Home About us Contact
|
Home About us Contact | ||
|
|
||
Prospective
Kinds of Prospective Terms modified by Prospective Selected AbstractsTolerability, Safety, and Efficacy of ,-Blockade in Black Patients With Heart Failure in the Community Setting: Insights From a Large Prospective ,-Blocker RegistryCONGESTIVE HEART FAILURE, Issue 1 2007William T. Abraham MD Heart failure (HF) clinical trials suggest different responses of blacks and whites to ,-blockers. Differences between clinical trial and community settings may also have an impact. The Carvedilol Heart Failure Registry (COHERE) observed experience with carvedilol in 4280 patients with HF in a community setting. This analysis compares characteristics, outcomes, and carvedilol dosing of blacks and whites in COHERE. Compared with whites (n=3433), blacks (n=523) had more severe HF symptoms despite similar systolic function. At similar carvedilol maintenance doses, symptoms improved in 33% of blacks vs 28% of whites, while worsening in 10% and 11%, respectively (both nonsignificant), and HF hospitalization rates were reduced comparably in both groups (,58% vs ,56%, respectively; both P<.001). Incidence and hazard ratios of death were similar in blacks and whites (6.9% vs 7.5%, hazard ratio 1.2 vs 1.0, P=.276). Thus carvedilol was similarly effective in blacks and whites with HF in the community setting, consistent with carvedilol clinical trials. [source] Detecting Adverse Events in Dermatologic SurgeryDERMATOLOGIC SURGERY, Issue 1 2010DANIEL PINNEY BS BACKGROUND Despite increasing awareness of and public attention to patient safety, little is documented about how adverse events (AEs) can or should be monitored in dermatologic surgery. Data to address this shortcoming are needed, although well-defined methodologies have yet to be implemented. OBJECTIVE To summarize current strategies in detecting adverse outcomes of dermatologic surgical procedures. MATERIALS AND METHODS A Medline literature search was conducted using the terms "adverse event,""detection,""reporting,""monitoring," and "surgery." Articles selected addressed the efficacy of one or more AE reporting techniques in surgical patients. RESULTS Prospective and retrospective reporting methods were identified, with morbidity and mortality conference being the most commonly used method of AE reporting. Retrospective medical record review, the retrospective trigger tool approach, and an anonymous electronic reporting system were more sensitive approaches. The Surgical Quality Improvement Program, a program that has successfully translated AE data into lower postoperative morbidity and mortality, was analyzed. CONCLUSIONS Although generally considered safe, dermatologic surgery has no current standard for AE reporting. Standard definitions and high-quality data regarding AEs" currently limit this analysis. Pilot studies are needed to develop feasible measures, with the goal of increasing the sensitivity of AE detection and ultimately improving patient outcomes. The Center for Dermatology Research is supported by an unrestricted educational grant from Galderma Laboratories. [source] Autologous Cultured Fibroblast Injection for Facial Contour Deformities: A Prospective, Placebo-Controlled, Phase III Clinical TrialDERMATOLOGIC SURGERY, Issue 3 2007ROBERT A. WEISS MD BACKGROUND Previous data indicate that injections of autologous fibroblasts increase collagen formation, accompanied by a concomitant increase in thickness and density of dermal collagen. OBJECTIVE The purpose of this study was to determine efficacy and side effects of autologous living fibroblast injections versus placebo in a randomized Phase III trial for the treatment of various facial contour defects. METHODS This was a double-blind, randomized comparison of injectable living autologous fibroblast cells and placebo for the treatment of facial contour defects (N=215). Live fibroblasts (20 million/mL) or placebo (the transport medium without living cells) were given as three doses administered at 1- to 2-week intervals. Efficacy evaluations were performed 1, 2, 4, 6, 9, and 12 months after the first injection. RESULTS Living fibroblasts produced statistically significantly greater improvements in dermal deformities and acne scars than did placebo. The difference between live fibroblast injections and placebo achieved statistical significance at 6 months (p<.0001). At 9- and 12-month follow-up, live fibroblast,treated patients continued to demonstrate benefit from treatment with response rates of 75.0 and 81.6%, respectively. No serious treatment-related adverse events were reported. CONCLUSIONS Our results indicate that autologous fibroblast injections can safely and effectively produce improvements in rhytids, acne scars, and other dermal defects continuing for at least 12 months after injection. [source] Appraising the mitogenicity of insulin analogues relative to human insulin,response to: Weinstein D, Simon M, Yehezkel E, Laron Z, Werner H. Insulin analogues display IGF-I-like mitogenic and anti-apoptotic activity in cultured cancer cells.DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 3 2010Diabetes Metab Res Rev 2009; 25(1): 4 Abstract Interest in mitogenic and potentially carcinogenic effects of insulin and insulin analogues has been renewed by several recent publications that have examined the relationship between cancer and insulin analogues. Actions mediated through the insulin-like growth factor-I receptor in a hyperinsulinaemic state have been implicated mechanistically. Both type 2 diabetes and endogenously elevated insulin-like growth factor-I have been epidemiologically linked to malignancies. Therefore, in vitro mitogenic effects and binding affinities of the various analogues have been analysed. A recent publication by Weinstein et al. studied the in vitro mitogenic and anti-apoptotic activities of insulin analogues, and their conclusion asserts that insulins glargine, detemir, and lispro displayed proliferative and anti-apoptotic effects in a number of malignant cell lines. However, their conclusions are not supported by the data which are not complete and lack clear statistical significance. This data should be interpreted cautiously in light of all other presently available scientific evidence. Prospective, randomized clinical trials will best address any direct relationship between insulin analogues and cancer. Until those studies are designed and completed, clinicians should consider the demonstrated strong benefit of glycaemic control in balance with any alleged risk. Copyright © 2010 John Wiley & Sons, Ltd. [source] Insulin aspart vs. human insulin in the management of long-term blood glucose control in Type 1 diabetes mellitus: a randomized controlled trialDIABETIC MEDICINE, Issue 11 2000P. D. Home SUMMARY Aims To compare the efficacy of insulin aspart, a rapid-acting insulin analogue, with that of unmodified human insulin on long-term blood glucose control in Type 1 diabetes mellitus. Methods Prospective, multi-centre, randomized, open-labelled, parallel-group trial lasting 6 months in 88 centres in eight European countries and including 1070 adult subjects with Type 1 diabetes. Study patients were randomized 2:1 to insulin aspart or unmodified human insulin before main meals, with NPH-insulin as basal insulin. Main outcome measures were blood glucose control as assessed by HbA1c, eight-point self-monitored blood glucose profiles, insulin dose, quality of life, hypoglycaemia, and adverse events. Results After 6 months, insulin aspart was superior to human insulin with respect to HbA1c with a baseline-adjusted difference in HbA1c of 0.12 (95% confidence interval 0.03,0.22) %Hb, P < 0.02. Eight-point blood glucose profiles showed lower post-prandial glucose levels (mean baseline-adjusted ,0.6 to ,1.2 mmol/l, P < 0.01) after all main meals, but higher pre-prandial glucose levels before breakfast and dinner (0.7,0.8 mmol/l, P < 0.01) with insulin aspart. Satisfaction with treatment was significantly better in patients treated with insulin aspart (WHO Diabetes Treatment Satisfaction Questionnaire (DTSQ) baseline-adjusted difference 2.3 (1.2,3.3) points, P < 0.001). The relative risk of experiencing a major hypoglycaemic episode with insulin aspart compared to human insulin was 0.83 (0.59,1.18, NS). Major night hypoglycaemic events requiring parenteral treatment were less with insulin aspart (1.3 vs. 3.4% of patients, P < 0.05), as were late post-prandial (4,6 h) events (1.8 vs. 5.0% of patients, P < 0.005). Conclusions These results show small but useful advantage for the rapid-acting insulin analogue insulin aspart as a tool to improve long-term blood glucose control, hypoglycaemia, and quality of life, in people with Type 1 diabetes mellitus. [source] The Accuracy and Completeness of Data Collected by Prospective and Retrospective MethodsACADEMIC EMERGENCY MEDICINE, Issue 9 2005J. Tobias Nagurney MD Abstract Objectives: To describe and test a model that compares the accuracy of data gathered prospectively versus retrospectively among adult emergency department patients admitted with chest pain. Methods: The authors developed a model of information flow from subject to medical record to the clinical study case report form, based on a literature review. To test this model, a bidirectional (prospective and retrospective) study was conducted, enrolling all eligible adult patients who were admitted with a chief complaint of chest pain. The authors interviewed patients in the emergency department to determine their chest pain history and established a prospective database; this was considered the criterion standard. Then, patient medical records were reviewed to determine the accuracy and completeness of the information available through a retrospective medical record review. Results: The model described applies the concepts of reliability and validity to information passed on by the study subject, the clinician, and the medical record abstractor. This study was comprised of 104 subjects, of which 63% were men and the median age was 63 years. Subjects were uncertain of responses for 0,8% of questions and responded differently upon reinterview for subsets of questions 0,30% of the time. The sensitivity of the medical record for risk factors for coronary artery disease was 0.77 to 0.93. Among the 88 subjects (85%) who indicated that their chest pain was substernal or left chest, the medical record described this location in 44%. Timing of the chest pain was the most difficult item to accurately capture from the medical record. Conclusions: Information obtained retrospectively from the abstraction of medical records is measurably less accurate than information obtained prospectively from research subjects. For certain items, more than half of the information is not available. This loss of information is related to the data types included in the study and by the assumptions that a researcher performing a retrospective study makes about implied versus explicitly stated responses. A model of information flow that incorporates the concepts of reliability and validity can be used to measure some of the loss of information that occurs at each step along the way from subject to clinician to medical record abstractor. [source] Risk perception and smoking behavior in medically ill smokers: a prospective studyADDICTION, Issue 6 2010Belinda Borrelli ABSTRACT Aims To examine the influence of risk perception on intentions to quit smoking and post-treatment abstinence. Design Prospective and longitudinal. Setting United States. Participants A total of 237 adult smokers (mean age 56 years) receiving medical care from home health-care nurses. Participants did not have to want to quit smoking to participate, but received cessation counseling within the context of their medical care. Measurements Three measures of risk perception were given pre- and post-treatment: perceived vulnerability, optimistic bias and precaution effectiveness. Smoking status was verified biochemically at end of treatment and at 2, 6 and 12 months later. Findings Principal components analysis supported the theoretical discriminability of the risk perception measures, and intercorrelations provided evidence for concurrent and predictive validity. Elevated risk perception was associated with a variety of socio-demographic and psychosocial characteristics. Optimistic bias was associated significantly with older age and ethnic minority status. Smokers in pre-contemplation had lower perceived vulnerability and precaution effectiveness and greater optimistic bias than those in contemplation and preparation. Smokers in preparation had higher perceived vulnerability and lower optimistic bias than those in earlier stages. Change in perceived vulnerability predicted smoking cessation at follow-up. Optimistic bias predicted a lower likelihood of cessation and precaution effectiveness predicted a greater likelihood of smoking cessation, but only among those with a smoking-related illness. Conclusions In patients receiving medical care from home health-care nurses, change in perceived vulnerability to smoking-related disease is predictive of smoking cessation. In those with smoking-related illnesses, optimistic bias predicts continued smoking while precaution effectiveness predicts cessation. [source] Anxiety and depression among abstainers and low-level alcohol consumers.ADDICTION, Issue 9 2009The Nord-Trøndelag Health Study ABSTRACT Aims The aim of this study was to examine the levels of anxiety and depression among individuals consuming low levels of alcohol. Design Prospective and cross-sectional population-based study. Setting and participants This study employed data from the Nord-Trøndelag Health Survey (HUNT-2, n = 38 930). Measurements Alcohol consumption was measured by self-report of usual alcohol consumption during a 2-week period. Low-level alcohol consumption was defined as self-reported abstainers and non-abstainers currently consuming no alcohol. Anxiety and depression were measured using the Hospital Anxiety and Depression Rating Scale. Potential explanatory variables included somatic illness and symptoms, health-related behaviour, socio-economic status and social activity. In a subsample (n = 20 337), we also looked at the impact of previous heavy drinking among abstainers ('sick-quitting'). Findings A U-shaped association between alcohol consumption and the risk of anxiety and depression was found. Abstention was related to increased odds for both case-level anxiety [1.34, 95% confidence interval (CI) 1.19,1.52] and depression (1.52, 95% CI 1.30,1.77). This association was accounted for partly by adjustments for socio-economic status, social network, somatic illness, age (depression only), gender (anxiety only) and ,sick-quitting'. We also identified significant differences between participants who label themselves as abstainers compared to those who report no usual alcohol consumption, but who do not label themselves as abstainers. Conclusions The risk of case-level anxiety and depression is elevated in individuals with low alcohol consumption compared to those with moderate consumption. Individuals who label themselves as abstainers are at particularly increased risk. This increased risk cannot fully be explained by somatic illness, social activity or ,sick-quitting'. [source] Maintenance therapy and 3-year outcome of opioid-dependent prisoners: a prospective study in France (2003,06)ADDICTION, Issue 7 2009Jean-Noël Marzo ABSTRACT Aims To describe the profile of imprisoned opioid-dependent patients, prescriptions of maintenance therapy at imprisonment and 3-year outcome in terms of re-incarceration and mortality. Design Prospective, observational study (France, 2003,06). Setting Health units of 47 remand prisons. Participants A total of 507 opioid-dependent patients included within the first week of imprisonment between June 2003 and September 2004, inclusive. Measurements Physicians collected socio-demographic data, penal history, history of addiction, maintenance therapy and psychoactive agent use, general health status and comorbidities. Prescriptions at imprisonment were recorded by the prison pharmacist. Re-incarceration data were retrieved from the National Register of Inmates, survival data and causes of death from the National Registers of vital status and death causes. Findings Prison maintenance therapy was delivered at imprisonment to 394/507 (77.7%) patients. These patients had poorer health status, heavier opioid use and prison history and were less socially integrated than the remaining 113 patients. Over 3 years, 238/478 patients were re-incarcerated [51.3 re-incarcerations per 100 patient-years, 95% confidence interval (CI) 46.4,56.2]. Factors associated independently with re-incarceration were prior imprisonment and benzodiazepine use. After adjustment for confounders, maintenance therapy was not associated with a reduced rate of re-incarceration (adjusted relative risk 1.28, 95% CI 0.89,1.85). The all-cause mortality rate was eight per 1000 patient-years (n = 10, 95% CI 4,13). Conclusions Prescription of maintenance therapy has increased sharply in French prisons since its introduction in the mid-1990s. However, the risk of re-imprisonment or death remains high among opioid-dependent prisoners. Substantial efforts are needed to implement more effective preventive policies. [source] Community-based, Prospective, Controlled Study of Obstetric and Neonatal Outcome of 179 Pregnancies in Women with EpilepsyEPILEPSIA, Issue 1 2006Katriina Viinikainen Summary:,Purpose: This study evaluated obstetric and neonatal outcome in a community-based cohort of women with active epilepsy (WWAE) compared with the general pregnant population receiving modern obstetric care. Methods: We reviewed the total population who gave birth between January 1989 and October 2000 at Kuopio University Hospital. Obstetric, demographic, and epilepsy data were collected prospectively from 179 singleton pregnancies of women with epilepsy and from 24,778 singleton pregnancies of unaffected controls. The obstetric data from the pregnancy register was supplemented with detailed neurologic data retrieved from the medical records. The data retrieved were comprehensive because of a follow-up strategy according to a predecided protocol. Results: During pregnancy, the seizure frequency was unchanged, or the change was for the better in the majority (83%) of the patients. We found no significant differences between WWAE and controls in the incidence of preeclampsia, preterm labor, or in the rates of caesarean sections, perinatal mortality, or low birth weight. However, the rate of small-for-gestational-age infants was significantly higher, and the head circumference was significantly smaller in WWAE. Apgar score at 1 min was lower in children of WWAE, and the need for care in the neonatal ward and neonatal intensive care were increased as compared with controls. The frequency of major malformations was 4.8% (,0.6,10.2%; 95% confidence interval) in the 127 children of WWAE. Conclusions: Pregnancy course is uncomplicated and neonatal outcome is good in the majority of cases when a predecided protocol is used for the follow-up of WWAE in antenatal and neurologic care. Long-term follow-up of the neurologic and cognitive development of the children of WWAE is still needed. [source] Incidence of Status Epilepticus in Adults in Germany: A Prospective, Population-Based StudyEPILEPSIA, Issue 6 2001Susanne Knake Summary: ,Purpose: To determine the incidence and case-fatality rate of status epilepticus (SE) in adults in Hessen, Germany, we performed a prospective, population-based study from July 1997 through June 1999. Methods: All adult patients residing within the zip-code area 35 (area-35) with SE were included. Area-35 had 743.285 adult inhabitants, including 123.353 adult inhabitants of the primary service area of the University Hospital Marburg (PS-area). Patients were reported by 16 hospitals in the area and were prospectively identified and carefully reviewed within 5 days by one of the authors. Based on the crude annual incidence of SE and a rate of underascertainment of 10% determined for the PS-area, the corrected, age-adjusted incidence of SE in area 35, more representative of the population of Germany, was calculated. Results: The crude annual incidence in the PS-area was 15.8/100,000 [95% confidence interval (CI), 11.2,21.6]. The calculated, corrected, age-adjusted incidence of SE in area 35 was 17.1/100,000. It was higher for men compared with women (26.1 vs. 13.7) and for those aged 60 years and older (54.5 vs. 4.2/100,000, p < 0.0001). The etiology was mainly remote symptomatic due to cerebrovascular disease. Epilepsy was previously diagnosed in only 50% of the patients. The case-fatality rate was 9.3%. Conclusions: Based on our data, at least 14,000 patients would be affected by SE in Germany, associated with ,1,300 deaths annually. The incidence of SE in Germany is similar to that found in the white United States population. Furthermore, this study confirms the higher incidence of SE in male patients and in the elderly population. This may be due to a higher incidence of cerebrovascular disease in these subpopulations. [source] Eating disturbance and severe personality disorder: outcome of specialist treatment for severe personality disorderEUROPEAN EATING DISORDERS REVIEW, Issue 2 2006Fiona Warren Abstract Objective To assess the outcome for patients receiving specialist democratic therapeutic community treatment for personality disorder (PD) when they also have eating disturbance. Method Prospective, naturalistic study. Personality psychopathology and disturbed eating attitudes of 135 male and female referrals to tertiary treatment for PD were assessed at referral. Seventy-five referrals were admitted for treatment and 60 were not. Participants were reassessed at 1-year follow-up. Results There was a significant effect of treatment on dieting but not other aspects of eating disturbance. However, patients with eating disturbance were not more likely than those without to terminate treatment early or to have poorer outcome in terms of their personality pathology. Severity of baseline personality pathology did not predict treatment response. Conclusion Clients with comorbidity should be considered for treatment of the personality disorder prior to treatment for the eating disorder. Copyright © 2006 John Wiley & Sons, Ltd and Eating Disorders Association. [source] Quality of life in 1000 patients with early relapsing,remitting multiple sclerosisEUROPEAN JOURNAL OF NEUROLOGY, Issue 6 2009N. Putzki Background and purpose:, To examine the quality of life (QoL) in a large cohort of untreated patients with relapsing,remitting multiple sclerosis (RRMS) and to investigate the impact of intramuscular (IM) interferon beta-1a (IFNß-1a) treatment. Methods:, Prospective, observational, open-label, multicentre study conducted in Germany. Untreated patients with RRMS who initiated treatment with IM IFNß-1a were included and followed for 12 months. QoL was measured using the EQ-5D questionnaire. Clinical response was assessed by relapse rate and disability (Expanded Disability Status Scale; EDSS). Results:, A total of 1157 patients were included [mean age 37.6 years, median disease duration 13 months, mean relapse rate 1.7 (95%CI: 1.58,1.73), median EDSS score 2.0]. Relapse rate was reduced to 0.6 at 12 months (95%CI: 0.51,0.69, P < 0.0001). EDSS did not change significantly. At baseline, QoL was considerably lower in MS patients compared with the general German population, but was improved after treatment initiation [utilities of EQ-5D: 0.77 (95%CI: 0.75,0.78) vs. 0.75 (95%CI: 0.74,0.76) at baseline, 95%CI for difference: 0.01,0.03, P = 0.0046]. Higher disease activity and inability to work were negative predictors of QoL. 14.7% of patients were incapable of working for MS-related reasons. Conclusions:, Quality of life is considerably impaired in early stages of MS. Treatment initiation with IM IFNß attenuates MS disease activity and improves QoL. Inability to work early during the disease is a major challenge for the social security systems. [source] Highly Efficient Fluorine-Promoted Intramolecular Condensation of Benzo[c]phenanthrene: A New Prospective on Direct Fullerene SynthesisEUROPEAN JOURNAL OF ORGANIC CHEMISTRY, Issue 36 2009Konstantin Yu. Abstract Various functional groups have been tested as alternative promoters of the intramolecular condensation of benzo[c]phenanthrene under flash vacuum pyrolysis conditions. Methyl and fluorine functionalization were found to be promising approaches. Unexpectedly high selectivity was observed in the cyclization of fluorinated benzo[c]phenanthrenes. The mechanism for the condensation reaction and the advantages of fluorine as a promoter for the rational synthesis of fullerenes are discussed.(© Wiley-VCH Verlag GmbH & Co. KGaA, 69451 Weinheim, Germany, 2009) [source] Utility of an Initial D-dimer Assay in Screening for Traumatic or Spontaneous Intracranial HemorrhageACADEMIC EMERGENCY MEDICINE, Issue 9 2001Mark E. Hoffmann MD Abstract Objective: To evaluate the sensitivity of a D-dimer assay as a screening tool for possible traumatic or spontaneous intracranial hemorrhage. If adequately sensitive, the D-dimer assay may potentially permit omission of a more expensive computed tomography (CT) scan of the head when such hemorrhage is clinically suspected. Methods: Prospective, consecutive, blinded study of patients (age > 16 years) requiring a CT scan of the head for suspected intracranial hemorrhage over a five-month period at a university, Level I trauma center. All study patients had a serum D-dimer assay obtained prior to their CT scans. Sensitivity and specificity, with 95% confidence intervals (95% CIs), of the enzyme-linked immunosorbent assay (ELISA) D-dimer assay for the detection of intracranial hemorrhage were calculated. Results: Of the 319 patients entered in the study, 25 (7.8%) had a CT scan positive for intracranial hemorrhage. Patients with intracranial hemorrhage were more likely to have a positive D-dimer assay (chi-square ? 13.075, p < 0.001). The D-dimer assay had 21 true-positive and four false-negative tests, resulting in a sensitivity of 84.0% (95% CI ? 63.7% to 95.5%) and a specificity of 55.8% (95% CI ? 55.5% to 55.9%). The four false-negative cases included one small intraparenchymal hemorrhage, one small subarachnoid hemorrhage, one moderate-sized intraparenchymal hemorrhage with mid-line shift, and one large subdural hematoma requiring emergent surgery. Conclusions: Due to the catastrophic nature of missing an intracranial hemorrhage in the emergency department, the D-dimer assay is not adequately sensitive or predictive to use as a screening tool to allow routine omission of head CT scanning. [source] Antiepileptic Drugs in Migraine PreventionHEADACHE, Issue 2001Ninan T. Mathew MD Migraineurs may continue to experience attacks, despite daily use of one or more agents from a wide range of drugs, including , -blockers, calcium channel blockers, serotonin antagonists, tricyclic antidepressants, monoamine oxidase inhibitors, and antiepileptic agents. Divalproex sodium is the only antiepileptic drug approved for migraine prevention. Gabapentin, topiramate, and other antiepileptic agents are being evaluated for migraine prevention and treatment. Prospective, double-blind, placebo-controlled clinical trials of divalproex, gabapentin, and topiramate for migraine prevention generally were composed of a prospective baseline period, a dose titration period, and a fixed-dose treatment period. The primary efficacy variable was a reduction in the 28-day frequency of migraine headache. Patients receiving divalproex for 12 weeks at doses up to 1500 mg/day achieved significant decreases in the migraine frequency (P<.05), corresponding to reductions of 30% to 40% compared with baseline. Nearly half of the divalproex-treated patients had a 50% or more reduction from baseline in headache frequencies (P.05). Asthenia, vomiting, somnolence, tremor, and alopecia were common adverse events associated with divalproex. Significant reductions in migraine frequency were also observed with gabapentin (1800 to 2400 mg/day) when compared with placebo (P<.01), and nearly half of all patients treated at the highest dose experienced a reduction in headache rate of 50% or more. Somnolence was the most commonly reported adverse event among the gabapentin-treated patients. Two single-center, double-blind, placebo-controlled clinical trials evaluated topiramate for migraine prevention. A lower 28-day migraine frequency was seen during 18 weeks of administration at a maximum daily dose of 200 mg (P = .09). In a second study, a significantly lower mean 28-day migraine frequency was observed during 16 weeks of treatment with topiramate (P = .0015). Mean reduction in migraine frequency was also significantly greater in topiramate-treated patients (P = .0037). Paresthesias, diarrhea, somnolence, and altered taste were commonly reported adverse events in the topiramate-treated patients. Unlike some patients given divalproex or gabapentin, some given topiramate reported weight loss. Large, double-blind, placebo-controlled trials may prove the effectiveness of novel antiepileptic drugs in migraine prevention. [source] Mitochondrial hepatopathies: Advances in genetics and pathogenesis,HEPATOLOGY, Issue 6 2007Way S. Lee Hepatic involvement is a common feature in childhood mitochondrial hepatopathies, particularly in the neonatal period. Respiratory chain disorders may present as neonatal acute liver failure, hepatic steatohepatitis, cholestasis, or cirrhosis with chronic liver failure of insidious onset. In recent years, specific molecular defects (mutations in nuclear genes such as SCO1, BCS1L, POLG, DGUOK, and MPV17 and the deletion or rearrangement of mitochondrial DNA) have been identified, with the promise of genetic and prenatal diagnosis. The current treatment of mitochondrial hepatopathies is largely ineffective, and the prognosis is generally poor. The role of liver transplantation in patients with liver failure remains poorly defined because of the systemic nature of the disease, which does not respond to transplantation. Prospective, longitudinal, multicentered studies will be needed to address the gaps in our knowledge in these rare liver diseases. (HEPATOLOGY 2007;45:1555,1565.) [source] Efficacy of methotrexate in ulcerative colitis: Failure or promiseINFLAMMATORY BOWEL DISEASES, Issue 8 2010Hans H. Herfarth MD Abstract Background: Low-dose methotrexate is a widely used and efficacious therapy in chronic inflammatory disorders such as psoriasis and rheumatoid arthritis. Prospective randomized controlled trials have demonstrated the efficacy of parenteral methotrexate in Crohn's disease (CD). We performed a systematic review of the efficacy of methotrexate in ulcerative colitis (UC) and discuss the results in the context of the known pharmacokinetics and adverse events of methotrexate therapy in inflammatory bowel diseases and other inflammatory conditions. Materials and Methods: We performed a systematic review of the literature in Medline, Embase, and Web of Science. All publications describing patients with UC treated with methotrexate were included. Results: We identified 12 studies or retrospective case series and 5 meeting abstracts that met the inclusion criteria. Only 1 study reported a prospective randomized placebo-controlled trial using methotrexate at a dose of 12.5 mg orally with no significant clinical benefit. However, the majority of uncontrolled retrospective analyses suggest a clinical response to methotrexate therapy in a range of 30%,80% when the drug is applied by parenteral route in doses between 20,25 mg. Conclusions: The only randomized controlled trial of methotrexate in UC employed oral dosing and doses lower than those shown to be effective in CD and did not demonstrate efficacy, whereas uncontrolled, retrospective studies using doses and routes of administration similar to those employed in CD suggest benefit. Well-designed, prospective, placebo-controlled trials of methotrexate in UC are needed. Inflamm Bowel Dis 2010 [source] Larger tidal volume increases sevoflurane uptake in blood: a randomized clinical studyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 9 2010B. ENEKVIST Background: The rate of uptake of volatile anesthetics is dependent on alveolar concentration and ventilation, blood solubility and cardiac output. We wanted to determine whether increased tidal volume (VT), with unchanged end-tidal carbon dioxide partial pressure (PETCO2), could affect the arterial concentration of sevoflurane. Methods: Prospective, randomized, clinical study. ASA physical status 2 and II patients scheduled for elective surgery of the lower abdomen were randomly assigned to one of the two groups with 10 patients in each: one group with normal VT (NVT) and one group with increased VT (IVT) achieved by increasing the inspired plateau pressure 0.04 cmH2O/kg above the initial plateau pressure. A corrugated tube added extra apparatus dead space to maintain PETCO2 at 4.5 kPa. The respiratory rate was set at 15 min,1, and sevoflurane was delivered to the fresh gas by a vaporizer set at 3%. Arterial sevoflurane tensions (Pasevo), Fisevo, PETsevo, PETCO2, PaCO2, VT and airway pressure were measured. Results: The two groups of patients were similar with regard to gender, age, weight, height and body mass index. The mean PETsevo did not differ between the groups. Throughout the observation time, arterial sevoflurane tension (mean±SE) was significantly higher in the IVT group compared with the NVT group, e.g. 1.9±0.23 vs. 1.6±0.25 kPa after 60 min of anesthesia (P<0.05). Conclusion: Ventilation with larger tidal volumes with isocapnia maintained with added dead-space volume increases the tension of sevoflurane in arterial blood. [source] Evaluation of Interventions Proposed for Altered Tissue Perfusion: Cardiopulmonary in Patients Hospitalized With Acute Myocardial InfarctionINTERNATIONAL JOURNAL OF NURSING TERMINOLOGIES AND CLASSIFICATION, Issue 2003Ivanise Maria Gomes PURPOSE To evaluate the effectiveness and efficacy of the interventions proposed for patients with altered tissue perfusion: cardiopulmonary, according to NIC and NOC taxonomies. METHODS Prospective and descriptive study carried out in the cardiology unit of a school hospital with patients under clinical treatment followed from admission until discharge. Patient data were collected using the unit's assessment tool and nursing diagnoses were established. Daily activities were proposed for these patients based on NIC interventions "cardiac care: acute,""cardiac care," and "cardiac care: rehabilitative." Results were evaluated according to indicators selected from NOC's Tissue Perfusion: Cardiac. FINDINGS The sample comprised 25 patients (12 males, 13 females), age range 39 to 83 years. Days hospitalized averaged 3.5 in the coronary unit and 3.5 in the cardiology infirmary, for a total of 7 hospital days. The nursing diagnosis was made based on defining characteristics: enzymatic and ECG changes were found in 100% of the patients, chest pain (96%), diaphoresis (80%), and nausea (72%). The related factor in evidence for 100% of the sample was coronary arterial flow interruption. Patients were evaluated according to NOC outcomes both before starting activities and daily, with the following results: chest pain , 64% of patients initially presented pain with score 1, most (72%) presented scores 4 and 5 on day 2; on days 3, 5, 6, and 7 of hospitalization, all patients reported absence of pain (score 5). On day 4 only, 4% of patients reported pain with intensity 7 (score 2). Profuse diaphoresis was found in 80% of the sample on day 1 of hospitalization, and that disappeared in the course of the remaining days. Nausea was found in 44% of the population with score 1 on day 1 of hospitalization, and disappeared subsequently. Most the patients (84%) did not present with vomiting. Also, no evidence was found of vital sign changes in most of the sample. ECG presented score 1 in 72% of the sample on day 1, greatly decreasing from day 2. Cardiac enzymes appeared in 100% of the sample, decreasing in subsequent days. Heart ejection fraction, pulmonary artery pressure, heart rate, and myocardial scanning indicators were not measured. CONCLUSIONS Indicators evaluated achieved score 5 (no compromise) on hospital discharge in 100% of patients, which evidences effectiveness of the interventions performed. [source] Prospective randomised single blind study of epidural steroid injection comparing triamcinalone acetonide with methylprednisolone acetateINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 1 2005A. ANWAR Abstract Aim:, This study aims to assess the effectiveness of epidural steroid injection as well as comparing two agents commonly used in these procedures, namely triamcinalone acetonide and methylprednisolone acetate. Method:, Twenty subjects were recruited into each group receiving either agent. Results:, Overall result showed that there were marked improvement in symptoms in both agents but there were no differences in terms of superiority from one agent to another. Conclusion:, Epidural steroid injection is effective and both agents are equipotent. [source] Maximum Daily 6 Minutes of Activity: An Index of Functional Capacity Derived from Actigraphy and Its Application to Older Adults with Heart FailureJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2010Jason Howell BA OBJECTIVES: To compare the correlation between the maximum 6 minutes of daily activity (M6min) and standard measures of functional capacity in older adults with heart failure (HF) with that in younger subjects and its prognostic utility. DESIGN: Prospective, cohort study. SETTING: Tertiary care, academic HF center. PARTICIPANTS: Sixty, ambulatory, adults, New York Heart Association (NYHA) Class I to III, stratified into young (50.9 ± 9.4) and older cohorts (76.8 ± 8.0). MEASUREMENTS: Correlation between M6min and measures of functional capacity (6-minute walk test; 6MWT) and peak oxygen consumption (VO2) according to cardiopulmonary exercise testing in a subset of subjects. Survival analysis was employed to evaluate the association between M6min and adverse events. RESULTS: Adherence to actigraphy was high (90%) and did not differ according to age. The correlation between M6min and 6MWT was higher in subjects aged 65 and older than in those younger than 65 (correlation coefficient (r=0.702, P<.001 vs r=0.490, P=.002). M6min was also significantly associated with peak VO2 (r=0.612, P=.006). During the study, 26 events occurred (2 deaths, 10 hospitalizations, 8 emergency department visits, and 6 intercurrent illnesses). The M6min was significantly associated with subsequent events (hazard ratio=2.728, 95% confidence interval=1.10,6.77, P=.03), independent of age, sex, ejection fraction, NYHA class, brain natriuretic peptide, and 6MWT. CONCLUSION: The high adherence to actigraphy and association with standard measures of functional capacity and independent association with subsequent morbid events suggest that it may be useful for monitoring older adults with HF. [source] Clinical Features to Identify Urinary Tract Infection in Nursing Home Residents: A Cohort StudyJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2009(See editorial comments by Lindsay Nicolle on pp 111, 1114) OBJECTIVES: To identify clinical features associated with bacteriuria plus pyuria in noncatheterized nursing home residents with clinically suspected urinary tract infection (UTI). DESIGN: Prospective, observational cohort study from 2005 to 2007. SETTING: Five New Haven, Connecticut area nursing homes. PARTICIPANTS: Five hundred fifty-one nursing home residents each followed for 1 year for the development of clinically suspected UTI. MEASUREMENTS: The combined outcome of bacteriuria (>100,000 colony forming units from urine culture) plus pyuria (>10 white blood cells from urinalysis). RESULTS: After 178,914 person-days of follow-up, 228 participants had 399 episodes of clinically suspected UTI with a urinalysis and urine culture performed; 147 episodes (36.8%) had bacteriuria plus pyuria. The clinical features associated with bacteriuria plus pyuria were dysuria (relative risk (RR)=1.58, 95% confidence interval (CI)=1.10,2.03), change in character of urine (RR=1.42, 95% CI=1.07-1.79), and change in mental status (RR=1.38, 95% CI=1.03,1.74). CONCLUSION: Dysuria, change in character of urine, and change in mental status were significantly associated with the combined outcome of bacteriuria plus pyuria. Absence of these clinical features identified residents at low risk of having bacteriuria plus pyuria (25.5%), whereas presence of dysuria plus one or both of the other clinical features identified residents at high risk of having bacteriuria plus pyuria (63.2%). Diagnostic uncertainty still remains for the vast majority of residents who meet only one clinical feature. If validated in future cohorts, these clinical features with bacteriuria plus pyuria may serve as an evidence-based clinical definition of UTI to assist in management decisions. [source] Area-Level Poverty Is Associated with Greater Risk of Ambulatory,Care,Sensitive Hospitalizations in Older Breast Cancer SurvivorsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 12 2008Mario Schootman PhD OBJECTIVES: To estimate the frequency of ambulatory care,sensitive hospitalizations (ACSHs) and to compare the risk of ACSH in breast cancer survivors living in high-poverty with that of those in low-poverty areas. DESIGN: Prospective, multilevel study. SETTING: National, population-based 1991 to 1999 National Cancer Institute Surveillance, Epidemiology, and End Results Program data linked with Medicare claims data throughout the United States. PARTICIPANTS: Breast cancer survivors aged 66 and older. MEASUREMENTS: ACSH was classified according to diagnosis at hospitalization. The percentage of the population living below the U.S. federal poverty line was calculated at the census-tract level. Potential confounders included demographic characteristics, comorbidity, tumor and treatment factors, and availability of medical care. RESULTS: Of 47,643 women, 13.3% had at least one ACSH. Women who lived in high-poverty census tracts (,30% poverty rate) were 1.5 times (95% confidence interval (CI)=1.34,1.72) as likely to have at least one ACSH after diagnosis as women who lived in low-poverty census tracts (<10% poverty rate). After adjusting for most confounders, results remained unchanged. After adjustment for comorbidity, the hazard ratio (HR) was reduced to 1.34 (95% CI=1.18,1.52), but adjusting for all variables did not further reduce the risk of ACSH associated with poverty rate beyond adjustment for comorbidity (HR=1.37, 95% CI=1.19,1.58). CONCLUSION: Elderly breast cancer survivors who lived in high-poverty census tracts may be at increased risk of reduced posttreatment follow-up care, preventive care, or symptom management as a result of not having adequate, timely, and high-quality ambulatory primary care as suggested by ACSH. [source] An Educational Intervention to Improve Antimicrobial Use in a Hospital-Based Long-Term Care FacilityJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 8 2007(See Editorial Comments by Dr. Lona Mody on pp 130, 1302) OBJECTIVES: To improve antimicrobial use in patients receiving long-term care (LTC). DESIGN: Prospective, quasi-experimental before,after assessment of the effects of physician education and guideline implementation. SETTING: Public LTC and acute care hospital. PARTICIPANTS: Twenty salaried internists who provided most of the medical care to LTC patients. INTERVENTION: National guidelines, hospital resistance data, and physician feedback were incorporated into a series of four teaching sessions presented over 18 months and into booklets detailing institutional guidelines on the optimal management of common LTC infection syndromes. MEASUREMENTS: One hundred randomly selected LTC patients treated with antimicrobials were reviewed before these interventions were implemented and 100 after, and measures of the quality of care were compared. The effect of the interventions on antimicrobial days and starts were also assessed using interrupted time series analysis. RESULTS: Charted clinical abnormalities met guideline diagnostic criteria (62% vs 38%, P=.006), and initial therapy agreed with guideline recommendations (39% vs 11%, P<.001), more often in the post- than in the preintervention cohort. Mean census-adjusted monthly LTC antimicrobial days fell 29.7%, and antimicrobial starts fell 25.9% during the intervention period; both decreases were sustained during the 2-year postintervention period. CONCLUSION: The teaching and guideline intervention improved the quality and reduced the quantity of antimicrobial use in LTC patients. [source] Randomized Trial to Improve Prescribing Safety in Ambulatory Elderly PatientsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2007Marsha A. Raebel PharmD OBJECTIVES: To determine whether a computerized tool that alerted pharmacists when patients aged 65 and older were newly prescribed potentially inappropriate medications was effective in decreasing the proportion of patients dispensed these medications. DESIGN: Prospective, randomized trial. SETTING: U.S. health maintenance organization. PARTICIPANTS: All 59,680 health plan members aged 65 and older were randomized to intervention (n=29,840) or usual care (n=29,840). Pharmacists received alerts on all patients randomized to intervention who were newly prescribed a targeted medication. INTERVENTION: Prescription and age information were linked to alert pharmacists when a patient aged 65 and older was newly prescribed one of 11 medications that are potentially inappropriate in older people. MEASUREMENTS: Physicians and pharmacists collaborated to develop the targeted medication list, indications for medication use for which an intervention should occur, intervention guidelines and scripts, and to implement the intervention. RESULTS: Over the 1-year study, 543 (1.8%) intervention group patients aged 65 and older were newly dispensed prescriptions for targeted medications, compared with 644 (2.2%) usual care group patients (P=.002). For medication use indications in which an intervention should occur, dispensings of amitriptyline (P<.001) and diazepam (P=.02) were reduced. CONCLUSIONS: This study demonstrated the effectiveness of a computerized pharmacy alert system plus collaboration between healthcare professionals in decreasing potentially inappropriate medication dispensings in elderly patients. Coupling data available from information systems with the knowledge and skills of physicians and pharmacists can improve prescribing safety in patients aged 65 and older. [source] Change in Motor Function and Risk of Mortality in Older PersonsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 1 2007Aron S. Buchman MD OBJECTIVES: To assess the association between change in motor function and mortality. DESIGN: Prospective, observational cohort study. SETTING: Approximately 40 retirement communities across the Chicago metropolitan area participating in the Rush Memory and Aging Project. PARTICIPANTS: Eight hundred thirty-seven community-based older persons without dementia. MEASUREMENTS: Change in composite measures of motor performance and muscle strength. RESULTS: During a mean follow-up of 2.2 years, 81 persons died. In a proportional hazards model adjusted for age, sex, education, and body mass index, each 1-unit increase in the level of baseline motor performance was associated with an approximately 10% decrease in risk of mortality (hazard ratio (HR)=0.901, 95% confidence interval (CI)=0.863,0.941), and each unit of annual increase in motor performance was associated with an approximately 11% decrease in the risk of mortality (HR=0.887, 95% CI=0.835,0.942). In a similar model, each 1-unit increase in the level of baseline strength was associated with an approximately 9% decrease in the risk of mortality (HR=0.906, 95% CI=0.859,0.957), and each 1-unit annual increase in strength was associated with an approximately 10% decrease in the risk of mortality (HR=0.898, 95% CI=0.809,0.996). These results were similar when men and women were analyzed separately and after controlling for physical activity, cognition, and chronic disorders. When motor performance and muscle strength were examined in a single model, only baseline and annual change in motor performance were associated with mortality. CONCLUSION: Level and rate of change in strength and motor performance are associated with mortality. The attenuation of the association between strength and mortality by motor performance suggests that motor function is not a unitary process and that its components may vary in their associations with adverse health consequences in older persons. [source] Early Markers of Prolonged Hospital Stays in Older People: A Prospective, Multicenter Study of 908 Inpatients in French Acute HospitalsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 7 2006Pierre-Olivier Lang MD OBJECTIVES: To identify early markers of prolonged hospital stays in older people in acute hospitals. DESIGN: A prospective, multicenter study. SETTING: Nine hospitals in France. PARTICIPANTS: One thousand three hundred six patients aged 75 and older were hospitalized through an emergency department (Sujet Âgé Fragile: Évaluation et suivi (SAFEs) ,Frail Elderly Subjects: Evaluation and follow-up). MEASUREMENTS: Data used in a logistic regression were obtained through a gerontological evaluation of inpatients, conducted in the first week of hospitalization. The center effect was considered in two models as a random and fixed effect. Two limits were used to define a prolonged hospital stay. The first was fixed at 30 days. The second was adjusted for Diagnosis Related Groups according to the French classification (f-DRG). RESULTS: Nine hundred eight of the 1,306 hospital stays that made up the cohort were analyzed. Two centers (n=298) were excluded because of a large volume of missing f-DRGs. Two-thirds of subjects in the cohort analyzed were women (64%), with a mean age of 84. One hundred thirty-eight stays (15%) lasted more than 30 days; 46 (5%) were prolonged beyond the f-DRG-adjusted limit. No sociodemographic variables seemed to influence the length of stay, regardless of the limit used. For the 30-day limit, only cognitive impairment (odds ratio (OR)=2.2, 95% confidence interval (CI)=1.2,4.0) was identified as a marker for prolongation. f-DRG adjustment revealed other clinical markers. Walking difficulties (OR=2.6, 95% CI=1.2,16.7), fall risk (OR=2.5, 95% CI=1.7,5.3), cognitive impairment (OR=7.1, 95% CI=2.3,49.9), and malnutrition risk (OR=2.5, 95% CI=1.7,19.6) were found to be early markers for prolonged stays, although dependence level and its evolution, estimated using the Katz activity of daily living (ADL) index, were not identified as risk factors. CONCLUSION: When the generally recognized parameters of frailty are taken into account, a set of simple items (walking difficulties, risk of fall, risk of malnutrition, and cognitive impairment) enables a predictive approach to the length of stay of elderly patients hospitalized under emergency circumstances. Katz ADLs were not among the early markers identified. [source] Type 2 Diabetes Mellitus and Risk of Developing Urinary IncontinenceJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 11 2005Karen L. Lifford MD Objectives: To evaluate the association between type 2 diabetes mellitus (DM) and development of urinary incontinence in women. Design: Prospective, observational study. Setting: The Nurses' Health Study cohort. Participants: Eighty-one thousand eight hundred forty-five women who reported information on urinary function in 1996. Measurements: Self-reported, physician-diagnosed DM was ascertained using questionnaire from 1976 to 1996 and confirmed using standard criteria. Self-reported urinary incontinence, defined as leakage at least weekly, was ascertained in 1996 and 2000. Logistic regression models were used to calculate multivariate-adjusted relative risks (RRs) and 95% confidence intervals (CIs) for the relationship between DM (as of 1996) and prevalent and incident incontinence. Results: The risk of prevalent incontinence (multivariate RR=1.28, 95% CI=1.18,1.39) and incident incontinence (multivariate RR=1.21, 95% CI=1.02,1.43) was significantly greater in women with DM than women without. Using a validated severity index, risk of developing severe incontinence was even more substantial in women with DM than in those without (multivariate RR=1.40, 95% CI=1.15,1.71 for leakage enough to wet the underwear; RR=1.97, 95% CI=1.24,3.12 for leakage enough to wet the outer clothing). In addition, risk of incontinence increased with duration of DM (P -trend=.03 for prevalent incontinence; P=.001 for incident incontinence). Conclusion: DM independently increases risk of urinary incontinence in women. Because risk of incontinence appeared associated with longer duration of DM, even delaying the onset of DM could have important public health implications. [source] A Comparative Study of the Use of Four Fall Risk Assessment Tools on Acute Medical WardsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2005Michael Vassallo FRCP Objectives: To compare the effectiveness of four falls risk assessment tools (STRATIFY, Downton, Tullamore, and Tinetti) by using them simultaneously in the same environment. Design: Prospective, open, observational study. Setting: Two acute medical wards admitting predominantly older patients. Participants: One hundred thirty-five patients, 86 female, mean age±standard deviation 83.8±8.01 (range 56,100). Measurements: A single clinician prospectively completed the four falls risk assessment tools. The extent of completion and time to complete each tool was recorded. Patients were followed until discharge, noting the occurrence of falls. The sensitivity, specificity, negative predictive accuracy, positive predictive accuracy, and total predictive accuracy were calculated. Results: The number of patients that the STRATIFY correctly identified (n=90) was significantly higher than the Downton (n=46; P<.001), Tullamore (n=66; P=.005), or Tinetti (n=52; P<.001) tools, but the STRATIFY had the poorest sensitivity (68.2%). The STRATIFY was also the only tool that could be fully completed in all patients (n=135), compared with the Downton (n=130; P=.06), Tullamore (n=130; P=.06), and Tinetti (n=17; P<.001). The time required to complete the STRATIFY tool (average 3.85 minutes) was significantly less than for the Downton (6.34 minutes; P<.001), Tinetti (7.4 minutes; P<.001), and Tullamore (6.25 minutes; P<.001). The Kaplan-Meier test showed that the STRATIFY (log rank P=.001) and Tullamore tools (log rank P<.001) were effective at predicting falls over the first week of admission. The Downton (log rank P=.46) and Tinetti tools (log rank P=.41) did not demonstrate this characteristic. Conclusion: Significant differences were identified in the performance and complexity between the four risk assessment tools studied. The STRATIFY tool was the shortest and easiest to complete and had the highest predictive value but the lowest sensitivity. [source] | ||||||||||||||||||||||||||||||||||||||||