cricothyroid membrane (CTM) is definitive management; however, attempted FONA can fail. Point-of-care ultrasonography may provide useful information about CTM depth to aid FONA in obesity. This study determined the difference in CTM depth between severely obese and non-obese parturients, utilising ultrasonography. In this prospective observational study, two anaesthetists performed airway ultrasonography on 15 severely obese (BMI >45 kg m -2 ) and 15 normal-weight (BMI ≤25 kg m -2 ) parturients in the third trimester, using the transverse and longitudinal planes, sniffing and extended head positions, and nil and firm transducer pressures. The primary outcome was CTM depth (millimetres) measured in the transverse plane with the head extended and nil transducer pressure. Secondary outcomes included CTM depth measurements using other factor configurations. Intra-class correlation coefficients assessed the inter-observer reliability. CTM depth measured in the transverse plane with head extended and nil transducer pressure was significantly greater in severely obese parturients, mean 18.0 mm (95% confidence interval 16.3-19.8), vs 10.6 mm (8.81-12.4) in non-obese (P<0.001); mean difference 7.4 mm (4.9-9.9; P<0.001). CTM depths were increased in the severely obese group regardless of scanning plane, head and neck position, or transducer pressure (all P<0.001). There was excellent inter-observer reliability. Cricothyroid membrane depth is significantly increased in severely obese vs normal-weight parturients independently of scanning plane, head and neck position, or transducer pressure. Copyright © 2018 British Journal of Anaesthesia. All rights reserved.

Vitamin D Levels and 1-Year Fusion Outcomes in Elective Spine Surgery: A Prospective Observational Study.

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Ravindra, Vijay M; Godzik, Jakub; Dailey, Andrew T; Schmidt, Meic H; Bisson, Erica F; Hood, Robert S; Cutler, Andrew; Ray, Wilson Z

2015-10-01

Prospective observational study. To investigate the association of perioperative vitamin D levels and nonunion rates and time to fusion in patients undergoing elective spine fusion. Although there is a clear link between bone mineral density and the risk of osteoporosis, it is unclear whether low vitamin D levels affect rates and timing of spinal fusion. Serum 25-OH vitamin D levels were measured perioperatively in adults undergoing elective spinal fusion between 2011 and 2012. Vitamin D levels vitamin D deficiency. Mean patient age was 57 ± 13 years; 44% were female and 94% were Caucasian. The cervical spine was fused in 49%, the lumbar spine in 47%, and the thoracic spine in 4%. Mean construct length was 2 levels (range 1-16). At 12-month follow-up, 112/133 (84%) patients demonstrated fusion (median time to fusion 8.4 mo). Nonunion at 12 months was associated with vitamin D deficiency (20% of patients with adequate vitamin D level vs. 38% of vitamin D-deficient patients, P = 0.063). Kaplan-Meier survival analysis demonstrated time to fusion was significantly longer in the vitamin D-deficient group (12 vs. 6 mo, P = 0.001). On multivariate analysis, vitamin D deficiency was an independent predictor of nonunion (odds ratio 3.449, P = 0.045) when adjusted for age, sex, obesity, fusion length, location, graft type, smoking, and bone morphogenetic protein use. Vitamin D levels may affect nonunion rate and time to fusion. These results offer insight into the importance of the metabolic milieu for bony fusion as well as a potential avenue for therapeutic intervention. 3.

Acute renal failure in critically ill newborns increases the risk of death: a prospective observational study from India.

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Patel, Ankur; Sharma, Deepak; Shastri, Sweta; Sharma, Pradeep

2016-09-01

To determine the incidence and risk factors of acute renal failure (ARF) in hospitalized critically ill neonates and analyze outcome of all neonates with renal failure in relation to risk factors. In this prospective observational study 815 infants were enrolled. Renal profile (blood urea and serum creatinine) was done after 12 h of life (or at the time of admission for outborn babies) and then every 12 hourly. Daily 24 h urine output was evaluated. Incidence of renal failure in critically ill neonates was 10.67%. Out of 87 ARF neonates 52 (60%) expired. Mortality in the renal failure group was significantly higher in comparison to control group (p renal failure was more common than oliguric renal failure, but mortality in the oliguric renal failure group was more. Neonatal sepsis was the most common cause of ARF. Eight neonates underwent peritoneal dialysis (PD) out of which there were seven neonatal deaths. Prognosis of neonates with ARF requiring PD was very poor. It can thus be concluded that the health care personal should do rapid diagnosis of ARF in neonates with potential risk factors and also goal at an early and effective treatment of these risk factors in neonates with ARF.

Randomized, interventional, prospective, comparative study to ...

African Journals Online (AJOL)

Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

Patient-Related Determinants of the Administration of Continuous Palliative Sedation in Hospices and Palliative Care Units: A Prospective, Multicenter, Observational Study.

Science.gov (United States)

van Deijck, Rogier H P D; Hasselaar, Jeroen G J; Verhagen, Stans C A H H V M; Vissers, Kris C P; Koopmans, Raymond T C M

2016-05-01

Knowledge of determinants that are associated with the administration of continuous palliative sedation (CPS) helps physicians identify patients who are at risk of developing refractory symptoms, thereby enabling proactive care planning. This study aims to explore which patient-related factors at admission are associated with receiving CPS later in the terminal phase of life. A prospective multicenter observational study was performed in six Dutch hospices and three nursing home-based palliative care units. The association between patient-related variables at admission (age, gender, diagnosis, use of opioids or psycholeptics, number of medications, Karnofsky Performance Status scale score, Edmonton Symptom Assessment System distress score, and Glasgow Coma Scale score) and the administration of CPS at the end of life was analyzed. A total of 467 patients died during the study period, of whom 130 received CPS. In univariate analysis, statistically significant differences were noted between the sedated and nonsedated patients with respect to younger age (P = 0.009), malignancy as a diagnosis (P = 0.05), higher Karnofsky Performance Status score (P = 0.03), the use of opioids (P Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Time spent in primary care for hip osteoarthritis patients once the diagnosis is set: a prospective observational study

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van den Akker-Scheek Inge

2011-06-01

Full Text Available Abstract Background Previous research on time to referral to orthopaedic surgery has predominantly used hip complaints as starting point instead of the moment the diagnosis of osteoarthritis (OA of the hip is established, therefore little is known about the length of time a patient diagnosed with hip OA stays under the care of a general practitioner (GP. No knowledge on factors of influence on this time period is available either. Aim of this study was thus to determine the time an incident hip OA patient stays in the care of a GP until referral to an orthopaedic department. Influencing factors were also analyzed. Methods A prospective observational study was conducted based on data over a 10-year period from a general practice-based registration network (17 GPs, > 30,000 patients registered yearly. Patients with the diagnosis of hip OA were included. A survival analysis was used to determine time until referral to an orthopaedic department, and to determine factors of influence on this time. Results Of 391 patients diagnosed with hip OA, 121 (31% were referred; average survival time until referral was 82.0 months (95% CI 76.6-87.5. Less contact with the GP for hip complaints before the diagnosis of hip OA was established resulted in a decreased time to referral. Conclusions The results of this study show that patients with hip OA were under the care of a general practitioner, and thus in primary care, for a considerable amount of time once the diagnosis of hip OA was established.

Coffee Consumption and Risk of Gastric Cancer: A Large Updated Meta-Analysis of Prospective Studies

Directory of Open Access Journals (Sweden)

Feiyue Xie

2014-09-01

Full Text Available The potential role of coffee consumption in the development of various types of cancer has been extensively investigated in epidemiologic studies. How coffee consumption may modulate risk of gastric cancer, however, remains a subject open for investigation. To better quantify this relation, we quantitatively summarized evidence from prospective studies. Eligible studies were identified on PubMed and Embase databases. The summary risk estimates were obtained using the random-effects model. Subgroup, sensitivity and dose-response analyses were conducted. The present meta-analysis included 12 prospective cohort studies. A pooled analysis of these studies suggested that coffee consumption (highest vs. lowest consumption was not associated with risk of gastric cancer (RR = 1.12, 95% CI = 0.93–1.36. In the subgroup analysis, significant increased risk was detected in the U.S. studies (RR = 1.36, 95% CI = 1.06–1.74 and in the studies with <10 years of follow-up (RR = 1.24, 95% CI = 1.00–1.54, and the greatest increase in risk was observed in those studies without adjustment for smoking (RR = 1.48, 95% CI = 1.13–1.93. There was some evidence of publication bias (P for Egger’s test = 0.03. Cumulative evidence from prospective studies suggests that coffee consumption is not associated with risk of gastric cancer. The observed positive results may be confounded by smoking and need further investigation.

Prospective observational study on assessing the hemodynamic relevance of patent ductus arteriosus with frequency domain near-infrared spectroscopy.

Science.gov (United States)

Schwarz, Christoph E; Preusche, Antonio; Wolf, Martin; Poets, Christian F; Franz, Axel R

2018-02-16

What constitutes a hemodynamically relevant patent ductus arteriosus (hrPDA) in preterm infants is unclear. Different clinical and echocardiographic parameters are used, but a gold standard definition is lacking. Our objective was to evaluate associations between regional cerebral tissue oxygen saturation (rcStO 2 ), fraction of tissue oxygen extraction (rcFtO 2 E) measured by frequency domain near-infrared spectroscopy (fd-NIRS) and their correlation to echocardiographic, Doppler-ultrasound, and clinical parameters in preterm infants with and without a hrPDA. In this prospective observational study, 22 infants standard deviation (normalised to a median Hb of 13.8 mg/dl) was 57 ±5% for rcStO 2 and 0.39 ±0.05 for rcFtO 2 E. Comparing no-hrPDA with hrPDA infants, there were no significant differences in mean rcStO 2 (58 ±5% vs. 54 ±5%; p = .102), but in mean rcFtO 2 E (0.38 ±0.05 vs. 0.43 ±0.05; p = .038). Echocardiographic parameter and Doppler indices did not correlate with cerebral oxygenation. Oxygen transport capacity of the blood may confound NIRS data interpretation. Cerebral oxygenation determined by fd-NIRS provided additional information for PDA treatment decisions not offered by routine investigations. Whether indicating PDA therapy based on echocardiography complemented by data on cerebral oxygenation results in better outcomes should be investigated in future studies.

Correlation of Apgar Score with Asphyxial Hepatic Injury and Mortality in Newborns: A Prospective Observational Study from India

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Deepak Sharma

2016-01-01

Full Text Available Objective The objective of this study is to determine the correlation of Apgar score with asphyxial hepatic injury and neonatal mortality in moderately and severely asphyxiated newborns. Material and Methods This is a secondary analysis of our prospective observational case-controlled study. Sixteen neonates with severe birth asphyxia (five-minute Apgar ≤3 were compared with either 54 moderate asphyxia neonates (five-minute Apgar >3 or 30 normal neonates. Liver function tests were measured on postnatal days 1, 3, and 10 in the study and control groups. Neonatal mortality was observed in the study and control population. Results Correlation of Apgar score in severely asphyxiated neonates compared with normal Apgar score neonates and moderately asphyxiated neonates for deranged hepatic function showed significant correlation (odds ratio [OR] 4.88, 95% CI 3.26–5.84, P = 0.01 and OR 2.46, 95% CI 1.94–3.32, P = 0.02, respectively. There was a significant increase in serum lactate dehydrogenase (LDH and total bilirubin on day 1 and serum LDH at age of 10th postnatal life in severely asphyxiated neonates when compared to moderately asphyxiated neonates, whereas there was a significant decrease in total bilirubin and serum albumin on day 3 in severely asphyxiated neonates. There was a significant increase in serum alanine transaminase, serum LDH, and total bilirubin on day 1, serum aspartate transaminase, serum LDH, and total bilirubin on day 3, and International Normalized Ratio on day 10 of postnatal life when severely asphyxiated neonates were compared with normal neonates. There was a significant reduction in total protein and serum albumin on day 1 and direct bilirubin on day 3 in severely asphyxiated neonates when compared with normal neonates. There was a significant increase in neonatal mortality in severely asphyxiated neonates when compared to the other two groups. Correlation of Apgar score in severely asphyxiated neonates compared with

Management of minor head injury in patients receiving oral anticoagulant therapy: a prospective study of a 24-hour observation protocol.

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Menditto, Vincenzo G; Lucci, Moira; Polonara, Stefano; Pomponio, Giovanni; Gabrielli, Armando

2012-06-01

Patients receiving warfarin who experience minor head injury are at risk of intracranial hemorrhage, and optimal management after a single head computed tomography (CT) scan is unclear. We evaluate a protocol of 24-hour observation followed by a second head CT scan. In this prospective case series, we enrolled consecutive patients receiving warfarin and showing no intracranial lesions on a first CT scan after minor head injury treated at a Level II trauma center. We implemented a structured clinical pathway, including 24-hour observation and a CT scan performed before discharge. We then evaluated the frequency of death, admission, neurosurgery, and delayed intracranial hemorrhage. We enrolled and observed 97 consecutive patients. Ten refused the second CT scan and were well during 30-day follow-up. Repeated CT scanning in the remaining 87 patients revealed a new hemorrhage lesion in 5 (6%), with 3 subsequently hospitalized and 1 receiving craniotomy. Two patients discharged after completing the study protocol with 2 negative CT scan results were admitted 2 and 8 days later with symptomatic subdural hematomas; neither received surgery. Two of the 5 patients with delayed bleeding at 24 hours had an initial international normalized ratio greater than 3.0, as did both patients with delayed bleeding beyond 24 hours. The relative risk of delayed hemorrhage with an initial international normalized ratio greater than 3.0 was 14 (95% confidence interval 4 to 49). For patients receiving warfarin who experience minor head injury and have a negative initial head CT scan result, a protocol of 24-hour observation followed by a second CT scan will identify most occurrences of delayed bleeding. An initial international normalized ratio greater than 3 suggests higher risk. Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Molecular profiling in Italian patients with advanced non-small-cell lung cancer: An observational prospective study.

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Gobbini, Elisa; Galetta, Domenico; Tiseo, Marcello; Graziano, Paolo; Rossi, Antonio; Bria, Emilio; Di Maio, Massimo; Rossi, Giulio; Gregorc, Vanesa; Riccardi, Ferdinando; Scotti, Vieri; Ceribelli, Anna; Buffoni, Lucio; Delmonte, Angelo; Franchina, Tindara; Migliorino, Maria Rita; Cortinovis, Diego; Pisconti, Salvatore; Bordi, Paola; Catino, Annamaria; Maiello, Evaristo; Arizio, Francesca; Novello, Silvia

2017-09-01

Molecular profiling of advanced non-small-cell lung cancer (NSCLC) is recommended according to European and Italian guidelines. However, molecular routine assessment remains still heterogeneous. This observational study aimed to take a picture of the real clinical practice in molecular testing and therapeutic choices in advanced Italian NSCLCs. This study prospectively enrolled newly diagnosed advanced or recurrent NSCLCs referred to 38 Italian centres, from November 2014 to November 2015. Information regarding molecular profiling and treatment choices were collected. Description of patients' outcome included overall survival (OS), progression-free survival in first (PFS1) and second-line (PFS2). Among 1787 patients enrolled, 1388 (78%) performed at least one molecular analysis during the history of disease: 76% were tested for EGFR, 53% for ALK, 27% for KRAS, 16% for ROS1, 14% for BRAF, 5% for HER2, 4% for MET and 1% for FGFR. The remaining 399 patients (22.3%) did not receive any molecular test. Among patients receiving at least one molecular analysis, 583 (42%) presented a molecular alteration. Considering EGFR mutated and/or ALK rearranged patients (402), for which target agents were routinely reimbursed at time of study in Italy, the 86% received a personalized treatment as first and/or second line: the 90% (286) of EGFR mutants received an EGFR tyrosine kinase inhibitor, mostly gefitinib (41.1%) or afatinib (36.4%) while 74% (62) of ALK translocated patients received an ALK inhibitor, mostly crizotinib (64%). Median OS was 9.34 months (95% CI 8.62-10.0), median PFS1 was 4.61 months (95%CI 4.31-4.84) and median PFS2 was 2.76 months (95%CI 2.57-3.19). In the Italian clinical practice, routine molecular assessment was largely applied in NSCLC patients, according to national guidelines, but a low level of ALK test was reached. Most of EGFR mutants an ALK rearranged patients received a personalized treatment as first and/or second line. Copyright © 2017 Elsevier

Blood pressure and kidney cancer risk: meta-analysis of prospective studies.

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Hidayat, Khemayanto; Du, Xuan; Zou, Sheng-Yi; Shi, Bi-Min

2017-07-01

Globally, kidney cancer is the twelfth most common cancer, accounting for 337 860 cases recorded in 2012. By 2020, this number has been estimated to reach 412 929 or increase by 22%. Over the past few decades, a number of prospective studies have investigated the association between blood pressure (BP) and risk of kidney cancer, using either recorded BP levels or reported hypertension as the principal exposure variable. However, the relation of BP to kidney cancer remains incompletely understood, and the data on sex-specific differences in risk estimates have been inconsistent. PubMed and Web of Science databases were searched for studies assessing the association between BP and kidney cancer through July 2016. The summary relative risk with 95% confidence intervals was calculated using a random-effects model. A total of 18 prospective studies with 8097 kidney cancer cases from 3 628 479 participants were included in our meta-analysis. History of hypertension was associated with 67% increased risk of kidney cancer. Significant heterogeneity and evidence of publication bias were observed. However, the results remain unchanged after introducing the trim and fill method to correct the publication bias. Accordingly, each 10-mmHg increase in SBP and DBP was associated with 10 and 22% increased risk of kidney cancer. Collectively, the present meta-analysis of 18 prospective studies provides further support for a positive association between hypertension and kidney cancer risk.

Distant memories: a prospective study of vantage point of trauma memories.

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Kenny, Lucy M; Bryant, Richard A; Silove, Derrick; Creamer, Mark; O'Donnell, Meaghan; McFarlane, Alexander C

2009-09-01

Adopting an observer perspective to recall trauma memories may function as a form of avoidance that maintains posttraumatic stress disorder (PTSD). We conducted a prospective study to analyze the relationship between memory vantage point and PTSD symptoms. Participants (N= 947) identified the vantage point of their trauma memory and reported PTSD symptoms within 4 weeks of the trauma; 730 participants repeated this process 12 months later. Initially recalling the trauma from an observer vantage point was related to more severe PTSD symptoms at that time and 12 months later. Shifting from a field to an observer perspective a year after trauma was associated with greater PTSD severity at 12 months. These results suggest that remembering trauma from an observer vantage point is related to both immediate and ongoing PTSD symptoms.

Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

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Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

2012-04-01

The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Intrathecal Administration of Morphine Decreases Persistent Pain after Cesarean Section: A Prospective Observational Study.

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Kumi Moriyama

Full Text Available Chronic pain after cesarean section (CS is a serious concern, as it can result in functional disability. We evaluated the prevalence of chronic pain after CS prospectively at a single institution in Japan. We also analyzed perioperative risk factors associated with chronic pain using logistic regression analyses with a backward-stepwise procedure.Patients who underwent elective or emergency CS between May 2012 and May 2014 were recruited. Maternal demographics as well as details of surgery and anesthesia were recorded. An anesthesiologist visited the patients on postoperative day (POD 1 and 2, and assessed their pain with the Prince Henry Pain Scale. To evaluate the prevalence of chronic pain, we contacted patients by sending a questionnaire 3 months post-CS.Among 225 patients who questionnaires, 69 (30.7% of patients complained of persistent pain, although no patient required pain medication. Multivariate analyses identified lighter weight (p = 0.011 and non-intrathecal administration of morphine (p = 0.023 as determinant factors associated with persistent pain at 3 months. The adjusted odds ratio of intrathecal administration of morphine to reduce persistent pain was 0.424, suggesting that intrathecal administration of morphine could decrease chronic pain by 50%. In addition, 51.6% of patients had abnormal wound sensation, suggesting the development of neuropathic pain. Also, 6% of patients with abnormal wound sensation required medication, yet no patients with persistent pain required medication.Although no effect on acute pain was observed, intrathecal administration of morphine significantly decreased chronic pain after CS.

Polyp prevalence at colonoscopy among Nigerians: A prospective ...

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Polyp prevalence at colonoscopy among Nigerians: A prospective observational study. ... Materials and Methods: This is a prospective study of all colonoscopy examinations performed at the endoscopy unit of our hospital from January, 2007 to December 2013. The patient demographics, indications for colonoscopy, ...

A prospective study of ocular toxicity in patients receiving ethambutol as a part of directly observed treatment strategy therapy

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Pragati Garg

2015-01-01

Full Text Available Background and Objectives: India is among the largest countries to implement the revised National Tuberculosis Control Program (RNTCP. This program provides intermittent regimens to the patients, where the doses of isoniazid and ethambutol are more as compared to the daily regimen, which is a cause of concern, particularly with regard to the ocular toxicity of ethambutol. The present study was undertaken to explore the ocular toxicity in the patients registered under the program. Materials and Methods: This was a prospective single center cohort study of 64 patients of categories I and II, coming to the RNTCP-Directly Observed Treatment Strategy (DOTS center at a tertiary care referral hospital. The detailed history, best corrected visual acuity, fundus examination, and color vision test were carried out in all patients at the start of treatment and then at the first and second month of treatment. Results: Loss in visual acuity from the baseline was noted at the second month follow up in 12 (9.4% eyes (P = 0.001, visual field defects were seen in eight (6.3% eyes (P = 0.0412, and optic disc abnormalities were observed in six (4.7% (P = 0.013 eyes. Color vision abnormalities were noted in 16 (12.6% eyes (P = 0.003, four eyes showed impairment in red-green color perception, and the others showed impairment in blue-yellow color perception as well. Patients with ocular symptoms were advised to stop ethambutol and they showed improvement in visual acuity after follow up of one to two months. The overall outcome of treatment was not affected by discontinuation of ethambutol in these patients. Conclusion: Ethambutol when taken according to program could cause ocular toxicity. The early recognition of ocular symptoms is important to prevent unnecessary delay in diagnosis and probable irreversible visual loss.

Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

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Sven Karstens

Full Text Available BACKGROUND AND OBJECTIVE: From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. METHODS: We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. RESULTS: A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4, with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2, p<0.001. CONCLUSIONS: With minimal information available from observational studies on the predictors of development of back problems for physiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the

Evolution of target organ damage and haemodynamic parameters over 4 years in patients with increased insulin resistance: the LOD-DIABETES prospective observational study.

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Gómez-Marcos, Manuel Ángel; Recio-Rodríguez, José Ignacio; Patino-Alonso, María Carmen; Agudo-Conde, Cristina; Rodríguez-Sanchez, Emiliano; Maderuelo-Fernandez, Jose Angel; Gómez-Sánchez, Leticia; Gomez-Sanchez, Marta; García-Ortiz, Luís

2016-06-01

We prospectively examined the impact of type 2 diabetes compared with metabolic syndrome (MetS) on the development of vascular disease over 4 years as determined by anatomic and functional markers of vascular disease. By comparing the vascular outcomes of the 2 disorders, we seek to determine the independent effect of elevated glucose levels on vascular disease. 2 primary care centres in Salamanca, Spain. We performed a prospective observational study involving 112 patients (68 with type 2 diabetes and 44 with MetS) who were followed for 4 years. Measurements included blood pressure, blood glucose, lipids, smoking, body mass index, waist circumference, Homeostasis Model Assessment Insulin Resistance (HOMA-IR), hs-c-reactive protein and fibrinogen levels. We also evaluated vascular, carotid intima media thickness (IMT), pulse wave velocity (PWV) and ankle/brachial index, heart and renal target organ damage (TOD). The haemodynamic parameters were central (CAIx) and peripheral (PAIx) augmentation indices. In year 4, participants with type 2 diabetes had increased IMT thickness. These patients had more plaques and an IMT>0.90 mm. In participants with MetS, we only found an increase in the number of plaques. We found no changes in PWV, CAIx and PAIx. The patients with diabetes had a greater frequency of vascular TOD. There were no differences neither in renal nor cardiac percentage of TOD in the patients with MetS or diabetes mellitus type 2. This prospective study showed that the evolution of vascular TOD is different in participants with type 2 diabetes compared with those with MetS. While IMT and PWV increased in type 2 diabetes, these were not modified in MetS. The renal and cardiac TOD evolution, as well as the PAIx and CAIx, did not change in either group. NCT01065155; Results. 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/

Excess Mortality Associated With Colistin-Tigecycline Compared With Colistin-Carbapenem Combination Therapy for Extensively Drug-Resistant Acinetobacter baumannii Bacteremia: A Multicenter Prospective Observational Study.

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Cheng, Aristine; Chuang, Yu-Chung; Sun, Hsin-Yun; Sheng, Wang-Huei; Yang, Chia-Jui; Liao, Chun-Hsing; Hsueh, Po-Ren; Yang, Jia-Ling; Shen, Ni-Jiin; Wang, Jann-Tay; Hung, Chien-Ching; Chen, Yee-Chun; Chang, Shan-Chwen

2015-06-01

Since few therapeutic options exist for extensively drug resistant Acinetobacter baumannii, an emerging threat in ICUs worldwide, and comparative prospective studies of colistin-based combination therapies are lacking, our objective was to compare the outcomes of patients with extensively drug-resistant A. baumannii bacteremia, treated with colistin-carbapenem and colistin-tigecycline combinations. Prospective, observational, multicenter study. Adults with extensively drug-resistant A. baumannii bacteremia were prospectively followed from 2010 to 2013 at three hospitals in Taiwan. Extensively drug-resistant A. baumannii was defined as A. baumannii (genospecies 2) nonsusceptible to all drug classes except for colistin and tigecycline, and standard combination therapy as use of parenteral colistin-carbapenem or colistin-tigecycline for at least 48 hours after onset of bacteremia. Primary outcome measure was 14-day mortality. Of the 176 episodes of extensively drug-resistant A. baumannii bacteremia evaluated, 55 patients with a median (interquartile range) age of 62 years (44-79 yr) and Sequential Organ Failure Assessment score of 9 (5-13) points received standard combination therapy: colistin-tigecycline in 29 patients and colistin-carbapenem in 26. Crude 14-day and in-hospital mortality rates for patients receiving colistin-tigecycline versus patients receiving colistin-carbapenem were 35% versus 15% (p=0.105) and 69% versus 50% (p=0.152), respectively. Breakthrough extensively drug-resistant A. baumannii bacteremia under steady state concentrations of combination therapy for colistin-tigecycline group was 18% and for colistin-carbapenem group was 0% (p=0.059). Eleven patients (20.0%) developed nephrotoxicity. After adjusting for age, sex, comorbidity, initial disease severity, loading colistin dose, polymicrobial infection, and primary infection site, excess 14-day mortality was associated with the use of colistin-tigecycline in the subgroup with tigecycline

Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI

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Chuchalin Alexander

2013-01-01

Full Text Available Abstract Background Acute exacerbations of chronic bronchitis (AECB, including chronic obstructive pulmonary disease (AECOPD, represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox®, although moxifloxacin is widely approved in this region based on evidence from international clinical studies. Methods AVANTI (AVelox® in Acute Exacerbations of chroNic bronchiTIs was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. Results In the efficacy population (N = 2536, chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I was 6.4 ± 1.9 days. Symptom improvement was reported after a mean of 3.4 ± 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672, 57 (2.3% patients had treatment-emergent adverse events (TEAEs and 4 (0.15% had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. Conclusions A significant number of patients in this

Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

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Shah K

2017-05-01

Full Text Available Kshitij Shah,1 Omvijay B Chaudhari,2 Palash Gupta,3 R Hom Chaudhuri,4 Ranjan Kamilya,5 Shreedhar S Kulkarni,6 S Subbaiah,7 Zubair H Sorathia,8 Gauri Billa9 1MS Orthopedic, Prime Hospital, Andheri (West, 2Vatsalya Nursing Home, Kalyan (West, Mumbai, 3Dr. Palash Gupta Clinic, Rohini, New Delhi, 4Homchaudhuri’s Clinic, 5Apollo Gleneagles Hospital, Kolkata, West Bengal, 6Amrit Clinic, Matunga, Mumbai, 7Subbaiah’s Clinic, West Mambalam, Chennai, 8Medicare Hospital, Marol, Andheri East, 9Medical Services, Abbott Healthcare Pvt. Ltd, Mulund (West, Mumbai, Maharashtra, India Objective: To assess the effectiveness, overall tolerability, and gastrointestinal (GI tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg] in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods: In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at baseline, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results: A total of 351 patients (mean age 44.2 years; male 43%; female 57% were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001. The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 % patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients

Sustained favorable long-term outcome in the treatment of schizophrenia: a 3-year prospective observational study

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Ascher-Svanum Haya

2011-08-01

Full Text Available Abstract Background This study of chronically ill patients with schizophrenia aimed to identify patients who achieve sustained favorable long-term outcome - when the outcome incorporates severity of symptoms, level of functioning, and use of acute care services - and to identify the best baseline predictors of achieving this sustained favorable long-term outcome. Methods Using data from the United States Schizophrenia Care and Assessment Program (US-SCAP (N = 2327, a large 3-year prospective, multisite, observational study of individuals treated for schizophrenia in the US, a hierarchical cluster analysis was performed to group patients based upon baseline symptom severity. Symptom severity was assessed using the Positive and Negative Syndrome Scale (PANSS scores, level of functioning, and use of acute care services. Level of functioning reflected patient-reported productivity and clinician-rated occupational role functioning. Use of acute care services reflected self-reported psychiatric hospitalization and emergency service use. Change of health state was determined over the 3-year period. A patient was classified as having a sustained favorable long-term outcome if their health state values had the closest distance to the defined "best baseline cluster" at each point over the length of the study. Stepwise logistic regression was used to determine baseline predictors of sustained favorable long-term outcome. Results At baseline, 5 distinct health state clusters were identified, ranging from "best" to "worst." Of 1635 patients with sufficient data, only 157 (10% experienced sustained favorable long-term outcome during the 2-years postbaseline. The baseline predictors associated with sustained favorable long-term outcome included better quality of life, more daily activities, patient-reported clearer thinking from medication, better global functioning, being employed, not being a victim of a crime, not having received individual therapy, and not

Occipital nerve stimulation improves the quality of life in medically-intractable chronic cluster headache: Results of an observational prospective study.

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Fontaine, Denys; Blond, Serge; Lucas, Christian; Regis, Jean; Donnet, Anne; Derrey, Stéphane; Guegan-Massardier, Evelyne; Jarraya, Bechir; Dang-Vu, Bich; Bourdain, Frederic; Valade, Dominique; Roos, Caroline; Creach, Christèle; Chabardes, Stéphan; Giraud, Pierric; Voirin, Jimmy; Bloch, Jocelyne; Rocca, Alda; Colnat-Coulbois, Sophie; Caire, Francois; Roger, Coralie; Romettino, Sylvie; Lanteri-Minet, Michel

2017-10-01

Background Occipital nerve stimulation (ONS) has been proposed to treat chronic medically-intractable cluster headache (iCCH) in small series of cases without evaluation of its functional and emotional impacts. Methods We report the multidimensional outcome of a large observational study of iCCH patients, treated by ONS within a nationwide multidisciplinary network ( https://clinicaltrials.gov NCT01842763), with a one-year follow-up. Prospective evaluation was performed before surgery, then three and 12 months after. Results One year after ONS, the attack frequency per week was decreased >30% in 64% and >50% in 59% of the 44 patients. Mean (Standard Deviation) weekly attack frequency decreased from 21.5 (16.3) to 10.7 (13.8) ( p = 0.0002). About 70% of the patients responded to ONS, 47.8% being excellent responders. Prophylactic treatments could be decreased in 40% of patients. Functional (HIT-6 and MIDAS scales) and emotional (HAD scale) impacts were significantly improved, as well as the health-related quality of life (EQ-5D). The mean (SD) EQ-5D visual analogic scale score increased from 35.2 (23.6) to 51.9 (25.7) ( p = 0.0037). Surgical minor complications were observed in 33% of the patients. Conclusion ONS significantly reduced the attack frequency per week, as well as the functional and emotional headache impacts in iCCH patients, and dramatically improved the health-related quality of life of responders.

Evaluation of the Efficacy and Tolerability of Oral Ciprofloxacin used in the Comprehensive Treatment of External Bacterial Otitis: An Observational Prospective Study.

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Gurov, Alexander Vladimirovich; Kriukov, Andrey Ivanovich; Kunelskaya, Vera Yakovlevna; Isotova, Galina Nikolaevna; Shadrin, Georgiy Borisovich; Luchsheva, Yuliya Vladislavovna; Yakimov, Vladislav Olegovich; Garg, Amit; Akku, Shyam Prasad; Gupta, Namita

2017-10-01

Introduction  Otitis Externa is common ear infection with a prevalence of 1%. Objective  The objective of this study is to evaluate the clinical and microbiological efficacy and safety profile with oral ciprofloxacin in the external bacterial otitis (EBO) management. Methods  This is a prospective observational study conducted with EBO outpatients referred to the otorhinolaryngology center in Moscow between March and August 2013. Our study included patients from two cohorts, acute external bacterial otitis (AEBO) - Group 1 - and exacerbation of chronic otitis externa (CEBO) - Group 2. We administered Ciprofloxacin 500 mg twice daily with standard topical EBO treatment for up to 10 days. Patients underwent evaluation on study visit days 1, 3, 5, and 10 for the severity. Bacteriological examination of ear canal cultures took place on Day 1 and Day 10. Results  We collected data from 60 EBO outpatients (AEBO: N  = 30 and CEBO: N  = 30). Swimming was the major risk factor associated with the disease in addition to the most common pathogenic organisms - Staphylococcus aureus and Pseudomonas aeruginosa . was We attained complete resolution of the inflammatory process in 28 (93%) and 27 (90%) patients in the AEBO and CEBO group, respectively. We confirmed this by microbiological test with almost complete eradication of the causative organisms. Overall, we observed good positive dynamics of ear canal with no major side effects. Conclusion  We found that Ciprofloxacin 500 mg, when administered orally twice daily for 7 to 10 days in otitis externa patients is clinically and microbiologically effective and comparatively safer than other antimicrobials.

[Prospective study in 2 hospitals].

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Jiménez-Buñuales, M T; Martínez-Sáenz, M S; González-Diego, P; Vallejo-García, M; Gallardo-Anciano, J; Cestafe-Martínez, A

2016-06-01

The purpose of this study is to know the incidence rate of medication reconciliation at admission and discharge in patients of La Rioja and to improve the patient safety on medication reconciliation. An observational prospective study, part of the Joint Action PaSQ, Work Package 5, European Union Network for Patient Safety and Quality of Care. The study has taken into account the definitions of the Institute for Safe Medication Practices. Any unintended discrepancy in medication between chronic treatment and the treatment prescribed in the hospital was considered as a reconciliation error. A total of 750 patients were included, 9 (1.2%) of whom showed at least one discrepancy. The patients had a total of 3,156 mediations registered: 2,313 prescriptions (73.4%) showed no differences, while 821 prescriptions (26%) were intended discrepancies and 21 prescriptions (0.6%) unintended discrepancies were considered by the physician as reconciliation errors. A percentage of 1.2 of the patients, which represents 0.6% of the medicines (one in 166 medications registered) had reconciliation errors during their hospital stay. A proceeding has been implemented by means of the physician doing the medication reconciliation and reviewing it with the help of a medication reconciliation form. The medication reconciliation is a priority strategic objective to improve the safety of patients. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

Habitual chocolate intake and type 2 diabetes mellitus in the Maine-Syracuse Longitudinal Study: (1975-2010): Prospective observations.

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Crichton, Georgina E; Elias, Merrill F; Dearborn, Peter; Robbins, Michael

2017-01-01

Compounds in cocoa and chocolate have established cardiovascular benefits, including beneficial effects on insulin resistance, a risk factor for type 2 diabetes mellitus. The aims of this study was to investigate relations between habitual chocolate intakes and diabetes mellitus. Cross-sectional and prospective analyses were undertaken on 953 community-dwelling participants (mean age 62 years, 59% women) from the Maine-Syracuse Longitudinal Study (MSLS). Habitual chocolate intakes, measured using a food frequency questionnaire, were related to prevalence of diabetes mellitus (cross-sectionally) and with risk of diabetes measured approximately five years later (prospectively). We also examined the relation between diabetes (the predictor) and chocolate consumption (the outcome) up to 30 years later. Chocolate intake was inversely associated with type 2 diabetes. Compared to participants who consumed chocolate more than once per week, those who never or rarely ate chocolate exhibited a significantly higher odds of having type 2 diabetes 5 years later (OR: 1.91, 95% CI: 1.03, 3.55, p = 0.04), after adjustment for cardiovascular, lifestyle and dietary factors including other polyphenol-rich beverages. However, individuals diagnosed with diabetes prior to the nutritional assessment consumed lower amounts of chocolate at the time of the dietary assessment. Our findings suggest that relations between chocolate and type 2 diabetes may be bi-directional. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of aversive stimuli on prospective memory. An event-related fMRI study.

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Massimiliano Rea

Full Text Available Prospective memory (PM describes the ability to execute a previously planned action at the appropriate point in time. Although behavioral studies clearly showed that prospective memory performance is affected by the emotional significance attributed to the intended action, no study so far investigated the brain mechanisms subserving the modulatory effect of emotional salience on PM performance. The general aim of the present study was to explore brain regions involved in prospective memory processes when PM cues are associated with emotional stimuli. In particular, based on the hypothesised critical role of the prefrontal cortex in prospective memory in the presence of emotionally salient stimuli, we expected a stronger involvement of aPFC when the retrieval and execution of the intended action is cued by an aversive stimulus. To this aim BOLD responses of PM trials cued by aversive facial expressions were compared to PM trials cued by neutral facial expressions. Whole brain analysis showed that PM task cued by aversive stimuli is differentially associated with activity in the right lateral prefrontal area (BA 10 and in the left caudate nucleus. Moreover a temporal shift between the response of the caudate nucleus that preceded that of aPFC was observed. These findings suggest that the caudate nucleus might provide an early analysis of the affective properties of the stimuli, whereas the anterior lateral prefrontal cortex (BA10 would be involved in a slower and more deliberative analysis to guide goal-directed behaviour.

Characteristics of Headache After an Intracranial Endovascular Procedure: A Prospective Observational Study.

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Zhang, Linjing; Wu, Xiancong; Di, Hai; Feng, Tao; Wang, Yunxia; Wang, Jun; Cao, Xiangyu; Li, Baomin; Liu, Ruozhuo; Yu, Shengyuan

2017-03-01

Two editions of the International Classification of Headache Disorders (ICHD) diagnostic criteria for "Headache attributed to an intracranial endovascular procedure" have been published, in 2004 and 2013. 1,2 Despite studies that have suggested that the former is not very practical, the ICHD-3 beta did not contain major changes. Moreover, so far no consensus exists regarding characteristics of headache after intracranial endovascular procedure. Thus, there is a need for sound suggestions to improve the ICHD-3 beta diagnostic criteria. Using a prospective design, we identified consecutive patients with unruptured intracranial aneurysms (UIAs) with neuroendovascular treatment from January 2014 to December 2014. In total, 73 patients were enrolled, and 58 patients ultimately completed the 6-month follow-up. After the procedure, five of the 29 patients (17.2%) with pre-existing headache experienced marked worsening after the procedure, while seven of the 29 patients without prior headache developed new-onset headache post-procedurally. The headaches started within 24 hours, with a mean duration of 24-72 hours. The headaches were moderate to severe. The eligibility of these events to be considered headaches caused by neuroendovascular procedures according to the ICHD-3 beta diagnostic criteria for designation was far from ideal. Most cases of markedly worsening headaches and new-onset headaches started within 24 hours and persisted longer than that specified in the ICHD-3 beta diagnostic criteria. Moreover, considering that some items are not very practical, the ICHD-3 beta diagnostic criteria should be revised in the light of recent literature reports. © 2016 American Headache Society.

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

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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.

Statistical Machines for Trauma Hospital Outcomes Research: Application to the PRospective, Observational, Multi-Center Major Trauma Transfusion (PROMMTT Study.

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Sara E Moore

Full Text Available Improving the treatment of trauma, a leading cause of death worldwide, is of great clinical and public health interest. This analysis introduces flexible statistical methods for estimating center-level effects on individual outcomes in the context of highly variable patient populations, such as those of the PRospective, Observational, Multi-center Major Trauma Transfusion study. Ten US level I trauma centers enrolled a total of 1,245 trauma patients who survived at least 30 minutes after admission and received at least one unit of red blood cells. Outcomes included death, multiple organ failure, substantial bleeding, and transfusion of blood products. The centers involved were classified as either large or small-volume based on the number of massive transfusion patients enrolled during the study period. We focused on estimation of parameters inspired by causal inference, specifically estimated impacts on patient outcomes related to the volume of the trauma hospital that treated them. We defined this association as the change in mean outcomes of interest that would be observed if, contrary to fact, subjects from large-volume sites were treated at small-volume sites (the effect of treatment among the treated. We estimated this parameter using three different methods, some of which use data-adaptive machine learning tools to derive the outcome models, minimizing residual confounding by reducing model misspecification. Differences between unadjusted and adjusted estimators sometimes differed dramatically, demonstrating the need to account for differences in patient characteristics in clinic comparisons. In addition, the estimators based on robust adjustment methods showed potential impacts of hospital volume. For instance, we estimated a survival benefit for patients who were treated at large-volume sites, which was not apparent in simpler, unadjusted comparisons. By removing arbitrary modeling decisions from the estimation process and concentrating

Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study.

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Wolf, Marc E; Grittner, Ulrike; Böttcher, Tobias; Norrving, Bo; Rolfs, Arndt; Hennerici, Michael G

2015-01-01

The prospective, multinational European 'Stroke in Young Fabry Patients' (sifap1) study collected 4,467 patients with acute ischemic cerebrovascular events aged 18-55 years. Initially, aetiologic subtyping was performed using the TOAST classification; however, recently the phenotypic ASCO classification was presented and might be more useful to identify stroke aetiologies in young patients with a wide set of different causes. ASCO is a classification system divided in four etiologic categories (Atherosclerosis, Small vessel disease (SVD), Cardiac embolism, Other cause) with different grades of severity (1-3) and aims to characterise patients in a more comprehensive way. We determined the ASCO score for each patient, according to prospectively collected data using the study protocol. The distribution of aetiologies was analysed with regard to concomitant causes, cryptogenic stroke and different age groups. A potentially causal aetiology (grade 1) was detected in 29.3% of 4,467 patients. Merging grades 1 and 2, a suspected aetiology was found in 54.1%. In 8.6% of patients concomitant aetiologies were identified. Most common causes were cervical arterial dissection and persistent foramen ovale, but there was also a high prevalence of large artery atherosclerosis and SVD especially in older patients of this collective. About 50% of patients had more than one finding with a lower grade of evidence (grade 3). In 14% final classification of strictly cryptogenic stroke was made. This is the largest study to date, using the ASCO characterisation of ischemic stroke aetiologies. ASCO classification provides first evidence that many young patients presenting with acute stroke have concomitant stroke aetiologies associated with a substantial atherosclerosis risk profile. ASCO could be integrated in clinical routine and registry data banks, as well as large clinical trials to improve stroke documentation. © 2015 S. Karger AG, Basel.

Do daily ward interviews improve measurement of hospital quality and safety indicators? A prospective observational study.

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Sarkies, Mitchell N; Bowles, Kelly-Ann; Skinner, Elizabeth H; Haas, Romi; Mitchell, Deb; O'Brien, Lisa; May, Kerry; Ghaly, Marcelle; Ho, Melissa; Haines, Terry P

2016-10-01

The aim of this study was to determine if the addition of daily ward interview data improves the capture of hospital quality and safety indicators compared with incident reporting systems alone. An additional aim was to determine the potential characteristics influencing under-reporting of hospital quality and safety indicators in incident reporting systems. A prospective, observational study was performed at two tertiary metropolitan public hospitals. Research assistants from allied health backgrounds met daily with the nurse in charge of the ward and discussed the occurrence of any falls, pressure injuries and rapid response medical team calls. Data were collected from four general medical wards, four surgical wards, an orthopaedic, neurosciences, plastics, respiratory, renal, sub-acute and acute medical assessment unit. An estimated total of 303 falls, 221 pressure injuries and 884 rapid response medical team calls occurred between 15 wards across two hospitals, over a period of 6 months. Hospital incident reporting systems underestimated falls by 30.0%, pressure injuries by 59.3% and rapid response medical team calls by 17.0%. The use of ward interview data collection in addition to hospital incident reporting systems improved data capture of falls by 23.8% (n = 72), pressure injuries by 21.7% (n = 48) and rapid response medical team calls by 12.7% (n = 112). Falls events were significantly less likely to be reported if they occurred on a Monday (P = 0.04) and pressure injuries significantly more likely to be reported if they occurred on a Wednesday (P = 0.01). Hospital quality and safety indicators (falls, pressure injuries and rapid response medical team calls) were under-reported in incident reporting systems, with variability in under-reporting between wards and the day of event occurrence. The use of ward interview data collection in addition to hospital incident reporting systems improved reporting of hospital quality and safety

Who Can Have Parenteral Antibiotics at Home?: A Prospective Observational Study in Children with Moderate/Severe Cellulitis.

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Ibrahim, Laila F; Hopper, Sandy M; Babl, Franz E; Bryant, Penelope A

2016-03-01

The benefits of treating children at home or in an ambulatory setting have been well documented. We aimed to describe the characteristics and evaluate the outcomes of children with moderate/severe cellulitis treated at home with intravenous (IV) ceftriaxone via direct referral from the Emergency Department to a hospital-in-the-home (HITH) program. Patients aged 3 months to 18 years with moderate/severe cellulitis referred from a tertiary pediatric Emergency Department to HITH from September 2012 to January 2014 were prospectively identified. Data collection included demographics, clinical features, microbiological characteristics and outcomes. To ensure home treatment did not result in inferior outcomes, these patients were retrospectively compared with patients who were hospitalized for IV flucloxacillin, the standard-of-care over the same period. The primary outcome was home treatment failure necessitating hospital admission. Secondary outcomes included antibiotic changes, complications, length of stay and cost. Forty-one (28%) patients were treated on HITH and 103 (72%) were hospitalized. Compared with hospitalized patients, HITH patients were older (P antibiotic changes was similar in both groups (5% vs. 7%, P = 0.67), as was IV antibiotic duration (2.3 vs. 2.5 days, P = 0.23). Older children with moderate/severe limb cellulitis without systemic symptoms can be treated at home. To ascertain if this practice can be applied more widely, a comparative prospective, ideally randomized, study is needed.

Heart rate and leukocytes after air and ground transportation in artificially ventilated neonates: a prospective observational study.

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Grosek, Stefan; Mlakar, Gorazd; Vidmar, Ivan; Ihan, Alojz; Primozic, Janez

2009-01-01

To evaluate the effect of interhospital air and ground transportation of artificially ventilated neonates on heart rate and peripheral blood leukocyte counts. Prospective, observational study. Level III multidisciplinary Neonatal and Pediatric Intensive Care Unit. Fifty-eight near-term artificially ventilated transported neonates between May 2006 and April 2007. Day-helicopter, day- and night-ground transportation. Heart rate at retrieval, on admission to the ICU and 1 h later, and peripheral blood leukocyte counts on admission and 1 d later were compared. Fifteen neonates were transported by helicopter during the daytime (D-HEL), 20 by daytime ground and 23 by nighttime ground transportation (D-GROUND, N-GROUND). No differences in delivery mode, birth weight, gestational age, gender, primary diagnoses for transportation, response time and duration of transportation were found between the groups. Similarly, no differences in pH, pCO(2), blood pressure and skin temperature at retrieval and on admission to the ICU were found between the three groups. The mean heart rate at retrieval did not differ significantly, while on arrival in the ICU and 1 h later the D-GROUND group of patients showed a significantly higher mean heart rate compared to the D-HEL and N-GROUND groups. Moreover, leukocyte counts on arrival in the ICU showed significantly higher leukocyte counts in the D-GROUND group of patients compared to the D-HEL group of patients. These results demonstrate that there is an association between daytime ground transportation and higher heart rate and peripheral blood leukocytes.

Women awaken faster than men after electroencephalogram-monitored propofol sedation for colonoscopy: A prospective observational study.

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Riphaus, Andrea; Slottje, Mark; Bulla, Jan; Keil, Carolin; Mentzel, Christian; Limbach, Vera; Schultz, Barbara; Unzicker, Christian

2017-10-01

Sedation for colonoscopy using intravenous propofol has become standard in many Western countries. Gender-specific differences have been shown for general anaesthesia in dentistry, but no such data existed for gastrointestinal endoscopy. A prospective observational study. An academic teaching hospital of Hannover Medical School. A total of 219 patients (108 women and 111 men) scheduled for colonoscopy. Propofol sedation using electroencephalogram monitoring during a constant level of sedation depth (D0 to D2) performed by trained nurses or physicians after a body-weight-adjusted loading dose. The primary end-point was the presence of gender-specific differences in awakening time (time from end of sedation to eye-opening and complete orientation); secondary outcome parameters analysed were total dose of propofol, sedation-associated complications (bradycardia, hypotension, hypoxaemia and apnoea), patient cooperation and patient satisfaction. Multivariate analysis was performed to correct confounding factors such as age and BMI. Women awakened significantly faster than men, with a time to eye-opening of 7.3 ± 3.7 versus 8.4 ± 3.4 min (P = 0.005) and time until complete orientation of 9.1 ± 3.9 versus 10.4 ± 13.7 min (P = 0.008). The propofol dosage was not significantly different, with some trend towards more propofol per kg body weight in women (3.98 ± 1.81 mg versus 3.72 ± 1.75 mg, P = 0.232). The effect of gender aspects should be considered when propofol is used as sedation for gastrointestinal endoscopy. That includes adequate dosing for women as well as caution regarding potential overdosing of male patients. ClinicalTrials.gov (Identifier: NCT02687568).

Physical, psychological and occupational consequences of job burnout: A systematic review of prospective studies

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Melanda, Francine Nesello; Mesas, Arthur Eumann; González, Alberto Durán; Gabani, Flávia Lopes

2017-01-01

Burnout is a syndrome that results from chronic stress at work, with several consequences to workers’ well-being and health. This systematic review aimed to summarize the evidence of the physical, psychological and occupational consequences of job burnout in prospective studies. The PubMed, Science Direct, PsycInfo, SciELO, LILACS and Web of Science databases were searched without language or date restrictions. The Transparent Reporting of Systematic Reviews and Meta-Analyses guidelines were followed. Prospective studies that analyzed burnout as the exposure condition were included. Among the 993 articles initially identified, 61 fulfilled the inclusion criteria, and 36 were analyzed because they met three criteria that must be followed in prospective studies. Burnout was a significant predictor of the following physical consequences: hypercholesterolemia, type 2 diabetes, coronary heart disease, hospitalization due to cardiovascular disorder, musculoskeletal pain, changes in pain experiences, prolonged fatigue, headaches, gastrointestinal issues, respiratory problems, severe injuries and mortality below the age of 45 years. The psychological effects were insomnia, depressive symptoms, use of psychotropic and antidepressant medications, hospitalization for mental disorders and psychological ill-health symptoms. Job dissatisfaction, absenteeism, new disability pension, job demands, job resources and presenteeism were identified as professional outcomes. Conflicting findings were observed. In conclusion, several prospective and high-quality studies showed physical, psychological and occupational consequences of job burnout. The individual and social impacts of burnout highlight the need for preventive interventions and early identification of this health condition in the work environment. PMID:28977041

Relationship Between Prehypertension/Hypertension and Periodontal Disease: A Prospective Cohort Study.

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Kawabata, Yuya; Ekuni, Daisuke; Miyai, Hisataka; Kataoka, Kota; Yamane, Mayu; Mizutani, Shinsuke; Irie, Koichiro; Azuma, Tetsuji; Tomofuji, Takaaki; Iwasaki, Yoshiaki; Morita, Manabu

2016-03-01

Most cross-sectional studies have found a significant positive relationship between periodontal disease and prehypertension/hypertension. However, these studies had limitations and there are few prospective cohort studies in young adults. The purpose of this prospective cohort study was to investigate whether periodontal disease was related to prehypertension/hypertension in Japanese university students. Students (n = 2,588), who underwent health examinations before entering university and before graduation, were included in the analysis. The association between periodontal disease such as the percentage of bleeding on probing (BOP) and community periodontal index (CPI) scores, and change in blood pressure status was determined. At the reexamination, the numbers of participants with prehypertension (systolic blood pressure 120-139mm Hg or diastolic blood pressure 80-89mm Hg) and hypertension (≥140/90mm Hg) were 882 (34.1%) and 109 (4.2%), respectively. In a logistic regression model, the risk of hypertension was significantly associated with male (odds ratio (OR): 6.31; 95% confidence interval (CI): 2.63-15.13; P periodontal disease defined as the presence of both probing pocket depth (PPD) ≥ 4mm and BOP ≥ 30% at baseline (OR: 2.74; 95% CI: 1.19-6.29; P = 0.02) in participants with prehypertension at baseline. On the other hand, the risk of prehypertension was not associated with presence of periodontal disease (OR: 0.93; 95% CI: 0.51-1.70; P = 0.82). In the short-term prospective cohort study, a significant association between presence of periodontal disease and hypertension was observed in Japanese university students. © American Journal of Hypertension, Ltd 2015. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Development and Validation of a Risk Scale for Emergence Agitation After General Anesthesia in Children: A Prospective Observational Study.

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Hino, Maai; Mihara, Takahiro; Miyazaki, Saeko; Hijikata, Toshiyuki; Miwa, Takaaki; Goto, Takahisa; Ka, Koui

2017-08-01

Emergence agitation (EA) is a common complication in children after general anesthesia. The goal of this 2-phase study was (1) to develop a predictive model (EA risk scale) for the incidence of EA in children receiving sevoflurane anesthesia by performing a retrospective analysis of data from our previous study (phase 1) and (2) to determine the validity of the EA risk scale in a prospective observational cohort study (phase 2). Using data collected from 120 patients in our previous study, logistic regression analysis was used to predict the incidence of EA in phase 1. The optimal combination of the predictors was determined by a stepwise selection procedure using Akaike information criterion. The β-coefficient for the selected predictors was calculated, and scores for predictors determined. The predictive ability of the EA risk scale was assessed by a receiver operating characteristic (ROC) curve, and the area under the ROC curve (c-index) was calculated with a 95% confidence interval (CI). In phase 2, the validity of the EA risk scale was confirmed using another data set of 100 patients (who underwent minor surgery under general anesthesia). The ROC curve, the c-index, the best cutoff point, and the sensitivity and specificity at the point were calculated. In addition, we calculated the gray zone, which ranges between the two points where sensitivity and specificity, respectively, become 90%. In phase 1, the final model of the multivariable logistic regression analysis included the following 4 predictors: age (logarithm odds ratios [OR], -0.38; 95% CI, -0.81 to 0.00), Pediatric Anesthesia Behavior score (logarithm OR, 0.65; 95% CI, -0.09 to 1.40), anesthesia time (logarithm OR, 0.60; 95% CI, -0.18 to 1.19), and operative procedure (logarithm OR, 2.53; 95% CI, 1.30-3.75 for strabismus surgery and logarithm OR, 2.71; 95% CI, 0.99-4.45 for tonsillectomy). The EA risk scale included these 4 predictors and ranged from 1 to 23 points. In phase 2, the incidence of EA

Risk of low bone mineral density and low body mass index in patients with non-celiac wheat-sensitivity: a prospective observation study.

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Carroccio, Antonio; Soresi, Maurizio; D'Alcamo, Alberto; Sciumè, Carmelo; Iacono, Giuseppe; Geraci, Girolamo; Brusca, Ignazio; Seidita, Aurelio; Adragna, Floriana; Carta, Miriam; Mansueto, Pasquale

2014-11-28

Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the spectrum of gluten-related disorders. No data are available on the prevalence of low bone mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of low BMD in NCWS patients and search for correlations with other clinical characteristics. This prospective observation study included 75 NCWS patients (63 women; median age 36 years) with irritable bowel syndrome (IBS)-like symptoms, 65 IBS and 50 celiac controls. Patients were recruited at two Internal Medicine Departments. Elimination diet and double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All subjects underwent BMD assessment by Dual Energy X-Ray Absorptiometry (DXA), duodenal histology, HLA DQ typing, body mass index (BMI) evaluation and assessment for daily calcium intake. DBPC cow's milk proteins challenge showed that 30 of the 75 NCWS patients suffered from multiple food sensitivity. Osteopenia and osteoporosis frequency increased from IBS to NCWS and to celiac disease (CD) (P <0.0001). Thirty-five NCWS patients (46.6%) showed osteopenia or osteoporosis. Low BMD was related to low BMI and multiple food sensitivity. Values of daily dietary calcium intake in NCWS patients were significantly lower than in IBS controls. An elevated frequency of bone mass loss in NCWS patients was found; this was related to low BMI and was more frequent in patients with NCWS associated with other food sensitivity. A low daily intake of dietary calcium was observed in patients with NCWS.

Complications of ERCP: a prospective study

DEFF Research Database (Denmark)

Christensen, Merete; Matzen, Peter; Schulze, Svend

2004-01-01

included in this prospective study. Complications were assessed at the time of ERCP and by postal/telephone contact at 30-days after the procedure. RESULTS: A total of 1177 ERCPs were included in the analysis, of which 56.2% were therapeutic. The 30-day complication rate was 15.9%; the procedure...... occurred in relation to 5% of the ERCP procedures (3 deaths). Cardiorespiratory complications occurred in 2.3% (2 deaths). Dilated bile duct ( p = 0.0001), placement of stent ( p = 0.001), and use of more than 40 mg of hyoscine-N-butyl bromide ( p ... analysis. Risk of pancreatitis was increased with age under 40 years ( p = 0.0078), placement of stent ( p = 0.031), and a dilated bile duct ( p = 0.036). CONCLUSIONS: This prospective study confirms that the complication rate of ERCP including therapeutic procedures is high. Cardiopulmonary complications...

[Registration of observational studies: it is time to comply with the Declaration of Helsinki requirement].

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Dal-Ré, Rafael; Delgado, Miguel; Bolumar, Francisco

2015-01-01

Publication bias is a serious deficiency in the current system of disseminating the results of human research studies. Clinical investigators know that, from an ethical standpoint, they should prospectively register clinical trials in a public registry before starting them. In addition, it is believed that this approach will help to reduce publication bias. However, most studies conducted in humans are observational rather than experimental. It is estimated that less than 2% out of 2 million concluded or ongoing observational studies have been registered. The 2013 revision of the Declaration of Helsinki requires registration of any type of research study involving humans or identifiable samples or data. It is proposed that funding agencies, such as the Fondo de Investigaciones Sanitarias, as well as private companies, require preregistration of observational studies before providing funding. It is also proposed that Research Ethics Committees which, following Spanish regulation, have been using the Declaration as the framework for assessing the ethics of clinical trials with medicines since 1990, should follow the same provisions for the assessment of health-related observational studies: therefore, they should require prospective registration of studies before granting their final approval. This would allow observational study investigators to be educated in complying with an ethical requirement recently introduced in the most important ethical code for research involving humans. Copyright © 2014 SESPAS. Published by Elsevier Espana. All rights reserved.

Coinfection and Mortality in Pneumonia-Related Acute Respiratory Distress Syndrome Patients with Bronchoalveolar Lavage: A Prospective Observational Study.

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Kao, Kuo-Chin; Chiu, Li-Chung; Hung, Chen-Yiu; Chang, Chih-Hao; Yang, Cheng-Ta; Huang, Chung-Chi; Hu, Han-Chung

2017-05-01

Pneumonia is the leading risk factor of acute respiratory distress syndrome (ARDS). It is increasing studies in patients with pneumonia to reveal that coinfection with viral and bacterial infection can lead to poorer outcomes than no coinfection. This study evaluated the role of coinfection identified through bronchoalveolar lavage (BAL) examination on the outcomes of pneumonia-related ARDS. We performed a prospective observational study at Chang Gung Memorial Hospital from October 2012 to May 2015. Adult patients were included if they met the Berlin definition of ARDS. The indications for BAL were clinically suspected pneumonia-related ARDS and no definite microbial sample identified from tracheal aspirate or sputum. The presence of microbial pathogens and clinical outcomes were analyzed. Of the 19,936 patients screened, 902 (4.5%) fulfilled the Berlin definition of ARDS. Of these patients, 255 (22.7%) had pneumonia-related ARDS and were included for analysis. A total of 142 (55.7%) patients were identified to have a microbial pathogen through BAL and were classified into three groups: a virus-only group (n = 41 [28.9%]), no virus group (n = 60 [42.2%]), and coinfection group (n = 41 [28.9%]). ARDS severity did not differ significantly between the groups (P = 0.43). The hospital mortality rates were 53.7% in virus-only identified group, 63.3% in no virus identified group, and 80.5% in coinfection identified group. The coinfection group had significantly higher mortality than virus-only group (80.5% vs. 53.7%; P = 0.01). In patients with pneumonia-related ARDS, the BAL pathogen-positive patients had a trend of higher mortality rate than pathogen-negative patients. Coinfection with a virus and another pathogen was associated with increased hospital mortality in pneumonia-related ARDS patients.

Requests and usage of epidural analgesia in grand-grand multiparous and similar-aged women with lesser parity: prospective observational study.

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Ioscovich, Alexander; Fadeev, Angelika; Rivilis, Alina; Elstein, Deborah

2011-11-01

Epidural analgesia in older and multiparous women has been associated with risks. The aim of this study was to compare epidural analgesia use for labor/delivery in grand-grand multiparous women (GGMP; ≥10 births) relative to that in similar-aged women with lesser parity. This was a prospective observational study of advanced age gravida. All laboring women in a six-month period admitted to a tertiary Israeli center were included if they were advanced age (≥36 years old) with one to two previous births (Low parity; n=128) or four to five previous births (Medium parity; n=181), and all GGMP (any age; n=187). Primary outcome was comparison of requests for and use of epidural analgesia for labor/delivery. There were no significant differences across parity groups in percent of gravida requesting or receiving epidural analgesia (46.5-59.4%). Time from admission to epidural administration (range mean times: 168-187 min) and from advent of epidural to delivery (range mean times: 155-160 min) were comparable across parity groups. Use of other analgesia (5.8-8%) was not significantly different. Requests for and use of epidural analgesia was comparable in older gravida and was not correlated with parity. Mean times from presentation to epidural administration, mean cervical dilatation at epidural initiation, and mean time from performing of epidural to delivery were comparable across groups.

Surgical data and early postoperative outcomes after minimally invasive lumbar interbody fusion: results of a prospective, multicenter, observational data-monitored study.

Directory of Open Access Journals (Sweden)

Paulo Pereira

Full Text Available Minimally invasive lumbar interbody fusion (MILIF offers potential for reduced operative morbidity and earlier recovery compared with open procedures for patients with degenerative lumbar disorders (DLD. Firm conclusions about advantages of MILIF over open procedures cannot be made because of limited number of large studies of MILIF in a real-world setting. Clinical effectiveness of MILIF in a large, unselected real-world patient population was assessed in this Prospective, monitored, international, multicenter, observational study.To observe and document short-term recovery after minimally invasive interbody fusion for DLD.In a predefined 4-week analysis from this study, experienced surgeons (≥ 30 MILIF surgeries pre-study treated patients with DLD by one- or two-level MILIF. The primary study objective was to document patients' short-term post-interventional recovery (primary objective including back/leg pain (visual analog scale [VAS], disability (Oswestry Disability Index [ODI], health status (EQ-5D and Patient satisfaction.At 4 weeks, 249 of 252 patients were remaining in the study; the majority received one-level MILIF (83% and TLIF was the preferred approach (94.8%. For one-level (and two-level procedures, surgery duration was 128 (182 min, fluoroscopy time 115 (154 sec, and blood-loss 164 (233 mL. Time to first ambulation was 1.3 days and time to study-defined surgery recovery was 3.2 days. Patients reported significantly (P < 0.0001 reduced back pain (VAS: 2.9 vs 6.2, leg pain (VAS: 2.5 vs 5.9, and disability (ODI: 34.5% vs 45.5%, and a significantly (P < 0.0001 improved health status (EQ-5D index: 0.61 vs 0.34; EQ VAS: 65.4 vs 52.9 4 weeks postoperatively. One adverse event was classified as related to the minimally invasive surgical approach. No deep site infections or deaths were reported.For experienced surgeons, MILIF for DLD demonstrated early benefits (short time to first ambulation, early recovery, high patient satisfaction

Association between oxidative stress index and post-CPR early mortality in cardiac arrest patients: A prospective observational study.

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Yücel, Hasan; Türkdoğan, Kenan Ahmet; Zorlu, Ali; Aydın, Hüseyin; Kurt, Recep; Yılmaz, Mehmet Birhan

2015-09-01

Cardiopulmonary resuscitation (CPR) is a series of lifesaving actions that improve the chance of survival following cardiac arrest (CA). Many clinical and laboratory parameters, such as the presence of asystole, out-of-hospital CPR, and duration of cardiac arrest, are associated with failed CPR in patients with CA. Asystole is a state of no cardiac electrical activity, along with the absence of contractions of the myocardium and absence of cardiac output. Oxidative stress index (OSI), which is the ratio of total oxidative status to total antioxidant status, increases by ischemia-reperfusion injury. We investigated whether OSI levels in patients with CA could predict early mortality after CPR. This study has a prospective observational cohort design. Five patients with a history of cancer, four patients who developed hemolysis in their blood, six patients who were transferred to our hospital from other hospitals, and six patients in whom blood samples for OSI could not be stored properly were excluded. Finally, a total of 90 in-hospital or out-of-hospital CA patients and 40 age- and sex-matched healthy volunteers as the control group were evaluated prospectively. The patients were classified according to the CPR response into a successful group (n=46) and a failed group (n=44). Comparisons between groups were performed using one-way ANOVA with post hoc analysis by Tukey's HSD or independent samples t-test and the Kruskal-Wallis tests or Mann- Whitney U test for normally and abnormally distributed data, respectively. Also, we used chi-square test, Spearman's correlation test, univariate and multible logistic regression analyses, and receiver operator characteristic curve analysis. OSI was 3.0±4.0, 5.6±4.3, and 8.7±3.8 in the control group, the successful CPR group, and the failed CPR group, respectively (pOSI on admission, ischemia-modified albumin, presence of asystole, mean duration of cardiac arrest, out-of-hospital CPR, pH, and potassium and sodium levels were

Revisiting acute normovolemic hemodilution and blood transfusion during pediatric cardiac surgery: a prospective observational study.

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Sebastian, Roby; Ratliff, Todd; Winch, Peter D; Tumin, Dmitry; Gomez, Daniel; Tobias, Joseph; Galantowicz, Mark; Naguib, Aymen N

2017-01-01

The majority of allogeneic transfusions occur in the perioperative setting, especially during cardiac surgery. In addition to the economic implications, there is emerging evidence that blood transfusion may increase both morbidity and mortality. Acute normovolemic hemodilution (ANH) may limit the need for blood products. The primary objective of this study was to determine if the method of blood collection (syringe or bag) during the ANH process impacted the platelet count and function. The secondary objectives included the need for perioperative blood transfusions during the procedure and in the intensive care unit. In addition, we assessed these outcomes' associations with ANH parameters including the method of collection, time of storage, and volume removed. Data were collected prospectively from 50 patients undergoing cardiac surgery on cardiopulmonary bypass over a 6-month period. Platelet count and function were measured for the ANH blood immediately after collection and again prior to transfusing to the patient at the end of cardiopulmonary bypass. Other data collected included ANH volume, length of storage, and the quantity of all blood products given throughout the perioperative period. No change in platelet count or function was noted regardless of the length of time or collection method for the ANH blood. Twenty-three patients received blood or blood products in the operating room or the intensive care unit, while 27 patients received no blood transfusion during their entire hospitalization. Higher ANH volume (ml·kg -1 ) and longer storage time were associated with a greater need for intraoperative transfusions. Acute normovolemic hemodilution protects the platelets from the untoward effects of cardiopulmonary bypass and offers an important autologous blood product that improves hemostasis at the conclusion of surgery. Platelet count and function are preserved regardless of the method of collection or the length of storage. The volume of ANH removed

Tea consumption and the risk of five major cancers: a dose–response meta-analysis of prospective studies

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2014-01-01

Background We conducted a dose–response meta-analysis of prospective studies to summarize evidence of the association between tea consumption and the risk of breast, colorectal, liver, prostate, and stomach cancer. Methods We searched PubMed and two other databases. Prospective studies that reported risk ratios (RRs) with 95% confidence intervals (CIs) of cancer risk for ≥3 categories of tea consumption were included. We estimated an overall RR with 95% CI for an increase of three cups/day of tea consumption, and, usingrestricted cubic splines, we examined a nonlinear association between tea consumption and cancer risk. Results Forty-one prospective studies, with a total of 3,027,702 participants and 49,103 cancer cases, were included. From the pooled overall RRs, no inverse association between tea consumption and risk of five major cancers was observed. However, subgroup analysis showed that increase in consumption of three cups of black tea per day was a significant risk factor for breast cancer (RR, 1.18; 95% CI, 1.05-1.32). Conclusion Ourresults did not show a protective role of tea in five major cancers. Additional large prospective cohort studies are needed to make a convincing case for associations. PMID:24636229

Is total pancreatectomy as feasible, safe, efficacious, and cost-effective as pancreaticoduodenectomy? A single center, prospective, observational study.

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Casadei, Riccardo; Ricci, Claudio; Taffurelli, Giovanni; Guariniello, Anna; Di Gioia, Anthony; Di Marco, Mariacristina; Pagano, Nico; Serra, Carla; Calculli, Lucia; Santini, Donatella; Minni, Francesco

2016-09-01

Total pancreatectomy is actually considered a viable option in selected patients even if large comparative studies between partial versus total pancreatectomy are not currently available. Our aim was to evaluate whether total pancreatectomy can be considered as feasible, safe, efficacious, and cost-effective as pancreaticoduodenectomy. A single center, prospective, observational trial, regarding postoperative outcomes, long-term results, and cost-effectiveness, in a tertiary referral center was conducted, comparing consecutive patients who underwent elective total pancreatectomy and/or pancreaticoduodenectomy. Seventy-three consecutive elective total pancreatectomies and 184 pancreaticoduodenectomies were compared. There were no significant differences regarding postoperative outcomes and overall survival. The quality of life, evaluated in 119 patients according to the EQ-5D-5L questionnaire, showed that there were no significant differences regarding the five items considered. The mean EQ-5D-5L score was similar in the two procedures (total pancreatectomy = 0.872, range 0.345-1.000; pancreaticoduodenectomy = 0.832, range 0.393-1.000; P = 0.320). The impact of diabetes according to the Problem Areas in Diabetes (PAID) questionnaire did not show any significant differences except for question 13 (total pancreatectomy = 0.60; pancreaticoduodenectomy = 0.19; P = 0.022). The cost-effectiveness analysis suggested that the quality-adjusted life year was not significantly different between the two procedures (total pancreatectomy = 0.910, range 0.345-1.000; pancreaticoduodenectomy = 0.910, range -0.393-1.000; P = 0.320). From this study, it seems reasonable to suggest that total pancreatectomy can be considered as safe, feasible, and efficacious as PD and acceptable in terms of cost-effectiveness.

Prenatal treatment for serious neurological sequelae of congenital toxoplasmosis: an observational prospective cohort study.

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Mario Cortina-Borja

2010-10-01

Full Text Available The effectiveness of prenatal treatment to prevent serious neurological sequelae (SNSD of congenital toxoplasmosis is not known.Congenital toxoplasmosis was prospectively identified by universal prenatal or neonatal screening in 14 European centres and children were followed for a median of 4 years. We evaluated determinants of postnatal death or SNSD defined by one or more of functional neurological abnormalities, severe bilateral visual impairment, or pregnancy termination for confirmed congenital toxoplasmosis. Two-thirds of the cohort received prenatal treatment (189/293; 65%. 23/293 (8% fetuses developed SNSD of which nine were pregnancy terminations. Prenatal treatment reduced the risk of SNSD. The odds ratio for prenatal treatment, adjusted for gestational age at maternal seroconversion, was 0.24 (95% Bayesian credible intervals 0.07-0.71. This effect was robust to most sensitivity analyses. The number of infected fetuses needed to be treated to prevent one case of SNSD was three (95% Bayesian credible intervals 2-15 after maternal seroconversion at 10 weeks, and 18 (9-75 at 30 weeks of gestation. Pyrimethamine-sulphonamide treatment did not reduce SNSD compared with spiramycin alone (adjusted odds ratio 0.78, 0.21-2.95. The proportion of live-born infants with intracranial lesions detected postnatally who developed SNSD was 31.0% (17.0%-38.1%.The finding that prenatal treatment reduced the risk of SNSD in infected fetuses should be interpreted with caution because of the low number of SNSD cases and uncertainty about the timing of maternal seroconversion. As these are observational data, policy decisions about screening require further evidence from a randomized trial of prenatal screening and from cost-effectiveness analyses that take into account the incidence and prevalence of maternal infection. Please see later in the article for the Editors' Summary.

Prenatal treatment for serious neurological sequelae of congenital toxoplasmosis: an observational prospective cohort study.

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Cortina-Borja, Mario; Tan, Hooi Kuan; Wallon, Martine; Paul, Malgorzata; Prusa, Andrea; Buffolano, Wilma; Malm, Gunilla; Salt, Alison; Freeman, Katherine; Petersen, Eskild; Gilbert, Ruth E

2010-10-12

The effectiveness of prenatal treatment to prevent serious neurological sequelae (SNSD) of congenital toxoplasmosis is not known. Congenital toxoplasmosis was prospectively identified by universal prenatal or neonatal screening in 14 European centres and children were followed for a median of 4 years. We evaluated determinants of postnatal death or SNSD defined by one or more of functional neurological abnormalities, severe bilateral visual impairment, or pregnancy termination for confirmed congenital toxoplasmosis. Two-thirds of the cohort received prenatal treatment (189/293; 65%). 23/293 (8%) fetuses developed SNSD of which nine were pregnancy terminations. Prenatal treatment reduced the risk of SNSD. The odds ratio for prenatal treatment, adjusted for gestational age at maternal seroconversion, was 0.24 (95% Bayesian credible intervals 0.07-0.71). This effect was robust to most sensitivity analyses. The number of infected fetuses needed to be treated to prevent one case of SNSD was three (95% Bayesian credible intervals 2-15) after maternal seroconversion at 10 weeks, and 18 (9-75) at 30 weeks of gestation. Pyrimethamine-sulphonamide treatment did not reduce SNSD compared with spiramycin alone (adjusted odds ratio 0.78, 0.21-2.95). The proportion of live-born infants with intracranial lesions detected postnatally who developed SNSD was 31.0% (17.0%-38.1%). The finding that prenatal treatment reduced the risk of SNSD in infected fetuses should be interpreted with caution because of the low number of SNSD cases and uncertainty about the timing of maternal seroconversion. As these are observational data, policy decisions about screening require further evidence from a randomized trial of prenatal screening and from cost-effectiveness analyses that take into account the incidence and prevalence of maternal infection. Please see later in the article for the Editors' Summary.

Childhood IQ and all-cause mortality before and after age 65: Prospective observational study linking the Scottish Mental Survey 1932 and the Midspan studies

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Hart, C.L.; Taylor, M.D.; Davey Smith, G.; Whalley, L.J.; Starr, J.M.; Hole, D.; Wilson, V.; Deary, I.J.

2005-01-01

OBJECTIVES: The objective was to investigate how childhood IQ related to all-cause mortality before and after age 65. DESIGN: The Midspan prospective cohort studies, followed-up for mortality for 25 years, were linked to individuals' childhood IQ from the Scottish Mental Survey 1932. METHODS: The Midspan studies collected data on risk factors for cardiorespiratory disease from a questionnaire and at a screening examination, and were conducted on adults in Scotland in the 1970s. An age 11 IQ f...

Central venous pressure and shock index predict lack of hemodynamic response to volume expansion in septic shock: a prospective, observational study.

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Lanspa, Michael J; Brown, Samuel M; Hirshberg, Eliotte L; Jones, Jason P; Grissom, Colin K

2012-12-01

Volume expansion is a common therapeutic intervention in septic shock, although patient response to the intervention is difficult to predict. Central venous pressure (CVP) and shock index have been used independently to guide volume expansion, although their use is questionable. We hypothesize that a combination of these measurements will be useful. In a prospective, observational study, patients with early septic shock received 10-mL/kg volume expansion at their treating physician's discretion after brief initial resuscitation in the emergency department. Central venous pressure and shock index were measured before volume expansion interventions. Cardiac index was measured immediately before and after the volume expansion using transthoracic echocardiography. Hemodynamic response was defined as an increase in a cardiac index of 15% or greater. Thirty-four volume expansions were observed in 25 patients. A CVP of 8 mm Hg or greater and a shock index of 1 beat min(-1) mm Hg(-1) or less individually had a good negative predictive value (83% and 88%, respectively). Of 34 volume expansions, the combination of both a high CVP and a low shock index was extremely unlikely to elicit hemodynamic response (negative predictive value, 93%; P = .02). Volume expansion in patients with early septic shock with a CVP of 8 mm Hg or greater and a shock index of 1 beat min(-1) mm Hg(-1) or less is unlikely to lead to an increase in cardiac index. Copyright © 2012 Elsevier Inc. All rights reserved.

Bullied by Peers in Childhood and Borderline Personality Symptoms at 11-Years of Age: A Prospective Study

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Wolke, Dieter; Schreier, Andrea; Zanarini, Mary C.; Winsper, Catherine

2012-01-01

Background: Abuse by adults has been reported as a potent predictor of borderline personality disorder (BPD). Unclear is whether victimisation by peers increases the risk of borderline personality symptoms. Method: The Avon Longitudinal Study of Parents and Children (ALSPAC) prospective, longitudinal observation study of 6050 mothers and their…

A Study on the Spatial Abilities of Prospective Social Studies Teachers: A Mixed Method Research

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Yurt, Eyüp; Tünkler, Vural

2016-01-01

This study investigated prospective social studies teachers' spatial abilities. It was conducted with 234 prospective teachers attending Social Studies Teaching departments at Education Faculties of two universities in Central and Southern Anatolia. This study, designed according to the explanatory-sequential design, is a mixed research method,…

Validation of sputum Gram stain for treatment of community-acquired pneumonia and healthcare-associated pneumonia: a prospective observational study.

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Fukuyama, Hajime; Yamashiro, Shin; Kinjo, Kiyoshi; Tamaki, Hitoshi; Kishaba, Tomoo

2014-10-18

The usefulness of sputum Gram stain in patients with community-acquired pneumonia (CAP) is controversial. There has been no study to evaluate the diagnostic value of this method in patients with healthcare-associated pneumonia (HCAP). The purpose of this study was to evaluate the usefulness of sputum Gram stain in etiological diagnosis and pathogen-targeted antibiotic treatment of CAP and HCAP. We conducted a prospective observational study on hospitalized patients with pneumonia admitted to our hospital from August 2010 to July 2012. Before administering antibiotics on admission, Gram stain was performed and examined by trained physicians immediately after sputum samples were obtained. We analyzed the quality of sputum samples and the diagnostic performance of Gram stain. We also compared pathogen-targeted antibiotic treatment guided by sputum Gram stain with empirical treatment. Of 670 patients with pneumonia, 328 were CAP and 342 were HCAP. Sputum samples were obtained from 591 patients, of these 478 samples were good quality. The sensitivity and specificity of sputum Gram stain were 62.5% and 91.5% for Streptococcus pneumoniae, 60.9% and 95.1% for Haemophilus influenzae, 68.2% and 96.1% for Moraxella catarrhalis, 39.5% and 98.2% for Klebsiella pneumoniae, 22.2% and 99.8% for Pseudomonas aeruginosa, 9.1% and 100% for Staphylococcus aureus. The diagnostic yield decreased in patients who had received antibiotics or patients with suspected aspiration pneumonia. Pathogen-targeted treatment provided similar efficacy with a decrease in adverse events compared to empirical treatment. Sputum Gram stain is highly specific for the etiologic diagnosis and useful in guiding pathogen-targeted antibiotic treatment of CAP and HCAP.

Mathematical geology studies of deposit prospect types

International Nuclear Information System (INIS)

Liu Guangping

1998-08-01

Exact certainty prospect type of uranium deposit, not only can assure the quality of deposit prospects, but also increase economic benefits. Based on the standard of geological prospect of uranium deposit, the author introduces a method of Fuzzy Synthetical Comment for dividing prospect type of uranium deposit. The practical applications demonstrate that the regression accuracy, discriminated by Zadeh operator, of 15 known deposits is 100%

Serum Taurine and Stroke Risk in Women: A Prospective, Nested Case-Control Study

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Wu, Fen; Koenig, Karen L.; Zeleniuch-Jacquotte, Anne; Jonas, Saran; Afanasyeva, Yelena; Wójcik, Oktawia P.; Costa, Max; Chen, Yu

2016-01-01

Background Taurine (2-aminoethanesulfonic acid), a conditionally essential sulfur-containing amino acid, is mainly obtained from diet in humans. Experimental studies have shown that taurine’s main biological actions include bile salt conjugation, blood pressure regulation, anti-oxidation, and anti-inflammation. Methods We conducted a prospective case-control study nested in the New York University Women’s Health Study, a cohort study involving 14,274 women enrolled since 1985. Taurine was measured in pre-diagnostic serum samples of 241 stroke cases and 479 matched controls. Results There was no statistically significant association between serum taurine and stroke risk in the overall study population. The adjusted ORs for stroke were 1.0 (reference), 0.87 (95% CI, 0.59–1.28), and 1.03 (95% CI, 0.69–1.54) in increasing tertiles of taurine (64.3–126.6, 126.7–152.9, and 153.0–308.5 nmol/mL, respectively). A significant inverse association between serum taurine and stroke risk was observed among never smokers, with an adjusted OR of 0.66 (95% CI, 0.37–1.18) and 0.50 (95% CI, 0.26–0.94) for the second and third tertile, respectively (p for trend = 0.01), but not among past or current smokers (p for interaction taurine and stroke risk, although a protective effect was observed in never smokers, which requires further investigation. Taurine, Stroke, Epidemiology, Prospective, Case-control study, NYUWHS. PMID:26866594

The prognosis of incurable cachectic cancer patients on home parenteral nutrition: a multi-centre observational study with prospective follow-up of 414 patients

NARCIS (Netherlands)

Bozzetti, F.; Santarpia, L.; Pironi, L.; Thul, P.; Klek, S.; Gavazzi, C.; Tinivella, M.; Joly, F.; Jonkers, C.; Baxter, J.; Gramlich, L.; Chicharro, L.; Staun, M.; van Gossum, A.; Lo Vullo, S.; Mariani, L.

2014-01-01

The role of home parenteral nutrition (HPN) in incurable cachectic cancer patients unable to eat is extremely controversial. The aim of this study is to analyse which factors can influence the outcome. We studied prospectively 414 incurable cachectic (sub)obstructed cancer patients receiving HPN and

Social Capital and Health: A Review of Prospective Multilevel Studies

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Murayama, Hiroshi; Fujiwara, Yoshinori; Kawachi, Ichiro

2012-01-01

Background This article presents an overview of the concept of social capital, reviews prospective multilevel analytic studies of the association between social capital and health, and discusses intervention strategies that enhance social capital. Methods We conducted a systematic search of published peer-reviewed literature on the PubMed database and categorized studies according to health outcome. Results We identified 13 articles that satisfied the inclusion criteria for the review. In general, both individual social capital and area/workplace social capital had positive effects on health outcomes, regardless of study design, setting, follow-up period, or type of health outcome. Prospective studies that used a multilevel approach were mainly conducted in Western countries. Although we identified some cross-sectional multilevel studies that were conducted in Asian countries, including Japan, no prospective studies have been conducted in Asia. Conclusions Prospective evidence from multilevel analytic studies of the effect of social capital on health is very limited at present. If epidemiologic findings on the association between social capital and health are to be put to practical use, we must gather additional evidence and explore the feasibility of interventions that build social capital as a means of promoting health. PMID:22447212

A prospective study of gentamicin ototoxicity

DEFF Research Database (Denmark)

Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

2010-01-01

of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

A prospective study of gentamicin ototoxicity

DEFF Research Database (Denmark)

Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

1978-01-01

of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP): Design of a multinational, prospective, observational study examining the impact of gastrointestinal events on osteoporosis management in postmenopausal women.

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Modi, Ankita; Ebeling, Peter R; Lee, Mel S; Min, Yong-Ki; Mithal, Ambrish; Yang, Xiaoqin; Sajjan, Shiva

2015-12-01

The burden of osteoporosis in the Asia-Pacific region is not well characterized. The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP) was designed to better understand the association of gastrointestinal events with patient-reported outcomes in postmenopausal women of this region. MUSIC OS-AP is a prospective, multinational, observational cohort study of postmenopausal women ≥ 50 years of age diagnosed with osteoporosis. The study was conducted in five Asia-Pacific countries: Australia, New Zealand, Taiwan, Korea, and India. MUSIC OS-AP has three components: a physician questionnaire, a retrospective chart review, and a prospective cohort study. The physician questionnaire investigated the role of gastrointestinal events in physicians' pharmacologic management of osteoporosis. The retrospective chart review, also completed by physicians, recorded rate of osteoporosis treatment and the types of osteoporosis medications prescribed to osteoporosis patients. The prospective cohort study investigated the associations between gastrointestinal events and patient-reported outcomes among patients taking oral medications for osteoporosis as well as reasons for non-treatment in patients who remained untreated. The prospective cohort study enrolled two groups of patients: untreated, and treated with oral osteoporosis medications. Untreated patients completed only the baseline surveys, providing information on gastrointestinal event rates, quality of life, health care resource use, and reasons for non-treatment. Treated patients, who were either new to osteoporosis medication or continuing an ongoing medication course, completed surveys at baseline and 3, 6, and 12 months post-baseline. The evaluations recorded patient characteristics, gastrointestinal events, health-related and osteoporosis-specific quality of life, health care resource use, medication adherence, and satisfaction with

Self-projection in younger and older adults: a study of episodic memory, prospection, and theory of mind.

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Jarvis, Shoshana N; Miller, Jeremy K

2017-07-01

Self-projection is the ability to orient the self in different places in time and space. Episodic memory, prospection, and theory of mind (ToM) are all cognitive abilities that share an element of self-projection. Previous research has posited that each of these abilities stems from the same neural network. The current study compared performance of cognitively healthy older adults and younger adults on several self-projection tasks to examine the relatedness of these constructs behaviorally. Episodic memory and prospection were measured using an episodic interview task where the participants were asked to remember or imagine events that either had happened in the past or could happen in the future and then gave ratings describing the extent to which they were mentally experiencing the event and from what perspective they viewed it. ToM was measured by asking participants to make judgments regarding the intentions of characters described in stories that involved cognitive, affective, or ironic components. Our results demonstrate that aging influences episodic memory, prospection, and ToM similarly: older adult participants showed declines on each of these measures compared to younger adults. Further, we observed correlations between performance on the measures of episodic memory and prospection as well as between episodic memory and ToM, although no correlation between prospection and ToM was observed after controlling for chronological age. We discuss these results in the light of theories suggesting that each of these abilities is governed by a common brain system.

G6PD Deficiency and Antimalarial Efficacy for Uncomplicated Malaria in Bangladesh: A Prospective Observational Study.

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Benedikt Ley

Full Text Available The Bangladeshi national treatment guidelines for uncomplicated malaria follow WHO recommendations but without G6PD testing prior to primaquine administration. A prospective observational study was conducted to assess the efficacy of the current antimalarial policy.Patients with uncomplicated malaria, confirmed by microscopy, attending a health care facility in the Chittagong Hill Tracts, Bangladesh, were treated with artemether-lumefantrine (days 0-2 plus single dose primaquine (0.75mg/kg on day2 for P. falciparum infections, or with chloroquine (days 0-2 plus 14 days primaquine (3.5mg/kg total over 14 days for P. vivax infections. Hb was measured on days 0, 2 and 9 in all patients and also on days 16 and 30 in patients with P. vivax infection. Participants were followed for 30 days. The study was registered with the clinical trials website (NCT02389374.Between September 2014 and February 2015 a total of 181 patients were enrolled (64% P. falciparum, 30% P. vivax and 6% mixed infections. Median parasite clearance times were 22.0 (Interquartile Range, IQR: 15.2-27.3 hours for P. falciparum, 20.0 (IQR: 9.5-22.7 hours for P. vivax and 16.6 (IQR: 10.0-46.0 hours for mixed infections. All participants were afebrile within 48 hours, two patients with P. falciparum infection remained parasitemic at 48 hours. No patient had recurrent parasitaemia within 30 days. Adjusted male median G6PD activity was 7.82U/gHb. One male participant (1/174 had severe G6PD deficiency (<10% activity, five participants (5/174 had mild G6PD deficiency (10-60% activity. The Hb nadir occurred on day 2 prior to primaquine treatment in P. falciparum and P. vivax infected patients; mean fractional fall in Hb was -8.8% (95%CI -6.7% to -11.0% and -7.4% (95%CI: -4.5 to -10.4% respectively.The current antimalarial policy remains effective. The prevalence of G6PD deficiency was low. Main contribution to haemolysis in G6PD normal individuals was attributable to acute malaria rather

Radiation-induced acute dysphagia. Prospective observational study on 42 head and neck cancer patients

International Nuclear Information System (INIS)

Alterio, D.; Gerardi, M.A.; Fodor, C.; Ciardo, D.; Ferrari, A.; Colangione, S.; Cella, L.; D'Avino, V.; Conson, M.; Palma, G.; Spoto, R.; Dicuonzo, S.; Jereczek-Fossa, B.A.; Zurlo, V.; Bruschini, R.; Sabbatini, A.; Valoriani, F.; Pacelli, R.; Maisonneuve, P.; Preda, L.; Cossu Rocca, M.; Rondi, E.; Orecchia, R.; Sanguineti, G.

2017-01-01

Acute toxicity in head and neck (H and N) cancer patients treated with definitive radiotherapy (RT) has a crucial role in compliance to treatments. The aim of this study was to correlate doses to swallowing-associated structures and acute dysphagia. We prospectively analyzed 42 H and N cancer patients treated with RT. Dysphagia (grade ≥ 3) and indication for percutaneous endoscopic gastrostomy (PEG) insertion were classified as acute toxicity. Ten swallowing-related structures were considered for the dosimetric analysis. The correlation between clinical information and the dose absorbed by the contoured structures was analyzed. Multivariate logistic regression method using resampling methods (bootstrapping) was applied to select model order and parameters for normal tissue complication probability (NTCP) modelling. A strong multiple correlation between dosimetric parameters was found. A two-variable model was suggested as the optimal order by bootstrap method. The optimal model (Rs = 0.452, p < 0.001) includes V 45 of the cervical esophagus (odds ratio [OR] = 1.016) and D mean of the cricopharyngeal muscle (OR = 1.057). The model area under the curve was 0.82 (95% confidence interval 0.69-0.95). Our results suggested that the absorbed dose to the cricopharyngeal muscle and cervical esophagus might play a relevant role in the development of acute RT-related dysphagia. (orig.) [de

Cardiovascular assessment of asymptomatic patients with juvenile-onset localized and systemic scleroderma: 10 years prospective observation.

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Borowiec, A; Dabrowski, R; Wozniak, J; Jasek, S; Chwyczko, T; Kowalik, I; Musiej-Nowakowska, E; Szwed, H

2012-02-01

The aim of the present study was non-invasive evaluation of the cardiovascular system in asymptomatic young adult patients with juvenile localized scleroderma (JLS) and juvenile systemic sclerosis (JSS). A group of 34 consecutive children with scleroderma were prospectively observed in the study. The control group (CG) consisted of 20 healthy subjects. In each subject 12-lead electrocardiographic, echocardiographic, ECG Holter, and ambulatory blood pressure monitoring examinations were performed at the baseline visit and after 10 years. Additionally, B-type natriuretic peptide (BNP) concentrations were measured after 10 years. Examinations were performed in 13 patients with JLS and 15 with JSS at the final visit. Two children had died (one from each group). Four patients were alive but refused the final visit. After 10 years, a higher prevalence of ventricular extrasystoles (p = 0.01) and an elevated pulmonary arterial pressure (JLS: p = 0.04, JSS: p = 0.03) were observed in both groups, but in comparison with the controls there was no significant difference at the final visit. In JLS patients more cases of left ventricle diastolic dysfunction, hypertension, and sinus tachycardia were diagnosed at the final visit (p ≤ 0.05). More atrioventricular block episodes in both groups of scleroderma patients were observed. Over the 10 years, arterial hypertension was diagnosed in three patients from the JLS group and in two with JSS. There were no significant differences in BNP concentrations at the final visit. The results of the present study show that juvenile scleroderma seems to be more benign than adult-onset disease. This observational study shows subclinical, not severe, cardiac abnormalities in adult patients with juvenile-onset disease.

On-scene time and outcome after penetrating trauma: an observational study

DEFF Research Database (Denmark)

Funder, Kamillia S.; Steinmetz, Jacob; Petersen, John Asger

2011-01-01

This was an observational cohort study of penetrating trauma patients treated by the Mobile Emergency Care Unit in Copenhagen with a 30-day follow-up. Between January 2002 and September 2009, data were prospectively registered regarding the anatomical location of the trauma, time intervals and procedures performed......-scene time might be important in penetrating trauma, and ALS procedures should not delay transport to definite care at the hospital....

The effects of joint aspiration and intra-articular corticosteroid injection on flexion reflex excitability, quadriceps strength and pain in individuals with knee synovitis: a prospective observational study.

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Rice, David Andrew; McNair, Peter John; Lewis, Gwyn Nancy; Dalbeth, Nicola

2015-07-28

Substantial weakness of the quadriceps muscles is typically observed in patients with arthritis. This is partly due to ongoing neural inhibition that prevents the quadriceps from being fully activated. Evidence from animal studies suggests enhanced flexion reflex excitability may contribute to this weakness. This prospective observational study examined the effects of joint aspiration and intra-articular corticosteroid injection on flexion reflex excitability, quadriceps muscle strength and knee pain in individuals with knee synovitis. Sixteen patients with chronic arthritis and clinically active synovitis of the knee participated in this study. Knee pain flexion reflex threshold, and quadriceps peak torque were measured at baseline, immediately after knee joint aspiration alone and 5 ± 2 and 15 ± 2 days after knee joint aspiration and the injection of 40 mg of methylprednisolone acetate. Compared to baseline, knee pain was significantly reduced 5 (p = 0.001) and 15 days (p = 0.009) post intervention. Flexion reflex threshold increased immediately after joint aspiration (p = 0.009) and 5 (p = 0.01) and 15 days (p = 0.002) post intervention. Quadriceps peak torque increased immediately after joint aspiration (p = 0.004) and 5 (p = 0.001) and 15 days (p knee synovitis.

[Factors involved in the development of vasoplegia after cardiac surgery with extracorporeal circulation. A prospective observational study].

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Durán Bruce, M; Gomar Sancho, C; Holguera, J C; Muliterno Español, E

2014-05-01

The incidence and risk factors for vasoplegia in the early postoperative period and at 24h are investigated in patients subjected to cardiopulmonary bypass surgery. Vasoplegia following cardiac surgery with cardiopulmonary bypass is associated with a high morbimortality. The risk factors described emerged from retrospective, non-controlled studies. Observational prospective study of 188 consecutive patients subjected to cardiac surgery with cardiopulmonary bypass in a single hospital between November 2011 and May 2012. Emergency surgery or complex procedures were excluded. Vasoplegia was assessed during the immediate postoperative period, and at 24h after surgery, and was defined as a mean arterial pressure below 50mmHg, and the need for a noradrenaline perfusion of more than 0.08μg/kg/min, monitored by cardiac output and systemic vascular resistances. The anaesthetic and cardiopulmonary bypass protocols, as well as haemodynamic management, were the same in all patients. Almost half (48%) of patients had vasoplegia in the immediate postoperative period, and 34% at 24h. Risk factors for immediate vasoplegia development were preoperative use of angiotensin converting enzyme inhibitor drugs, a mean arterial pressure<50mmHg immediately after beginning cardiopulmonary bypass, duration of aortic clamping as well as the cardiopulmonary bypass, and minimum temperature in cardiopulmonary bypass. Vasoplegia at 24h after surgery was correlated to preoperative angiotensin converting enzyme inhibitor drug treatment and cardiopulmonary bypass duration. The incidence of vasoplegia after cardiac surgery with cardiopulmonary bypass is high during the first 24 postoperative hours. Preoperative treatment with angiotensin converting enzyme inhibitor and the mean arterial pressure at the beginning of cardiopulmonary bypass are the more easily controllable risk factors. In patients arriving to surgery with those drugs, treatment or prevention of vasoplejia should be planned. Copyright

Exposure to secondhand smoke and risk of tuberculosis: prospective cohort study.

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Lin, Hsien-Ho; Chiang, Yi-Ting; Chuang, Jen-Hsiang; Yang, Shiang-Lin; Chang, Hsing-Yi; Ezzati, Majid; Murray, Megan

2013-01-01

Prospective evidence on the association between secondhand-smoke exposure and tuberculosis is limited. We included 23,827 never smokers from two rounds (2001 and 2005) of Taiwan National Health Interview Survey. Information on exposure to secondhand smoke at home as well as other sociodemographic and behavioral factors was collected through in-person interview. The participants were prospectively followed for incidence of tuberculosis through cross-matching the survey database to the national tuberculosis registry of Taiwan. A total of 85 cases of active tuberculosis were identified after a median follow-up of 7.0 years. The prevalence of exposure to secondhand smoke at home was 41.8% in the study population. In the multivariable Cox proportional hazards analysis, secondhand smoke was not associated with active tuberculosis (adjusted hazard ratio [HR], 1.03; 95% CI, 0.64 to 1.64). In the subgroup analysis, the association between secondhand smoke and tuberculosis decreased with increasing age; the adjusted HR for those = 18 and = 40 and = 60 years old was 8.48 (0.77 to 93.56), 2.29 (0.75 to 7.01), 1.33 (0.58 to 3.01), and 0.66 (0.35 to 1.23) respectively. Results from extensive sensitivity analyses suggested that potential misclassification of secondhand-smoke exposure would not substantially affect the observed associations. The results from this prospective cohort study did not support an overall association between secondhand smoke and tuberculosis. However, the finding that adolescents might be particularly susceptible to secondhand smoke's effect warrants further investigation.

Cellular microparticle and thrombogram phenotypes in the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study: correlation with coagulopathy

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Matijevic, Nena; Wang, Yao-Wei W.; Wade, Charles E.; Holcomb, John B.; Cotton, Bryan A.; Schreiber, Martin A.; Muskat, Peter; Fox, Erin E.; del Junco, Deborah J.; Cardenas, Jessica C.; Rahbar, Mohammad H.; Cohen, Mitchell Jay

2014-01-01

Background Trauma-induced coagulopathy following severe injury is associated with increased bleeding and mortality. Injury may result in alteration of cellular phenotypes and release of cell-derived microparticles (MP). Circulating MPs are procoagulant and support thrombin generation (TG) and clotting. We evaluated MP and TG phenotypes in severely injured patients at admission, in relation to coagulopathy and bleeding. Methods As part of the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study, research blood samples were obtained from 180 trauma patients requiring transfusions at 5 participating centers. Twenty five healthy controls and 40 minimally injured patients were analyzed for comparisons. Laboratory criteria for coagulopathy was activated partial thromboplastin time (APTT) ≥35 sec. Samples were analyzed by Calibrated Automated Thrombogram to assess TG, and by flow cytometry for MP phenotypes [platelet (PMP), erythrocyte (RMP), leukocyte (LMP), endothelial (EMP), tissue factor (TFMP), and Annexin V positive (AVMP)]. Results 21.7% of patients were coagulopathic with the median (IQR) APTT of 44 sec (37, 53), and an Injury Severity Score of 26 (17, 35). Compared to controls, patients had elevated EMP, RMP, LMP, and TFMP (all p<0.001), and enhanced TG (p<0.0001). However, coagulopathic PROMMTT patients had significantly lower PMP, TFMP, and TG, higher substantial bleeding, and higher mortality compared to non-coagulopathic patients (all p<0.001). Conclusions Cellular activation and enhanced TG are predominant after trauma and independent of injury severity. Coagulopathy was associated with lower thrombin peak and rate compared to non-coagulopathic patients, while lower levels of TF-bearing PMPs were associated with substantial bleeding. PMID:25086657

A prospective PET study of patients with glioblastoma multiforme

DEFF Research Database (Denmark)

Andersen, Preben B.; Blinkenberg, M; Lassen, U

2006-01-01

OBJECTIVE: To study the post-surgical metabolic and structural cerebral changes in patients with glioblastoma multiforme (GBM). MATERIALS AND METHODS: We examined ten patients prospectively with newly diagnosed GBM. All patients were primarily treated with surgery, followed by chemotherapy...... compared with structural imaging in the prospective evaluation of GBM. We found a difference in metabolic increase and tumor growth between the two treatment regimens, although this finding has limited relevance due to the design of the study....

A PROSPECTIVE OBSERVATIONAL STUDY REGARDING PREVALENCE OF DRY EYE DISEASE IN POST-OPERATIVE CATARACT SURGERY PATIENTS OF 140 CASES.

Directory of Open Access Journals (Sweden)

S. Srinivasan

2017-02-01

Full Text Available BACKGROUND Dry eye disease is one of the most common ocular surface disorder with large number of studies carried out in various countries estimate the prevalence of dry eye disease to be between 5-34%. The prevalence of dry eye increases with age. As per Breaver Dam study regarding dry eye the prevalence of DED 13.3%. Dry eye was apparently higher in women than men. Studies have shown that cataract surgery worsen dry eye symptoms in patients with preexisting dry eye symptoms as well as without preexisting DES, mostly dry eye symptoms last for two months of post cataract surgery period. MATERIALS AND METHODS The prospective observational study was conducted in Department of Ophthalmology, Government Vellore Medical College and Hospital, Vellore. The total number of cataract surgery performed cases were 140 in number. The study period was four months, conducted in tertiary eye center. The Cataract patients were preoperatively at normal tear secretions. Post cataract surgery period from first POD, one week POD, four weeks, six weeks, two months and three months POD examined by slit lamp, Schirmer's test I, TBUT and corneal sensitivity test were performed. RESULTS Our study revealed that increased prevalence in female sex with increased age group range from 51-70 years showed post cataract surgery period dryness of eye. The ratio of Post cataract surgery DED in male and female is 13:29. This shows increased female sex prevalence of postoperative DED. In our study, the prevalence of post cataract surgery dry eye disease was 30%. CONCLUSION 73% cataract surgeries is now clear corneal cataract surgery and this procedure cuts a large part of corneal nerves. The nerve essential for tear production gets disturbed leading to dryness and hence decreased visual function. The corneal nerves are important in self-regulation of tears since they provide the sensation in the feedback loop that signals tear production. When the functions of the nerves get blocked

Office gel sonovaginography for the prediction of posterior deep infiltrating endometriosis: a multicenter prospective observational study.

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Reid, S; Lu, C; Hardy, N; Casikar, I; Reid, G; Cario, G; Chou, D; Almashat, D; Condous, G

2014-12-01

To use office gel sonovaginography (SVG) to predict posterior deep infiltrating endometriosis (DIE) in women undergoing laparoscopy. This was a multicenter prospective observational study carried out between January 2009 and February 2013. All women were of reproductive age, had a history of chronic pelvic pain and underwent office gel SVG assessment for the prediction of posterior compartment DIE prior to laparoscopic endometriosis surgery. Gel SVG findings were compared with laparoscopic findings to determine the diagnostic accuracy of office gel SVG for the prediction of posterior compartment DIE. In total, 189 women underwent preoperative gel SVG and laparoscopy for endometriosis. At laparoscopy, 57 (30%) women had posterior DIE and 43 (23%) had rectosigmoid/anterior rectal DIE. For the prediction of rectosigmoid/anterior rectal (i.e. bowel) DIE, gel SVG had an accuracy of 92%, sensitivity of 88%, specificity of 93%, positive predictive value (PPV) of 79%, negative predictive value (NPV) of 97%, positive likelihood ratio (LR+) of 12.9 and negative likelihood ratio (LR-) of 0.12 (P = 3.98E-25); for posterior vaginal wall and rectovaginal septum (RVS) DIE, respectively, the accuracy was 95% and 95%, sensitivity was 18% and 18%, specificity was 99% and 100%, PPV was 67% and 100%, NPV was 95% and 95%, LR+ was 32.4 and infinity and LR- was 0.82 and 0.82 (P = 0.009 and P = 0.003). Office gel SVG appears to be an effective outpatient imaging technique for the prediction of bowel DIE, with a higher accuracy for the prediction of rectosigmoid compared with anterior rectal DIE. Although the sensitivity for vaginal and RVS DIE was limited, gel SVG had a high specificity and NPV for all forms of posterior DIE, indicating that a negative gel SVG examination is highly suggestive of the absence of DIE at laparoscopy. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.

Validation of the new graded prognostic assessment scale for brain metastases: a multicenter prospective study

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Villà, Salvador; Verger, Eugènia; Balañà, Carme; Graus, Francesc; Weber, Damien C; Moretones, Cristina; Mañes, Anabel; Combescure, Christophe; Jové, Josep; Puyalto, Paloma; Cuadras, Patricia; Bruna, Jordi

2011-01-01

Prognostic indexes are useful to guide tailored treatment strategies for cancer patients with brain metastasis (BM). We evaluated the new Graded Prognostic Assessment (GPA) scale in a prospective validation study to compare it with two published prognostic indexes. A total of 285 newly diagnosed BM (n = 85 with synchronous BM) patients, accrued prospectively between 2000 and 2009, were included in this analysis. Mean age was 62 ± 12.0 years. The median KPS and number of BM was 70 (range, 20-100) and 3 (range, 1-50), respectively. The majority of primary tumours were lung (53%), or breast (17%) cancers. Treatment was administered to 255 (89.5%) patients. Only a minority of patients could be classified prospectively in a favourable prognostic class: GPA 3.5-4: 3.9%; recursive partitioning analysis (RPA) 1, 8.4% and Basic Score for BM (BSBM) 3, 9.1%. Mean follow-up (FU) time was 5.2 ± 4.7 months. During the period of FU, 225 (78.9%) patients died. The 6 months- and 1 year-OS was 36.9% and 17.6%, respectively. On multivariate analysis, performance status (P < 0.001), BSBM (P < 0.001), Center (P = 0.007), RPA (P = 0.02) and GPA (P = 0.03) were statistically significant for OS. The survival prediction performances' of all indexes were identical. Noteworthy, the significant OS difference observed within 3 months of diagnosis between the BSBM, RPA and GPA classes/groups was not observed after this cut-off time point. Harrell's concordance indexes C were 0.58, 0.61 and 0.58 for the GPA, BSBM and RPA, respectively. Our data suggest that the new GPA index is a valid prognostic index. In this prospective study, the prediction performance was as good as the BSBM or RPA systems. These published indexes may however have limited long term prognostication capability

Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study.

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Barnes, Darryl E; Beckley, James M; Smith, Jay

2015-01-01

Elbow tendinopathy is the most common cause of elbow pain affecting active populations. Surgical excision is reserved for patients with refractory symptoms. Percutaneous ultrasonic tenotomy performed under local anesthesia also removes degenerated tissue and therefore provides an alternative treatment option to surgical excision. This investigation prospectively documented the safety and 1-year efficacy of ultrasonic percutaneous tenotomy performed by a single operator. Nineteen patients, aged 38 to 67 years, in whom >6 months of conservative management for medial (7) or lateral (12) elbow tendinopathy had failed were prospectively studied. All patients were treated with percutaneous ultrasonic tenotomy of the elbow by a single operator. Visual analog scale (VAS) for pain, the 11-item version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed by an independent observer before treatment and at 6 weeks, 3 months, 6 months, and 12 months after treatment. No procedural complications occurred. Total treatment time was elbow tendinopathy up to 1 year after the procedure. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

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

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

2018-04-10

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

Childhood urinary tract infection in primary care: a prospective observational study of prevalence, diagnosis, treatment, and recovery

Science.gov (United States)

Butler, Christopher C; O’Brien, Kathryn; Pickles, Timothy; Hood, Kerenza; Wootton, Mandy; Howe, Robin; Waldron, Cherry-Ann; Thomas-Jones, Emma; Hollingworth, William; Little, Paul; Van Der Voort, Judith; Dudley, Jan; Rumsby, Kate; Downing, Harriet; Harman, Kim; Hay, Alastair D

2015-01-01

Background The prevalence of targeted and serendipitous treatment for, and associated recovery from, urinary tract infection (UTI) in pre-school children is unknown. Aim To determine the frequency and suspicion of UTI in children who are acutely ill, along with details of antibiotic prescribing, its appropriateness, and whether that appropriateness impacted on symptom improvement and recovery. Design and setting Prospective observational cohort study in primary care sites in urban and rural areas in England and Wales. Method Systematic urine sampling from children aged children’s urine samples, 339 (5.6%) met laboratory criteria for UTI and 162 (47.9%) were prescribed antibiotics at the initial consultation. In total, 576/7101 (8.1%) children were suspected of having a UTI prior to urine sampling, including 107 of the 338 with a UTI (clinician sensitivity 31.7%). Children with a laboratory-diagnosed UTI were more likely to be prescribed antibiotics when UTI was clinically suspected than when it was not (86.0% versus 30.3%, Pchildren with unsuspected UTI, 70 (30.3%) received serendipitous antibiotics (that is, antibiotics prescribed for a different reason). Overall, 176 (52.1%) children with confirmed UTI did not receive any initial antibiotic. Organism sensitivity to the prescribed antibiotic was higher when UTI was suspected than when treated serendipitously (77.1% versus 26.0%; PChildren with UTI prescribed appropriate antibiotics at the initial consultation improved a little sooner than those with a UTI who were not prescribed appropriate antibiotics initially (3.5 days versus 4.0 days; P = 0.005). Conclusion Over half of children with UTI on culture were not prescribed antibiotics at first presentation. Serendipitous UTI treatment was relatively common, but often inappropriate to the organism’s sensitivity. Methods for improved targeting of antibiotic treatment in children who are acutely unwell are urgently needed. PMID:25824181

Severity of Pneumonia in Under 5-Year-Old Children from Developing Countries: A Multicenter, Prospective, Observational Study.

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Bénet, Thomas; Picot, Valentina Sanchez; Awasthi, Shally; Pandey, Nitin; Bavdekar, Ashish; Kawade, Anand; Robinson, Annick; Rakoto-Andrianarivelo, Mala; Sylla, Maryam; Diallo, Souleymane; Russomando, Graciela; Basualdo, Wilma; Komurian-Pradel, Florence; Endtz, Hubert; Vanhems, Philippe; Paranhos-Baccalà, Gláucia; For The Gabriel Network

2017-07-01

Pneumonia is the leading cause of death in children. The objectives were to evaluate the microbiological agents linked with hypoxemia in hospitalized children with pneumonia from developing countries, to identify predictors of hypoxemia, and to characterize factors associated with in-hospital mortality. A multicenter, observational study was conducted in five hospitals, from India (Lucknow, Vadu), Madagascar (Antananarivo), Mali (Bamako), and Paraguay (San Lorenzo). Children aged 2-60 months with radiologically confirmed pneumonia were enrolled prospectively. Respiratory and whole blood specimens were collected, identifying viruses and bacteria by real-time multiplex polymerase chain reaction (PCR). Microbiological agents linked with hypoxemia at admission (oxygen saturation pneumonia cases (3,338 hospitalization days) were analyzed; 13 patients died within 14 days of hospitalization. Hypoxemia prevalence was 17.3%. Detection of human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) in respiratory samples was independently associated with increased risk of hypoxemia (adjusted odds ratio [aOR] = 2.4, 95% confidence interval [95% CI] = 1.0-5.8 and aOR = 2.5, 95% CI = 1.1-5.3, respectively). Lower chest indrawing and cyanosis were predictive of hypoxemia (positive likelihood ratios = 2.3 and 2.4, respectively). Predictors of death were Streptococcus pneumoniae detection by blood PCR (crude hazard ratio [cHR] = 4.6, 95% CI = 1.5-14.0), procalcitonin ≥ 50 ng/mL (cHR = 22.4, 95% CI = 7.3-68.5) and hypoxemia (cHR = 4.8, 95% CI = 1.6-14.4). These findings were consistent on bivariate analysis. hMPV and RSV in respiratory samples were linked with hypoxemia, and S. pneumoniae in blood was associated with increased risk of death among hospitalized children with pneumonia in developing countries.

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

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

2018-04-01

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

Leflunomide in active rheumatoid arthritis: A prospective study in daily practice

NARCIS (Netherlands)

Van Roon, E.N.; Jansen, T.L.Th.A.; Mourad, L.; Houtman, P.M.; Bruyn, G.A.W.; Griep, E.N.; Wilffert, B.; Tobi, H.; Brouwers, J.R.B.J.

2004-01-01

Aims: We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. Methods: In this prospective case series study, a standard dataset was collected from outpatient

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

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Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

2018-01-01

The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Leflunomide in active rheumatoid arthritis : a prospective study in daily practice

NARCIS (Netherlands)

Van Roon, EN; Jansen, TLTA; Mourad, L; Houtman, PM; Bruyn, GAW; Griep, EN; Wilffert, B; Tobi, H; Brouwers, JRBJ

Aims We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. Methods In this prospective case series study, from outpatient medical records a standard dataset was

Derivation and validation of two decision instruments for selective chest CT in blunt trauma: a multicenter prospective observational study (NEXUS Chest CT).

Science.gov (United States)

Rodriguez, Robert M; Langdorf, Mark I; Nishijima, Daniel; Baumann, Brigitte M; Hendey, Gregory W; Medak, Anthony J; Raja, Ali S; Allen, Isabel E; Mower, William R

2015-10-01

Unnecessary diagnostic imaging leads to higher costs, longer emergency department stays, and increased patient exposure to ionizing radiation. We sought to prospectively derive and validate two decision instruments (DIs) for selective chest computed tomography (CT) in adult blunt trauma patients. From September 2011 to May 2014, we prospectively enrolled blunt trauma patients over 14 y of age presenting to eight US, urban level 1 trauma centers in this observational study. During the derivation phase, physicians recorded the presence or absence of 14 clinical criteria before viewing chest imaging results. We determined injury outcomes by CT radiology readings and categorized injuries as major or minor according to an expert-panel-derived clinical classification scheme. We then employed recursive partitioning to derive two DIs: Chest CT-All maximized sensitivity for all injuries, and Chest CT-Major maximized sensitivity for only major thoracic injuries (while increasing specificity). In the validation phase, we employed similar methodology to prospectively test the performance of both DIs. We enrolled 11,477 patients-6,002 patients in the derivation phase and 5,475 patients in the validation phase. The derived Chest CT-All DI consisted of (1) abnormal chest X-ray, (2) rapid deceleration mechanism, (3) distracting injury, (4) chest wall tenderness, (5) sternal tenderness, (6) thoracic spine tenderness, and (7) scapular tenderness. The Chest CT-Major DI had the same criteria without rapid deceleration mechanism. In the validation phase, Chest CT-All had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of 20.8% (95% CI 19.2%-22.4%), and a negative predictive value (NPV) of 99.8% (95% CI 98.9%-100%) for major injury, and a sensitivity of 95.4% (95% CI 93.6%-96.9%), a specificity of 25.5% (95% CI 23.5%-27.5%), and a NPV of 93.9% (95% CI 91.5%-95.8%) for either major or minor injury. Chest CT-Major had a sensitivity of 99.2% (95% CI 95.4%-100%), a specificity of

Prognosis of patients excluded by the definition of septic shock based on their lactate levels after initial fluid resuscitation: a prospective multi-center observational study.

Science.gov (United States)

Ko, Byuk Sung; Kim, Kyuseok; Choi, Sung-Hyuk; Kang, Gu Hyun; Shin, Tae Gun; Jo, You Hwan; Ryoo, Seung Mok; Beom, Jin Ho; Kwon, Woon Yong; Han, Kap Su; Choi, Han Sung; Chung, Sung Phil; Suh, Gil Joon; Lim, Tae Ho; Kim, Won Young

2018-02-24

Septic shock can be defined both by the presence of hyperlactatemia and need of vasopressors. Lactate levels should be measured after volume resuscitation (as per the Sepsis-3 definition). However, currently, no studies have evaluated patients who have been excluded by the new criteria for septic shock. The aim of this study was to determine the clinical characteristics and prognosis of these patients, based on their lactate levels after initial fluid resuscitation. This observational study was performed using a prospective, multi-center registry of septic shock, with the participation of 10 hospitals in the Korean Shock Society, between October 2015 and February 2017. We compared the 28-day mortality between patients who were excluded from the new definition (defined as lactate level definition of septic shock. These patients, in whom perfusion was restored, demonstrated significantly lower age, platelet count, and initial and subsequent lactate levels (all p < 0.01). Similarly, significantly lower 28-day mortality was observed in these patients than in those who had not been excluded (8.2% vs 25.5%, p = 0.02). In-hospital mortality and the maximum SOFA score were also significantly lower in the excluded patients group (p = 0.03, both). It seems reasonable for septic shock to be defined by the lactate levels after volume resuscitation. However, owing to the small number of patients in whom lactate levels were improved, further study is warranted.

The impact of childhood acute rotavirus gastroenteritis on the parents’ quality of life: prospective observational study in European primary care medical practices

Directory of Open Access Journals (Sweden)

Domingo Javier

2012-05-01

Full Text Available Abstract Background Rotavirus (RV is the commonest cause of acute gastroenteritis in infants and young children worldwide. A Quality of Life study was conducted in primary care in three European countries as part of a larger epidemiological study (SPRIK to investigate the impact of paediatric rotavirus gastroenteritis (RVGE on affected children and their parents. Methods A self-administered questionnaire was linguistically validated in Spanish, Italian and Polish. The questionnaire was included in an observational multicentre prospective study of 302 children aged Results Questionnaire responses showed that acute RVGE in a child adversely affects the parents’ daily life as well as the child. Parents of children with RVGE experience worry, distress and impact on their daily activities. RVGE of greater clinical severity (assessed by the Vesikari scale was associated with higher parental worries due to symptoms and greater changes in the child’s behaviour, and a trend to higher impact on parents’ daily activities and higher parental distress, together with a higher score on the symptom severity scale of the questionnaire. Conclusions Parents of a child with acute RVGE presenting to primary care experience worry, distress and disruptions to daily life as a result of the child’s illness. Prevention of this disease through prophylactic vaccination will improve the daily lives of parents and children.

The effects of enactment and intention accessibility on prospective memory performance.

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Schult, Janette C; Steffens, Melanie C

2017-05-01

The intention-superiority effect denotes faster response latencies to stimuli linked with a prospective memory task compared to stimuli linked with no prospective task or with a cancelled task. It is generally assumed that the increased accessibility of intention-related materials contributes to successful execution of prospective memory tasks at an appropriate opportunity. In two experiments we investigated the relationship between the intention-superiority effect and actual prospective memory performance under relatively realistic conditions. We also manipulated enactment versus observation encoding to further investigate the similarity in representations of enacted and to-be-enacted tasks. Additionally, Experiment 1 included a control condition to investigate the development of the intention-superiority effect over time. Participants were asked to perform prospective tasks at the end of the experiment to prepare the room for the next participant. They studied these preparatory tasks at the beginning of the experiment either by enacting them themselves or by observing the experimenter perform them. In Experiment 2, participants in a control condition did not intend to perform prospective tasks. We observed a smaller intention-superiority effect after enactment encoding than after observation encoding, but only if response latencies were assessed immediately before the prospective memory task. In addition, Experiment 2 suggested that the size of the intention-superiority effect is related to successful prospective memory performance, thus providing evidence for a functional relationship between accessibility and memory.

[Prospective observational study of insulin detemir in patients with poorly controlled type 2 diabetes mellitus initiating insulin therapy for the first time (SOLVE Study)].

Science.gov (United States)

Orozco-Beltrán, Domingo; Artola-Menéndez, Sara

2016-02-01

Describe the experience in the primary care setting with insulin detemir in patients with poorly controlled type2 diabetes mellitus that need to add-on insulin to their oral antidiabetic drug therapy. Prospective observational study of 6 months of follow up, performed in 10 countries. In Spain, participating sites were only from the primary care setting. Eligible patients were those with poorly controlled type2 diabetes mellitus adding-on once-daily insulin detemir to their existing oral antidiabetic therapy in the month prior to their enrollment. The change of Hb1Ac and of weight at the end of the study and the incidence of hypoglycemia and adverse reactions, were analyzed. We report the results obtained in the Spanish cohort. Overall 17,374 patients were included, 973 in Spain [mean age 64.8 years (SE 12); duration of diabetes 9.4 years (SE 6.2); Hb1Ac 8.9% (DE 1.4)]. In the sample analyzed for efficacy (n=474) the mean change of Hb1Ac was -1.6% (95%CI: -1.75 to -1.42; P<.001), mean change of weight was -2.9 kg (95%CI: -3.72 to -2.08; P<.001). Only one episode of severe hypoglycemia was reported, which was also the only serious adverse reaction reported in the study. The incidence rate of non-severe hypoglycemia was 2.44 events/patient-year. In this cohort of patients with type 2 diabetes mellitus receiving newly initiated insulin therapy, once-daily detemir improved the glycemic control, with low incidence of hypoglycemia and a significant reduction of the weight. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Lower Bispectral index values in psychiatric patients: A prospective, observational study

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Venkatapura J Ramesh

2014-01-01

Full Text Available Background : Bispectral index score (BIS is a processed electroencephalographic parameter used to measure level of sedation in anaesthetised patients. In few studies of psychiatric patients undergoing electroconvulsive therapy (ECT, it was observed that the BIS values were lower at baseline. It is not clear from those studies whether the BIS values are really low. Also, it is not clear whether the lower values are related to the primary psychiatric illness or the due to the effect of ECT. Therefore, we studied the BIS values in psychiatric illnesses and compared them with the normal controls. Materials and Methods : BIS index was recorded in 237 patients with various psychiatric illness (Group P and 40 control patients without any psychiatric illness undergoing spinal surgery (Group C. BIS values were recorded in supine position before breakfast and before the morning doses of antipsychotic/benzodiazepine medications. It was recorded during resting state in all the subjects. Results : BIS values were lower in group P compared to control group (a mean of 89.8 ± 7.8 vs 95.7 ± 2.4, P < 0.0001. In the group P, the patients with psychosis and bipolar disorder had significantly lower BIS values than the patients with depression (P = 0.04. Conclusions : BIS values in psychiatric patients are lower than those in the control group. Psychotic and bipolar disorders are associated with significantly lower BIS values than the depression.

Prospective outcomes of injury study.

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Derrett, S; Langley, J; Hokowhitu, B; Ameratunga, S; Hansen, P; Davie, G; Wyeth, E; Lilley, R

2009-10-01

In New Zealand (NZ), 20% of adults report a disability, of which one-third is caused by injury. No prospective epidemiological studies of predictors of disability following all-cause injury among New Zealanders have been undertaken. Internationally, studies have focused on a limited range of predictors or specific injuries. Although these studies provide useful insights, applicability to NZ is limited given the importance of NZ's unique macro-social factors, such as NZ's no-fault accident compensation and rehabilitation scheme, the Accident Compensation Corporation (ACC). (1) To quantitatively determine the injury, rehabilitation, personal, social and economic factors leading to disability outcomes following injury in NZ. (2) To qualitatively explore experiences and perceptions of injury-related outcomes in face-to-face interviews with 15 Māori and 15 other New Zealanders, 6 and 12 months after injury. Four geographical regions within NZ. Prospective cohort study with telephone interviews 1, 4 and 12 months after injury. 2500 people (including 460 Māori), aged 18-64 years, randomly selected from ACC's entitlement claims register (people likely to be off work for at least 1 week or equivalent). Telephone interviews, electronic hospital and ACC injury data. Exposures include demographic, social, economic, work-related, health status, participation and/or environmental factors. Primary: disability (including WHODAS II) and health-related quality of life (including EQ-5D). Secondary: participation (paid and unpaid activities), life satisfaction and costs. Separate regression models will be developed for each of the outcomes. Repeated measures outcomes will be modelled using general estimating equation models and generalised linear mixed models.

Effect of Diabetes Mellitus on Tuberculosis Treatment Outcome and Adverse Reactions in Patients Receiving Directly Observed Treatment Strategy in India: A Prospective Study

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Ali Nasir Siddiqui

2016-01-01

Full Text Available Despite successful implementation of directly observed treatment, short course (DOTS in India, the growing number of diabetes mellitus (DM patients appears to be a cause in the increasing tuberculosis (TB incidence, affecting their management. In this regard, a prospective study was conducted on DOTS patients in three primary health care centers in urban slum region of South Delhi, India, to evaluate the effect of DM on sputum conversion, treatment outcome, and adverse drug reactions (ADR due to anti-TB treatment. Eligible TB patients underwent blood glucose screening at treatment initiation. Disease presentation, clinical outcome, and ADRs were compared between patients of TB with and without DM. Out of 316 patients, the prevalence of DM was found to be 15.8%, in which 19.4% and 9.6% were PTB and EPTB patients, respectively. DM patients have observed higher sputum positivity (OR 1.247 95% CI; 0.539–2.886 at the end of 2-month treatment and poor outcome (OR 1.176 95% CI; 0.310–4.457 at the completion of treatment compared with non DM patients. Presence of DM was significantly associated (OR 3.578 95% CI; 1.114–11.494, p=0.032 with the development of ADRs. DM influences the treatment outcome of PTB patients in our setting and also on the ADR incidence.

Lymphocytic gastritis--prospective study of its relationship with varioliform gastritis.

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Haot, J; Jouret, A; Willette, M; Gossuin, A; Mainguet, P

1990-01-01

Lymphocytic gastritis is a new histopathological entity characterised by a dense lymphocytic infiltration of surface and pit gastric epithelium. Previous retrospective work has suggested that lymphocytic gastritis is related to an endoscopic form of gastropathy comprising enlarged folds, nodules and erosions, commonly denoted as varioliform gastritis. In the present prospective study, the relationship is clearly shown; nearly 82% (54/66) of the varioliform gastritis observed in four different endoscopy units correspond histologically to lymphocytic gastritis. The correlation is even better if cases showing strictly antral localisation are excluded (53/55) - that is, more than 96%. The histological concept of lymphocytic gastritis seems, however, to extend beyond varioliform gastritis as of 67 cases of lymphocytic gastritis diagnosed during the period under study, one third had no particular endoscopic expression. Images Figure 1 Figure 2 PMID:2323590

Hand trauma: A prospective observational study reporting diagnostic concordance in emergency hand trauma which supports centralised service improvements.

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Miranda, B H; Spilsbury, Z P; Rosala-Hallas, A; Cerovac, S

2016-10-01

Hand injuries are common, contributing up to 30% of accident and emergency (A&E) attendances. The aim of this study was to prospectively analyse the pathological demographics of hand injuries in a level 1 trauma centre with a Hand Trauma Unit and direct A&E links, and compare clinical and intra-operative findings. The null hypothesis was that there would be no differences between clinical and intra-operative findings (100% diagnostic concordance). Data were prospectively collected for referrals during 2012. Referral diagnosis, additional pathologies found on clinical assessment and intra-operative findings were documented on a live database accessible from both the Hand Unit and associated operating theatres. Odds ratios were calculated using SAS. Injuries (1526) were identified in 1308 patients included in the study. Diagnostic concordance between Hand Unit clinical examination and intra-operative findings was 92.5% ± 2.85% (mean ± SEM); this was lower for flexor tendon injuries (56.3%) because a greater number of additional pathologies were found intra-operatively (2.25 ± 0.10). This 'trend' was noted across multiple referral pathologies including phalangeal fractures (1.28 ± 0.02; 82.9%), lacerations (1.33 ± 0.04; 79.1%), extensor tendon injuries (1.30 ± 0.05; 87.8%) and dislocations (1.18 ± 0.05; 87.8%). Odds ratio analysis indicated a relationship between primary referral diagnoses that were more or less likely to be associated with additional injuries (p management of hand trauma. Our findings, coupled with the presented relevant literature reports, lead us to advocate that A&E departments should move towards a system wherein links to specialist hand trauma services are in place; we hereby present useful data for hospitals implementing such services. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Characteristics of acute treatment costs of traumatic brain injury in Eastern China--a multi-centre prospective observational study.

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Yuan, Qiang; Liu, Hua; Wu, Xing; Sun, Yirui; Yao, Haijun; Zhou, Liangfu; Hu, Jin

2012-12-01

This study investigated acute treatment costs and related factors for traumatic brain injuries (TBI) in eastern China based on a prospective multicentre study. Data were prospectively collected from 80 hospitals in eastern China by standardized structured questionnaires during 2004. Included patients were admitted to hospitals via an emergency service with a diagnosis of TBI. The total acute hospitalization treatment costs derived from unsubsidized total hospital billings were used as the main outcome measure. Univariate and multivariable regression models were used to examine factors associated with each outcome. In total, 13,007 TBI cases were identified from 80 hospitals in eastern China. The median cost per hospitalization was $879 US (range, $72-45,894). The median cost per day was $79 (interquartile range, $49-126). The hospitalization costs varied based on the cause of TBI, with a median of $1017 for traffic accidents, $816 for falls, $490 for blows to the head, and $712 for falls. The hospitalization costs also varied by injury type with a mean of $918 for TBI associated with other injuries and $831 for isolated TBI. Using multiple regression analyses, lower admission Glasgow Coma score, longer hospital stay (LOS), male sex, transient patient status, traffic accident, injury occurring on a construction site, treatment at a tertiary hospital, neurosurgical intensive care unit (NICU) or ICU stay, associated polytrauma, and those who needed a neurosurgical operation had significantly higher total acute hospitalization costs than those of other groups. Good recovery and self-paying patients had lower total costs. A double LOS was associated with a 1.61 (95% confidence interval, 1.59-1.62) times higher hospital cost. Our results have potential implications for health-care resource planning during TBI treatment. Measures to prevent traffic accidents and reduce the LOS may help to reduce acute hospitalization costs. Crown Copyright © 2012. Published by Elsevier

Impact of xerostomia on dysphagia after chemotherapy-intensity-modulated radiotherapy for oropharyngeal cancer: Prospective longitudinal study.

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Vainshtein, Jeffrey M; Samuels, Stuart; Tao, Yebin; Lyden, Teresa; Haxer, Marc; Spector, Matthew; Schipper, Matthew; Eisbruch, Avraham

2016-04-01

The purpose of this study was to assess how xerostomia affects dysphagia. Prospective longitudinal studies of 93 patients with oropharyngeal cancer treated with definitive chemotherapy-intensity-modulated radiotherapy (IMRT). Observer-rated dysphagia (ORD), patient-reported dysphagia (PRD), and patient-reported xerostomia (PRX) assessment of the swallowing mechanics by videofluoroscopy (videofluoroscopy score), and salivary flow rates, were prospectively assessed from pretherapy through 2 years. ORD grades ≥2 were rare and therefore not modeled. Of patients with no/mild videofluoroscopy abnormalities, a substantial proportion had PRD that peaked 3 months posttherapy and subsequently improved. Through 2 years, highly significant correlations were observed between PRX and PRD scores for all patients, including those with no/mild videofluoroscopy abnormalities. Both PRX and videofluoroscopy scores were highly significantly associated with PRD. On multivariate analysis, PRX score was a stronger predictor of PRD than the videofluoroscopy score. Xerostomia contributes significantly to PRD. Efforts to further decrease xerostomia, in addition to sparing parotid glands, may translate into improvements in PRD. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1605-E1612, 2016. © 2015 Wiley Periodicals, Inc.

Effects of periodontal treatment on carotid intima-media thickness in patients with lifestyle-related diseases: Japanese prospective multicentre observational study.

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

2018-01-12

Atherosclerosis, a chronic inflammatory disease in arterial blood vessels, is one of the major causes of death in worldwide. Meanwhile, periodontal disease is a chronic inflammatory disease caused by infection with periodontal pathogens such as P. gingivalis (Porphyromonas gingivalis). Several studies have reported association between periodontal infection and atherosclerosis, but direct investigation about the effects of periodontal treatment on atherosclerosis has not been reported. We have planned Japanese local clinics to determine the relationship between periodontal disease and atherosclerosis under collaborative with medical and dental care. A prospective, multicentre, observational study was conducted including 38 medical patients with lifestyle-related diseases in the stable period under consultation at participating medical clinics and 92 periodontal patients not undergoing medical treatment but who were consulting at participating dental clinics. Systemic and periodontal examinations were performed before and after periodontal treatment. At baseline, LDL-C (low-density lipoprotein cholesterol) levels and percentage (%) of mobile teeth were positively related to plasma IgG (immunoglobulin) antibody titer against P. gingivalis with multivariate analysis. Corresponding to improvements in periodontal clinical parameters after treatment, right and left max IMT (maximum intima-media thickness) levels were decreased significantly after treatment (SPT-S: start of supportive periodontal therapy, SPT-1y: at 1 year under SPT, and SPT-3y: at 3 years under SPT). The present study has clarified our previous univariate analysis results, wherein P. gingivalis infection was positively associated with progression of atherosclerosis. Thus, routine screening using plasma IgG antibody titer against P. gingivalis and periodontal treatment under collaborative with medical and dental care may prevent cardiovascular accidents caused by atherosclerosis.

A comparison of medication administration errors from original medication packaging and multi-compartment compliance aids in care homes: A prospective observational study.

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Gilmartin-Thomas, Julia Fiona-Maree; Smith, Felicity; Wolfe, Rory; Jani, Yogini

2017-07-01

No published study has been specifically designed to compare medication administration errors between original medication packaging and multi-compartment compliance aids in care homes, using direct observation. Compare the effect of original medication packaging and multi-compartment compliance aids on medication administration accuracy. Prospective observational. Ten Greater London care homes. Nurses and carers administering medications. Between October 2014 and June 2015, a pharmacist researcher directly observed solid, orally administered medications in tablet or capsule form at ten purposively sampled care homes (five only used original medication packaging and five used both multi-compartment compliance aids and original medication packaging). The medication administration error rate was calculated as the number of observed doses administered (or omitted) in error according to medication administration records, compared to the opportunities for error (total number of observed doses plus omitted doses). Over 108.4h, 41 different staff (35 nurses, 6 carers) were observed to administer medications to 823 residents during 90 medication administration rounds. A total of 2452 medication doses were observed (1385 from original medication packaging, 1067 from multi-compartment compliance aids). One hundred and seventy eight medication administration errors were identified from 2493 opportunities for error (7.1% overall medication administration error rate). A greater medication administration error rate was seen for original medication packaging than multi-compartment compliance aids (9.3% and 3.1% respectively, risk ratio (RR)=3.9, 95% confidence interval (CI) 2.4 to 6.1, ppackaging (from original medication packaging-only care homes) and multi-compartment compliance aids (RR=2.3, 95%CI 1.1 to 4.9, p=0.03), and between original medication packaging and multi-compartment compliance aids within care homes that used a combination of both medication administration

Two novel blood-based biomarker candidates measuring degradation of tau are associated with dementia: A prospective study

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Neergaard, Jesper Skov; Dragsbæk, Katrine; Christiansen, Claus

2018-01-01

fragments were detected in serum of 5,309 women from the Prospective Epidemiological Risk Factor study. The study was an observational, prospective study of Danish postmenopausal women. Subjects were followed with registry-linkage for up to 15 years (median follow-up time 13.7 years). Cox regression......Truncated tau appears to be specifically related to disease pathology and recent studies have shown the presence and elevation of several truncated tau species in Cerebrospinal fluid (CSF) of subjects with Alzheimer's disease (AD); however, the relevance of truncated Tau measurements in blood...... is still being studied. The aim of the current study was to assess the longitudinal associations between baseline levels of two novel blood biomarker candidates measuring truncated tau, Tau-A and Tau-C, and the risk of incident dementia and AD in elderly women. Using solid phase competitive ELISA, two tau...

Optimal preparation-to-colonoscopy interval in split-dose PEG bowel preparation determines satisfactory bowel preparation quality: an observational prospective study.

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Seo, Eun Hee; Kim, Tae Oh; Park, Min Jae; Joo, Hee Rin; Heo, Nae Yun; Park, Jongha; Park, Seung Ha; Yang, Sung Yeon; Moon, Young Soo

2012-03-01

Several factors influence bowel preparation quality. Recent studies have indicated that the time interval between bowel preparation and the start of colonoscopy is also important in determining bowel preparation quality. To evaluate the influence of the preparation-to-colonoscopy (PC) interval (the interval of time between the last polyethylene glycol dose ingestion and the start of the colonoscopy) on bowel preparation quality in the split-dose method for colonoscopy. Prospective observational study. University medical center. A total of 366 consecutive outpatients undergoing colonoscopy. Split-dose bowel preparation and colonoscopy. The quality of bowel preparation was assessed by using the Ottawa Bowel Preparation Scale according to the PC interval, and other factors that might influence bowel preparation quality were analyzed. Colonoscopies with a PC interval of 3 to 5 hours had the best bowel preparation quality score in the whole, right, mid, and rectosigmoid colon according to the Ottawa Bowel Preparation Scale. In multivariate analysis, the PC interval (odds ratio [OR] 1.85; 95% CI, 1.18-2.86), the amount of PEG ingested (OR 4.34; 95% CI, 1.08-16.66), and compliance with diet instructions (OR 2.22l 95% CI, 1.33-3.70) were significant contributors to satisfactory bowel preparation. Nonrandomized controlled, single-center trial. The optimal time interval between the last dose of the agent and the start of colonoscopy is one of the important factors to determine satisfactory bowel preparation quality in split-dose polyethylene glycol bowel preparation. Copyright © 2012 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study

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Leo Massari

2018-01-01

Full Text Available Background. Healing of tibia fractures occurs over a wide time range of months, with a number of risk factors contributing to prolonged healing. In this prospective, multicentre, observational study, we investigated the capability of FRACTING (tibia FRACTure prediction healING days score, calculated soon after tibia fracture treatment, to predict healing time. Methods. The study included 363 patients. Information on patient health, fracture morphology, and surgical treatment adopted were combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. Results. 319 fractures (88% healed within 12 months from treatment. Forty-four fractures healed after 12 months or underwent a second surgery. FRACTING score positively correlated with days to healing: r=0.63 (p<0.0001. Average score value was 7.3 ± 2.5; ROC analysis showed strong reliability of the score in separating patients healing before versus after 6 months: AUC = 0.823. Conclusions. This study shows that the FRACTING score can be employed both to predict months needed for fracture healing and to identify immediately after treatment patients at risk of prolonged healing. In patients with high score values, new pharmacological and nonpharmacological treatments to enhance osteogenesis could be tested selectively, which may finally result in reduced disability time and health cost savings.

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

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

2015-10-01

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

Yogurt and Diabetes: Overview of Recent Observational Studies.

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Salas-Salvadó, Jordi; Guasch-Ferré, Marta; Díaz-López, Andrés; Babio, Nancy

2017-07-01

The effects of dairy consumption on the prevention of type 2 diabetes remain controversial and depend on the dairy subtype. Yogurt intake has received special attention because its association with health benefits is more consistent than that of other types of dairy products. In the present article, we review those observational studies that evaluated the association between yogurt consumption and type 2 diabetes. We also discuss the possible mechanisms involved in these associations. We found that 13 prospective studies evaluated the association between yogurt intake and type 2 diabetes, most of which showed an inverse association between the frequency of yogurt consumption and the risk of diabetes. In addition to the scientific evidence accumulated from individual prospective studies, several meta-analyses have shown that yogurt consumption has a potential role in diabetes prevention. The most recent analysis shows a 14% lower risk of type 2 diabetes when yogurt consumption was 80-125 g/d compared with no yogurt consumption. The intake of fermented dairy products, especially yogurt, has been inversely associated with variables of glucose metabolism. Yogurt may have probiotic effects that could modulate glucose metabolism. We conclude that yogurt consumption, in the context of a healthy dietary pattern, may reduce the risk of type 2 diabetes in healthy and older adults at high cardiovascular risk. Large-scale intervention studies and randomized clinical trials are warranted to determine if yogurt consumption has beneficial effects on insulin sensitivity and reduces the risk of type 2 diabetes. © 2017 American Society for Nutrition.

Presentation, management, and outcomes of sepsis in adults and children admitted to a rural Ugandan hospital: A prospective observational cohort study.

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Kristina E Rudd

Full Text Available Limited data are available on sepsis in low-resource settings, particularly outside of urban referral centers. We conducted a prospective observational single-center cohort study in May 2013 to assess the presentation, management and outcomes of adult and pediatric patients admitted with sepsis to a community hospital in rural Uganda.We consecutively screened all patients admitted to medical wards who met sepsis criteria. We evaluated eligible patients within 24 hours of presentation and 24-48 hours after admission, and followed them until hospital discharge. In addition to chart review, mental status evaluation, peripheral capillary oxygen saturation, and point-of-care venous whole blood lactate and glucose testing were performed.Of 56 eligible patients, we analyzed data on 51 (20 adults and 31 children. Median age was 8 years (IQR 2-23 years. Sepsis accounted for a quarter of all adult and pediatric medical ward admissions during the study period. HIV prevalence among adults was 30%. On enrollment, over half of patients had elevated point-of-care whole blood lactate, few were hypoglycemic or had altered mental status, and one third were hypoxic. Over 80% of patients received at least one antibiotic, all severely hypoxic patients received supplemental oxygen, and half of patients with elevated lactate received fluid resuscitation. The most common causes of sepsis were malaria and pneumonia. In-hospital mortality was 3.9%.This study highlights the importance of sepsis among adult and pediatric patients admitted to a rural Ugandan hospital and underscores the need for continued research on sepsis in low resource settings.

A Case Study on Mathematical Literacy of Prospective Elementary School Teachers

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Suharta, I. Gusti Putu; Suarjana, I. Made

2018-01-01

The purpose of this study is to describe Mathematical Literacy (ML) of Prospective Elementary School Teachers with attention to aspects of mathematical skills and gender. The type of research is qualitative with the research design of Case Study. Respondents are assigned 12 Prospective Elementary School Teachers, consisting of 6 men and 6 women.…

[Dental agenesis. Results of a prospective study of 30 cases].

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Romieux, G; Bonin, B; Laure, B; Van Hove, A; Goga, D

2000-11-01

We conducted a prospective study to determine the types of bone anomalies observed in different types of dental agenesia. This prospective series included 30 patients who attended our pluridisciplinary clinic since 1988. There were 22 cases of non syndromal agenesia and 8 cases of syndromal agenesia. Patients consulted for a variety of reasons, no specific sign was found. The diagnosis was based on the panoramic x-ray and confirmed at the genetic consultation. Results were systemized by localization of the agenesia. In all cases, the height of the bone crest was preserved compared with the adjacent teeth. In the anterior part of the maxillary, the bone crest was thin showing a water drop aspect. In the posterior maxillary, there was a decrease in the subsinusal height due to invagination of the floor of the sinus. In the anterior part of the mandible, the crest had a knife blade aspect but no loss of height and in the posterior part, a preserved distance between the residual crest rim and the dental canal. In 60% of the solitary agenesias in the anterior part of the maxillary, augmentation was not required. A sinus graft was required in all cases involving the posterior maxillary. Multiple anterior or lateral agenesias were treated with a parietal graft.

Prediction of methotrexate intolerance in juvenile idiopathic arthritis: a prospective, observational cohort study.

Science.gov (United States)

van Dijkhuizen, Evert Hendrik Pieter; Bulatović Ćalasan, Maja; Pluijm, Saskia M F; de Rotte, Maurits C F J; Vastert, Sebastiaan J; Kamphuis, Sylvia; de Jonge, Robert; Wulffraat, Nico M

2015-01-01

Methotrexate (MTX) is an effective and safe drug in the treatment of juvenile idiopathic arthritis (JIA). Despite its safety, MTX-related gastrointestinal adverse effects before and after MTX administration, termed MTX intolerance, occur frequently, leading to non-compliance and potentially premature MTX termination. The aim of this study was to construct a risk model to predict MTX intolerance. In a prospective JIA cohort, clinical variables and single nucleotide polymorphisms were determined at MTX start. The Methotrexate Intolerance Severity Score was employed to measure MTX intolerance in the first year of treatment. MTX intolerance was most prevalent at 6 or 12 months after MTX start, which was defined as the outcome for the prediction model. The model was developed in 152 patients using multivariable logistic regression analysis and subsequently internally validated using bootstrapping. The prediction model included the following predictors: JIA category, antinuclear antibody, parent/patient assessment of pain, Juvenile Arthritis Disease Activity Score-27, thrombocytes, alanine aminotransferase and creatinine. The model classified 77.5% of patients correctly, and 66.7% of patients after internal validation by bootstrapping. The lowest predicted risk of MTX intolerance was 18.9% and the highest predicted risk was 85.9%. The prediction model was transformed into a risk score (range 0-17). At a cut-off of ≥6, sensitivity was 82.0%, specificity 56.1%, positive predictive value was 58.7% and negative predictive value 80.4%. This clinical prediction model showed moderate predictive power to detect MTX intolerance. To develop into a clinically usable tool, it should be validated in an independent cohort and updated with new predictors. Such an easy-to-use tool could then assist clinicians in identifying patients at risk to develop MTX intolerance, and in turn to monitor them closely and intervene timely in order to prevent the development of MTX intolerance

Hypertension resistant to antihypertensive agents commonly occurs with the progression of diabetic nephropathy in Japanese patients with type 2 diabetes mellitus: a prospective observational study

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Ito Hiroyuki

2012-06-01

Full Text Available Abstract Background We investigated 1 the frequency of hypertension in patients with type 2 diabetes graded by the new classification of chronic kidney disease (CKD reported by the Kidney Disease: Improving Global Outcomes (KDIGO and 2 the number of antihypertensive agents needed to achieve treatment goals using a prospective observational study. Methods A population of 2018 patients with type 2 diabetes mellitus was recruited for the study. The CKD stage was classified according to the eGFR and the urinary albumin excretion levels. Results Hypertension was found in 1420 (70% of the patients, and the proportion of subjects showing a blood pressure  Conclusions Hypertension resistant to antihypertensive agents was common in the patients with type 2 diabetes mellitus and increased with the progression of CKD. Although powerful combination therapy using antihypertensive agents is considered necessary for the strict control of blood pressure, this became difficult in individuals who were in advanced stages as graded based on the eGFR and the urinary albumin excretion levels.

Clinical outcome of nonculprit plaque ruptures in patients with acute coronary syndrome in the PROSPECT study.

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Xie, Yong; Mintz, Gary S; Yang, Junqing; Doi, Hiroshi; Iñiguez, Andrés; Dangas, George D; Serruys, Patrick W; McPherson, John A; Wennerblom, Bertil; Xu, Ke; Weisz, Giora; Stone, Gregg W; Maehara, Akiko

2014-04-01

The aim of this study was to report the frequency, patient and lesion-related characteristics, and outcomes of subclinical, nonculprit plaque ruptures in the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study. Plaque rupture and subsequent thrombosis is the most common cause of acute coronary syndrome (ACS). Secondary, subclinical, nonculprit plaque ruptures have been seen in both stable patients and patients with ACS; however, reports of the natural history of these secondary plaque ruptures are limited. After successful stenting in 697 patients with ACS, 3-vessel grayscale and intravascular ultrasound virtual histology (IVUS-VH) was performed in the proximal-mid segments of all 3 coronary arteries as part of a prospective multicenter study. Among 660 patients with complete IVUS data, 128 plaque ruptures were identified in 105 nonculprit lesions in 100 arteries from 93 patients (14.1%). Although the minimum lumen area (MLA) was similar, the plaque burden was significantly greater in nonculprit lesions with a plaque rupture compared with nonculprit lesions without a plaque rupture (66.0% [95% confidence interval: 64.5% to 67.4%] vs. 56.0% [95% confidence interval: 55.6% to 56.4%]; p PROSPECT]; NCT00180466). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Serum Cystatin C Predicts AKI and the Prognosis of Patients in Coronary Care Unit: a Prospective, Observational Study

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Yugang Hu

2017-11-01

Full Text Available Background/Aims: Acute Kidney Injury (AKI is a serious clinical state associated with high morbidity and mortality, particularly in critical ill patients. We investigated the hypothesis that serum Cystatin C (sCysC is a good predictor for AKI and may affect the short-term prognosis of coronary care unit (CCU patients. Methods: In this prospective, observational study, we screened 412 adults admitted to the CCU from January 1, 2014 to June 1, 2015 at Zhongnan Hospital of Wuhan University. Serum samples were obtained at the time of admission, and sCysC was quantified through nephelometry. AKI was defined based on KDIGO-AKI criteria. After the patients’ hospital discharge, the survivors in this study were followed up for up to 2 years. The primary endpoint was the incidence of AKI stratified by severity stage, while the second endpoints included 2-year mortality, rehospitalization and failure in renal recovery rates, as well as the progression of AKI to CKD. Results: According to the KDIGO-AKI criteria, AKI occurred in 130 (31.6% patients. After multivariate adjustments, the highest quartile of sCysC was associated with a 9-fold increased risk of incident AKI compared with the lowest quartile. For predicting AKI, sCysC [area under the receiver operating characteristic curve (AUC=0.842] outperformed β2-micro globulin (AUC=0.813 and the clinical model (AUC=0.777, and a cutoff of 1.255 mg/L yielded good sensitivity and specificity. After a median 19.8-month follow-up, 112 (27.2% patients died within 2 years after admission. The sCysC independently predicted the risk of 2-year mortality [adjusted odds ratio (OR, 4.955; 95% confidence interval (95% CI, 2.853 to 8.603] and rehospitalization (OR, 3.128; 95% CI, 2.011 to 4.867, as well as renal recovery failure (OR, 3.618, 95% CI, 1.753 to 7.463. Conclusions: Serum CysC is a strong predictor of AKI and the short-term prognosis of CCU patients.

The intended and unintended consequences of communication systems on general internal medicine inpatient care delivery: a prospective observational case study of five teaching hospitals.

Science.gov (United States)

Wu, Robert C; Lo, Vivian; Morra, Dante; Wong, Brian M; Sargeant, Robert; Locke, Ken; Cavalcanti, Rodrigo; Quan, Sherman D; Rossos, Peter; Tran, Kim; Cheung, Mark

2013-01-01

Effective clinical communication is critical to providing high-quality patient care. Hospitals have used different types of interventions to improve communication between care teams, but there have been few studies of their effectiveness. To describe the effects of different communication interventions and their problems. Prospective observational case study using a mixed methods approach of quantitative and qualitative methods. General internal medicine (GIM) inpatient wards at five tertiary care academic teaching hospitals. Clinicians consisting of residents, attending physicians, nurses, and allied health (AH) staff working on the GIM wards. Ethnographic methods and interviews with clinical staff (doctors, nurses, medical students, and AH professionals) were conducted over a 16-month period from 2009 to 2010. We identified four categories that described the intended and unintended consequences of communication interventions: impacts on senders, receivers, interprofessional collaboration, and the use of informal communication processes. The use of alphanumeric pagers, smartphones, and web-based communication systems had positive effects for senders and receivers, but unintended consequences were seen with all interventions in all four categories. Interventions that aimed to improve clinical communications solved some but not all problems, and unintended effects were seen with all systems.

Neurological outcomes following suicidal hanging: A prospective study of 101 patients

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Mohammed Turab Jawaid

2017-01-01

Full Text Available Context: Survivors of suicidal hanging can have variable neurological outcomes – from complete recovery to irreversible brain damage. Literature on the neurological outcomes in these patients is confined to retrospective studies and case series. Hence, this prospective study was carried out. Aims: The aim is to study the neurological outcomes in suicidal hanging. Settings and Design: This was a prospective observational study carried out from July 2014 to July 2016. Subjects and Methods: Consecutive patients admitted to the emergency and medicine wards were included in the study. Details of the clinical and radiological findings, course in hospital and at 1 month postdischarge were analyzed. Statistical Analysis Used: Statistical analysis was performed using IBM SPSS advanced statistics 20.0 (SPSS Inc., Chicago, USA. Univariate analysis was performed using Chi-square test for significance and Odd's ratio was calculated. Results: Of the 101 patients, 6 died and 4 had residual neuro deficits. Cervical spine injury was seen in 3 patients. Interestingly, 39 patients could not remember the act of hanging (retrograde amnesia. Hypotension, pulmonary edema, Glasgow coma scale (GCS score <8 at admission, need for mechanical ventilation, and cerebral edema on plain computed tomography were more in those with amnesia as compared to those with normal memory and these findings were statistically significant. Conclusions: Majority of patients recovered without any sequelae. Routine imaging of cervical spine may not be warranted in all patients, even in those with poor GCS. Retrograde amnesia might be more common than previously believed and further studies are needed to analyze this peculiar feature.

Hemorrhagic, Hemostatic, and Thromboelastometric Disorders in 35 Dogs with a Clinical Diagnosis of Leptospirosis: A Prospective Study

OpenAIRE

Barth?lemy, A.; Magnin, M.; Pouzot?Nevoret, C.; Bonnet?Garin, J.?M.; Hugonnard, M.; Goy?Thollot, I.

2016-01-01

Background Leptospirosis in dogs is occasionally associated with a hemorrhagic syndrome, the pathophysiology of which is not fully understood. Hypothesis/Objectives To characterize hematologic, hemostatic, and thromboelastometric abnormalities in dogs with leptospirosis and to study their association with hemorrhagic diatheses and outcomes. Animals Thirty?five client?owned dogs. Methods A prospective observational single cohort study was conducted. Results from the CBC, coagulation tests (pro...

Oropharyngeal dysphagia is a risk factor for readmission for pneumonia in the very elderly persons: observational prospective study.

Science.gov (United States)

Cabré, Mateu; Serra-Prat, Mateu; Force, Ll; Almirall, Jordi; Palomera, Elisabet; Clavé, Pere

2014-03-01

To determine whether oropharyngeal dysphagia is a risk factor for readmission for pneumonia in elderly persons discharged from an acute geriatric unit. Observational prospective cohort study with data collection based on clinical databases and electronic clinical notes. All elderly individuals discharged from an acute geriatric unit from June 2002 to December 2009 were recruited and followed until death or December 31, 2010. All individuals were initially classified according to the presence of oropharyngeal dysphagia assessed by bedside clinical examination. Main outcome measure was readmission for pneumonia. Clinical notes were reviewed by an expert clinician to verify diagnosis and classify pneumonia as aspiration or nonaspiration pneumonia. A total of 2,359 patients (61.9% women, mean age 84.9 y) were recruited and followed for a mean of 24 months. Dysphagia was diagnosed in 47.5% of cases. Overall, 7.9% of individuals were readmitted for pneumonia during follow-up, 24.2% of these had aspiration pneumonia. The incidence rate of hospital readmission for pneumonia was 3.67 readmissions per 100 person-years (95% CI 3.0-4.4) in individuals without dysphagia and 6.7 (5.5-7.8) in those with dysphagia, with an attributable risk of 3.02 readmissions per 100 person-years (1.66-4.38) and a rate ratio of 1.82 (1.41-2.36). Multivariate Cox regression showed an independent effect of oropharyngeal dysphagia, with a hazard ratio of 1.6 (1.15-2.2) for hospitalization for pneumonia, 4.48 (2.01-10.0) for aspiration pneumonia, and 1.44 (1.02-2.03) for nonaspiration pneumonia. Oropharyngeal dysphagia is a very prevalent and relevant risk factor associated with hospital readmission for both aspiration and nonaspiration pneumonia in the very elderly persons.

The BEST study - a prospective study to compare business class ...

African Journals Online (AJOL)

Background. As many as 10% of airline passengers travelling without prophylaxis for long distances may develop a venous thrombosis. There is, however, no evidence that economy class travellers are at increased risk of thrombosis. Objectives. A suitably powered prospective study, based on the incidence of deep-vein ...

Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study

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Rowe Leslie R

2005-08-01

Full Text Available Abstract Background Detection of cytologic atypia in nipple aspirate fluid (NAF has been shown to be a predictor of risk for development of breast carcinoma. Manual collection of NAF for cytologic evaluation varies widely in terms of efficacy, ease of use, and patient acceptance. We investigated a new automated device for the non-invasive collection of NAF in the office setting. Methods A multi-center prospective observational clinical trial involving asymptomatic women designed to assess fluid production, adequacy, safety and patient acceptance of the HALO NAF Collection System (NeoMatrix, Irvine, CA. Cytologic evaluation of all NAF samples was performed using previously described classification categories. Results 500 healthy women were successfully enrolled. Thirty-eight percent (190/500 produced fluid and 187 were available for cytologic analysis. Cytologic classification of fluid producers showed 50% (93/187 Category 0 (insufficient cellular material, 38% (71/187 Category I (benign non-hyperplastic ductal epithelial cells, 10% (18/187 Category II (benign hyperplastic ductal epithelial cells, 3% (5/187 Category III (atypical ductal epithelial cells and none were Category IV (unequivocal malignancy. Overall, 19% of the subjects produced NAF with adequate cellularity and 1% were found to have cytologic atypia. Conclusion The HALO system is a simple, safe, rapid, automated method for standardized collection of NAF which is acceptable to patients. Cytologic assessment of HALO-collected NAF showed the ability to detect benign and pre-neoplastic ductal epithelial cells from asymptomatic volunteers.

Clinical and Biological Predictors of Plasma Levels of Soluble RAGE in Critically Ill Patients: Secondary Analysis of a Prospective Multicenter Observational Study

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Thibaut Pranal

2018-01-01

Full Text Available Rationale. Although soluble forms of the receptor for advanced glycation end products (RAGE have been recently proposed as biomarkers in multiple acute or chronic diseases, few studies evaluated the influence of usual clinical and biological parameters, or of patient characteristics and comorbidities, on circulating levels of soluble RAGE in the intensive care unit (ICU setting. Objectives. To determine, among clinical and biological parameters that are usually recorded upon ICU admission, which variables, if any, could be associated with plasma levels of soluble RAGE. Methods. Data for this ancillary study were prospectively obtained from adult patients with at least one ARDS risk factor upon ICU admission enrolled in a large multicenter observational study. At ICU admission, plasma levels of total soluble RAGE (sRAGE and endogenous secretory (esRAGE were measured by duplicate ELISA and baseline patient characteristics, comorbidities, and usual clinical and biological indices were recorded. After univariate analyses, significant variables were used in multivariate, multidimensional analyses. Measurements and Main Results. 294 patients were included in this ancillary study, among whom 62% were admitted for medical reasons, including septic shock (11%, coma (11%, and pneumonia (6%. Although some variables were associated with plasma levels of RAGE soluble forms in univariate analysis, multidimensional analyses showed no significant association between admission parameters and baseline plasma sRAGE or esRAGE. Conclusions. We found no obvious association between circulating levels of soluble RAGE and clinical and biological indices that are usually recorded upon ICU admission. This trial is registered with NCT02070536.

Predictors for half-year outcome of impairment in daily life for back pain patients referred for physiotherapy: a prospective observational study.

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Karstens, Sven; Hermann, Katja; Froböse, Ingo; Weiler, Stephan W

2013-01-01

From observational studies, there is only sparse information available on the predictors of development of impairment in daily life for patients receiving physiotherapy. Therefore, our aim was to identify factors which predict impairment in daily life for patients with back pain 6 months after receiving physiotherapy. We conducted a prospective cohort study with 6-month follow-up. Patients were enrolled for treatment in private physiotherapy practices. Patients with a first physiotherapy referral because of thoracic or low back pain, aged 18 to 65 years were included. Primary outcome impairment was measured utilising the 16-item version of the Musculoskeletal Function Assessment Questionnaire. Therapy was documented on a standardized form. Baseline scores for impairment in daily life, symptom characteristics, sociodemographic and psychosocial factors, physical activity, nicotine consumption, intake of analgesics, comorbidity and delivered primary therapy approach were investigated as possible predictors. Univariate and multiple linear regression analyses were performed. A total of 792 patients participated in the study (59% female, mean age 44.4 (SD 11.4), with 6-month follow-up results available from 391 patients. In univariate analysis 17 variables reached significance. In multiple linear regression identified predictors were: impairment in daily life before therapy, mental disorders, duration of the complaints, self-prognosis on work ability, rheumatoid arthritis, age, form of stress at work and physical activity. The variables explain 34% of variance (adjusted R(2), pphysiotherapy patients, this study adds new knowledge for forming appropriate referral guidelines. Impairment in daily life before therapy, mental disorder as comorbidity and the duration of the complaints can be named as outstanding factors. The results of this study can be used to facilitate comparison of patient therapy goals with the prognosis in everyday practice.

Working conditions and psychotropic drug use: cross-sectional and prospective results from the French national SIP study.

Science.gov (United States)

Lassalle, Marion; Chastang, Jean-François; Niedhammer, Isabelle

2015-04-01

Prospective studies exploring the associations between a large range of occupational factors and psychotropic drug use among national samples of workers are seldom. This study investigates the cross-sectional and prospective associations between occupational factors, including a large set of psychosocial work factors, and psychotropic drug use in the national French working population. The study sample comprised 7542 workers for the cross-sectional analysis and 4213 workers followed up for a 4-year period for the prospective analysis. Psychotropic drug use was measured within the last 12 months and defined by the use of antidepressants, anxiolytics or hypnotics. Three groups of occupational factors were explored: classical and emergent psychosocial work factors, working time/hours and physical work exposures. Weighted Poisson regression analyses were performed to adjust for covariates. In the cross-sectional analysis, psychological demands, low social support and hiding emotions were associated with psychotropic drug use. Job insecurity for men and night work for women were associated with psychotropic drug use. In the prospective analysis, hiding emotions and physical exposure were predictive of psychotropic drug use. Dose-response associations were observed for the frequency/intensity of exposure and repeated exposure to occupational factors. This study underlines the role of psychosocial work factors, including emergent factors, in psychotropic drug use. Prevention policies oriented toward psychosocial work factors comprehensively may be useful to reduce this use. Copyright © 2015 Elsevier Ltd. All rights reserved.

Prospect-EPIC Utrecht: study design and characteristics of the cohort population. European Prospective Investigation into Cancer and Nutrition.

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Boker, L K; van Noord, P A; van der Schouw, Y T; Koot, N V; Bueno de Mesquita, H B; Riboli, E; Grobbee, D E; Peeters, P H

2001-01-01

The European Prospective Investigation into Cancer and Nutrition (EPIC), which has been established in order to investigate the relations between nutrition and cancer, was initiated in 1990 and involves 10 European countries with heterogeneous dietary patterns and differing cancer incidence rates. This manuscript presents the design, recruitment and baseline characteristics of the Prospect-EPIC cohort co-ordinated in Utrecht, The Netherlands. The cohort is based on volunteers recruited among women participating in a regional breast cancer screening program. It comprises of 17,357 subjects aged 50-69 years at enrolment from Utrecht and vicinity, who have consented to participate in the study and its follow-up. Each participant filled out a general questionnaire and a food frequency questionnaire. Participants were also physically examined and have donated a blood sample. Participation rate was 34.5%. Blood samples were donated by most participants (97.5%) and detailed informed consents were obtained from 87.4% of participants. Mean age at enrolment was 57 years. Anthropometric, lifestyle and morbidity characteristics of the cohort population did not differ largely from those of similar study populations in The Netherlands. Based on the Prospect-EPIC population, we intend to conduct prospective total cohort, nested case-control or case-cohort studies, in order to investigate relations between consumption of certain food groups or nutrients and chronic diseases, including hormone dependant cancers such as breast, colon, endometrial and ovary cancers.

Parents' preferences strongly influence their decisions to withhold prescribed opioids when faced with analgesic trade-off dilemmas for children: a prospective observational study.

Science.gov (United States)

Voepel-Lewis, Terri; Zikmund-Fisher, Brian J; Smith, Ellen Lavoie; Zyzanski, Sarah; Tait, Alan R

2015-08-01

Despite parents' stated desire to treat pain in their children, recent studies have critiqued their underuse of prescribed analgesics to treat pain in their children after painful procedures. Parents' analgesic preferences, including their perceived importance of providing pain relief or avoiding adverse drug effects may have important implications for their analgesic decisions, yet no studies have evaluated the influence of preferences on decisions to withhold prescribed opioids for children. We prospectively explored how parents' preferences influenced decisions to withhold prescribed opioids when faced with hypothetical dilemmas and after hospital discharge. Prospective Observational Study Design: Phase 1 included hypothetical analgesic decisions and Phase 2, real analgesic decisions after hospital discharge. Large tertiary care pediatric hospital in the Midwest of the United States. Five-hundred seven parents whose children underwent a painful surgical procedure requiring an opioid prescription were included. At baseline, parents completed surveys assessing their pain relief preference (i.e., their rated importance of pain relief relative to adverse drug event avoidance), preferred treatment thresholds (i.e., pain level at which they would give an opioid), adverse drug event understanding, and hypothetical trade-off decisions (i.e., scenarios presenting variable pain and adverse drug event symptoms in a child). After discharge, parents recorded all analgesics they gave their child as well as pain scores at the time of administration. Higher preference to provide pain relief (over avoid analgesic risk) lessened the likelihood that parents would withhold the prescribed opioid when adverse drug event symptoms were present together with high pain scores in the hypothetical scenarios. Additionally, higher preferred treatment thresholds increased the likelihood of parents withholding opioids during their hypothetical decision-making as well as at home. The strong

A Model of Microteaching Lesson Study Implementation in the Prospective History Teacher Education

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Utami, Indah Wahyu Puji; Mashuri; Nafi'ah, Ulfatun

2016-01-01

Microteaching lesson study is a model to improve prospective teacher quality by incorporating several element of microteaching and lesson study. This study concern on the implementation of microteaching lesson study in prospective history teacher education. Microteaching lesson study model implemented in this study consist of three stages: plan,…

Ultrasonography as a prognostic and objective parameter in Achilles tendinopathy: A prospective observational study

International Nuclear Information System (INIS)

Bakkegaard, Mads; Johannsen, Finn E.; Højgaard, Betina; Langberg, Henning

2015-01-01

Objectives: To study prospectively whether structural changes determined by ultrasound scanning (US) can be used as prognostic markers for outcome in patients with symptomatic Achilles tendinopathy (AT) and to investigate whether there exists an association between US findings and pain measured by visual analog scale (VAS) and a general assessment score (GA). Methods: 92 consecutive patients with AT symptoms were recruited from two outpatient clinics in rheumatology. The patients underwent a conservative treatment protocol consisting of reduced activities, controlled rehabilitation including eccentric exercises of the calf muscles and if needed supplemented with corticosteroid injections. The patients were examined clinically and by US (tendon thickness, hyper- and hypoechogenicity, calcification, bursitis, calcaneusspure, tenosynovitis, gray scale and color Doppler focusing on increased flow intra- or peritendinous). The clinical and US examination were performed at entry, 1, 2, 3 and at 6 month. Results: 42 women and 50 men were included (mean age of 47 years). They had symptoms for more than 13 months and a symptomatic Achilles tendon mean thickness of 7.4 ± 2.3 mm. Heterogeneity at the initial examination was found to be a prognostic marker for the clinical outcome. Tendon thickness, hypoechogenicity and increased flow at any time point were significantly correlated to pain at function, palpatory pain and morning pain at the same time points. A reduction in tendon thickness was statistically associated with a decrease in palpatory pain. Conclusion: Heterogeneity is a prognostic marker in AT. Tendon thickness, hypoechogenicity and increased Doppler activity can be used as objective outcome parameters for the treatment effect of AT

Ultrasonography as a prognostic and objective parameter in Achilles tendinopathy: A prospective observational study

Energy Technology Data Exchange (ETDEWEB)

Bakkegaard, Mads, E-mail: mbakkegaard@hotmail.com [Department of Rheumatology, Holbæk Hospital, Smedelundsgade 60, 4300 Holbæk (Denmark); Johannsen, Finn E., E-mail: f.e.johannsen@dadlnet.dk [Private Department of Rheumatology, Furesø-reumatologerne, Farum and ISMC, Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Bispebjerg Bakke 23, 2. Tværvej, Indgang 8, 1. sal, 2400 København NV (Denmark); Højgaard, Betina, E-mail: beho@kora.dk [Danish Institute for Local and Regional Government Research, Købmagergade 22, 1150 København K (Denmark); Langberg, Henning, E-mail: henninglangberg@gmail.com [Institute of Social Medicine, Department of Public Health and Centre for Healthy Ageing, Faculty of Heath Sciences, University of Copenhagen, Øster Farimagsgade 5, bygn. 24, postboks 2099, 1014 København (Denmark)

2015-03-15

Objectives: To study prospectively whether structural changes determined by ultrasound scanning (US) can be used as prognostic markers for outcome in patients with symptomatic Achilles tendinopathy (AT) and to investigate whether there exists an association between US findings and pain measured by visual analog scale (VAS) and a general assessment score (GA). Methods: 92 consecutive patients with AT symptoms were recruited from two outpatient clinics in rheumatology. The patients underwent a conservative treatment protocol consisting of reduced activities, controlled rehabilitation including eccentric exercises of the calf muscles and if needed supplemented with corticosteroid injections. The patients were examined clinically and by US (tendon thickness, hyper- and hypoechogenicity, calcification, bursitis, calcaneusspure, tenosynovitis, gray scale and color Doppler focusing on increased flow intra- or peritendinous). The clinical and US examination were performed at entry, 1, 2, 3 and at 6 month. Results: 42 women and 50 men were included (mean age of 47 years). They had symptoms for more than 13 months and a symptomatic Achilles tendon mean thickness of 7.4 ± 2.3 mm. Heterogeneity at the initial examination was found to be a prognostic marker for the clinical outcome. Tendon thickness, hypoechogenicity and increased flow at any time point were significantly correlated to pain at function, palpatory pain and morning pain at the same time points. A reduction in tendon thickness was statistically associated with a decrease in palpatory pain. Conclusion: Heterogeneity is a prognostic marker in AT. Tendon thickness, hypoechogenicity and increased Doppler activity can be used as objective outcome parameters for the treatment effect of AT.

Dietary fibre, whole grains, and risk of colorectal cancer: systematic review and dose-response meta-analysis of prospective studies

NARCIS (Netherlands)

Aune, D.; Chan, D.S.; Lau, R.; Vieira, R.; Greenwood, D.C.; Kampman, E.; Norat, T.

2011-01-01

OBJECTIVE: To investigate the association between intake of dietary fibre and whole grains and risk of colorectal cancer. DESIGN: Systematic review and meta-analysis of prospective observational studies. DATA SOURCES: PubMed and several other databases up to December 2010 and the reference lists of

Dietary fibre, whole grains, and risk of colorectal cancer: systematic review and dose-response meta-analysis of prospective studies

NARCIS (Netherlands)

Aune, D.; Chan, D.S.M.; Lau, R.; Vieira, R.; Greenwood, D.C.; Kampman, E.; Norat, T.

2011-01-01

Objective To investigate the association between intake of dietary fibre and whole grains and risk of colorectal cancer. Design Systematic review and meta-analysis of prospective observational studies. Data sources PubMed and several other databases up to December 2010 and the reference lists of

Correlates of non-technical skills in surgery: a prospective study.

Science.gov (United States)

Gillespie, Brigid M; Harbeck, Emma; Kang, Evelyn; Steel, Catherine; Fairweather, Nicole; Chaboyer, Wendy

2017-01-30

Communication and teamwork failures have frequently been identified as the root cause of adverse events and complications in surgery. Few studies have examined contextual factors that influence teams' non-technical skills (NTS) in surgery. The purpose of this prospective study was to identify and describe correlates of NTS. We assessed NTS of teams and professional role at 2 hospitals using the revised 23-item Non-TECHnical Skills (NOTECHS) and its subscales (communication, situational awareness, team skills, leadership and decision-making). Over 6 months, 2 trained observers evaluated teams' NTS using a structured form. Interobserver agreement across hospitals ranged from 86% to 95%. Multiple regression models were developed to describe associations between operative time, team membership, miscommunications, interruptions, and total NOTECHS and subscale scores. We observed 161 surgical procedures across 8 teams. The total amount of explained variance in NOTECHS and its 5 subscales ranged from 14% (adjusted R 2 0.12, p<0.001) to 24% (adjusted R 2 0.22, p<0.001). In all models, inverse relationships between the total number of miscommunications and total number of interruptions and teams' NTS were observed. Miscommunications and interruptions impact on team NTS performance. 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/.

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

Science.gov (United States)

Azmat, Syed Khurram; Hameed, Waqas; Lendvay, Anja; Shaikh, Babar Tasneem; Mustafa, Ghulam; Siddiqui, Muhammad Ahmed; Brohi, Sajid; Karim, Asif; Ishaque, Muhammad; Hussain, Wajahat; Bilgrami, Mohsina; Feldblum, Paul J

2014-01-01

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). 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. 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 users with Femplant (Sino-implant II). This will help to guide policies to enhance access to and the use of long-acting contraceptive implants in Pakistan and similar developing countries.

The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

NARCIS (Netherlands)

Collaboration, H.-C.; Koopmans †, P.P.; Brouwer, A.M.; Dofferhoff, A.S.M.; Flier, M. van der; Groot, R. de; Hofstede, H.J.M. ter; Keuter, M.; Ven, A.J.A.M. van der; et al.,

2012-01-01

OBJECTIVE: To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. DESIGN: Prospective

Botulinum Toxin Injection for Internal Rotation Contractures in Brachial Plexus Birth Palsy. A Minimum 5-Year Prospective Observational Study.

Science.gov (United States)

Duijnisveld, Bouke J; van Wijlen-Hempel, Marie S; Hogendoorn, Simone; de Boer, Kees S; Malessy, Martijn J A; Keurentjes, J Christiaan; Nagels, Jochem; Nelissen, Rob G H H

Brachial plexus birth palsy is frequently associated with internal rotation contractures of the shoulder as a result of muscle imbalance. The purpose of this study is to assess the effect of botulinum toxin A (BTX-A) injection in the subscapular (SC) muscle on external rotation and the need for tendon transfer for external rotation of the shoulder. A prospective comparative study was performed including 15 consecutive patients treated with BTX-A and a historic control group of 67 patients with mean age 30 months (SD 10). The BTX-A injection (2 IU/kg body weight) was performed immediately following MRI under general anesthesia in the SC muscle. Passive external rotation, the need for tendon transfer surgery, glenohumeral deformity, and muscle degeneration were evaluated. The hazard ratio for no relapse of internal rotation contracture after BTX-A injection compared with no BTX-A injection was calculated. In the BTX-A group, the passive external rotation in adduction increased from -1 degree (95% CI, -10 to 8) to 32 degrees (95% CI, 17-46) at 3 months and 6 patients were indicated for surgery compared with a decline from -2 degrees (95% CI, -7 to 3) to -11 degrees (95% CI, -17 to -6) in the control group with 66 indications for surgery. At 5 years of follow-up, 10 patients in the BTX-A group were indicated for surgery with a hazard ratio of 4.0 (95% CI, 1.9 to 8.4). BTX-A injection in the SC muscle of brachial plexus birth palsy patients can reduce internal rotation contractures and subsequently the need for tendon transfer surgery. At 5 years of follow-up a relapse was seen in 67% of the patients treated with BTX-A. Because at MRI less SC degeneration was found in the good responders on BTX-A treatment, this group seems to be the best target group. Further research is needed on patient selection for BTX-A injection including glenohumeral deformity, SC degeneration, as well as doses of BTX-A to be used. Level II-prospective comparative study.

Neurocutaneous syndrome: A prospective study

Directory of Open Access Journals (Sweden)

Radheshyam Purkait

2011-01-01

Full Text Available Background: Neurocutaneous syndromes (NCS are a group of genetic disorders that produce a variety of developmental abnormalities of the skin along with an increased risk of neurological complications. Cutaneous manifestations usually appear early in life and progress with time, but neurological features generally present at a later age. There is a paucity of data regarding the evolution of skin lesions and their correlation with the central nervous system involvement in children. Aim: The primary objective was to track the course of skin lesions in various forms of NCS in the pediatric age group. Our secondary aim was to assess whether there was any predictive value of the lesions in relation to the neurological manifestations. Materials and Methods: This prospective longitudinal study was conducted at a tertiary care pediatric dermatology referral clinic of the Institute of Child Health, Kolkata, West Bengal. Children between the age group 0 and 12 years were included in the study on the basis of standard diagnostic criteria for different NCS, during the period from March, 2000 to February, 2004, and each of the enrolled cases were followed up for a duration of six years. Results: The study population comprised of 67 children (35 boys, 32 girls.The mean age of presentation was 33.8±27.8 months (range 10 days to 111 months. The various forms of NCS observed was neurofibromatosis 1(NF1 (n=33, tuberous sclerosis complex (TSC (n=23, Sturge Weber syndrome (n=6, ataxia telangiectasia (n=2, PHACE syndrome (n=1, incontinentia pigmenti (n=1, and hypomelanosis of Ito (n=1. The presentations were varied, ranging from predominantly cutaneous to primarily neurological, depending on the disease entity and age group concerned. There was a significant increase in the number of café au lait macules (CALMs with time (P=0.0002 in NF1, unlike that of hypopigmented macules of TSC (P=0.15. Statistically, no relation was documented between the evolution of skin

Organisational justice and mental health: a systematic review of prospective studies.

Science.gov (United States)

Ndjaboué, Ruth; Brisson, Chantal; Vézina, Michel

2012-10-01

The models most commonly used, to study the effects of psychosocial work factors on workers' health, are the demand-control-support (DCS) model and Effort-Reward Imbalance (ERI) model. An emerging body of research has identified Organisational Justice as another model that can help to explain deleterious health effects. This review aimed: (1) to identify prospective studies of the associations between organisational justice and mental health in industrialised countries from 1990 to 2010; (2) to evaluate the extent to which organisational justice has an effect on mental health independently of the DCS and ERI models; and (3) to discuss theoretical and empirical overlap and differences with previous models. The studies had to present associations between organisational justice and a mental health outcome, be prospective, and be entirely available in English or in French. Duplicated papers were excluded. Eleven prospective studies were selected for this review. They provide evidence that procedural justice and relational justice are associated with mental health. These associations remained significant even after controlling for the DCS and ERI models. There is a lack of prospective studies on distributive and informational justice. In conclusion, procedural and relational justice can be considered a different and complementary model to the DCS and ERI models. Future studies should evaluate the effect of change in exposure to organisational justice on employees' mental health over time.

Associations of obesity with tracheal intubation success on first attempt and adverse events in the emergency department: An analysis of the multicenter prospective observational study in Japan.

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Yakushiji, Hiromasa; Goto, Tadahiro; Shirasaka, Wataru; Hagiwara, Yusuke; Watase, Hiroko; Okamoto, Hiroshi; Hasegawa, Kohei

2018-01-01

Obesity is deemed to increase the risk of difficult tracheal intubation. However, there is a dearth of research that examines the relationship of obesity with intubation success and adverse events in the emergency department (ED). We analyzed the data from a prospective, observational, multicenter study-the Japanese Emergency Airway Network (JEAN) 2 study from 2012 through 2016. We included all adults (aged ≥18 years) who underwent tracheal intubation in the ED. Patients were categorized into three groups according to their body mass index (BMI): lean (<25.0 kg/m²), overweight (25.0-29.9 kg/m²), and obesity (≥30.0 kg/m²). Outcomes of interest were intubation success on the first attempt and intubation-related adverse events. Of 6,889 patients who are eligible for the analysis, 5,370 patients (77%) were lean, 1,177 (17%) were overweight, and 342 (4%) were obese. Compared to the lean patients, the intubation success rates were significantly lower in the overweight and obese patients (70.9% in lean, 66.4% in overweight, and 59.3% in obese patients; P<0.001). In the multivariable analysis, compared to the lean patients, overweight (adjusted odds ratio [OR], 0.85; 95%CI, 0.74-0.98) and obese (adjusted OR, 0.62; 95%CI, 0.49-0.79) patients had a significantly lower success rate on the first attempt. Additionally, obesity was significantly associated with a higher risk of adverse events (adjusted OR, 1.62; 95%CI, 1.23-2.13). Based on the data from a multicenter prospectively study, obesity was associated with a lower success rate on the first intubation attempt and a higher risk of adverse event in the ED.

Predictors for replanning in loco-regionally advanced nasopharyngeal carcinoma patients undergoing intensity-modulated radiation therapy: a prospective observational study

International Nuclear Information System (INIS)

Yan, DanFang; Yan, SenXiang; Wang, QiDong; Liao, XinBiao; Lu, ZhongJie; Wang, YiXiang

2013-01-01

Replanning in intensity-modulated radiotherapy (IMRT) has been reported to improve quality of life and loco-regional control in patients with nasopharyngeal cancer (NPC). Determination of the criteria for replanning is, however, urgently needed. We conducted a prospective study to determine when and for what type of patients is replanning preferred through weekly repeat computed tomography (CT) imaging during the course of IMRT. We recruited 20 patients who were diagnosed as having loco-regionally advanced, non-metastatic stage III or IVa NPC and treated with concurrent platinum-based chemoradiotherapy (CRT) using IMRT. Patients received CT simulation (sim-CT) and plain magnetic resonance imaging (MRI) plus diffusion-weighted imaging (DWI) weekly for five consecutive weeks. The gross tumor volume (GTV) and clinical target volume (CTV) were delineated and recorded weekly based on the CT-CT fusion. The relationship between GTV/CTV reduction and clinical characteristics of the patients were assessed using Pearson correlation test. GTV and CTV decreased during the treatment by 36.03 mL (range, 10.91–98.82 mL) and 76.79 mL (range, 33.94–125.14 mL), respectively, after 25 fractions of treatment. The percentage reductions from their initial volume were 38.4% (range, 25.3–50.7%) and 11.8% (range, 6.7–18.3%), respectively. The greatest reductions in GTV and CTV were observed at the fourth week (i.e., upon completion of 20 fractions), compared to pre-treatment sim-CT. Weight loss and CTV reduction were significantly correlated with pre-treatment body mass index (BMI) (r = 0.58, P = 0.012, and r = 0.48, P = 0.046, respectively). However, no significant correlation was observed between CTV reduction and initial tumor volume. In addition, GTV reduction was not significantly correlated with pre-treatment tumor volume (P = 0.65), but negatively correlated with pre-treatment tumor apparent diffusion coefficient (ADC) values (r = −0.46, P = 0.042). Our results indicate

The role of personality, disability and physical activity in the development of medication-overuse headache: a prospective observational study.

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Mose, Louise S; Pedersen, Susanne S; Debrabant, Birgit; Jensen, Rigmor H; Gram, Bibi

2018-05-25

Factors associated with development of medication-overuse headache (MOH) in migraine patients are not fully understood, but with respect to prevention, the ability to predict the onset of MOH is clinically important. The aims were to examine if personality characteristics, disability and physical activity level are associated with the onset of MOH in a group of migraine patients and explore to which extend these factors combined can predict the onset of MOH. The study was a single-center prospective observational study of migraine patients. At inclusion, all patients completed questionnaires evaluating 1) personality (NEO Five-Factor Inventory), 2) disability (Migraine Disability Assessment), and 3) physical activity level (Physical Activity Scale 2.1). Diagnostic codes from patients' electronic health records confirmed if they had developed MOH during the study period of 20 months. Analyses of associations were performed and to identify which of the variables predict onset MOH, a multivariable least absolute shrinkage and selection operator (LASSO) logistic regression model was fitted to predict presence or absence of MOH. Out of 131 participants, 12 % (n=16) developed MOH. Migraine disability score (OR=1.02, 95 % CI: 1.00 to 1.04), intensity of headache (OR=1.49, 95 % CI: 1.03 to 2.15) and headache frequency (OR=1.02, 95 % CI: 1.00 to 1.04) were associated with the onset of MOH adjusting for age and gender. To identify which of the variables predict onset MOH, we used a LASSO regression model, and evaluating the predictive performance of the LASSO-mode (containing the predictors MIDAS score, MIDAS-intensity and -frequency, neuroticism score, time with moderate physical activity, educational level, hours of sleep daily and number of contacts to the headache clinic) in terms of area under the curve (AUC) was weak (apparent AUC=0.62, 95% CI: 0.41-0.82). Disability, headache intensity and frequency were associated with the onset of MOH whereas personality and the

Dietary and circulating lycopene and stroke risk: a meta-analysis of prospective studies

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LI, Xinli; XU, Jiuhong

2014-01-01

Epidemiological studies support a protective role of lycopene against stroke occurrence or mortality, but the results have been conflicting. We conducted a meta-analysis to assess the relationship between dietary or circulating lycopene and stroke risk (including stroke occurrence or mortality). Relevant papers were collected by screening the PubMed database through October 2013. Only prospective studies providing relative risk estimates with 95% confidence intervals for the association between lycopene and stroke were included. A random-effects model was used to calculate the pooled estimate. Subgroup analysis was conducted to investigate the effects of various factors on the final results. The pooled analysis of seven prospective studies, with 116,127 participants and 1,989 cases, demonstrated that lycopene decreased stroke risk by 19.3% (RR = 0.807, 95% CI = 0.680–0.957) after adjusting for confounding factors. No heterogeneity was observed (p = 0.234, I2 = 25.5%). Circulating lycopene, not dietary lycopene, was associated with a statistically significant decrease in stroke risk (RR = 0.693, 95% CI = 0.503–0.954). Lycopene could protect European, or males against stroke risk. Duration of follow-up had no effect on the final results. There was no evidence of publication bias. Lycopene, especially circulating lycopene, is negatively associated with stroke risk. PMID:24848940

Unexpected allergic reactions to food, a prospective study

NARCIS (Netherlands)

Michelsen-Huisman, A.D.; Os-Medendorp, H. van; Versluis, A.; Kruizinga, A.G.; Castenmiller, J.J.M.; Noteborn, H.P.J.M.; Houben, G.F.; Knulst, A.C.

2013-01-01

Unexpected reactions occur in patients with food allergy, but frequency data are scare. This prospective study investigates the frequency, severity and causes of unexpected allergic reactions to food in adults with a doctor's diagnosed food allergy. Participants complete an online questionnaire

Presentation of life-threatening invasive nontyphoidal Salmonella disease in Malawian children: A prospective observational study.

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MacLennan, Calman A; Msefula, Chisomo L; Gondwe, Esther N; Gilchrist, James J; Pensulo, Paul; Mandala, Wilson L; Mwimaniwa, Grace; Banda, Meraby; Kenny, Julia; Wilson, Lorna K; Phiri, Amos; MacLennan, Jenny M; Molyneux, Elizabeth M; Molyneux, Malcolm E; Graham, Stephen M

2017-12-01

Nontyphoidal Salmonellae commonly cause invasive disease in African children that is often fatal. The clinical diagnosis of these infections is hampered by the absence of a clear clinical syndrome. Drug resistance means that empirical antibiotic therapy is often ineffective and currently no vaccine is available. The study objective was to identify risk factors for mortality among children presenting to hospital with invasive Salmonella disease in Africa. We conducted a prospective study enrolling consecutive children with microbiologically-confirmed invasive Salmonella disease admitted to Queen Elizabeth Central Hospital, Blantyre, in 2006. Data on clinical presentation, co-morbidities and outcome were used to identify children at risk of inpatient mortality through logistic-regression modeling. Over one calendar year, 263 consecutive children presented with invasive Salmonella disease. Median age was 16 months (range 0-15 years) and 52/256 children (20%; 95%CI 15-25%) died. Nontyphoidal serovars caused 248/263 (94%) of cases. 211/259 (81%) of isolates were multi-drug resistant. 251/263 children presented with bacteremia, 6 with meningitis and 6 with both. Respiratory symptoms were present in 184/240 (77%; 95%CI 71-82%), 123/240 (51%; 95%CI 45-58%) had gastrointestinal symptoms and 101/240 (42%; 95%CI 36-49%) had an overlapping clinical syndrome. Presentation at Salmonella disease in Malawi is characterized by high mortality and prevalence of multi-drug resistant isolates, along with non-specific presentation. Young infants, children with dyspnea and HIV-infected children bear a disproportionate burden of the Salmonella-associated mortality in Malawi. Strategies to improve prevention, diagnosis and management of invasive Salmonella disease should be targeted at these children.

Reproducing a Prospective Clinical Study as a Computational Retrospective Study in MIMIC-II.

Science.gov (United States)

Kury, Fabrício S P; Huser, Vojtech; Cimino, James J

2015-01-01

In this paper we sought to reproduce, as a computational retrospective study in an EHR database (MIMIC-II), a recent large prospective clinical study: the 2013 publication, by the Japanese Association for Acute Medicine (JAAM), about disseminated intravascular coagulation, in the journal Critical Care (PMID: 23787004). We designed in SQL and Java a set of electronic phenotypes that reproduced the study's data sampling, and used R to perform the same statistical inference procedures. All produced source code is available online at https://github.com/fabkury/paamia2015. Our program identified 2,257 eligible patients in MIMIC-II, and the results remarkably agreed with the prospective study. A minority of the needed data elements was not found in MIMIC-II, and statistically significant inferences were possible in the majority of the cases.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer : Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

NARCIS (Netherlands)

Khankari, Nikhil K.; Shu, Xiao Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Eeles, Rosalind A.; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei; Blalock, Kendra; Campbell, Peter T.; Casey, Graham; Conti, David V.; Edlund, Christopher K.; Figueiredo, Jane; James Gauderman, W.; Gong, Jian; Green, Roger C.; Harju, John F.; Harrison, Tabitha A.; Jacobs, Eric J.; Jenkins, Mark A.; Jiao, Shuo; Li, Li; Lin, Yi; Manion, Frank J.; Moreno, Victor; Mukherjee, Bhramar; Raskin, Leon; Schumacher, Fredrick R.; Seminara, Daniela; Severi, Gianluca; Stenzel, Stephanie L.; Thomas, Duncan C.; Hopper, John L.; Southey, Melissa C.; Makalic, Enes; Schmidt, Daniel F.; Fletcher, Olivia; Peto, Julian; Gibson, Lorna; dos Santos Silva, Isabel; Ahsan, Habib; Whittemore, Alice; Waisfisz, Quinten; Meijers-Heijboer, Hanne; Adank, Muriel; van der Luijt, Rob B.; Uitterlinden, Andre G.; Hofman, Albert; Meindl, Alfons; Schmutzler, Rita K.; Müller-Myhsok, Bertram; Lichtner, Peter; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Chang-Claude, Jenny; Hein, Rebecca; Dahmen, Norbert; Beckman, Lars; Crisponi, Laura; Hall, Per; Czene, Kamila; Irwanto, Astrid; Liu, Jianjun; Easton, Douglas F.; Turnbull, Clare; Rahman, Nazneen; Eeles, Rosalind; Kote-Jarai, Zsofia; Muir, Kenneth; Giles, Graham; Neal, David; Donovan, Jenny L.; Hamdy, Freddie C.; Wiklund, Fredrik; Gronberg, Henrik; Haiman, Christopher; Schumacher, Fred; Travis, Ruth; Riboli, Elio; Hunter, David; Gapstur, Susan; Berndt, Sonja; Chanock, Stephen; Han, Younghun; Su, Li; Wei, Yongyue; Hung, Rayjean J.; Brhane, Yonathan; McLaughlin, John; Brennan, Paul; McKay, James D.; Rosenberger, Albert; Houlston, Richard S.; Caporaso, Neil; Teresa Landi, Maria; Heinrich, Joachim; Wu, Xifeng; Ye, Yuanqing; Christiani, David C.

2016-01-01

Background: Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using

Status and prospects of nuclear arms control study

International Nuclear Information System (INIS)

Sun Xiangli; Wang Deli

1995-01-01

Some main issues and problems involved in nuclear arms control study, such as nuclear policy, NPT regime, verification technologies for a CTBT and disposal of military nuclear materials are introduced, in which both the current state and prospects of these issues are analyzed

Future prospects for studying CP violation in B-meson decays

International Nuclear Information System (INIS)

Nakada, T.

1997-01-01

Experimental prospects for observing CP violation in B-meson decays are reviewed. Comparisons are made for various options: experiments a e + e - B-Meson Factories, HERA and the TEVATRON will produce results n near future. They will have a good chance to discover CP violation in B-meson decays. On a longer time scale, experiments at the LHC will aim at accurate measurements to make a precision test of the standard model in CP violation. (author)

A Study on Perception of Librarian's Job Prospects

Directory of Open Access Journals (Sweden)

Younghee Noh

2017-03-01

Full Text Available The purpose of this study is to investigate awareness of librarian’s job prospects, and to do this a survey was conducted with 502 college students in 14 Departments of Library and Information Science around Korea and 753 librarians in libraries and related agencies. The study results are as follows. First, satisfaction with educational curriculum was higher in students than librarians. Second, both students and librarians regarded workplace based practical training as employment requirements and also evaluated certifications and academic performance as important requirements. Third, both groups asked that information on employment rates be available in a timely manner, and perceived that the librarian’s job prospects were not bright. Therefore, in order to improve employment of librarians, it will be necessary to establish a job information system, reorganize the current educational curriculum into a practice-oriented curriculum, and introduce the national curriculum statements (NCS-based curriculum.

Help-seeking and antibiotic prescribing for acute cough in a Chinese primary care population: a prospective multicentre observational study.

Science.gov (United States)

Wong, Carmen Ka Man; Liu, Zhaomin; Butler, Chris C; Wong, Samuel Yeung Shan; Fung, Alice; Chan, Dicken; Yip, Benjamin Hon Kei; Kung, Kenny

2016-01-21

Acute cough is a common reason to prescribe antibiotics in primary care. This study aimed to explore help-seeking and antibiotic prescribing for acute cough in Chinese primary care population. This is a prospective multicentre observational study that included adults presenting with acute cough. Clinicians recorded patients' presenting symptoms, examination findings and medication prescription. Patients completed symptom diaries for up to 28 days by charting their symptom severity and recovery. Adjusted binary logistic regression models identified factors independently associated with antibiotic prescription. Primary care clinicians (n=19) recruited 455 patients. A total of 321 patients (70.5%) returned their completed symptom diaries. Concern about illness severity (41.6%) and obtaining a prescription for symptomatic medications (45.9%), rather than obtaining a prescription for antibiotics, were the main reasons for consulting. Antibiotics were prescribed for 6.8% (n=31) of patients, of which amoxicillin was the most common antimicrobial prescribed (61.3%), as it was associated with clinicians' perception of benefit from antibiotic treatment (odds ratio (OR): 25.9, 95% confidence interval (CI): 6.7-101.1), patients' expectation for antibiotics (OR: 5.1, 95% CI: 1.7-11.6), anticipation (OR: 5.1, 95% CI: 1.6-15.0) and request for antibiotics (OR 15.7, 95% CI: 5.0-49.4), as well as the severity of respiratory symptoms (cough, sputum, short of breath and wheeze OR: 2.7-3.7, all Pantibiotic prescription rates between private primary care clinicians and public primary care clinicians (17.4 vs 1.6%, P=0.00). Symptomatic medication was prescribed in 98.0% of patients. Mean recovery was 9 days for cough and 10 days for all symptoms, which was not significantly associated with antibiotic treatment. Although overall antibiotic-prescribing rates were low, there was a higher rate of antibiotic prescribing among private primary care clinicians, which warrants further

Prospective studies of infectious mononucleosis in university students

Science.gov (United States)

Grimm, Jennifer M; Schmeling, David O; Dunmire, Samantha K; Knight, Jennifer A; Mullan, Beth D; Ed, Julie A; Brundage, Richard C; Hogquist, Kristin A; Balfour, Henry H

2016-01-01

We performed an intensive prospective study designed to obtain as much data as possible on the incubation and early illness periods of primary Epstein–Barr virus (EBV) infection. Undergraduate students who lacked EBV antibody and oral EBV DNA (EBV-naive) were seen every 2 weeks during their freshman year. Clinical and behavioral data, oral washes and venous blood were obtained. EBV antibodies were quantified by enzyme immunoassay and viral loads by PCR. During a median 8 months of observation, 14/85 subjects experienced primary EBV infections (24 cases/100 person-years). The only significant risk factor for acquisition of EBV infection was deep kissing (P=0.02). Eleven subjects had infectious mononucleosis with a median duration of 21 days. Two subjects were hospitalized. Infections were initially identified in 12 subjects by finding EBV DNA in oral cells before onset of symptoms and in 2 subjects by symptom reporting. EBV DNA and viral capsid antigen (VCA) IgM and gp350 IgG antibodies were present in the blood before onset of illness. To provide a more robust evaluation of primary EBV infection in undergraduate university students, we combined data on risk factors and antibody responses from this and an earlier study that used the exact same clinical and laboratory methods. The observation that the only significant risk factor for acquisition of EBV infection was deep kissing was confirmed. Most importantly, higher amounts of gp350 antibody correlated significantly with a lower severity of infectious mononucleosis (P<0.0001), which strengthens the rationale for a gp350-based prophylactic EBV vaccine. PMID:27588199

Cancer of the larynx: the outcomes of conventionally fractionated radiotherapy in prospective and retrospective studies. Is the meaning of conventionality the same?

International Nuclear Information System (INIS)

Hliniak, A.; Michalski, W.; Kraszewska, E.; Szutkowski, Z.; Jarzabski, A.

2001-01-01

Two studies on the radiotherapy of laryngeal cancer were completed at the Radiotherapy Department of the Cancer Center Warsaw at the end of 1999. One of them was a multicenter randomized clinical trial, and the second one - a retrospective study on patients treated between years 1989 and 1995. An opinion exists that the trial outcomes of the conventional arm correspond to the outcomes of everyday practice. The subject of the study was to evaluate this thesis, and to find out, whether the outcomes of prospective and retrospective studies following the same treatment protocol are comparable. Selection criteria were - age ≤75, WHO 0-1, T1, T2, T3, N0, M0 stage of glottic and supraglottic laryngeal cancer. The treatment was: 66 Gy/2 Gy/33 fraction/45 days. The prospective group had - 199 patients, and the retrospective group: 150 patients. The two groups were comparable according to the age, site, sex and mean hemoglobin level. There was a significant difference in T-stage and performance status between the two groups. Overall survival, local control and CR-response were analyzed. To eliminate the influence of the differences in T=stage and performance status, regression models were applied - Cox's for survival and local control, logit for CR-response endpoint. The protocol compliance (prospective, retrospective) was as follows - total dose: (88%, 49%), treatment time: (47%, 11%) respectively. Three-year survival for the prospective and the retrospective groups were 89% and 74%, respectively (p=0.035), CR-response rates were 96% and 75%, respectively (p<0.001). There were no significant differences in probability of local recurrence in CR patients. A better outcome of treatment was observed in the prospective study group. It is probably due to a certain 'over-selection' of patients for the prospective study and many deviations from the therapeutic protocol in the historical group. 'Conventional treatment' has the same meaning in the prospective and retrospective

The Korea Nurses' Health Study: A Prospective Cohort Study.

Science.gov (United States)

Kim, Oksoo; Ahn, Younjhin; Lee, Hea-Young; Jang, Hee Jung; Kim, Sue; Lee, Jung Eun; Jung, Heeja; Cho, Eunyoung; Lim, Joong-Yeon; Kim, Min-Ju; Willett, Walter C; Chavarro, Jorge E; Park, Hyun-Young

2017-08-01

The Korea Nurses' Health Study (KNHS) is a prospective cohort study of female nurses, focusing on the effects of occupational, environmental, and lifestyle risk factors on the health of Korean women. Female registered nurses aged 20-45 years and living in the Republic of Korea were invited to join the study, which began in July 2013. They were asked to complete a web-based baseline survey. The study protocols and questionnaires related to the KNHS are based on the Nurses' Health Study 3 (NHS3) in the United States, although they were modified to reflect the Korean lifestyle. Participants were asked about demographic, lifestyle factors, disease history, occupational exposure, reproductive factors, and dietary habits during their adolescence: Follow-up questionnaires were/will be completed at 6-8 month intervals after the baseline survey. If a participant became pregnant, she answered additional questionnaires containing pregnancy-related information. Among 157,569 eligible female nurses, 20,613 (13.1%) completed the web-based baseline questionnaire. The mean age of the participants was 29.4 ± 5.9 years, and more than half of them were in their 20s. Eighty-eight percent of the participants had worked night shifts as a nurse (mean, 5.3 ± 4.3 nights per month). Approximately 80% of the participants had a body mass index below 23 kg/m 2 . Gastrointestinal diseases were the most prevalent health issues (25.9%). The findings from this prospective cohort study will help to identify the effects of lifestyle-related and occupational factors on reproductive health and development of chronic diseases in Korean women.

Predictors of Plaque Rupture Within Nonculprit Fibroatheromas in Patients With Acute Coronary Syndromes: The PROSPECT Study.

Science.gov (United States)

Zheng, Bo; Mintz, Gary S; McPherson, John A; De Bruyne, Bernard; Farhat, Naim Z; Marso, Steven P; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

2015-10-01

The study sought to examine the relative importance of lesion location versus vessel area and plaque burden in predicting plaque rupture within nonculprit fibroatheromas (FAs) in patients with acute coronary syndromes. Previous studies have demonstrated that plaque rupture is associated with larger vessel area and greater plaque burden clustering in the proximal segments of coronary arteries. In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study 3-vessel grayscale and radiofrequency-intravascular ultrasound was performed after successful percutaneous coronary intervention in 697 patients with acute coronary syndromes. Untreated nonculprit lesion FAs were classified as proximal (40 mm) according to the distance from the ostium to the maximum necrotic core site. Overall, 74 ruptured FAs and 2,396 nonruptured FAs were identified in nonculprit vessels. The majority of FAs (73.6%) were located within 40 mm of the ostium, and the vessel area and plaque burden progressively decreased from proximal to distal FA location (both p PROSPECT]; NCT00180466). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Naturalistic Observations to Investigate Conflicts Between Drivers and VRUs in the PROSPECT Project

OpenAIRE

BRUYAS, Marie-Pierre; APARICIO, Andrés; KOSEL, Miklos; AMBELLOUIS, Sébastien; ESTRAILLIER, Céline; MOREAU, Fabien; SANZ, Laura; COSTA, Joan; SOLTESZ, Tamas; BANFI, Miklos

2017-01-01

ESV 2017 - 25th International Technical Conference on the Enhanced Safety of Vehicles, DETROIT, ETATS-UNIS, 05-/06/2017 - 08/06/2017; PROSPECT aims at developing a new generation of proactive safety systems to protect Vulnerable Road Users (VRUs), with an emphasis on pedestrians and cyclists. To improve sensor effectiveness, PROSPECT will expand the scope of scenarios addressed by sensors already on the market, enhancing their overall performance. Interactions between vehicles and VRUs were i...

Neonatal and maternal outcomes of successful manual rotation to correct malposition of the fetal head; A retrospective and prospective observational study.

Science.gov (United States)

Tempest, Nicola; McGuinness, Naomi; Lane, Steven; Hapangama, Dharani K

2017-01-01

To evaluate the neonatal and maternal outcomes associated with successful operative vaginal births assisted by manual rotation. Prospective and retrospective observational study. Delivery suite in a tertiary referral teaching hospital in England. A cohort of 2,426 consecutive operative births, in the second stage of labour, complicated with malposition of the fetal head during 2006-2013. Outcomes of all births successfully assisted by manual rotation followed by direct traction instruments were compared with other methods of operative birth for fetal malposition in the second stage of labour (rotational ventouse, Kielland forceps and caesarean section). Associated neonatal outcomes (admission to the special care baby unit, low cord pH, low Apgar and shoulder dystocia) and maternal outcomes (massive obstetric haemorrhage (blood loss of >1500ml) and obstetric anal sphincter injury). Births successfully assisted with manual rotation followed by direct traction instruments, resulted in 10% (36/346) of the babies being admitted to the Special Care Baby Unit, 4.9% (17/349) shoulder dystocia, 2% (7/349) massive obstetric haemorrhage and 1.7% (6/349) obstetric anal sphincter injury, similar to other methods of rotational births. Adverse neonatal and maternal outcomes associated with successful manual rotations followed by direct traction instruments were comparable to traditional methods of operative births. There is an urgent need to standardise the practice (guidance, training) and documentation of manual rotation followed by direct traction instrumental deliveries that will enable assessment of its efficacy and the absolute safety in achieving a vaginal birth.

A prospective study of 137 patients with Parkinson's disease and anosmia

Directory of Open Access Journals (Sweden)

Soltanzadeh A

1997-08-01

Full Text Available In this research we tried to study frequency of clinical manifestations in Parkinson's disease. Hence, a prospective study was conducted in 317 patients who were affected by Parkinson's disease. In a questionnaire we collected data of patient's age, gender and signs and symptoms and then analyzed them. The most common features in our patients were tremor and muscular rigidity. Olfactory dysfunction was observed in 61% of our patients. Dysarthria, stooped posture, fixed facial expression, intellectual deterioration and the on-off response had various frequency among the patients. A new and important point in our research was considerable frequency of Anosmia or Hyposmia in spite of it's low prevalence among the patients of previous studies.

Prevalence, diagnosis, and disease course of pertussis in adults with acute cough: a prospective, observational study in primary care.

Science.gov (United States)

Teepe, Jolien; Broekhuizen, Berna D L; Ieven, Margareta; Loens, Katherine; Huygen, Kris; Kretzschmar, Mirjam; de Melker, Hester; Butler, Chris C; Little, Paul; Stuart, Beth; Coenen, Samuel; Goossens, Herman; Verheij, Theo J M

2015-10-01

Most cases of adult pertussis probably remain undiagnosed. To explore the prevalence, diagnosis, and disease course of acute pertussis infection in adult patients presenting with acute cough. Prospective observational study between 2007 and 2010 in primary care in 12 European countries. Adults presenting with acute cough (duration of ≤28 days) were included. Bordetella pertussis infection was determined by polymerase chain reaction (from nasopharyngeal flocked swabs and sputa) and by measurement of immunoglobulin G antibodies to pertussis toxin (PT) in venous blood at day 28. An antibody titre to PT of ≥125 IU/ml or PCR positive result in a respiratory sample defined recent infection. Patients completed a symptom diary for 28 days. Serum and/or respiratory samples were obtained in 3074 patients. Three per cent (93/3074) had recent B. pertussis infection. Prior cough duration >2 weeks discriminated to some extent between those with and without pertussis (adjusted odds ratio 1.89, 95% confidence interval = 1.17 to 3.07; P = 0.010). Median cough duration after presentation was 17 and 12 days in patients with and without pertussis, respectively (P = 0.008). Patients with pertussis had longer duration of phlegm production (P = 0.010), shortness of breath (P = 0.037), disturbed sleep (P = 0.013) and interference with normal activities or work (P = 0.033) after presentation. Pertussis infection plays a limited role among adults presenting with acute cough in primary care, but GPs should acknowledge the possibility of pertussis in uncomplicated lower respiratory tract infection. As in children, pertussis also causes prolonged symptoms in adults. However, pertussis is difficult to discern from other acute cough syndromes in adults at first presentation. © British Journal of General Practice 2015.

Consumption of garlic and risk of colorectal cancer: an updated meta-analysis of prospective studies.

Science.gov (United States)

Hu, Ji-Yi; Hu, Yi-Wang; Zhou, Jiao-Jiao; Zhang, Meng-Wen; Li, Dan; Zheng, Shu

2014-11-07

To conduct an updated meta-analysis of prospective studies addressing the association between garlic consumption and colorectal cancer. Eligible cohort studies were identified by searching MEDLINE (PubMed) and screening the references of related articles published up to October 2013. Meta-analyses were conducted for colorectal cancer in relation to consumption of raw and cooked (RC) garlic and garlic supplements, separately. The summary relative risks (RR) with 95%CI were calculated using fixed-effects or random-effects model depending on the heterogeneity among studies. A total of 5 prospective cohort studies were identified. In contrast to the previous meta-analysis, no significant associations were found between consumption of RC garlic (RR: 1.06; 95%CI: 0.95-1.19) or garlic supplements (RR: 1.12; 95%CI: 0.96-1.31) and risk of colorectal cancer. A non-significant protective effect of garlic supplement intake against colorectal cancer was observed in females (RR: 0.84; 95%CI: 0.64-1.11), but the opposite was the case in males (RR: 1.24; 95%CI: 0.96-1.59). Consumption of RC garlic or garlic supplements is not significantly associated with reduced colorectal cancer risk.

DADOS-Prospective: an open source application for Web-based prospective data collection

Directory of Open Access Journals (Sweden)

Nguyen Lam

2006-11-01

Full Text Available Abstract Background Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. Results Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched. Conclusion DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.

Hard X-ray Emission from Galaxy Clusters Observed with INTEGRAL and Prospects for Simbol-X

Science.gov (United States)

Eckert, D.; Paltani, S.; Courvoisier, T. J.-L.

2009-05-01

Some galaxy clusters are known to contain a large population of relativistic electrons, which produce radio emission through synchrotron radiation. Therefore, it is expected that inverse-Compton scattering of the relativistic electrons with the CMB produce non-thermal emission which should be observable in the hard X-ray domain. Here we focus on the recent results by INTEGRAL, which shed a new light on the non-thermal emission thanks to its angular resolution and sensitivity in the hard X-ray range. We also present the exciting prospects in this field for Simbol-X, which will allow us to detect the non-thermal emission in a number of clusters and map the magnetic field throughout the intra-cluster medium.

Accuracy of a Wrist-Worn Wearable Device for Monitoring Heart Rates in Hospital Inpatients: A Prospective Observational Study.

Science.gov (United States)

Kroll, Ryan R; Boyd, J Gordon; Maslove, David M

2016-09-20

As the sensing capabilities of wearable devices improve, there is increasing interest in their application in medical settings. Capabilities such as heart rate monitoring may be useful in hospitalized patients as a means of enhancing routine monitoring or as part of an early warning system to detect clinical deterioration. To evaluate the accuracy of heart rate monitoring by a personal fitness tracker (PFT) among hospital inpatients. We conducted a prospective observational study of 50 stable patients in the intensive care unit who each completed 24 hours of heart rate monitoring using a wrist-worn PFT. Accuracy of heart rate recordings was compared with gold standard measurements derived from continuous electrocardiographic (cECG) monitoring. The accuracy of heart rates measured by pulse oximetry (Spo2.R) was also measured as a positive control. On a per-patient basis, PFT-derived heart rate values were slightly lower than those derived from cECG monitoring (average bias of -1.14 beats per minute [bpm], with limits of agreement of 24 bpm). By comparison, Spo2.R recordings produced more accurate values (average bias of +0.15 bpm, limits of agreement of 13 bpm, P<.001 as compared with PFT). Personal fitness tracker device performance was significantly better in patients in sinus rhythm than in those who were not (average bias -0.99 bpm vs -5.02 bpm, P=.02). Personal fitness tracker-derived heart rates were slightly lower than those derived from cECG monitoring in real-world testing and not as accurate as Spo2.R-derived heart rates. Performance was worse among patients who were not in sinus rhythm. Further clinical evaluation is indicated to see if PFTs can augment early warning systems in hospitals. ClinicalTrials.gov NCT02527408; https://clinicaltrials.gov/ct2/show/NCT02527408 (Archived by WebCite at  http://www.webcitation.org/6kOFez3on).

[Observation of critically ill patients

DEFF Research Database (Denmark)

Fuhrmann, L.; Hesselfeldt, R.; Lippert, A.

2009-01-01

. MATERIAL AND METHODS: Prospective observational study at Herlev Hospital, Copenhagen, Denmark. Study personnel measured vital signs on all patients present on five wards during the evening and night and interviewed nursing staff about patients with abnormal vital signs. Subsequently, patient records were...

Prospective observational study of the effect of dual antiplatelet therapy with tranexamic acid treatment on platelet function and bleeding after cardiac surgery.

Science.gov (United States)

Amour, J; Garnier, M; Szymezak, J; Le Manach, Y; Helley, D; Bertil, S; Ouattara, A; Riou, B; Gaussem, P

2016-12-01

The bleeding impact of dual antiplatelet therapy (DAPT), aspirin and clopidogrel, maintained until coronary artery bypass graft surgery (CABG), is still a matter of debate. The lack of preoperative antiplatelet activity measurement and heterogeneity of antifibrinolytic protocols in prior studies make the conclusions questionable. The aim of this prospective study was to determine, after preoperative antiplatelet activity measurement, if the maintenance of DAPT until CABG increases bleeding in patients treated with tranexamic acid (TA). This observational study included 150 consecutive patients, 89 treated with aspirin and 61 treated with DAPT, undergoing a first-time planned on-pump CABG with TA treatment. Antiplatelet activity was measured with platelet aggregation tests and quantification of VASP phosphorylation. Postoperative bleeding at 24 h was recorded and propensity score analysis was performed. Based on VASP assay, 54% of patients showed high on-clopidogrel platelet activity inhibition. Postoperative bleeding at 24 h increased by 22% in the DAPT group, compared with the aspirin group (680 [95% CI: 360-1670] vs 558 [95%CI: 267-1270] ml, P < 0.01), consistent with increased blood transfusion (21% vs 7%, P = 0.01); a higher incidence of mediastinitis did not reach statistical significance (15% vs 4%, P = 0.05). Bleeding correlated with the extent of clopidogrel antiplatelet effect, with the best correlation for the VASP assay. Maintenance of DAPT until the day of CABG in patients treated with TA, increased postoperative bleeding at 24 h in parallel with preoperative antiplatelet activity induced by clopidogrel. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

The correlation between white matter hyperintensity and balance disorder and fall risk: An observational, prospective cohort study.

Science.gov (United States)

Shen, Dong-Chao; Wu, Shuo-Lin; Shi, Yu-Zhi; Wang, Shuo; Zhang, Yu-Mei; Wang, Chun-Xue

2016-09-01

The presence of an association between white matter hyperintensity (WMH) and the risk of falls in older people is uncertain, with little supporting prospective evidence available at present. We aimed to determine whether WMH was associated with dysfunctions of balance and gait, and other sensorimotor factors leading to falls, and the independent factors related to falls in older Chinese people. The protective effect of exercise against falls was also addressed. In a representative sample of hospital-based individuals aged 50 years and older in China, the patients' history of falls, magnetic resonance imaging data, scores on the 9-item Berg Balance Scale (BBS-9) test and timed up-and-go test (TUGT), and sensorimotor measures of computerized dynamic posturography (CDP) were analyzed. Incident falls were recorded prospectively over a 12-month period. Using regression modeling, the association between the risk of falls and baseline WMH was estimated. Only individuals with severe WMH were at an increased risk of falls, and CDP was more sensitive than BBS-9 in detecting WMH-related balance and gait dysfunction. However, WMH was not an independent predictor of falls. Taller height and overweight or obese body habitus were identified as novel protective factors for falls. Female, fall history, and increased TUGT score were identified as independent risk factors for falls in older Chinese people. Although WMH was associated with an increased risk of falls, it was not an independent predictor.

Clinical Practice in the Use of Adjuvant Chemotherapy for Patients with Colon Cancer in South Korea: a Multi-Center, Prospective, Observational Study.

Science.gov (United States)

Kim, Jung Han; Baek, Moo Jun; Ahn, Byung-Kwon; Kim, Dae Dong; Kim, Ik Yong; Kim, Jin Soo; Bae, Byung-Noe; Seo, Bong-Gun; Jung, Sang Hun; Hong, Kwan Hee; Kim, Hungdai; Park, Dong Guk; Lee, Ji Hye

2016-01-01

Adjuvant chemotherapy is a crucial part of treatment for patients with locally advanced colon cancer. This study was conducted to investigate the actual practice in the use of adjuvant chemotherapy for patients with high-risk stage II or stage III colon cancer in South Korea. This was a 24-month open-label, prospective, observational study conducted at 12 centers across South Korea. Patients with high-risk stage II and stage III colon cancer receiving adjuvant chemotherapy after curative surgery were included, and data were collected at baseline, third, and sixth month. A total of 246 patients were included in the analyses. Of five available regimens (FOLFOX, CAPOX, 5-FU/LV, capecitabine, and UFT/LV), FOLFOX was most commonly used (82.5%). Investigators indicated the "efficacy" as the major cause for selecting FOLFOX or CAPOX. For 5-FU/LV, capecitabine, or UFT/LV, the "safety" or "patient's characteristics (age, comorbidity, and stage)" was one of the most important selecting factors. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX. Hematologic toxicities were the most common cause of dose adjustment and treatment delay. In South Korea, FOLFOX was the most commonly used regimen for adjuvant chemotherapy and its efficacy was the main cause for selecting this regimen. Patients receiving 5-FU/LV, capecitabine, or UFT/LV had older age, worse PS and lower disease stage (stage II) than patients receiving FOLFOX or CAPOX.

The role of unconditional cash transfers during a nutritional emergency in Maradi region, Niger: A prospective observational study

International Nuclear Information System (INIS)

Fenn, Bridget; Noura, Garba; Sibson, Victoria; Dolan, Carmel; Shoham, Jeremy

2014-01-01

Full text: Cash transfers (CTs) are becoming a popular intervention of choice by agencies and NGOs as a complementary or alternative approach to food-based assistance, as part of an emergency response. There is strong evidence that CT programmes lead to an increase in household income and protect household assets from being sold, resulting in an increase in food quantity and improved dietary diversity which in turn are thought to protect children from malnutrition. However, the evidence for an impact of CTs on undernutrition is mixed and inconclusive. Despite this, CTs are increasingly being used in emergency responses with an objective of preventing acute malnutrition. The main objective was to assess the effect of an unconditional CT implemented as part of an emergency response to food insecurity during a declared state of emergency in Aguie district, Maradi, Niger. This was a prospective observational study involving 6 consecutive months of data collection starting pre-intervention in April 2012 (baseline), on the same cohort of ‘poor’ and ‘very poor’ households, with a non-acutely malnourished child 6-36 months, enrolled by Save the Children in an unconditional CT programme (n = 412). Analyses using pre-post intervention data were carried out to assess changes in the potential mediating factors within the causal pathway between CT and acute malnutrition over time and to estimate risk factors associated with acute malnutrition. The study showed that the living standards of ‘poor’ and ‘very poor’ households improved; indicated by reduction in poverty (improvement in household expenditures, incomes, employment, asset protection, wealth rank and access to social networks) and improvement in household food security (reduced household hunger and greater household and child dietary diversity). Child anthropometric outcomes (weight-for-height and MUAC) significantly improved (p 0•05). The results from this study are consistent with the available

Compensatory enlargement of the left main coronary artery: insights from the PROSPECT study.

Science.gov (United States)

Inaba, Shinji; Mintz, Gary S; Shimizu, Takehisa; Weisz, Giora; Mehran, Roxana; Marso, Steven P; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

2014-03-01

Glagov proposed that remodeling delayed development of significant coronary artery stenoses until plaque occupied, on average, 40% of arterial area (40% plaque burden). The aim of the current study was to confirm the previously proposed concept of coronary remodeling as first described by Glagov who studied postmortem left main coronary arteries (LMCAs). Using the in-vivo intravascular ultrasound data from the Providing Regional Observations to Study Predictors of Events in the Coronary Tree (PROSPECT) study, we evaluated 552 LMCAs in 552 patients. External elastic membrane cross-sectional areas (CSAs) increased in proportion to the increase in plaque and media CSAs (r=0.61, P40% plaque burden), there was an inverse relationship between lumen CSA and plaque burden (r=-0.57, PPROSPECT study patients. In addition, the present study suggested that plaque phenotype worsened with increasing LMCA plaque growth.

Danish Observational Study of Eldercare work and musculoskeletal disorderS (DOSES)

DEFF Research Database (Denmark)

Karstad, Kristina; Jørgensen, Anette F B; Greiner, Birgit A

2018-01-01

PURPOSE: Musculoskeletal disorders (MSDs), sickness absence and premature retirement are highly prevalent among eldercare workers. We conducted a prospective observational workplace study with the main purpose to investigate longitudinal associations between physical and psychosocial working...... and team factors for distribution of physical work demands and development of MSD among the workers. This will provide important knowledge for future workplace interventions to reduce MSD and sickness absence....... conditions and occurrence of MSD and its consequences (pain-related interference with daily work activities and sickness absence) among Danish eldercare workers. PARTICIPANTS: At 20 Danish nursing homes, a total of 941 eldercare workers employed in day and evening shifts were invited to the study. Of those...

Applications of prospecting geochemical techniques to the search for and to the study of uranium deposits in metropolitan France; Applications des techniques geochimiques de prospection a la recherche et a l'etude des gites uraniferes en France metropolitaine

Energy Technology Data Exchange (ETDEWEB)

Grimbert, Arnold

1957-07-01

After having recalled facts which leaded the CEA to use new geochemical techniques for the prospecting of uranium deposits through sampling and analysis of soils and waters, the author describes the organisation and methods implemented for this prospecting activity: team composition for sampling and analysis, role of each engineer and technician in the prospecting stages (preliminary study, routine prospecting, result interpretation), sampling and analysis processes. He also reports campaigns of geochemical prospecting: study of the La Chapelle Largeau deposit (objectives, geological context, preliminary study, routine prospecting, study of geochemical anomalies), tactical research on Verneix indices (study of radioactivity anomaly discovered by radio-prospecting), strategical searches in a non prospected area in the South of Avallon. The author discusses the issues of efficiency and cost price of this geochemical prospecting technique in soils and in waters. Appendices present the equipment and operation modality for soil sampling, and for soil sample preparation, and principles, equipment and products for soil analysis and for water analysis [French] A la suite des resultats satisfaisants obtenus dans la recherche de methodes de dosage adaptees au cas de l'uranium, la Direction des Recherches Minieres du Commissariat a l'Energie atomique a decide, en decembre 1954, d'utiliser, conjointement avec les methodes classiques de prospection, les techniques geochimiques pour la recherche et l'etude des gites uraniferes. Ces applications pratiques ont ete confiees a une Section de Geochimie dont l'organisation, les moyens en personnel et en materiel, ainsi que les methodes de travail, font l'objet d'un expose detaille. Quelques exemples de prospection, en France metropolitaine, montrent la nature des problemes poses (etude d'un gisement connu, recherche tactique sur des indices, recherche strategique dans une region non prospectee), les methodes utilisees pour les

Persistent postsurgical pain after video-assisted thoracic surgery – an observational study

DEFF Research Database (Denmark)

Wildgaard, Kim; Ringsted, T K; Jessen Hansen, Henrik

2016-01-01

on activities of daily living of PPP after VATS. METHODS: Using a prospective observational design, 47 patients undergoing VATS completed both preoperative, early postoperative and 3 months follow-up. Preoperative pain, pain characteristics, psychological factors, pain-related functional impairment...

Scientific knowledge and modern prospecting

Science.gov (United States)

Neuerburg, G.J.

1985-01-01

Modern prospecting is the systematic search for specified and generally ill-exposed components of the Earth's crust known as ore. This prospecting depends entirely on reliable, or scientific knowledge for guidance and for recognition of the search objects. Improvement in prospecting results from additions and refinements to scientific knowledge. Scientific knowledge is an ordered distillation of observations too numerous and too complex in themselves for easy understanding and for effective management. The ordering of these observations is accomplished by an evolutionary hierarchy of abstractions. These abstractions employ simplified descriptions consisting of characterization by selected properties, sampling to represent much larger parts of a phenomenon, generalized mappings of patterns of geometrical and numerical relations among properties, and explanation (theory) of these patterns as functional relations among the selected properties. Each abstraction is predicated on the mode of abstraction anticipated for the next higher level, so that research is a deductive process in which the highest level, theory, is indispensible for the growth and refinement of scientific knowledge, and therefore of prospecting methodology. ?? 1985 Springer-Verlag.

Prospective elementary school teachers’ views about socioscientific issues: A concurrent parallel design study

Directory of Open Access Journals (Sweden)

Muhammet Özden

2015-07-01

Full Text Available The purpose of this research is to examine the prospective elementary school teachers’ perceptions on socioscientific issues. The research was conducted on prospective elementary school teachers studying at a university located in western Turkey. The researcher first taught the subjects of global warming and nuclear power plants from a perspective of socioscientific issues in the science and technology education course and then conducted the research. Concurrent parallel design, one of the mixed-method research approaches, was used to conduct the research. In this context, semi-structured interviews were conducted with eight teachers in the qualitative strand of the study to explore the phenomenon. The data obtained from the interviews were analyzed using thematic analysis. During the quantitative strand of the research, 113 prospective teachers were administered a questionnaire form. The results of the study revealed that none of the participating prospective teachers mentioned about the religious and cultural characteristics of socioscientific issues, and they need training about how to use socioscientific issues in teaching.

Prospective Elementary School Teachers’ Views about Socioscientific Issues: A Concurrent Parallel Design Study

Directory of Open Access Journals (Sweden)

Muhammet ÖZDEN

2015-06-01

Full Text Available The purpose of this research is to examine the prospective elementary school teachers’ perceptions on socioscientific issues. The research was conducted on prospective elementary school teachers studying at a university located in western Turkey. The researcher first taught the subjects of global warming and nuclear power plants from a perspective of socioscientific issues in the science and technology education course and then conducted the research. Concurrent parallel design, one of the mixed-method research approaches, was used to conduct the research. In this context, semi-structured interviews were conducted with eight teachers in the qualitative strand of the study to explore the phenomenon. The data obtained from the interviews were analyzed using thematic analysis. During the quantitative strand of the research, 113 prospective teachers were administered a questionnaire form. The results of the study revealed that none of the participating prospective teachers mentioned about the religious and cultural characteristics of socioscientific issues, and they need training about how to use socioscientific issues in teaching.

Formulating autism systemically: Part 2 - A 12-year prospective case study.

Science.gov (United States)

Brewerton, Nicky; Robson, Katrina; Crittenden, Patricia M

2017-07-01

This prospective case study illustrates the ideas on the developmental origins of some cases of autism that were described in Part 1 of this article. We explored and found support for several systemic hypotheses regarding the experience of 'Graeme' and his mother. Graeme's story is told prospectively from the age of 3 until 15. Three independent sources of information are reported: hypotheses from the literature and case review in Part 1 of this article, the school's experience, and observations from the assessments of attachment when Graeme was turning 6. These three streams of information are integrated here. The review of the literature and clinical cases gives us a wide-angle lens, empirically supporting our focus on danger in relationships. The school's experience describes working with a child with undiagnosed autism. The assessments of attachment both provide information about family members' psychological strategies for protection from danger and also include the mother's childhood history of family threat. Their synthesis permits us to construct a developmental history, from Graeme's mother's childhood history of being triangulated into her parents' hidden marital discord to it's repetition for Graeme in her own marriage. New observations included mum's postural/gestural communication to Graeme and her possible ambivalence about males. Strikingly, Graeme was a case study (Attachment & Family Therapy, ch. 6) before he was diagnosed with autism. That presentation focused on Graeme's feeling of rejection by his father. In the same book, an interpersonal formulation of autism was offered (ch. 3), but it was not connected to Graeme, showing that when one lacks crucial information, the clinical formulation is distorted. The crucial information in this case was the mother's psychological history. Our case suggests that filling the blind spot in the research on autism with information about family functioning over at least two generations might change the

Observational prospective study on Lactobacillus plantarum P 17630 in the prevention of vaginal infections, during and after systemic antibiotic therapy or in women with recurrent vaginal or genitourinary infections.

Science.gov (United States)

Cianci, Antonio; Cicinelli, Ettore; De Leo, Vincenzo; Fruzzetti, Franca; Massaro, Maria Giulia; Bulfoni, Alessandro; Parazzini, Fabio; Perino, Antonio

2018-03-12

We performed a prospective cohort parallel observational study on the use of Lactobacillus plantarum P 17630 in the prevention of vaginal infections. Eligible were women with a diagnosis of bacterial vaginosis (Lactobacillus plantarum P 17630 > 100.000.000 UFC one vaginal capsule per day for 6 days, then a capsule per week for 16 weeks. Eligible subjects were enrolled in two parallel cohorts: 85 women using (group A) and 39 not using (group B) Lactobacillus plantarum P 17630. The risk of recurrent infection within 4 months from the study entry, was higher among untreated women: multivariate OR 2.6 (95%CI 0.7-9.4). The modification of presence/intensity or symptoms was significant in both the study groups (p Lactobacillus plantarum P 17630 has been shown to be active in the treatment of bacterial vaginosis and vaginal candidiasis. No data are available on its efficacy in the prevention of recurrent vaginal or urological infection or as a prevention strategy during systemic treatment with antibiotics. What do the results of this study add? This observational study suggests that Lactobacillus plantarum given for 4 months may lower the risk of recurrent infection in women with recurrent vaginal or genitourinary infection or after antibiotic systemic treatment for bacterial respiratory tract infection. The finding, however, is not statistically significant, possibly due to the lower than expected rate of infection observed in our population and consequently the limited power of the study. What are the implications of these findings for clinical practice and/or further research? New studies are needed in order to evaluate in different populations the role of Lactobacillus plantarum in lowering the risk of recurrent infection in a high-risk populations.

Relationship between lower limb position and pelvic floor muscle surface electromyography activity in menopausal women: a prospective observational study

Directory of Open Access Journals (Sweden)

Halski T

2017-01-01

Full Text Available Tomasz Halski,1 Kuba Ptaszkowski,2 Lucyna Słupska,1 Robert Dymarek,3 Małgorzata Paprocka-Borowicz2 1Department of Physiotherapy, Opole Medical School, Opole, 2Department of Clinical Biomechanics and Physiotherapy in Motor System Disorders, 3Department of Nervous System Diseases, Faculty of Health Science, Wroclaw Medical University, Wroclaw, Poland Objectives: In physiotherapeutic practice, special attention is being given to the reciprocal anatomical, physiological, and biomechanical relationship of the pelvis and the structures connected to it. However, the scientific literature shows mainly the theoretical information about their mutual connections. The lack of information about these relations from a practical aspect coupled with the paucity of scientific papers on the impact of posture changes on the pelvic floor led the authors to conduct this study. The primary aim of this study was to compare the resting and functional bioelectrical activities of pelvic floor muscles (PFMs depending on three different positions of the lower limbs (positions A, B, and C in the supine position.Materials and methods: This was a prospective observational study evaluating resting and functional activities of the PFM depending on the position of the lower limbs. The study was carried out at the Department and Clinic of Urology, University Hospital in Wroclaw, Poland and the target group were women in the menopausal period. Bioelectrical activity of PFM was recorded using a surface electromyographic instrument in the supine position. Results of the values obtained in A, B, and C positions were compared using a one-way analysis of variance.Results: In position A, the average resting surface electromyography (sEMG activity of PFM was 6.9±2.6 µV; in position B, the result was 6.9±2.5 µV and in position C, the resting sEMG activity was 5.7±1.8 µV (P=0.0102. The results of the functional bioelectrical activity of PFM were as follows: position A – 20.3�

Minimising post-operative risk using a Post-Anaesthetic Care Tool (PACT): protocol for a prospective observational study and cost-effectiveness analysis.

Science.gov (United States)

Street, Maryann; Phillips, Nicole M; Kent, Bridie; Colgan, Stephen; Mohebbi, Mohammadreza

2015-06-01

While the risk of adverse events following surgery has been identified, the impact of nursing care on early detection of these events is not well established. A systematic review of the evidence and an expert consensus study in post-anaesthetic care identified essential criteria for nursing assessment of patient readiness for discharge from the post-anaesthetic care unit (PACU). These criteria were included in a new nursing assessment tool, the Post-Anaesthetic Care Tool (PACT), and incorporated into the post-anaesthetic documentation at a large health service. The aim of this study is to test the clinical reliability of the PACT and evaluate whether the use of PACT will (1) enhance the recognition and response to patients at risk of deterioration in PACU; (2) improve documentation for handover from PACU nurse to ward nurse; (3) result in improved patient outcomes and (4) reduce healthcare costs. A prospective, non-randomised, pre-implementation and post-implementation design comparing: (1) patients (n=750) who have surgery prior to the implementation of the PACT and (2) patients (n=750) who have surgery after PACT. The study will examine the use of the tool through the observation of patient care and nursing handover. Patient outcomes and cost-effectiveness will be determined from health service data and medical record audit. Descriptive statistics will be used to describe the sample and compare the two patient groups (pre-intervention and post-intervention). Differences in patient outcomes between the two groups will be compared using the Cochran-Mantel-Haenszel test and regression analyses and reported as ORs with the corresponding 95% CIs. This study will test the clinical reliability and cost-effectiveness of the PACT. It is hypothesised that the PACT will enable nurses to recognise and respond to patients at risk of deterioration, improve handover to ward nurses, improve patient outcomes, and reduce healthcare costs. Published by the BMJ Publishing Group

Open abdominal management after damage-control laparotomy for trauma: a prospective observational American Association for the Surgery of Trauma multicenter study.

Science.gov (United States)

Dubose, Joseph J; Scalea, Thomas M; Holcomb, John B; Shrestha, Binod; Okoye, Obi; Inaba, Kenji; Bee, Tiffany K; Fabian, Timothy C; Whelan, James; Ivatury, Rao R

2013-01-01

We conducted a prospective observational multi-institutional study to examine the natural history of the open abdomen (OA) after trauma and identify risk factors for failure to achieve definitive primary fascial closure (DPC) after OA use in trauma. Adults requiring OA for trauma were enrolled during a 2-year period. Demographics, presentation, and management variables were used to compare primary fascial closure and non-primary fascial closure patients, with logistic regression used to identify independent risk factors for failure to achieve primary fascial closure. A total of 572 patients from 14 American College of Surgeons-verified Level I trauma centers were enrolled. The majority were male (79%), mean (SD) age 39 (17) years. Injury Severity Score (ISS) was 15 or greater in 85% of patients and 84% had an abdominal Abbreviated Injury Scale (AIS) score of 3 or greater. Overall mortality was 23%. Initial primary fascial closure with unaltered native fascia was achieved in 379 patients (66%). Patients surviving at least 48 hours were grouped into those achieving DPC and those who did not achieve DPC after OA use. After logistic regression, independent risk factors for failure to achieve DPC included the number of reexplorations required (adjusted odds ratio [AOR], 1.3; 95% confidence interval (CI), 1.2-1.6; p < 0.001) the development of intra-abdominal abscess/sepsis (AOR, 2.4; 95% CI, 1.2-4.8; p = 0.011) bloodstream infection (AOR, 2.6; 95% CI, 1.2-5.7; p = 0.017), acute renal failure (AOR, 2.3; 95% CI, 1.2-5.7; p = 0.007), enteric fistula (AOR, 6.4; 95% CI, 1.2-32.8; p = 0.010) and ISS of greater than 15 (AOR, 2.5; 95% CI, 1.1-5.9; p = 0.037). Our study identifies independent risk factors associated with failure to achieve primary fascial closure during initial hospitalization after OA use for trauma. Additional study is required to validate appropriate algorithms that optimize the opportunity to achieve primary fascial closure and outcomes in this population

Differences in kinetic variables between injured and noninjured novice runners : A prospective cohort study

NARCIS (Netherlands)

Bredeweg, Steef W.; Kluitenberg, Bas; Bessem, Bram; Buist, Ida

Objectives: This prospective study examined differences in kinetic variables between injured and noninjured novice female and male runners and their potential contribution to RRIs. Design: A prospective cohort study. Methods: At baseline vertical ground reaction forces were assessed with an

Depression after CABG: a prospective study

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Joana Kátya Veras Rodrigues Sampaio Nunes

2013-12-01

Full Text Available INTRODUCTION: Depression during or shortly after hospitalization elevated two to three times the risk of mortality or nonfatal cardiac events, significantly increasing the morbidity and mortality of these patients. OBJECTIVE: To assess the impact of revascularization on symptoms of depression in patients with coronary artery disease. METHODS: A prospective cohort study of 57 patients of both sexes undergoing coronary artery bypass grafting between June 2010 and June 2011. We used the SF-36 to assess quality of life, and the Beck Depression Inventory to detect depressive symptoms, applied preoperatively and six months. RESULTS: The prevalence of patients aged 60-69 years was 22 patients (38.60%, 39 men (68.42%, 26 described themselves as mixed race (45.61%, 16 literate (28.07 % and 30 married (52.63%. The beck depression inventory score demonstrated increased after revascularization: 15 patients mild (26.32% at time zero to 17 (29.82% after. And with moderate, seven patients (12.28% before and 10 (17.54% after. In the categories of individuals with decreased minimum degree of 32 (56.14% to 28 (49.12%, and severe of three (5.26% for two (3.51% patients. Association was observed between beck depression inventory, gender, age, lifestyle, comorbidities and quality of life. CONCLUSION: There was a high prevalence of elevated beck depression inventory scores, lowest scores of depressive symptoms among men and association between the improvement of quality of life scores and beck depression inventory.

The correlation between white matter hyperintensity and balance disorder and fall risk: An observational, prospective cohort study

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Dong-Chao Shen

2016-09-01

Full Text Available Objective: The presence of an association between white matter hyperintensity (WMH and the risk of falls in older people is uncertain, with little supporting prospective evidence available at present. We aimed to determine whether WMH was associated with dysfunctions of balance and gait, and other sensorimotor factors leading to falls, and the independent factors related to falls in older Chinese people. The protective effect of exercise against falls was also addressed. Methods: In a representative sample of hospital-based individuals aged 50 years and older in China, the patients' history of falls, magnetic resonance imaging data, scores on the 9-item Berg Balance Scale (BBS-9 test and timed up-and-go test (TUGT, and sensorimotor measures of computerized dynamic posturography (CDP were analyzed. Incident falls were recorded prospectively over a 12-month period. Using regression modeling, the association between the risk of falls and baseline WMH was estimated. Results: Only individuals with severe WMH were at an increased risk of falls, and CDP was more sensitive than BBS-9 in detecting WMH-related balance and gait dysfunction. However, WMH was not an independent predictor of falls. Taller height and overweight or obese body habitus were identified as novel protective factors for falls. Female, fall history, and increased TUGT score were identified as independent risk factors for falls in older Chinese people. Conclusion: Although WMH was associated with an increased risk of falls, it was not an independent predictor. Keywords: White matter hyperintensity, Balance disorder, Gait disorder, Fall risk

The incidence and prevalence of ankle sprain injury: a systematic review and meta-analysis of prospective epidemiological studies.

Science.gov (United States)

Doherty, Cailbhe; Delahunt, Eamonn; Caulfield, Brian; Hertel, Jay; Ryan, John; Bleakley, Chris

2014-01-01

Ankle sprain is one of the most common musculoskeletal injuries, yet a contemporary review and meta-analysis of prospective epidemiological studies investigating ankle sprain does not exist. Our aim is to provide an up-to-date account of the incidence rate and prevalence period of ankle sprain injury unlimited by timeframe or context activity. We conducted a systematic review and meta-analyses of English articles using relevant computerised databases. Search terms included Medical Search Headings for the ankle joint, injury and epidemiology. The following inclusion criteria were used: the study must report epidemiology findings of injuries sustained in an observed sample; the study must report ankle sprain injury with either incidence rate or prevalence period among the surveyed sample, or provide sufficient data from which these figures could be calculated; the study design must be prospective. Independent extraction of articles was performed by two authors using pre-determined data fields. One-hundred and eighty-one prospective epidemiology studies from 144 separate papers were included. The average rating of all the included studies was 6.67/11, based on an adapted version of the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) guidelines for rating observational studies. 116 studies were considered high quality and 65 were considered low quality. The main findings of the meta-analysis demonstrated a higher incidence of ankle sprain in females compared with males (13.6 vs 6.94 per 1,000 exposures), in children compared with adolescents (2.85 vs 1.94 per 1,000 exposures) and adolescents compared with adults (1.94 vs 0.72 per 1,000 exposures). The sport category with the highest incidence of ankle sprain was indoor/court sports, with a cumulative incidence rate of 7 per 1,000 exposures or 1.37 per 1,000 athlete exposures and 4.9 per 1,000 h. Low-quality studies tended to underestimate the incidence of ankle sprain when compared with

Utility of Volume Assessment Using Bioelectrical Impedance Analysis in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Prospective Observational Study

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Ki Hyun Park

2017-08-01

Full Text Available Background Fluid overload prior to continuous renal replacement therapy (CRRT is an important prognostic factor. Thus, precise evaluation of fluid status is necessary to treat such patients. In this study, we investigated whether fluid assessment using bioelectrical impedance analysis (BIA can predict outcomes in critically ill patients requiring CRRT. Methods A prospective observational study was performed in patients who were admitted to the intensive care unit and who required CRRT. BIA was conducted before CRRT; then, the ratio of extracellular water to total body water (ECW/TBW was derived to estimate volume status. Results A total of 31 patients treated with CRRT were included. There were 18 men (58.1%, and the median age was 67 years (interquartile range, 51 to 78 years. Fourteen patients (45.2% died within 28 days after CRRT initiation. Patients were divided into 16 with ECW/TBW ≥0.41 and 15 with ECW/TBW <0.41. Survival rate within 28 days was different between the two groups (P = 0.044. Cox regression analysis revealed a relationship between ECW/TBW ≥0.41 and 28-day mortality, but it was not statistically significant (hazard ratio, 3.0; 95% confidence interval, 0.9 to 9.8; P = 0.061. Lastly, the area under the curve of ECW/TBW for 28-day mortality was analyzed. The area under the curve of ECW/TBW was 0.73 (95% confidence interval, 0.54 to 0.92, and this was significant (P = 0.037. Conclusions Fluid status can be assessed using BIA in critically ill patients requiring CRRT, and BIA can predict mortality. Further large trials are needed to confirm the usefulness of BIA in critically ill patients.

Usefulness of temporal bone prototype for drilling training: A prospective study.

Science.gov (United States)

Aussedat, C; Venail, F; Nguyen, Y; Lescanne, E; Marx, M; Bakhos, D

2017-12-01

Dissection of cadaveric temporal bones (TBs) is considered the gold standard for surgical training in otology. For many reasons, access to the anatomical laboratory and cadaveric TBs is difficult for some facilities. The aim of this prospective and comparative study was to evaluate the usefulness of a physical TB prototype for drilling training in residency. Prospective study. Tertiary referral centre. Thirty-four residents were included. Seventeen residents (mean age 26.7±1.6) drilled on only cadaveric TBs ("traditional" group), in the traditional training method, while seventeen residents (mean age 26.5±1.7) drilled first on a prototype and then on a cadaveric TB ("prototype" group). Drilling performance was assessed using a validated scale. Residents completed a mastoid image before and after each drilling to enable evaluation of mental representations of the mastoidectomy. No differences were observed between the groups with respect to age, drilling experience and level of residency. Regarding drilling performance, we found a significant difference across the groups, with a better score in the prototype group (P=.0007). For mental representation, the score was statistically improved (P=.0003) after drilling in both groups, suggesting that TB drilling improves the mental representation of the mastoidectomy whether prototype or cadaveric TB is used. The TB prototype improves the drilling performance and mental representation of the mastoidectomy in the young resident population. A drilling simulation with virtual or physical systems seems to be a beneficial tool to improve TB drilling. © 2017 John Wiley & Sons Ltd.

Fruit and vegetables consumption and incident hypertension: dose-response meta-analysis of prospective cohort studies.

Science.gov (United States)

Wu, L; Sun, D; He, Y

2016-10-01

The role of dietary factors on chronic diseases seems essential in the potentially adverse or preventive effects. However, no evidence of dose-response meta-analysis of prospective cohort studies has verified the association between the intake of fruit and/or vegetables and the risk of developing hypertension. The PubMed and Embase were searched for prospective cohort studies. A generic inverse-variance method with random effects model was used to calculate the pooled relative risks (RRs) and 95% confidence intervals (CIs). Generalized least squares trend estimation model was used to calculate the study-specific slopes for the dose-response analyses. Seven articles comprised nine cohorts involving 185 676 participants were assessed. The highest intake of fruit or vegetables separately, and total fruit and vegetables were inversely associated with the incident risk of hypertension compared with the lowest level, and the pooled RRs and 95% CIs were 0.87 (0.79, 0.95), 0.88 (0.79, 0.99) and 0.90 (0.84, 0.98), respectively. We also found an inverse dose-response relation between the risk of developing hypertension and fruit intake, and total fruit and vegetables consumption. The incident risk of hypertension was decreased by 1.9% for each serving per day of fruit consumption, and decreased by 1.2% for each serving per day of total fruit and vegetables consumption. Our results support the recommendation to increase the consumption of fruit and vegetables with respect to preventing the risk of developing hypertension. However, further large prospective studies and long-term high-quality randomized controlled trials are still needed to confirm the observed association.

Neonatal and maternal outcomes of successful manual rotation to correct malposition of the fetal head; A retrospective and prospective observational study.

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Nicola Tempest

Full Text Available To evaluate the neonatal and maternal outcomes associated with successful operative vaginal births assisted by manual rotation.Prospective and retrospective observational study.Delivery suite in a tertiary referral teaching hospital in England.A cohort of 2,426 consecutive operative births, in the second stage of labour, complicated with malposition of the fetal head during 2006-2013.Outcomes of all births successfully assisted by manual rotation followed by direct traction instruments were compared with other methods of operative birth for fetal malposition in the second stage of labour (rotational ventouse, Kielland forceps and caesarean section.Associated neonatal outcomes (admission to the special care baby unit, low cord pH, low Apgar and shoulder dystocia and maternal outcomes (massive obstetric haemorrhage (blood loss of >1500ml and obstetric anal sphincter injury.Births successfully assisted with manual rotation followed by direct traction instruments, resulted in 10% (36/346 of the babies being admitted to the Special Care Baby Unit, 4.9% (17/349 shoulder dystocia, 2% (7/349 massive obstetric haemorrhage and 1.7% (6/349 obstetric anal sphincter injury, similar to other methods of rotational births.Adverse neonatal and maternal outcomes associated with successful manual rotations followed by direct traction instruments were comparable to traditional methods of operative births. There is an urgent need to standardise the practice (guidance, training and documentation of manual rotation followed by direct traction instrumental deliveries that will enable assessment of its efficacy and the absolute safety in achieving a vaginal birth.

ADVERSE REACTIONS OF BLOOD DONATION: A PROSPECTIVE OBSERVATIONAL STUDY

OpenAIRE

Kandukuri Mahesh; Ravikanth; Chinthakindi; Shashi Kiran; Sudhir Kuma

2014-01-01

BACKGROUND: Voluntary donors normally tolerate blood donation very well as the history and preliminary examination is clear without any hidden history or facts related to the health status of the donor, occasionally, adverse reactions of variable severity may occur during or at the end of the collection. AIM: Aim of this study is to estimate and possibly avoid the cause of unwanted reactions. MATERIALS AND METHODS: This study is conducted over a period of three years, from ...

Association of body temperature and antipyretic treatments with mortality of critically ill patients with and without sepsis: multi-centered prospective observational study

Science.gov (United States)

2012-01-01

Introduction Fever is frequently observed in critically ill patients. An independent association of fever with increased mortality has been observed in non-neurological critically ill patients with mixed febrile etiology. The association of fever and antipyretics with mortality, however, may be different between infective and non-infective illness. Methods We designed a prospective observational study to investigate the independent association of fever and the use of antipyretic treatments with mortality in critically ill patients with and without sepsis. We included 1,425 consecutive adult critically ill patients (without neurological injury) requiring > 48 hours intensive care admitted in 25 ICUs. We recorded four-hourly body temperature and all antipyretic treatments until ICU discharge or 28 days after ICU admission, whichever occurred first. For septic and non-septic patients, we separately assessed the association of maximum body temperature during ICU stay (MAXICU) and the use of antipyretic treatments with 28-day mortality. Results We recorded body temperature 63,441 times. Antipyretic treatment was given 4,863 times to 737 patients (51.7%). We found that treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen independently increased 28-day mortality for septic patients (adjusted odds ratio: NSAIDs: 2.61, P = 0.028, acetaminophen: 2.05, P = 0.01), but not for non-septic patients (adjusted odds ratio: NSAIDs: 0.22, P = 0.15, acetaminophen: 0.58, P = 0.63). Application of physical cooling did not associate with mortality in either group. Relative to the reference range (MAXICU 36.5°C to 37.4°C), MAXICU ≥ 39.5°C increased risk of 28-day mortality in septic patients (adjusted odds ratio 8.14, P = 0.01), but not in non-septic patients (adjusted odds ratio 0.47, P = 0.11). Conclusions In non-septic patients, high fever (≥ 39.5°C) independently associated with mortality, without association of administration of NSAIDs or

Foot pronation is not associated with increased injury risk in novice runners wearing a neutral shoe : a 1-year prospective cohort study

NARCIS (Netherlands)

Nielsen, Rasmus Oestergaard; Buist, Ida; Parner, Erik Thorlund; Nohr, Ellen Aagaard; Sorensen, Henrik; Lind, Martin; Rasmussen, Sten

Objective To investigate if running distance to first running-related injury varies between foot postures in novice runners wearing neutral shoes. Design A 1-year epidemiological observational prospective cohort study. Setting Denmark. Participants A total of 927 novice runners equivalent to 1854

Subclinical Hypothyroidism: A Prospective Observational Study from Southern India.

Science.gov (United States)

Sridhar, Mathrubootham; Mahadevan, Shriraam; Vishwanathan, Latha; Subbarayan, Anbezhil

2018-03-15

To assess the natural history and progression of subclinical hypothyroidism and to study factors which help predict evolution of subclinical hypothyroidism into overt hypothyroidism. Longitudinal study in 40 children (2-16 yrs) presenting with subclinical hypothyroidism in a tertiary care unit in Chennai, India. Patients showing evidence of overt hypothyroidism or thyroid stimulating hormone ≥15 mIU/mL during follow-up were started on thyroxine. Others were followed up with 3-monthly thyroid function tests up to one year. At the end of our study period 3 (7.5%) were overtly hypothyroid, 16 (40%) remained as subclinical hypothyroid, and 21 (52.5%) became euthyroid. Evidence of auto- immunity at baseline was a significant (Phypothyroidism. Subclinical hypothyroidism in children, with thyroid stimulating hormone upto 15 mIU/L and irrespective of thyroid autoimmunity, needs only periodic clinical and biochemical follow up. Thyroid autoimmunity may point to an increased probability of progression to overt hypothyroidism.

Uranium prospect inventory on general prospection stage at Sigli sector Aceh

International Nuclear Information System (INIS)

Soetopo, Bambang; Sutriyono, Agus; Sajiyo

2002-01-01

This study based on the considering of the existence of reductive sedimentary rock and acid igneous rocks. The rocks could be favorable for uranium accumulation and source rocks respectively. The aim of this study is to understand the uranium geology, radiometric and geochemical anomalies distribution and it to delineate the prospective area to uranium accumulation. Method of this study field geological observations, radiometric measurements, stream sediment and heavy mineral concentrate sampling, mineralogical and geochemical laboratory analysis. Litho logically, the area composed of slate (Early Yurassic), schist and phyllite (Triassic) and meta calcareous marl (Cretaceous). Those rocks un conformably overly by black siltstone and sandstone (Eocene) conglomerate sandstone (Late Oligocene-Early Miocene) siltstone (Middle Miocene). Some intrusions have been identified as biotite granodiorite (Cretaceous) porphyritic granodiorite (Eocene) and Olivine basalt (Middle Miocene-late Miocene). The rock have been faulted by dextral strike slip fault NW-SE, thrust fault NW-SE, sinistral; strike slip fault NE-SW, and normal faults WNW-ESE. Radioactivity value of rocks range between 40-100 cps SPP2NF and it contains is range about 0.36-150.84 ppm U. The geochemical prospect area has been defined at the area of 93.186 km 2

A prospective descriptive study of the management of miscarriages ...

African Journals Online (AJOL)

Objective: To assess the current management of incomplete miscarriage at Harare and Parirenyatwa Hospitals and to determine the proportion of patients with incomplete miscarriage managed with Manual Vacuum Aspiration (MVA), sharp curettage or medical evacuation. Design: A prospective descriptive study.

Increased Cardiovascular Events and Subclinical Atherosclerosis in Rheumatoid Arthritis Patients: 1 Year Prospective Single Centre Study.

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Piero Ruscitti

Full Text Available Several studies showed the close relationship between Rheumatoid Arthritis (RA and cerebro-cardiovascular events (CVEs and subclinical atherosclerosis. In this study, we investigated the occurrence of CVEs and subclinical atherosclerosis during the course of RA and we evaluated the possible role of both traditional cardiovascular (CV and disease related risk factors to predict the occurrence of new CVEs and the onset of subclinical atherosclerosis.We designed a single centre, bias-adjusted, prospective, observational study to investigate, in a homogeneous subset of RA patients, the occurrence of new onset of CVEs and subclinical atherosclerosis. Statistical analyses were performed to evaluate the role of traditional CV and disease-related risk factors to predict the occurrence of new CVEs and subclinical atherosclerosis.We enrolled 347 RA patients prospectively followed for 12 months. An increased percentage of patients experienced CVEs, developed subclinical atherosclerosis and was affected by systemic arterial hypertension (SAH, type 2 diabetes mellitus and metabolic syndrome (MS, at the end of follow up. Our analysis showed that the insurgence of both SAH and MS, during the follow up, the older age, the CVE familiarity and the lack of clinical response, were associated with a significantly increased risk to experience CVEs and to develop subclinical atherosclerosis.Our study quantifies the increased expected risk for CVEs in a cohort of RA patients prospectively followed for 1 year. The occurrence of both new CVEs and subclinical atherosclerosis in RA patients may be explained by inflammatory burden as well as traditional CV risk factors.

Labelling of Students by Prospective Teachers.

Science.gov (United States)

Frerichs, Allen H.; Adelman, Stan I.

The basic purpose of this study was to determine the effects of telling prospective teachers that a classroom of adolescents, viewed on video tape, were low-achieving students. An experimental group was informed that the adolescents were slow learners having considerable difficulty in school. A control group, observing the same video tape was told…

Impact of harmful use of alcohol on the sedation of critical patients on mechanical ventilation: A multicentre prospective, observational study in 8 Spanish intensive care units.

Science.gov (United States)

Sandiumenge, A; Torrado, H; Muñoz, T; Alonso, M Á; Jiménez, M J; Alonso, J; Pardo, C; Chamorro, C

2016-05-01

To evaluate the impact of a history of harmful use of alcohol (HUA) on sedoanalgesia practices and outcomes in patients on mechanical ventilation (MV). A prospective, observational multicentre study was made of all adults consecutively admitted during 30 days to 8 Spanish ICUs. Patients on MV >24h were followed-up on until discharge from the ICU or death. Data on HUA, smoking, the use of illegal (IP) and medically prescribed psychotropics (MPP), sedoanalgesia practices and their related complications (sedative failure [SF] and sedative withdrawal [SW]), as well as outcome, were prospectively recorded. A total of 23.4% (119/509) of the admitted patients received MV >24h; 68.9% were males; age 57.0 (17.9) years; APACHE II score 18.8 (7.2); with a medical cause of admission in 53.9%. Half of them consumed at least one psychotropic agent (smoking 27.7%, HUA 25.2%; MPP 9.2%; and IP 7.6%). HUA patients more frequently required PS (86.7% vs. 64%; p2 sedatives (56.7% vs. 28.1%; p<0.02). HUA was associated to an eightfold (p<0.001) and fourfold (p<0.02) increase in SF and SW, respectively. In turn, the duration of MV and the stay in the ICU was increased by 151h (p<0.02) and 4.4 days (p<0.02), respectively, when compared with the non-HUA group. No differences were found in terms of mortality. HUA may be associated to a higher risk of SF and WS, and can prolong MV and the duration of stay in the ICU in critical patients. Early identification could allow the implementation of specific sedation strategies aimed at preventing these complications. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

Assessment of oxidative stress markers in recurrent pregnancy loss: a prospective study.

Science.gov (United States)

Yiyenoğlu, Özgür Bilgin; Uğur, Mete Gürol; Özcan, Hüseyin Çağlayan; Can, Günay; Öztürk, Ebru; Balat, Özcan; Erel, Özcan

2014-06-01

To determine the levels of oxidative stress markers in recurrent pregnancy loss using a novel automated method. 30 pregnant women in their first trimester with a history of recurrent pregnancy loss (RPL) and 30 healthy pregnant women were enrolled in this prospective controlled study. Total antioxidant capacity (TAC), total oxidant level (TOL) and oxidative stress index (OSI) in maternal serum were measured using the more recently designated Erel method. We observed statistically significant increased TOL and OSI levels in patient group (p = 0.032, p = 0.007, respectively). We also demonstrated statistically significant decreased TAC in pregnant women who had a history of RPL (p = 0.013). Our results support the concept that oxidative stress plays a central role in the etiopathogenesis of RPL. Further studies to evaluate the predictive role of TAC, TOL, OSI levels using Erel method are needed.

A PROSPECTIVE, OBSERVATIONAL STUDY OF ADVERSE REACTIONS TO DRUG REGIME FOR MULTI-DRUG RESISTANT PULMONARY TUBERCULOSIS IN CENTRAL INDIA.

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Dr. Rohan C. Hire

2014-09-01

Full Text Available Abstract Objective: 1 To assess the adverse drug reactions of second line anti-tubercular drugs used to treat Multi-drug resistant Tuberculosis (MDR TB in central India on the basis of causality, severity and avoidability scales. 2 To study the relationship of type of MDR TB (primary or secondary and presence of diabetes mellitus (DM with mean smear conversion time. Material and Methods: A prospective, observational study was carried out on diagnosed multidrug resistant tuberculosis patients enrolled for DOTS‑Plus regimen at TB and Chest Disease Department from January to December 2012. They were followed for 9 months thereafter and encountered adverse drug reactions (ADRs were noted along with the time of sputum conversion. The data were analysed by Chi-square or Fisher’s exact test and unpaired student’s‘t’ test. Results: Total 64 ADRs were reported in 55 patients out of total 110 patients (n = 110. As per the Naranjo causality assessment of ADRs, 7 patients had “definite” causal relation, 45 had “probable” causal relation and 3 had “possible” causal relation with drugs of DOTS Plus regime. As per the Hartwig’s severity assessment scale, there were total 7 ADRs in Level 1, 6 in Level 2, 33 in Level 3 and 9 in Level 4. Hallas avoidability assessment scale divided the ADRs as 3 being “Definitely avoidable”, 26 “Possibly avoidable”, 23 “Not avoidable” and 3 “unevaluable”. . Mean sputum smear conversion time is significantly higher in patients with secondary type than that of primary type of MDR TB (p = 0.0001 and in patients with DM than those without DM (p <0.0001. Conclusion: ADRs were common in patients of MDR TB on DOTs-Plus drug regime. It was due to lack of availability of safer and equally potent drugs in DOTs-Plus drug regime compared to DOTS regime in non-resistant TB. The frequency and severity of ADRs can be reduced by strict vigilance about known and unknown ADRs, monitoring their laboratory and

The immunological response to syphilis differs by HIV status; a prospective observational cohort study.

Science.gov (United States)

Kenyon, Chris; Osbak, Kara Krista; Crucitti, Tania; Kestens, Luc

2017-01-31

It is not known if there is a difference in the immune response to syphilis between HIV-infected and uninfected individuals. We prospectively recruited all patients with a new diagnosis of syphilis and tested their plasma for IFNα, IFNγ, IL-1β, IL-12p40, IL-12p70, IP-10, MCP-1, MIP-1α, MIP-1β, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10 and IL-17A at baseline pre-treatment and 6 months following therapy. A total of 79 HIV-infected [44 primary/secondary syphilis (PSS) and 35 latent syphilis (LS)] and 12 HIV-uninfected (10 PSS and 2 LS) cases of syphilis and 30 HIV-infected controls were included in the study. At the baseline visit, compared to the control group, concentrations of IL-10 were significantly elevated in the HIV-infected and uninfected groups. The level of IL-10 was significantly higher in the HIV-infected compared to the HIV-uninfected PSS group (25.3 pg/mL (IQR, 4.56-41.76) vs 2.73 pg/mL (IQR, 1.55-9.02), P = 0.0192). In the HIV-infected PSS group (but not the HIV-infected LS or HIV-uninfected PSS groups) the IP-10, MIP-1b, IL-6 and IL-8 were raised compared to the controls. IL-10 levels decreased but did not return to control baseline values by 6 months in HIV infected PSS and LS and HIV uninfected PSS. PSS and LS in HIV-infected individuals is characterized by an increase in inflammatory and anti-inflammatory cytokines such as IL-10. The increase of IL-10 is greater in HIV-infected than uninfected individuals. Further work is required to ascertain if this is part of an immunological profile that correlates with adverse outcomes such as serofast syphilis and neurosyphilis, in HIV-infected individuals.

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

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Dean Kaptsis

2016-12-01

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

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

Science.gov (United States)

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

2016-12-01

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

Relative associations between depression and anxiety on adverse cardiovascular events: does a history of coronary artery disease matter? A prospective observational study.

Science.gov (United States)

Pelletier, Roxanne; Bacon, Simon L; Arsenault, André; Dupuis, Jocelyn; Laurin, Catherine; Blais, Lucie; Lavoie, Kim L

2015-12-15

To assess whether depression and anxiety increase the risk of mortality and major adverse cardiovascular events (MACE), among patients with and without coronary artery disease (CAD). DECADE (Depression Effects on Coronary Artery Disease Events) is a prospective observational study of 2390 patients referred at the Montreal Heart Institute. Patients were followed for 8.8 years, between 1998 and 2009. Depression and anxiety were assessed using a psychiatric interview (Primary Care Evaluation of Mental Disorders, PRIME-MD). Outcomes data were obtained from Quebec provincial databases. All-cause mortality and MACE. After adjustment for covariates, patients with depression were at increased risks of all-cause mortality (relative risk (RR)=2.84; 95% CI 1.25 to 6.49) compared with patients without depression. Anxiety was not associated with increased mortality risks (RR=0.86; 95% CI 0.31 to 2.36). When patients were stratified according to CAD status, depression increased the risk of mortality among patients with no CAD (RR=4.39; 95% CI 1.12 to 17.21), but not among patients with CAD (RR=2.32; 95% CI 0.78 to 6.88). Neither depression nor anxiety was associated with MACE among patients with or without CAD. Depression, but not anxiety, was an independent risk factor for all-cause mortality in patients without CAD. The present study contributes to a better understanding of the relative and unique role of depression versus anxiety among patients with versus without CAD. 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/

Advanced Life Support in Obstetrics (ALSO) and postpartum hemorrhage: A prospective intervention study in Tanzania

DEFF Research Database (Denmark)

Sorensen, Bjarke Lund; Rasch, Vibeke; Massawe, Siriel

2011-01-01

Objective. To evaluate the impact of Advanced Life Support in Obstetrics (ALSO) training on staff performance and the incidences of postpartum hemorrhage (PPH) at a regional hospital in Tanzania. Design. Prospective intervention study. Setting. A regional, referral hospital. Population. A total...... of 510 delivered women before and 505 after the intervention. Methods. All high- and midlevel providers involved in childbirth at the hospital attended a two day ALSO provider course. Staff management was observed and postpartum bleeding assessed at all vaginal deliveries for seven weeks before and seven...

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.

A one season prospective cohort study of volleyball injuries

NARCIS (Netherlands)

Verhagen, E.A.L.M.; van der Beek, A.J.; Bouter, L.M.; Bahr, R.; van Mechelen, W.

2004-01-01

Objective: To estimate the overall incidence of acute and overuse volleyball injuries, and to describe factors associated with ankle sprains. Methods: 486 players from the second and third Dutch national volleyball divisions participated in the study and were followed prospectively during a whole

Three-year colonoscopy surveillance after polypectomy in Korea: a Korean Association for the Study of Intestinal Diseases (KASID multicenter prospective study

Directory of Open Access Journals (Sweden)

Won Seok Choi

2018-01-01

Full Text Available Background/Aims: Colonoscopic surveillance is currently recommended after polypectomy owing to the risk of newly developed colonic neoplasia. However, few studies have investigated colonoscopy surveillance in Asia. This multicenter and prospective study was undertaken to assess the incidence of advanced adenoma based on baseline adenoma findings at 3 years after colonoscopic polypectomy. Methods: A total of 1,323 patients undergoing colonoscopic polypectomy were prospectively assigned to 3-year colonoscopy surveillance at 11 tertiary endoscopic centers. Relative risks for advanced adenoma after 3 years were calculated according to baseline adenoma characteristics. Results: Among 1,323 patients enrolled, 387 patients (29.3% were followed up, and the mean follow-up interval was 31.0±9.8 months. The percentage of patients with advanced adenoma on baseline colonoscopy was higher in the surveillance group compared to the non-surveillance group (34.4% vs. 25.7%. Advanced adenoma recurrence was observed in 17 patients (4.4% at follow-up. The risk of advanced adenoma recurrence was 2 times greater in patients with baseline advanced adenoma than in those with baseline non-advanced adenoma, though the difference was not statistically significant (6.8% [9/133] vs. 3.1% [8/254], P=0.09. Advanced adenoma recurrence was observed only in males and in subjects aged ≥50 years. In contrast, adenoma recurrence was observed in 187 patients (48.3% at follow-up. Male sex, older age (≥50 years, and multiple adenomas (≥3 at baseline were independent risk factors for adenoma recurrence. Conclusions: A colonoscopy surveillance interval of 3 years in patients with baseline advanced adenoma can be considered appropriate.

Evaluation of PET and laparoscopy in STagIng advanced gastric cancer: a multicenter prospective study (PLASTIC-study).

Science.gov (United States)

Brenkman, H J F; Gertsen, E C; Vegt, E; van Hillegersberg, R; van Berge Henegouwen, M I; Gisbertz, S S; Luyer, M D P; Nieuwenhuijzen, G A P; van Lanschot, J J B; Lagarde, S M; de Steur, W O; Hartgrink, H H; Stoot, J H M B; Hulsewe, K W E; Spillenaar Bilgen, E J; van Det, M J; Kouwenhoven, E A; van der Peet, D L; Daams, F; van Sandick, J W; van Grieken, N C T; Heisterkamp, J; van Etten, B; Haveman, J W; Pierie, J P; Jonker, F; Thijssen, A Y; Belt, E J T; van Duijvendijk, P; Wassenaar, E; van Laarhoven, H W M; Wessels, F J; Haj Mohammad, N; van Stel, H F; Frederix, G W J; Siersema, P D; Ruurda, J P

2018-04-20

Initial staging of gastric cancer consists of computed tomography (CT) and gastroscopy. In locally advanced (cT3-4) gastric cancer, fluorodeoxyglucose positron emission tomography with CT (FDG-PET/CT or PET) and staging laparoscopy (SL) may have a role in staging, but evidence is scarce. The aim of this study is to evaluate the impact and cost-effectiveness of PET and SL in addition to initial staging in patients with locally advanced gastric cancer. This prospective observational cohort study will include all patients with a surgically resectable, advanced gastric adenocarcinoma (cT3-4b, N0-3, M0), that are scheduled for treatment with curative intent after initial staging with gastroscopy and CT. The modalities to be investigated in this study is the addition of PET and SL. The primary outcome of this study is the proportion of patients in whom the PET or SL lead to a change in treatment strategy. Secondary outcome parameters are: diagnostic performance, morbidity and mortality, quality of life, and cost-effectiveness of these additional diagnostic modalities. The study recently started in August 2017 with a duration of 36 months. At least 239 patients need to be included in this study to demonstrate that the diagnostic modalities are break-even. Based on the annual number of gastrectomies in the participating centers, it is estimated that approximately 543 patients are included in this study. In this study, it is hypothesized that performing PET and SL for locally advanced gastric adenocarcinomas results in a change of treatment strategy in 27% of patients and an annual cost-reduction in the Netherlands of €916.438 in this patient group by reducing futile treatment. The results of this study may be applicable to all countries with comparable treatment algorithms and health care systems. NCT03208621 . This trial was registered prospectively on June 30, 2017.

The Clinical Assessment Study of the Hand (CAS-HA: a prospective study of musculoskeletal hand problems in the general population

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Marshall Michelle

2007-08-01

Full Text Available Abstract Background Pain in the hand affects an estimated 12–21% of the population, and at older ages the hand is one of the most common sites of pain and osteoarthritis. The association between symptomatic hand osteoarthritis and disability in everyday life has not been studied in detail, although there is evidence that older people with hand problems suffer significant pain and disability. Despite the high prevalence of hand problems and the limitations they cause in older adults, little attention has been paid to the hand by health planners and policy makers. We plan to conduct a prospective, population-based, observational cohort study designed in parallel with our previously reported cohort study of knee pain, to describe the course of musculoskeletal hand problems in older adults and investigate the relative merits of different approaches to classification and defining prognosis. Methods/Design All adults aged 50 years and over registered with two general practices in North Staffordshire will be invited to take part in a two-stage postal survey. Respondents to the survey who indicate that they have experienced hand pain or problems within the previous 12 months will be invited to attend a research clinic for a detailed assessment. This will consist of clinical interview, hand assessment, screening test of lower limb function, digital photography, plain x-rays, anthropometric measurement and brief self-complete questionnaire. All consenting clinic attenders will be followed up by (i general practice medical record review, (ii repeat postal questionnaire at 18-months, and (iii repeat postal questionnaire at 3 years. Discussion This paper describes the protocol for the Clinical Assessment Study of the Hand (CAS-HA, a prospective, population-based, observational cohort study of community-dwelling older adults with hand pain and hand problems based in North Staffordshire.

Ethical validity of palliative sedation therapy: a multicenter, prospective, observational study conducted on specialized palliative care units in Japan.

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Morita, Tatsuya; Chinone, Yoshikazu; Ikenaga, Masayuki; Miyoshi, Makoto; Nakaho, Toshimichi; Nishitateno, Kenji; Sakonji, Mitsuaki; Shima, Yasuo; Suenaga, Kazuyuki; Takigawa, Chizuko; Kohara, Hiroyuki; Tani, Kazuhiko; Kawamura, Yasuo; Matsubara, Tatsuhiro; Watanabe, Akihiko; Yagi, Yasuo; Sasaki, Toru; Higuchi, Akiko; Kimura, Hideyuki; Abo, Hirofumi; Ozawa, Taketoshi; Kizawa, Yoshiyuki; Uchitomi, Yosuke

2005-10-01

Although palliative sedation therapy is often required in terminally ill cancer patients to achieve acceptable symptom relief, empirical data supporting the ethical validity of this approach are lacking. The primary aim of this study was to systematically investigate whether empirical evidence supports the ethical validity of sedation. This was a multicenter, prospective, observational study, which was conducted by 21 specialized palliative care units in Japan. One-hundred two consecutive adult cancer patients who received continuous deep sedation were enrolled. Continuous deep sedation was defined as the continuous use of sedative medications to relieve intolerable and refractory distress by achieving almost or complete unconsciousness until death. Prior to the study, we conceptualized the ethical validity of sedation from the viewpoints of physicians' intent, proportionality, and autonomy. Sedation was performed mainly with midazolam and phenobarbital. The initial doses of midazolam and phenobarbital were 1.5 mg/hour and 20 mg/hour, respectively. Main administration routes were continuous subcutaneous infusion and continuous intravenous infusion, and no rapid intravenous injection was reported. Of 59 patients who received artificial hydration or could intake adequate fluids/foods orally before sedation, 63% received artificial hydration therapy after sedation, and in the remaining patients, artificial hydration was withheld or withdrawn due to fluid retention symptoms and/or patient wishes. Of 66 patients who were able to verbally express themselves, 95% explicitly stated that symptoms were intolerable. The etiologies of the symptoms requiring sedation were primarily related to the progression of the underlying malignancy, such as cancer cachexia and organ failure, and standard palliative treatments had failed: steroids in 68% of patients with fatigue, opioids in 95% of patients with dyspnea, antisecretion medications in 75% of patients with bronchial secretion

40 CFR 26.405 - Observational research involving greater than minimal risk but presenting the prospect of direct...

Science.gov (United States)

2010-07-01

... greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 26.405... but presenting the prospect of direct benefit to the individual subjects. If the IRB finds that an...: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject...

Weight at birth and subsequent fecundability: a prospective cohort study

DEFF Research Database (Denmark)

Nielsen, Cathrine Wildenschild; Hammerich Riis, Anders; Ehrenstein, Vera

2014-01-01

OBJECTIVE: To examine the association between a woman's birth weight and her subsequent fecundability. METHOD: In this prospective cohort study, we included 2,773 Danish pregnancy planners enrolled in the internet-based cohort study "Snart-Gravid", conducted during 2007-2012. Participants were 18...

The preventive effect of tamsulosin on voiding dysfunction after prostate biopsy: a prospective, open-label, observational study.

Science.gov (United States)

Chung, Seung Jun; Jung, Seung Il; Ryu, Ji Won; Hwang, Eu Chang; Kwon, Dong Deuk; Park, Kwangsung; Kim, Jin Woong

2015-05-01

To evaluate the association of prostate biopsy with voiding impairment and to investigate whether tamsulosin treatment given before prostate biopsy could improve voiding dysfunction after the procedure. The study included 88 consecutive patients who underwent transrectal ultrasound-guided prostate biopsy without prior BPH medication and were prospectively randomized. Of these 88 patients, 44 patients underwent prostate biopsy only without tamsulosin treatment and served as the control group. The remaining 44 patients were treated with tamsulosin (0.2 mg daily) beginning the day before the biopsy procedure for 7 days. The International Prostate Symptom Score (IPSS) was recorded in all patients before the procedure and on postbiopsy day 7. Maximal flow rate (Q(max)) and postvoid residual urine volume were recorded in all patients before the procedure and on postbiopsy days 1 and 7. No difference was found in baseline characteristics between the two groups. The IPSS (total, storage, and voiding symptom) was not significantly changed after biopsy in both groups. In the control group, the postvoid residual urine volume was increased on postbiopsy days 1 (P tamsulosin group, Q(max) was significantly increased on postbiopsy days 1 and 7 (P tamsulosin group, but it developed in two patients (4.5%) of the control group. The results of our study show that prostate biopsy leads to objective voiding impairment. Therefore, the use of alpha-1 blocker tamsulosin before biopsy in patients without prior BPH medication may decrease this morbidity.

Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

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Jung-Nein Lai

2013-01-01

Full Text Available Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM. Methods. We have proactively monitored the safety profiles of Duhuo Jisheng Tang (DJT, Suan Zao Ren Tang (SZRT, and TMN-1. A list of adverse events (AEs, complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens. Results. A total of 221, 287, and 203 AEs were detected after SZRT, DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related to SZRT treatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such as Mu Tong and an increased risk of CKD, ESRD, and urinary tract cancer. Conclusion. Prospective and retrospective observational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies.

Observational Studies on Evaluating the Safety and Adverse Effects of Traditional Chinese Medicine

Science.gov (United States)

Tang, Jin-Ling; Wang, Jung-Der

2013-01-01

Background. This study aims to share our experiences when carrying out observational studies of traditional Chinese medicine (TCM). Methods. We have proactively monitored the safety profiles of Duhuo Jisheng Tang (DJT), Suan Zao Ren Tang (SZRT), and TMN-1. A list of adverse events (AEs), complete blood counts, and liver and kidney function tests were obtained from the participants during their scheduled hospital visits. Retrospective observational studies were conducted based on the reimbursement database of the National Health Insurance system, Taiwan, to explore the relationship between the use of TCM that have been adulterated by aristolochic acid and the risk from both nephrotoxins and carcinogens. Results. A total of 221, 287, and 203 AEs were detected after SZRT, DJT, and TMN-1 had been taken, respectively. Dizziness, headache, stomach ache, and diarrhea were judged to be probably related to SZRT treatment. Retrospective observational studies found an association between the consumption of aristolochic acid-containing Chinese formulae such as Mu Tong and an increased risk of CKD, ESRD, and urinary tract cancer. Conclusion. Prospective and retrospective observational studies seem to have specific advantages when investigating the safety and adverse effects of TCM therapies, as well as possibly other alternative/complementary therapies. PMID:24159351

Chocolate consumption and risk of myocardial infarction: a prospective study and meta-analysis.

Science.gov (United States)

Larsson, Susanna C; Åkesson, Agneta; Gigante, Bruna; Wolk, Alicja

2016-07-01

To examine whether chocolate consumption is associated with a reduced risk of ischaemic heart disease, we used data from a prospective study of Swedish adults and we performed a meta-analysis of available prospective data. The Swedish prospective study included 67 640 women and men from the Cohort of Swedish Men and the Swedish Mammography Cohort who had completed a food-frequency questionnaire and were free of cardiovascular disease at baseline. Myocardial infarction (MI) cases were ascertained through linkage with the Swedish National Patient and Cause of Death Registers. PubMed and EMBASE databases were searched from inception until 4 February 2016 to identify prospective studies on chocolate consumption and risk of ischaemic heart disease. The results from eligible studies were combined using a random-effects model. During follow-up (1998-2010), 4417 MI cases were ascertained in the Swedish study. Chocolate consumption was inversely associated with MI risk. Compared with non-consumers, the multivariable relative risk for those who consumed ≥3-4 servings/week of chocolate was 0.87 (95% CI 0.77 to 0.98; p for trend =0.04). Five prospective studies on chocolate consumption and ischaemic heart disease were identified. Together with the Swedish study, the meta-analysis included six studies with a total of 6851 ischaemic heart disease cases. The overall relative risk for the highest versus lowest category of chocolate consumption was 0.90 (95% CI 0.82 to 0.97), with little heterogeneity among studies (I(2)=24.3%). Chocolate consumption is associated with lower risk of MI and ischaemic heart disease. 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/

Applications of prospecting geochemical techniques to the search for and to the study of uranium deposits in metropolitan France

International Nuclear Information System (INIS)

Grimbert, Arnold

1957-01-01

After having recalled facts which leaded the CEA to use new geochemical techniques for the prospecting of uranium deposits through sampling and analysis of soils and waters, the author describes the organisation and methods implemented for this prospecting activity: team composition for sampling and analysis, role of each engineer and technician in the prospecting stages (preliminary study, routine prospecting, result interpretation), sampling and analysis processes. He also reports campaigns of geochemical prospecting: study of the La Chapelle Largeau deposit (objectives, geological context, preliminary study, routine prospecting, study of geochemical anomalies), tactical research on Verneix indices (study of radioactivity anomaly discovered by radio-prospecting), strategical searches in a non prospected area in the South of Avallon. The author discusses the issues of efficiency and cost price of this geochemical prospecting technique in soils and in waters. Appendices present the equipment and operation modality for soil sampling, and for soil sample preparation, and principles, equipment and products for soil analysis and for water analysis [fr

Serum Procalcitonin and Peripheral Venous Lactate for Predicting Dengue Shock and/or Organ Failure: A Prospective Observational Study.

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Vipa Thanachartwet

2016-08-01

Full Text Available Currently, there are no biomarkers that can predict the incidence of dengue shock and/or organ failure, although the early identification of risk factors is important in determining appropriate management to reduce mortality. Therefore, we sought to determine the factors associated with dengue shock and/or organ failure and to evaluate the prognostic value of serum procalcitonin (PCT and peripheral venous lactate (PVL levels as biomarkers of dengue shock and/or organ failure.A prospective observational study was conducted among adults hospitalized for confirmed viral dengue infection at the Hospital for Tropical Diseases in Bangkok, Thailand between October 2013 and July 2015. Data, including baseline characteristics, clinical parameters, laboratory findings, serum PCT and PVL levels, management, and outcomes, were recorded on pre-defined case report forms. Of 160 patients with dengue, 128 (80.0% patients had dengue without shock or organ failure, whereas 32 (20.0% patients developed dengue with shock and/or organ failure. Using a stepwise multivariate logistic regression analysis, PCT ≥0.7 ng/mL (odds ratio [OR]: 4.80; 95% confidence interval [CI]: 1.60-14.45; p = 0.005 and PVL ≥2.5 mmol/L (OR: 27.99, 95% CI: 8.47-92.53; p <0.001 were independently associated with dengue shock and/or organ failure. A combination of PCT ≥0.7 ng/mL and PVL ≥2.5 mmol/L provided good prognostic value for predicting dengue shock and/or organ failure, with an area under the receiver operating characteristics curve of 0.83 (95% CI: 0.74-0.92, a sensitivity of 81.2% (95% CI: 63.6-92.8%, and a specificity of 84.4% (95% CI: 76.9-90.2%. Dengue shock patients with non-clearance of PCT and PVL expired during hospitalization.PCT ≥0.7 ng/mL and PVL ≥2.5 mmol/L were independently associated with dengue shock and/or organ failure. The combination of PCT and PVL levels could be used as prognostic biomarkers for the prediction of dengue shock and/or organ failure.

The prospective impact of food pricing on improving dietary consumption: A systematic review and meta-analysis

OpenAIRE

Afshin, Ashkan; Peñalvo, José L.; Del Gobbo, Liana; Silva, Jose; Michaelson, Melody; O'Flaherty, Martin; Capewell, Simon; Spiegelman, Donna; Danaei, Goodarz; Mozaffarian, Dariush

2017-01-01

Background: While food pricing is a promising strategy to improve diet, the prospective impact of food pricing on diet has not been systematically quantified. Objective: To quantify the prospective effect of changes in food prices on dietary consumption. Design: We systematically searched online databases for interventional or prospective observational studies of price change and diet; we also searched for studies evaluating adiposity as a secondary outcome. Studies were excluded if price dat...

Treatment of Crohn's disease with cannabis: an observational study.

Science.gov (United States)

Naftali, Timna; Lev, Lihi Bar; Yablecovitch, Doron; Yablekovitz, Doron; Half, Elisabeth; Konikoff, Fred M

2011-08-01

The marijuana plant cannabis is known to have therapeutic effects, including improvement of inflammatory processes. However, no report of patients using cannabis for Crohn's disease (CD) was ever published. To describe the effects of cannabis use in patients suffering from CD. In this retrospective observational study we examined disease activity, use of medication, need for surgery, and hospitalization before and after cannabis use in 30 patients (26 males) with CD. Disease activity was assessed by the Harvey Bradshaw index for Crohn's disease. Of the 30 patients 21 improved significantly after treatment with cannabis. The average Harvey Bradshaw index improved from 14 +/- 6.7 to 7 +/- 4.7 (P disease in humans. The results indicate that cannabis may have a positive effect on disease activity, as reflected by reduction in disease activity index and in the need for other drugs and surgery. Prospective placebo-controlled studies are warranted to fully evaluate the efficacy and side effects of cannabis in CD.

A prospective longitudinal study to estimate the prevalence of ...

African Journals Online (AJOL)

A prospective longitudinal study to estimate the prevalence of obesity in Egyptian children with nocturnal enuresis and the association between body mass index and ... Egyptian Journal of Medical Human Genetics ... Response to the treatment was evaluated statistically and correlated with body mass index percentile.

Independent and combined relationship of habitual unhealthy eating behaviors with depressive symptoms: A prospective study

OpenAIRE

Huang, Cong; Momma, Haruki; Cui, Yufei; Chujo, Masahiko; Otomo, Atsushi; Sugiyama, Shota; Ren, Zhongyu; Niu, Kaijun; Nagatomi, Ryoichi

2016-01-01

Background: Unhealthy eating has been found to be associated with the prevalence of depressive symptoms. However, prospective evidence of the combined effects of unhealthy eating and depressive symptoms has not been reported. This study aimed to elucidate the prospective relationship between habitual unhealthy eating habits and depressive symptoms. Methods: A 2-year prospective cohort study of 376 Japanese adults aged 24–83 years without depressive symptoms at baseline was conducted. Infor...

Home sampling for sexually transmitted infections and HIV in men who have sex with men: a prospective observational study.

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Martin Fisher

Full Text Available To determine uptake of home sampling kit (HSK for STI/HIV compared to clinic-based testing, whether the availability of HSK would increase STI testing rates amongst HIV infected MSM, and those attending a community-based HIV testing clinic compared to historical control. Prospective observational study in three facilities providing STI/HIV testing services in Brighton, UK was conducted. Adult MSM attending/contacting a GUM clinic requesting an STI screen (group 1, HIV infected MSM attending routine outpatient clinic (group 2, and MSM attending a community-based rapid HIV testing service (group 3 were eligible. Participants were required to have no symptomatology consistent with STI and known to be immune to hepatitis A and B (group 1. Eligible men were offered a HSK to obtain self-collected specimens as an alternative to routine testing. HSK uptake compared to conventional clinic-based STI/HIV testing in group 1, increase in STI testing rates due to availability of HSK compared to historical controls in group 2 and 3, and HSK return rates in all settings were calculated. Among the 128 eligible men in group 1, HSK acceptance was higher (62.5% (95% CI: 53.5-70.9 compared to GUM clinic-based testing (37.5% (95% CI: 29.1-46.5, (p = 0.0004. Two thirds of eligible MSM offered an HSK in all three groups accepted it, but HSK return rates varied (highest in group 1, 77.5%, lowest in group 3, 16%. HSK for HIV testing was acceptable to 81% of men in group 1. Compared to historical controls, availability of HSK increased the proportion of MSM testing for STIs in group 2 but not in group 3. HSK for STI/HIV offers an alternative to conventional clinic-based testing for MSM seeking STI screening. It significantly increases STI testing uptake in HIV infected MSM. HSK could be considered as an adjunct to clinic-based services to further improve STI/HIV testing in MSM.

Placental methylome analysis from a prospective autism study.

Science.gov (United States)

Schroeder, Diane I; Schmidt, Rebecca J; Crary-Dooley, Florence K; Walker, Cheryl K; Ozonoff, Sally; Tancredi, Daniel J; Hertz-Picciotto, Irva; LaSalle, Janine M

2016-01-01

Autism spectrum disorders (ASD) are increasingly prevalent neurodevelopmental disorders that are behaviorally diagnosed in early childhood. Most ASD cases likely arise from a complex mixture of genetic and environmental factors, an interface where the epigenetic marks of DNA methylation may be useful as risk biomarkers. The placenta is a potentially useful surrogate tissue characterized by a methylation pattern of partially methylated domains (PMDs) and highly methylated domains (HMDs) reflective of methylation patterns observed in the early embryo. In this study, we investigated human term placentas from the MARBLES (Markers of Autism Risk in Babies: Learning Early Signs) prospective study by whole genome bisulfite sequencing. We also examined the utility of PMD/HMDs in detecting methylation differences consistent with ASD diagnosis at age three. We found that while human placental methylomes have highly reproducible PMD and HMD locations, there is a greater variation between individuals in methylation levels over PMDs than HMDs due to both sampling and individual variability. In a comparison of methylation differences in placental samples from 24 ASD and 23 typically developing (TD) children, a HMD containing a putative fetal brain enhancer near DLL1 was found to reach genome-wide significance and was validated for significantly higher methylation in ASD by pyrosequencing. These results suggest that the placenta could be an informative surrogate tissue for predictive ASD biomarkers in high-risk families.

Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

Science.gov (United States)

Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

2016-01-01

Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

Investing in Prospective Cohorts for Etiologic Study of Occupational Exposures

Science.gov (United States)

Prospective cohorts have played a major role in understanding the role of diet, physical activity, medical conditions, and genes in the development of many diseases, but have not been widely used in the study of occupational exposures. Studies in agriculture are an exception. W...

Early versus late rehabilitation for stroke survivors: A prospective study

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Moshiur Rahman Khasru

2017-11-01

Full Text Available The aim of this study was to examine the optimum time of rehabilitation initiation after stroke in terms of disabilities, mobility and fall risk assessment. Data were collected prospectively at seven tertiary level health care centers in Bangladesh during the 36 months period from 2013 to 2016. All respondents were divided into four groups based on the initiation of rehabilitation as: a 0-24 hours, b 25-72 hours, c 4-7 days and d 8-60 days. Results show that significant improvement on stroke recovery, disabilities reduction, improvement in mobility restriction and reduction of fall risks in all the four groups but more improvement was observed in 0-24 hour’s group during follow-up after 3 and 12 weeks. On multinomial logistic regression analysis, the independent factors shows the mobility restriction and fall risk were more in the younger patients, male gender, married, hemorrhagic lesion and bilateral stroke.

The role of rostral prefrontal cortex in prospective memory: a voxel-based lesion study.

Science.gov (United States)

Volle, Emmanuelle; Gonen-Yaacovi, Gil; Costello, Angela de Lacy; Gilbert, Sam J; Burgess, Paul W

2011-07-01

Patients with lesions in rostral prefrontal cortex (PFC) often experience problems in everyday-life situations requiring multitasking. A key cognitive component that is critical in multitasking situations is prospective memory, defined as the ability to carry out an intended action after a delay period filled with unrelated activity. The few functional imaging studies investigating prospective memory have shown consistent activation in both medial and lateral rostral PFC but also in more posterior prefrontal regions and non-frontal regions. The aim of this study was to determine regions that are necessary for prospective memory performance, using the human lesion approach. We designed an experimental paradigm allowing us to assess time-based (remembering to do something at a particular time) and event-based (remembering to do something in a particular situation) prospective memory, using two types of material, words and pictures. Time estimation tasks and tasks controlling for basic attention, inhibition and multiple instructions processing were also administered. We examined brain-behaviour relationships with a voxelwise lesion method in 45 patients with focal brain lesions and 107 control subjects using this paradigm. The results showed that lesions in the right polar prefrontal region (in Brodmann area 10) were specifically associated with a deficit in time-based prospective memory tasks for both words and pictures. This deficit could not be explained by impairments in basic attention, detection, inhibition or multiple instruction processing, and there was also no deficit in event-based prospective memory conditions. In addition to their prospective memory difficulties, these polar prefrontal patients were significantly impaired in time estimation ability compared to other patients. The same region was found to be involved using both words and pictures, suggesting that right rostral PFC plays a material nonspecific role in prospective memory. This is the first

Prospective study of emergency presentation of abdominal tuberculosis

Directory of Open Access Journals (Sweden)

Akhilesh R. Mishra

2016-08-01

Full Text Available Background: In developing countries like India, where poverty, malnutrition and overcrowding prevail, tuberculosis continues to be one of the important causes of morbidity, mortality and loss of working man hours. Abdominal tuberculosis (TB can affect the gastrointestinal tract, the peritoneum, lymph nodes of the small bowel mesentery or the solid viscera (e.g. liver, spleen, pancreas etc Patient of abdominal Koch’s can present as those with a chronic undulating course and those with an acute or subacute abdominal catastrophe. In emergency the patient may present with various presentations like stricture causing obstruction or with perforation and require a different management from those routine such cases Aim and Objective: To study the varied presentation of patients with Abdominal Tuberculosis as acute surgical abdomen presenting in emergency setting to those with a subacute course. To evaluate the line of management whether operative or conservative, the operative details, post operative course and the final outcome of the disease. To study the incidence of HIV positivity in patients with abdominal tuberculosis. Methods and material: The study was designed as a prospective observational study conducted during a study period between June 2006 and June 2008 in a tertiary care centre in Mumbai. All patients with a clinical suspicion of abdominal tuberculosis were included in the study with confirmation on histopathological examination. Patient’s written informed valid consent was taken after explaining the nature of study. Result and Conclusion: Age group commonly affected was between 21-30 years with male predominance. Amongst the various complications of abdominal tuberculosis intestinal obstruction was the most common mainly due to stricture and less commonly due to hyperplastic ileocaecal mass. Next common complication observed was free perforation of the intestine which occurs at a site proximal to a tight stricture. All patients were

Electronic Banking in Nigeria: Concepts, Challenges and Prospects ...

African Journals Online (AJOL)

Electronic Banking in Nigeria: Concepts, Challenges and Prospects. ... examined its prospects for Nigerian banks and discussed associated risks. ... E banking, it also observed, holds enormous potentials for the banking industry in Nigeria.

Electroacupuncture Modulates Reproductive Hormone Levels in Patients with Primary Ovarian Insufficiency: Results from a Prospective Observational Study

Directory of Open Access Journals (Sweden)

Kehua Zhou

2013-01-01

Full Text Available To investigate the effects of electroacupuncture (EA on serum FSH, E2, and LH levels, women with primary ovarian insufficiency (POI were treated with EA once a day, five times a week for the first four weeks and once every other day, three times a week, for the following two months, and then were followed up for three months. Serum E2, FSH, and LH levels were measured at baseline, at the end of treatment, and during followup. A total of 11 women with POI were included in this prospective consecutive case series study. Compared with baseline, patients’ serum E2 increased, FSH decreased, and LH decreased (P=0.002, 0.001, and 0.002, resp. after EA treatment, and these effects persisted during followup. With treatment, 10 patients resumed menstruation (10/11, 90.91%, whereas one patient remained amenorrhea. During followup, two patients, including the one with amenorrhea during treatment, reported absence of menstruation. Temporary pain occurred occasionally, and no other adverse events were found during treatment. The results suggest that EA could decrease serum FSH and LH levels and increase serum E2 level in women with POI with little or no side effects; however, further randomized control trials are needed.

Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies.

Science.gov (United States)

Lee, Aeyoung; Myung, Seung Kwon; Cho, Jung Jin; Jung, Yu Jin; Yoon, Jong Lull; Kim, Mee Young

2017-07-01

This study aimed to assess whether night shift work is associated with the risk of depression by using a meta-analysis of observational studies. We searched PubMed and EMBASE in August, 2016 to locate eligible studies and investigated the association between night shift work and the risk of depression, reporting outcome measures with adjusted odds ratios (ORs) or relative risks (RRs) and 95% confidence intervals (CIs). In the meta-analysis of a total of 11 observational studies with 9 cross-sectional study, 1 longitudinal study, and 1 cohort study, night shift work was significantly associated with an increased risk of depression (OR/RR, 1.43; 95% CI, 1.24-1.64; I² = 78.0%). Also, subgroup meta-analyses by gender, night shift work duration, type of occupation, continent, and type of publication showed that night shift work was consistently associated with the increased risk of depression. The current meta-analysis suggests that night shift work is associated with the increased risk of depression. However, further large prospective cohort studies are needed to confirm this association. © 2017 The Korean Academy of Medical Sciences.

Patients with cardiac arrest are ventilated two times faster than guidelines recommend : An observational prehospital study using tracheal pressure measurement

NARCIS (Netherlands)

Maertens, Vicky L.; De Smedt, Lieven E. G.; Lemoyne, Sabine; Huybrechts, Sofie A. M.; Wouters, Kristien; Kalmar, Alain F.; Monsieurs, Koenraad G.

Aim: To measure ventilation rate using tracheal airway pressures in prehospitally intubated patients with and without cardiac arrest. Methods: Prospective observational study. In 98 patients (57 with and 41 without cardiac arrest) an air-filled catheter was inserted into the endotracheal tube and

Critical Outcomes in Longitudinal Observational Studies and Registries in Patients with Rheumatoid Arthritis

DEFF Research Database (Denmark)

Zamora, Natalia V; Christensen, Robin; Goel, Niti

2017-01-01

OBJECTIVE: Outcomes important to patients are those that are relevant to their well-being, including quality of life, morbid endpoints, and death. These outcomes often occur over the longterm and can be identified in prospective longitudinal observational studies (PLOS). There are no standards...... for which outcome domains should be considered. Our overarching goal is to identify critical longterm outcome domains for patients with rheumatic diseases, and to develop a conceptual framework to measure and classify them within the scope of OMERACT Filter 2.0. METHODS: The steps of this initiative...

Non-surgical treatment for localized gastric mucosa-associated lymphoid tissue (MALT) lymphoma. Interium analysis of a multicenter prospective study in Japan

International Nuclear Information System (INIS)

Mera Kiyomi

2004-01-01

Although eradication of Helicobacter pylori and radiation therapy (RT) have curative potential for gastric mucosa-associated lymphoid tissue (MALT) lymphoma, no prospective study has yet been reported. This prospective study evaluated the efficacy and safety of this non-surgical treatment for localized gastric MALT lymphoma. Among the 115 eligible patients, 89 (77.3%) achieved remission with eradication therapy. Twenty five (21.7%) patients received RT as additional treatment for residual tumor and 22 (88%) achieved complete remission. No serious adverse events, such as hemorrhage or perforation of the stomach, were observed. This organ-preserving treatment for localized gastric MALT lymphoma is safe and effective and has the potential to become the standard treatment for this disease, although long-term follow up is necessary. (author)

Study of geothermal prospects in the western United States

Energy Technology Data Exchange (ETDEWEB)

1976-08-20

The commercial development potential of 13 underdeveloped geothermal prospects in the Western United States has been examined and the prospects have been ranked in order of relative potential for development on the basis of investment considerations. The following were considered in the ranking: geotechnical and engineering data, energy market accessibility, administrative constraints, and environmental and socio-economic factors. The primary ranking criterion is the unit cost of energy production expected from each prospect. This criterion is obtained principally from expected reservoir temperatures and depths. Secondary criteria are administrative constraints, environmental factors and the quality of the geotechnical data. The Roosevelt, Utah, prospect ranks first in development potential followed in order by Beowawe, Nevada; Coso Hot Springs, California; Long Valley, California; and Brady's Hot Springs, Nevada.

Study of geothermal prospects in the western United States

Energy Technology Data Exchange (ETDEWEB)

1975-01-01

The commercial development potential of 13 underdeveloped geothermal prospects in the western United States has been examined and the prospects have been ranked in order of relative potential for development on the basis of investment considerations. The following were considered in the ranking: geotechnical and engineering data, energy market accessibility, administrative constraints, and environmental and socio-economic factors. The primary ranking criterion is the unit cost of energy production expected from each prospect. This criterion is obtained principally from expected reservoir temperatures and depths. Secondary criteria are administrative constraints, environmental factors and the quality of the geotechnical data. The Roosevelt, Utah, prospect ranks first in development potential followed in order by Beowawe, Nevada; Coso Hot Springs, California; Long Valley, California; and Brady's Hot Springs, Nevada.

Prevalence and Impact on Weaning of Pleural Effusion at the Time of Liberation from Mechanical Ventilation: A Multicenter Prospective Observational Study.

Science.gov (United States)

Dres, Martin; Roux, Damien; Pham, Tài; Beurton, Alexandra; Ricard, Jean-Damien; Fartoukh, Muriel; Demoule, Alexandre

2017-06-01

Pleural effusion is frequent in intensive care unit patients, but its impact on the outcome of weaning remains unknown. In a prospective study performed in three intensive care units, pleural ultrasound was performed at the first spontaneous breathing trial to detect and quantify pleural effusion (small, moderate, and large). Weaning failure was defined by a failed spontaneous breathing trial and/or extubation requiring any form of ventilatory support within 48 h. The primary endpoint was the prevalence of pleural effusion according to weaning outcome. Pleural effusion was detected in 51 of 136 (37%) patients and was quantified as moderate to large in 18 (13%) patients. As compared to patients with no or small pleural effusion, their counterparts were more likely to have chronic renal failure (39 vs. 7%; P = 0.01), shock as the primary reason for admission (44 vs. 19%; P = 0.02), and a greater weight gain (+4 [0 to 7] kg vs. 0 [-1 to 5] kg; P = 0.02). The prevalence of pleural effusion was similar in weaning success and weaning failure patients (odds ratio, 1.23; 95% CI, 0.61 to 2.49; P = 0.56), as was the prevalence of moderate to large pleural effusion (odds ratio, 0.89; 95% CI, 0.33 to 2.41; P = 1.00). Duration of mechanical ventilation and intensive care unit length of stay were similar between patients with no or small pleural effusion and those with moderate to large pleural effusion. Significant pleural effusion was observed in 13% of patients at the time of liberation from mechanical ventilation and was not associated with an alteration of weaning outcome. (ANESTHESIOLOGY 2017; 126:1107-15).

Dropout from exercise programs for seniors: A prospective cohort study

NARCIS (Netherlands)

Stiggelbout, M.; Hopman-Rock, M.; Tak, E.; Lechner, L.; Mechelen, W. van

2005-01-01

This study examines dropout incidence, moment of dropout, and switching behavior in organized exercise programs for seniors in the Netherlands, as determined in a prospective cohort study (with baseline measurements at the start of the exercise program and follow-up after 6 months; N = 1,725,

Perioperative echocardiography-derived right ventricle function parameters and early outcomes after tetralogy of Fallot repair in mid-childhood: a single-center, prospective observational study.

Science.gov (United States)

Raj, Ravi; Puri, Goverdhan Dutt; Jayant, Aveek; Thingnam, Shyam Kumar Singh; Singh, Rana Sandip; Rohit, Manoj Kumar

2016-11-01

Right ventricular (RV) function alterations are invariably present in all patients after tetralogy of Fallot (TOF) repair. Unlike the developed world where most of the patients with TOF are corrected in infancy, average age of presentation and thus surgery for these patients in the developing world may be higher. We aimed to study the correlation between RV function parameters such as tricuspid annular peak systolic excursion (TAPSE), fractional area change (FAC), and tricuspid annular peak systolic velocity (S') with early outcome variables after intracardiac repair for TOF. Fifty patients with a preoperative diagnosis of tetralogy of Fallot scheduled for corrective surgery were included in this single-center, prospective observational study. A preoperative transthoracic echocardiogram was performed to measure RV function parameters (FAC0, TAPSE0, S'0). Transthoracic echocardiography was repeated postoperatively to measure FAC1, TAPSE1, S'1 (day 1) and FAC2, TAPSE2, and S'2 (day 3). The relationship between preoperative and postoperative RV function parameters with in-hospital mortality, duration of mechanical ventilation, and intensive care unit stay was studied. The median age of patients was 6 years (range 1-14 years). Multiple stepwise logistic regression analysis showed RV FAC as best predictor of clinical outcome. Area under the receiver operating characteristic curve for postoperative RV function parameters, that is, FAC, TAPSE, and S' to predict early or delayed recovery was 0.944, 0.875, and 0.655, respectively. Among the RV function parameters studied, RV FAC best predicted the early outcome variables after TOF repair, followed by TAPSE while lateral tricuspid annular velocity S' being the least predictive. © 2016, Wiley Periodicals, Inc.

Maternal near-misses at a provincial hospital in Papua New Guinea: A prospective observational study.

Science.gov (United States)

Bolnga, John W; Morris, Marilyn; Totona, Catherine; Laman, Moses

2017-12-01

Maternal near-miss indices are World Health Organisation (WHO) recognised indicators that may improve our understanding of factors associated with maternal morbidity and mortality. In Papua New Guinea (PNG) where maternal mortality is among the highest in the world, only one study has documented near-miss indices in a tertiary-level hospital, but none from provincial hospitals where the majority of under-privileged women access healthcare services. To determine the near-miss ratio, maternal mortality index (MMI), and associated maternal indices for Modilon Hospital in Madang Province of PNG. All women attending Modilon Hospital who met the WHO maternal near-miss definition and/or a WHO-modified (PNG-specific) near-miss definition, were prospectively enrolled. There were 6019 live births during the audit period; 163 women presented with life-threatening conditions (153 near-misses and 10 maternal deaths). The maternal near-miss ratio was 25.4/1000 live births and the maternal mortality ratio (MMR) was 166/100 000 live births, with a maternal death to near-miss ratio of 1:15.3. The severe maternal outcome ratio was 27.1/1000 live births and the total mortality index was 6.8%. Higher proportions of near-miss women were aged ≥30 years, nulliparous, illiterate, from rural communities, lacked formal employment, referred from peripheral health facilities, unbooked, had history of still births and were anaemic. Sociodemographic factors such as women's rights, education level and status in society, in addition to appropriate health reforms with greater financial and political support are urgently needed to ensure underprivileged women in rural PNG have access to family planning, supervised deliveries and skilled emergency obstetric care. © 2017 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

Sociodemographic status, stress, and risk of prostate cancer. A prospective cohort study

DEFF Research Database (Denmark)

Nielsen, Naja Rod; Kristensen, Tage S; Zhang, Zuo-Feng

2007-01-01

PURPOSE: The social gradient in prostate cancer incidence observed in several studies may be a result of differential access to prostate cancer screening. We aim to assess if socioeconomic status, stress, and marital status are associated with prostate cancer risk in a population with free access...... to health care. METHODS: The 5,496 men who participated in the Copenhagen City Heart Study were asked about their income, educational level, stress level, and marital status during 1981-1983. These men were prospectively followed up in the Danish Cancer Registry until the end of 2002 and fewer than 0...... in prostate cancer risk according to stress (HR = 0.99; 95% CI: 0.90-1.09) or marital status. CONCLUSION: In a racially homogeneous population of Caucasians with free access to health care, we found no evidence of a relation between sociodemographic variables or stress and subsequent risk of prostate cancer....

Prospect Theory: A Study of the Endowment Effect

Directory of Open Access Journals (Sweden)

Jurandir Sell Macedo

2007-01-01

Full Text Available Behavioral Finance is a recent field of study which contradicts the presupposition supported by Modern Finance that decision makers act rationally. Prospect Theory, developed by Kahneman and Tversky (1979, is presented as an alternative model to the Theory of Expected Utility in relation to the way people decide in face of possibilities of risk. According to Prospect Theory, people define gains and losses based on a given point of reference, which can be established on grounds of a given level of expected gain. This fact leads to the Endowment Effect - a behavioral trend investigated in this study – whereby investors are influenced by a portfolio which they have received as an inheritance or endowment. The reason this occurs is that individuals usually define their expectations of gain according to the future profitability of the portfolio received, and not according to the future profitability of the market. Using an investment simulation, the Endowment Effect was tested among 226 university students taking courses in the subject of capital markets. The results demonstrate that the students were influenced by the different initial portfolios, which were randomly assigned.

Long-term weight regain after gastric bypass: a 5-year prospective study.

Science.gov (United States)

Magro, Daniéla Oliveira; Geloneze, Bruno; Delfini, Regis; Pareja, Bruna Contini; Callejas, Francisco; Pareja, José Carlos

2008-06-01

A certain weight gain occurs after obesity surgery compared to the lower weight usually observed between 18 and 24 months postsurgery. The objective of this study was to evaluate weight regain in patients submitted to gastric bypass over a 5-year follow-up period. A longitudinal prospective study was conducted on 782 obese patients of both genders. Only patients with at least 2 years of surgery were included. The percentage of excess body mass index (BMI) loss at 24, 36, 48, and 60 months postsurgery was compared to the measurements obtained at 18 months after surgery. Surgical therapeutic failure was also evaluated. Percent excess BMI loss was significant up to 18 months postsurgery (p < 0.001), with a mean difference in BMI of 1.06 kg/m2 compared to 12 months postsurgery. Percent BMI loss was no longer significant after 24 months, and weight regain became significant within 48 months after surgery (p < 0.01). Among the patients who presented weight regain, a mean 8% increase was observed within 60 months compared to the lowest weight obtained at 18 months after surgery. The percentage of surgical failure was higher in the superobese group at all times studied, reaching 18.8% at 48 months after surgery. Weight regain was observed within 24 months after surgery in approximately 50% of patients. Both weight regain and surgical failure were higher in the superobese group. Studies in regard to metabolic and hormonal mechanisms underlying weight regain might elucidate the causes of this finding.

Prospects for new information relevant to radiation protection from studies of experimental animals

International Nuclear Information System (INIS)

McClellan, R.O.

1988-01-01

The theory underlying radiation protection was developed from studies of people, laboratory animals, tissues, cells and macromolecules. Data on people were obtained from opportunistic studies of individuals previously exposed to radiation. Rarely has it been possible to conduct prospective studies of people exposed to known quantities of radiation, which sharply restricts the nature of questions that they can address. In contrast, studies using laboratory animals and simpler biological systems can be designed to address specific questions, using controlled exposure conditions. In-vitro research with macromolecules, cells and tissues leads to understanding normal and disease processes in isolated biological components. Studies of the intact animals provide opportunities to study in vivo interactive mechanisms observed in vitro and their role in development of radiation-induced diseases such as cancer. In the future, studies of intact animals should prove increasingly valuable in linking new knowledge at the subanimal level with the more fragmentary information obtained from direct observations on people. This will provide insight into important issues such as (a) effects of low-level radiation exposures, (b) mechanism of cancer induction at high versus low radiation doses, and (c) influence of factors such as nutrition and exposure to chemicals on radiation-induced cancer. This presentation describes strategies for conducting and integrating results of research using macromolecules, cells, tissues, laboratory animals and people to improve our understanding of radiation-induced cancer. It will also emphasize the problems encountered in studies at all levels of biological organization when the disease is observed in low excess incidence long after exposure to the toxicant

Primary and secondary patient data in contrast: the use of observational studies like RABBIT.

Science.gov (United States)

Richter, Adrian; Meißner, Yvette; Strangfeld, Anja; Zink, Angela

2016-01-01

The study of secondary patient data, particularly represented by claims data, has increased in recent years. The strength of this approach involves easy access to data that have been generated for administrative purposes. By contrast, collection of primary data for research is time-consuming and may therefore appear outdated. Both administrative data and data collected prospectively in clinical care can address similar research questions concerning effectiveness and safety of treatments. Therefore, why should we invest the precious time of rheumatologists to generate primary patient data? This article will outline some features of primary patient data collection illustrated by the German biologics register RABBIT (Rheumatoid arthritis: observation of biologic therapy). RABBIT is a long-term observational cohort study that was initiated more than 15 years ago. We will discuss as quality indicators: (i) study design, (ii) type of documentation, standardisation of (iii) clinical and (iv) safety data, (v) monitoring of the longitudinal follow-up, (vi) losses to follow-up as well as (vii) the possibilities to link the data base. The impact of these features on interpretation and validity of results is illustrated using recent publications. We conclude that high quality and completeness of data prospectively-collected offers many advantages over large quantities of non-standardised data collected in an unsupervised manner. We expect the enthusiasm about the use of secondary patient data to decline with more awareness of their methodological limitations while studies with primary patient data like RABBIT will maintain and broaden their impact on daily clinical practice.

Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

Science.gov (United States)

Iliou, Marie C; Vergès-Patois, Bénédicte; Pavy, Bruno; Charles-Nelson, Anais; Monpère, Catherine; Richard, Rudy; Verdier, Jean C

2017-08-01

Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant

Helicobacter pylori infection, atrophic gastritis, and pancreatic cancer risk: A meta-analysis of prospective epidemiologic studies.

Science.gov (United States)

Liu, Hong; Chen, Yue-Tong; Wang, Rui; Chen, Xin-Zu

2017-08-01

To investigate the associations of Helicobacter pylori (Hp) infection and atrophic gastritis (AG) with pancreatic cancer risk. A literature search in PubMed was performed up to July 2017. Only prospective cohort and nested case-control studies enrolling cancer-free participants were eligible. Incident pancreatic cancer cases were ascertained during the follow-up. The risks of pancreatic cancer were compared between persons infected and noninfected with Hp, or between those with and without AG status at baseline. Odds ratios (ORs) or hazard ratios were combined. Subgroup and sensitivity analyses were performed, and publication bias was estimated. Three cohort studies and 6 nested case-control studies, including 65,155 observations, were analyzed. The meta-analyses did not confirm the association between pancreatic cancer risk and Hp infection (OR = 1.09, 95% confidence interval [CI] = 0.81-1.47) or AG status (OR = 1.18, 95% CI = 0.80-1.72). However, particular subpopulations potentially had increased risks of pancreatic cancer. Cytotoxin-associated gene A (CagA)-negative strains of Hp might be a causative factor of pancreatic cancer (OR = 1.30, 95% CI = 1.05-1.62), but a sensitivity analysis by leave-one-out method did not fully warrant it (OR = 1.20, 95% CI = 0.93-1.56). In 1 nested case-control study, AG at stomach corpus in Hp-negative subpopulation might have increased risk of pancreatic cancer, but with a poor test power = 0.56. Publication biases were nonsignificant in the present meta-analysis. Based on current prospective epidemiologic studies, the linkage of pancreatic cancer to Hp infection or AG status was not warranted on the whole. Nevertheless, prospective studies only focusing on those specific subpopulations are further required to obtain better power.

Air pollution exposure estimation using dispersion modelling and continuous monitoring data in a prospective birth cohort study in the Netherlands