Gut-directed hypnotherapy significantly augments clinical remission in quiescent ulcerative colitis

PubMed Central

Keefer, Laurie; Taft, Tiffany H; Kiebles, Jennifer L; Martinovich, Zoran; Barrett, Terrence A; Palsson, Olafur S

2013-01-01

Summary Background Psychotherapy is not routinely recommended for in ulcerative colitis (UC). Gut-directed hypnotherapy (HYP) has been linked to improved function in the gastrointestinal tract and may operate through immune-mediated pathways in chronic diseases. Aims To determine the feasibility and acceptability of hypnotherapy and estimate the impact of hypnotherapy on clinical remission status over a 1 year period in patients with an historical flare rate of 1.3 times per year. Methods 54 patients were randomized at a single site to 7 sessions of gut-directed hypnotherapy (N = 26) or attention control (CON; N = 29) and followed for 1 year. The primary outcome was the proportion of participants in each condition that had remained clinically asymptomatic (clinical remission) through 52 weeks post-treatment. Results One-way ANOVA comparing hypnotherapy and control subjects on number of days to clinical relapse favored the hypnotherapy condition [F = 4.8 (1, 48), p = .03] by 78 days. Chi square analysis comparing the groups on proportion maintaining remission at 1 year was also significant [X2(1) = 3.9, p = .04], with 68% of hypnotherapy and 40% of control patients maintaining remission for 1 year. There were no significant differences between groups over time in quality of life, medication adherence, perceived stress or psychological factors. Conclusions This is the first prospective study that has demonstrated a significant effect of a psychological intervention on prolonging clinical remission in patients with quiescent UC. Clinical Trial # NCT00798642 PMID:23957526

Impact of an emergency department pain management protocol on the pattern of visits by patients with sickle cell disease.

PubMed

Givens, Melissa; Rutherford, Cynthia; Joshi, Girish; Delaney, Kathleen

2007-04-01

This study explores how implementation of pain management guidelines in concert with clinic case management affected emergency department (ED) utilization, clinic visits, and hospital admissions for patients with sickle cell disease. A pain management guideline that eliminated meperidine and encouraged timely use of morphine or hydromorphone for pain control in sickle cell crisis was introduced as a quality improvement project. This study is a retrospective review of ED visits, clinic visits, and admissions from 1 year before and 3 years after the guideline implementation. Working with the ED, the Hematology Clinic began to proactively seek the return of their patients for clinic follow-up. A formal case management program for sickle cell patients was initiated in June 2003. A total of 1584 visits by 223 patients were collected, 1097 to the ED and 487 to the Hematology Clinic. Total hospital visits did not change significantly in any of the 4 years, p > 0.10 for each comparison. Total ED visits decreased significantly over the 4-year study period (p < 0.001), whereas clinic visits steadily increased (p < 0.001). Return visits to the ED within 30 days also declined significantly, p < 0.001. Both the absolute number of admissions per year and the total admissions per hospital visit per year declined significantly over the study period, p = 0.001. Although total admissions per hospital visit did not change, the proportion of ED visits that resulted in admission in year 1 (29%) was significantly lower than the proportion admitted in year 2 (43%), p = 0.04. A pain protocol using morphine or hydromorphone coupled with increased access to outpatient clinics decreased ED visits, hospitalizations, and increased utilization of a more stable primary care clinic setting by patients with sickle cell disease.

Increasing access by priority populations to Australian sexual health clinics.

PubMed

Ali, Hammad; Donovan, Basil; Fairley, Christopher K; Chen, Marcus Y; O'Connor, Catherine C; Grulich, Andrew E; McNulty, Anna; Ryder, Nathan; Hellard, Margaret E; Guy, Rebecca J

2013-10-01

Data from a network of 35 Australian sexual health clinics, in geographically diverse locations, showed that the number and proportion of patients from priority populations (ie, young people, men who have sex with men, indigenous people, and female sex workers) increased significantly between 2004 and 2011.

Children with Phonological Problems: A Survey of Clinical Practice

ERIC Educational Resources Information Center

Joffe, Victoria; Pring, T.

2008-01-01

Background: Children with phonological problems are a significant proportion of many therapists' caseloads. However, little is known about current clinical practice with these children or whether research on the effects of therapy have influenced this practice. Aims: To investigate the methods of assessment and remediation used by therapists…

Validating indicators of treatment response: application to trichotillomania.

PubMed

Nelson, Samuel O; Rogers, Kate; Rusch, Natalie; McDonough, Lauren; Malloy, Elizabeth J; Falkenstein, Martha J; Banis, Maria; Haaga, David A F

2014-09-01

Different studies of the treatment of trichotillomania (TTM) have used varying standards to determine the proportion of patients who obtain clinically meaningful benefits, but there is little information on the similarity of results yielded by these methods or on their comparative validity. Data from a stepped-care (Step 1: Web-based self-help; Step 2: Individual behavior therapy; N = 60) treatment study of TTM were used to evaluate 7 potential standards: complete abstinence, ≥ 25% symptom reduction, recovery of normal functioning, and clinical significance (recovery + statistically reliable change), each of the last 3 being measured by self-report (Massachusetts General Hospital Hairpulling Scale; MGH-HPS) or interview (Psychiatric Institute Trichotillomania Scale). Depending on the metric, response rates ranged from 25 to 68%. All standards were significantly associated with one another, though less strongly for the 25% symptom reduction metrics. Concurrent (with deciding to enter Step 2 treatment) and predictive (with 3-month follow-up treatment satisfaction, TTM-related impairment, quality of life, and diagnosis) validity results were variable but generally strongest for clinical significance as measured via self-report. Routine reporting of the proportion of patients who make clinically significant improvement on the MGH-HPS, supplemented by data on complete abstinence, would bolster the interpretability of TTM treatment outcome findings. PsycINFO Database Record (c) 2014 APA, all rights reserved.

Clinical Relevance of Vilazodone Treatment in Patients With Major Depressive Disorder: Categorical Improvement in Symptoms

PubMed Central

Culpepper, Larry; Mathews, Maju; Ghori, Razi; Edwards, John

2014-01-01

Objective: To assess clinically relevant symptom improvement in patients with major depressive disorder (MDD) receiving vilazodone by using the Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale used to measure MDD symptom severity and improvement. Method: Pooled data from 2 positive, phase 3, 8-week, double-blind, randomized, placebo-controlled trials in patients with MDD were analyzed. Patients received vilazodone 40 mg/d or placebo; post hoc analyses were conducted on study completers. Depression symptom improvement was evaluated by analyzing the proportions of patients who shifted from the baseline MADRS single-item symptom severity category of ≥ 2 (mild to severe symptoms) to an end-of-study category < 2 (minimal to no symptoms) or from ≥ 4 (moderate to severe symptoms) to ≤ 2 (mild to no symptoms). The proportion of patients who shifted from anxious depression to no anxious depression was also analyzed. Results: The percentage of patients who completed these studies with severity category shift from baseline ≥ 2 to end of study < 2 was significantly higher for vilazodone versus placebo on all MADRS items (odds ratio [OR] range, 1.4–1.7, P < .05) except reduced appetite (OR = 1.3, P = .232). A significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from baseline ≥ 4 to end of study ≤ 2 on MADRS items of apparent sadness, reported sadness, inner tension, reduced sleep, and lassitude (OR range, 1.5–2.0, P < .05). Additionally, a significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from anxious depression at baseline to no anxious depression at end of study (OR = 1.5, P = .031). Conclusions: These results suggest that vilazodone treatment is associated with clinically relevant changes in depression symptoms in patients with MDD. Trial Registration: ClinicalTrials.gov identifiers: NCT00285376 and NCT00683592 PMID:24940525

Lack of efficacy of homeopathic therapy against post-calving clinical mastitis in dairy herds in the Waikato region of New Zealand.

PubMed

Williamson, J H; Lacy-Hulbert, S J

2014-01-01

To compare clinical and bacteriological cure rates of clinical mastitis following treatment with either antimicrobials or homeopathic preparations. Seven spring-calving herds from the Waikato region of New Zealand were used to source cases of clinical mastitis (n = 263 glands) during the first 90 days following calving. Duplicate milk samples were collected for bacteriology from each clinically infected gland at diagnosis and 25 (SD 5.3) days after initial treatment. Affected glands were treated with either an antimicrobial formulation or a homeopathic remedy. Generalised linear models with binomial error distribution and logit link were used to analyse the proportion of cows that were clinical treatment cures and the proportion of glands that were classified as bacteriological cures, based on initial and post-treatment milk samples. Mean cumulative incidence of clinical mastitis was 7% (range 2-13% across herds) of cows. Streptococcus uberis was the most common pathogen isolated from culture-positive samples from affected glands (140/209; 67%). The clinical cure rate was higher for cows treated with antimicrobials (107/113; 95%) than for cows treated with homeopathic remedies (72/114; 63%) (p < 0.001) based on the observance of clinical signs following initial treatment. Across all pathogen types bacteriological cure rate at gland level was higher for those cows treated with antimicrobials (75/102; 74%) than for those treated with a homeopathic preparation (39/107; 36%) (p < 0.001). Using herds located in the Waikato region of New Zealand, homeopathic remedies had significantly lower clinical and bacteriological cure rates compared with antimicrobials when used to treat post-calving clinical mastitis where S. uberis was the most common pathogen. The proportion of cows that needed retreatment was significantly higher for the homeopathic treated cows. This, combined with lower bacteriological cure rates, has implications for duration of infection, individual cow somatic cell count, costs associated with treatment and animal welfare.

Birth Rates Among Hispanics and Non-Hispanics and their Representation in Contemporary Obstetric Clinical Trials.

PubMed

Kahr, Maike K; De La Torre, Rosa; Racusin, Diana A; Suter, Melissa A; Mastrobattista, Joan M; Ramin, Susan M; Clark, Steven L; Dildy, Gary A; Belfort, Michael A; Aagaard, Kjersti M

2016-10-01

Objective Our study aims were to establish whether subjects enrolled in current obstetric clinical trials proportionately reflects the contemporary representation of Hispanic ethnicities and their birth rates in the United States. Methods Using comprehensive source data over a defined interval (January 2011-September 2015) on birth rates by ethnicity from the Centers for Disease Control and Prevention (CDC), we evaluated the proportional rate by ethnicity, then analyzed the observed to expected relative ratio of enrolled subjects. Results Hispanic women comprise a significant contribution to births in the United States (23% of all births). Systematic analysis of 90 published obstetric clinical trials showed a correlation between inclusion of Hispanic gravidae and the corresponding state's birth rates (r = 0.501, p < 0.001). While the mean was strongly correlated, individual clinical trials may have relatively over-enrolled (n = 31, or 34%) or under-enrolled (n = 33, or 37%) relative to their regional population. In 48% of obstetric clinical trials the Hispanic proportion of the study population was not reported. Conclusion Hispanic gravidae represent a significant number of contemporary U.S. births, and are generally adequately represented as obstetric subjects in clinical trials. However, this is trial-dependent, with significant trial-specific under- and over-enrollment of Hispanic subjects relative to the regional birth population. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Use of diagnostic imaging in the emergency department for cervical spine injuries in Kingston, Ontario.

PubMed

Pickett, William; Kukaswadia, Atif; Thompson, Wendy; Frechette, Mylene; McFaull, Steven; Dowdall, Hilary; Brison, Robert J

2014-01-01

This study assessed the use and clinical yield of diagnostic imaging (radiography, computed tomography, and medical resonance imaging) ordered to assist in the diagnosis of acute neck injuries presenting to emergency departments (EDs) in Kingston, Ontario, from 2002-2003 to 2009-2010. Acute neck injury cases were identified using records from the Kingston sites of the Canadian National Ambulatory Care Reporting System. Use of radiography was analyzed over time and related to proportions of cases diagnosed with clinically significant cervical spine injuries. A total of 4,712 neck injury cases were identified. Proportions of cases referred for diagnostic imaging to the neck varied significantly over time, from 30.4% in 2002-2003 to 37.6% in 2009-2010 (ptrend  =  0.02). The percentage of total cases that were positive for clinically significant cervical spine injury ("clinical yield") also varied from a low of 5.8% in 2005-2006 to 9.2% in 2008-2009 (ptrend  =  0.04), although the clinical yield of neck-imaged cases did not increase across the study years (ptrend  =  0.23). Increased clinical yield was not observed in association with higher neck imaging rates whether that yield was expressed as a percentage of total cases positive for clinically significant injury (p  =  0.29) or as a percentage of neck-imaged cases that were positive (p  =  0.77). We observed increases in the use of diagnostic images over time, reflecting a need to reinforce an existing clinical decision rule for cervical spine radiography. Temporal increases in the clinical yield for total cases may suggest a changing case mix or more judicious use of advanced types of diagnostic imaging.

The use of insecticide-treated nets for reducing malaria morbidity among children aged 6-59 months, in an area of high malaria transmission in central Côte d'Ivoire

PubMed Central

2010-01-01

Background Long-lasting insecticidal nets (LLINs) are an important tool for controlling malaria. Much attention has been devoted to determine both the effect of LLINs on the reduction of Plasmodium infection rate and on clinically-confirmed malaria cases in sub-Saharan Africa. We carried out an epidemiological study to investigate whether LLINs impact on Plasmodium prevalence rate and the proportion of clinically-confirmed malaria cases, in five villages in the district of Toumodi, central Côte d'Ivoire. Methods From April 2007 to November 2008, a community-based malaria control programme was implemented in the study villages, which involved large-scale distribution of LLINs, and training and sensitization activities within the community. We determined the effect of this programme on Plasmodium prevalence rate, clinically-confirmed malaria cases and proportion of high parasitaemia rates in children aged 6-59 months through a series of cross-sectional surveys starting in April 2007 and repeated once every 6 months. Results We observed a significant decrease in the mean P. falciparum prevalence rate from April 2007 to April 2008 (p = 0.029). An opposite trend was observed from November 2007 to November 2008 when P. falciparum prevalence rate increased significantly (p = 0.003). Highly significant decreases in the proportions of clinical malaria cases were observed between April 2007 and April 2008 (p < 0.001), and between November 2007 and November 2008 (p = 0.001). Conclusions Large-scale distribution of LLINs, accompanied by training and sensitization activities, significantly reduced Plasmodium prevalence rates among young children in the first year of the project, whereas overall clinical malaria rates dropped over the entire 18-month project period. A decrease in community motivation to sleep under bed nets, perhaps along with changing patterns of malaria transmission, might explain the observed increase in the Plasmodium prevalence rate between November 2007 and November 2008. PMID:20860829

Medication discrepancies associated with subsequent pharmacist-performed medication reconciliations in an ambulatory clinic.

PubMed

Philbrick, Ann M; Harris, Ila M; Schommer, Jon C; Fallert, Christopher J

2015-01-01

To describe the number of medication discrepancies associated with subsequent medication reconciliations by a clinical pharmacist in an ambulatory family medicine clinic and the proportion of subsequent medication reconciliation visits that were associated with hospital discharge, long-term anticoagulation management, or both. Data on medication reconciliations were collected over a 2-year time period in an ambulatory family medicine clinic for patients taking 10 or more medications. Medication reconciliation was performed 752 times for 500 patients. A total of 5,046 discrepancies were identified, with more than one-half deemed clinically important. A mean (± SD) of 6.7 ± 4.6 discrepancies per visit (3.5 ± 3.2 clinically important) were identified. The findings showed that the distribution of total discrepancies identified by pharmacist-performed medication reconciliation was significantly different over the course of subsequent medication reconciliations. However, the distribution of clinically important discrepancies was not significantly different; important discrepancies were as likely to be found in later reconciliations as in earlier ones. As subsequent medication reconciliation visits were performed, an increasing proportion consisted of post-hospital discharge visits, long-term anticoagulation managed by a clinical pharmacist, or both. Patients with a recent hospital discharge, on long-term anticoagulation management, or both, were more likely to have multiple sessions with a clinical pharmacist for medication reconciliation. These findings can help identify patients for whom medication reconciliation is warranted.

Improved malignant melanoma prognosis at a consultant-delivered multidisciplinary pigmented lesion clinic in Cork.

PubMed

Field, S; Deady, S; Fitzgibbon, J; Murphy, M; Comber, H

2010-02-01

Early detection and excision is the only effective treatment for malignant melanoma. To assess the effect of a consultant-delivered, rapid-access pigmented lesion clinic (PLC) established at the South Infirmary-Victoria University Hospital (SIVUH), we analyzed melanoma tumour-stage prior to (1998-2002) and after (2003-2007) the advent of the PLC. Patients attending SIVUH had a greater proportion of early-stage tumours (65.3%) compared to the rest of Cork (51.2%), County Cork as a whole (56.7%) and all of Ireland (57.4%). The proportion of SIVUH males with early-stage tumours was statistically significantly higher than the rest of County Cork (chi2 = 11.23, P < 0.05). The proportion of patients > 50y with early-stage tumours was also statistically significantly higher than the rest of County Cork (chi2 = 18.88, P < 0.05), the whole of County Cork (chi2 = 7.84, P < 0.05) and all of Ireland (chi2 = 9.67, P < 0.05). We believe that the early detection and improved prognosis of Cork melanoma patients is at least partly due to the PLC.

Differences between right- and left-sided colon cancer in patient characteristics, cancer morphology and histology.

PubMed

Nawa, Toru; Kato, Jun; Kawamoto, Hirofumi; Okada, Hiroyuki; Yamamoto, Hiroshi; Kohno, Hiroyuki; Endo, Hisayuki; Shiratori, Yasushi

2008-03-01

Recently, the clinical and biological differences between right- and left-sided colon cancers have been widely debated. However, close analyses of these clinical differences, based on large-scale studies, have been scarcely reported. A total of 3552 consecutive Japanese colorectal cancer cases were examined and the clinical differences between right- and left-sided colon cancer cases were investigated. The proportion of right-sided colon cancer was relatively high in patients aged less than 40 years (33%) and more than 80 years (43%). The proportion of right-sided colon cancer in patients aged 40-59 years was relatively low (male 22% and female 29%). In male patients the proportion increased in the 70-79 years age group (30%), while in female patients the proportion increased in the 60-69 years age group (39%). Right-sided colon cancer was more likely to be detected at an advanced stage (T1 stage; left 22%, right 15%) (P < 0.01) with severe symptoms. Polypoid-type early cancer was dominant in the left colon (left 59%; right 40%) (P < 0.01), while the proportion of flat-type early cancer in the right colon was significantly higher than that in the left colon (left 25%; right 44%) (P < 0.01). Specific age distribution of right-sided colon cancer was observed and the difference between male and female patients was highlighted. Other clinical features also differed between right- and left-sided colon cancer, suggesting that different mechanisms may be at work during right and left colon carcinogenesis.

Improved quality of care for cardiovascular disease for Latinos seen in high proportion Latino vs low proportion Latino clinics.

PubMed

López, Lenny; Cook, Nakela; Hicks, Leroi

2015-01-01

Primary care practices that concentrate linguistically and culturally appropriate services for Latinos may result in higher cardiology consultation rates and improved process measure performance for patients with coronary artery disease (CAD) and congestive heart failure (CHF). Multivariable Cox proportional-hazards regression was used to assess differences in referral at high proportion (HP) vs low proportion (LP) practices. Multivariable Poisson regression was used to assess the frequency of follow-up consultation. Among the 9,761 patients, 9,168 had CAD, 4,444 had CHF, and 3,851 had both conditions. Latinos comprised 11% of the CAD cohort and 11% of the CHF cohort. Multivariable analyses showed higher consultation rates for Latinos at HP practices for CAD and CHF. Blacks and Whites at HP practices had no significant differences in rates of consultation compared to those in LP practices. Latinos at HP practices had 25% more consultations for CAD and 23% more consultations for CHF than Latinos at LP practices. Latinos at HP clinics had higher overall mean quality performance on clinical measures for both CAD and CHF. Latinos at an LP clinic had the largest improvement in quality performance with consultation. Among Latinos with CAD or CHF receiving care within a single large academic care network, Latino patients at HP practices have higher rates of cardiologist consultation and performance on CVD process measures compared to Latino patients at LP practices. Elucidating the essential components of individual practice environments that provide higher quality of care for Latinos will allow for well designed systems to reduce health care disparities.

Body proportions in children with Kabuki syndrome.

PubMed

Penders, Bas; Schott, Nina; Gerver, Willem-Jan M; Stumpel, Constance T R M

2016-03-01

Facial characteristics, short stature, and skeletal anomalies have been described for the clinical diagnosis of Kabuki Syndrome (KS) in children. However, no studies have investigated body proportions in KS. Knowledge of body proportions in KS may contribute to better insight into the growth pattern and characterization of this genetic disorder. Therefore we compared body proportions of children with KS to normally proportioned controls to investigate if atypical body proportions are part of this genetic disorder. This study was designed and conducted within the setting of the Maastricht University Medical Centre (MUMC+), the official Dutch expert center for Kabuki syndrome. We conducted a cross-sectional study in 32 children (11 children with KS and 21 controls). Body proportions were determined by means of photogrammetric anthropometry, measurements based on digital photography. Body proportions, quantified as body ratios, differ significantly in children with KS from normally proportioned children. Children with KS have larger heads and longer arms proportional to their trunks and have been found to have longer upper arms proportional to their tibia length and feet. Based on deviations in body proportions it was shown possible to discern children with KS from normally proportioned controls. © 2015 Wiley Periodicals, Inc.

The impact of the introduction of PECARN head CT rules on the utilisation of head CT scans in a private tertiary hospital in Sub-Saharan Africa.

PubMed

Kobe, Isaac O; Qureshi, Mahmoud M; Hassan, Saidi; Oluoch-Olunya, David L

2017-12-01

The decision to order head CT scans to rule out clinically significant traumatic brain injury in mild head injury in children is made on the basis of clinical decision rules of which the Paediatric Emergency Care Applied Research Network (PECARN) CT head rules have been found to be most sensitive. The purpose of this study is to determine the proportion of head CT scans done for children with mild head injury and to determine disposition of patients from casualty after the introduction of PECARN head CT rules compared to the period before. The research question is "will introduction of the PECARN CT head rules reduce the proportion of head CT scans requested for children under 18 years with mild head injury at the AKUHN?" A before and after quasi experimental study with a study population including all children under 18 years presenting to the AKUHN with mild head injury and a Glasgow coma scale of 14 and above on presentation. Sample size was 85. A total of 42 patients files were analysed in the before study while 43 patients were selected for the after study. The median age was 5 years. The proportion of head CT scans reduced from 56% in the before group to 33% in the after group with no missed clinically significant traumatic brain injury. More patients were discharged home after evaluation in the after group (81%) than in the before group (58%). The number of head CT scans ordered reduced without missing any clinically significant traumatic brain injury.

HIV-associated anal dysplasia: experience from a multiethnic-HIV clinic in Hawaii.

PubMed

Payam, Ahoora; Shiramizu, Bruce; Shikuma, Cecilia; Milne, Cris; Terada, Kevin; Kajioka, Eric; Ka'opua, Lana Sue; Cassel, Kevin; Chow, Dominic

2011-01-01

To assess the proportion as well as predictors of anal dysplasia in HIV-infected Asian/Pacific Islanders. This was a retrospective chart review evaluating the proportion of anal dysplasia among a multiethnic population from an ambulatory university-based HIV clinic in Hawaii. Demographic, clinical, and virologic parameters were examined with respect to abnormal anal Pap smear. Variables included: Pap smear results (outcome variable), cytology results, age, self-reported ethnicity, CD4/ nadir CD4 counts, HIV viral load, antiretroviral therapy use, Hepatitis B and C co-infections, history of sexually transmitted diseases, personal history of cancer, tobacco use, alcohol use, intravenous drug abuse, family history of cancer, and history of genital/anal warts. There were no significant differences in rates of abnormal Pap smear among the ethnic groups. Abnormal Pap smears were associated with history of genital warts (7% normal vs. 18% abnormal, p=.01) and alcohol consumption (16% vs. 27%, p=.05). Hepatitis B infection and current anti-retroviral therapy (ART) were associated with normal Pap cytology (9.7% vs. 0%, p=.03) and (96.8% vs. 86.5%, p=.05) respectively. No differences in the proportion of abnormal Pap smears were seen among ethnic groups followed within an ambulatory HIV clinic.

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study

PubMed Central

Bouchard, Simon; Sidani, Sacha

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO. PMID:27446865

Prevalence of Small Intestinal Bacterial Overgrowth among Chronic Pancreatitis Patients: A Case-Control Study.

PubMed

Therrien, Amelie; Bouchard, Simon; Sidani, Sacha; Bouin, Mickael

2016-01-01

Background. Patients with chronic pancreatitis (CP) exhibit numerous risk factors for the development of small intestinal bacterial overgrowth (SIBO). Objective. To determine the prevalence of SIBO in patients with CP. Methods. Prospective, single-centre case-control study conducted between January and September 2013. Inclusion criteria were age 18 to 75 years and clinical and radiological diagnosis of CP. Exclusion criteria included history of gastric, pancreatic, or intestinal surgery or significant clinical gastroparesis. SIBO was detected using a standard lactulose breath test (LBT). A healthy control group also underwent LBT. Results. Thirty-one patients and 40 controls were included. The patient group was significantly older (53.8 versus 38.7 years; P < 0.01). The proportion of positive LBTs was significantly higher in CP patients (38.7 versus 2.5%: P < 0.01). A trend toward a higher proportion of positive LBTs in women compared with men was observed (66.6 versus 27.3%; P = 0.056). The subgroups with positive and negative LBTs were comparable in demographic and clinical characteristics, use of opiates, pancreatic enzymes replacement therapy (PERT), and severity of symptoms. Conclusion. The prevalence of SIBO detected using LBT was high among patients with CP. There was no association between clinical features and the risk for SIBO.

Effects of total knee and hip arthroplasty on body weight.

PubMed

Duchman, Kyle R; Gao, Yubo; Phisitkul, Phinit

2014-03-01

Patients frequently report functional and subjective improvement following total hip (THA) and knee arthroplasty (TKA), but these improvements do not correlate with decreased body weight at 1- and 2-year follow-up. The purpose of this retrospective study was to investigate changes in body weight following THA and TKA at longer follow-up than the 1- to 2-year follow-up frequently reported in the literature. A retrospective review of patients undergoing THA and TKA, as well as other commonly performed lower extremity orthopedic surgeries, was completed for January 2002 to October 2011 at a single tertiary care facility. Adults who underwent a single lower extremity orthopedic procedure during that time period were included in the study. Patients undergoing THA and TKA were analyzed for clinically and statistically significant weight changes at 1- and minimum 2-year follow-up. At a mean follow-up of 4.82 years, TKA resulted in a statistically significant decrease in mean body weight (1.47 kg; P=.0109). This finding was unique to TKA. The proportion of individuals who experienced clinically significant weight loss between the 1- and minimum 2-year follow-up was higher than the proportion of individuals who gained clinically significant weight over the same time period following THA and TKA. The results of this study suggest that clinically significant weight loss may continue for several years beyond the 1- and 2-year follow-up that is frequently reported in the literature. Copyright 2014, SLACK Incorporated.

Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

PubMed

Sacristán, J A; Gómez, J C; Montejo, A L; Vieta, E; Gregor, K J

2000-05-01

The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score < or = 4. A total of 2657 patients were included in the analysis. The initial and overall mean daily doses for the 3 groups were as follows: OLZ, 12.2 and 13.0 mg, respectively; RIS, 5.2 and 5.4 mg; and HAL, 13.9 and 13.6 mg. Initial and overall median daily doses were the same in each group: OLZ, 10 mg; RIS, 6 mg; and HAL, 10 mg. A significantly lower proportion of OLZ-treated patients (36.9%) experienced EPS compared with RIS-treated (49.6%) and HAL-treated (76.0%) patients (P < or = 0.001). A significantly lower proportion of patients in the OLZ group (47.8%) experienced adverse events compared with patients in the RIS (57.2%) and HAL (79.8%) groups (P < or = 0.001). A significantly greater proportion of OLZ-treated patients (37.3%) were responders compared with RIS-treated patients (31.5%) (P < 0.05). In all 3 groups, patients who had an initial CGI score > or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

A Retrospective Survey of Research Design and Statistical Analyses in Selected Chinese Medical Journals in 1998 and 2008

PubMed Central

Jin, Zhichao; Yu, Danghui; Zhang, Luoman; Meng, Hong; Lu, Jian; Gao, Qingbin; Cao, Yang; Ma, Xiuqiang; Wu, Cheng; He, Qian; Wang, Rui; He, Jia

2010-01-01

Background High quality clinical research not only requires advanced professional knowledge, but also needs sound study design and correct statistical analyses. The number of clinical research articles published in Chinese medical journals has increased immensely in the past decade, but study design quality and statistical analyses have remained suboptimal. The aim of this investigation was to gather evidence on the quality of study design and statistical analyses in clinical researches conducted in China for the first decade of the new millennium. Methodology/Principal Findings Ten (10) leading Chinese medical journals were selected and all original articles published in 1998 (N = 1,335) and 2008 (N = 1,578) were thoroughly categorized and reviewed. A well-defined and validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation. Main outcomes were the frequencies of different types of study design, error/defect proportion in design and statistical analyses, and implementation of CONSORT in randomized clinical trials. From 1998 to 2008: The error/defect proportion in statistical analyses decreased significantly ( = 12.03, p<0.001), 59.8% (545/1,335) in 1998 compared to 52.2% (664/1,578) in 2008. The overall error/defect proportion of study design also decreased ( = 21.22, p<0.001), 50.9% (680/1,335) compared to 42.40% (669/1,578). In 2008, design with randomized clinical trials remained low in single digit (3.8%, 60/1,578) with two-third showed poor results reporting (defects in 44 papers, 73.3%). Nearly half of the published studies were retrospective in nature, 49.3% (658/1,335) in 1998 compared to 48.2% (761/1,578) in 2008. Decreases in defect proportions were observed in both results presentation ( = 93.26, p<0.001), 92.7% (945/1,019) compared to 78.2% (1023/1,309) and interpretation ( = 27.26, p<0.001), 9.7% (99/1,019) compared to 4.3% (56/1,309), some serious ones persisted. Conclusions/Significance Chinese medical research seems to have made significant progress regarding statistical analyses, but there remains ample room for improvement regarding study designs. Retrospective clinical studies are the most often used design, whereas randomized clinical trials are rare and often show methodological weaknesses. Urgent implementation of the CONSORT statement is imperative. PMID:20520824

Evaluation of maxillary anterior teeth and their relation to the golden proportion in Malaysian population.

PubMed

Al-Marzok, Maan Ibrahim; Majeed, Kais Raad Abdul; Ibrahim, Ibrahim Khalil

2013-01-24

The maxillary anterior teeth are important in achieving pleasing dental aesthetics. Various methods are used to measure the size and form of them, including the golden proportion between their perceived widths, and the width-to-height ratio, referred to as the golden standard. The purpose of this study was conducted to evaluate whether consistent relationships exist between tooth width and height of the clinical crown dimensions; and to investigate the occurrence of the golden proportion of the maxillary anterior teeth. Dental casts of the maxillary arches were made in this cross-sectional study from MAHSA University College students who met the inclusion criteria. The 49 participants represented the Malaysian population main ethnics. The dimensions of the anterior teeth and the perceived width of anterior teeth viewed from front were measured using a digital caliper. Comparison of the perceived width ratio of lateral to central incisor and canine to lateral incisor with the golden proportion of 0.618 revealed there were a significant statistical difference (p < 0.05). The statistical difference was significant for the width-to-height ratio of central incisors to the golden standard of 80%. There was no significant difference in the comparison among ethnic groups for the golden proportion and the golden standard. The golden proportion was not found to exist between the perceived widths of maxillary anterior teeth. No golden standard were detected for the width-to-height proportions of maxillary incisors. Specific population characteristics and perception of beauty must be considered. However, ethnicity has no association with the proportions of maxillary anterior teeth.

Research Design and Statistical Methods in Indian Medical Journals: A Retrospective Survey

PubMed Central

Hassan, Shabbeer; Yellur, Rajashree; Subramani, Pooventhan; Adiga, Poornima; Gokhale, Manoj; Iyer, Manasa S.; Mayya, Shreemathi S.

2015-01-01

Good quality medical research generally requires not only an expertise in the chosen medical field of interest but also a sound knowledge of statistical methodology. The number of medical research articles which have been published in Indian medical journals has increased quite substantially in the past decade. The aim of this study was to collate all evidence on study design quality and statistical analyses used in selected leading Indian medical journals. Ten (10) leading Indian medical journals were selected based on impact factors and all original research articles published in 2003 (N = 588) and 2013 (N = 774) were categorized and reviewed. A validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation of the articles. Main outcomes considered in the present study were – study design types and their frequencies, error/defects proportion in study design, statistical analyses, and implementation of CONSORT checklist in RCT (randomized clinical trials). From 2003 to 2013: The proportion of erroneous statistical analyses did not decrease (χ2=0.592, Φ=0.027, p=0.4418), 25% (80/320) in 2003 compared to 22.6% (111/490) in 2013. Compared with 2003, significant improvement was seen in 2013; the proportion of papers using statistical tests increased significantly (χ2=26.96, Φ=0.16, p<0.0001) from 42.5% (250/588) to 56.7 % (439/774). The overall proportion of errors in study design decreased significantly (χ2=16.783, Φ=0.12 p<0.0001), 41.3% (243/588) compared to 30.6% (237/774). In 2013, randomized clinical trials designs has remained very low (7.3%, 43/588) with majority showing some errors (41 papers, 95.3%). Majority of the published studies were retrospective in nature both in 2003 [79.1% (465/588)] and in 2013 [78.2% (605/774)]. Major decreases in error proportions were observed in both results presentation (χ2=24.477, Φ=0.17, p<0.0001), 82.2% (263/320) compared to 66.3% (325/490) and interpretation (χ2=25.616, Φ=0.173, p<0.0001), 32.5% (104/320) compared to 17.1% (84/490), though some serious ones were still present. Indian medical research seems to have made no major progress regarding using correct statistical analyses, but error/defects in study designs have decreased significantly. Randomized clinical trials are quite rarely published and have high proportion of methodological problems. PMID:25856194

Research design and statistical methods in Indian medical journals: a retrospective survey.

PubMed

Hassan, Shabbeer; Yellur, Rajashree; Subramani, Pooventhan; Adiga, Poornima; Gokhale, Manoj; Iyer, Manasa S; Mayya, Shreemathi S

2015-01-01

Good quality medical research generally requires not only an expertise in the chosen medical field of interest but also a sound knowledge of statistical methodology. The number of medical research articles which have been published in Indian medical journals has increased quite substantially in the past decade. The aim of this study was to collate all evidence on study design quality and statistical analyses used in selected leading Indian medical journals. Ten (10) leading Indian medical journals were selected based on impact factors and all original research articles published in 2003 (N = 588) and 2013 (N = 774) were categorized and reviewed. A validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation of the articles. Main outcomes considered in the present study were - study design types and their frequencies, error/defects proportion in study design, statistical analyses, and implementation of CONSORT checklist in RCT (randomized clinical trials). From 2003 to 2013: The proportion of erroneous statistical analyses did not decrease (χ2=0.592, Φ=0.027, p=0.4418), 25% (80/320) in 2003 compared to 22.6% (111/490) in 2013. Compared with 2003, significant improvement was seen in 2013; the proportion of papers using statistical tests increased significantly (χ2=26.96, Φ=0.16, p<0.0001) from 42.5% (250/588) to 56.7 % (439/774). The overall proportion of errors in study design decreased significantly (χ2=16.783, Φ=0.12 p<0.0001), 41.3% (243/588) compared to 30.6% (237/774). In 2013, randomized clinical trials designs has remained very low (7.3%, 43/588) with majority showing some errors (41 papers, 95.3%). Majority of the published studies were retrospective in nature both in 2003 [79.1% (465/588)] and in 2013 [78.2% (605/774)]. Major decreases in error proportions were observed in both results presentation (χ2=24.477, Φ=0.17, p<0.0001), 82.2% (263/320) compared to 66.3% (325/490) and interpretation (χ2=25.616, Φ=0.173, p<0.0001), 32.5% (104/320) compared to 17.1% (84/490), though some serious ones were still present. Indian medical research seems to have made no major progress regarding using correct statistical analyses, but error/defects in study designs have decreased significantly. Randomized clinical trials are quite rarely published and have high proportion of methodological problems.

Headache management: pharmacological approaches

PubMed Central

Sinclair, Alex J; Sturrock, Aaron; Davies, Brendan; Matharu, Manjit

2015-01-01

Headache is one of the most common conditions presenting to the neurology clinic, yet a significant proportion of these patients are unsatisfied by their clinic experience. Headache can be extremely disabling; effective treatment is not only essential for patients but is rewarding for the physician. In this first of two parts review of headache, we provide an overview of headache management, emerging therapeutic strategies and an accessible interpretation of clinical guidelines to assist the busy neurologist. PMID:26141299

[Application of SAS macro to evaluated multiplicative and additive interaction in logistic and Cox regression in clinical practices].

PubMed

Nie, Z Q; Ou, Y Q; Zhuang, J; Qu, Y J; Mai, J Z; Chen, J M; Liu, X Q

2016-05-01

Conditional logistic regression analysis and unconditional logistic regression analysis are commonly used in case control study, but Cox proportional hazard model is often used in survival data analysis. Most literature only refer to main effect model, however, generalized linear model differs from general linear model, and the interaction was composed of multiplicative interaction and additive interaction. The former is only statistical significant, but the latter has biological significance. In this paper, macros was written by using SAS 9.4 and the contrast ratio, attributable proportion due to interaction and synergy index were calculated while calculating the items of logistic and Cox regression interactions, and the confidence intervals of Wald, delta and profile likelihood were used to evaluate additive interaction for the reference in big data analysis in clinical epidemiology and in analysis of genetic multiplicative and additive interactions.

A Randomized Clinical Trial of the Effect of the Time of Administration of Cloprostenol on Detention of Estrus in Dairy Cattle

PubMed Central

Hodges, Richard J.; White, Maurice E.; Guard, Charles L.; Powers, Pamela M.; Dinsmore, R. Page; Kelton, David F.; Stehman, Susan M.; Hillman, Robert B.; Yoder, Samuel S.

1988-01-01

We performed a clinical trial to study whether cows with palpable corpora lutea treated with cloprostenol by the farmer on the morning following examination (median time 0630 hours) were seen in heat and conceived more frequently than cows treated by the veterinarian immediately following the reproductive examination (median time 1210 hours). There were no significant differences between the two groups in the proportions of cows seen in estrus or fertility at the induced estrus. The proportions of animals that had the time of onset of estrus recorded and were seen in estrus during working hours (0800-1600 hours) were also not significantly different between the veterinary-treated and farmer-treated groups. Under the conditions of this study, there was no reason to prefer prescribing early morning administration of cloprostenol by farmers over immediate administration of the drug by the clinician. PMID:17423022

Clinical profile of children with kerosene aspiration.

PubMed

Venkatesh, C; Sriram, P; Adhisivam, B; Mahadevan, S

2011-07-01

Accidental aspiration of kerosene is a common problem among children in developing countries. This descriptive study involved the retrospective analysis of children admitted with kerosene aspiration in a tertiary care hospital in South India for a year. Kerosene aspiration contributed to 60.4% of poisoning cases. Boys aged less than three years and from a rural background formed a significant proportion. Tachypnoea, cough and crepitations were the predominant clinical findings. Male gender and malnutrition (weight for age <80%) were significantly associated with prolonged hospital stay.

Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review.

PubMed

Zhang, Jiaxing; Liang, Yi; Ai, Yuan; Xie, Juan; Li, Youping; Zheng, Wenyi

2017-10-01

We conducted a systematic review to assess the efficacy and safety of Thrombopoietin-receptor agonists (TPOras) for pediatric immune thrombocytopenia (ITP). We searched PubMed, Embase and Cochrane Library from their earliest records to January 2017. Randomized controlled trials (RCTs) were included. Primary outcomes were durable response and clinically significant bleeding. Secondary outcomes were overall response, overall bleeding events, the use of rescue medication and adverse events (AEs). Five randomized RCTs (261participants) were included. Compared with placebo group, the proportion of patients achieving durable platelet response was significantly higher in Eltrombopag (P = 0.0004) or Romiplostim (P = 0.002) group, so was the overall response in Eltrombopag [RR = 2.64, 95% CI (1.58, 4.44)] or Romiplostim [RR = 5.05, 95% CI (2.21, 11.53)] group. Both clinically significant bleeding (P = 0.04) and total bleeding (P = 0.01) in Eltrombopag group were significantly less frequent than those in placebo group, while no significant difference between Romiplostim and placebo group. The proportion of patients receiving rescue medication, the incidence of overall AEs and serious AEs between TPO-receptor agonists and placebo group were not significantly different. TPOras might improve both durable and overall platelet response in pediatric ITP, compared with placebo.

MO-AB-BRA-05: [18F]NaF PET/CT Imaging Biomarkers in Metastatic Prostate Cancer

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

Harmon, S; Perk, T; Lin, C

Purpose: Clinical use of {sup 18}F-Sodium Fluoride (NaF) PET/CT in metastatic settings often lacks technology to quantitatively measure full disease dynamics due to high tumor burden. This study assesses radiomics-based extraction of NaF PET/CT measures, including global metrics of overall burden and local metrics of disease heterogeneity, in metastatic prostate cancer for correlation to clinical outcomes. Methods: Fifty-six metastatic Castrate-Resistant Prostate Cancer (mCRPC) patients had NaF PET/CT scans performed at baseline and three cycles into chemotherapy (N=16) or androgen-receptor (AR) inhibitors (N=39). A novel technology, Quantitative Total Bone Imaging (QTBI), was used for analysis. Employing hybrid PET/CT segmentation and articulatedmore » skeletal-registration, QTBI allows for response assessment of individual lesions. Various SUV metrics were extracted from each lesion (iSUV). Global metrics were extracted from composite lesion-level statistics for each patient (pSUV). Proportion of detected lesions and those with significant response (%-increase or %-decrease) was calculated for each patient based on test-retest limits for iSUV metrics. Cox proportional hazard regression analyses were conducted between imaging metrics and progression-free survival (PFS). Results: Functional burden (pSUV{sub total}) assessed mid-treatment was the strongest univariate predictor of PFS (HR=2.03; p<0.0001). Various global metrics outperformed baseline clinical markers, including fraction of skeletal burden, mean uptake (pSUV{sub mean}), and heterogeneity of average lesion uptake (pSUV{sub hetero}). Of 43 patients with paired baseline/mid-treatment imaging, 40 showed heterogeneity in lesion-level response, containing populations of lesions with both increasing/decreasing metrics. Proportion of lesions with significantly increasing iSUV{sub mean} was highly predictive of clinical PFS (HR=2.0; p=0.0002). Patients exhibiting higher proportion of lesions with decreasing iSUV{sub total} saw prolonged radiographic PFS (HR=0.51; p=0.02). Conclusion: Technology presented here provides comprehensive disease quantification on NaF PET/CT imaging, showing strong correlation to clinical outcomes. Total functional burden as well as proportions of similarly responding lesions was predictive of PFS. This supports ongoing development of NaF PET/CT based imaging biomarkers in mCRPC. Prostate Cancer Foundation.« less

To explore and develop a model to maintain and build upon a dental clinic open for all in developing regions, with a primary focus on India

PubMed Central

Sugandhi, Ayushi; Mangal, Brijesh; Mishra, Amit Kumar; Sethia, Bhavna

2014-01-01

AIM: To study a service model that enables a clinic to be open to all members of the community, irrespective of their ability to pay. METHODS: Sampling methodology was used to gather information in two phases, with the city of Indore as the target region. In the first phase, dental professionals were surveyed to gather the cost of the facility, land and equipment and the cost of sustaining the practice. In the second phase, the residents of Indore were surveyed to collect information regarding their oral health problems and their expenditure for the same. Assessing the current situation, the questions to answer are related to the issues of dental health care access problems and the resources required, human and financial. RESULTS: (1) People younger than 20 years of age form a large proportion (43%) of the population of the city and also a large proportion (54%) of people who visit dental clinics; (2) Dental caries are commonly found in the population younger than 20 years of age and mobile teeth in those older than 50 years of age; (3) Dental caries and mobile teeth are almost equally found in people of the age group 20-50 years old; (4) A significantly large proportion of those older than 50 years old have had all their teeth extracted; and (5) A significantly large proportion of the 20-30 years of age group has had no teeth extracted. CONCLUSION: The model which we propose works well for low income patients; however, it places a lot of extra burden on the higher income group. A lot of effort can be put into generating revenue from other sources, including events and donations. PMID:25232547

To explore and develop a model to maintain and build upon a dental clinic open for all in developing regions, with a primary focus on India.

PubMed

Sugandhi, Ayushi; Mangal, Brijesh; Mishra, Amit Kumar; Sethia, Bhavna

2014-09-16

To study a service model that enables a clinic to be open to all members of the community, irrespective of their ability to pay. Sampling methodology was used to gather information in two phases, with the city of Indore as the target region. In the first phase, dental professionals were surveyed to gather the cost of the facility, land and equipment and the cost of sustaining the practice. In the second phase, the residents of Indore were surveyed to collect information regarding their oral health problems and their expenditure for the same. Assessing the current situation, the questions to answer are related to the issues of dental health care access problems and the resources required, human and financial. (1) People younger than 20 years of age form a large proportion (43%) of the population of the city and also a large proportion (54%) of people who visit dental clinics; (2) Dental caries are commonly found in the population younger than 20 years of age and mobile teeth in those older than 50 years of age; (3) Dental caries and mobile teeth are almost equally found in people of the age group 20-50 years old; (4) A significantly large proportion of those older than 50 years old have had all their teeth extracted; and (5) A significantly large proportion of the 20-30 years of age group has had no teeth extracted. The model which we propose works well for low income patients; however, it places a lot of extra burden on the higher income group. A lot of effort can be put into generating revenue from other sources, including events and donations.

Problem-based learning outcomes: the glass half-full.

PubMed

Distlehorst, Linda H; Dawson, Elizabeth; Robbs, Randall S; Barrows, Howard S

2005-03-01

To compare the characteristics and outcome data of students from a single institution with a two-track, problem based learning (PBL) and standard (STND) curriculum. PBL and STND students from nine graduating classes at Southern Illinois University School of Medicine were compared using common medical school performance outcomes (USMLE Step 1, USMLE Step 2, clerkship mean ratings, number of clerkship honors and remediation designations, and the senior clinical competency exam), as well as common admission and demographic variables. PBL students were older, and the cohort had a higher proportion of women. The two tracks had similar USMLE Step 1 and 2 mean scores and pass rates. Performance differences were significant for PBL students in two clerkships as well as in the clerkship subcategories of clinical performance, knowledge and clinical reasoning, and noncognitive behaviors. In addition, the proportion of PBL students earning honors was greater. The traditional undergraduate educational outcomes for the PBL and STND students are very positive. In several of the clerkship performance measures, the PBL students performed significantly better, and in no circumstance did they perform worse than the STND students.

Comparison of clinical and survival characteristics between prostate cancer patients of PSA-based screening and clinical diagnosis in China.

PubMed

Xu, Libo; Wang, Jinguo; Guo, Baofeng; Zhang, Haixia; Wang, Kaichen; Wang, Ding; Dai, Chang; Zhang, Ling; Zhao, Xuejian

2018-01-02

Prostate-specific antigen (PSA)-based mass screening remains the most controversial topic in prostate cancer. PSA-based mass screening has not been widely used in China yet. The aim of our study was to evaluate the effect of the PSA-based screening in China. The cohort consisted of 1,012 prostate cancer patients. Data were retrospectively collected and clinical characteristics of the cohorts were investigated. Survival was analyzed for prostatic carcinoma of both PSA screened and clinically diagnosed patients according to clinical characteristics and the National Comprehensive Cancer Network (NCCN) risk classification. Cox Proportional Hazards Model analysis was done for risk predictor identification. The median age was 71 years old. Five-year overall and prostate-cancer-specific survival in prostatic adenocarcinoma patients were 77.52% and 79.65%; 10-year survivals were 62.57% and 68.60%, respectively. Survival was significantly poorer in patients with metastases and non-curative management. T staging and Gleason score by NCCN classification effectively stratified prostatic adenocarcinoma patients into different risk groups. T staging was a significant predictor of survival by COX Proportional Hazard Model. PSA screened patients had a significantly higher percentage diagnosed in early stage. PSA screened prostatic adenocarcinoma patients had a better prognosis in both overall and prostate cancer-specific survivals. This Chinese cohort had a lower overall and prostate cancer survival rate than it is reported in western countries. The incidence of early-stage prostate cancer found in PSA-based mass screening was high and there were significant differences in both overall and prostate cancer-specific survival between the PSA-screened and clinically diagnosed patients.

Comparison of clinical and survival characteristics between prostate cancer patients of PSA-based screening and clinical diagnosis in China

PubMed Central

Xu, Libo; Wang, Jinguo; Guo, Baofeng; Zhang, Haixia; Wang, Kaichen; Wang, Ding; Dai, Chang; Zhang, Ling; Zhao, Xuejian

2018-01-01

Prostate-specific antigen (PSA)-based mass screening remains the most controversial topic in prostate cancer. PSA-based mass screening has not been widely used in China yet. The aim of our study was to evaluate the effect of the PSA-based screening in China. The cohort consisted of 1,012 prostate cancer patients. Data were retrospectively collected and clinical characteristics of the cohorts were investigated. Survival was analyzed for prostatic carcinoma of both PSA screened and clinically diagnosed patients according to clinical characteristics and the National Comprehensive Cancer Network (NCCN) risk classification. Cox Proportional Hazards Model analysis was done for risk predictor identification. The median age was 71 years old. Five-year overall and prostate-cancer-specific survival in prostatic adenocarcinoma patients were 77.52% and 79.65%; 10-year survivals were 62.57% and 68.60%, respectively. Survival was significantly poorer in patients with metastases and non-curative management. T staging and Gleason score by NCCN classification effectively stratified prostatic adenocarcinoma patients into different risk groups. T staging was a significant predictor of survival by COX Proportional Hazard Model. PSA screened patients had a significantly higher percentage diagnosed in early stage. PSA screened prostatic adenocarcinoma patients had a better prognosis in both overall and prostate cancer-specific survivals. This Chinese cohort had a lower overall and prostate cancer survival rate than it is reported in western countries. The incidence of early-stage prostate cancer found in PSA-based mass screening was high and there were significant differences in both overall and prostate cancer-specific survival between the PSA-screened and clinically diagnosed patients. PMID:29416625

Reporting of statistically significant results at ClinicalTrials.gov for completed superiority randomized controlled trials.

PubMed

Dechartres, Agnes; Bond, Elizabeth G; Scheer, Jordan; Riveros, Carolina; Atal, Ignacio; Ravaud, Philippe

2016-11-30

Publication bias and other reporting bias have been well documented for journal articles, but no study has evaluated the nature of results posted at ClinicalTrials.gov. We aimed to assess how many randomized controlled trials (RCTs) with results posted at ClinicalTrials.gov report statistically significant results and whether the proportion of trials with significant results differs when no treatment effect estimate or p-value is posted. We searched ClinicalTrials.gov in June 2015 for all studies with results posted. We included completed RCTs with a superiority hypothesis and considered results for the first primary outcome with results posted. For each trial, we assessed whether a treatment effect estimate and/or p-value was reported at ClinicalTrials.gov and if yes, whether results were statistically significant. If no treatment effect estimate or p-value was reported, we calculated the treatment effect and corresponding p-value using results per arm posted at ClinicalTrials.gov when sufficient data were reported. From the 17,536 studies with results posted at ClinicalTrials.gov, we identified 2823 completed phase 3 or 4 randomized trials with a superiority hypothesis. Of these, 1400 (50%) reported a treatment effect estimate and/or p-value. Results were statistically significant for 844 trials (60%), with a median p-value of 0.01 (Q1-Q3: 0.001-0.26). For the 1423 trials with no treatment effect estimate or p-value posted, we could calculate the treatment effect and corresponding p-value using results reported per arm for 929 (65%). For 494 trials (35%), p-values could not be calculated mainly because of insufficient reporting, censored data, or repeated measurements over time. For the 929 trials we could calculate p-values, we found statistically significant results for 342 (37%), with a median p-value of 0.19 (Q1-Q3: 0.005-0.59). Half of the trials with results posted at ClinicalTrials.gov reported a treatment effect estimate and/or p-value, with significant results for 60% of these. p-values could be calculated from results reported per arm at ClinicalTrials.gov for only 65% of the other trials. The proportion of significant results was much lower for these trials, which suggests a selective posting of treatment effect estimates and/or p-values when results are statistically significant.

A retrospective survey of research design and statistical analyses in selected Chinese medical journals in 1998 and 2008.

PubMed

Jin, Zhichao; Yu, Danghui; Zhang, Luoman; Meng, Hong; Lu, Jian; Gao, Qingbin; Cao, Yang; Ma, Xiuqiang; Wu, Cheng; He, Qian; Wang, Rui; He, Jia

2010-05-25

High quality clinical research not only requires advanced professional knowledge, but also needs sound study design and correct statistical analyses. The number of clinical research articles published in Chinese medical journals has increased immensely in the past decade, but study design quality and statistical analyses have remained suboptimal. The aim of this investigation was to gather evidence on the quality of study design and statistical analyses in clinical researches conducted in China for the first decade of the new millennium. Ten (10) leading Chinese medical journals were selected and all original articles published in 1998 (N = 1,335) and 2008 (N = 1,578) were thoroughly categorized and reviewed. A well-defined and validated checklist on study design, statistical analyses, results presentation, and interpretation was used for review and evaluation. Main outcomes were the frequencies of different types of study design, error/defect proportion in design and statistical analyses, and implementation of CONSORT in randomized clinical trials. From 1998 to 2008: The error/defect proportion in statistical analyses decreased significantly ( = 12.03, p<0.001), 59.8% (545/1,335) in 1998 compared to 52.2% (664/1,578) in 2008. The overall error/defect proportion of study design also decreased ( = 21.22, p<0.001), 50.9% (680/1,335) compared to 42.40% (669/1,578). In 2008, design with randomized clinical trials remained low in single digit (3.8%, 60/1,578) with two-third showed poor results reporting (defects in 44 papers, 73.3%). Nearly half of the published studies were retrospective in nature, 49.3% (658/1,335) in 1998 compared to 48.2% (761/1,578) in 2008. Decreases in defect proportions were observed in both results presentation ( = 93.26, p<0.001), 92.7% (945/1,019) compared to 78.2% (1023/1,309) and interpretation ( = 27.26, p<0.001), 9.7% (99/1,019) compared to 4.3% (56/1,309), some serious ones persisted. Chinese medical research seems to have made significant progress regarding statistical analyses, but there remains ample room for improvement regarding study designs. Retrospective clinical studies are the most often used design, whereas randomized clinical trials are rare and often show methodological weaknesses. Urgent implementation of the CONSORT statement is imperative.

Maintenance of pain in children with functional abdominal pain

USDA-ARS?s Scientific Manuscript database

A significant proportion of children with functional abdominal pain develop chronic pain. Identifying clinical characteristics predicting pain persistence is important in targeting interventions. We examined whether child anxiety and/or pain-stooling relations were related to maintenance of abdomina...

Area-level poverty, race/ethnicity & dialysis star ratings.

PubMed

Kshirsagar, Abhijit V; Manickam, Raj N; Mu, Yi; Flythe, Jennifer E; Chin, Andrew I; Bang, Heejung

2017-01-01

The Centers for Medicare and Medicaid Services recently released a five star rating system as part of 'Dialysis Facility Compare' to help patients identify and choose high performing clinics in the US. Eight dialysis-related measures determine ratings. Little is known about the association between surrounding community sociodemographic characteristics and star ratings. Using data from the U.S. Census and over 6000 dialysis clinics across the country, we examined the association between dialysis clinic star ratings and characteristics of the local population: 1) proportion of population below the federal poverty level (FPL); 2) proportion of black individuals; and 3) proportion of Hispanic individuals, by correlation and regression analyses. Secondary analyses with Quality Incentive Program (QIP) scores and population characteristics were also performed. We observed a negligible correlation between star ratings and the proportion of local individuals below FPL; Spearman coefficient, R = -0.09 (p<0.0001), and a stronger correlation between star ratings and the proportion of black individuals; R = -0.21 (p<0.0001). Ordered logistic regression analyses yielded adjusted odds ratio of 0.91 (95% confidence interval [0.80-1.30], p = 0.12) and 0.55 ([0.48-0.63], p<0.0001) for high vs. low level of proportion below FPL and proportion of black individuals, respectively. In contrast, a near-zero correlation was observed between star ratings and the proportion of Hispanic individuals. Correlations varied substantially by country region, clinic profit status and clinic size. Analyses using clinic QIP scores provided similar results. Sociodemographic characteristics of the surrounding community, factors typically outside of providers' direct control, have varying levels of association with clinic dialysis star ratings.

A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

PubMed Central

Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

2008-01-01

Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

PubMed

Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

2008-06-01

To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

Large-Scale Evaluation of Quality of Care in 6 Countries of Eastern Europe and Central Asia Using Clinical Performance and Value Vignettes.

PubMed

Peabody, John W; DeMaria, Lisa; Smith, Owen; Hoth, Angela; Dragoti, Edmond; Luck, Jeff

2017-09-27

A significant determinant of population health outcomes is the quality of care provided for noncommunicable diseases, obstetric, and pediatric care. We present results on clinical practice quality in these areas as measured among nearly 4,000 providers working at more than 1,000 facilities in 6 Eastern European and Central Asian countries. This study was conducted between March 2011 and April 2013 in Albania, Armenia, Georgia, Kazakhstan, Kirov Province in Russia, and Tajikistan. Using a probability proportional-to-size sampling technique, based on number of hospital beds, we randomly selected within each country 42 hospitals and their associated primary health care clinics. Physicians and midwives within each clinical area of interest were randomly selected from each hospital and clinic and asked how they would care for simulated patients using Clinical Performance and Value (CPV) vignettes. Facility administrators were also asked to complete a facility survey to collect structural measures of quality. CPV vignettes were scored on a scale of 0% to 100% for each provider. We used descriptive statistics and t tests to identify significant differences in CPV scores between hospitals and clinics and rural vs. urban facilities, and ANOVA to identify significant differences in CPV scores across countries. We found that quality of care, as concurrently measured by performance on CPV vignettes, was generally poor and widely variable within and between countries. Providers in Kirov Province, Russia, had the highest overall performance, with an average score of 70.8%, while providers in Albania and Tajikistan had the lowest average score, each at 50.8%. The CPV vignettes with the lowest scores were for multiple noncommunicable disease risk factors and birth asphyxia. A considerable proportion (11%) of providers performed well on the CPV vignettes, regardless of country, facility, or structural resources available to them. Countries of Eastern Europe and Central Asia are challenged by poor performance as measured by clinical care vignettes, but there is potential for provision of high-quality care by a sizable proportion of providers. Large-scale assessments of quality of care have been hampered by the lack of effective measurement tools that provide generalizable and reliable results across diverse economic, cultural, and social settings. The feasibility of quality measurement using CPV vignettes in these 6 countries and the ability to combine results with individual feedback could significantly enhance strategies to improve quality of care, and ultimately population health. © Peabody et al.

How frequently do the results from completed US clinical trials enter the public domain?--A statistical analysis of the ClinicalTrials.gov database.

PubMed

Saito, Hiroki; Gill, Christopher J

2014-01-01

Achieving transparency in clinical trials, through either publishing results in a journal or posting results to the ClinicalTrials.gov (CTG) web site, is an essential public health good. However, it remains unknown what proportion of completed studies achieve public disclosure of results (PDOR), or what factors explain these differences. We analyzed data from 400 randomly selected studies within the CTG database that had been listed as 'completed' and had at least four years in which to disclose results. Using Kaplan-Meier curves, we calculated times from completion to PDOR (defined as publishing the primary outcomes in a journal and/or posting results to CTG), and identified explanatory variables predicting these outcomes using Cox proportional hazards models. Among the 400 clinical trials, 118 (29.5%) failed to achieve PDOR within four years of completion. The median day from study completion to PDOR among 282 studies (70.5%) that achieved PDOR was 602 days (mean 647 days, SD 454 days). Studies were less likely to achieve PDOR if at earlier stages (phase 2 vs. phase 3/4, adjusted HR 0.60, 95% CI 0.47-0.78), if they only included adult subjects (adjusted HR 0.61, 95% CI 0.45-0.83), involved randomization (adjusted HR 0.62, 95% CI 0.46-0.83), or had smaller sample sizes (≤50 subjects vs. >50, adjusted HR 0.60, 95% CI 0.44-0.83). Industry-funded studies were significantly less likely to be published than non-industry or blended studies (adjusted HR 0.49, 95% CI 0.36-0.66). A significant proportion of completed studies did not achieve PDOR within the four years of follow-up, particularly smaller studies at earlier stages of development with industry funding. This constitutes reporting bias and threatens the validity of the clinical research literature in the US.

Best strategies to recruit and enroll elderly Blacks into clinical and biomedical research

PubMed Central

Graham, Lennox A; Ngwa, Julius; Ntekim, Oyonumo; Ogunlana, Oludolapo; Wolday, Saba; Johnson, Steven; Johnson, Megan; Castor, Chimene; Fungwe, Thomas V; Obisesan, Thomas O

2018-01-01

Background Historically, Blacks have been disproportionately underrepresented in clinical trials. Outcomes associated with low Blacks’ participation in research include poor understanding of the predictors and treatment of the disease, increasing health disparities, poor health equity, and suboptimal wellness of the nation as a whole. To address this gap in research participation, we analyzed our recruitment data to identify the most effective strategies for enrolling older Blacks in clinical trials. Methods Data used in these analyses were obtained from 3,266 potential volunteers, ages 50 or older, who completed a Mini-Mental State Exam as part of recruitment and screening for various clinical studies on Alzheimer’s disease. In order to determine the most effective strategies for engaging Blacks in clinical research, we used tests of proportion to assess significant differences in recruitment sources, counts, and percentages for optimal recruitment strategies by gender. Finally, we employed regression analyses to confirm our findings. Results Of the total 3,266 screened, 2,830 Black volunteers were identified for further analysis. Overall, more women than men (73.8% vs 26.2%) participated in our recruitment activities. However, a significantly higher proportion of men than women were engaged through family (3.86% vs 1.30%, p=0.0004) and referral sources (5.89% vs 2.59%, p=0.0005). Compared to other sources for recruitment, we encountered a higher proportion of volunteers at health fairs (42.95%), and through advertisements (14.97%). In our sample, years of education and age did not appear to influence the likelihood of an encounter, screening, and potential participation. Conclusion Our findings indicate Black men and women in our sample were predominantly recruited from health fairs and through advertisements tailored to their health needs and interests. Conversely, we mostly engaged Black men through family referrals and persons known to them, indicating a need for trust in their decision to engage study personnel and/or participate in clinical trials. PMID:29317809

Predictors of quality of life outcomes in chronic rhinosinusitis after sinus surgery.

PubMed

Katotomichelakis, Michael; Simopoulos, Efthimios; Tripsianis, Gregory; Balatsouras, Dimitrios; Danielides, Gerasimos; Kourousis, Christos; Livaditis, Miltos; Danielides, Vassilios

2014-04-01

The predictive value of olfaction for quality of life (QoL) recovery after endoscopic sinus surgery (ESS) in chronic rhinosinusitis (CRS) is still underestimated. The aim of this study was to explore the proportion of patients suffering from CRS who experience clinically significant QoL improvement after ESS and identify pre-operative clinical phenotypes that best predict surgical outcomes for QoL, focusing mainly on the role of patients' olfaction. One hundred eleven patients following ESS for CRS and 48 healthy subjects were studied. Olfactory function was expressed by the combined "Threshold Discrimination Identification" score using "Sniffin' sticks" test pre-treatment and 12 months after treatment. All subjects completed validated, widely used QoL questionnaires, specific for olfaction (Questionnaire of Olfactory Deficits: QOD), for assessing psychology (Beck Depression Inventory: BDI) and for general health (Short Form-36: SF-36). Statistically significant improvement of olfactory function by 41.8% and of all QoL questionnaires scores (all p < 0.001) was observed on the 12-month follow-up examination. Clinically significant improvement for QoL was measured in a proportion of 56.8% of patients on QOD, 64.9% on SF-36 and 49.5% on BDI scales results. Although olfactory dysfunction, nasal polyps, female gender, high socio-economic status and non-smoking habits were significantly associated with better QoL results, multivariate logistic regression analysis revealed that only olfactory dysfunction and nasal polyps were independent predictors significantly associated with higher likelihood of clinically significant improvement in all QoL questionnaire results. Olfactory dysfunction and nasal polyps were independent pre-operative predictors for surgical outcomes with regard to QoL results.

Implementation of GINA guidelines in Ho Chi Minh City: a model for Viet Nam.

PubMed

Tho, N V; Loan, H T H; Thao, N T P; Dung, N T T; Lan, L T T

2012-12-21

The Global Initiative for Asthma (GINA) guidelines have not been implemented effectively in primary care settings in Viet Nam. To estimate the proportion of patients with controlled asthma and the direct health care costs of managing asthma according to GINA guidelines at four out-patient clinics in Ho Chi Minh City (HCMC), Viet Nam. One hundred and six patients with asthma were treated and followed up according to GINA guidelines for 12 months. Clinical and pulmonary function responses and direct health care costs were evaluated every 3 months during the study. The proportion of patients with controlled asthma rose from 1.0% at the start of the study to 36.8% by the end of the study (P < 0.0001). The proportion of patients who had at least one hospitalisation per year decreased significantly, from 32.1% to 5.7% (P < 0.0001). The annual per patient median direct health care cost was US$169. Using asthma controllers continuously gave better asthma control than using them intermittently (OR 12.9, 95%CI 4.7-35.7). The implementation of GINA guidelines at out-patient clinics in HCMC, Viet Nam, improved asthma control with modest direct health care costs.

Funding source and primary outcome changes in clinical trials registered on ClinicalTrials.gov are associated with the reporting of a statistically significant primary outcome: a cross-sectional study.

PubMed

Ramagopalan, Sreeram V; Skingsley, Andrew P; Handunnetthi, Lahiru; Magnus, Daniel; Klingel, Michelle; Pakpoor, Julia; Goldacre, Ben

2015-01-01

We and others have shown a significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. The objectives of this study were to investigate whether changes made to primary outcomes are associated with the likelihood of reporting a statistically significant primary outcome on ClinicalTrials.gov. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 20 November 2014 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. 13,238 completed interventional trials were registered with ClinicalTrials.gov that also had study results posted on the website. 2555 (19.3%) had one or more statistically significant primary outcomes. Statistical analysis showed that registration year, funding source and primary outcome change after trial completion were associated with reporting a statistically significant primary outcome .  Funding source and primary outcome change after trial completion are associated with a statistically significant primary outcome report on clinicaltrials.gov.

Use of a Clinical Decision Support System Alert to Prevent Supratherapeutic Vancomycin Concentrations

PubMed Central

Ralph, Rachel; Patel, Jean A.; Postelnick, Michael; Ziauddin, Salma; Flis, Weronika; Galal, Audrey N.

2014-01-01

Background: Alerts issued by clinical decision support systems (CDSS) may be useful to identify and prevent the occurrence of acute kidney injury among patients on nephrotoxic drugs, particularly vancomycin. Objective: The purpose of this instructive study was to determine the effectiveness of using a pharmacist-run CDSS alert of early serum creatinine increases in patients receiving intravenous vancomycin to decrease the proportion of severely elevated vancomycin concentrations. Methods: This was a retrospective study of a prospectively reviewed CDSS alert that triggered in patients with an increase in serum creatinine by 25% from baseline within 24 hours. Severely elevated vancomycin concentrations were divided into a control group (before alert implementation) and a study group (after alert implementation) and considered for study inclusion. The proportion of severely elevated vancomycin concentrations (ie, >30 mg/L) were collected in the control and study groups. Results: There were 1290 and 1501 vancomycin concentrations in the control group and the study group, respectively. A total of 696 CDSS alerts triggered during the study period. The proportion of severely elevated vancomycin troughs decreased from 5.3% (n = 68, median = 36.6 mg/L, interquartile range = 33.75-43.2 mg/L) in the control group to 3.7% (n = 55, median = 34.7 mg/L, interquartile range = 31.3-39.3 mg/L) in the study group. This reflects a statistically significant decrease in the proportion of severely elevated vancomycin concentrations (P = .04). Conclusion: Overall, this instructive analysis on a novel use of CDSS software suggests that the implementation of an alert based on early detection of serum creatinine changes led to a significant decrease in the proportion of severely elevated serum vancomycin concentrations.

Prevalence and characteristics of spontaneous tinnitus in 11-year-old children.

PubMed

Humphriss, Rachel; Hall, Amanda J; Baguley, David M

2016-01-01

To estimate the prevalence of spontaneous tinnitus in 11-year-old children. A prospective UK population-based study. A total of 7092 children from the Avon longitudinal study of parents and children (ALSPAC) who attended the hearing session at age 11 years and answered questions about tinnitus. We estimated the prevalence of any spontaneous tinnitus as 28.1% (95% CI 27.1, 29.2%), and the prevalence of 'clinically significant' tinnitus as 3.1% (95% CI 2.7, 3.5%). Children were less likely to have clinically significant tinnitus if the tinnitus was 'soft' rather than 'loud' and if continuous rather than intermittent. Clinical significance was more likely if the tinnitus occurred more than once a week. Neither pitch nor length of history were important determinants of clinical significance. Small increases in mean hearing threshold (of up to 2.3 dB HL) were associated with clinically significant tinnitus. Although the prevalence of any tinnitus in 11-year-old children appears high, the small proportion in which this was found to be clinically significant implies that this does not necessarily indicate a large unmet clinical demand. We would expect approximately one child per class of 30 to have clinically significant tinnitus which is, by definition, problematic.

Clinical features of hepatitis B and C virus infections, with high α-fetoprotein levels but not hepatocellular carcinoma

PubMed Central

Kim, Cha Young; Kim, Bo Ra; Lee, Sang Soo; Jeon, Dae-Hong; Lee, Chang Min; Kim, Wan Soo; Cho, Hyun Chin; Kim, Jin Joo; Lee, Jae Min; Kim, Hong Jun; Ha, Chang Yoon; Kim, Hyun Jin; Kim, Tae Hyo; Jung, Woon Tae; Lee, Ok-Jae

2017-01-01

Abstract The appropriate α-fetoprotein (AFP) level to confirm hepatocellular carcinoma (HCC) could be 100 ng/mL; however, the clinical significance of falsely elevated AFP in patients without HCC has not been fully studied. We investigated the clinical features and outcome of patients without HCC but with high AFP levels (100 ng/mL), especially with chronic hepatitis B (CHB) or C (CHC). The sample included 124 consecutive patients with CHB (n = 97) or CHC (n = 27), with AFP levels >100 ng/mL and without HCC at baseline. Multivariate Cox proportional regression analysis was performed to determine the factors associated with AFP normalization and HCC development. During the mean 52-month follow-up, the proportion of patients with CHB with AFP normalization (90.7%) was significantly higher than the proportion of patients with CHC (59.3%, P < 0.001). Initial aspartate aminotransferase levels (hazard ratio [HR] = 1.02 per 10 U/L increase, P = 0.021) and antiviral therapy (HR = 2.89, P < 0.001) were significantly associated with AFP normalization. Of the 16 (12.9%) patients who developed HCC, hepatitis B virus infection (HR = 10.82, P = 0.001), initiation of antiviral treatment postenrollment (HR = 0.23, P = 0.030), and AFP normalization within 12 months (HR = 0.13, P = 0.011) were associated with HCC development. CHB and CHC were the most common causes of falsely elevated AFP (>100 ng/mL). With either CHB or CHC, persistent AFP elevation (>12 months), regardless of antiviral treatment, might be an important marker of HCC development. PMID:28079817

Understanding Clinical Expertise: Nurse Education, Experience, and the Hospital Context

PubMed Central

McHugh, Matthew D.; Lake, Eileen T.

2010-01-01

Clinical nursing expertise is central to quality patient care. Research on factors that contribute to expertise has focused largely on individual nurse characteristics to the exclusion of contextual factors. To address this, we examined effects of hospital contextual factors and individual nurse education and experience on clinical nursing expertise in a cross-sectional analysis of data from 8,611 registered nurses. In a generalized ordered logistic regression analysis, the composition of the hospital staff, particularly the proportion of nurses with at least a bachelor of science in nursing degree, was associated with significantly greater odds of a nurse reporting a more advanced expertise level. Our findings suggest that, controlling for individual characteristics, the hospital context significantly influences clinical nursing expertise. PMID:20645420

The effects of competition on assisted reproductive technology outcomes.

PubMed

Henne, Melinda B; Bundorf, M Kate

2010-04-01

To evaluate the relationship between competition among fertility clinics and assisted reproductive technology (ART) treatment outcomes, particularly multiple births. Using clinic-level data from 1995 to 2001, we examined the relationship between competition and clinic-level ART outcomes and practice patterns. National database registry. Clinics performing ART. The number of clinics within a 20-mile (32.19-km) radius of a given clinic. Clinic-level births, singleton births, and multiple births per ART cycle; multiple births per ART birth; average number of embryos transferred per cycle; and the proportion of cycles for women under age 35 years. The number of competing clinics is not strongly associated with ART birth and multiple birth rates. Relative to clinics with no competitors, the rate of multiple births per cycle is lower (-0.03 percentage points) only for clinics with more than 15 competitors. Embryo transfer practices are not statistically significantly associated with the number of competitors. Clinic-level competition is strongly associated with patient mix. The proportion of cycles for patients under 35 years old is 6.4 percentage points lower for clinics with more than 15 competitors than for those with no competitors. Competition among fertility clinics does not appear to increase rates of multiple births from ART by promoting more aggressive embryo transfer decisions. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.Published by Elsevier Inc.

[Treatment reality with respect to laparoscopic surgery of colonic cancer in Germany].

PubMed

Ptok, H; Gastinger, I; Bruns, C; Lippert, H

2014-07-01

Prospective randomized studies and meta-analyses have shown that laparoscopic resection for colonic cancer is equivalent to open resection with respect to the oncological results and has short-term advantages in the early postoperative outcome. The aim of this study was to investigate whether laparoscopic colonic resection has become established as the standard in routine treatment. Data from the multicenter observational study "Quality assurance colonic cancer (primary tumor)" from the time period from 1 January 2009 to 21 December 2011 were evaluated with respect to the total proportion of laparoscopic colonic cancer resections and tumor localization and specifically for laparoscopic sigmoid colon cancer resections. A comparison between low and high volume clinics (< 30 versus ≥ 30 colonic cancer resections/year) was carried out. Laparoscopic colonic cancer resections were carried out in 12 % versus 21.4 % of low and high volume clinics, respectively (p < 0.001) with a significant increase for low volume clinics (from 8.0 % to 15.6 %, p < 0.001) and a constant proportion in high volume clinics (from 21.7 % to 21.1 %, p = 0.905). For sigmoid colon cancer laparoscopic resection was carried out in 49.7 % versus 47.6 % (p = 0.584). Differences were found between low volume and high volume clinics in the conversion rates (17.3 % versus 6.6 %, p < 0.001), the length of the resected portion (Ø 23.6 cm versus 36.0 cm, p < 0.001) and the lymph node yield (Ø n = 15.7 versus 18.2, p = 0.008). There were no differences between the two groups of clinics regarding postoperative morbidity and mortality. The postoperative morbidity and length of stay were significantly lower for laparoscopic sigmoid resection than for conventional sigmoid resection. The laparoscopic access route for colonic cancer resection is not the standard approach in the participating clinics. The laparoscopic access route has the highest proportion for sigmoid colon resection. The differences in the conversion rates, length of the resected portion and the number of lymph nodes investigated between the low volume and high volume clinics must be viewed critically and must be interpreted in connection with the long-term oncological results.

Sex differences in disinhibition and its relationship to physical abuse in a sample of stimulant-dependent patients.

PubMed

Winhusen, Theresa; Lewis, Daniel

2013-04-01

Research suggests that impulsivity is a vulnerability factor for developing stimulant dependence, that women develop dependence more quickly than men, and that physical abuse can increase impulsivity and may have greater adverse health consequences in women. This study sought to tie these findings together by evaluating: (1) sex differences in disinhibition prior to lifetime initiation of stimulant abuse and (2) the relationship between physical abuse and disinhibition in stimulant-dependent patients. The Frontal Systems Behavior Scale (FrSBe) is a reliable and valid self-report assessment of three neurobehavioral domains associated with frontal systems functioning (Apathy, Disinhibition, and Executive Dysfunction, summed for a Total), that assesses pre-morbid functioning and has a specific cutoff for defining clinically significant abnormalities. Six sites evaluating 12-step facilitation for stimulant abusers obtained the FrSBe from 118 methamphetamine- and/or cocaine-dependent participants. Lifetime physical abuse was measured by the Addiction Severity Index (ASI). The proportion reporting clinically significant disinhibition was significantly higher in women (64.9%) than in men (45.0%, p=0.04), with no significant difference on the other FrSBe scales. Physical abuse in women, but not men, was associated with worse functioning, with physically abused, relative to non-abused, women having a significantly greater proportion with clinically significant disinhibition (p<0.01) and total neurobehavioral abnormalities (p<0.01). These findings suggest that women may have significantly greater disinhibition than men prior to lifetime initiation of stimulant abuse and that physical abuse in women is associated with greater disinhibition. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

[Excess respiratory diseases in children and elderly people in a community of Santiago with high particulate air pollution].

PubMed

Prieto C, María José; Mancilla F, Pedro; Astudillo O, Pedro; Reyes P, Alvaro; Román A, Oscar

2007-02-01

The relationship between air pollution and health damage has been sufficiently documented. In station "R" of the air quality monitoring system, located in a community of Metropolitan Santiago (Cerro Navia), the Chilean standard of 150 microg/m3, averaged in 24 hours, for particles with a diameter of 10 micrometers or less (PM10), has been exceeded more days than in the rest of the city stations. To investigate if the population living near that station has a higher proportion of lower respiratory infections than the Metropolitan Region (MR) as a whole. An outpatient clinic located near station "R" (Centro Albertz), was implemented as a sentinel center according to UNICEF methodology, used since 1992 by the Acute Respiratory Infections National Program. Daily information was collected between May and December 2004. Monitoring data included total number of consults by children less than 15 years old for lower respiratory tract infections, pneumonia, obstructive bronchitis syndrome in children and by adults over 64 years old for lower airway disease, chronic obstructive pulmonary disease (COPD), and pneumonia. Results were compared with those of the rest of MR. Compared with the MR, children from the sentinel clinic had a significantly higher proportion of consults for obstructive bronchial syndrome (20.1% and 26.4% respectively, in p<0.01) and pneumonia (1.3 and 2.7% respectively, p<0.01). In the elderly, the average consults for lower airway disease were 17% in the sentinel clinic and 12.2% in MR (p<0.04). Children and elderly subjects at the sentinel clinic had a significantly higher proportion of respiratory infections (pneumonia and obstructive bronchial syndrome in children and lower airway disease in the elderly) as compared to the Metropolitan Region.

Effect of clinical information and previous exam execution on observer agreement and reliability in the analysis of hysteroscopic video-recordings.

PubMed

Martinho, Margarida Suzel Lopes; da Costa Santos, Cristina Maria Nogueira; Silva Carvalho, João Luís Mendonça; Bernardes, João Francisco Montenegro Andrade Lima

2018-02-01

Inter-observer agreement and reliability in hysteroscopic image assessment remain uncertain and the type of factors that may influence it has only been studied in relation to the experience of hysteroscopists. We aim to assess the effect of clinical information and previous exam execution on observer agreement and reliability in the analysis of hysteroscopic video-recordings. Ninety hysteroscopies were video-recorded and randomized into a group without (Group 1) and with clinical information (Group 2). The videos were independently analyzed by three hysteroscopists, regarding lesion location, dimension, and type, as well as decision to perform a biopsy. One of the hysteroscopists had executed all the exams before. Proportions of agreement (PA) and kappa statistics (κ) with 95% confidence intervals (95% CI) were used. In Group 2, there was a higher proportion of a normal diagnosis (p < 0.001) and a lower proportion of biopsies recommended (p = 0.027). Observer agreement and reliability were better in Group 2, with the PA and κ ranging, respectively, from 0.73 (95% CI 0.62, 0.83) and 0.44 (95% CI 0.26, 0.63), for image quality, to 0.94 (95% CI 0.88, 0.99) and 0.85 (95% CI 0.65, 0.95), for the decision to perform a biopsy. Execution of the exams before the analysis of the video-recordings did not significantly affect the results. With clinical information, agreement and reliability in the overall analysis of hysteroscopic video-recordings may reach almost perfect results and this was not significantly affected by the execution of the exams before the analysis. However, there is still uncertainty in the analysis of specific endometrial cavity abnormalities.

Negro Versus Caucasian Psychological Test Performance Revisited

ERIC Educational Resources Information Center

Davis, William E.; Jones, Mark H.

1974-01-01

Differences in proportion of Negroes versus Caucasians receiving schizophrenic, alcoholic, and depressive psychiatric diagnoses were found. No significant race-related main effects were found on the nine Minnesota Multiphasic Personality Inventory (MMPI) clinical scales. Results are discussed in terms of education having an inculturating effect on…

An audit of clinical service examining the uptake of genetic testing by at-risk family members.

PubMed

Forrest, Laura; Delatycki, Martin; Curnow, Lisette; Gen Couns, M; Skene, Loane; Aitken, Maryanne

2012-01-01

The aim of this study was to investigate the uptake of genetic testing by at-risk family members for four genetic conditions: chromosomal translocations, fragile X syndrome, Huntington disease, and spinal muscular atrophy. A clinical audit was undertaken using genetics files from Genetic Health Services Victoria. Data were extracted from the files regarding the number of at-risk family members and the proportion tested. Information was also collected about whether discussion of at-risk family members and family communication during the genetic consultation was recorded. The proportion of at-risk family members who had genetic testing ranged from 11% to 18%. First-degree family members were most frequently tested and the proportion of testing decreased by degree of relatedness to the proband. Smaller families were significantly more likely to have genetic testing for all conditions except Huntington disease. Female at-risk family members were significantly more likely to have testing for fragile X syndrome. The majority of at-risk family members do not have genetic testing. Family communication is likely to influence the uptake of genetic testing by at-risk family members and therefore it is important that families are supported while communicating to ensure that at-risk family members are able to make informed decisions about genetic testing.

Dropout rates and factors associated with dropout from treatment among elderly patients attending the outpatient services of a tertiary care hospital.

PubMed

Grover, Sandeep; Dua, Devakshi; Chakrabarti, Subho; Avasthi, Ajit

2018-01-01

This study aimed to evaluate the "dropout" rates from treatment and associated factors among elderly patients attending a tertiary care psychiatry outpatient facility. Data of 1422 patients aged ≥60 years, attending the walk-in clinic were evaluated. Out of 1422 patients, 406 (28.55%) belonged to the "dropout" group. In the "dropout" group, the age of patients was significantly higher than the followed-up group, and a higher proportion of patients were >70 years old. Significantly lower proportion of patients with diagnosis of depressive disorders belonged to the "dropout" group and significantly higher proportion of patients with "other" diagnoses belonged to the dropped out group. In patients with depressive disorders, a higher proportion of the patients in the "dropout" group were Hindu by religion (68.7% vs. 58.7%; χ 2 = 4.26; P = 0.03). In patients with bipolar disorder, patients in the "dropout" group had significantly higher income (Rs. 13,323 [standard deviation [SD] = 16,769] vs. 5681 [SD = 9422]; t -test value: 2-25; P = 0.028) and lesser proportion of patients were of the male gender (63.15 vs. 86.95%; Mann-Whitney U value = 257.5; P = 0.039). In the group of other diagnoses, a higher proportion of patients in the "dropout" group were currently single (32.3% vs. 18.7%; χ 2 = 4.12; P = 0.042), from rural locality (63.1% vs. 46.72%; χ 2 = 4.33; P = 0.037) and were not prescribed medications (40% vs. 22.4%; χ 2 = 6.05; P = 0.04). Dropout from treatment among elderly patients is associated with higher age, not being prescribed medications, and diagnosis other than the affective disorders, psychotic disorders, and the cognitive disorders.

A waste walk through clinical pharmacy: how do the 'seven wastes' of Lean techniques apply to the practice of clinical pharmacists.

PubMed

Green, Christopher F; Crawford, Victoria; Bresnen, Gaynor; Rowe, Philip H

2015-02-01

This study used a 'Lean' technique, the 'waste walk' to evaluate the activities of clinical pharmacists with reference to the seven wastes described in 'Lean' including 'defects', 'unnecessary motion', 'overproduction', 'transport of products or material', 'unnecessary waiting', 'unnecessary inventory' and 'inappropriate processing'. The objectives of the study were to categorise the activities of ward-based clinical pharmacists into waste and non-waste, provide detail around what constitutes waste activity and quantify the proportion of time attributed to each category. This study was carried out in a district general hospital in the North West of England. Staff were observed using work-sampling techniques, to categorise activity into waste and non-waste, with waste activities being allocated to each of the seven wastes described earlier and subdivided into recurrent themes. Twenty different pharmacists were observed for 1 h on two separate occasions. Of 1440 observations, 342 (23.8%) were categorised as waste with 'defects' and 'unnecessary motion' accounting for the largest proportions of waste activity. Observation of clinical pharmacists' activities has identified that a significant proportion of their time could be categorised as 'waste'. There are practical steps that could be implemented in order to ensure their time is used as productively as possible. Given the challenges facing the UK National Health Service, the adoption of 'Lean' techniques provides an opportunity to improve quality and productivity while reducing costs. © 2014 Royal Pharmaceutical Society.

Using simulation to prepare for clinical practice.

PubMed

Morgan, James; Green, Victoria; Blair, John

2018-02-01

A significant proportion of medical students feel underprepared for clinical practice, especially in skills such as decision making, prioritisation and prescribing. Changes to medical curricula, including assistantships and shadowing, provide supervised practise, but students remain unable to fully take responsibility for patient care. Simulation may assist in addressing this deficit. A simulation course entitled 'Simulated ward round and professional skills' (SWAPS) was developed to improve student preparation for clinical practice. Preliminary work surveyed 22 foundation doctors to identify perceived areas of weakness and to guide the learning outcomes of the course. Following the design and development of the course, 133 final-year medical students were observed completing a 60-minute simulation scenario aimed at providing experiential learning in a ward environment, reflecting professional practice. Students received structured feedback and completed pre- and post-course questionnaires to evaluate changes in confidence over the learning domains. Qualitative feedback was also collected. A significant proportion of medical students feel underprepared for clinical practice RESULTS: The p values were significant in all assessed domains, indicating a perceived improvement in confidence following the SWAPS course. Qualitative feedback highlighted the perceived utility of the course in exposing students to clinical ward-based scenarios infrequently encountered in their medical curriculum. Students praised the personal feedback received and realism of the simulation. This paper contributes to the growing body of literature supporting the use of simulation to replicate a ward round and the daily roles of a junior doctor. The SWAPS course seems to empower students to take responsibility for clinical decision making and experience some of the realities of foundation training in a simulated setting. © 2017 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Mirror movements in parkinsonism: evaluation of a new clinical sign

PubMed Central

Espay, A; Li, J; Johnston, L; Chen, R; Lang, A

2005-01-01

Background: Mirror movements (MM) are not widely appreciated in parkinsonism and no report has evaluated this clinical sign in detail. Objectives: To define the parkinsonian clinical features associated with MM in patients with early, asymmetric parkinsonism. Methods: Twenty seven patients with early Parkinson's disease were evaluated using a standardised videotaping protocol. MM were scored from blinded video assessment using a clinical scale that rates the amplitude, distribution, and proportion of mirroring in the less affected limb. Parkinsonian features were combined into axial and lateralised scores using related items of the Unified Parkinson's Disease Rating Scale. Results: MM were present in 24 of 27 patients. There was a significant linear correlation between the degree of asymmetry of motor deficits and MM on the less affected side. The effect of asymmetry was greater when the proportional rather than the absolute motor difference between sides was largest. Asymmetry in leg rigidity was the most important examination feature in the prediction of contralateral foot mirroring. Conclusions: MM are a clinical feature of the unaffected or less affected side in mild asymmetric parkinsonism. Their presence may be a useful clinical finding in early parkinsonism. PMID:16170075

Association of carbohydrate and fat intake with metabolic syndrome.

PubMed

Kwon, Yu-Jin; Lee, Hye-Sun; Lee, Ji-Won

2018-04-01

In Asia, dietary pattern has been changed with increased intake of refined carbohydrates, sugar, and saturated fat, while the prevalence of metabolic syndrome (MetS) is on the rise. However, it remains unclear whether a high-carbohydrate or a high-fat diet is more metabolically harmful, and the optimal amount of carbohydrates and fat has not been determined. The aim of our study was to examine the role of carbohydrate and fat intake in MetS in a Korean population. Data were obtained from a large, population-based, cross-sectional study (6737 males and 8845 females). The subjects were divided into nine groups based on carbohydrate and fat proportion, and multiple logistic regression analysis was performed after adjusting for confounding variables. Regardless of fat intake, the risk of MetS significantly increased in males with higher carbohydrate proportions (of total energy intake). In females, the risk of MetS was significantly elevated only in those with both the highest carbohydrate proportion and lowest fat proportion. A high carbohydrate proportion was associated with a higher prevalence of MetS in males, and a high carbohydrate proportion combined with a low fat proportion was associated with MetS in females. Our results indicate that reduction of excessive carbohydrate intake paired with an adequate fat intake, taking into consideration optimal types of fat, is useful for MetS prevention. Longitudinal studies are needed to clarify the optimal types and amounts of carbohydrate and fat proportions as well as the mechanism underlying these relationships. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Evidence that congenital hydrocephalus is a precursor to idiopathic normal pressure hydrocephalus in only a subset of patients

PubMed Central

Wilson, Robin K; Williams, Michael A

2007-01-01

Objective To identify the proportion of patients in a large idiopathic normal pressure hydrocephalus (INPH) cohort with large head circumference (HC) who presumably have congenital hydrocephalus that has not become clinically apparent until late in life. Methods HC was measured in 158 patients diagnosed with communicating INPH and assigned to HC centile range adjusted for height and sex. The proportion of patients with INPH and HC above the 97th, 90th or 50th centiles was compared with the proportion expected in a normal population. Results The proportion of patients with HC >90th centile was significantly larger than would be expected in a normal distribution (19.6% vs 10%, p = 0.0001), as was the proportion of patients with HC >97th centile (8.9% vs 3%, p = 0.0001). The relative association between INPH and HC >97th centile was nearly tripled (relative association 2.95; CI 1.36 to 6.41), but the relative association between INPH and HC >50th centile was not significantly higher than predicted (relative association 1.13; CI 0.95 to 1.34). Conclusion A significantly larger proportion of elderly adults with INPH have a HC greater than the 90th or 97th centile than predicted by population norms, supporting the concept that compensated congenital hydrocephalus that does not become symptomatic until late in life is one aetiology of INPH, but is not responsible for all INPH. The mechanism that leads to the development of INPH in most patients remains elusive. PMID:17202229

Increasing proportion of carbapenemase-producing Enterobacteriaceae and emergence of a MCR-1 producer through a multicentric study among hospital-based and private laboratories in Belgium from September to November 2015.

PubMed

Huang, Te Din; Bogaerts, Pierre; Berhin, Catherine; Hoebeke, Martin; Bauraing, Caroline; Glupczynski, Youri

2017-05-11

Carbapenemase-producing Enterobacteriaceae (CPE) strains have been increasingly reported in Belgium. We aimed to determine the proportion of CPE among Enterobacteriaceae isolated from hospitalised patients and community outpatients in Belgium in 2015. For the hospitalised patients, the results were compared to a previous similar survey performed in the same hospitals in 2012. Twenty-four hospital-based and 10 private laboratories collected prospectively 200 non-duplicated Enterobacteriaceae isolates from clinical specimens. All isolates were screened locally by carbapenem disk diffusion using European Committee on Antimicrobial Susceptibility Testing methodology. Putative CPE strains with inhibition zone diameters below the screening breakpoints were referred centrally for confirmation of carbapenemase production. From September to November 2015, we found a proportion of clinical CPE of 0.55% (26/4,705) and of 0.60% (12/1,991) among hospitalised patients and among ambulatory outpatients respectively. Klebsiella pneumoniae (26/38) and OXA-48-like carbapenemase (28/38) were the predominant species and enzyme among CPE. One OXA-48-producing Escherichia coli isolated from a hospital was found carrying plasmid-mediated MCR-1 colistin resistance. Compared with the 2012 survey, we found a significant increased proportion of clinical CPE (0.55% in 2015 vs 0.25% in 2012; p = 0.02) and an increased proportion of hospitals (13/24 in 2015 vs 8/24 in 2012) with at least one CPE detected. The study results confirmed the concerning spread of CPE including a colistin-resistant MCR-1 producer in hospitals and the establishment of CPE in the community in Belgium. This article is copyright of The Authors, 2017.

Suicide Prevention in Special Populations.

ERIC Educational Resources Information Center

Bogdaniak, Roman C.; Coronado, Maria G.

Suicide prevention techniques, from a clinical perspective, need to be as diversified as the population they serve. In certain special population groups, suicide has reached epidemic proportions, and there is a significant public health need for specific suicide prevention strategies. Special populations need to be identified and their suicide…

Gender issues in clinical dental education.

PubMed

Tiwana, Karen K; Kutcher, Mark J; Phillips, Ceib; Stein, Margot; Oliver, Jessica

2014-03-01

In spring 2011, a study was initiated to investigate the nature and extent of gender issues in clinical dental education at the University of North Carolina at Chapel Hill School of Dentistry. Surveys were sent to 236 dental students in the second, third, and fourth years; eighty-six (36.4 percent) responded. Surveys were also sent to seventy-one full-time dental faculty members who had clinical contact with students, and thirty-four (47.9 percent) responded. Of the student respondents, fifty-one were female and thirty-five were male; the faculty respondents were ten women and twenty-four men. A significantly greater proportion of female than male student respondents reported that issues related to gender affected clinical training. The female students also responded that mentorship was less available and less in content for them compared to males, and significantly more female than male students reported lower self-confidence in clinical settings. Among faculty respondents, a higher proportion of women than men reported insufficient awareness of gender issues. These faculty members also reported thinking that female students showed more empathy toward patients than males. Both faculty and student respondents said that female faculty members received less respect from students than did male faculty members. Forty-eight percent of the students reported experiencing or witnessing gender-based prejudice in clinical settings, and 7.0 percent reported experiencing or witnessing unwelcome sexual advances or conduct. A more robust study to include other dental institutions is needed. With confirmation of specific gender issues, corrective measures could be recommended to improve the climate for both females and males in the clinical component of dental education.

Implementing a Measurement Feedback System in Community Mental Health Clinics: A Case Study of Multilevel Barriers and Facilitators

PubMed Central

Gleacher, Alissa A.; Olin, Serene S.; Nadeem, Erum; Pollock, Michele; Ringle, Vanesa; Bickman, Leonard; Douglas, Susan; Hoagwood, Kimberly

2015-01-01

Measurement feedback systems (MFSs) have been proposed as a means of improving practice. The present study examined the implementation of a MFS, the Contextualized Feedback System (CFS), in two community-based clinic sites. Significant implementation differences across sites provided a basis for examining factors that influenced clinician uptake of CFS. Following the theoretical implementation framework of Aarons, Hurlburt & Horwitz (2011), we coded qualitative data collected from eighteen clinicians (13 from Clinic U and 5 from Clinic R) who participated in semi-structured interviews about their experience with CFS implementation. Results suggest that clinicians at both clinics perceived more barriers than facilitators to CFS implementation. Interestingly, clinicians at the higher implementing clinic reported a higher proportion of barriers to facilitators (3:1 vs. 2:1); however, these clinicians also reported a significantly higher level of organizational and leadership supports for CFS implementation. Implications of these findings are discussed. PMID:25735619

[HIV/STD prevalence and related behaviors among male STD clinic attendees in Xi'an and Xianyang cities, Shaanxi province].

PubMed

Hu, T; Dong, L F; Ding, Z W; Jia, H; Li, X; Zhang, J S; Song, Y L; Chang, W H

2017-12-10

Objective: To compare the prevalence of HIV/STD and related health care seeking behaviors among male STD clinic attendees between Xi'an and Xianyang cities. Methods: During June and July 2016, 206 male STD clinic attendees were studied in Xi'an city, with another 221 male STD clinic attendees in Xianyang city. Cross-sectional questionnaire survey was used to collect attendees'behavioral information. Blood samples were collected via HIV/HCV/Syphilis testing. Results: The prevalence rate of HIV infection was 2.4% (5/206) in Xi'an and 0.9% (2/221) in Xianyang, with no statistical significant difference between the two cities. The prevalence rate of syphilis was 4.9% (10/206) in Xi'an, which was significantly lower than 13.6% (30/221) in Xianyang. The proportion of respondents, diagnosed with other sexually transmitted diseases, in Xi'an was higher than that of Xianyang. The proportions of commercial heterosexual sex and sex with temporary sexual partners in the past 3 months were 18.0% (37/206) and 15.5% (32/206) in Xi'an, lower than 46.6% (103/221) and 15.8% (35/221) in Xianyang ( χ (2)=39.70, Р <0.01; χ (2)=0.01, P =0.93) . The proportions of condom use with commercial sex workers or temporary sexual partners in the past 3 months among Xi'an were 37.8% (14/37) and 6.3% (2/32) , lower than 93.1% (95/102) and 57.1% (20/35) in Xianyang ( χ (2)=49.06, Р <0.01; χ (2)=19.63, Р <0.01) . Conclusion: Differences were noticed between Xi'an and Xianyang city in terms of STD and HIV prevalences, behaviors related to commercial sex and use of condoms among the male STD clinic attendees that calling for targeted actions in control of high risk behavlors in both HIV/AIDS and STDs transmission.

Attitude and satisfaction of health care providers towards clinical pharmacy services in Ethiopia: A post-deployment survey.

PubMed

Bilal, Arebu Issa; Tilahun, Zelalem; Beedemariam, Gebremedhin; Ayalneh, Belete; Hailemeskel, Bisrat; Engidawork, Ephrem

2016-01-01

Clinical pharmacy service has evolved steadily over the past few decades and is contributing to the 'patient care journey' at all stages. The service improves safety and effectiveness of medicines, thereby avoiding medication errors. As part of this global shift in pharmacy education and practice, Ethiopian Universities revamped the undergraduate pharmacy curriculum and the first graduates came out in July 2013. These graduates were immediately deployed in public hospital settings, with the ultimate aim of providing clinical pharmacy services. As such an initiative is new to the Ethiopian pharmacy sector, there is a need to do assessment of the health care providers' perception and satisfaction towards the service. A cross-sectional survey using self-administered questionnaire was conducted in six regions and one-city administration of the country. Physicians, Health officers and Nurses working along with the new pharmacy graduates formed the study population. A total of 650 healthcare professionals participated in the study. Data were entered, cleaned and analyzed using appropriate statistical tools. Majority of the health care providers agreed that clinical pharmacy service could have a significant contribution to the patient care. A large proportion of them (70-90 %) had a positive attitude, although there appeared to be some differences across professions. About 50 % of the professionals were of the opinion that patient care should be left to the health care providers and pharmacists should concentrate on drug products. In addition, the same proportion of respondents said that the setup in their respective hospital was appropriate for provision of clinical pharmacy service. Multivariable analysis indicated that attitude of the health care providers was significantly associated with year of experience. A large proportion of the health care providers had positive attitude towards the service, although the extent of the service was below their expectation. Hence, efforts should be in place to organize continuous professional training for pharmacists and awareness creation forums for other healthcare professionals.

Proportion and clinical features of never-smokers with non-small cell lung cancer.

PubMed

Cho, Jaeyoung; Choi, Sun Mi; Lee, Jinwoo; Lee, Chang-Hoon; Lee, Sang-Min; Kim, Dong-Wan; Yim, Jae-Joon; Kim, Young Tae; Yoo, Chul-Gyu; Kim, Young Whan; Han, Sung Koo; Park, Young Sik

2017-02-08

The proportion of never-smokers with non-small cell lung cancer (NSCLC) is increasing, but that in Korea has not been well addressed in a large population. We aimed to evaluate the proportion and clinical features of never-smokers with NSCLC in a large single institution. We analyzed clinical data of 1860 consecutive patients who were newly diagnosed with NSCLC between June 2011 and December 2014. Of the 1860 NSCLC patients, 707 (38.0%) were never-smokers. The proportions of women (83.7% vs. 5.6%) and adenocarcinoma (89.8% vs. 44.9%) were higher among never-smokers than among ever-smokers. Significantly more never-smokers were diagnosed at a younger median age (65 vs. 68 years, P < 0.001) and earlier stage (stage I-II, 44.5% vs. 38.9%, P = 0.015) compared with ever-smokers. Epidermal growth factor receptor mutations (57.8% vs. 24.4%, P < 0.001) and anaplastic lymphoma kinase rearrangements (7.8% vs. 2.8%, P < 0.001) were more common in never-smokers, whereas Kirsten rat sarcoma viral oncogene homolog mutations (5.8% vs. 9.6%, P = 0.021) were less frequently encountered in never-smokers than in ever-smokers. Never-smokers showed longer survival after adjusting for the favorable effects of younger age, female sex, adenocarcinoma histology, better performance status, early stage disease, being asymptomatic at diagnosis, received antitumor treatment, and the presence of driver mutations (hazard ratio, 0.624; 95% confidence interval, 0.460-0.848; P = 0.003). More than one-third of the Korean patients with NSCLC were never-smokers. NSCLC in never-smokers had different clinical characteristics and major driver mutations and resulted in longer overall survival compared with NSCLC in ever-smokers.

Survey of animal shelter managers regarding shelter veterinary medical services.

PubMed

Laderman-Jones, B E; Hurley, K F; Kass, P H

2016-04-01

Veterinary services are increasingly used in animal shelters, and shelter medicine is an emerging veterinary specialty. However, little is known about working relationships between animal shelters and veterinarians. The aims of this survey were to characterize working relationships that shelter personnel have and want with veterinarians, identify opinions that shelter managers have regarding the veterinarians they work with, and determine areas for relationship growth between veterinarians and shelter managers. An electronic survey was distributed to 1373 managers of North American animal shelters; 536 (39.0%) responded. Almost all shelters had some veterinary relationship, and most had regular relationships with veterinarians. The proportion of shelters that used local clinics (73.9%) was significantly higher than the proportion that retained on-site paid veterinarians (48.5%). The proportion of respondents who did not have but wanted a paid on-site veterinarian (42%) was significantly higher than the proportion of respondents who did not use local clinics but wanted to (7.9%). These data suggest shelter managers valued veterinary relationships, and wished to expand on-site veterinary services. Almost all shelters in this study provided some veterinary care, and all respondents identified at least one common infectious disease, which, for most, had a substantial negative impact on shelter successes. Respondents indicated that the most important roles and greatest expertise of veterinarians were related to surgery, diagnosis and treatment of individual animals. Education of both veterinarians and shelter managers may help ensure that shelters benefit from the full range of services veterinarians can provide, including expertise in disease prevention and animal behavior. Copyright © 2016 Elsevier Ltd. All rights reserved.

An Analysis of Maxillary Anterior Teeth Dimensions for the Existence of Golden Proportion: Clinical Study.

PubMed

Sandeep, Nalla; Satwalekar, Parth; Srinivas, Siva; Reddy, Chandra Sekhar; Reddy, G Ramaswamy; Reddy, B Anantha

2015-09-01

Appearance of the face is a great concern to everyone, as it is a significant part of self-image. The study analyzed the clinical crown dimensions of the maxillary anterior teeth with respect to their apparent mesiodistal widths, width-to-height ratio to determine whether golden proportion existed among the South Indian population. A total of 240 dentulous subjects were chosen for the study (120 males and 120 females) age ranging between 18 and 28 years. Full face and anterior teeth images of the subjects were made on specially designed device resembling a face-bow, mounted onto the wall under a standard light source. The width and height of the maxillary central incisors were measured on the stone casts using a digital caliper. The mean perceived maxillary lateral incisor to central incisor width ratio was 0.67 in males and 0.703 in females. The mean perceived maxillary canine to lateral incisor width ratio was 0.744 in males and 0.714 in females. The mean width-to-height ratio of the maxillary central incisor was 79.49% in males and 79.197% in females. The golden proportion was not found between perceived mesiodistal widths of maxillary central and lateral incisors and nor between perceived mesiodistal widths of maxillary lateral incisors and canines. In the majority of subjects, the width-to-height ratio of maxillary central incisor was within 75-80%. There are no statistically significant differences in maxillary anterior teeth proportions between males and females. The results may serve as guidelines for treatment planning in restorative dentistry and periodontal surgery.

Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection.

PubMed

Regueiro, Miguel; Feagan, Brian G; Zou, Bin; Johanns, Jewel; Blank, Marion A; Chevrier, Marc; Plevy, Scott; Popp, John; Cornillie, Freddy J; Lukas, Milan; Danese, Silvio; Gionchetti, Paolo; Hanauer, Stephen B; Reinisch, Walter; Sandborn, William J; Sorrentino, Dario; Rutgeerts, Paul

2016-06-01

Most patients with Crohn's disease (CD) eventually require an intestinal resection. However, CD frequently recurs after resection. We performed a randomized trial to compare the ability of infliximab vs placebo to prevent CD recurrence. We evaluated the efficacy of infliximab in preventing postoperative recurrence of CD in 297 patients at 104 sites worldwide from November 2010 through May 2012. All study patients had undergone ileocolonic resection within 45 days before randomization. Patients were randomly assigned (1:1) to groups given infliximab (5 mg/kg) or placebo every 8 weeks for 200 weeks. The primary end point was clinical recurrence, defined as a composite outcome consisting of a CD Activity Index score >200 and a ≥70-point increase from baseline, and endoscopic recurrence (Rutgeerts score ≥i2, determined by a central reader) or development of a new or re-draining fistula or abscess, before or at week 76. Endoscopic recurrence was a major secondary end point. A smaller proportion of patients in the infliximab group had a clinical recurrence before or at week 76 compared with the placebo group, but this difference was not statistically significant (12.9% vs 20.0%; absolute risk reduction [ARR] with infliximab, 7.1%; 95% confidence interval: -1.3% to 15.5%; P = .097). A significantly smaller proportion of patients in the infliximab group had endoscopic recurrence compared with the placebo group (30.6% vs 60.0%; ARR with infliximab, 29.4%; 95% confidence interval: 18.6% to 40.2%; P < .001). Additionally, a significantly smaller proportion of patients in the infliximab group had endoscopic recurrence based only on Rutgeerts scores ≥i2 (22.4% vs 51.3%; ARR with infliximab, 28.9%; 95% confidence interval: 18.4% to 39.4%; P < .001). Patients previously treated with anti-tumor necrosis factor agents or those with more than 1 resection were at greater risk for clinical recurrence. The safety profile of infliximab was similar to that from previous reports. Infliximab is not superior to placebo in preventing clinical recurrence after CD-related resection. However, infliximab does reduce endoscopic recurrence. ClinicalTrials.gov ID NCT01190839. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Comparison of Mineral Trioxide Aggregate and Diluted Formocresol in Pulpotomized Human Primary Molars: 42-month Follow-up and Survival Analysis

PubMed Central

Mettlach, Sarah E.; Zealand, Cameron M.; Botero, Tatiana M.; Boynton, James R.; Majewski, Robert F.; Hu, Jan ChingChun

2015-01-01

Purpose The purpose of this study was to test the hypothesis that there is no significant difference in the clinical and radiographic outcomes of diluted formocresol (DFC) compared to gray mineral trioxide aggregate (GMTA) pulpotomy in human primary molars. Methods A total of 152 children with 252 primary molars met selection criteria. Of those, 119 and 133 teeth were randomly assigned to the GMTA and DFC groups, respectively. Periapical radiographs, taken pre- and/or postoperatively and at each 6-month follow-up, were digitized and evaluated by three blinded and calibrated examiners. Results Over a 42-month period, a total of 865 clinical and radiographic evaluations were conducted. There was no significant difference in clinical success, with the cumulative proportion of GMTA-treated teeth surviving at 0.98 vs DFC-treated teeth at 0.95 (P>.05). Radiographic success, however, was significantly greater for GMTA vs DFC, with the cumulative proportion of GMTA-treated teeth surviving at 0.90 vs DFC-treated teeth at 0.47 (P<.001). Overall, DFC-treated teeth were 5.1 times more likely to fail than GMTA-treated teeth. Radiographic pathologies were observed more frequently in the DFC-treated teeth (P<.05). Conclusion Gray mineral trioxide aggregate can be considered an acceptable replacement for diluted formocresol when used as a medicament for primary molar pulpotomies. PMID:23756301

Measurement of peripheral venous catheter-related phlebitis: a cross-sectional study.

PubMed

Göransson, Katarina; Förberg, Ulrika; Johansson, Eva; Unbeck, Maria

2017-09-01

Many instruments for measurement of peripheral venous catheter (PVC)-related phlebitis are available, but no consensus exists on their applicability in clinical practice. This absence of consensus affects the ability to identify and compare proportions of PVCs causing phlebitis within and across hospitals as the range varies between 2% and 62% in previous studies. We hypothesised that the instruments' ability to identify phlebitis varies. The aim of this study is to illustrate the complexity of application of phlebitis instruments to a clinical dataset. In this cross-sectional study, we applied 17 instruments for phlebitis identification (divided into three groups [instruments using definitions, severity rating systems, and scoring systems]) to PVCs in adult patients admitted to 12 inpatient units at Karolinska University Hospital in Sweden. We calculated the proportion of PVCs causing phlebitis on the basis of each instrument's minimum criterion for phlebitis. We also analysed each instrument's face validity. We compared proportions using the Z test. On the basis of data collected between Feb 2, 2009, and Feb 20, 2009, May 18, 2009, and June 5, 2009, and Feb 8, 2010, and Feb 26, 2010, we applied 17 instruments for phlebitis identification (eight instruments using definitions, seven severity rating systems, and two scoring systems) to 1175 observed PVCs in 1032 patients. The highest number of PVCs causing phlebitis generated by definitions was 137 (11·7%), by severity rating systems was 395 (33·6%), and by scoring systems was 363 (30·9%). The proportion generated by instruments using definitions was significantly different to that of both the severity rating (difference 21·9% [95% CI 18·6-25·2]; p<0·0001) and scoring (19·2% [12·0-26·4]; p<0·0001) systems. Proportions did not differ significantly between severity rating systems and scoring system (difference 2·7% [95% CI -1·1 to 6·6]; p=0·16). The proportion within instruments ranged from less than 1% to 28%. We identified face validity issues, such as use of indistinct or complex measurements and inconsistent measurements or definitions. Our study highlights several concerns regarding instruments to measure phlebitis published in the scientific community. From a work environment and patient safety perspective, clinical staff engaged in PVC management should be aware of the absence of adequately validated instruments for phlebitis assessment. We suggest that researchers within the field of PVC come together in a joint research programme aiming to develop valid and reliable methods that accurately identify PVC-related adverse events that also includes decision support for clinical staff concerning clinical indications for PVC removal. Such actions could lead to a revised view on what is best practice for management of PVCs. None. Copyright © 2017 Elsevier Ltd. All rights reserved.

Association of serum anti-rotavirus immunoglobulin A antibody seropositivity and protection against severe rotavirus gastroenteritis: analysis of clinical trials of human rotavirus vaccine.

PubMed

Cheuvart, Brigitte; Neuzil, Kathleen M; Steele, A Duncan; Cunliffe, Nigel; Madhi, Shabir A; Karkada, Naveen; Han, Htay Htay; Vinals, Carla

2014-01-01

Clinical trials of the human rotavirus vaccine Rotarix™ (RV1) have demonstrated significant reductions in severe rotavirus gastroenteritis (RVGE) in children worldwide. However, no correlate of vaccine efficacy (VE) has yet been established. This paper presents 2 analyses which aimed to investigate whether serum anti-RV IgA measured by ELISA 1 or 2 mo post-vaccination can serve as a correlate of efficacy against RVGE: (1) In a large Phase III efficacy trial (Rota-037), the Prentice criteria for surrogate endpoints was applied to anti-RV IgA seropositivity 1 mo post-vaccination. These criteria determine whether a significant vaccine group effect can be predicted from the surrogate, namely seropositivity (anti-RV IgA concentration>20 U/mL); (2) Among other GSK-sponsored RV1 VE studies, 8 studies which assessed immunogenicity at 1 or 2 mo post-vaccination in all or a sub-cohort of enrolled subjects and had at least 10 RVGE episodes were included in a meta-analysis to measure the regression between clinical VE and VE predicted from immunogenicity (VE1). In Rota-037, anti-RV IgA seropositivity post-vaccination was associated with a lower incidence of any or severe RVGE, however, the proportion of vaccine group effect explained by seropositivity was only 43.6% and 32.7% respectively. This low proportion was due to the vaccine group effect observed in seronegative subjects. In the meta-analysis, the slope of the regression between clinical VE and VE1 was statistically significant. These two independent analyses support the hypothesis that post-vaccination anti-RV IgA seropositivity (antibody concentration ≥20 U/mL) may serve as a useful correlate of efficacy in clinical trials of RV1 vaccines.

Safety and tolerability of atomoxetine in treatment of attention deficit hyperactivity disorder in adult patients: an integrated analysis of 15 clinical trials.

PubMed

Camporeale, Angelo; Porsdal, Vibeke; De Bruyckere, Katrien; Tanaka, Yoko; Upadhyaya, Himanshu; Deix, Claudia; Deberdt, Walter

2015-01-01

The safety profile of atomoxetine in the treatment of attention deficit hyperactivity disorder has been studied in many clinical trials. We performed an integrated safety analysis of 15 clinical trials in adults with attention deficit hyperactivity disorder. The analysis pooled patient data into three groups: acute placebo-controlled trials; long-term placebo-controlled trials; all trials. In total, 4829 adults (18-77 years, median: 36 years) were exposed to atomoxetine. Statistically significantly more atomoxetine-treated than placebo-treated patients experienced treatment-emergent adverse events (81.3% vs. 68.3% acute; 90.6% vs. 76.8% long term) and discontinued due to adverse events (8.9% vs. 4.0% acute; 17.9% vs. 6.3% long term). No statistically significant differences were observed in the proportion of patients experiencing serious adverse events. No previously unknown adverse events were identified. The most common adverse events included nausea, dry mouth, decreased appetite, insomnia and erectile dysfunction. Mean increases in heart rate (+5.2 beats per min) and blood pressure (systolic +2 mmHg, diastolic +1.9 mmHg) were modest. The proportion of patients experiencing clinically significant increases in blood pressure and heart rate at any time was statistically significantly higher with atomoxetine (systolic blood pressure 13-17%, diastolic blood pressure 37-40%, heart rate 42-43%) compared to placebo (systolic blood pressure 8-13%, diastolic blood pressure 29-34%, heart rate 21-26%). There was no increased risk of suicidal ideation or behaviour. Our findings confirm atomoxetine's known safety profile. From a safety perspective, atomoxetine is a useful treatment option for adults with attention deficit hyperactivity disorder. © The Author(s) 2014.

Outpatient clinic referrals and their outcome.

PubMed Central

Sullivan, F M; Hoare, T; Gilmour, H

1992-01-01

A cohort of 392 patients referred to six outpatient clinics by general practitioners during 1987 with diagnoses of rheumatoid arthritis, osteoarthritis, peripheral vascular disease, psoriasis or eczema, were studied from the time of their first attendance until up to two years later. Six consultant clinics were studied in the three specialties: rheumatology, vascular surgery and dermatology. For each specialty a clinic in both a teaching hospital and a district general hospital were included. The cohort members were predominantly middle-aged or elderly people, with a greater proportion of women, except at the vascular surgery clinic where 65% of patients were men. The 392 patients made a total of 936 visits (median two, range one-eight) during the study period; 91 patients were still attending up to two years after the first visit. Patients referred by their general practitioner for therapy were less likely to be discharged than those referred for other reasons. The principal reason for continuing attendance as perceived by patients, general practitioners and hospital doctors was the necessity for consultant supervision, although agreement was far from complete in individual cases. Junior staff tended to see a higher proportion of patients at follow-up visits than did consultants, and were found to have lower discharge rates than consultants. Analyses of data showed that at the first visit, diagnosis, disease severity and the grade of doctor seeing the patient in the clinic was significantly associated with patient discharge at the P < 0.05 level of significance. Patients considered that their visits had produced improvement in their condition in 38% of cases.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1493027

Life-science research within US academic medical centers.

PubMed

Zinner, Darren E; Campbell, Eric G

2009-09-02

Besides the generic "basic" vs "applied" labels, little information is known about the types of life-science research conducted within academic medical centers (AMCs). To determine the relative proportion, characteristics, funding, and productivity of AMC faculty by the type of research they conduct. Mailed survey conducted in 2007 of 3080 life-science faculty at the 50 universities with medical schools that received the most funding from the National Institutes of Health in 2004. Response rate was 74%. Research faculty affiliated with a medical school or teaching hospital, representing 77% of respondents (n = 1663). Type of research (basic, translational, clinical trials, health services research/clinical epidemiology, multimode, other), total funding, industry funding, publications, professional activities, patenting behavior, and industry relationships. Among AMC research faculty, 33.6% exclusively conducted basic science research as principal investigators compared with translational researchers (9.1%), clinical trial investigators (7.1%), and health services researchers/clinical epidemiologists (9.0%). While principal investigators garnered a mean of $410,755 in total annual research funding, 22.1% of all AMC research faculty were unsponsored, a proportion that ranged from 11.5% for basic science researchers to 46.8% for health services researchers (P < .001). The average AMC faculty member received $33,417 in industry-sponsored funding, with most of this money concentrated among clinical trial ($110,869) and multimode ($59,916) principal investigators. Translational (61.3%), clinical trial (67.3%), and multimode (70.9%) researchers were significantly more likely than basic science researchers (41.9%) to report a relationship with industry and that these relationships contributed to their most important scientific work (P < .05 for all comparisons). The research function of AMCs is active and diverse, incorporating a substantial proportion of faculty who are conducting research and publishing without sponsorship.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

Introduction and evaluation of a ‘pre-ART care’ service in Swaziland: an operational research study

PubMed Central

Burtle, David; Elden, Susan; Mamvura, Canaan; Vandelanotte, Joris; Petherick, Emily; Walley, John; Wright, John

2012-01-01

Objective To implement and evaluate a formal pre-antiretroviral therapy (ART) care service at a district hospital in Swaziland. Design Operational research. Setting District hospital in Southern Africa. Participants 1171 patients with a previous diagnosis of HIV. A baseline patient group consisted of the first 200 patients using the service. Two follow-up groups were defined: group 1 was all patients recruited from April to June 2009 and group 2 was 200 patients recruited in February 2010. Intervention Introduction of pre-ART care—a package of interventions, including counselling; regular review; clinical staging; timely initiation of ART; social and psychological support; and prevention and management of opportunistic infections, such as tuberculosis. Primary and secondary outcome measures Proportion of patients assessed for ART eligibility, proportion of eligible patients who were started on ART and proportion receiving defined evidence-based interventions (including prophylactic co-trimoxazole and tuberculosis screening). Results Following the implementation of the pre-ART service, the proportion of patients receiving defined interventions increased; the proportion of patient being assessed for ART eligibility significantly increased (baseline: 59%, group 1: 64%, group 2: 76%; p=0.001); the proportion of ART-eligible patients starting treatment increased (baseline: 53%, group 1: 81%, group: 2, 81%; p<0.001) and the median time between patients being declared eligible for ART and initiation of treatment significantly decreased (baseline: 61 days, group 1: 39 days, group 2: 14 days; p<0.001). Conclusions This intervention was part of a shift in the model of care from a fragmented acute care model to a more comprehensive service. The introduction of structured pre-ART was associated with significant improvements in the assessment, management and timeliness of initiation of treatment for patients with HIV. PMID:22422913

Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial.

PubMed

Pondo, Tracy; Rose, Charles E; Martin, Stacey W; Keitel, Wendy A; Keyserling, Harry L; Babcock, Janiine; Parker, Scott; Jacobson, Robert M; Poland, Gregory A; McNeil, Michael M

2014-06-12

Anthrax vaccine adsorbed (AVA) administered intramuscularly (IM) results in fewer adverse events (AEs) than subcutaneous (SQ) administration. Women experience more AEs than men. Antibody response, female hormones, race, and body mass index (BMI) may contribute to increased frequency of reported injection site AEs. We analyzed data from the CDC AVA human clinical trial. This double blind, randomized, placebo controlled trial enrolled 1563 participants and followed them through 8 injections (AVA or placebo) over a period of 42 months. For the trial's vaccinated cohort (n=1267), we used multivariable logistic regression to model the effects of study group (SQ or IM), sex, race, study site, BMI, age, and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade. Also, in a women-only subset (n=227), we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs. Participants who received SQ injections had significantly higher proportions of itching, redness, swelling, tenderness and warmth compared to the IM study group after adjusting for other risk factors. The proportions of redness, swelling, tenderness and warmth were all significantly lower in blacks vs. non-black participants. We found arm motion limitation, itching, pain, swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations. In the SQ study group, redness and swelling were more common for obese participants compared to participants who were not overweight. Females had significantly higher proportions of all AEs compared to males. Menstrual phase was not associated with any AEs. Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by sex and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants. Published by Elsevier Ltd.

Evaluation of sex, race, body mass index and pre-vaccination serum progesterone levels and post-vaccination serum anti-anthrax protective immunoglobulin G on injection site adverse events following anthrax vaccine adsorbed (AVA) in the CDC AVA human clinical trial✩

PubMed Central

Pondo, Tracy; Rose, Charles E.; Martin, Stacey W.; Keitel, Wendy A.; Keyserling, Harry L.; Babcock, Janiine; Parker, Scott; Jacobson, Robert M.; Poland, Gregory A.; McNeil, Michael M.

2017-01-01

Background Anthrax vaccine adsorbed (AVA) administered intramuscularly (IM) results in fewer adverse events (AEs) than subcutaneous (SQ) administration. Women experience more AEs than men. Antibody response, female hormones, race, and body mass index (BMI) may contribute to increased frequency of reported injection site AEs. Methods We analyzed data from the CDC AVA human clinical trial. This double blind, randomized, placebo controlled trial enrolled 1563 participants and followed them through 8 injections (AVA or placebo) over a period of 42 months. For the trial’s vaccinated cohort (n = 1267), we used multivariable logistic regression to model the effects of study group (SQ or IM), sex, race, study site, BMI, age, and post-vaccination serum anti-PA IgG on occurrence of AEs of any severity grade. Also, in a women-only subset (n = 227), we assessed effect of pre-vaccination serum progesterone level and menstrual phase on AEs. Results Participants who received SQ injections had significantly higher proportions of itching, redness, swelling, tenderness and warmth compared to the IM study group after adjusting for other risk factors. The proportions of redness, swelling, tenderness and warmth were all significantly lower in blacks vs. non-black participants. We found arm motion limitation, itching, pain, swelling and tenderness were more likely to occur in participants with the highest anti-PA IgG concentrations. In the SQ study group, redness and swelling were more common for obese participants compared to participants who were not overweight. Females had significantly higher proportions of all AEs compared to males. Menstrual phase was not associated with any AEs. Conclusions Female and non-black participants had a higher proportion of AVA associated AEs and higher anti-PA IgG concentrations. Antibody responses to other vaccines may also vary by sex and race. Further studies may provide better understanding for higher proportions of AEs in women and non-black participants. PMID:24768633

Death anxiety in clinical and non-clinical groups.

PubMed

Abdel-Khalek, Ahmed M

2005-04-01

The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N = 765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The female and male anxiety disorder patients means were, respectively, significantly higher than the means of the other 5 groups on the ASDA, while male schizophrenics attained the lowest mean score in proportion to all the other 6 groups, including the non-clinical 2 groups. All female groups have higher mean scores than their male counterparts.

The topical penta-peptide Gly-Pro-Ile-Gly-Ser increases the proportion of thick hair in Japanese men with androgenetic alopecia.

PubMed

Iwabuchi, Tokuro; Takeda, Shunsuke; Yamanishi, Haruyo; Ideta, Ritsuro; Ehama, Ritsuko; Tsuruda, Akinori; Shibata, Hideaki; Ito, Tomoko; Komatsu, Nobuyuki; Terai, Keiko; Oka, Syuichi

2016-06-01

A penta-peptide, Gly-Pro-Ile-Gly-Ser (GPIGS), promotes proliferation of mouse hair keratinocytes and accelerates hair growth in mice. This study focused on the ability of the peptide to promote human hair growth. We used a human hair keratinocyte proliferation assay and organ cultures of human hair follicle as in vitro systems. The lotions with and without the penta-peptide were administered to 22 Japanese men with androgenetic alopecia (AGA) for 4 months in a double-blind and randomized clinical study. The penta-peptide significantly stimulated the proliferation of human hair keratinocytes at a concentration of 2.3 μm (P < 0.01), and 5.0 μm of this peptide had a marked effect on hair shaft elongation in the organ culture (P < 0.05). The change in the proportion of thick hair (≥60 μm) compared to baseline in patients that received the peptide was significantly higher than in the placebo (P = 0.006). The change in the proportion of vellus hair (<40 μm) was also significantly lower in the peptide group than in the placebo (P = 0.029). The penta-peptide also significantly improved the appearance of baldness (P = 0.020) when blinded reviewers graded photographs of the participants according to a standardized baldness scale. No adverse dermatological effects due to treatment were noted during this clinical study. This penta-peptide promotes proliferation of human hair keratinocytes and hair shaft elongation of human hair follicles, in vitro. This peptide increases thick hair ratio in vivo, and this compound is useful for the improvement of AGA. © 2016 Wiley Periodicals, Inc.

Demographic, Clinical, and Prognostic Factors of Ovarian Clear Cell Adenocarcinomas According to Endometriosis Status.

PubMed

Schnack, Tine H; Høgdall, Estrid; Thomsen, Lotte Nedergaard; Høgdall, Claus

2017-11-01

Women with endometriosis carry an increased risk for ovarian clear cell adenocarcinomas (CCCs). Clear cell adenocarcinoma may develop from endometriosis lesions. Few studies have compared clinical and prognostic factors and overall survival in patients diagnosed as having CCC according to endometriosis status. Population-based prospectively collected data on CCC with coexisting pelvic (including ovarian; n = 80) and ovarian (n = 46) endometriosis or without endometriosis (n = 95) were obtained through the Danish Gynecological Cancer Database. χ Test, independent-samples t test, logistic regression, Kaplan-Meier test, and Cox regression were used. Statistical tests were 2 sided. P values less than 0.05 were considered statistically significant. Patients with CCC and pelvic or ovarian endometriosis were significantly younger than CCC patients without endometriosis, and a higher proportion of them were nulliparous (28% and 31% vs 17% (P = 0.07 and P = 0.09). Accordingly, a significantly higher proportion of women without endometriosis had given birth to more than 1 child. Interestingly, a significantly higher proportion of patients with ovarian endometriosis had pure CCCs (97.8% vs 82.1%; P = 0.001) as compared with patients without endometriosis. Overall survival was poorer among CCC patients with concomitant ovarian endometriosis (hazard ratio, 2.56 [95% confidence interval, 1.29-5.02], in the multivariate analysis. Age at CCC diagnosis and parity as well as histology differ between CCC patients with and without concomitant endometriosis. Furthermore, CCC patients with concomitant ovarian endometriosis have a poorer prognosis compared with endometriosis-negative CCC patients. These differences warrant further research to determine whether CCCs with and without concomitant endometriosis develop through distinct pathogenic pathways.

Adding "Circle of Security - Parenting" to treatment as usual in three Swedish infant mental health clinics. Effects on parents' internal representations and quality of parent-infant interaction.

PubMed

Risholm Mothander, Pia; Furmark, Catarina; Neander, Kerstin

2018-06-01

This study presents effects of adding Circle of Security-Parenting (COS-P) to an already established comprehensive therapeutic model for early parent-child intervention in three Swedish infant mental health (IMH) clinics. Parents' internal representations and quality of parent-infant interaction were studied in a clinical sample comprised of 52 parent-infant dyads randomly allocated to two comparable groups. One group consisted of 28 dyads receiving treatment as usual (TAU) supplemented with COS-P in a small group format, and another group of 24 dyads receiving TAU only. Assessments were made at baseline (T1), 6 months after inclusion (T2) and 12 months after inclusion (T3). Changes over time were explored in 42 dyads. In the COS-P group, the proportion of balanced representations, as assessed with Working Model of the Child Interview (WMCI), significantly increased between T1 and T3. Further, the proportion of emotionally available interactions, as assessed with Emotional Availability scales (EA), significantly increased over time in the COS-P group. Improvements in the TAU-group were close to significant. Limitations of the study are mainly related to the small sample size. Strength is the real world character of the study, where COS-P was implemented in a clinical context not otherwise adapted to research. We conclude by discussing the value of supplementing TAU with COS-P in IMH treatment. © 2017 The Authors. Scandinavian Journal of Psychology published by Scandinavian Psychological Associations and John Wiley & Sons Ltd.

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia

PubMed Central

Bowers, Alex R.; Keeney, Karen; Peli, Eli

2013-01-01

Objective To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia and without visual neglect. Methods Patients recruited at 13 clinics were allocated by minimization into a double-masked, crossover trial with two groups. One group received real (57Δ) oblique and sham (≤ 5Δ) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. A masked data collector at each clinic administered questionnaires after each 4-week crossover period. Main outcome measure The primary outcome was the overall difference, across the two periods of the crossover, between the proportion of participants who wanted to continue with (said “yes” to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Results Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs. 36%; odds ratio 5.3, 95% CI 1.8 to 21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (p=0.002); participants who discontinued wear reported no difference. Conclusion Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Applications to clinical practice Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. PMID:24201760

Hospital Variation in Intensive Care Resource Utilization and Mortality in Newly Diagnosed Pediatric Leukemia.

PubMed

Fitzgerald, Julie C; Li, Yimei; Fisher, Brian T; Huang, Yuan-Shung; Miller, Tamara P; Bagatell, Rochelle; Seif, Alix E; Aplenc, Richard; Thomas, Neal J

2018-06-01

To evaluate hospital-level variability in resource utilization and mortality in children with new leukemia who require ICU support, and identify factors associated with variation. Retrospective cohort study. Children's hospitals contributing to the Pediatric Health Information Systems administrative database from 1999 to 2011. Inpatients less than 25 years old with newly diagnosed acute lymphocytic leukemia or acute myeloid leukemia requiring ICU support (n = 1,754). Evaluated exposures included leukemia type, year of diagnosis, and hospital-wide proportion of patients with public insurance. The main outcome was hospital mortality. Wide variability existed in the ICU resources used across hospitals. Combined acute lymphocytic leukemia and acute myeloid leukemia mortality varied by hospital from 0% (95% CI, 0-14.8%) to 42.9% (95% CI, 17.7-71.1%). A mixed-effects model with a hospital-level random effect suggests significant variation across hospitals in mortality (p = 0.007). When including patient and hospital factors as fixed effects into the model, younger age, acute myeloid leukemia versus acute lymphocytic leukemia diagnosis, leukemia diagnosis prior to 2005, hospital-wide proportion of public insurance patients, and hospital-level proportion of leukemia patients receiving ICU care are significantly associated with mortality. The variation across hospitals remains significant with all patient factors included (p = 0.021) but is no longer significant after adjusting for the hospital-level factors proportion of public insurance and proportion receiving ICU care (p = 0.48). Wide hospital-level variability in ICU resource utilization and mortality exists in the care of children with leukemia requiring ICU support. Hospital payer mix is associated with some mortality variability. Additional study into how ICU support could be standardized through clinical practice guidelines, impact of payer mix on hospital resources allocation to the ICU, and subsequent impact on patient outcomes is warranted.

Changes in the provision of post-exposure prophylaxis for HIV after sexual exposure following introduction of guidelines and publicity campaigns.

PubMed

Roedling, S; Reeves, I; Copas, A J; Beattie, A; Edwards, S G; Fisher, M; Benn, P

2008-04-01

In July 2004, British Association of Sexual Health and HIV (BASHH) published guidelines for post-exposure prophylaxis following sexual exposure (PEPSE) and the Terence Higgins Trust (THT) launched a campaign promoting PEPSE among men who have sex with men (MSM). We evaluated subsequent changes in PEPSE attendances. Individuals requesting PEPSE in 2004 were identified from clinic databases. Comparisons of clinical data, exposure characteristics and follow-up were made pre and post campaign. Data were available for 197/216 (91%) PEP attendances. The proportion requesting PEP following sexual exposure increased significantly following the campaign. The majority commencing PEPSE were MSM, with the proportion of MSM increasing significantly from 36/46 (78%) pre to 76/80 (95%) following the campaign. Most prescriptions were in high-risk groups and within guidelines. Times to initiation and completion rates were unchanged. Access to PEPSE following the THT campaign and introduction of BASHH guidelines increased. Promotion of earlier initiation of PEPSE and improvement of completion and follow-up is required.

[Clinical trial of a combination of three drugs in fixed proportions in the treatment of tuberculosis. Groupe de Travail sur la Chimiothérapie de la Tuberculose].

PubMed

Chaulet, P; Boulahbal, F

1995-10-01

The Matiben Chest Clinic at the West Algiers University Teaching Hospital, and 3 outpatient clinics specializing in tuberculosis and lung disease in Algiers. To determine the tolerance and efficacy of a fixed proportion combination of 3 antituberculosis drugs (per tablet: 50 mg isoniazid + 120 mg rifampicin + 300 mg pyrazinamide) given during the first 2 months of a daily 6-month chemotherapy regimen. Random prospective treatment trial comparing a group of 124 patients receiving the triple combination with another group of 126 patients receiving the 3 drugs separately during the initial treatment phase. The continuation phase was identical for the 2 groups. Comparison of tolerance in the first 2 months, and of the failure and relapse rates (respectively at the end of treatment and 24 months after the end of treatment). During the first 2 months side-effects were significantly more common in the group receiving the drugs separately. At the end of treatment and during the following 24 months there were no significant differences in the cumulative rates of observed failures and relapses (2% and 1%). The triple combination studied could replace the separate drugs in the initial treatment phase in countries where the bioavailability of the drugs used has been proven.

Intraindividual variation in core microbiota in peri-implantitis and periodontitis

PubMed Central

Maruyama, Noriko; Maruyama, Fumito; Takeuchi, Yasuo; Aikawa, Chihiro; Izumi, Yuichi; Nakagawa, Ichiro

2014-01-01

The oral microbiota change dramatically with each part of the oral cavity, even within the same mouth. Nevertheless, the microbiota associated with peri-implantitis and periodontitis have been considered the same. To improve our knowledge of the different communities of complex oral microbiota, we compared the microbial features between peri-implantitis and periodontitis in 20 patients with both diseases. Although the clinical symptoms of peri-implantitis were similar to those of periodontitis, the core microbiota of the diseases differed. Correlation analysis revealed the specific microbial co-occurrence patterns and found some of the species were associated with the clinical parameters in a disease-specific manner. The proportion of Prevotella nigrescens was significantly higher in peri-implantitis than in periodontitis, while the proportions of Peptostreptococcaceae sp. and Desulfomicrobium orale were significantly higher in periodontitis than in peri-implantitis. The severity of the peri-implantitis was also species-associated, including with an uncultured Treponema sp. that correlated to 4 clinical parameters. These results indicate that peri-implantitis and periodontitis are both polymicrobial infections with different causative pathogens. Our study provides a framework for the ecologically different bacterial communities between peri-implantitis and periodontitis, and it will be useful for further studies to understand the complex microbiota and pathogenic mechanisms of oral polymicrobial diseases. PMID:25308100

Current trends of reproductive immunology practices in in vitro fertilization (IVF) - a first world survey using IVF-Worldwide.com.

PubMed

Kwak-Kim, Joanne; Han, Ae Ra; Gilman-Sachs, Alice; Fishel, Simon; Leong, Milton; Shoham, Zeev

2013-01-01

Reproductive immunology has evolved from basic research studies to clinical applications. In this study, we aim to investigate the actual application of reproductive immunology concepts and findings in clinical reproductive medicine such as recurrent pregnancy losses (RPL), repeated implantation failures (RIF), and failed in vitro fertilization (IVF) cycles. A web-based survey was performed on IVF-Worldwide.com. Collected data were analyzed by the computerized software. A significant proportion of physicians recommend thrombophilia workups (86%), parental genetic study (79%), and immunologic evaluations (69%) to IVF candidates who have a history of RPL or chemical pregnancy losses. IVF physicians consider an immunologic workup when patients have two (30%) or three (21%) failed IVF cycles. Assays for anticardiolipin antibody, lupus anticoagulant, thyroid peroxidase antibody, and antinuclear antibody are the four most commonly ordered immunologic tests for RPL (88, 84, 50, 47% each) and RIF (68, 63, 38, 38% each). Cellular immune evaluations, such as NK assay, human leukocyte antigen study, Th1/Th2 study or immunophenotype assay, are less commonly ordered. Reproductive immunology principles have been applied to the clinical management of RPL, RIF, and failed IVF cycles, and a significant proportion of IVF physicians acknowledge the importance of immunologic alterations with reproductive outcomes. © 2012 John Wiley & Sons A/S.

The emergence of "lifestyle medicine" as a structured approach for management of chronic disease.

PubMed

Egger, Garry J; Binns, Andrew F; Rossner, Stephan R

2009-02-02

Chronic diseases with a lifestyle-based aetiology currently make up a significant proportion of primary care consultations, but management often falls between the demands of public and clinical health. A modified clinical approach, based around the concept of "lifestyle medicine", helps fill the gap by adding behavioural, motivational and environmental skills to conventional medical practice. When used in a multidisciplinary setting, lifestyle medicine offers potential cost and effectiveness benefits, which are beginning to be realised.

Prevalence and etiological profile of chronic obstructive pulmonary disease in nonsmokers

PubMed Central

Mahmood, Tariq; Singh, Ravindra Kumar; Kant, Surya; Shukla, Amitabh Das; Chandra, Alok; Srivastava, Rajneesh Kumar

2017-01-01

Background: Tobacco smoking has been recognized as the most important risk factor for chronic obstructive pulmonary disease (COPD) for a long time, but recent studies have shown that nonsmokers also contribute to a significant proportion of COPD. This study was performed to find out the proportion of nonsmoker individuals among COPD patients and to determine various etiologies in nonsmoker COPD patients. Materials and Methods: This study was an observational cross-sectional study conducted in Department of Pulmonary Medicine, MLN Medical College, Allahabad. A total of 200 COPD patients, aged >18 years of either gender with COPD, diagnosed by clinical and spirometric criteria (GOLD guideline) were included in the study. Results: Of the 200 COPD patients, the proportion of nonsmoker patients was 56.5%, and the smoker was 43.5%. Among 113 nonsmoker COPD patients, maximum number of patients (69.03%) belonged to low socioeconomic status but most important and statistically significant risk factor was exposure to biomass smoke (53.98%), other significant risk factors were treated pulmonary tuberculosis (32.74%), and long-standing asthma (14.16%). Risk factors that were not statistically significant were occupational exposure (9.73%), exposure to outdoor air pollution (3.54%), and lower respiratory tract infection during childhood (1.77%). The patients who were exposed to more than one risk factors, developed COPD at an earlier age. Conclusions: This study revealed that nonsmokers contribute a significant proportion of COPD patients. Multiple risk factors other than smoking also play a major role in the development of COPD, particularly exposure to biomass smoke, treated pulmonary tuberculosis, and long-standing asthma. PMID:28360458

Relationship between preventable hospital deaths and other measures of safety: an exploratory study.

PubMed

Hogan, Helen; Healey, Frances; Neale, Graham; Thomson, Richard; Vincent, Charles; Black, Nick

2014-06-01

To explore associations between the proportion of hospital deaths that are preventable and other measures of safety. Retrospective case record review to provide estimates of preventable death proportions. Simple monotonic correlations using Spearman's rank correlation coefficient to establish the relationship with eight other measures of patient safety. Ten English acute hospital trusts. One thousand patients who died during 2009. The proportion of preventable deaths varied between hospitals (3-8%) but was not statistically significant (P = 0.94). Only one of the eight measures of safety (Methicillin-resistant Staphylococcus aureus bacteraemia rate) was clinically and statistically significantly associated with preventable death proportion (r = 0.73; P < 0.02). There were no significant associations with the other measures including hospital standardized mortality ratios (r = -0.01). There was a suggestion that preventable deaths may be more strongly associated with some other measures of outcome than with process or with structure measures. The exploratory nature of this study inevitably limited its power to provide definitive results. The observed relationships between safety measures suggest that a larger more powerful study is needed to establish the inter-relationship of different measures of safety (structure, process and outcome), in particular the widely used standardized mortality ratios. © The Author 2014. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Inverse correlation between the proportion of salivary bacteria inhibiting Streptococcus mutans and the percentage of untreated carious teeth.

PubMed

Goyette, N; Parrot, M; Sutzescu, D; Leduc, M; Dufour, L; Trahan, L; Lavoie, M C

1995-11-01

To evaluate the role of inhibitory substances produced by bacteria in the oral cavity, we estimated, by a deferred test on Todd-Hewitt agar enriched with hemin and vitamin K, the proportion of bacteria that inhibited or stimulated the growth of Streptococcus mutans and Porphyromonas gingivalis, from the saliva of 109 patients (54 males and 55 females) attending our dental clinics. The patients, aged from 8 to 75 years old (mean: 31 +/- 18 years), were randomly selected whatever the reason for their visit. The results, evaluated with the Spearman rank test, indicated that there was no statistically significant (P > 0.05) correlation between the proportion of salivary bacteria inhibiting or stimulating P. gingivalis with the Community Periodontal Index of Treatment Needs (CPITN), the number of carious, missing and filled teeth, or with the decayed, missing and filled teeth index (DMFT). Also, no statistically significant correlation was observed between the proportion of salivary bacteria stimulating the growth of S. mutans and the above mentioned health indexes. However, a statistically significant (P < 0.005) negative correlation was found between the percentage of cultivated bacteria that inhibit S. mutans and the percentage of untreated carious teeth as well as with the CPITN. The results thus indicate a possible role for inhibitory substances produced by bacteria in the maintenance of oral health.

Dropout rates and factors associated with dropout from treatment among elderly patients attending the outpatient services of a tertiary care hospital

PubMed Central

Grover, Sandeep; Dua, Devakshi; Chakrabarti, Subho; Avasthi, Ajit

2018-01-01

Aim: This study aimed to evaluate the “dropout” rates from treatment and associated factors among elderly patients attending a tertiary care psychiatry outpatient facility. Materials and Methods: Data of 1422 patients aged ≥60 years, attending the walk-in clinic were evaluated. Results: Out of 1422 patients, 406 (28.55%) belonged to the “dropout” group. In the “dropout” group, the age of patients was significantly higher than the followed-up group, and a higher proportion of patients were >70 years old. Significantly lower proportion of patients with diagnosis of depressive disorders belonged to the “dropout” group and significantly higher proportion of patients with “other” diagnoses belonged to the dropped out group. In patients with depressive disorders, a higher proportion of the patients in the “dropout” group were Hindu by religion (68.7% vs. 58.7%; χ2 = 4.26; P = 0.03). In patients with bipolar disorder, patients in the “dropout” group had significantly higher income (Rs. 13,323 [standard deviation [SD] = 16,769] vs. 5681 [SD = 9422]; t-test value: 2–25; P = 0.028) and lesser proportion of patients were of the male gender (63.15 vs. 86.95%; Mann–Whitney U value = 257.5; P = 0.039). In the group of other diagnoses, a higher proportion of patients in the “dropout” group were currently single (32.3% vs. 18.7%; χ2 = 4.12; P = 0.042), from rural locality (63.1% vs. 46.72%; χ2 = 4.33; P = 0.037) and were not prescribed medications (40% vs. 22.4%; χ2 = 6.05; P = 0.04). Conclusion: Dropout from treatment among elderly patients is associated with higher age, not being prescribed medications, and diagnosis other than the affective disorders, psychotic disorders, and the cognitive disorders. PMID:29736062

Patient-reported symptoms during radiotherapy : Clinically relevant symptom burden in patients treated with palliative and curative intent.

PubMed

Körner, Philipp; Ehrmann, Katja; Hartmannsgruber, Johann; Metz, Michaela; Steigerwald, Sabrina; Flentje, Michael; van Oorschot, Birgitt

2017-07-01

The benefits of patient-reported symptom assessment combined with integrated palliative care are well documented. This study assessed the symptom burden of palliative and curative-intent radiation oncology patients. Prior to first consultation and at the end of RT, all adult cancer patients planned to receive fractionated percutaneous radiotherapy (RT) were asked to answer the Edmonton Symptom Assessment Scale (ESAS; nine symptoms from 0 = no symptoms to 10 = worst possible symptoms). Mean values were used for curative vs. palliative and pre-post comparisons, and the clinical relevance was evaluated (symptom values ≥ 4). Of 163 participating patients, 151 patients (90.9%) completed both surveys (116 curative and 35 palliative patients). Before beginning RT, 88.6% of palliative and 72.3% of curative patients showed at least one clinically relevant symptom. Curative patients most frequently named decreased general wellbeing (38.6%), followed by tiredness (35.0%), anxiety (32.4%), depression (30.0%), pain (26.3%), lack of appetite (23.5%), dyspnea (17.8%), drowsiness (8.0%) and nausea (6.1%). Palliative patients most frequently named decreased general wellbeing (62.8%), followed by pain (62.8%), tiredness (60.0%), lack of appetite (40.0%), anxiety (38.0%), depression (33.3%), dyspnea (28.5%), drowsiness (25.7%) and nausea (14.2%). At the end of RT, the proportion of curative and palliative patients with a clinically relevant symptom had increased significantly to 79.8 and 91.4%, respectively; whereas the proportion of patients reporting clinically relevant pain had decreased significantly (42.8 vs. 62.8%, respectively). Palliative patients had significantly increased tiredness. Curative patients reported significant increases in pain, tiredness, nausea, drowsiness, lack of appetite and restrictions in general wellbeing. Assessment of patient-reported symptoms was successfully realized in radiation oncology routine. Overall, both groups showed a high symptom burden. The results prove the need of systematic symptom assessment and programs for early integrated supportive and palliative care in radiation oncology.

Improved amputation-free survival in unreconstructable critical limb ischemia and its implications for clinical trial design and quality measurement.

PubMed

Benoit, Eric; O'Donnell, Thomas F; Kitsios, Georgios D; Iafrati, Mark D

2012-03-01

Amputation-free survival (AFS), a composite endpoint of mortality and amputation, is the preferred outcome measure in critical limb ischemia (CLI). Given the improvements in systemic management of atherosclerosis and interventional management of limb ischemia over the past 2 decades, we examined whether these outcomes have changed in patients with CLI without revascularization options (no option-critical limb ischemia [NO-CLI]). We reviewed the literature for published 1-year AFS, mortality, and amputation rates from control groups in NO-CLI trials. Summary proportions of events were estimated by conducting a random effects meta-analysis of proportions. To determine whether there had been any change in event rates over time, we performed a random effects meta-regression and a mixed effects logistic regression, both regressed against the variable "final year of recruitment." Eleven trials consisting of 886 patients satisfied search criteria, 7 of which presented AFS data. Summary proportion of events (95% confidence interval) were 0.551 (0.399 to 0.693) for AFS; 0.198 (0.116 to 0.317) for death; and 0.341 (0.209 to 0.487) for amputation. Regression analyses demonstrated that AFS has risen over time as mortality rates have fallen, and these improvements are statistically significant. The decrease in amputation rates failed to reach statistical significance. The lack of published data precluded a quantitative evaluation of any change in the clinical severity or comorbidities in the NO-CLI population. AFS and mortality rates in NO-CLI have improved over the past 2 decades. Due to declining event rates, clinical trials may underestimate treatment effects and thus fail to reach statistical significance unless sample sizes are increased or unless a subgroup with a higher event rate can be identified. Alternatively, comparing outcomes to historical values for quality measurement may overestimate treatment effects. Benchmark values of AFS and morality require periodic review and updating. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Synergistetes cluster A in saliva is associated with periodontitis.

PubMed

Belibasakis, G N; Oztürk, V-Ö; Emingil, G; Bostanci, N

2013-12-01

Synergistetes is a novel bacterial phylum consisting of gram-negative anaerobes. Increasing lines of evidence demonstrate that this phylum is associated with periodontal diseases. This study aimed to compare the presence and levels of Synergistetes clusters A and B, in saliva of patients with chronic periodontitis (CP), generalized aggressive periodontitis (G-AgP) and non-periodontitis subjects, and investigate their correlation with clinical parameters. Saliva was collected from patients with CP (n = 20), G-AgP (n = 21) and non-periodontitis subjects (n = 18). Full mouth clinical periodontal measurements were recorded. The numbers of Synergistetes cluster A and cluster B or the associated species Jonquetella anthropi were quantified by fluorescent in situ hybridization and microscopy. Synergistetes cluster A bacteria were detected more frequently, and at higher numbers and proportions in the two periodontitis groups, than the non-periodontitis control group. The prevalence was 27.7% in the control group, 85% in CP and 86% in G-AgP. Compared to the control group, the numbers were significantly higher by 12.5-fold in CP and 26.5-fold in G-AgP, whereas the difference between the two forms of periodontitis was not statistically significant. Within the total bacterial population, the proportion of this cluster was increased in CP and G-AgP compared to the control group, with the difference between the two forms of periodontitis being also significant. There was a positive correlation between the levels of Synergistetes cluster A in saliva and all full mouth clinical periodontal parameters. Nevertheless, Synergistetes cluster B bacteria and J. anthropi species were detected infrequently and at low levels in all the three subject groups. Synergistetes cluster A, but not cluster B, bacteria are found at higher prevalence, numbers and proportions in saliva from patients with periodontitis, than non-periodontitis subjects. These findings support the association of this cluster with periodontitis. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Evaluation of cellular immunological responses in mono- and polymorphic clinical forms of post-kala-azar dermal leishmaniasis in India.

PubMed

Kaushal, H; Bras-Gonçalves, R; Avishek, K; Kumar Deep, D; Petitdidier, E; Lemesre, J-L; Papierok, G; Kumar, S; Ramesh, V; Salotra, P

2016-07-01

Post-kala-azar dermal leishmaniasis (PKDL) is a chronic dermal complication that occurs usually after recovery from visceral leishmaniasis (VL). The disease manifests into macular, papular and/or nodular clinical types with mono- or polymorphic presentations. Here, we investigated differences in immunological response between these two distinct clinical forms in Indian PKDL patients. Peripheral blood mononuclear cells of PKDL and naive individuals were exposed in vitro to total soluble Leishmania antigen (TSLA). The proliferation index was evaluated using an enzyme-linked immunosorbent assay (ELISA)-based lymphoproliferative assay. Cytokines and granzyme B levels were determined by cytometric bead array. Parasite load in tissue biopsy samples of PKDL was quantified by quantitative polymerase chain reaction (qPCR). The proportion of different lymphoid subsets in peripheral blood and the activated T cell population were estimated using flow cytometry. The study demonstrated heightened cellular immune responses in the polymorphic PKDL group compared to the naive group. The polymorphic group showed significantly higher lymphoproliferation, increased cytokines and granzyme B levels upon TSLA stimulation, and a raised proportion of circulating natural killer (NK) T cells against naive controls. Furthermore, the polymorphic group showed a significantly elevated proportion of activated CD4(+) and CD8(+) T cells upon in-vitro TSLA stimulation. Thus, the polymorphic variants showed pronounced cellular immunity while the monomorphic form demonstrated a comparatively lower cellular response. Additionally, the elevated level of both activated CD4(+) and CD8(+) T cells, coupled with high granzyme B secretion upon in-vitro TSLA stimulation, indicated the role of cytotoxic cells in resistance to L. donovani infection in polymorphic PKDL. © 2016 British Society for Immunology.

Imported human rabies cases worldwide, 1990-2012.

PubMed

Carrara, Philippe; Parola, Phillipe; Brouqui, Phillipe; Gautret, Philippe

2013-01-01

Sixty cases of human rabies in international travelers were reviewed from 1990-2012. A significant proportion of the cases were observed in migrants or their descendants when emigrating from their country of origin or after a trip to visit friends and relatives or for other reasons (43.3%). The cases were not necessarily associated with long-term travel or expatriation to endemic countries; moreover, cases were observed in travelers after short trips of two weeks or less. A predominance of male patients was observed (75.0%). The proportion of children was low (11.7%). Cases from India and Philippines were frequent (16 cases/60). In a significant proportion of cases (51.1%), diagnosis was challenging, with multiple missed diagnoses and transfers from ward to ward before the final diagnosis of rabies. Among the 28 patients whose confirmed diagnosis was obtained ante-mortem, the mean time between hospitalization and diagnosis was 7.7 days (median time: 6.0 days, range 2-30) including four cases with a diagnosis delayed by 15 or more days. In five cases, a patient traveled through one or more countries before ultimately being hospitalized. Three factors played a role in delaying the diagnosis of rabies in a number of cases: (i) a low index of suspicion for rabies in countries where the disease has been eradicated for a long time or is now rare, (ii) a negative history of animal bites or exposure to rabies, and (iii) atypical clinical presentation of the disease. Clinical symptomatology of rabies is complex and commonly confuses physicians. Furthermore, failure in diagnosing imported cases in more developed countries is most likely related to the lack of medical familiarity with even the typical clinical features of the disease.

Predictive factors for long-term survival in patients with clinically significant portal hypertension following resection of hepatocellular carcinoma.

PubMed

Choi, Gi H; Park, Jun Y; Hwang, Ho K; Kim, Dong H; Kang, Chang M; Choi, Jin S; Park, Young N; Kim, Do Y; Ahn, Sang H; Han, Kwang-Hyub; Chon, Chae Y; Lee, Woo J

2011-04-01

Hepatic resection for hepatocellular carcinoma (HCC) is not currently recommended for patients with clinically significant portal hypertension (PHT); however, recent studies have shown similar post-operative outcomes between patients with and without clinically significant PHT. To clarify the post-operative prognostic relevance of clinically significant PHT in Child-Pugh A cirrhotic patients. A total of 100 Child-Pugh A cirrhotic patients who underwent curative resection of HCC were eligible for this analysis. Patients were divided into two groups: PHT group (n=47) and non-PHT group (n=53). Clinicopathological variables showed no significant differences except for prothrombine time. Liver-related complications were significantly higher in the PHT group (P=0.015), and the 5-year overall survival rate was significantly higher in the non-PHT group (78.7 vs. 37.9%, P<0.001). The proportion of patients who died because of complications of cirrhosis was significantly higher in the PHT group (P=0.001). Multivariate analysis indicated that the presence of clinically significant PHT was the most powerful adverse prognostic factor for overall survival. Multivariate analysis of the 47 patients with clinically significant PHT indicated that gross vascular invasion and non-single nodular type were poor prognostic factors. The 5-year survival rate of patients with single nodular type and without gross vascular invasion (n=17) was 78.4%. In Child-Pugh A cirrhotic patients, the presence of clinically significant PHT was significantly associated with post-operative hepatic decompensation and poor prognosis after resection of HCC. However, in patients with clinically significant PHT, those with single nodular tumours lacking gross vascular invasion may be good surgical candidates. © 2011 John Wiley & Sons A/S.

The selective treatment of clinical mastitis based on on-farm culture results: I. Effects on antibiotic use, milk withholding time, and short-term clinical and bacteriological outcomes.

PubMed

Lago, A; Godden, S M; Bey, R; Ruegg, P L; Leslie, K

2011-09-01

The objective of this multi-state, multi-herd clinical trial was to evaluate the efficacy of using an on-farm culture system to guide strategic treatment decisions in cows with clinical mastitis. The study was conducted in 8 commercial dairy farms ranging in size from 144 to 1,795 cows from Minnesota, Wisconsin, and Ontario, Canada. A total of 422 cows affected with mild or moderate clinical mastitis in 449 quarters were randomly assigned to either (1) a positive-control treatment program or (2) an on-farm, culture-based treatment program. Quarter cases assigned to the positive-control group received immediate on-label intramammary treatment with cephapirin sodium. Quarters assigned to the culture-based treatment program were cultured on-farm and treated with cephapirin sodium after 18 to 24h of incubation if they had gram-positive growth or a mixed infection. Quarters with gram-negative or no growth did not receive intramammary therapy. The proportion of quarter cases assigned to positive-control and culture-based treatments that received intramammary antibiotic therapy because of study assignment was 100 and 44%, respectively; the proportion of cases that received secondary antibiotic therapy was 36 and 19%, respectively; and the proportion of cases that received intramammary antibiotic therapy because of study assignment or secondary therapy was 100 and 51%, respectively. A tendency existed for a decrease in the number of days in which milk was discarded from cows assigned to the culture-based treatment program versus cows assigned to the positive-control group (5.9 vs. 5.2 d). No statistically significant differences existed between cases assigned to the positive-control and cases assigned to the culture-based treatment program in days to clinical cure (2.7 vs. 3.2 d), bacteriological cure risk within 21 d of enrollment (71 vs. 60%), new intramammary infection risk within 21 d of enrollment (50 vs. 50%), and treatment failure risk (presence of infection, secondary treatment, clinical mastitis recurrence, or removal from herd within 21 d after enrollment; 81 vs. 78%). In summary, the use of an on-farm culture system to guide the strategic treatment of clinical mastitis reduced intramammary antibiotic use by half and tended to decrease milk withholding time by 1 d, without significant differences in days to clinical cure, bacteriological cure risk, new intramammary infection risk, and treatment failure risk within 21 d after the clinical mastitis event. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Implementing a Measurement Feedback System in Community Mental Health Clinics: A Case Study of Multilevel Barriers and Facilitators.

PubMed

Gleacher, Alissa A; Olin, Serene S; Nadeem, Erum; Pollock, Michele; Ringle, Vanesa; Bickman, Leonard; Douglas, Susan; Hoagwood, Kimberly

2016-05-01

Measurement feedback systems (MFSs) have been proposed as a means of improving practice. The present study examined the implementation of a MFS, the Contextualized Feedback System (CFS), in two community-based clinic sites. Significant implementation differences across sites provided a basis for examining factors that influenced clinician uptake of CFS. Following the theoretical implementation framework of Aarons et al. (Adm Policy Mental Health Mental Health Serv Res 38(1):4-23, 2011), we coded qualitative data collected from eighteen clinicians (13 from Clinic U and 5 from Clinic R) who participated in semi-structured interviews about their experience with CFS implementation. Results suggest that clinicians at both clinics perceived more barriers than facilitators to CFS implementation. Interestingly, clinicians at the higher implementing clinic reported a higher proportion of barriers to facilitators (3:1 vs. 2:1); however, these clinicians also reported a significantly higher level of organizational and leadership supports for CFS implementation. Implications of these findings are discussed.

Use of fingolimod in patients with relapsing remitting multiple sclerosis in Kuwait.

PubMed

Alroughani, R; Ahmed, S F; Behbehani, R; Al-Hashel, J

2014-04-01

Post-marketing studies are important to confirm what was established in clinical trials, and to assess the intermediate and long-term efficacy and safety. To assess efficacy and safety of fingolimod in multiple sclerosis (MS) in Kuwait. We retrospectively evaluated MS patients using the MS registries in 3 MS clinics. Relapsing remitting MS patients according to revised 2010 McDonald criteria who had been treated with fingolimod for at least 12 months were included. Primary endpoint was proportion of relapse-free patients at last follow-up. Secondary endpoints were mean change in EDSS and proportion of patients with MRI activity (gadolinium-enhancing or new/enlarging T2 lesions). 76 patients met the inclusion criteria. Mean age and mean disease duration were 34.43 and 7.82 years respectively. Mean duration of exposure to fingolimod was 18.50 months. Proportion of relapse-free patients was 77.6% at last follow-up. Mean EDSS score significantly improved (2.93 versus 1.95; p<0.0001) while 17.1% of patients continued to have MRI activity versus 77.6% at baseline (p<0.0001). Four patients stopped fingolimod due to disease breakthrough (n=3) and lymphadenitis (n=1). Fingolimod is safe and effective in reducing clinical and radiological disease activity in relapsing remitting MS patients. Our results are comparable to reported results of phase III studies. Copyright © 2014 Elsevier B.V. All rights reserved.

Beyond Necrotizing Enterocolitis: Other Clinical Advantages of an Exclusive Human Milk Diet.

PubMed

Hair, Amy B; Rechtman, David J; Lee, Martin L; Niklas, Victoria

2018-06-07

Articles previously published by Sullivan et al. and Cristofalo et al. were reanalyzed using the proportion of cow milk-based nutrition received to determine whether that affected clinical outcomes during hospitalization for infants birth weight 500-1250 g. Abrams et al. showed in the same cohort incidences of necrotizing enterocolitis (NEC), NEC requiring surgery and sepsis increased proportionally to the amount of dietary cow milk. The data from the two studies conducted under essentially the same protocol were combined yielding a cohort of 260 infants receiving a diet ranging from 0% to 100% cow milk. Data analysis utilized negative binomial regression which mitigates differences between subjects in terms of their time on study by incorporating that number into the statistical model. The percent of cow milk-based nutrition was the only predictor investigated. For all outcomes the larger the amount of cow's milk in the diet the greater the number of days of that intervention required. A trend toward statistical significance was seen for ventilator days; however, only parenteral nutrition (PN) days and days to full feeds achieved statistical significance. Incorporation of any cow milk-based nutrition into the diet of extremely premature infants correlates with more days on PN and a longer time to achieve full feeds. There was a nonstatistically significant trend toward increased ventilator days. These represent additional clinical consequences of the use of any cow milk-based protein in feeding EP infants.

Origin and funding of the most frequently cited papers in medicine: database analysis.

PubMed

Patsopoulos, Nikolaos A; Ioannidis, John P A; Analatos, Apostolos A

2006-05-06

To evaluate changes in the role of academics and the sources of funding for the medical research cited most frequently over the past decade. Database analysis. Web of Knowledge database. For each year from 1994 to 2003, articles in the domain of clinical medicine that had been cited most often by the end of 2004 were identified. Changes in authors' affiliations and funding sources were evaluated. Of the 289 frequently cited articles, most had at least one author with a university (76%) or hospital (57%) affiliation, and the proportion of articles with each type of affiliation was constant over time. Government or public funding was most common (60% of articles), followed by industry (36%). The proportion of most frequently cited articles funded by industry increased over time (odds ratio 1.17 per year, P = 0.001) and was equal to the proportion funded by government or public sources by 2001. 65 of the 77 most cited randomised controlled trials received funding from industry, and the proportion increased significantly over time (odds ratio 1.59 per year, P = 0.003). 18 of the 32 most cited trials published after 1999 were funded by industry alone. Academic affiliations remain prominent among the authors of the most frequently cited medical research. Such research is increasingly funded by industry, often exclusively so. Academics may be losing control of the clinical research agenda.

Is anxiety more common in school students with newly diagnosed specific learning disabilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India.

PubMed

Thakkar, A N; Karande, S; Bala, N; Sant, H; Gogtay, N J; Sholapurwala, R

2016-01-01

School students with specific learning disabilities (SpLDs) experience chronic academic underachievement and resultant stress. The present study aimed to determine if school students with newly diagnosed SpLD were more likely to have anxiety than their regular peers. The study cases (aged 8-15 years) were recruited from our institute's learning disability clinic. The matched controls were recruited from four schools in Mumbai, Maharashtra, India. Anxiety was measured using the Spence Children's Anxiety Scale (SCAS)-child self-report version questionnaire. Median SCAS scores and the proportion of students with an SCAS score in the "clinical anxiety" range were compared between the groups. SCAS scores were significantly higher in 8-11-year-old learning-disabled male and female students (P < 0.0001 for both groups) and 12-15-year-old female students (P = 0.004), as compared with matched controls. A significantly higher number of learning-disabled students were found to have "clinical anxiety" [24.64% vs. 4.35%, crude odds ratio (OR) = 7.19, 95% confidence interval (CI) 2.91-17.78, P = 0.0001], as compared with the controls regardless of gender, age group, presence of comorbid attention-deficit/hyperactivity disorder (ADHD), or associated medical conditions. A significantly higher proportion of 8-11-year-old learning-disabled students, especially males, were found to have "clinical anxiety" as compared with 12-15-year-old learning-disabled students (crude OR = 4.38, 95% CI 1.94-9.92, P = 0.0004). Gender, presence of comorbid ADHD or associated medical conditions, and type of school attended or curriculum did not impact the prevalence of "clinical anxiety" in learning-disabled students. Students with newly diagnosed SpLD have greater odds of being "clinically anxious" relative to their regular peers. We recommend screening for anxiety in children with SpLD immediately after diagnosis so that their optimum rehabilitation can be facilitated.

Colonic stenting as a bridge to surgery for obstructive colorectal cancer: advantages and disadvantages.

PubMed

Haraguchi, Naotsugu; Ikeda, Masataka; Miyake, Masakazu; Yamada, Takuya; Sakakibara, Yuko; Mita, Eiji; Doki, Yuichiro; Mori, Masaki; Sekimoto, Mitsugu

2016-11-01

To clarify the advantages and disadvantages of stenting as a bridge to surgery (BTS) by comparing the clinical features and outcomes of patients who underwent BTS with those of patients who underwent emergency surgery (ES). We assessed technical success, clinical success, surgical procedures, stoma formation, complications, clinicopathological features, and Onodera's prognostic nutritional index (OPNI) in patients who underwent BTS and those who underwent ES. Twenty-six patients underwent stenting, which was successful in 22 (BTS group). The remaining four patients with unsuccessful stenting underwent emergency surgery. A total of 22 patients underwent emergency surgery (ES group). The rates of technical and clinical success were 85.0 and 81.0 %, respectively. The proportion of patients able to be treated by laparoscopic surgery (P = 0.0001) and avoid colostomy (P = 0.0042) was significantly higher in the BTS group. Although the incidence of anastomotic leakage in the two groups was not significantly different, it was significantly reduced by colonoscopic evaluation of obstructive colitis (P = 0.0251). The mean number of harvested lymph nodes (P = 0.0056) and the proportion of D3 lymphadenectomy (P = 0.0241) were significantly greater in the BTS group. Perineural invasion (PNI) was noted in 59.1 and 18.2 % of the BTS group and ES group patients, respectively (P = 0.0053). OPNI and serum albumin decreased significantly after stenting (P = 0.0084). The advantages of stenting as a BTS were that it avoided colostomy and allowed for laparoscopic surgery and lymphadenectomy, whereas its disadvantage lay in the decreased PNI and OPNI levels. A larger study including an analysis of prognosis is warranted.

Self-Reported Training Adequacy, Experience, and Comfort Level in Performing Schizophrenia-Related Clinical Skills among Psychiatry Residents and Fellows.

PubMed

Greene, Laurence; Moreo, Kathleen; Nasrallah, Henry; Tandon, Rajiv; Sapir, Tamar

2017-08-01

In the context of an educational program on schizophrenia for psychiatry trainees, this survey study analyzed associations between self-reported training adequacy, experience in providing patient care, and comfort level in performing schizophrenia-related clinical skills. The influence of the education on comfort level was also assessed for each skill. Survey respondents were psychiatry residents and fellows who participated in a schizophrenia education program at an in-person workshop or through online videos recorded at the workshop. In a pre-program survey, participants reported their experience in providing schizophrenia patient care and rated their training adequacy and comfort level for performing seven clinical skills involved in diagnosing and treating schizophrenia. The post-program survey included items for reassessing comfort level in performing the skills. Across the seven clinical skills, the proportion of respondents (n = 79) who agreed or strongly agreed that their training was adequate ranged from 29 to 88 %. The proportion of high ratings for comfort level in skill performance ranged from 45 to 83 %. Comfort level was significantly associated with training adequacy for all seven clinical skills and with experience in providing patient care for four skills. For all skills, comfort level ratings were significantly higher after versus before the educational workshop. Commonly indicated needs for further training included education on new therapies, exposure to a broader range of patients, and opportunities for longitudinal patient management. Psychiatry trainees' self-reported, disease-specific training adequacy, experiences, and comfort level have unique applications for developing and evaluating graduate medical curriculum.

Open access gastroscopy: too much to swallow?

PubMed Central

Kerrigan, D D; Brown, S R; Hutchinson, G H

1990-01-01

OBJECTIVES--To ascertain the proportion of endoscopic examinations with normal findings in patients referred for gastroscopy through hospital medical staff or directly by their general practitioner and to assess the likely effect of targeting endoscopy in older patients. DESIGN--Retrospective audit of the gastroscopy practice of one consultant from 1986 to 1988 from information recorded on a standard form completed at the time of the examination, which contained details of patients, their endoscopic findings, and mode of referral (open access or clinic). SETTING--One district general hospital. PATIENTS--1545 Consecutive patients from primary catchment area attending for their first gastroscopy; 454 were referred through the outpatient clinic or by hospital colleagues (clinic group) and 1091 were accepted for endoscopy solely on their general practitioner's clinical diagnosis (open access group). RESULTS--Similar numbers (about 40%) of examinations with normal findings were performed in each group, although in patients aged over 40 the proportion with normal findings was significantly higher in the clinic group (p less than 0.03). Endoscopic evidence of gastro-oesophageal reflux disease, peptic ulceration, and gastroduodenal inflammation was equally common in each group; upper gastrointestinal malignancy, however, was significantly more common in patients referred through hospital doctors (5%, 23/454 v 2%, 22/1091 respectively; p less than 0.005) (although many of these patients had already been extensively investigated). IMPLICATIONS--Open access gastroscopy does not increase the number of unnecessary examinations and should become more widely available. Targeting this service to patients aged over 40 would reduce the number of requests but increase the diagnostic yield. PMID:2106992

General practitioners' referrals to specialist outpatient clinics. II. Locations of specialist outpatient clinics to which general practitioners refer patients.

PubMed Central

Coulter, A.; Noone, A.; Goldacre, M.

1989-01-01

Although linkage by computer of hospital administration systems across all clinics in a health district is becoming a practical possibility, complete records of general practitioners' referrals to outpatient clinics will be difficult to achieve. Data from a large study of general practitioners' referrals to such clinics were used to calculate the proportion of referrals that crossed district boundaries, the proportion that were made to the private sector; and the number of locations that each practice referred patients to. Of the 17,601 referrals from practices in Oxford Regional Health Authority, 13,857 (78.7%) were made to NHS outpatient clinics within practices' own districts, 1524 (8.7%) to clinics in other districts in the same region, 420 (2.4%) to NHS clinics in other regions, and 1800 (10.2%) to the private sector; but these proportions varied considerably among the practices. The mean number of different NHS hospitals or clinics that each practice referred patients to was 15.8 (range 4-42). PMID:2504414

Histological Disease Activity as a Predictor of Clinical Relapse Among Patients With Ulcerative Colitis: Systematic Review and Meta-Analysis.

PubMed

Park, Sunhee; Abdi, Tsion; Gentry, Mark; Laine, Loren

2016-12-01

Endoscopic remission in ulcerative colitis (UC) is associated with improved clinical outcomes. We assessed whether histological remission predicts clinical outcomes, estimated the magnitude of effect, and determined whether histological remission provides additional prognostic utility beyond clinical or endoscopic remission. Bibliographic databases were searched for studies in inflammatory bowel disease providing baseline histological status and relation to an outcome of clinical relapse or exacerbation. Our primary analysis compared the proportion of patients with study-defined histological remission vs. the proportion with histological activity who developed clinical relapse/exacerbation. Additional analyses compared the proportion with relapse/exacerbation for the presence vs. absence of different histological features and for histological remission vs. endoscopic remission and clinical remission. A fixed-effect model was used for meta-analysis, with a random-effects model if statistical heterogeneity was present. Fifteen studies met inclusion criteria. The major methodological shortcoming was lack of blinding of the assessor of clinical relapse/exacerbation to baseline histological status in 13 of the 15 studies. Relapse/exacerbation was less frequent with baseline histological remission vs. histological activity (relative risk (RR)=0.48, 95% confidence interval (CI) 0.39-0.60) and vs. baseline clinical and endoscopic remission (RR=0.81, 95% CI 0.70-0.94). Relapse/exacerbation was also less common in the absence vs. presence of specific histological features: neutrophils in epithelium (RR=0.32, 95% CI 0.23-0.45), neutrophils in lamina propria (RR=0.43, 95% CI 0.32-0.59), crypt abscesses (RR=0.38, 95% CI 0.27-0.54), eosinophils in the lamina propria (RR=0.43, 95% CI 0.21-0.91), and chronic inflammatory cell infiltrate (RR=0.28, 95% CI 0.10-0.75). Histological remission was present in 964 (71%) of the 1360 patients with combined endoscopic and clinical remission at baseline. UC patients with histological remission have a significant 52% RR reduction in clinical relapse/exacerbation compared with those with histological activity. Histological remission is also superior to endoscopic and clinical remission in predicting clinical outcomes. As ~30% of patients with endoscopic and clinical remission still have histological activity, addition of histological status as an end point in clinical trials or practice has the potential to improve clinical outcomes.

Overrepresentation of Women Veterans Among Homeless Women

PubMed Central

Gamache, Gail; Rosenheck, Robert; Tessler, Richard

2003-01-01

Objectives. This study estimated the proportion of veterans among homeless women and their risk of homelessness relative to that of nonveterans. Methods. Data came from 2 surveys of homeless women (1 clinical and 1 nonclinical) and 1 survey of domiciled women. Results. The proportion of veterans (4.4%, 3.1%) among homeless women was greater than the proportion among domiciled women (1.3%, 1.2%). When we computed odds ratios for being a veteran among homeless women compared with nonhomeless women, homeless women were significantly more likely than nonhomeless women to be veterans. Conclusions. Women veterans are at greater risk for homelessness than are nonveterans. Further study is needed to determine whether increased risks for veterans are a product of military service or reflect volunteers’ self-selection into the armed forces. (Am J Public Health. 2003;93:1132–1136) PMID:12835198

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

PubMed

Koonrungsesomboon, Nut; Tharavanij, Thipaporn; Phiphatpatthamaamphan, Kittichet; Vilaichone, Ratha-Korn; Manuwong, Sudsayam; Curry, Parichat; Siramolpiwat, Sith; Punchaipornpon, Thanachai; Kanitnate, Supakit; Tammachote, Nattapol; Yamprasert, Rodsarin; Chanvimalueng, Waipoj; Kaewkumpai, Ruchirat; Netanong, Soiphet; Kitipawong, Peerapong; Sritipsukho, Paskorn; Karbwang, Juntra

2017-02-01

This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

A Double-Blind Placebo-Controlled Randomized Clinical Trial With Magnesium Oxide to Reduce Intrafraction Prostate Motion for Prostate Cancer Radiotherapy

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

Lips, Irene M., E-mail: i.m.lips@umcutrecht.nl; Gils, Carla H. van; Kotte, Alexis N.T.J.

2012-06-01

Purpose: To investigate whether magnesium oxide during external-beam radiotherapy for prostate cancer reduces intrafraction prostate motion in a double-blind, placebo-controlled randomized trial. Methods and Materials: At the Department of Radiotherapy, prostate cancer patients scheduled for intensity-modulated radiotherapy (77 Gy in 35 fractions) using fiducial marker-based position verification were randomly assigned to receive magnesium oxide (500 mg twice a day) or placebo during radiotherapy. The primary outcome was the proportion of patients with clinically relevant intrafraction prostate motion, defined as the proportion of patients who demonstrated in {>=}50% of the fractions an intrafraction motion outside a range of 2 mm. Secondarymore » outcome measures included quality of life and acute toxicity. Results: In total, 46 patients per treatment arm were enrolled. The primary endpoint did not show a statistically significant difference between the treatment arms with a percentage of patients with clinically relevant intrafraction motion of 83% in the magnesium oxide arm as compared with 80% in the placebo arm (p = 1.00). Concerning the secondary endpoints, exploratory analyses demonstrated a trend towards worsened quality of life and slightly more toxicity in the magnesium oxide arm than in the placebo arm; however, these differences were not statistically significant. Conclusions: Magnesium oxide is not effective in reducing the intrafraction prostate motion during external-beam radiotherapy, and therefore there is no indication to use it in clinical practice for this purpose.« less

Clinical experience with generic levetiracetam in people with epilepsy

PubMed Central

Chaluvadi, Siresha; Chiang, Sharon; Tran, Larry; Goldsmith, Corey E.; Friedman, David E.

2015-01-01

SUMMARY Purpose To describe the clinical outcomes of a compulsory switch from branded to generic levetiracetam (LEV) among people with epilepsy (PWE) in an outpatient setting. Methods We conducted a retrospective chart review of 760 unduplicated consecutive adult patients attending a tertiary care epilepsy clinic at Ben Taub General Hospital. On November 1, 2008 hospital policy required all patients receiving branded LEV to be automatically switched to generic LEV. We calculated the proportion of patients switching back to branded LEV and reasons for the switch back. Key Findings Of the 260 patients (34%) being prescribed LEV (generic and brand name) during the study period, 105 (42.9%) were switched back to brand name LEV by their treating physicians. Reasons for switch back included increase in seizure frequency (19.6% vs. 1.6%; p < 0.0001) and adverse effects (AEs) (3.3%). AEs included headache, fatigue, and aggression. Patient age was associated with switchback when controlling for gender, epilepsy classification, and treatment characteristics [relative risk (RR) 2.44; 95% confidence interval (CI) 2.09–2.84; p < 0.05)]. An increase in seizure frequency subsequent to generic substitution was associated with polytherapy compared to monotherapy (3.225; 1.512–6.880; p < 0.05). Significance A significant proportion of patients in our cohort on generic LEV required switch back to the branded drug. Careful monitoring is imperative because a compulsory switch from branded to generic LEV may lead to poor clinical outcomes, with risk of AEs and increased seizure frequency. PMID:21426334

Effectiveness of collaborative care depression treatment in Veterans' Affairs primary care.

PubMed

Hedrick, Susan C; Chaney, Edmund F; Felker, Bradford; Liu, Chuan-Fen; Hasenberg, Nicole; Heagerty, Patrick; Buchanan, Jan; Bagala, Rocco; Greenberg, Diane; Paden, Grady; Fihn, Stephan D; Katon, Wayne

2003-01-01

To compare collaborative care for treatment of depression in primary care with consult-liaison (CL) care. In collaborative care, a mental health team provided a treatment plan to the primary care provider, telephoned patients to support adherence to the plan, reviewed treatment results, and suggested modifications to the provider. In CL care, study clinicians informed the primary care provider of the diagnosis and facilitated referrals to psychiatry residents practicing in the primary care clinic. Patients were randomly assigned to treatment model by clinic firm. VA primary care clinic. One hundred sixty-eight collaborative care and 186 CL patients who met criteria for major depression and/or dysthymia. Hopkins Symptom Checklist (SCL-20), Short Form (SF)-36, Sheehan Disability Scale. Collaborative care produced greater improvement than CL in depressive symptomatology from baseline to 3 months (SCL-20 change scores), but at 9 months there was no significant difference. The intervention increased the proportion of patients receiving prescriptions and cognitive behavioral therapy. Collaborative care produced significantly greater improvement on the Sheehan at 3 months. A greater proportion of collaborative care patients exhibited an improvement in SF-36 Mental Component Score of 5 points or more from baseline to 9 months. Collaborative care resulted in more rapid improvement in depression symptomatology, and a more rapid and sustained improvement in mental health status compared to the more standard model. Mounting evidence indicates that collaboration between primary care providers and mental health specialists can improve depression treatment and supports the necessary changes in clinic structure and incentives.

Optimizing stroke clinical trial design: estimating the proportion of eligible patients.

PubMed

Taylor, Alexis; Castle, Amanda; Merino, José G; Hsia, Amie; Kidwell, Chelsea S; Warach, Steven

2010-10-01

Clinical trial planning and site selection require an accurate estimate of the number of eligible patients at each site. In this study, we developed a tool to calculate the proportion of patients who would meet a specific trial's age, baseline severity, and time to treatment inclusion criteria. From a sample of 1322 consecutive patients with acute ischemic cerebrovascular syndromes, we developed regression curves relating the proportion of patients within each range of the 3 variables. We used half the patients to develop the model and the other half to validate it by comparing predicted vs actual proportions who met the criteria for 4 current stroke trials. The predicted proportion of patients meeting inclusion criteria ranged from 6% to 28% among the different trials. The proportion of trial-eligible patients predicted from the first half of the data were within 0.4% to 1.4% of the actual proportion of eligible patients. This proportion increased logarithmically with National Institutes of Health Stroke Scale score and time from onset; lowering the baseline limits of the National Institutes of Health Stroke Scale score and extending the treatment window would have the greatest impact on the proportion of patients eligible for a stroke trial. This model helps estimate the proportion of stroke patients eligible for a study based on different upper and lower limits for age, stroke severity, and time to treatment, and it may be a useful tool in clinical trial planning.

Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy.

PubMed

Feres, Magda; Gursky, Lauren Christine; Faveri, Marcelo; Tsuzuki, Claudia Ota; Figueiredo, Luciene Cristina

2009-10-01

To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical [professional plaque control (PPC)] or chemical [chlorhexidine rinsing (CHX)] control of supragingival plaque in the treatment of chronic periodontitis. Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and were continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analysed for 38 bacterial species by checkerboard DNA-DNA hybridization. The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing.

Urinary paraben concentrations and in vitro fertilization outcomes among women from a fertility clinic.

PubMed

Mínguez-Alarcón, Lidia; Chiu, Yu-Han; Messerlian, Carmen; Williams, Paige L; Sabatini, Mary E; Toth, Thomas L; Ford, Jennifer B; Calafat, Antonia M; Hauser, Russ

2016-03-01

To explore the relationship between urinary paraben concentrations and IVF outcomes among women attending an academic fertility center. Prospective cohort study. Fertility clinic in a hospital setting. A total of 245 women contributing 356 IVF cycles. None. Quantification of urinary concentrations of parabens by isotope-dilution tandem mass spectrometry, and assessment of clinical endpoints of IVF treatments abstracted from electronic medical records at the academic fertility center. Total and mature oocyte counts, proportion of high-quality embryos, fertilization rates, and rates of implantation, clinical pregnancy, and live births. The geometric means of the urinary concentrations of methylparaben, propylparaben, and butylparaben in our study population were 133, 24, and 1.5 μg/L, respectively. In models adjusted for age, body mass index, race/ethnicity, smoking status, and primary infertility diagnosis, urinary methylparaben, propylparaben, and butylparaben concentrations were not associated with IVF outcomes, specifically total and mature oocyte counts, proportion of high embryo quality, and fertilization rates. Moreover, no significant associations were found between urinary paraben concentrations and rates of implantation, clinical pregnancy, and live births. Urinary paraben concentrations were not associated with IVF outcomes among women undergoing infertility treatments. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Bloom syndrome: a mendelian prototype of somatic mutational disease.

PubMed

German, J

1993-11-01

Spontaneous mutations in human somatic cells occur far more often than normal in individuals with Bloom syndrome. The basis for understanding these mutations and their developmental consequences emerges from examination of BS at the molecular, cellular, and clinical levels. The major clinical feature of BS, proportional dwarfism, as well as its major clinical complication, an exceptionally early emergence of neoplasia of the types and sites that affect the general population, are attributable to the excessive occurrence of mutations in somatic cells. Here, the following aspects of BS are discussed: (i) the BS phenotype; (ii) neoplasia in BS, including the means--the Bloom's Syndrome Registry--by which the significant risk for diverse sites and types of cancer in these patients was revealed; (iii) the biological basis for the cancer proneness of BS; and, finally, (iv) the significance for both basic human biology and clinical medicine of BS as the prototype of somatic mutational disease.

Cognitive bias in clinical practice - nurturing healthy skepticism among medical students.

PubMed

Bhatti, Alysha

2018-01-01

Errors in clinical reasoning, known as cognitive biases, are implicated in a significant proportion of diagnostic errors. Despite this knowledge, little emphasis is currently placed on teaching cognitive psychology in the undergraduate medical curriculum. Understanding the origin of these biases and their impact on clinical decision making helps stimulate reflective practice. This article outlines some of the common types of cognitive biases encountered in the clinical setting as well as cognitive debiasing strategies. Medical educators should nurture healthy skepticism among medical students by raising awareness of cognitive biases and equipping them with robust tools to circumvent such biases. This will enable tomorrow's doctors to improve the quality of care delivered, thus optimizing patient outcomes.

Publication proportions for registered breast cancer trials: before and following the introduction of the ClinicalTrials.gov results database.

PubMed

Asiimwe, Innocent Gerald; Rumona, Dickson

2016-01-01

To limit selective and incomplete publication of the results of clinical trials, registries including ClinicalTrials.gov were introduced. The ClinicalTrials.gov registry added a results database in 2008 to enable researchers to post the results of their trials as stipulated by the Food and Drug Administration Amendment Act of 2007. This study aimed to determine the direction and magnitude of any change in publication proportions of registered breast cancer trials that occurred since the inception of the ClinicalTrials.gov results database. A cross-sectional study design was employed using ClinicalTrials.gov, a publicly available registry/results database as the primary data source. Registry contents under the subcategories 'Breast Neoplasms' and 'Breast Neoplasms, Male' were downloaded on 1 August 2015. A literature search for included trials was afterwards conducted using MEDLINE and DISCOVER databases to determine publication status of the registered breast cancer trials. Nearly half (168/340) of the listed trials had been published, with a median time to publication of 24 months (Q1 = 14 months, Q3 = 42 months). Only 86 trials were published within 24 months of completion. There was no significant increase in publication proportions of trials that were completed before the introduction of the results database compared to those completed after (OR = 1.00, 95 % CI = .61 to 1.63; adjusted OR = 0.84, 95 % CI = .51 to 1.39). Characteristics associated with publication included trial type (observational versus interventional adjusted OR = .28, 95 % CI = .10 to .74) and completion/termination status (terminated versus completed adjusted OR = .22, 95 % CI = .09 to .51). Less than a half of breast cancer trials registered in ClinicalTrials.gov are published in peer-reviewed journals.

Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

PubMed

Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

2016-11-14

The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c < 6.5%. Secondary outcomes were the change in proportion of patients achieving targets for blood pressure, lipid profile, body mass index and waist circumference. Intention to treat analysis was performed for all outcome measures. A generalised estimating equation method was used to account for baseline differences and clustering effect. A total of 888 type 2 diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P < 0.002). Patients who received the EMPOWER-PAR intervention were twice more likely to achieve HbA1c target compared to those in the control group (adjusted OR 2.16, 95% CI 1.34-3.50, P < 0.002). However, there was no significant improvement found in the secondary outcomes. This study demonstrates that the EMPOWER-PAR intervention was effective in improving the primary outcome for type 2 diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

The impact of hyperglycemia on survival in glioblastoma: A systematic review and meta-analysis.

PubMed

Lu, Victor M; Goyal, Anshit; Vaughan, Lachlin S; McDonald, Kerrie L

2018-07-01

In the management of glioblastoma (GBM), there is a considerable predisposition to hyperglycemia due to significant integration of corticosteroid therapy to treat predictable clinical sequelae following diagnosis and treatment. The aim of this study was to quantify effect of hyperglycemia during the management of GBM on overall survival (OS). Searches of seven electronic databases from inception to January 2018 were conducted following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. There were 1475 articles identified for screening. Prognostic hazard ratios (HRs) derived from multivariate regression analysis were extracted, and analyzed using meta-analysis of proportions and linear regression. Six observational studies reporting prognostic HRs in 10 cohorts were included. They described 1481 GBM diagnoses, all surveyed for hyperglycemia during management. Hyperglycemia was found to confer a statistically significant poorer OS outcome (HR, 1.671; p < 0.001). This trend and its significance was not modified by study year, size or proportion of pre-diagnostic diabetes mellitus. Hyperglycemia in GBM is an independent poor prognostic factor for OS. Heterogeneity in clinical course limits inter-study comparability. Future, prospective, randomized studies will validate the findings of this study, and ascertain the potential benefit of more rigorous monitoring for hyperglycemia and glycemic control. Copyright © 2018 Elsevier B.V. All rights reserved.

Impact of the implementation of an evidence-based guideline on diagnostic testing, management, and clinical outcomes for infants with bronchiolitis

PubMed Central

Henao-Villada, Ricardo; Sossa-Briceño, Monica P.; Rodríguez-Martínez, Carlos E.

2016-01-01

Background: Although bronchiolitis poses a significant health problem in low- and middle-income countries (LMICs), to the best of our knowledge, to date it has not been determined whether evidence-based bronchiolitis clinical practice guidelines (CPGs) complemented by standardized educational strategies reduce the use of unnecessary diagnostic tests and medications and improve clinically important outcomes in LMICs. Methods: In an uncontrolled before and after study, we assessed the impact of the implementation of an evidence-based bronchiolitis CPG on physician behavior and the care of infants with bronchiolitis by comparing pre-guideline (March to August 2014) and post-guideline (March to August 2015) use of diagnostic tests and medications through an electronic medical record review in a children’s hospital in Bogota, Colombia. We also sought to assess the impact of the implementation of the CPG on clinically important outcomes such as lengths of stay, hospital admissions, intensive care admissions, and hospital readmissions. Results: Data from 662 cases of bronchiolitis (pre-guideline period) were compared with the data from 703 cases (post-guideline period). On comparing the pre- and post-guideline periods, it was seen that there was a significant increase in the proportion of patients with an appropriate diagnosis and treatment of bronchiolitis (36.4% versus 44.5%, p = 0.003), and there were statistically significant decreases in the use of a hemogram (33.2% versus 26.6%, p=0.010), procalcitonin (3.9% versus 1.6%, p=0.018), nebulized beta-2 agonists (45.6% versus 3.4%, p < 0.001), nebulized anticholinergics (3.3% versus 1.4%, p= 0.029), and nebulized epinephrine (16.2% versus 7.8%, p < 0.001). Likewise, a significant increase in the use of nebulized hypertonic saline was seen (79.6% versus 91.7%, p < 0.001). However, implementation of the CPG for bronchiolitis was not associated with significant changes in clinically important outcomes. Conclusions: The development and implementation of a good quality bronchiolitis CPG is associated with a significant increase in the proportion of cases with an appropriate diagnosis and treatment of the disease in the context of a university-based hospital located in the capital of an LMIC. However, we could not demonstrate an improvement in clinically important outcomes such as any of the bronchiolitis severity parameters. PMID:27492738

Do Online Information Retrieval Systems Help Experienced Clinicians Answer Clinical Questions?

PubMed Central

Westbrook, Johanna I.; Coiera, Enrico W.; Gosling, A. Sophie

2005-01-01

Objective: To assess the impact of clinicians' use of an online information retrieval system on their performance in answering clinical questions. Design: Pre-/post-intervention experimental design. Measurements: In a computer laboratory, 75 clinicians (26 hospital-based doctors, 18 family practitioners, and 31 clinical nurse consultants) provided 600 answers to eight clinical scenarios before and after the use of an online information retrieval system. We examined the proportion of correct answers pre- and post-intervention, direction of change in answers, and differences between professional groups. Results: System use resulted in a 21% improvement in clinicians' answers, from 29% (95% confidence interval [CI] 25.4–32.6) correct pre- to 50% (95% CI 46.0–54.0) post-system use. In 33% (95% CI 29.1–36.9) answers were changed from incorrect to correct. In 21% (95% CI 17.1–23.9) correct pre-test answers were supported by evidence found using the system, and in 7% (95% CI 4.9–9.1) correct pre-test answers were changed incorrectly. For 40% (35.4–43.6) of scenarios, incorrect pre-test answers were not rectified following system use. Despite significant differences in professional groups' pre-test scores [family practitioners: 41% (95% CI 33.0–49.0), hospital doctors: 35% (95% CI 28.5–41.2), and clinical nurse consultants: 17% (95% CI 12.3–21.7; χ2 = 29.0, df = 2, p < 0.01)], there was no difference in post-test scores. (χ2 = 2.6, df = 2, p = 0.73). Conclusions: The use of an online information retrieval system was associated with a significant improvement in the quality of answers provided by clinicians to typical clinical problems. In a small proportion of cases, use of the system produced errors. While there was variation in the performance of clinical groups when answering questions unaided, performance did not differ significantly following system use. Online information retrieval systems can be an effective tool in improving the accuracy of clinicians' answers to clinical questions. PMID:15684126

[Size of lower jaw as an early indicator of skeletal class III development].

PubMed

Stojanović, Zdenka; Nikodijević, Angelina; Udovicić, Bozidar; Milić, Jasmina; Nikolić, Predrag

2008-08-01

Malocclusion of skeletal class III is a complex abnormality, with a characteristic sagital position of the lower jaw in front of the upper one. A higher level of prognatism of the lower jaw in relation to the upper one can be the consequence of its excessive length. The aim of this study was to find the differences in the length of the lower jaw in the children with skeletal class III and the children with normal sagital interjaw relation (skeletal class I) in the period of mixed dentition. After clinical and x-ray diagnostics, profile tele-x-rays of the head were analyzed in 60 examinees with mixed dentition, aged from 6 to 12 years. The examinees were divided into two groups: group 1--the children with skeletal class III and group 2--the children with skeletal class I. The length of the lower jaw, upper jaw and cranial base were measured. The proportional relations between the lengths measured within each group were established and the level of difference in the lengths measured and their proportions between the groups were estimated. No significant difference between the groups was found in the body length, ramus and the total length of the lower jaw. Proportional relation between the body length and the length of the lower jaw ramus and proportional relation between the forward cranial base and the lower jaw body were not significantly different. A significant difference was found in proportional relations of the total length of the lower jaw with the total lengths of cranial base and the upper jaw and proportional relation of the length of the lower and upper jaw body. Of all the analyzed parameters, the following were selected as the early indicators of the development of skeletal class III on the lower jaw: greater total length of the lower jaw, proportional to the total lengths of cranial base and theupper jaw, as well as greater length of the lower jaw body, proportional to the length of the upper jaw body.

Private and Non-Private Disc Herniation Patients: Do they Differ?

PubMed

Gregebo, Birgitta; Dai, Deliang; Schillberg, Birgitta; Baehr, Martin; Nyström, Bo; Taube, Adam

2014-01-01

In the 2006 yearly report from the Swedish National Register for Lumbar Spine Surgery it was claimed that international studies show obvious differences between private and non-private patients with regard to results from back surgery. Therefore our aim was to reveal such possible differences by comparing the two categories of patients at a private clinic. The material comprises 1184 patients operated on for lumbar disc herniation during the period of 1987 to 2007. Basic pre-operative data were obtained from the medical records and follow-up was performed by a questionnaire around 5 years post-operatively. Small but statistically significant differences between private and non-private patients were seen pre-operatively regarding the proportions of a/ men and women in the samples, b/ those with physically demanding jobs, c/ those on sick leave and d/ those with lumbar pain. Over the years the admitted private patients had a decreasing mean duration of symptoms which was not seen in the non-private patients. No apparent differences (n.s.) were seen between the two categories of patients pre-operatively regarding age, presence and level of leg pain or the proportion who smoked. Post-operative improvement in leg and lumbar pain was very similar in private and non-private patients as was satisfaction with the results and the proportion of patients returning to work. Despite small pre-operative differences concerning some variables and a significant difference in symptom duration between private and non-private disc herniation patients, the final clinical results were very similar.

The efficacy of the direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in the pediatric ward of a tertiary medical facility without a pediatric antimicrobial stewardship program.

PubMed

Hoshina, T; Yamamoto, N; Ogawa, M; Nakamoto, T; Kusuhara, K

2017-08-01

Antimicrobial stewardship programs (ASPs) have been introduced in most hospital complexes; however, they are not always useful for pediatric patients. The aim of this study is to investigate the efficacy of direct clinical intervention for infectious diseases by a pediatric infectious disease specialist in a tertiary medical facility without pediatric ASP. This retrospective study included 1,821 patients who were hospitalized in the pediatric ward of a large metropolitan hospital from 2010 to 2015. The clinical course, the use of intravenous antimicrobial agents and the results of a microbiological analysis were compared between the period after the beginning of direct intervention by the specialist (post-intervention period) and the previous period (pre-intervention period). In the post-intervention period, the proportion of the patients who received intravenous antimicrobial agents, the number of antimicrobial agents used for each episode, and the proportion of episodes in which an antimicrobial agent was re-administrated were significantly lower (P = 0.006, P = 0.004, P = 0.036, respectively), and the duration of antimicrobial treatment was significantly shorter (P < 0.001). In addition, narrower spectrum antimicrobial agents were used, and the incidence of meropenem-sensitive Pseudomonas aeruginosa significantly increased (P = 0.037) in the post-intervention period. There was no change of mortality between the two periods. Direct clinical intervention by a pediatric infectious diseases specialist is useful for the treatment of infectious diseases in the pediatric ward of a tertiary medical facility without a pediatric ASP. The creation of a pediatric ASP is recommended in hospital complexes.

Can Low-Cost Strategies Improve Attendance Rates in Brief Psychological Therapy? Double-Blind Randomized Controlled Trial.

PubMed

Delgadillo, Jaime; Moreea, Omar; Murphy, Elizabeth; Ali, Shehzad; Swift, Joshua K

2015-12-01

To assess if telephone text message appointment reminders and orientation leaflets can increase the proportion of patients who attend brief interventions after being assessed as suitable for guided self-help following cognitive behavioral therapy principles. Attendance was operationally defined as having accessed at least 1 therapy appointment. A secondary outcome was the proportion of attenders who completed or dropped out of therapy. After initial assessment, 254 patients with depression and anxiety disorders were randomly assigned to 1 of 3 groups: (a) usual waitlist control, (b) leaflet, (c) leaflet plus text message. Differences in the proportions of patients who started and completed therapy across groups were assessed using chi-square and logistic regression analyses. Overall, 63% of patients in this sample attended therapy. Between-group differences were not significant for attendance, x(2) (2) = 3.94, p = .14, or completion rates, x(2) (2) = 2.98, p = .23. These results were not confounded by demographic or clinical characteristics. Low-cost strategies appear to make no significant difference to therapy attendance and completion rates. © 2015 Wiley Periodicals, Inc.

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

The Long and Short Incubation Periods of Plasmodium vivax Malaria in Korea: The Characteristics and Relating Factors

PubMed Central

Kim, Sun-Ja; Kim, Si-Heon; Jo, Soo-Nam; Gwack, Jin; Youn, Seung-Ki

2013-01-01

Background The cases of Plasmodium vivax malaria in Korea are mixed with long and short incubation periods. This study aims to define clinico-epidemiologic chracteristcs of Plasmodium vivax malaria in Korea. Materials and Methods We selected the civilian cases infected with P. vivax malaria in Korea from the epidemiological investigation data of 2001 to 2010, whose incubation periods could be estimated. The long and short incubation periods were defined by duration of infection and onset time, and the cases were compared by demographic factors and clinical symptom, infection and onset time. The correlation was analyzed between the proportion of cases in the infected region with the long incubation period and meteorological factors along with latitude. Results The length of the mean short and long incubation periods for the cases were 25.5 days and 329.4 days, respectively. The total number of the study subjects was 897, and the number cases of short and long incubation periods was 575 (64.1%) and 322 (35.9%), respectively. The aspect of incubation period showed a significant difference by region of infection; there was a higher proportion of long incubation period infection cases in Gangwon-do than in Gyeonggi-do and Incheon. The proportion of long incubation period cases showed significant correlation with latitude and temperature of August and September of the infected regions. Conclusions Incubation period of P. vivax malaria in Korea showed significant difference by infected region, infection and onset time and the proportion of long incubation period cases showed significant correlation with latitude and meteorological factors of the infected regions. PMID:24265966

Efficacy and safety outcomes in vitamin D supplement users in the fingolimod phase 3 trials.

PubMed

Hongell, Kira; Silva, Diego G; Ritter, Shannon; Meier, Daniela Piani; Soilu-Hänninen, Merja

2018-02-01

Low serum levels of 25-hydroxyvitamin D have been associated with worse outcomes in multiple sclerosis (MS) patients treated with interferon-beta. Association of vitamin D nutrition on the outcomes of other MS therapies has been studied less. Whether patients in the phase 3 fingolimod trials using vitamin D supplements have better clinical, MRI and safety outcomes than non-users. Pooled data from phase 3 FREEDOMS trials was analyzed post hoc. Vitamin D use was defined as 'non-users' (n = 562), 'casual users' (n = 157) and 'daily users' (usage 100% time in the study, n = 110). Expanded Disability Status Scale change from baseline to month 24, and annual relapse rate and proportion of patients with relapses were similar across the vitamin D user groups. Proportion of patients free of new/enlarging T2 lesions significantly favored vitamin D 'daily users' versus 'non-users'. Mean number of lesions were lower and proportion of patients free of gadolinium-enhanced T1-lesions were higher in the 'daily users'. At month 12, percent brain volume change was significantly lower in the 'daily users' versus 'non-users' and remained low at month 24 (non-significant). Incidence of depression was lower for vitamin D 'daily users' (non-significant). We observed improved MRI outcomes on percent brain volume change and proportion of patients free of new/enlarging T2 lesions, and a trend of less depression in the 'daily users' of vitamin D supplement in patients in the FREEDOMS trials.

High prevalence of underweight and undernutrition in Japanese inpatients with schizophrenia: a nationwide survey

PubMed Central

Sugai, Takuro; Suzuki, Yutaro; Yamazaki, Manabu; Shimoda, Kazutaka; Mori, Takao; Ozeki, Yuji; Matsuda, Hiroshi; Sugawara, Norio; Yasui-Furukori, Norio; Minami, Yoshitake; Okamoto, Kurefu; Sagae, Toyoaki; Someya, Toshiyuki

2015-01-01

Objectives To clarify the prevalence of underweight and overweight/obesity, and laboratory data for nutritional status in Japanese outpatients and inpatients with schizophrenia. Design Cross-sectional study. Setting A questionnaire conducted in inpatient and outpatient facilities in Japan. Participants The population of adult patients with schizophrenia in Japan (N=23 116). Main outcome measures The prevalence of underweight and undernutrition in Japanese inpatients and outpatients with schizophrenia. Results We conducted a large-scale investigation of the prevalence of underweight and undernutrition in 520 outpatient facilities and 247 inpatient facilities belonging to the Japan Psychiatric Hospitals Association between January 2012 and July 2013. There were 7655 outpatients and 15 461 inpatients with schizophrenia. There was a significant difference in the distribution of three body mass index levels between outpatients and inpatients (p<0.001). The proportion of underweight inpatients with schizophrenia was significantly higher than that among outpatients (p<0.001). Age-specific analysis revealed that the proportion of underweight individuals aged ≥40 years was higher in inpatients than in outpatients and in the general Japanese population. The proportion of individuals with hypocholesterolaemia was significantly higher in inpatients with schizophrenia than in outpatients (p<0.001). There was a significant difference in the severity of underweight between outpatients and inpatients with schizophrenia; the proportion of severe underweight in inpatients was twofold higher than in outpatients. Conclusions The prevalence of underweight and undernutrition in Japanese inpatients with schizophrenia was higher than in outpatients and the general population. Therefore, the physical risk of inpatients should be carefully considered in clinical practice. PMID:26656016

The Long and Short Incubation Periods of Plasmodium vivax Malaria in Korea: The Characteristics and Relating Factors.

PubMed

Kim, Sun-Ja; Kim, Si-Heon; Jo, Soo-Nam; Gwack, Jin; Youn, Seung-Ki; Jang, Jae-Yeon

2013-06-01

The cases of Plasmodium vivax malaria in Korea are mixed with long and short incubation periods. This study aims to define clinico-epidemiologic chracteristcs of Plasmodium vivax malaria in Korea. We selected the civilian cases infected with P. vivax malaria in Korea from the epidemiological investigation data of 2001 to 2010, whose incubation periods could be estimated. The long and short incubation periods were defined by duration of infection and onset time, and the cases were compared by demographic factors and clinical symptom, infection and onset time. The correlation was analyzed between the proportion of cases in the infected region with the long incubation period and meteorological factors along with latitude. The length of the mean short and long incubation periods for the cases were 25.5 days and 329.4 days, respectively. The total number of the study subjects was 897, and the number cases of short and long incubation periods was 575 (64.1%) and 322 (35.9%), respectively. The aspect of incubation period showed a significant difference by region of infection; there was a higher proportion of long incubation period infection cases in Gangwon-do than in Gyeonggi-do and Incheon. The proportion of long incubation period cases showed significant correlation with latitude and temperature of August and September of the infected regions. Incubation period of P. vivax malaria in Korea showed significant difference by infected region, infection and onset time and the proportion of long incubation period cases showed significant correlation with latitude and meteorological factors of the infected regions.

Clinical Characteristics and Outcomes of Late-Onset BK Virus Nephropathy in Kidney and Kidney-Pancreas Transplant Recipients.

PubMed

Imlay, Hannah; Whitaker, Kathryn; Fisher, Cynthia E; Limaye, Ajit P

2018-05-29

BK virus nephropathy (BKPyVAN) is a major complication in kidney transplant recipients (KTR) and typically occurs within 1 year of transplant. Guidelines vary in recommendations for BKPyV screening beyond 1 year. A systematic characterization of risk factors and outcomes of late-onset (>1 year) BKPyVAN has not previously been reported. We retrospectively compared characteristics and outcomes of early- (<1 year) and late-onset BKPyVAN (definitive [biopsy-confirmed] or presumptive [plasma BKPyV >10,000 copies/mL]) in a cohort of 671 KTR and simultaneous kidney-pancreas transplant (SPK) recipients between 2008 and 2013 at a single US transplant center. Proportions were compared using Chi square or Fisher's exact test with p < 0.05 considered significant. BKPyVAN was diagnosed in 96 (14.3%) patients (proven 16.7%, presumptive 83.3%): 79 (82.3%) early- and 17 (17.7%) late-onset. The proportion with late-onset BKPyVAN was significantly higher among SPK than KTR (4 of 7 [57.1%] vs 13 of 89 [14.6%], p=0.017). Late-onset represented "de novo" infection (no BKPyV detection within the first year) in 14 (82.4%) and progression of earlier lower-grade BKPyV reactivation in 3 (17.6%). Clinical outcomes were similar for early- and late-onset BKPyVAN (p>0.05 all comparisons). In a pooled analysis of prior studies of BKPyVAN in SPK recipients, 62.9% (17 of 27) were late-onset. A significant proportion of BKPyVAN is late-onset, especially among SPK recipients, and supports a longer duration of BKPyV monitoring for SPK recipients than recommended in some guidelines. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A high proportion of cells carrying trisomy 12 is associated with a worse outcome in patients with chronic lymphocytic leukemia.

PubMed

González-Gascón Y Marín, Isabel; Hernández-Sánchez, María; Rodríguez-Vicente, Ana-Eugenia; Sanzo, Carmen; Aventín, Anna; Puiggros, Anna; Collado, Rosa; Heras, Cecilia; Muñoz, Carolina; Delgado, Julio; Ortega, Margarita; González, María-Teresa; Marugán, Isabel; de la Fuente, Ignacio; Recio, Isabel; Bosch, Francesc; Espinet, Blanca; González, Marcos; Hernández-Rivas, Jesús-María; Hernández, José-Ángel

2016-06-01

The prognosis of chronic lymphocytic leukemia (CLL) patients displaying trisomy 12 (+12) remains unclear. In this study, we analyzed the influence of the proportion of cells with +12, and other clinical and biologic factors, in time to first therapy (TTFT) and overall survival (OS), in 289 patients diagnosed with CLL carrying +12. Median OS was 129 months. One hundred seventy-four patients (60.2%) presented +12 in <60% of cells. TTFT and OS for this subgroup were longer than for the subgroup with +12 in ≥60% of cells, with a median TTFT of 49 months (CI95%, 39-58) vs 30 months (CI95%, 22-38) (P = 0.001); and a median OS of 159 months (CI95%, 119-182), vs 96 months (CI95%, 58-134) (P = 0.015). Other factors associated with a shorter TTFT were: Binet stage, B symptoms, lymphadenopathy, splenomegaly, high lymphocyte count, 11q-, high β2 microglobulin, and high LDH. In the multivariate analysis, clinical stage, +12 in ≥60% of cells, high lymphocyte count, B symptoms, and 11q- in addition, resulted of significance in predicting shorter TTFT. Significant variables for OS were: Binet stage, lymphadenopathy, splenomegaly, high LDH, high β2 microglobulin, 11q-, and CD38. In the multivariate analysis, only Binet stage, 11q-, and high β2microglobulin significantly predicted shorter OS. CLL with +12 entails a heterogeneous group with intermediate prognosis. However, a high proportion of cells carrying +12 separates a subgroup of patients with poor outcome. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Orthotopic sigmoid vs. ileal neobladders in Japanese patients: a comparative assessment of complications, functional outcomes, and quality of life.

PubMed

Miyake, Hideaki; Furukawa, Junya; Sakai, Iori; Muramaki, Mototsugu; Yamashita, Masuo; Inoue, Taka-Aki; Fujisawa, Masato

2013-10-01

To compare the clinical outcomes of sigmoid and ileal neobladders (NBs) created following radical cystectomy. This study included 90 and 144 Japanese patients undergoing radical cystectomy and orthotopic NB reconstruction with a sigmoid and ileal segment, respectively. Postoperative clinical outcomes between the sigmoid and ileal NB groups (SNBG and INBG) were compared. In this series, 110 early and 51 late complications occurred in 71 and 41 patients, respectively; however, there was no significant difference in the incidence of complications between SNBG and INBG. At 1 year postoperatively, there were no significant differences in the proportion of spontaneous voiders and the continence status between these 2 groups; however, despite the lack of significant differences in the maximal flow rate and voided volume, the post-void residual in SNBG was significantly smaller than that in INBG. Voiding functional outcomes at 5 years postoperatively were also obtained from 28 and 49 in SNBG and INBG, respectively. Although there were no significant changes in the functional outcomes in SNBG, the proportion of spontaneous voiders and post-void residual in INBG at 5 years postoperatively were significantly poorer than those at 1 year postoperatively. Furthermore, the postoperative health-related quality of life assessed by a Short-Form 36 survey did not show any significant differences in all 8 scores between these 2 groups. Both types of NB reconstruction resulted in comparatively satisfactory outcomes; however, the voiding function, particularly that on long-term follow-up, in SNBG appeared to be more favorable than that in INBG. Copyright © 2013 Elsevier Inc. All rights reserved.

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

Comparison of Women in Department Leadership in Obstetrics and Gynecology With Those in Other Specialties.

PubMed

Hofler, Lisa G; Hacker, Michele R; Dodge, Laura E; Schutzberg, Rose; Ricciotti, Hope A

2016-03-01

To compare the representation of women in obstetrics and gynecology department-based leadership to other clinical specialties while accounting for proportions of women in historical residency cohorts. This was a cross-sectional observational study. The gender of department-based leaders (chair, vice chair, division director) and residency program directors was determined from websites of 950 academic departments of anesthesiology, diagnostic radiology, general surgery, internal medicine, neurology, obstetrics and gynecology, pathology, pediatrics, and psychiatry. Each specialty's representation ratio-proportion of leadership roles held by women in 2013 divided by proportion of residents in 1990 who were women-and 95% confidence interval (CI) were calculated. A ratio of 1 indicates proportionate representation. Women were significantly underrepresented among chairs for all specialties (ratios 0.60 or less, P≤.02) and division directors for all specialties except anesthesiology (ratio 1.13, 95% CI 0.87-1.46) and diagnostic radiology (ratio 0.97, 95% CI 0.81-1.16). The representation ratio for vice chair was below 1.0 for all specialties except anesthesiology; this finding reached statistical significance only for pathology, pediatrics, and psychiatry. Women were significantly overrepresented as residency program directors in general surgery, anesthesiology, obstetrics and gynecology, and pediatrics (ratios greater than 1.19, P≤.046). Obstetrics and gynecology and pediatrics had the highest proportions of residents in 1990 and department leaders in 2013 who were women. Despite having the largest proportion of leaders who were women, representation ratios demonstrate obstetrics and gynecology is behind other specialties in progression of women to departmental leadership. Women's overrepresentation as residency program directors raises concern because education-based academic tracks may not lead to major leadership roles.

Epidemiology of antibiotic-resistant wound infections from six countries in Africa

PubMed Central

Bebell, Lisa M; Meney, Carron; Valeri, Linda

2017-01-01

Introduction Little is known about the antimicrobial susceptibility of common bacteria responsible for wound infections from many countries in sub-Saharan Africa. Methods We performed a retrospective review of microbial isolates collected based on clinical suspicion of wound infection between 2004 and 2016 from Mercy Ships, a non-governmental organisation operating a single mobile surgical unit in Benin, Congo, Liberia, Madagascar, Sierra Leone and Togo. Antimicrobial resistant organisms of interest were defined as methicillin-resistant Staphylococcus aureus (MRSA) or Enterobacteriaceae resistant to third-generation cephalosporins. Generalised mixed-effects models accounting for repeated isolates in a patient, potential clustering by case mix for each field service, age, gender and country were used to test the hypothesis that rates of antimicrobial resistance differed between countries. Results 3145 isolates from repeated field services in six countries were reviewed. In univariate analyses, the highest proportion of MRSA was found in Benin (34.6%) and Congo (31.9%), while the lowest proportion was found in Togo (14.3%) and Madagascar (14.5%); country remained a significant predictor in multivariate analyses (P=0.002). In univariate analyses, the highest proportion of third-generation cephalosporin-resistant Enterobacteriaceae was found in Benin (35.8%) and lowest in Togo (14.3%) and Madagascar (16.3%). Country remained a significant predictor for antimicrobial-resistant isolates in multivariate analyses (P=0.009). Conclusion A significant proportion of isolates from wound cultures were resistant to first-line antimicrobials in each country. Though antimicrobial resistance isolates were not verified in a reference laboratory and these data may not be representative of all regions of the countries studied, differences in the proportion of antimicrobial-resistant isolates and resistance profiles between countries suggest site-specific surveillance should be a priority and local antimicrobial resistance profiles should be used to guide empiric antibiotic selection. PMID:29588863

Clinical effect of reducing curing times with high-intensity LED lights

PubMed Central

Ward, Justin D.; Wolf, Bethany J.; Leite, Luis P.; Zhou, Jing

2016-01-01

Objective To evaluate the clinical performance of brackets cured with a high-intensity, light-emitting diode (LED) with a shorter curing time. Materials and Methods Thirty-four patients and a total of 680 brackets were examined using a randomized split-mouth design. The maxillary right and mandibular left quadrants were cured for 6 seconds with a high-intensity LED light (3200 mW/cm2) and the maxillary left and mandibular right quadrants were cured for 20 seconds with a standard-intensity LED light (1200 mW/cm2). Alternating patients had the quadrants inverted for the curing protocol. The number and date of each first-time bracket failure was recorded from 199 to 585 days posttreatment. Results The bracket failure rate was 1.18% for both curing methods. The proportion of bracket failure was not significantly different between curing methods (P = 1.000), genders (P = 1.000), jaws (P = .725), sides (P = .725), or quadrants (P = .547). Posterior teeth exhibited a greater proportion of failures (2.21%) relative to anterior teeth (0.49%), although the difference was not statistically significant (P = .065). Conclusions No difference was found in bond failure rates between the two curing methods. Both methods showed bond failure rates low enough to be considered clinically sufficient. The high-intensity LED light used with a shorter curing time may be considered an advantage due to the reduced chair time. PMID:25760887

Overcoming barriers to HIV testing: preferences for new strategies among clients of a needle exchange, a sexually transmitted disease clinic, and sex venues for men who have sex with men.

PubMed

Spielberg, Freya; Branson, Bernard M; Goldbaum, Gary M; Lockhart, David; Kurth, Ann; Celum, Connie L; Rossini, Anthony; Critchlow, Cathy W; Wood, Robert W

2003-03-01

To determine strategies to overcome barriers to HIV testing among persons at risk. We developed a survey that elicited testing motivators, barriers, and preferences for new strategies among 460 participants at a needle exchange, three sex venues for men who have sex with men, and a sexually transmitted disease clinic. Barriers to testing included factors influenced by individual concern (fear and discrimination); by programs, policies, and laws (named reporting and inability to afford treatment); and by counseling and testing strategies (dislike of counseling, anxiety waiting for results, and venipuncture). The largest proportions of participants preferred rapid testing strategies, including clinic-based testing (27%) and home self-testing (20%); roughly equal proportions preferred oral fluid testing (18%), urine testing (17%), and standard blood testing (17%). One percent preferred home specimen collection. Participants who had never tested before were significantly more likely to prefer home self-testing compared with other strategies. Blacks were significantly more likely to prefer urine testing. Strategies for improving acceptance of HIV counseling and testing include information about access to anonymous testing and early treatment. Expanding options for rapid testing, urine testing, and home self-testing; providing alternatives to venipuncture; making pretest counseling optional; and allowing telephone results disclosure may encourage more persons to learn their HIV status.

The prevalence and impact of depression in self-referred clients attending an employee assistance program.

PubMed

Lam, Raymond W; Wolinsky, Debra; Kinsella, Cynthia; Woo, Cindy; Cayley, Paula M; Walker, Anne B

2012-11-01

To determine the prevalence and characteristics of clients with depression attending an employee assistance program (EAP). Anonymized data were obtained from 10,794 consecutive clients, including 9105 employees, self-referred to PPC Canada, a large, external EAP. Assessment measures included the self-rated nine-item Patient Health Questionnaire (PHQ-9). Clinical characteristics of depressed clients (PHQ-9 score ≥ 10) were compared with those of nondepressed clients. Thirty-seven percent of the employee sample met PHQ-9 criteria for clinically significant depression. Compared with clients without depression, they had significantly higher rates of anxiety, psychotropic medication use, problem substance use, global problems with functioning, absenteeism, impairment in work-related tasks, and low job satisfaction. A large proportion of EAP clients were clinically depressed with associated negative effects on personal and occupational functioning.

Significance of hyphae formation in virulence of Candida tropicalis and transcriptomic analysis of hyphal cells.

PubMed

Jiang, Cen; Li, Zhen; Zhang, Lihua; Tian, Yuan; Dong, Danfeng; Peng, Yibing

2016-11-01

Recently, the proportion of Candida tropicalis in clinical isolates has significantly increased. Some C. tropicalis strains colonize the skin or mucosal surfaces as commensals; others trigger invasive infection. To date, the pathogenicity of C. tropicalis has not been thoroughly researched. This study reports several virulence factors, including biofilm and hyphae formation, proteinase, phospholipase, lipase and hemolytic activity, in 52 clinical isolates of C. tropicalis collected from five hospitals in four provinces of China. Some C. tropicalis tended to produce more hyphae than others in the same circumstance. Six C. tropicalis strains with different morphologies were injected into mice via the tail vein, and the survival proportions and fungal burdens of the strains were evaluated. Hyphal production by C. tropicalis was associated with stronger virulence. RNA sequencing revealed that C. tropicalis with more hyphae up-regulated several genes involved in morphological differentiation and oxidative response, including IF2, Atx1, and Sod2. It appears that hyphal formation plays a vital role in the pathogenicity of C. tropicalis, and interacts with the oxidative stress response to strengthen the organism's virulence. Copyright © 2016 Elsevier GmbH. All rights reserved.

Hospital attendance patterns in long term survivors of cancer

PubMed Central

Johnson, R; Horne, B; Feltbower, R; Butler, G; Glaser, A

2004-01-01

Aims: To identify attendance patterns in a childhood cancer long term follow up clinic, in order to inform decision making strategies for efficient, cost effective local and national surveillance of survivors. Methods: Cross-sectional review of 385 individuals >5 years from completion of cancer therapy in childhood or adolescence, attending a regional paediatric oncology and haematology centre. Results: Attenders were younger than non-attenders in the <18 age group; no differences were found for ⩾18 year age group. Those attending clinic were more recently off treatment; no significant difference existed for those <7 years from completion of therapy. A greater proportion of attenders were in the most affluent socioeconomic groups with a greater proportion of non-attenders in the lower groups. Those in full time education or training were more likely to attend and those unemployed were less likely. Multiple regression analysis confirmed a significant trend in reduction in attendance with increasing social deprivation, and that attenders were more than twice as likely to be in full time education or training. Conclusions: Following cancer treatment in childhood and adolescence, attendance at long term follow up programmes is determined by social factors including education, employment, and deprivation. PMID:15033851

Red blood cell alloimmunization in transfused patients in sub-Saharan Africa: A systematic review and meta-analysis.

PubMed

Ngoma, Alain M; Mutombo, Paulin B; Ikeda, Kazuhiko; Nollet, Kenneth E; Natukunda, Bernard; Ohto, Hitoshi

2016-04-01

Previous studies of Sub-Saharan Africans show significant alloimmunization to red blood cell (RBC) antigens, but country-specific data are limited. Thus, the aim of this study was to estimate, by meta-analysis, the overall proportion of red blood cell alloantibodies among transfused patients. We systematically searched Medline, Embase, and the Africa-Wide Information database to identify relevant studies in any language. Case reports, comments, letters, conference abstracts, editorials, and review articles were excluded. Of the 269 potentially relevant articles, 11 studies fulfilled our selection criteria. Overall proportions of alloimmunization were 6.7 (95% CI: 5.7, 7.8) per 100 transfused patients. With regard to antibody specificity, among clinically significant antibodies, anti-E ranked as the most common, followed by anti-K, anti-C and anti-D. Meta-analysis of available literature quantifies and qualifies the clinical challenge of RBC alloimmunization among transfused patients in Sub-Saharan Africa. These results should drive policy decisions in favour of routine testing of RBC antigens and irregular antibodies for transfused patients as a standard of care throughout Sub-Saharan Africa. Copyright © 2015 Elsevier Ltd. All rights reserved.

Influenza vaccination program for elderly outpatients.

PubMed

Knoell, K R; Leeds, A L

1991-02-01

The effect of pharmacist interventions on the rate at which elderly outpatients were offered influenza vaccination was studied. Pharmacists at a university-based ambulatory-care facility reviewed the medical records of a random sample of control patients over the age of 65 who had been seen during the influenza vaccination months in 1987 or 1988 or both years. The purpose was to estimate the percentage of patients who had been documented as being offered influenza vaccination. In 1989 an intervention program was undertaken consisting of inservice presentations to the facility's nursing staff, dissemination of influenza information sheets to patients upon check-in, placement of wall posters, placement of reminders in patient charts, and institution and advertisement of a vaccination clinic. At the end of the 1989 vaccination season, the records of a random sample of intervention group patients were reviewed to determine the proportion of patients who had been offered influenza virus vaccine. Of the 280 control group patients, 47% were offered influenza vaccination during 1987 and 1988. A significantly higher proportion of the 153 intervention group patients, 71%, was offered influenza vaccine during 1989. A combination of pharmacist-initiated interventions significantly increased the number of elderly patients who were offered vaccinations during scheduled clinic visits.

What Are Women Told When Requesting Family Planning Services at Clinics Associated with Catholic Hospitals? A Mystery Caller Study.

PubMed

Guiahi, Maryam; Teal, Stephanie B; Swartz, Maryke; Huynh, Sandy; Schiller, Georgia; Sheeder, Jeanelle

2017-12-01

Catholic Church directives restrict family planning service provision at Catholic health care institutions. It is unclear whether obstetrics and gynecology clinics that are owned by or have business affiliations with Catholic hospitals offer family planning appointments. Mystery callers phoned 144 clinics nationwide that were found on Catholic hospital websites between December 2014 and February 2016, and requested appointments for birth control generally, copper IUD services specifically, tubal ligation and abortion. Chi-square and Fisher's exact tests assessed potential correlates of appointment availability, and multivariable logistic regressions were computed if bivariate testing suggested multiple correlates. Although 95% of clinics would schedule birth control appointments, smaller proportions would schedule appointments for copper IUDs (68%) or tubal ligation (58%); only 2% would schedule an abortion. Smaller proportions of Catholic-owned than of Catholic-affiliated clinics would schedule appointments for birth control (84% vs. 100%), copper IUDs (4% vs. 97%) and tubal ligation (29% vs. 72%); for birth control and copper IUD services, no other clinic characteristics were related to appointment availability. Multivariable analysis confirmed that tubal ligation appointments were less likely to be offered at Catholic-owned than at Catholic-affiliated clinics (odds ratio. 0.1); location and association with one of the top 10 Catholic health care systems also were significant. Adherence to church directives is inconsistent at Catholic-associated clinics. Women visiting such clinics who want highly effective methods may need to rely on less effective methods or delay method uptake while seeking services elsewhere. Copyright © 2017 by the Guttmacher Institute.

Evaluation of the Effectiveness of an Alar Transfixion Suture for the Correction of a Vestibular Web and Alar-Facial Groove: A Photogrammetric Analysis.

PubMed

Han, Kihwan; Oh, Sangho; Choi, Jaehoon; Park, Sang Woo

2018-05-01

Alar transfixion sutures are commonly used for vestibular web correction. The purpose of this study was to evaluate the long-term results of the use of alar transfixion sutures in patients with a unilateral cleft lip nasal deformity using photogrammetric analysis. The study included 42 patients who were divided into child and adult groups. A total of 4 measurement items were evaluated from a basal view by photogrammetry using standardized clinical photographic techniques preoperatively, immediately postoperatively, 3 months postoperatively, and 6 months postoperatively. When the preoperative and last postoperative values were compared, no significant changes in any measurement items were noted in the adult group. In the child group, the proportional index (the ratio of the cleft side to the noncleft side) of the alar slope line inclination was significantly increased, but other measurement items showed no significant change. When the measurement items were compared between time points, no significant changes in any measurement items were noted in the adult group. In the child group, the proportional indexes of the alar length, the width between the subnasale and the alare, and the webbing degree were significantly decreased immediately postoperatively compared with the preoperative values. However, these significant changes were diminished at 3 months postoperatively. The proportional index of the alar slope line inclination was significantly increased at 3 months postoperatively compared with the preoperative value, but the significant change was diminished at 6 months postoperatively. The alar transfixion suture procedure is not effective for correcting a vestibular web and alar-facial groove.

MRI outcomes with cladribine tablets for multiple sclerosis in the CLARITY study.

PubMed

Comi, Giancarlo; Cook, Stuart D; Giovannoni, Gavin; Rammohan, Kottil; Rieckmann, Peter; Sørensen, Per Soelberg; Vermersch, Patrick; Hamlett, Anthony C; Viglietta, Vissia; Greenberg, Steven J

2013-04-01

We herein provide a comprehensive assessment of magnetic resonance imaging (MRI) outcomes from CLARITY, a 96-week, double-blind study demonstrating significant clinical and MRI improvements in patients with relapsing-remitting multiple sclerosis (RRMS) treated with cladribine tablets. Patients with RRMS were randomized 1:1:1 to annual short-course therapy with cladribine tablets cumulative dose 3.5 or 5.25 mg/kg or placebo. MRI endpoints included mean number of T1 gadolinium-enhancing (Gd+), active T2 and combined unique (CU) lesions/patient/scan. MRI-measured disease activity was significantly reduced in both cladribine tablets groups versus placebo. The proportion of patients with no active lesions at study end was: T1 Gd+ lesions: 86.8 and 91.0 versus 48.3 % (p < 0.001); active T2 lesions: 61.7 and 62.5 versus 28.4 % (p < 0.001); CU lesions: 59.6 and 60.7 versus 26.1 % (p < 0.001). Clinically meaningful and significant reductions in active lesion counts and increases in proportions of active lesion-free patients were achieved consistently in cladribine tablet groups when data were stratified by baseline disease characteristics. For example, the percentage of patients who remained lesion-free over the study was significantly greater in cladribine tablet groups than in the placebo group for all lesion types regardless of relapse category at baseline (p < 0.001 for all analyses of patients with ≤1 or 2 relapses; p ≤ 0.022 for analyses of patients with ≥3 relapses). MRI-measured disease activity was greatly reduced by both doses of cladribine tablets, with consistent effect across clinically relevant patient populations. These findings add to our scientific understanding of the neurological impact of this therapeutic modality in patients with RRMS.

Solid Lymph Nodes as an Imaging Biomarker for Risk Stratification in Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma.

PubMed

Rath, T J; Narayanan, S; Hughes, M A; Ferris, R L; Chiosea, S I; Branstetter, B F

2017-07-01

Human papillomavirus-related oropharyngeal squamous cell carcinoma is associated with cystic lymph nodes on CT and has a favorable prognosis. A subset of patients with aggressive disease experience treatment failure. Our aim was to determine whether the extent of cystic lymph node burden on staging CT can serve as an imaging biomarker to predict treatment failure in human papillomavirus-related oropharyngeal squamous cell carcinoma. We identified patients with human papilloma virus-related oropharyngeal squamous cell carcinoma and staging neck CTs. Demographic and clinical variables were recorded. We retrospectively classified the metastatic lymph node burden on CT as cystic or solid and assessed radiologic extracapsular spread. Biopsy, subsequent imaging, or clinical follow-up was the reference standard for treatment failure. The primary end point was disease-free survival. Cox proportional hazard regression analyses of clinical, demographic, and anatomic variables for treatment failure were performed. One hundred eighty-three patients were included with a mean follow-up of 38 months. In univariate analysis, the following variables had a statistically significant association with treatment failure: solid-versus-cystic lymph nodes, clinical T-stage, clinical N-stage, and radiologic evidence of extracapsular spread. The multivariate Cox proportional hazard model resulted in a model that included solid-versus-cystic lymph nodes, T-stage, and radiologic evidence of extracapsular spread as independent predictors of treatment failure. Patients with cystic nodal metastasis at staging had significantly better disease-free survival than patients with solid lymph nodes. In human papilloma virus-related oropharyngeal squamous cell carcinoma, patients with solid lymph node metastases are at higher risk for treatment failure with worse disease-free survival. Solid lymph nodes may serve as an imaging biomarker to tailor individual treatment regimens. © 2017 by American Journal of Neuroradiology.

Effect of Performance Deficiencies on Graduation and Board Certification Rates: A 10-Year Multicenter Study of Anesthesiology Residents

PubMed Central

Turner, Judi A.; Fitzsimons, Michael G.; Pardo, Manuel C.; Hawkins, Joy L.; Huang, Yue Ming; Rudolph, Maria D. D.; Keyes, Mary A.; Howard-Quijano, Kimberly J.; Naim, Natale Z.; Buckley, Jack C.; Grogan, Tristan R.; Steadman, Randolph H.

2016-01-01

Background This multi-center, retrospective study was conducted to determine how resident performance deficiencies affect graduation and board certification. Methods Primary documents pertaining to resident performance were examined over a 10-year period at four academic anesthesiology residencies. Residents entering training between 2000 and 2009 were included, with follow-up through February 2016. Residents receiving actions by the programs’ Clinical Competency Committee were categorized by the area of deficiency and compared to peers without deficiencies. Results A total of 865 residents were studied (range: 127–275 per program). Of these, 215 residents received a total of 405 actions from their respective Clinical Competency Committee. Among those who received an action compared to those who did not, the proportion graduating differed (93% versus 99%, respectively, P<0.001), as did the proportion achieving board certification (89% versus 99%, respectively, P<0.001). When a single deficiency in an Essential Attribute (e.g., ethical, honest, respectful behavior; absence of impairment) was identified, the proportion graduating dropped to 55%. When more than three Accreditation Council for Graduate Medical Education core competencies were deficient, the proportion graduating also dropped significantly. Conclusions Overall graduation and board certification rates were consistently high in residents with no, or isolated, deficiencies. Residents deficient in an Essential Attribute, or multiple competencies, are at high risk of not graduating or achieving board certification. More research is needed on the effectiveness and selective deployment of remediation efforts, particularly for high-risk groups. PMID:27119434

Effect of Performance Deficiencies on Graduation and Board Certification Rates: A 10-yr Multicenter Study of Anesthesiology Residents.

PubMed

Turner, Judi A; Fitzsimons, Michael G; Pardo, Manuel C; Hawkins, Joy L; Huang, Yue Ming; Rudolph, Maria D D; Keyes, Mary A; Howard-Quijano, Kimberly J; Naim, Natale Z; Buckley, Jack C; Grogan, Tristan R; Steadman, Randolph H

2016-07-01

This multicenter, retrospective study was conducted to determine how resident performance deficiencies affect graduation and board certification. Primary documents pertaining to resident performance were examined over a 10-yr period at four academic anesthesiology residencies. Residents entering training between 2000 and 2009 were included, with follow-up through February 2016. Residents receiving actions by the programs' Clinical Competency Committee were categorized by the area of deficiency and compared to peers without deficiencies. A total of 865 residents were studied (range: 127 to 275 per program). Of these, 215 residents received a total of 405 actions from their respective Clinical Competency Committee. Among those who received an action compared to those who did not, the proportion graduating differed (93 vs. 99%, respectively, P < 0.001), as did the proportion achieving board certification (89 vs. 99%, respectively, P < 0.001). When a single deficiency in an Essential Attribute (e.g., ethical, honest, respectful behavior; absence of impairment) was identified, the proportion graduating dropped to 55%. When more than three Accreditation Council for Graduate Medical Education Core Competencies were deficient, the proportion graduating also dropped significantly. Overall graduation and board certification rates were consistently high in residents with no, or isolated, deficiencies. Residents deficient in an Essential Attribute, or multiple competencies, are at high risk of not graduating or achieving board certification. More research is needed on the effectiveness and selective deployment of remediation efforts, particularly for high-risk groups.

Longitudinal study of objective and subjective cognitive performance and psychological distress in OEF/OIF Veterans with and without traumatic brain injury.

PubMed

Donnelly, Kerry; Donnelly, James P; Warner, Gary C; Kittleson, C James; King, Paul R

2018-04-01

To describe changes in post-deployment objective and subjective cognitive performance in combat Veterans over 18 months, relative to traumatic brain injury (TBI) status and psychological distress. This prospective cohort study examined 500 Veterans from Upstate New York at four time points, six months apart. TBI status was determined by a structured clinical interview. Neuropsychological instruments focused on attention, memory, and executive functions. Subjective cognitive complaints were assessed with the Neurobehavioral Symptom Inventory (NSI). A psychological distress composite included measures of post-traumatic stress disorder (PTSD), depression, and generalized anxiety. Forty-four percent of the sample was found to have sustained military-related TBI, 97% of which were classified as mild (mTBI), with a mean time since injury of 41 months. Veterans with TBI endorsed moderate cognitive symptoms on the NSI. In contrast to these subjective complaints, mean cognitive test performance was within normal limits at each time point in all domains, regardless of TBI status. Multilevel models examined effects of TBI status, time, and psychological distress. Psychological distress was a strong predictor of all cognitive domains, especially the subjective domain. Substantial proportions of both TBI+ and TBI- groups remained in the clinically significant range at the initial and final assessment for all three distress measures, but the TBI+ group had higher proportions of clinically significant cases. Objective cognitive performance was generally within normal limits for Veterans with mTBI across all assessments. Psychological distress was elevated and significantly related to both objective and subjective cognitive performance.

A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder.

PubMed

Amsterdam, Jay D; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

2009-08-01

We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate generalized anxiety disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Sixty-one outpatients with mild to moderate GAD were enrolled, and 57 were randomized to either double-blind chamomile extract (n = 28) or placebo therapy (n = 29) for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory, Psychological Well Being, and Clinical Global Impression Severity scores and the proportion of patients with 50% reduction or more in baseline HAM-A score. We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (P = 0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or 3 adverse events or more was not significantly different between groups (P = 0.417). This is the first controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations.

Systematic kidney disease management in a population with diabetes mellitus: turning the tide of kidney failure.

PubMed

Rayner, Hugh C; Hollingworth, Lee; Higgins, Robert; Dodds, Simon

2011-10-01

A significant proportion of patients with diabetes mellitus do not get the benefit of treatment that would reduce their risk of progressive kidney disease and reach a nephrologist once significant loss of kidney function has already occurred. Systematic disease management of patients with diabetes and kidney disease. Diverse population (approximately 800,000) in and around Birmingham, West Midlands, UK. Number of outpatient appointments, estimated glomerular filtration rate (eGFR) at first contact with nephrologist, number of patients starting kidney replacement therapy (KRT) and mode of KRT at start. Identification of patients with low or deteriorating trend in eGFR from weekly database review, specialist diabetes-kidney clinic, self-management of blood pressure and transfer to multidisciplinary clinic >12 months before end-stage kidney disease. New patients increased from 62 in 2003 to 132 in 2010; follow-ups fell from 251 to 174. Median eGFR at first clinic visit increased from 28.8 ml/min/1.73 m(2) (range 6.1-67.0) in 2000/2001 to 35.0 (11.1-147.5) in 2010 (p<0.006). In 2010, the number of patients starting KRT fell 30% below the projected activity using 1993-2003 data as baseline (p<0.003). The proportion starting KRT with either a kidney transplant, peritoneal dialysis or haemodialysis via an arteriovenous fistula increased from 26% in 2000 to 55% in 2010. Systematic disease management across a large population significantly improves patient outcomes, increases the productivity of a specialist service and could reduce healthcare costs compared with the current model of care.

Lesbian, gay, bisexual, transgender content on reproductive endocrinology and infertility clinic websites.

PubMed

Wu, Harold Y; Yin, Ophelia; Monseur, Brent; Selter, Jessica; Collins, Lillian J; Lau, Brandyn D; Christianson, Mindy S

2017-07-01

To assess geographical distribution and practice characteristics of fertility clinics inclusive of lesbian, gay, bisexual, and transgender (LGBT) patients. Cross-sectional analysis. Not applicable. None. None. Prevalence and geographical distribution of fertility clinic websites with LGBT-specific content, indicated by keywords and home page cues specific to the LGBT patient population. Assessment of relationship between LGBT-specific content and clinic characteristics, including U.S. region, clinic size, private versus academic setting, and state-mandated fertility insurance coverage. Of 379 websites analyzed, 201 (53%) contained LGBT content. Clinics with the highest proportion of LGBT website content were in the Northeast (59/82, 72%) and West (63/96, 66%), while the lowest proportion was in the Midwest (29/74, 39%) and South (50/127, 39%). Most frequently used terms included lesbian (72%), LGBT/LGBTQ (69%), and gay (68%), while less used terms included trans/transgender (32%) and bisexual (15%). Larger clinic size was associated with LGBT-specific website content (odds ratio, 4.42; 95% confidence interval, 2.07-9.67). Practice type and state-mandated fertility insurance coverage were not associated with a clinic website having LGBT content. Over half of Society for Assisted Reproductive Technology member fertility clinics included LGBT content on their websites, yet those in the Midwest and South were significantly less likely to do so. Predictive factors for having LGBT website content included location in northeastern and western regions and increasing clinic size. Further studies are needed to evaluate whether inclusion of LGBT content on clinic websites impacts use of reproductive services by the LGBT patient population. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Poor reporting of scientific leadership information in clinical trial registers.

PubMed

Sekeres, Melanie; Gold, Jennifer L; Chan, An-Wen; Lexchin, Joel; Moher, David; Van Laethem, Marleen L P; Maskalyk, James; Ferris, Lorraine; Taback, Nathan; Rochon, Paula A

2008-02-20

In September 2004, the International Committee of Medical Journal Editors (ICMJE) issued a Statement requiring that all clinical trials be registered at inception in a public register in order to be considered for publication. The World Health Organization (WHO) and ICMJE have identified 20 items that should be provided before a trial is considered registered, including contact information. Identifying those scientifically responsible for trial conduct increases accountability. The objective is to examine the proportion of registered clinical trials providing valid scientific leadership information. We reviewed clinical trial entries listing Canadian investigators in the two largest international and public trial registers, the International Standard Randomized Controlled Trial Number (ISRCTN) register, and ClinicalTrials.gov. The main outcome measures were the proportion of clinical trials reporting valid contact information for the trials' Principal Investigator (PI)/Co-ordinating Investigator/Study Chair/Site PI, and trial e-mail contact address, stratified by funding source, recruiting status, and register. A total of 1388 entries (142 from ISRCTN and 1246 from ClinicalTrials.gov) comprised our sample. We found non-compliance with mandatory registration requirements regarding scientific leadership and trial contact information. Non-industry and partial industry funded trials were significantly more likely to identify the individual responsible for scientific leadership (OR = 259, 95% CI: 95-701) and to provide a contact e-mail address (OR = 9.6, 95% CI: 6.6-14) than were solely industry funded trials. Despite the requirements set by WHO and ICMJE, data on scientific leadership and contact e-mail addresses are frequently omitted from clinical trials registered in the two leading public clinical trial registers. To promote accountability and transparency in clinical trials research, public clinical trials registers should ensure adequate monitoring of trial registration to ensure completion of mandatory contact information fields identifying scientific leadership.

Estimating antiretroviral treatment coverage rates and viral suppression rates for homosexual men in Australia

PubMed Central

De La Mata, Nicole L.; Mao, Limin; De Wit, John; Smith, Don; Holt, Martin; Prestage, Garrett; Wilson, David P.; Petoumenos, Kathy

2016-01-01

Gay and other men who have sex with men (GMSM) are disproportionally affected by the HIV epidemic in Australia. The study objective is to combine a clinical-based cohort with a community-based surveillance system to present a broader representation of the GMSM community to determine estimates of proportions receiving antiretroviral therapy (ART) and/or with an undetectable viral load. Between 2010 and 2012, small increases were shown in ART uptake (to 70.2%) and proportions with undetectable viral load (to 62.4%). The study findings highlight the potential for significantly increasing ART uptake among HIV-positive GMSM to reduce the HIV epidemic in Australia. PMID:26166247

Increased gonorrhoea and chlamydia testing did not increase case detection in an HIV clinical cohort 1999-2007.

PubMed

Berry, Stephen A; Ghanem, Khalil G; Page, Kathleen R; Gange, Stephen J; Thio, Chloe L; Moore, Richard D; Gebo, Kelly A

2011-10-01

Since 2003, US organisations have recommended universal screening, rather than targeted screening, of HIV-infected persons for gonorrhoea and chlamydia. The objective of this study was to determine whether wider testing resulting from these guidelines would produce an increase in gonorrhoea/chlamydia diagnoses. 3283 patients receiving HIV care in 1999-2007 in the Johns Hopkins Hospital HIV clinic were studied. The two primary outcomes were the occurrence of any gonorrhoea/chlamydia testing in each year of care and the occurrence of any positive result(s) in years of testing. The proportion of all patients in care who were diagnosed with gonorrhoea/chlamydia was defined as the number of patients with positive results divided by the number of patients in care. Trends were analysed with repeated measures logistic regression. The proportion of patients tested for gonorrhoea/chlamydia increased steadily from 0.12 in 1999 to 0.33 in 2007 (OR per year for being tested 1.17, 95% CI 1.15 to 1.19). The proportion positive among those tested decreased significantly after 2003 (OR per year 0.67, 95% CI 0.55 to 0.81). The proportion of all patients in care diagnosed with gonorrhoea/chlamydia therefore remained generally stable in 1999-2007 (OR per year 0.97, 95% CI 0.91 to 1.04). Universal annual screening, as implemented, did not increase the proportion of all patients in care who were diagnosed with gonorrhoea/chlamydia. Similarly low implementation rates have been reported in cross-sectional studies. If future efforts to enhance implementation do not yield increases in diagnoses, then guidelines focusing on targeted screening of high-risk groups rather than universal screening may be warranted.

Trends in funding, internationalization, and types of study for original articles published in five implant-related journals between 2005 and 2009.

PubMed

Barão, Valentim Adelino Ricardo; Shyamsunder, Nodesh; Yuan, Judy Chia-Chun; Knoernschild, Kent L; Assunção, Wirley Gonçalves; Sukotjo, Cortino

2012-01-01

The aims of this study were to evaluate the trends in funding, geographic origin, and study types of original articles in the dental implant literature and to investigate the relationships among these factors. Articles published in Clinical Oral Implants Research, The International Journal of Oral and Maxillofacial Implants, Clinical Implant Dentistry and Related Research, Implant Dentistry, and Journal of Oral Implantology from 2005 to 2009 were reviewed. Nonoriginal articles were excluded. For each article included, extramural funding source, geographic origin, and study type were recorded. Descriptive and analytic analyses (α = .05), including a logistic regression analysis, and chi-square test were used where appropriate. Of a total of 2,085 articles published, 1,503 met the inclusion criteria. The most common source of funding was from industry (32.4%). The proportion of studies that reported funding increased significantly over time. Europe represented the highest percentage (55.8%) of published articles. Most of the articles reported on clinical studies (49.9%), followed by animal studies (25.9%). Articles from Asia and South America and animal and in vitro studies were significantly more likely to be funded. Almost half of the original dental implant articles were funded. The trend toward internationalization of authorship was evident. A strong association was observed between funding and geographic origin and between funding and study type. Most studies in North America and Europe were clinical studies and supported by industry, whereas a greater proportion of studies in Asia and South America were in vitro or animal studies funded through government resources.

Are medical marijuana users different from recreational users? The view from primary care.

PubMed

Roy-Byrne, Peter; Maynard, Charles; Bumgardner, Kristin; Krupski, Antoinette; Dunn, Chris; West, Imara I; Donovan, Dennis; Atkins, David C; Ries, Richard

2015-10-01

Marijuana is currently approved for medical use in 23 states. Both clinicians and the lay public have questioned whether users of marijuana for medical purposes are different from users of marijuana for recreational purposes. This study examined similarities and differences in important clinical characteristics between users of medical marijuana and users of recreational marijuana. The sample consisted of 868 adult primary care patients in Washington State, who reported use of medical marijuana (n = 131), recreational marijuana (n = 525), or drugs other than marijuana (n = 212). Retention was over 87% at 3-, 6-, 9-, and 12-month assessments. The majority of medical, psychiatric, substance use, and service utilization characteristic comparisons were not significant. However, medical marijuana users had significantly more medical problems, a significantly larger proportion reported >15 days medical problems in the past month, and significantly smaller proportions reported no pain and no mobility limitations (p < .001). Medical marijuana users also had significantly lower drug problem severity, lower alcohol problem severity, and significantly larger proportions reported using marijuana alone and concomitant opioid use only (p < .001). There was no significant difference between medical and recreational users in the percentage using marijuana with at least two additional substances (48% vs. 58%, respectively, p = .05). Although our results suggest that there are few distinct differences between medical and recreational users of marijuana, the differences observed, while mostly very small in effect size (<.2), are consistent with at least some medical users employing marijuana to relieve symptoms and distress associated with medical illness. © American Academy of Addiction Psychiatry.

Little science, big science: strategies for research portfolio selection in academic surgery departments.

PubMed

Shah, Anand; Pietrobon, Ricardo; Cook, Chad; Sheth, Neil P; Nguyen, Lam; Guo, Lucie; Jacobs, Danny O; Kuo, Paul C

2007-12-01

To evaluate National Institutes of Health (NIH) funding for academic surgery departments and to determine whether optimal portfolio strategies exist to maximize this funding. The NIH budget is expected to be relatively stable in the foreseeable future, with a modest 0.7% increase from 2005 to 2006. Funding for basic and clinical science research in surgery is also not expected to increase. NIH funding award data for US surgery departments from 2002 to 2004 was collected using publicly available data abstracted from the NIH Information for Management, Planning, Analysis, and Coordination (IMPAC) II database. Additional information was collected from the Computer Retrieval of Information on Scientific Projects (CRISP) database regarding research area (basic vs. clinical, animal vs. human, classification of clinical and basic sciences). The primary outcome measures were total NIH award amount, number of awards, and type of grant. Statistical analysis was based on binomial proportional tests and multiple linear regression models. The smallest total NIH funding award in 2004 to an individual surgery department was a single $26,970 grant, whereas the largest was more than $35 million comprising 68 grants. From 2002 to 2004, one department experienced a 336% increase (greatest increase) in funding, whereas another experienced a 73% decrease (greatest decrease). No statistically significant differences were found between departments with decreasing or increasing funding and the subspecialty of basic science or clinical research funded. Departments (n = 5) experiencing the most drastic decrease (total dollars) in funding had a significantly higher proportion of type K (P = 0.03) grants compared with departments (n = 5) with the largest increases in total funding; the latter group had a significantly increased proportion of type U grants (P = 0.01). A linear association between amount of decrease/increase was found with the average amount of funding per grant and per investigator (P < 0.01), suggesting that departments that increased their total funding relied on investigators with large amounts of funding per grant. Although incentives to junior investigators and clinicians with secondary participation in research are important, our findings suggest that the best strategy for increasing NIH funding for surgery departments is to invest in individuals with focused research commitments and established track records of garnering large and multiple research grants.

Clinical Factors and Postoperative Impact of Bile Leak After Liver Resection.

PubMed

Martin, Allison N; Narayanan, Sowmya; Turrentine, Florence E; Bauer, Todd W; Adams, Reid B; Stukenborg, George J; Zaydfudim, Victor M

2018-04-01

Despite technical advances, bile leak remains a significant complication after hepatectomy. The current study uses a targeted multi-institutional dataset to characterize perioperative factors that are associated with bile leakage after hepatectomy to better understand the impact of bile leak on morbidity and mortality. Adult patients in the 2014-2015 ACS NSQIP targeted hepatectomy dataset were linked to the ACS NSQIP PUF dataset. Bivariable and multivariable regression analyses were used to assess the associations between clinical factors and post-hepatectomy bile leak. Of 6859 patients, 530 (7.7%) had a postoperative bile leak. Proportion of bile leaks was significantly greater in patients after major compared to minor hepatectomy (12.6 vs. 5.1%, p < 0.001). The proportion of patients with bile leak was significantly greater in patients after major hepatectomy who had concomitant enterohepatic reconstruction (31.8 vs. 10.1%, p < 0.001). Postoperative mortality was significantly greater in patients with bile leaks (6.0 vs. 1.7%, p < 0.001). After adjusting for significant covariates, bile leak was independently associated with increased risk of postoperative morbidity (OR = 4.55; 95% CI 3.72-5.56; p < 0.001). After adjusting for significant effects of postoperative complications, liver failure, and reoperation (all p<0.001), bile leak was not independently associated with increased risk of postoperative mortality (p = 0.262). Major hepatectomy and enterohepatic biliary reconstruction are associated with significantly greater rates of bile leak after liver resection. Bile leak is independently associated with significant postoperative morbidity. Mitigation of bile leak is critical in reducing morbidity and mortality after liver resection.

Significance of Age in Japanese Patients Receiving Sunitinib as First-line Systemic Therapy for Metastatic Renal Cell Carcinoma: Comparative Assessment of Efficacy and Safety between Patients Aged <75 and ≥75 Years.

PubMed

Miyake, Hideaki; Aki, Ryota; Matsushita, Yuto; Tamura, Keita; Motoyama, Daisuke; Ito, Toshiki; Sugiyama, Takayuki; Otsuka, Atsushi

2018-06-01

To date, it has not been well characterized whether sunitinib is effective in elderly patients with metastatic renal cell carcinoma (mRCC). The objective of this study was to investigate the impact of age on clinical outcomes of mRCC patients receiving sunitinib. The efficacy and safety of first-line sunitinib in 154 consecutive mRCC patients were retrospectively compared between patients aged <75 (n=125) and ≥75 (n=29) years. There were no significant differences in the major clinicopathological characteristics between younger and older patients; however, the reduction of the initial dose of sunitinib was significantly more frequent in older than younger patients. No significant difference in response rate, clinical benefit rate or proportion of patients going on to receive second-line therapy was noted between these two groups. Furthermore, there was no significant difference in progression-free survival (PFS) or overall survival (OS) between the two groups, and no significant impact of age on PFS or OS was documented by the Cox proportional hazards regression analyses. Of several adverse events, only anemia and fatigue were significantly more frequently observed in older than younger patients. Although there was no significant difference in the incidence of dose reduction or discontinuation of sunitinib between the two groups, the interruption of sunitinib was more frequently required in older than younger patients. These findings suggest that advanced age alone should not be regarded as a contraindication to the introduction of sunitinib as first-line systemic therapy for mRCC patients. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Vitamin C with metabolites: additional analysis suggests favorable changes in oxalate.

PubMed

Moyad, Mark A; Combs, Maile A; Baisley, Joshua E; Evans, Malkanthi

2009-01-01

A previously published randomized trial found a significant difference in the proportion of individuals experiencing oxalate reduction with a vitamin C with metabolites product compared with ascorbic acid (vitamin C). This represented a notable finding, which argued against the possibility of a chance finding due to the design and consistency of results. However, these researchers believed it was necessary to further analyze this study to continue to garner more insight on the strength or weakness of original findings. All favorable, neutral, and non-favorable changes of 24-hour oxalate from the previous clinical trial were grouped. Oxalate was considered to "decrease" or "increase" with each intervention only if a 10% or larger change occurred in the 24-hour oxalate baseline value when taking one product compared to another. A greater proportion of subjects taking both products at different time periods experienced favorable oxalate changes with vitamin C with metabolites product compared to ascorbic acid. If this reflects the true clinical scenario, this would represent an important clinical finding on a population level because at least 20% more individuals would experience a more favorable change. Regardless, this further analysis continues to suggest that the original observations were valid and could have positive clinical implications for some patients.

Long-term Effectiveness of Online Anaphylaxis Education for Pharmacists

PubMed Central

Vale, Sandra; Sanfilippo, Frank M; Loh, Richard; Clifford, Rhonda M

2014-01-01

Objective. To evaluate the long-term effectiveness of an Australasian Society of Clinical Immunology and Allergy (ASCIA) anaphylaxis e-learning program compared to lectures or no training. Design. A controlled interrupted-time-series study of Australian pharmacists and pharmacy students who completed ASCIA anaphylaxis e-learning or lecture programs was conducted during 2011-2013. Effectiveness was measured using a validated test administered pretraining, posttraining, and 3 and 7 months after training. Assessment. All learning groups performed significantly better on all posttests compared to the pretest, and compared to a control group (p<0.001). The proportion of e-learners achieving the minimum standard for anaphylaxis knowledge improved from 45% at pretest to 87% at 7 months. Conclusion. The ASCIA e-learning program significantly increased anaphylaxis knowledge. The high proportion of participants achieving the minimum standard at 7 months indicates long-term knowledge change. PMID:25258441

Monitoring the impact of decentralised chronic care services on patient travel time in rural Africa--methods and results in Northern Malawi.

PubMed

Houben, Rein M G J; Van Boeckel, Thomas P; Mwinuka, Venance; Mzumara, Peter; Branson, Keith; Linard, Catherine; Chimbwandira, Frank; French, Neil; Glynn, Judith R; Crampin, Amelia C

2012-11-15

Decentralised health services form a key part of chronic care strategies in resource-limited settings by reducing the distance between patient and clinic and thereby the time and costs involved in travelling. However, few tools exist to evaluate the impact of decentralisation on patient travel time or what proportion of patients attend their nearest clinic. Here we develop methods to monitor changes in travel time, using data from the antiretroviral therapy (ART) roll-out in a rural district in North Malawi. Clinic position was combined with GPS information on the home village of patients accessing ART services in Karonga District (North Malawi) between July 2005 and July 2009. Potential travel time was estimated as the travel time for an individual attending their nearest clinic, and estimated actual travel time as the time to the clinic attended. This allowed us to calculate changes in potential and actual travel time as new clinics opened and track the proportion and origin of patients not accessing their nearest clinic. The model showed how the opening of further ART clinics in Karonga District reduced median potential travel time from 83 to 43 minutes, and median actual travel time fell from 83 to 47 minutes. The proportion of patients not attending their nearest clinic increased from 6% when two clinics were open, to 12% with four open. Integrating GPS information with patient data shows the impact of decentralisation on travel time and clinic choice to inform policy and research questions. In our case study, travel time decreased, accompanied by an increased uptake of services. However, the model also identified an increasing proportion of ART patients did not attend their nearest clinic.

Trends in Authorship of Articles in Major Ophthalmology Journals by Gender, 2002-2014.

PubMed

Mimouni, Michael; Zayit-Soudry, Shiri; Segal, Ori; Barak, Yoreh; Nemet, Arie Y; Shulman, Shiri; Geffen, Noa

2016-08-01

To evaluate trends in the prevalence of women authors in ophthalmology in recent years. Cohort study. Authors listed in publications of 6 leading ophthalmology journals between January 2002 and December 2014. Using the PubMed search engine, we conducted an observational study of trends in gender distribution of all authors in 6 leading ophthalmology journals between January 2002 and December 2014. In multiauthored articles, the first listed author often is the lead investigator and the last author is the senior author. Therefore, the full names and positions (first, middle, or last) of all authors in every article were collected. A Google-based name identifier was used to assign the gender of authors. Proportion of women authors throughout the study period in all journals, general ophthalmology versus subspecialty journals, and basic science versus clinical research journals. Furthermore, we assessed the proportion of women in different authorship positions (first, middle, and last). A total of 102 254 authors from 23 026 published articles were analyzed. There was a significant rise over time in the percentage of women authors, with a steeper slope for first authors than for last authors (P<0.001), although in 2014, women authors were less than the 50% mark in all categories of authorship. The rise in the percentage of women authors was similar in basic and clinical research, but was steeper for first authorship than for last authorship (P<0.001). In all 3 authorship positions (first, middle, or last), women's contributions consistently were higher in basic research publications. The rise in the percentage of women authors was significantly steeper for general journals than for subspecialty journals (P<0.001). There was no significant rise for last authorship in subspecialty journals. In all 3 authorship positions, the proportion of women was consistently higher in general ophthalmology journals than for subspecialty journals. Despite an overall increase in the contribution of women to the field of ophthalmology, contributions to articles published in subspecialty ophthalmology journals and the proportion of women listed as last authors on overall articles published in ophthalmology journals are still low. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Relationship between ketosis and dairy cows' blood metabolites in intensive production farms of the periurban area of Dakar.

PubMed

Yameogo, Nongasida; Ouedraogo, Georges Anicet; Kanyandekwe, Christine; Sawadogo, Germain Jerome

2008-10-01

This study which involved 140 Holstein and Montbeliard was carried out in the periurban area of Dakar with the aim to establish the relationship between ketosis, milk production and biochemical blood metabolites. The results showed that ketosis is a real problem in periurban farms around the city of Dakar with high proportions of 33.57% for subclinical ketosis and 6.43% for clinical ketosis. In their second month of milking, cows with subclinical ketosis had a decrease of 12.4 and 15.,6% in milk yield respectively for Montbeliard and Holstein, whereas cows with clinical ketosis had a decrease of 18.6 and 26%. Ketogenic cows (subclinical and clinical) have significantly lower average levels of blood glucose (p<0.05) and significantly higher average levels of blood urea (p<0.05) than cows with normal blood beta-Hydroxy Butyrate (BbHB) levels. Also, from one farm to another, significant difference was recorded with concentration of total proteins and globulin, calcium and magnesium.

Control conditions for footwear insole and orthotic research.

PubMed

Lewinson, Ryan T; Worobets, Jay T; Stefanyshyn, Darren J

2016-07-01

Footwear insoles/orthotics alter variables associated with musculoskeletal injury; however, their clinical effectiveness is inconclusive. One explanation for this is the possibility that control conditions may actually produce biomechanical changes that induce clinical responses. The purpose of this study was to compare insole/orthotic control conditions to identify if variables at the ground, ankle and knee that are associated with injury are altered relative to what participants would normally experience in their own shoes. Gait analysis was performed on 15 participants during walking and running while wearing (1) their own shoes, (2) #1 with a 3mm flat insole, (3) a standardized shoe, and (4) #3 with a 3mm flat insole, where external knee adduction moments, external knee adduction angular impulses, internal ankle inversion moments, and vertical ground reaction force loading rates were determined. Conditions 2-4 were expressed as percent changes relative to condition 1, and tests of proportions assessed if there were a significant number of individuals experiencing a biomechanically relevant change for each variable. Repeated-measures ANOVAs were used to identify group differences between conditions. The majority of movement-footwear-variable combinations contained a proportion of individuals experiencing biomechanically relevant changes compared to condition 1 that was significantly greater than the expected proportion of 20%. No systematic differences were found between conditions. This suggests that conditions 2-4 may alter biomechanics relative to baseline for many participants, but not in a consistent way across participants. It is recommended that participant's own footwear be used as control conditions in future trials where biomechanics are primary variables of interest. Copyright © 2016 Elsevier B.V. All rights reserved.

Determining research priorities for young people with haematological cancer: a value-weighting approach.

PubMed

Clinton-McHarg, Tara; Paul, Christine; Sanson-Fisher, Rob; D'Este, Catherine; Williamson, Anna

2010-12-01

Haematological malignancies account for a third of all cancers affecting adolescents and young adults (AYAs). Funding agencies are regularly faced with the dilemma of how to deploy resources in order to provide the greatest possible benefit to this patient group. This study used a value-weighting approach to quantify the stakeholders' perceptions about how resources should be allocated to best improve outcomes for AYA patients and their families. One hundred and fifty seven participants (112 health care providers, researchers and other professionals and 45 patients and carers) were invited to complete a web-based value-weighting questionnaire and indicate how they would allocate 100 units of funding among various research approaches, areas and populations. Eighty participants (51%) completed the questionnaire. Strategic research was allocated a significantly higher proportion of funding than investigator-driven research. For research areas, clinical medicine and psychosocial research were allocated the highest proportion of funding. Within research populations, AYAs who were newly diagnosed, relapsed or finished treatment were allocated the largest proportion of funds. Psychosocial research which focussed on identifying risk and resilience, developing psychosocial measures, translating research into practice and improving the treatment centre was allocated funding slightly above other items, however the difference was not significant. To improve potential congruence between the views of stakeholders and funding agencies, research funding for AYA haematological cancer patients and their families could be targeted towards newly diagnosed patients and those who have relapsed. Research in the areas of clinical medicine and psychosocial care is perceived to be of utmost value. Copyright © 2010 Elsevier Ltd. All rights reserved.

[Modern technologies and prospects of rehabilitation of patients after ischemic stroke].

PubMed

Ekusheva, E V

Despite the great achievements in the field of neurorehabilitation, a significant proportion of patients after an ischemic stroke have persistent motor disturbances even after timely and adequately carried out restorative measures. The article discusses the issues of neuroplasticity, modern diagnostic technologies for studying this phenomenon; prognostic factors for recovery deficit following stroke and determining the effectiveness of ongoing treatment. The principles of neuroprotective therapy in ischemic stroke are considered, which is a pathogenetically justified direction at all stages of restorative treatment after cerebral circulation disorders. One of the most studied original cytoprotectors, demonstrating safety, efficacy and good tolerability, is cytoflavin. The results of numerous clinical trials have revealed a significant positive clinical and morphological dynamics when taking cytoflavin in patients after ischemic stroke.

Flood disaster preparedness: a retrospect from Grand Forks, North Dakota.

PubMed

Siders, C; Jacobson, R

1998-01-01

Natural disasters often come without warning. The clinical, financial, and business risks can be enormous. Grand Forks' (ND) healthcare systems experienced a flooding disaster of unprecedented proportions in April of 1997. Planned and practiced disaster and evacuation procedures can significantly reduce a healthcare facilities' risk to life, health, and safety. This article retrospectively analyzes disaster preparation and the complete evacuation of the facilities' patients.

Fibromyalgia, mood disorders, and intense creative energy: A1AT polymorphisms are not always silent.

PubMed

Schmechel, Donald E; Edwards, Christopher L

2012-12-01

Persons with single copies of common alpha-1-antitrypsin polymorphisms such as S and Z are often considered "silent carriers". Published evidence however supports a complex behavioral phenotype or trait - intense creative energy ("ICE")-associated with A1AT polymorphisms. We now confirm that phenotype and present an association of fibromyalgia syndrome (FMS) and A1AT in a consecutive series of neurological patients. This is a retrospective case control series of 3176 consecutive patients presenting to Duke University Memory Clinic (747 patients) and to regional community-based Caldwell Hospital Neurology and Memory center (2429 patients). Work-up included medical history and examination, psychological evaluation, and genetic analysis. Chronic widespread pain (CWP) or FMS were diagnosed according to clinical guidelines, mostly as secondary diagnoses. Neurological patients carrying A1AT polymorphisms were common (ca 16% prevalence) and carriers had significantly higher use of inhaler and anxiolytic medications. Patients with ICE phenotype had a significantly higher proportion of A1AT polymorphisms (42%) compared to non-ICE patients (13%). Presence of CWP or FMS was common (14-22%) with average age at presentation of 56 years old and mostly female gender (82%). Patients with CWP/FMS had again significantly higher proportion of A1AT polymorphisms (38%) compared to other neurological patients (13%). Patients with anxiety disorders, bipolar I or bipolar II disorders or PTSD also had increased proportion of A1AT polymorphisms and significant overlap with ICE and FMS phenotype. Significant reductions in CWP/FMS prevalence are seen in apolipoprotein E4 carriers and methylene tetrahydrofolate reductase (MTHFR) mutation homozygotes. Since ICE phenotype is reported as a lifelong behavioral attribute, the presumption is that A1AT carriers have fundamental differences in brain development and inflammatory response. In support of this concept is finding those persons reporting a diagnosis of juvenile rheumatoid or idiopathic arthritis (JRA, JIA) had a significantly high proportion of A1AT polymorphisms (63%), suggesting a spectrum for JRA to later FMS presentations. Likewise, persons reporting a history of attention deficit disorder (ADD) had an increased proportion of A1AT polymorphisms (26%) compared to non-ADD persons (13%). Toxic environmental exposures are common (23%) and associated with diagnoses of PSP, PPA, FTD, FTD-PD, PD and ADVD. A1AT carriers were increased in cases of toxic exposure and PSP, PPA and FTD-PD. Our findings support the ICE behavioral phenotype for A1AT polymorphism carriers and the reported association with anxiety and bipolar spectrum disorders. We now extend that phenotype to apparent vulnerability to inflammatory muscle disease in a spectrum from JRA to fibromyalgia (FMS) and specific behavioral subsets of ADD, PTSD, and specific late onset neurological syndromes (FTD-PD and PPA). High and low risk FMS subsets can be defined using A1AT, MTHFR and APOE genotyping. Clinical diagnoses associated with A1AT polymorphisms included fibromyalgia, JRA/JIA, bipolar disorder, PTSD, primary progressive aphasia and FTDPD, but not most Alzheimer Disease subtypes. These results support an extended phenotype for A1AT mutation carriers beyond liver and lung vulnerability to selective advantages: ICE phenotype and disadvantages: fibromyalgia, affective disorders, and selected late onset neurological syndromes. Copyright © 2012 Elsevier Inc. All rights reserved.

[Abnormality of blood coagulation indexes in patients with de novo acute leukemia and its clinical significance].

PubMed

Xiao, Fang-Fang; Hu, Kai-Xun; Guo, Mei; Qiao, Jian-Hui; Sun, Qi-Yun; Ai, Hui-Sheng; Yu, Chang-Lin

2013-04-01

To explore hemorrhage risk and the clinical significance of abnormal change of prothrombin time (PT), activated partial thromboplastin time (APTT), plasma fibrinogen (FIB), plasma thrombin time (TT) and d-dimer (D-D) in de novo acute leukemia (except for APL), the different bleeding manifestations of 114 cases of de novo acute leukemia with different coagulation indexes were analyzed retrospectively. The correlation between these blood coagulation indexes and the possible correlative clinical characteristics were analysed, including age, sex, type of acute leukemia, initial white blood cell(WBC) and platelet(Plt) count, the proportion of blast cells in bone marrow and cytogenetic abnormality of patients at diagnosis. The results indicated that the incidence of abnormal blood coagulation was as high as 78.1% for de novo AL patients. These patients with 5 normal blood coagulation indexes may have mild bleeding manifestation, but the more abnormal indexes, the more severe bleeding. Both PT and D-D were sensitive indexes for diagnosis of level II bleeding. Incidence of abnormal blood coagulation significantly correlates with the proportion of blast cells in bone marrow (χ(2) = 4.184, OR = 1.021, P < 0.05) and more with D-D (P < 0.01), while age, sex, type of AL, WBC count, Plt count and abnormality of cytogenetics did not correlate with abnormal blood coagulation. It is concluded that the coagulation and fibrinolysis are abnormal in most patients with de novo acute leukemia. More abnormal indexes indicate more severe bleeding, and both PT and D-D are sensitive indexes for diagnosis of level II bleeding. Higher proportion of blast cells in bone marrow predicts higher incidence of abnormal blood clotting. Acute leukemia with elderly age, high white blood cell count and adverse cytogenetics do not predict severer abnormal blood clotting. Detection of PT, APTT, TT, FIB, and D-D may help to judge whether the patients are in a state of hypercoagulability or disseminated intravenous coagulation, which will provide experiment evidences for early intervention and medication.

Clinical Impact of Emphysema Evaluated by High-Resolution Computed Tomography on Idiopathic Pulmonary Fibrosis Diagnosed by Surgical Lung Biopsy.

PubMed

Kohashi, Yasuo; Arai, Toru; Sugimoto, Chikatoshi; Tachibana, Kazunobu; Akira, Masanori; Kitaichi, Masanori; Hayashi, Seiji; Inoue, Yoshikazu

2016-01-01

The prognosis of combined cases of pulmonary fibrosis and emphysema is unresolved partially because radiological differentiation between usual interstitial pneumonia and nonspecific interstitial pneumonia is difficult in coexisting emphysema cases. The purpose of this study was to clarify the clinical impact of emphysema on the survival of patients with idiopathic pulmonary fibrosis (IPF). One hundred and seven patients with interstitial lung diseases were diagnosed by surgical lung biopsies between 2006 and 2012, and 47 patients were diagnosed with IPF through multidisciplinary discussion. Emphysema on high-resolution computed tomography scans was evaluated semiquantitatively by visual scoring. Eight out of the 47 IPF patients showed a higher emphysema score (>3) and were diagnosed to have IPF-emphysema. The median survival time of patients with IPF-emphysema (1,734 days) from the initial diagnosis was significantly shorter than that of patients with IPF alone (2,229 days) by Kaplan-Meier analysis (p = 0.007, log-rank test). Univariate Cox proportional hazard regression analyses revealed that a higher total emphysema score (>3.0) was a significantly poor prognostic factor in addition to Krebs von den Lungen-6, surfactant protein-D, arterial oxygen tension, percent forced vital capacity, and percent diffusing capacity of carbon monoxide (%DLCO). Multivariate Cox proportional hazard regression analyses with the stepwise method showed that higher total emphysema score (>3) and %DLCO were significantly poor prognostic factors. The prognosis of IPF-emphysema was significantly worse than that of IPF alone. © 2016 S. Karger AG, Basel.

Determinants of Heterosexual Adolescents Having Sex with Female Sex Workers in Singapore

PubMed Central

Ng, Junice Y. S.; Wong, Mee-Lian

2016-01-01

Objectives We assessed the proportion of and socio-ecological factors associated with ever having had sex with female sex workers (FSWs) among heterosexual adolescents. We also described the characteristics of the adolescents who reported inconsistent condom use with FSWs. Methods This is a cross-sectional study (response rate: 73%) of 300 heterosexually active male adolescents of 16 to 19 years attending a national STI clinic in Singapore between 2009 and 2014. We assessed the ecological factors (individual, parental, peer, school and medial influences) and sexual risk behaviors using a self-reported questionnaire. Poisson regression was used to obtain the adjusted prevalence ratios (aPR) and confidence intervals (CI). Results The proportion of heterosexual male adolescents who had ever had sex with FSWs was 39%. Multivariate analysis showed that significant factors associated with ever having had sex with FSWs were sex initiation before 16 years old (aPR 1.79 CI: 1.30–2.46), never had a sexually active girlfriend (aPR 1.75 CI 1.28–2.38), reported lower self-esteem score (aPR 0.96 CI: 0.93–0.98), higher rebelliousness score (aPR 1.03 CI: 1.00–1.07) and more frequent viewing of pornography (aPR 1.47 CI: 1.04–2.09). Lifetime inconsistent condom use with FSWs was 30%. Conclusions A significant proportion of heterosexual male adolescents attending the public STI clinic had ever had sex with FSWs. A targeted intervention that addresses different levels of influence to this behavior is needed. This is even more so because a considerable proportion of adolescents reported inconsistent condom use with FSWs, who may serve as a bridge of STI transmission to the community. National surveys on adolescent health should include the assessment of frequency of commercial sex visits and condom use with FSWs for long-term monitoring and surveillance. PMID:26808561

Identification of recent HIV infections and of factors associated with virus acquisition among pregnant women in 2004 and 2006 in Swaziland.

PubMed

Bernasconi, Daniela; Tavoschi, Lara; Regine, Vincenza; Raimondo, Mariangela; Gama, Dan; Sulgencio, Leonides; Almaviva, Mauro; Galli, Claudio; Ensoli, Barbara; Suligoi, Barbara; Sukati, Hosea; Buttò, Stefano

2010-07-01

HIV continues to spread at high rates in sub-Saharan Africa. In particular, Swaziland is one of the countries most affected by the HIV/AIDS pandemic. Monitoring of HIV infection in Swaziland is being made by periodical investigations on HIV prevalence in pregnant women. However, knowledge of proportion of recent HIV infections is important for epidemiologic purposes to assess HIV transmission patterns. To evaluate the proportion of recent HIV infections among pregnant women and its change overtime and to analyze factors associated with recent HIV infection in Swaziland. HIV-positive sera from pregnant women were collected during the 2004 and 2006 National HIV Serosurveys conducted in Swaziland and tested for the HIV antibody avidity, in order to identify recent HIV infections. Socio-demographic and clinical information was also collected. A multivariate analysis was conducted to assess the association between recent HIV infection and socio-demographic and clinical factors. A total of 1636 serum samples were tested for HIV antibody avidity. The overall proportion of recent infections was 13.8%, with no significant difference between 2004 and 2006 (14.6% vs. 13.1%, P>0.05, respectively). At the multivariate analysis, the younger age [14-19 vs. >or=20 years; adjusted odds ratio (aOR) 2.17, 95% CI: 1.45-3.24], as well as being at first pregnancy (1 vs. >or=2; aOR 1.61, 95% CI: 1.10-2.35) was independently associated with recent HIV infection. This study shows no significant difference in the proportion of recent infections between 2004 and 2006 and suggests that young women and women at their first pregnancy are currently high-risk groups for HIV acquisition, highlighting the importance of developing targeted youth programmes to reduce the spread of HIV infection in the country. Copyright (c) 2010 Elsevier B.V. All rights reserved.

[Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

PubMed

Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

2015-04-01

To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

Determinants of pre-exposure rabies vaccination among foreign backpackers in Bangkok, Thailand.

PubMed

Gautret, Philippe; Tantawichien, Terapong; Vu Hai, Vinh; Piyaphanee, Watcharapong

2011-05-23

Important variations were observed regarding the proportion of backpackers seeking information about travel-associated diseases before departing for Thailand. The main determinants were nationality, reason for travel and age. Sources of information used by travelers varied substantially according to nationality. Moreover, significant differences were recorded regarding pre-exposure vaccination rates against rabies. Having British or Irish citizenship and seeking advice from travel clinic specialists or friends were the strongest and most significant determinants of rabies vaccination history. A significant relationship between vaccine cost and vaccination coverage was also evidenced. Copyright © 2011 Elsevier Ltd. All rights reserved.

Assessing health seeking behaviour among tuberculosis patients in rural South Africa.

PubMed

Pronyk, R M; Makhubele, M B; Hargreaves, J R; Tollman, S M; Hausler, H P

2001-07-01

South Africa's rural Northern Province. To examine patterns of health seeking behaviour among hospitalised tuberculosis patients. Information on personal characteristics, health seeking behaviour and delays to presentation and hospitalisation was collected from hospitalised TB patients. Analysis of rates was used to investigate factors associated with delay. Among 298 patients, median total delay to hospitalisation was 10 weeks, with patient delay contributing a greater proportion than service provider delay. Patients more often presented initially to public hospitals (41%) or clinics (31 %) than to spiritual/traditional healers (15%) or private GPs (13%). Total delay was shorter amongst those presenting to hospitals than those presenting to clinics (rate ratio 1.33, 95%CI 1.13-1.85), with a significantly smaller proportion of the total delay attributable to the health service provider (18% vs. 42%). Those exhibiting a conventional risk profile for TB (migrants, alcohol drinkers, history of TB) were diagnosed most quickly by health services, while women remained undiagnosed for longer. Considerable delay exists between symptom onset and treatment initiation among pulmonary tuberculosis patients. While a substantial delay was attributable to late patient presentation, an important, preventable period of infectiousness was caused by the failure of recognised clinical services to diagnose tuberculosis among symptomatic individuals.

Rapid Growth in Surgeons’ Use of Secure Messaging in a Patient Portal

PubMed Central

Shenson, Jared A.; Cronin, Robert M.; Davis, Sharon E.; Chen, Qingxia; Jackson, Gretchen Purcell

2016-01-01

Background Use of secure messaging through patient portals has risen substantially in recent years due to provider incentives and consumer demand. Secure messaging may increase patient satisfaction and improve outcomes, but also adds to physician workload. Most prior studies of secure messaging focused on primary care and medical specialties. We examined surgeons’ use of secure messaging and the contribution of messaging to outpatient interactions in a broadly-deployed patient portal. Methods We determined the number of clinic visits and secure messages for surgical providers in the first three years (2008–10) after patient portal deployment at an academic medical center. We calculated the proportion of outpatient interaction conducted through messaging for each specialty. Logistic regression models compared the likelihood of message-based versus clinic outpatient interaction across surgical specialties. Results Over the study period, surgical providers delivered care in 648,200 clinic visits and received 83,912 messages, with more than 200% growth in monthly message volume. Surgical specialties receiving the most messages were orthopedics/podiatry (25.1%), otolaryngology (20.1%), urology (10.8%), and general surgery (9.6%); vascular surgery (0.8%) and pediatric general surgery (0.2%) received the fewest. The proportion of outpatient interactions conducted through secure messaging increased significantly from 5.4% in 2008 to 15.3% in 2010 (p<0.001) with all specialties experiencing growth. Heart/lung transplantation (74.9%), liver/kidney/pancreas transplantation (69.5%), and general surgery (48.7%) had the highest proportion of message-based outpatient interaction by the end of the study. Conclusions This study demonstrates rapid adoption of online secure messaging across surgical specialties with significant growth in its use for outpatient interaction. Some specialties, particularly those with long-term follow-up, interacted with patients more through secure messaging than in person. As surgeons devote more time to secure messaging, additional research will be needed to understand the care delivered through online interactions and to develop models for reimbursement. PMID:26123340

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

PubMed

Bowers, Alex R; Keeney, Karen; Peli, Eli

2014-02-01

There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia. Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline. Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks. The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference. Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. clinicaltrials.gov Identifier: NCT00494676.

Late presentation to HIV testing is overestimated when based on the consensus definition.

PubMed

Sasse, A; Florence, E; Pharris, A; De Wit, S; Lacor, P; Van Beckhoven, D; Deblonde, J; Delforge, M-L; Fransen, K; Goffard, J-C; Legrand, J-C; Moutschen, M; Piérard, D; Ruelle, J; Vaira, D; Vandercam, B; Van Ranst, M; Van Wijngaerden, E; Vandekerckhove, L; Verhofstede, C

2016-03-01

In 2011, a consensus was reached defining "late presenters" (LPs) as individuals presenting for care with a CD4 count < 350 cells/μL or with an AIDS-defining event, regardless of CD4 count. However, a transient low CD4 count is not uncommon in recent infections. The objective of this study was to investigate how measurements of late presentation change if the clinical stage at the time of diagnosis is taken into account. Case surveillance data for newly diagnosed patients in Belgium in 1998-2012 were analysed, including CD4 count at diagnosis, the presence of AIDS-defining events, and recent infections (< 6 months) as reported by clinicians in the case of acute illness or a recent negative test. First, proportions of LPs were calculated according to the consensus definition. Secondly, LPs were reclassified as "nonlate" if infections were reported as recent. A total of 7949 HIV diagnoses were included in the study. Recent infections were increasingly reported over time, accounting for 8.2% of new infections in 1998 and 37.5% in 2012. The consideration of clinical stage significantly modified the proportion of LPs: 18.2% of men who have sex with men (MSM) diagnosed in 2012 would be classified as LPs instead of 30.9% using the consensus definition (P < 0.001). The proportion of patients misclassified as LPs increased significantly over time: 5% in MSM in 1998 vs. 41% in 2012. This study suggests that low CD4 counts in recent infections may lead to overestimation of late presentation when applying the consensus definition. The impact of transient CD4 count on late presentation estimates should be assessed and, if relevant, the introduction of clinical stage in the definition of late presentation should be considered. © 2015 British HIV Association.

[A clinical study on pulmonary tuberculosis in younger age groups].

PubMed

Takahara, M; Suzuki, T; Toyota, E; Kobayashi, N; Kawada, H; Kudoh, K

2000-04-01

In 1997, the number of newly registered patients with pulmonary tuberculosis increased, compared with that in 1996, in Japan. The majority of the increase were occupied by elder patients 70 years of age or higher. But in younger group less than 30 years old, a reduction in the incidence of tuberculosis had been slowed down, until 1996. The purpose of this report is to elucidate the characteristics of these younger patients. 139 cases younger than 30 years of age, who were hospitalized in the tuberculous ward of IMCJ from April 1995 to March 1998, were investigated, and were compared with the control group (557 cases), 30-79 years old who were hospitalized during the same period. In the younger group, the proportion of women cases, discovered by health examination, foreigners, and contact with TB patients in the past was significantly higher than in the control group. But there were no difference between the both groups, concerning the proportion of those spending irregular life or living alone. The proportion of sputa smear negative cases was significantly higher in the younger group than in the control. For early diagnosis of TB among younger group, the application of bronchofiberscopy and nucleic acid diagnostic method, are encouraged.

Comparisons of Latinos, African Americans, and Caucasians with multiple sclerosis.

PubMed

Buchanan, Robert J; Zuniga, Miguel A; Carrillo-Zuniga, Genny; Chakravorty, Bonnie J; Tyry, Tuula; Moreau, Rachel L; Huang, Chunfeng; Vollmer, Timothy

2010-01-01

Identify racial/ethnic differences among people with multiple sclerosis (MS) in demographics, MS disease characteristics, and health services received. We analyzed enrollment data from the Registry of the North American Research Committee on Multiple Sclerosis (NARCOMS) Project to compare 26,967 Caucasians, 715 Latinos, and 1,313 African Americans with MS. Racial/ethnic analyses of NARCOMS data focused on descriptive characteristics, using ANOVA and chi-square tests to identify significant differences in means and frequencies among Caucasians, Latinos, and African Americans. We identified significant racial/ethnic differences in demographics, MS disease characteristics, and treatments. Caucasians were older when first MS symptoms were experienced (30.1 years) and at MS diagnosis (37.4 years) than Latinos (28.6 years and 34.5 years) or African Americans (29.8 years and 35.8 years). Larger proportions of Latinos reported normal function for mobility and bladder/bowel function compared to Caucasians. Larger proportions of Latinos (44.2 percent) and African Americans (45.8 percent) reported at least mild depression compared to only 38.7 percent of Caucasians. Larger proportions of Latinos never received mental health care or care from rehabilitation specialists than Caucasians or African Americans. A larger proportion of African Americans had never been treated by a neurologist specializing in MS and a smaller proportion of African Americans received care at a MS clinic than Caucasians or Latinos. Our findings highlight the need for future analyses to determine if age, disease duration, MS symptoms, and disability levels provide additional insights into racial/ethic differences in the use of MS-related providers.

Protein-bound polysaccharide-K reduces the proportion of regulatory T cells in vitro and in vivo.

PubMed

Aoki, Rieko; Iijima, Hiroko; Kato, Mariko; Uchida, Motoyuki; Wada, Tsutomu; Murata, Masatsune; Ogawa, Kenji; Naritaka, Yoshihiko; Yoshimatsu, Kazuhiko

2014-01-01

Regulatory T cells (Tregs) play an important role in maintaining immunological tolerance. However, this mechanism is one of the major obstacles to overcome when attempting to improve antitumor immunity. Protein-bound polysaccharide‑K (PSK) has been used clinically as an antitumor drug, and one of its antitumor mechanisms involves improvement of the tumor-induced immunosuppressive state. Therefore, we investigated whether PSK affects Tregs in vitro and in vivo. In the in vitro study, CD4⁺CD25⁻ cells were separated from normal mouse spleen and cultured with or without PSK in the presence of TGF-β. Although TGF-β induced CD4⁺CD25⁺Foxp3⁺ Tregs, PSK reduced the proportion of TGF-β-induced Tregs. In the in vivo study, BALB/c mice were injected subcutaneously with methylcholanthrene-induced fibrosarcoma (Meth A) cells on day 0, and were administered PSK (50 mg/kg) intraperitoneally from day 1, three times per week. After 4 weeks, the tumor volume, the proportion of Tregs and the CD8+/Treg ratio in the spleen, plasma TGF-β concentration, and IFN-γ production by spleen cells were measured. PSK significantly reduced tumor growth, the proportion of Tregs in the spleen and the plasma TGF-β concentration, and significantly increased the CD8+/Treg ratio in the spleen and IFN-γ production by spleen cells. The reduction of the TGF-β concentration in blood by PSK appears to decrease the proportion of Tregs in lymphoid organs and to augment antitumor immunity.

Neurophysiological and clinical responses to rituximab in patients with anti-MAG polyneuropathy.

PubMed

Zara, Gabriella; Zambello, Renato; Ermani, M

2011-12-01

Rituximab treatment has shown clinical improvement in anti-myelin associated glycoprotein (MAG) polyneuropathy. We analyzed scores of clinical scales and the most sensitive electrophysiological parameters before and after immunomodulating treatment with rituximab in a group of patients affected by anti-MAG demyelinating polyneuropathy. Clinical scores, the percentage of CD20 B-lymphocytes, anti-MAG antibody titers and electrophysiological data in 7 patients with anti-MAG polyneuropathy were analyzed. The patients were examined before a cycle with rituximab, 6, 12 and 24 months after the end of the treatment. Two patients were treated with rituximab additional cycles and re-evaluated 48 months after the first treatment. There were no evident correlation between anti-MAG serum antibody titers or clinical scales and electrodiagnostic data. Significant decrease in the proportion of CD20 B-lymphocytes was observed. Significant anti-MAG antibodies titers reduction was detected after re-treatment. At follow-up, pinprik sensation and two point discrimination presented a significant improvement compared with the score before treatment. In our patients, rituximab did not improve any electrophysiological data. No correlation with anti-MAG serum antibodies course was found. With rituximab only pin sensibility improved. Rituximab re-treatment significantly reduces anti-MAG serum antibodies titers but improves only small fibers sensibility. Copyright © 2011 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Retrospective case evaluation of gender differences in sports injuries in a Japanese sports medicine clinic.

PubMed

Iwamoto, Jun; Takeda, Tsuyoshi; Sato, Yoshihiro; Matsumoto, Hideo

2008-12-01

Although both gender- and sports-specific injuries exist among athletes, gender differences in the types of injuries caused by sports activities, except for anterior cruciate ligament (ACL) injury and anterior knee pain, are not well established. An observational study with a retrospective case-series design was conducted to investigate gender-specific differences in the types of injuries sustained while engaging in sports activities common to both males and females. We analyzed injuries sustained during sports activities including basketball, volleyball, tennis, skiing, track and field, and swimming, using data on age, sex, sports activities, activity levels, and sports injuries that had been computerized at our sports medicine (orthopedics) clinic. Inclusion criteria were sports activities that had a record of >100 injuries in total and athletes aged <50 years who were engaging in only 1 sports activity. We determined the absolute number of patients in each category and their percentage (proportion) of our cohort. The proportions of common injuries caused by sports activities were investigated, and gender-specific differences in the types of common injuries caused by sports activities were clarified. The Fisher exact test was used to determine the significance (P < 0.01) of the gender-specific differences in the types of sports injuries. According to our database, during the 14-year period between October 1992 and December 2006, a total of 2,989 athletes (1,624 males and 1,365 females) aged <50 years who engaged in 1 of the 6 sports activities described consulted our sports medicine clinic. The most common sports injuries were ACL injury (14.3%) and knee pain (13.7%), followed by ankle sprain (9.4%), lumbar disc disease (7.0%), meniscus injury (5.1%), stress fracture (2.9%), low back pain (2.5%), patellar tendinitis (2.1%), injury of the medial collateral ligament of the knee (2.0%), lumbar spondylolysis (1.7%), and muscle strain (1.5%). Among these 11 types of sports injuries, a significantly higher proportion of females who engaged in basketball (24.4% vs 10.5%), volleyball (20.5% vs 4.5%), or skiing (41.4% vs 26.5%) presented with an ACL injury, compared with their male counterparts (all, P < 0.001). There was also a significantly higher proportion of females than of males among the track and field athletes who presented with stress fractures (18.7% vs 3.9%; P < 0.001). The findings of this retrospective study suggest that there are gender-specific differences in the types of injuries sustained during sports activities.

Clinical competency evaluation of Brazilian chiropractic interns

PubMed Central

Facchinato, Ana Paula A.; Benedicto, Camila C.; Mora, Aline G.; Cabral, Dayane M.C.; Fagundes, Djalma J.

2015-01-01

Objective This study compares the results of an objective structured clinical examination (OSCE) between 2 groups of students before an internship and after 6 months of clinical practice in an internship. Methods Seventy-two students participated, with 36 students in each cohort. The OSCEs were performed in the simulation laboratory before the participants' clinical practice internship and after 6 months of the internship. Students were tested in 9 stations for clinical skills and knowledge. The same procedures were repeated for both cohorts. The t test was used for unpaired parametric samples and Fisher's exact test was used for comparison of proportions. Results There was no difference in the mean final score between the 2 groups (p = .34 for test 1; p = .08 for test 2). The performance of the students in group 1 was not significantly different when performed before and after 6 months of clinical practice, but in group 2 there was a significant decrease in the average score after 6 months of clinical practice. Conclusions There was no difference in the cumulative average score for the 2 groups before and after 6 months of clinical practice in the internship. There were differences within the cohorts, however, with a significant decrease in the average score in group 2. Issues pertaining to test standardization and student motivation for test 2 may have influenced the scores. PMID:25588200

Is anxiety more common in school students with newly diagnosed specific learning disabilities? A cross-sectional questionnaire-based study in Mumbai, Maharashtra, India

PubMed Central

Thakkar, AN; Karande, S; Bala, N; Sant, H; Gogtay, NJ; Sholapurwala, R

2016-01-01

Background and Objectives: School students with specific learning disabilities (SpLDs) experience chronic academic underachievement and resultant stress. The present study aimed to determine if school students with newly diagnosed SpLD were more likely to have anxiety than their regular peers. Materials and Methods: The study cases (aged 8-15 years) were recruited from our institute's learning disability clinic. The matched controls were recruited from four schools in Mumbai, Maharashtra, India. Anxiety was measured using the Spence Children's Anxiety Scale (SCAS)-child self-report version questionnaire. Median SCAS scores and the proportion of students with an SCAS score in the “clinical anxiety” range were compared between the groups. Results: SCAS scores were significantly higher in 8-11-year-old learning-disabled male and female students (P < 0.0001 for both groups) and 12-15-year-old female students (P = 0.004), as compared with matched controls. A significantly higher number of learning-disabled students were found to have “clinical anxiety” [24.64% vs 4.35%, crude odds ratio (OR) = 7.19, 95% confidence interval (CI) 2.91-17.78, P = 0.0001], as compared with the controls regardless of gender, age group, presence of comorbid attention-deficit/hyperactivity disorder (ADHD), or associated medical conditions. A significantly higher proportion of 8-11-year-old learning-disabled students, especially males, were found to have “clinical anxiety” as compared with 12-15-year-old learning-disabled students (crude OR = 4.38, 95% CI 1.94-9.92, P = 0.0004). Gender, presence of comorbid ADHD or associated medical conditions, and type of school attended or curriculum did not impact the prevalence of “clinical anxiety” in learning-disabled students. Interpretation and Conclusions: Students with newly diagnosed SpLD have greater odds of being “clinically anxious” relative to their regular peers. We recommend screening for anxiety in children with SpLD immediately after diagnosis so that their optimum rehabilitation can be facilitated. PMID:26482116

Clinical competence of Guatemalan and Mexican physicians for family dysfunction management.

PubMed

Cabrera-Pivaral, Carlos Enrique; Orozco-Valerio, María de Jesús; Celis-de la Rosa, Alfredo; Covarrubias-Bermúdez, María de Los Ángeles; Zavala-González, Marco Antonio

2017-01-01

To evaluate the clinical competence of Mexican and Guatemalan physicians to management the family dysfunction. Cross comparative study in four care units first in Guadalajara, Mexico, and four in Guatemala, Guatemala, based on a purposeful sampling, involving 117 and 100 physicians, respectively. Clinical competence evaluated by validated instrument integrated for 187 items. Non-parametric descriptive and inferential statistical analysis was performed. The percentage of Mexican physicians with high clinical competence was 13.7%, medium 53%, low 24.8% and defined by random 8.5%. For the Guatemalan physicians'14% was high, average 63%, and 23% defined by random. There were no statistically significant differences between healthcare country units, but between the medium of Mexicans (0.55) and Guatemalans (0.55) (p = 0.02). The proportion of the high clinical competency of Mexican physicians' was as Guatemalans.

The burden of attending a pediatric surgical clinic and family preferences toward telemedicine.

PubMed

Bator, Eli X; Gleason, Joseph M; Lorenzo, Armando J; Kanaroglou, Niki; Farhat, Walid A; Bägli, Darius J; Koyle, Martin A

2015-10-01

Indirect expenses for accessing health care may place significant fiscal strain on Canadian families. Telemedicine alternatives, using email, telephone, and video conferencing, can mitigate such financial burdens by reducing travel and related costs. Our objectives were to assess costs that families incur visiting an outpatient pediatric surgical clinic, and family attitudes toward telemedicine alternatives. A survey was offered pre-consult to all families who attended pediatric urology and general surgery outpatient clinics over a three-month period. A total of 1032 of 1574 families screened participated (66.0%). Less than half (18.5%) of participants traveled over 200 km, and 32.9% spent over 4 hours in transit, round-trip. The proportion of participants who spent over $50 on travel and ancillary expenses was 33.0%. In 74.0% of families, 1 or more adults missed work. The proportion of families who perceived costs as somewhat high or high was 29.1%. Perceived cost was positively correlated to distance traveled, money spent, and missed work (p<0.01). Most were comfortable with medical communication using technology; and 34.3%-42.7% would avoid an in-person clinic visit utilizing email, telephone, and video conferencing. Higher perceived cost (p<0.001) and distance traveled (p<0.01) were only weakly associated with greater willingness to substitute a clinic visit with video conferencing. Many families face high costs related to routine outpatient clinical visits, and there is a substantial willingness by them to access telemedicine alternatives, rather than the traditional face-to-face clinical visit. Copyright © 2015 Elsevier Inc. All rights reserved.

The relationship between adherence to clinic appointments and year-one mortality for newly enrolled HIV infected patients at a regional referral hospital in Western Kenya, January 2011-December 2012.

PubMed

Kimeu, Muthusi; Burmen, Barbara; Audi, Beryl; Adega, Anne; Owuor, Karen; Arodi, Susan; Bii, Dennis; Zielinski-Gutiérrez, Emily

2016-01-01

This retrospective cohort analysis was conducted to describe the association between adherence to clinic appointments and mortality, one year after enrollment into HIV care. We examined appointment-adherence for newly enrolled patients between January 2011 and December 2012 at a regional referral hospital in western Kenya. The outcomes of interest were patient default, risk factors for repeat default, and year-one risk of death. Of 582 enrolled patients, 258 (44%) were defaulters. GEE revealed that once having been defaulters, patients were significantly more likely to repeatedly default (OR 1.4; 95% CI 1.12-1.77), especially the unemployed (OR 1.43; 95% CI 1.07-1.91), smokers (OR 2.22; 95% CI 1.31-3.76), and those with no known disclosure (OR 2.17; 95% CI 1.42-3.3). Nineteen patients (3%) died during the follow-up period. Cox proportional hazards revealed that the risk of death was significantly higher among defaulters (HR 3.12; 95% CI 1.2-8.0) and increased proportionally to the rate of patient default; HR was 4.05 (95% CI1.38-11.81) and 4.98 (95% CI 1.45-17.09) for a cumulative of 4-60 and ≥60 days elapsed between all scheduled and actual clinic appointment dates, respectively. Risk factors for repeat default suggest a need to deliver targeted adherence programs.

A prospective, randomized, comparative clinical study of resin composite and glass ionomer cement for retrograde root filling.

PubMed

Jensen, S S; Nattestad, A; Egdø, P; Sewerin, I; Munksgaard, E C; Schou, S

2002-12-01

To compare the clinical and radiographic treatment outcome of retrograde root filling with either dentin-bonded resin composite (Retroplast, RP) or glass ionomer cement (Chelon-Silver, CS). A prospective, randomized clinical study of 134 consecutive patients with indication of retrograde root filling of an incisor, canine, premolar, or first molar. Either RP or CS was chosen at random as retrograde filling material. Either material was applied onto the entire resection surface after prepared slightly concave. This preparation technique makes a sealing of the entire resection surface possible and prevents marginal contraction gaps during polymerization. A total of 122 patients were available for 1-year follow-up. After 1 year the proportion of successful cases was significantly higher in the RP group (73%) than in the CS group (31%) (p<0.001). Doubtful healing with a need for a longer observation period was seen in 17% of the RP cases and 19% of the CS cases. The proportion of failures in the RP group (10%) was significantly lower than that in the CS group (50%) (p<0.001). Most of the unsuccessful CS cases failed due to loosening of the retrograde filling. Dentin-bonded RP applied onto the entire, slightly concave resection surface is a predictable apical sealant characterized by a high success rate. In contrast, retrograde root filling with CS results in an unacceptably high failure rate due to insufficient bonding strength to the concave resection surface.

Quality improvement intervention to increase adherence to ART prescription policy at HIV treatment clinics in Lusaka, Zambia: A cluster randomized trial

PubMed Central

Subramaniam, Hamsa L.; Prust, Margaret L.; Prescott, Marta R.; Mpasela, Felton; Mwango, Albert; Namonje, Leah; Moyo, Crispin; Chibuye, Benjamin; van den Broek, Jan Willem; Hehman, Lindsey; Moberley, Sarah

2017-01-01

Introduction In urban areas, crowded HIV treatment facilities with long patient wait times can deter patients from attending their clinical appointments and picking up their medications, ultimately disrupting patient care and compromising patient retention and adherence. Methods Formative research at eight facilities in Lusaka revealed that only 46% of stable HIV treatment patients were receiving a three-month refill supply of antiretroviral drugs, despite it being national policy for stable adult patients. We designed a quality improvement intervention to improve the operationalization of this policy. We conducted a cluster-randomized controlled trial in sixteen facilities in Lusaka with the primary objective of examining the intervention’s impact on the proportion of stable patients receiving three-month refills. The secondary objective was examining whether the quality improvement intervention reduced facility congestion measured through two proxy indicators: daily volume of clinic visits and average clinic wait times for services. Results The mean change in the proportion of three-month refills among control facilities from baseline to endline was 10% (from 38% to 48%), compared to a 25% mean change (an increase from 44% to 69%) among intervention facilities. This represents a significant 15% mean difference (95% CI: 2%-29%; P = 0.03) in the change in proportion of patients receiving three-month refills. On average, control facilities had 15 more visits per day in the endline than in the baseline, while intervention facilities had 20 fewer visits per day in endline than in baseline, a mean difference of 35 fewer visits per day (P = 0.1). The change in the mean facility total wait time for intervention facilities dropped 19 minutes between baseline and endline when compared to control facilities (95% CI: -10.2–48.5; P = 0.2). Conclusion A more patient-centred service delivery schedule of three-month prescription refills for stable patients is viable. We encourage the expansion of this sustainable intervention in Zambia’s urban clinics. PMID:28419106

Quality improvement intervention to increase adherence to ART prescription policy at HIV treatment clinics in Lusaka, Zambia: A cluster randomized trial.

PubMed

McCarthy, Elizabeth A; Subramaniam, Hamsa L; Prust, Margaret L; Prescott, Marta R; Mpasela, Felton; Mwango, Albert; Namonje, Leah; Moyo, Crispin; Chibuye, Benjamin; van den Broek, Jan Willem; Hehman, Lindsey; Moberley, Sarah

2017-01-01

In urban areas, crowded HIV treatment facilities with long patient wait times can deter patients from attending their clinical appointments and picking up their medications, ultimately disrupting patient care and compromising patient retention and adherence. Formative research at eight facilities in Lusaka revealed that only 46% of stable HIV treatment patients were receiving a three-month refill supply of antiretroviral drugs, despite it being national policy for stable adult patients. We designed a quality improvement intervention to improve the operationalization of this policy. We conducted a cluster-randomized controlled trial in sixteen facilities in Lusaka with the primary objective of examining the intervention's impact on the proportion of stable patients receiving three-month refills. The secondary objective was examining whether the quality improvement intervention reduced facility congestion measured through two proxy indicators: daily volume of clinic visits and average clinic wait times for services. The mean change in the proportion of three-month refills among control facilities from baseline to endline was 10% (from 38% to 48%), compared to a 25% mean change (an increase from 44% to 69%) among intervention facilities. This represents a significant 15% mean difference (95% CI: 2%-29%; P = 0.03) in the change in proportion of patients receiving three-month refills. On average, control facilities had 15 more visits per day in the endline than in the baseline, while intervention facilities had 20 fewer visits per day in endline than in baseline, a mean difference of 35 fewer visits per day (P = 0.1). The change in the mean facility total wait time for intervention facilities dropped 19 minutes between baseline and endline when compared to control facilities (95% CI: -10.2-48.5; P = 0.2). A more patient-centred service delivery schedule of three-month prescription refills for stable patients is viable. We encourage the expansion of this sustainable intervention in Zambia's urban clinics.

ALK gene copy number gain and its clinical significance in hepatocellular carcinoma.

PubMed

Jia, Shou-Wei; Fu, Sha; Wang, Fang; Shao, Qiong; Huang, Hong-Bing; Shao, Jian-Yong

2014-01-07

To examine the status and clinical significance of anaplastic lymphoma kinase (ALK) gene alterations in hepatocellular carcinoma (HCC) patients. A total of 213 cases of HCC were examined by fluorescent in situ hybridization using dual color break-apart ALK probes for the detection of chromosomal translocation and gene copy number gain. HCC tissue microarrays were constructed, and the correlation between the ALK status and clinicopathological variables was assessed by χ(2) test or Fisher's exact test. Survival analysis was estimated using the Kaplan-Meier approach with a Log-rank test. Univariate and multivariate analyses of clinical variables were performed using the Cox proportional hazards regression model. ALK gene translocation was not observed in any of the HCC cases included in the present study. ALK gene copy number gain (ALK/CNG) (≥ 4 copies/cell) was detected in 28 (13.15%) of the 213 HCC patients. The 3-year progression-free-survival (PFS) rate for ALK/CNG-positive HCC patients was significantly poorer than ALK/CNG-negative patients (27.3% vs 42.5%, P = 0.048), especially for patients with advanced stage III/IV (0% vs 33.5%, P = 0.007), and patients with grade III disease (24.8% vs 49.9%, P = 0.023). ALK/CNG-positive HCC patients had a significantly poorer prognosis than ALK/CNG-negative patients in the subgroup that was negative for serum hepatitis B virus DNA, with significantly different 3-year overall survival rates (18.2% vs 63.6%, P = 0.021) and PFS rates (18.2% vs 46.9%, P = 0.019). Multivariate Cox proportional hazards regression analysis suggested that ALK/CNG prevalence can predict death in HCC (HR = 1.596; 95%CI: 1.008-2.526, P = 0.046). ALK/CNG, but not translocation of ALK, is present in HCC and may be an unfavorable prognostic predictor.

ALK gene copy number gain and its clinical significance in hepatocellular carcinoma

PubMed Central

Jia, Shou-Wei; Fu, Sha; Wang, Fang; Shao, Qiong; Huang, Hong-Bing; Shao, Jian-Yong

2014-01-01

AIM: To examine the status and clinical significance of anaplastic lymphoma kinase (ALK) gene alterations in hepatocellular carcinoma (HCC) patients. METHODS: A total of 213 cases of HCC were examined by fluorescent in situ hybridization using dual color break-apart ALK probes for the detection of chromosomal translocation and gene copy number gain. HCC tissue microarrays were constructed, and the correlation between the ALK status and clinicopathological variables was assessed by χ2 test or Fisher’s exact test. Survival analysis was estimated using the Kaplan-Meier approach with a Log-rank test. Univariate and multivariate analyses of clinical variables were performed using the Cox proportional hazards regression model. RESULTS: ALK gene translocation was not observed in any of the HCC cases included in the present study. ALK gene copy number gain (ALK/CNG) (≥ 4 copies/cell) was detected in 28 (13.15%) of the 213 HCC patients. The 3-year progression-free-survival (PFS) rate for ALK/CNG-positive HCC patients was significantly poorer than ALK/CNG-negative patients (27.3% vs 42.5%, P = 0.048), especially for patients with advanced stage III/IV (0% vs 33.5%, P = 0.007), and patients with grade III disease (24.8% vs 49.9%, P = 0.023). ALK/CNG-positive HCC patients had a significantly poorer prognosis than ALK/CNG-negative patients in the subgroup that was negative for serum hepatitis B virus DNA, with significantly different 3-year overall survival rates (18.2% vs 63.6%, P = 0.021) and PFS rates (18.2% vs 46.9%, P = 0.019). Multivariate Cox proportional hazards regression analysis suggested that ALK/CNG prevalence can predict death in HCC (HR = 1.596; 95%CI: 1.008-2.526, P = 0.046). CONCLUSION: ALK/CNG, but not translocation of ALK, is present in HCC and may be an unfavorable prognostic predictor. PMID:24415871

A report on an acute, in-hours, outpatient review clinic with ultrasonography facilities for the early evaluation of general surgical patients.

PubMed

Pidgeon, T E; Shariff, U; Devine, F; Menon, V

2016-09-01

Introduction In 2013 our hospital introduced an in-hours, consultant-led, outpatient acute surgical clinic (ASC) for emergency general surgical patients. In 2014 this clinic was equipped with a dedicated ultrasonography service. This prospective cohort study evaluated this service before and after the introduction of ultrasonography facilities. Methods Data were recorded prospectively for all patients attending the clinic during 2013 and 2014. The primary outcome was patient destination (whether there was follow-up/admission) after clinic attendance. Results The ASC reviewed patients with a wide age range and array of general surgical complaints. In 2013, 186 patients attended the ASC. After the introduction of the ultrasonography service in 2014, 304 patients attended. In 2014, there was a reduction in the proportion of patients admitted to hospital from the clinic (18.3% vs 8.9%, p=0.002). However, the proportion of patients discharged after ASC review remained comparable with 2013 (30.1% in 2013 vs 38.8% in 2014, p=0.051). The proportion of patients undergoing computed tomography (CT) scans also fell (14.0% vs 4.9%, p<0.001). Conclusions The ASC assessed a wide array of general surgical complaints. Only a small proportion required hospital admission. The introduction of an ultrasonography service was associated with a further reduction in admission rates and computed tomography.

Myoelectric control system and task-specific characteristics affect voluntary use of simultaneous control

PubMed Central

Smith, Lauren H.; Kuiken, Todd A.; Hargrove, Levi J.

2015-01-01

Clinically available myoelectric control does not enable simultaneous proportional control of prosthetic degrees of freedom. Multiple studies have proposed systems that provide simultaneous control, though few have investigated whether subjects voluntarily use simultaneous control or how they implement it. Additionally, few studies have explicitly evaluated the effect of providing proportional velocity control. The objective of this study was to evaluate factors influencing when and how subjects use simultaneous myoelectric control, including the ability to proportionally control the velocity and the required task precision. Five able-bodied subjects used simultaneous myoelectric control systems with and without proportional velocity control in a virtual Fitts’ Law task. Though subjects used simultaneous control to a substantial degree when proportional velocity control was present, they used very little simultaneous control when using constant-velocity control. Furthermore, use of simultaneous control varied significantly with target distance and width, reflecting a strategy of using simultaneous control for gross cursor positioning and sequential control for fine corrective movements. These results provide insight into how users take advantage of simultaneous control and highlight the need for real-time evaluation of simultaneous control algorithms, as the potential benefit of providing simultaneous control may be affected by other characteristics of the myoelectric control system. PMID:25769167

Cyclin D1 is significantly associated with stage of tumor and predicts poor survival in endometrial carcinoma patients.

PubMed

Khabaz, Mohamad Nidal; Abdelrahman, Amer Shafie; Butt, Nadeem Shafique; Al-Maghrabi, Basim; Al-Maghrabi, Jaudah

2017-10-01

Cyclin D1 overexpression has been described to have oncogenic role and association with diagnosis, prognosis and survival in various tumors. This study will describe the immunohistochemical phenotype of cyclin D1, and investigate the correlation between these patterns of expression and clinicopathological parameters of endometrial carcinomas, to conclude the clinical relevance of cyclin D1 expression in the evolution of endometrial neoplasms. This study employed 101 endometrial tissue samples which include 71 endometrial carcinomas and thirty normal and benign endometrium cases. All these tissue samples were used in the assembly of tissue microarrays which have been utilized afterward in immunohistochemistry staining to detect cyclin D1 expression. Forty (56.3%) cases of endometrial carcinomas showed brown nuclear expression of cyclin D1 including 36 (61%) cases of endometrioid carcinomas, and 3 (33.3%) cases of serous carcinomas. Twenty three (76.6%) cases of control group demonstrated nuclear expression. High score cyclin D1 immunohistochemical staining has been significantly linked with patient age (P=0.0001). Large proportion of high score cyclin D1 immunohistochemical staining was observed in females who are <40years of age while high proportions of negative staining were observed in older age groups. Histologic type of tissue was also significantly related to cyclin D1 immunohistochemical staining (P-value=0.0001), high staining is more common in normal proliferative and secretory endometrium while serous carcinoma is more prevalent with negative staining. Stage of tumor was significantly associated with cyclin D1 immunohistochemical staining (P-value=0.029), proportion of stage III and IV are higher in negative cyclin D1 immunostaining. Significantly higher proportion of high score cyclin D1 immunostaining is observed in controls while higher proportion of negative cyclin D1 immunostaining is observed among carcinoma cases (P-value=0.0001). No significant associations between cyclin D1 immunohistochemical staining and grade, recurrence and alive status were observed. Significant different survival distributions were observed (P-value=0.011) and poor survival behavior was correlated with negative cyclin D1 immunohistochemical staining. In conclusion, greater frequency of cyclin D1 expression was revealed in normal endometrial tissues in comparison with carcinomas. The distribution pattern of cyclin D1 immunoexpression suggests poor prognoses in endometrial carcinoma patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Dairy herd mastitis and reproduction: using simulation to aid interpretation of results from discrete time survival analysis.

PubMed

Hudson, Christopher D; Bradley, Andrew J; Breen, James E; Green, Martin J

2015-04-01

Probabilistic sensitivity analysis (PSA) is a simulation-based technique for evaluating the relative importance of different inputs to a complex process model. It is commonly employed in decision analysis and for evaluation of the potential impact of uncertainty in research findings on clinical practice, but has a wide variety of other possible applications. In this example, it was used to evaluate the association between herd-level udder health and reproductive performance in dairy herds. Although several recent studies have found relatively large associations between mastitis and fertility at the level of individual inseminations or lactations, the current study demonstrated that herd-level intramammary infection status is highly unlikely to have a clinically significant impact on the overall reproductive performance of a dairy herd under typical conditions. For example, a large increase in incidence rate of clinical mastitis (from 92 to 131 cases per 100 cows per year) would be expected to increase a herd's modified FERTEX score (a cost-based measure of overall reproductive performance) by just £4.50(1) per cow per year. The herd's background level of submission rate (proportion of eligible cows served every 21 days) and pregnancy risk (proportion of inseminations leading to a pregnancy) correlated strongly with overall reproductive performance and explained a large proportion of the between-herd variation in performance. PSA proved to be a highly useful technique to aid understanding of results from a complex statistical model, and has great potential for a wide variety of applications within the field of veterinary science. Copyright © 2015 Elsevier Ltd. All rights reserved.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ORAL MATRICARIA RECUTITA (CHAMOMILE) EXTRACT THERAPY OF GENERALIZED ANXIETY DISORDER

PubMed Central

Amsterdam, Jay D.; Li, Yimei; Soeller, Irene; Rockwell, Kenneth; Mao, Jun James; Shults, Justine

2013-01-01

Objective We conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of Matricaria recutita (chamomile) extract therapy in patients with mild to moderate Generalized Anxiety Disorder (GAD). We hypothesized that chamomile would be superior to placebo in reducing GAD symptoms with a comparable tolerability profile. Materials & Methods 61 outpatients with mild to moderate GAD were enrolled and 57 were randomized to either double blind chamomile extract (n=28) or placebo (n=29) therapy for 8 weeks. The study was powered to detect a statistically significant and clinically meaningful group difference in change over time in total Hamilton Anxiety Rating (HAM-A) scores. Secondary outcomes included change in the Beck Anxiety Inventory score, Psychological Well Being score, Clinical Global Impression Severity score, and the proportion of patients with ≥50% reduction in baseline HAM-A score. Results We observed a significantly greater reduction in mean total HAM-A score during chamomile versus placebo therapy (p=0.047). Although the study was not powered to identify small to moderate differences in secondary outcomes, we observed a positive change in all secondary outcomes in the same direction as the primary outcome measure. One patient in each treatment group discontinued therapy for adverse events. The proportion of patients experiencing 0, 1, 2, or ≥3 adverse events was not significantly different between groups (p=0.417). Conclusion This is the first, controlled clinical trial of chamomile extract for GAD. The results suggest that chamomile may have modest anxiolytic activity in patients with mild to moderate GAD. Future studies are needed to replicate these observations. PMID:19593179

Shivering in Febrile Children: Frequency and Usefulness in Predicting Serious Bacterial Infections - A Prospective Case-Control Study.

PubMed

Erell, Yair; Youngster, Ilan; Abu-Kishk, Ibrahim; Kozer, Eran

2017-11-01

A prospective case-control study was conducted in a pediatric emergency department to describe the proportion of febrile children experiencing shivering and its clinical significance. Shivering was reported in 186 of 645 febrile children (28.8%). The rate of serious bacterial infection was similar in 86 children with shivering and 86 matched controls. Copyright © 2017 Elsevier Inc. All rights reserved.

Understanding health anxiety following breast cancer diagnosis.

PubMed

Jones, Shannon L; Hadjistavropoulos, Heather D; Gullickson, Kirsten

2014-01-01

Health anxiety is a persistent fear of illness or disease that often involves the misinterpretation of bodily symptoms as signs of serious illness. Evidence shows that health anxiety affects a proportion of women following a diagnosis of breast cancer, but there are some limitations to how health anxiety has been measured. The objectives of this study were to (1) provide an estimate of clinically elevated health anxiety in women after a diagnosis of breast cancer using a validated measure appropriate for medical populations and (2) understand patient, disease, and anxiety/vulnerability variables that predict health anxiety in this group. Canadian women (n = 137) diagnosed with breast cancer within the past five years completed an online survey measuring health anxiety, along with patient, disease, and anxiety/vulnerability variables. Clinically significant health anxiety was reported by 23.4% of the sample. The regression model revealed that younger age, more advanced stage of breast cancer, increased cognitive anxiety sensitivity, and greater body vigilance were significant unique predictors of health anxiety. These findings highlight that a proportion of women report substantial health anxiety following breast cancer diagnosis, with a combination of patient, disease, and anxiety/vulnerability variables associated with the experience. Further research is needed to better understand the impact of health anxiety in this population.

The Real-World Effect of Intravitreous Anti-Vascular Endothelial Growth Factor Drugs on Intraocular Pressure: An Analysis Using the IRIS Registry.

PubMed

Atchison, Elizabeth A; Wood, Kevin M; Mattox, Cynthia G; Barry, Catherine N; Lum, Flora; MacCumber, Mathew W

2018-05-01

To identify sustained differences in intraocular pressure (IOP) after intravitreous injections of anti-vascular endothelial growth factor (VEGF) drugs. Database study. Patients seeing an ophthalmic provider who contributes to the database. We identified a total of 23 776 unique patients who received only a single type of anti-VEGF medication (bevacizumab, aflibercept, or ranibizumab) by injection in the right eye in the American Academy of Ophthalmology Intelligent Research in Sight Registry. Subgroups included patients with age-related macular degeneration only and patients who had not received an anti-VEGF injection for at least 1 year before the study. We examined those with at least 12, 18, and 25 injections for each of these 3 medications. For all groups, we used fellow, untreated eyes for comparison. The mean change in IOP from baseline at a minimum of 1 year of follow-up and the proportion of eyes with a clinically significant IOP increase (defined as sustained rise of at least 6 mmHg to an IOP of more than 21 mmHg). All patients in all groups receiving all drugs showed a decrease in IOP from baseline, with a mean of 0.9 mmHg in treated eyes compared with an average decrease of 0.2 mmHg in fellow untreated eyes, a statistically significant difference. A generalized linear model accounting for confounders associated bevacizumab with slightly less lowering of IOP than aflibercept and ranibizumab in most subgroups. A clinically significant IOP increase was seen in 2.6% of eyes receiving injections compared with 1.5% in the associated untreated fellow eyes. Clinically significant IOP increases occurred at a rate of 1.9%, 2.8%, and 2.8% for aflibercept, ranibizumab, and bevacizumab, respectively, which was significantly higher than untreated fellow eyes for bevacizumab and ranibizumab, but not for aflibercept. These analyses from real-world data indicate that anti-VEGF intravitreous injections are associated with a small but statistically significant decrease in IOP over time. A proportion of patients, on average 2.6%, experienced a sustained clinically significant IOP rise with these drugs overall compared with 1.5% in the fellow untreated eyes. However, such an increase was not seen with aflibercept. Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Addition of a Short Course of Prednisolone to a Gluten-Free Diet vs. Gluten-Free Diet Alone in Recovery of Celiac Disease: A Pilot Randomized Controlled Trial.

PubMed

Abbas, Asad; Shahab, Tabassum; Sherwani, Rana K; Alam, Seema

2018-01-28

Background A gluten-free diet (GFD) is the standard of care in the management of patients with celiac disease, but clinical and histological recovery are often delayed. In newly diagnosed patients, strict compliance to GFD is difficult to achieve; this is especially true in developing countries where gluten-free food is often difficult to obtain. Steroids, when used alone, can be effective in inducing recovery in patients with celiac disease. We performed a randomized controlled trial to study the effect of a short course of prednisolone combined with a GFD on the recovery of celiac disease. Materials and methods This study was a single-center, randomised, open-label trial. This investigation was done in a pediatric gastroenterology unit of a tertiary teaching hospital in north India.Twenty-eight newly diagnosed celiac disease patients were enrolled in the study. Prednisolone was given at 1 mg/kg for four weeks; duodenal biopsies and IgA anti-tissue transglutaminase (tTg) levels were assessed at eight weeks, six months, and 12 months from the start of the study. Outcome measures The primary outcome measures used to indicate clinical, histological, and immunological recovery of celiac disease were clinical improvement at eight weeks and the proportion of patients with improved histology by at least one grade and who were tissue transglutaminase (tTg) seronegative at eight weeks. The secondary measures were the proportion of patients showing normalization of histological features and the proportions of patients becoming seronegative at six months and one year of GFD. Results Patients were randomized into the GFD only (n = 14) or GFD with prednisolone (GFD+P) (n = 14) groups. No significant differences were detected in clinical recovery at eight weeks; none of the patients became seronegative at eight weeks, six months, or 12 months. The proportion of patients with improvement in histology by at least one grade was higher in the GFD+P group at eight weeks, and there was no difference in overall histological improvement at 12 months after starting treatment. Conclusion The addition of a short course of prednisolone to a GFD does not affect clinical and serological recovery but might result in rapid histological recovery compared to a GFD alone in patients newly diagnosed with celiac disease.

Clinical Significance of p53 and p16(ink4a) Status in a Contemporary North American Penile Carcinoma Cohort.

PubMed

Zargar-Shoshtari, Kamran; Spiess, Philippe E; Berglund, Anders E; Sharma, Pranav; Powsang, Julio M; Giuliano, Anna; Magliocco, Anthony M; Dhillon, Jasreman

2016-08-01

Because of the low incidence of penile carcinoma (PC), the value of p16(ink4a), p53, and human papilloma virus (HPV) infection status in clinical practice remains unclear. Herein, we report our experience with potential clinical utility of these markers in men with PC treated at our institution. Tissue microarrays of 57 cases of invasive penile squamous cell carcinomas were immunohistochemically stained for p16 and p53. HPV in situ hybridization (ISH) for high-risk subtypes was also performed. Association between marker status, nodal disease, overall (OS) and cancer-specific survival (CSS) were assessed. p16 and HPV ISH were positive in 23 (40%) and 24 (42%) of the cohort, respectively. The proportion of warty, basaloid, or mixed warty basaloid tumor subtypes were significantly greater in the p16-positive patients (48% vs. 3%; P < .01). p53 expression was negative in 31 (54%) cases. Only in p16-negative patients, positive p53 status was associated with pN+ disease (odds ratio, 4.4 [95% confidence interval (CI), 1.04-18.6]). In Kaplan-Meier analysis, the unadjusted estimated OS was insignificantly longer in p16-positive patients (median OS, 75 vs. 27 months; P = .27) and median CSS was not reached (P = .16). In a multivariable Cox proportional hazard model, when controlling for pathological nodal status and adjuvant chemotherapy, p16 status was a significant predictor for improved CSS (hazard ratio, 0.36 [95% CI, 0.13-0.99]). The worst CSS was seen in pN+ patients with double negative p16 and p53 expression (8 vs. 34 months; P = .01). In this current cohort, p53 and p16 status showed clinical utility in predicting nodal disease as well as survival. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical factors associated with success of proportional assist ventilation in the acute phase of critical illness: pilot study.

PubMed

Delgado, M; Zavala, E; Tomás, R; Fernandez, R

2014-03-01

Proportional assist ventilation plus (PAV+) applies pressure depending on the patient's inspiratory effort, automatically adjusting flow and volume assist to changes in respiratory mechanics. We aimed to assess the clinical factors associated with the success of PAV+ as first-line support in the acute phase of critical illness. A prospective cohort study was carried out. Mechanically ventilated patients>24h were switched from assist-control ventilation to PAV+ as soon as they regained spontaneous breathing activity. PAV+ was set to deliver the highest assistance. We compared patients in whom PAV+ succeeded versus those in whom it failed. PAV+ succeeded in 12 (63%) patients, but failed in 7 (37%) due to tachypnea (n=4), hypercapnia (n=2), and metabolic acidosis (n=1), but without statistical significance. Both groups had similar clinical parameters. On the day of inclusion, total work of breathing per breath was lower in the successful PAV+ group (WOBTOT: 0.95 [0.8-1.35] vs. 1.6 [1.4-1.8] J/L; P<.007). The area under the ROC curve was 0.89 ± 0.08 for WOBTOT. The best cut-off for predicting PAV+ success was WOBTOT<1.4 J/L (sensitivity: 1 [0.7-1], specificity: 0.6 [0.4-0.6], PPV: 0.7 [0.5-0.7], and NPV: 1 [0.6-1]). PAV+ proved feasible as first-line ventilatory support in 63% of the patients, mostly in individuals without extreme derangements in WOBTOT. Tachypnea and hypercapnia were the clinical factors associated with failure, though statistical significance was not reached. Copyright © 2013 Elsevier España, S.L. and SEMICYUC. All rights reserved.

Analysis of internet use behaviors among clinical medical students in China.

PubMed

Yang, Hua; Chen, Yunxiang; Zheng, Liqiang; Xu, Xin; Cao, Xia

2014-04-02

The availability of internet-based information resources is increasing and the appropriate use of such resources is an important subject for clinical medical students. The aims of this study were to investigate the behaviors of clinical medical students regarding the use of internet-based activities, to analyze the behavior and characteristics of the students' information demands, and to discuss the behaviors and time preferences related to internet use of students with different levels of education. Librarians obtained real-time feedback from 999 clinical medical students to record online activities. The data was recorded in a standard form and then analyzed statistically. There were significant differences in the use of the internet for learning activities among the different groups of clinical medical students (P < 0.0001). Learning accounted for 73.5% of all internet use for doctoral candidates, 47.6% of internet use for master's candidates, 28.7% of internet use for seven-year undergraduate students, and 14.1% of use for five-year undergraduate students. There was also a significant difference in the proportions of leisure and e-commerce activities among the student groups (P < 0.0001), with five-year students displaying the highest total proportion of these activities (59.4% and 18.8%). Internet use for entertainment activities was the same for all groups of clinical medical students. Time of day of internet use was consistent across all student groups, but internet use differed by day of the week (P < 0.01). There was no difference among the time of day of internet use for learning, leisure and entertainment activities during a single day (P > 0.05), but e-commerce activities varied according to time of day (P < 0.05). Learning and e-commerce activities by clinical medical students did not vary by day of the week (P > 0.05), but the distributions of leisure and entertainment activities were different according to day of the week (P < 0.05). A stronger demand for learning is associated with a higher academic level of clinical medical students. Differences exist among student groups regarding internet use behaviors and internet use during different time periods.

Default patterns of patients attending clinics for sexually transmitted diseases.

PubMed Central

Mahony, J D; Bevan, J; Wall, B

1978-01-01

The influence of gender, propaganda, and treatment methods was studied in relation to default behaviour of patients with sexually transmitted diseases. The overall default rate of men and women was similar, but a larger proportion of men defaulted after the initial visit, while the biggest fall-out in women was after the second attendance at the clinic. The institution of a propaganda campaign was followed by a reduction in defaulting. The statistical significance of this is open to question, however: moreover the observed improvement in default rate was not maintained once the propaganda had been relaxed. Men treated for non-gonococcal urethritis by a regimen which included one injection a week for three weeks showed a highly significantly lower default rate compared with those who received tablets alone. PMID:580413

Incidence of potentially avoidable urgent readmissions and their relation to all-cause urgent readmissions

PubMed Central

van Walraven, Carl; Jennings, Alison; Taljaard, Monica; Dhalla, Irfan; English, Shane; Mulpuru, Sunita; Blecker, Saul; Forster, Alan J.

2011-01-01

Background: Urgent, unplanned hospital readmissions are increasingly being used to gauge the quality of care. We reviewed urgent readmissions to determine which were potentially avoidable and compared rates of all-cause and avoidable readmissions. Methods: In a multicentre, prospective cohort study, we reviewed all urgent readmissions that occurred within six months among patients discharged to the community from 11 teaching and community hospitals between October 2002 and July 2006. Summaries of the readmissions were reviewed by at least four practising physicians using standardized methods to judge whether the readmission was an adverse event (poor clinical outcome due to medical care) and whether the adverse event could have been avoided. We used a latent class model to determine whether the probability that each readmission was truly avoidable exceeded 50%. Results: Of the 4812 patients included in the study, 649 (13.5%, 95% confidence interval [CI] 12.5%–14.5%) had an urgent readmission within six months after discharge. We considered 104 of them (16.0% of those readmitted, 95% CI 13.3%–19.1%; 2.2% of those discharged, 95% CI 1.8%–2.6%) to have had a potentially avoidable readmission. The proportion of patients who had an urgent readmission varied significantly by hospital (range 7.5%–22.5%; χ2 = 92.9, p < 0.001); the proportion of readmissions deemed avoidable did not show significant variation by hospital (range 1.2%–3.7%; χ2 = 12.5, p < 0.25). We found no association between the proportion of patients who had an urgent readmission and the proportion of patients who had an avoidable readmission (Pearson correlation 0.294; p = 0.38). In addition, we found no association between hospital rankings by proportion of patients readmitted and rankings by proportion of patients with an avoidable readmission (Spearman correlation coefficient 0.28, p = 0.41). Interpretation: Urgent readmissions deemed potentially avoidable were relatively uncommon, comprising less than 20% of all urgent readmissions following hospital discharge. Hospital-specific proportions of patients who were readmitted were not related to proportions with a potentially avoidable readmission. PMID:21859870

Environmental Lead Pollution in an Urban Soft-water Area

PubMed Central

Beattie, A. D.; Moore, M. R.; Devenay, W. T.; Miller, A. R.; Goldberg, A.

1972-01-01

An investigation has been reported on the clinical and metabolic effects of lead acquired by soft domestic water from lead plumbing systems in 23 Glasgow households. The lead content of water from cold taps was up to 18 times the upper acceptable limit and was proportional to the amount of lead in the plumbing system. The blood lead of 71 inhabitants of these houses showed a significant positive correlation with water lead content. Delta-aminolaevulic acid dehydrase activity, an extremely sensitive indicator of lead exposure, showed a significant negative correlation with water-lead content. Atmospheric lead was within acceptable limits in all but one house and no significant correlation could be found with biochemical measurements. A small number of clinical abnormalities were found but could not be directly attributed to lead toxicity. The results of the study underline the possible danger to health of lead plumbing systems in soft-water regions. PMID:5031207

Evaluation of peripheral blood T lymphocyte surface activation markers and transcription factors in patients with early stage non-small cell lung cancer.

PubMed

Rutkowski, Jacek; Cyman, Marta; Ślebioda, Tomasz; Bemben, Kamila; Rutkowska, Aleksandra; Gruchała, Marcin; Kmieć, Zbigniew; Pliszka, Agnieszka; Zaucha, Renata

2017-12-01

Lung cancer cells harboring multiple mutations as a consequence of long-term damage by different etiologic factors are responsible for high immunogenicity. Immune checkpoint inhibitors significantly improve treatment results in non-small cell lung cancer (NSCLC). Unfortunately, the role of T-lymphocytes in early NSCLC has not been sufficiently elucidated. The aim of this study was to characterize peripheral blood T cells expressing several selected surface antigens (CD4, CD8, CD25, CD28, PD-1, CTLA-4) and transcription factors (T-bet, ROR-yt, Fox-P3, GATA-3) in this patient population. The study group (LC) consisted of 80 treatment-naïve patients with T1/2aN0M0 NSCLC and was compared with 40 cancer-free patients matched for non-oncological diseases and demographic parameters (CG). Significantly higher counts of CTLA-4+cells (in both CD4+and CD8+subtypes), a lower proportion of PD-1 expressing cells and a significantly higher percentage of Fox-P3+CD4+cells were found in the LC group. The high proportion of CD4+PD-1+cells significantly correlated with poor outcomes in LC group, while low CD4/CD8 ratio predicted a better prognosis. Based on our results it seems that NSCLC even at early stages of development initiate changes in the proportions of T cells that may have a significant impact on the clinical outcome. Copyright © 2017 Elsevier Inc. All rights reserved.

Unexpected deaths in cardiology outpatients - what can we learn from case review?

PubMed

Kitz, Thomas Michael; Burnand, Nikki; Ortner, Astrid; Rudd, Ian G; Sampson, Rod; Rushworth, Gordon F; Leslie, Stephen James

2016-12-01

A proportion of cardiac patients managed at a cardiology outpatient clinic will die between clinic visits. This study aimed to identify the cause of death, to determine if case review occurred and if a formal review of such cases might be useful. Single-centre retrospective cohort study. A remote regional centre in the North of Scotland. All patients who had been removed from the cardiology outpatient clinic due to death in the community. Cause of death, comorbidities and treatments were collected from hospital records and the national register of deaths. Chi-squared test and Student's t -test were used with significance taken at the 5% level. Of 10,606 patients who attended the cardiology outpatient clinic, 75 (0.7%) patients died in the community. The majority (57.0%) died from a non-cardiac cause. Eleven patients (14.9%) died due to an unexpected cardiac death. A detailed case note review was undertaken. In only two (18.2%) cases was any note made as to the cause of death in the hospital records and in only one was there details of post mortem discussion between primary and secondary care. A small proportion of patients attending a cardiology outpatient clinic died in the community. Documentation of the death in the hospital notes was very poor and evidence of post mortem communication between primary and secondary care was absent in all but one case. Better documentation and communication between primary and secondary care would seem desirable.

External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme.

PubMed

Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

2007-07-01

Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over-express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the "real world".

[Pressure support ventilation and proportional assist ventilation during weaning from mechanical ventilation].

PubMed

Aguirre-Bermeo, H; Bottiroli, M; Italiano, S; Roche-Campo, F; Santos, J A; Alonso, M; Mancebo, J

2014-01-01

To compare tolerance, duration of mechanical ventilation (MV) and clinical outcomes during weaning from MV in patients subjected to either pressure support ventilation (PSV) or proportional assist ventilation (PAV). A prospective, observational study was carried out. Intensive Care Unit. A total of 40 consecutive subjects were allocated to either the PSV or the PAV group until each group contained 20 patients. Patients were included in the study when they met the criteria to begin weaning and the attending physician decided to initiate the weaning process. The physician selected the modality and set the ventilatory parameters. None. Demographic data, respiratory mechanics, ventilatory parameters, duration of MV, and clinical outcomes (reintubation, tracheostomy, mortality). Baseline characteristics were similar in both groups. No significant differences were observed between the PSV and PAV groups in terms of the total duration of MV (10 [5-18] vs. 9 [7-19] days; P=.85), reintubation (5 [31%] vs. 3 [19%]; P=.69), or mortality (4 [20%] vs. 5 [25%] deaths; P=1). Eight patients (40%) in the PSV group and 6 patients (30%) in the PAV group (P=.74) required a return to volume assist-control ventilation due to clinical deterioration. Tolerance, duration of MV and clinical outcomes during weaning from mechanical ventilation were similar in PSV and PAV. Copyright © 2013 Elsevier España, S.L. and SEMICYUC. All rights reserved.

Evaluation of the effect of storage condition on cell extraction and flow cytometric analysis from intestinal biopsies.

PubMed

Wildenberg, Manon E; Duijvestein, Marjolijn; Westera, Liset; van Viegen, Tanja; Buskens, Christianne J; van der Bilt, Jarmila D W; Stitt, Larry; Jairath, Vipul; Feagan, Brian G; Vande Casteele, Niels

2018-06-01

Flow cytometric (FC) analysis of intestinal tissue biopsies requires prompt cell isolation and processing to prevent cell death and generate valid data. We examined the effect of storage conditions prior to cell isolation and FC on viable cell yield and the proportions of immune cell phenotypes from intestinal biopsies. Biopsies (N = 224) from inflamed or non-inflamed ileal and/or colonic tissue from three patients with Crohn's disease were processed and analyzed immediately in duplicate, or stored under different conditions. Cells were isolated and stained for specific markers, followed by FC. Decreased mean live CD45+ cell counts were observed after storage of biopsies at -80 °C dimethyl sulfoxide (DMSO)/citrate buffer compared with immediate processing (1794.3 vs. 19,672.7; p = 0.006]). A non-significant decrease in CD45+ live cell count occurred after storage at -20 °C in DMSO/citrate buffer and cell yield was adequate for subsequent analysis. CD3+ cell proportions were significantly lower after storage at 4 °C in complete medium for 48 h compared with immediate analysis. Mean CD14+ cell proportions were significantly higher after storage of biopsies at -80 °C in DMSO/citrate buffer compared with immediate analysis (2.61% vs. 1.31%, p = 0.007). CD4+, CD8+ and CD4+/CD8+ cell proportions were unaffected by storage condition. Storage of intestinal tissue biopsies at -20 °C in DMSO/citrate buffer for up to 48 h resulted in sufficient viable cell yield for FC analysis without affecting subsequent marker-positive cell proportions. These findings support the potential shipping and storage of intestinal biopsies for centralized FC analysis in multicenter clinical trials. Copyright © 2018 Elsevier B.V. All rights reserved.

Measurement of Lacrimal Sac Fossa Using Orbital Computed Tomography.

PubMed

Kang, Dongwan; Park, Jinhwan; Na, Jaehoon; Lee, Hwa; Baek, Sehyun

2017-01-01

To evaluate the clinical usefulness of measuring the lacrimal sac fossa length using orbital computed tomography in normal Koreans. The authors retrospectively evaluated 140 patients (70 males and 70 females) who underwent orbital computed tomography at Guro Hospital and who had no history of orbital disease or orbital trauma. Computed tomography scans of the right orbit, including the proportion of the lacrimal bone and maxillary bone that comprise the lacrimal sac fossa, were evaluated at 3 different axial planes (lower, middle, and upper levels). Additionally, the mid-point thickness and maximum thickness of the maxillary bone were measured. Finally, the authors also evaluated the relationship between nasal bone height and maxillary bone thickness in the lacrimal sac fossa. Maxillary bone thickness in the lacrimal sac fossa was thicker in males than in females at mid-point thickness and maximum thickness (P < 0.05). However, there was no significant difference in the size of the lacrimal sac fossa and the proportion of the maxillary bone between males and females.In comparisons between maxillary cross-sections, bone thickness was greater toward the upper level of the lacrimal sac fossa (P = 0.008), and the proportion of the maxillary bone was also greater (P = 0.006).Aging had a significant positive correlation with maxillary bone thickness at all 3 axial planes (P < 0.05), but there was no relationship between age and maxillary bone proportion. Nasal bone height and maxillary bone thickness were also not significantly related. In comprising the lacrimal sac fossa, the maxillary bone accounted for a bigger proportion than the lacrimal bone. Male maxillary bone thickness was greater than female thickness. The authors also observed that maxillary bone thickness increased toward the upper areas of the lacrimal sac fossa and with increasing subject age. Understanding the form and variation of a normal lacrimal sac fossa is helpful for preparing for a successful osteotomy with endoscopic dacryocystorhinostomy.

Evidence for Ordering of Alzheimer’s Disease Biomarkers

PubMed Central

Jack, Clifford R.; Vemuri, Prashanthi; Wiste, Heather J.; Weigand, Stephen D.; Aisen, Paul S.; Trojanowski, John Q.; Shaw, Leslie M.; Bernstein, Matthew A.; Petersen, Ronald C.; Weiner, Michael W.

2012-01-01

Objective To empirically assess the concept that Alzheimer’s disease (AD) biomarkers significantly depart from normality in a temporally ordered manner. Design Validation sample Setting Multi-site, referral centers Patients We studied 401 elderly cognitively normal (CN), Mild Cognitive Impairment (MCI) and AD dementia subjects from the Alzheimer’s Disease Neuroimaging Initiative. We compared the proportions of three AD biomarkers – CSF Aβ42, CSF total tau (t-tau), and hippocampal volume adjusted by intra-cranial volume (HVa) - that were abnormal as cognitive impairment worsened. Cut-points demarcating normal vs. abnormal for each biomarker were established by maximizing diagnostic accuracy in independent autopsy samples. Interventions None Main Outcome measures AD biomarkers Results Within each clinical group in the entire sample (n=401) CSF Aβ42 was abnormal more often than t-tau or HVa. Among the 298 subjects with both baseline and 12 month data, the proportion of subjects with abnormal Aβ42 did not change from baseline to 12 months in any group. The proportion of subjects with abnormal t-tau increased from baseline to 12 months in CN (p=0.05) but not in MCI or dementia. In 209 subjects with abnormal CSF AB42 at baseline, the percent abnormal HVa, but not t-tau, increased from baseline to 12 months in MCI. Conclusions Reduction in CSF Aβ42 denotes a pathophysiological process that significantly departs from normality (i.e., becomes dynamic) early, while t-tau and HVa are biomarkers of downstream pathophysiological processes. T-tau becomes dynamic before HVa, but HVa is more dynamic in the clinically symptomatic MCI and dementia phases of the disease than t-tau. PMID:21825215

Impact of arterial access site on outcomes after primary percutaneous coronary intervention: prespecified subgroup analysis from the EUROMAX trial.

PubMed

Hamon, Martial; Coste, Pierre; Van't Hof, Arnoud; Ten Berg, Jurrien; Clemmensen, Peter; Tabone, Xavier; Benamer, Hakim; Kristensen, Steen D; Cavallini, Claudio; Marzocchi, Antonio; Hamm, Christian; Kanic, Vojko; Bernstein, Debra; Anthopoulos, Prodromos; Deliargyris, Efthymios N; Steg, Philippe Gabriel

2015-06-01

In European Ambulance Acute Coronary Syndrome Angiography (EUROMAX), bivalirudin improved 30-day clinical outcomes with reduced major bleeding compared with heparins plus optional glycoprotein IIb/IIIa inhibitors. We assessed whether choice of access site (radial or femoral) had an impact on 30-day outcomes and whether it interacted with the benefit of bivalirudin. In EUROMAX, choice of arterial access was left to operator discretion. Overall, 47% of patients underwent radial and 53% femoral access. Baseline risk was higher in the femoral access group. Unadjusted proportions for the primary outcome (death or noncoronary artery bypass graft protocol major bleeding at 30 days) were lower with radial access, however, without differences in major or major plus minor bleeding proportions. After multivariable adjustment, ischemic outcomes were no longer different between access site groups, except for a lower risk of stroke in radial patients. Bivalirudin was associated with lower proportions of the primary outcome in both the radial (odds ratio, 0.58; 95% CI, 0.33-1.03; P=0.058) and the femoral groups (odds ratio, 0.59; 95% CI, 0.37-0.93; P=0.022; interaction P=0.97). Bleeding was significantly lower in the bivalirudin group both in the radial- and femoral-treated patients but no significant difference was observed in ischemic outcomes. In multivariable analysis, bivalirudin emerged as the only independent predictor of reduced major bleeding (odds ratio, 0.45; 95% CI, 0.27-0.74; P=0.002). In this prespecified analysis from EUROMAX, radial access was preferred in lower risk patients and did not improve clinical outcomes. Bivalirudin was associated with less bleeding irrespective of access site. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01087723. © 2015 American Heart Association, Inc.

Clinicoradiological Correlation of Infarct Patterns on Diffusion-weighted Magnetic Resonance Imaging in Stroke.

PubMed

Hussain, Zainab; Hilal, Kiran; Ahmad, Muhammad; Sajjad, Zafar; Sayani, Raza

2018-03-02

Diffusion-weighted magnetic resonance imaging (DW-MRI) represents a major advance in the early diagnosis of acute ischemic stroke. It can detect edema due to ischemia in the brain tissue. It not only establishes the presence and location of ischemic brain injury but also a relatively new concept is the determination of infarct patterns seen on diffusion imaging and its clinical correlation. Objective To determine the frequency of various infarct patterns and their relationship with functional outcome of the patient. Materials and methods A total of 108 patients with acute stroke were enrolled by purposive sampling. Magnetic resonance imaging (MRI) was obtained with departmental protocol and diffusion-weighted sequences. The clinical data was collected from medical records and functional outcome was assessed at the time of admission using Barthel Index (BI) which was dichotomized into poor and favorable outcomes. The radiological data was collected and three infarct patterns (cortical, subcortical, and territorial infarcts) were recorded from diffusion-weighted images. Association of other risk factors such as age, gender, diabetes, hypertension (HTN), hyperlipidemia, and smoking were also evaluated. Results Amongst the three infarct patterns, subcortical infarcts were noted with the highest proportion of 62% (67/108). The highest proportion of territorial infarcts (78.6%) was significantly associated with a poor outcome in comparison to cortical and subcortical infarcts. Cortical infarcts (61.5%) were significantly associated with good outcomes followed by subcortical and then territorial infarcts (p-value < 0.002). Amongst the risk factors, HTN was found to be highly prevalent followed by diabetes mellitus (DM). Conclusion Subcortical infarct pattern was the most common, followed by territorial and cortical infarct. The highest proportion of infarct pattern with good outcomes was seen with cortical infarcts followed by subcortical and then territorial infarct pattern. HTN and coronary artery disease (CAD) were the effect modifiers showing significant association with poor outcomes.

Update on dialysis economics in the UK.

PubMed

Sharif, Adnan; Baboolal, Keshwar

2011-03-01

The burgeoning population of patients requiring renal replacement therapy contributes a disproportionate strain on National Health Service resources. Although renal transplantation is the preferred treatment modality for patients with established renal failure, achieving both clinical and financial advantages, limitations to organ donation and clinical comorbidities will leave a significant proportion of patients with established renal failure requiring expensive dialysis therapy in the form of either hemodialysis or peritoneal dialysis. An understanding of dialysis economics is essential for both healthcare providers and clinical leaders to establish clinically efficient and cost-effective treatment modalities that maximize service provision. In light of changes to the provision of healthcare funds in the form of "Payment by Results," it is imperative for UK renal units to adopt clinically effective and financially accountable dialysis programs. This article explores the role of dialysis economics and implications for UK renal replacement therapy programs.

Longitudinal motor development of "apparently normal" high-risk infants at 18 months, 3 and 5 years.

PubMed

Goyen, Traci Anne; Lui, Kei

2002-12-01

Motor development appears to be more affected by premature birth than other developmental domains, however few studies have specifically investigated the development of gross and fine motor skills in this population. To examine longitudinal motor development in a group of "apparently normal" high-risk infants. Developmental follow-up clinic in a perinatal centre. Longitudinal observational cohort study. Fifty-eight infants born less than 29 weeks gestation and/or 1000 g and without disabilities detected at 12 months. Longitudinal gross and fine motor skills at 18 months, 3 and 5 years using the Peabody Developmental Motor Scales. The HOME scale provided information of the home environment as a stimulus for development. A large proportion (54% at 18 months, 47% at 3 years and 64% at 5 years) of children continued to have fine motor deficits from 18 months to 5 years. The proportion of infants with gross motor deficits significantly increased over this period (14%, 33% and 81%, p<0.001), particularly for the 'micropreemies' (born <750 g). In multivariate analyses, gross motor development was positively influenced by the quality of the home environment. A large proportion of high-risk infants continued to have fine motor deficits, reflecting an underlying problem with fine motor skills. The proportion of infants with gross motor deficits significantly increased, as test demands became more challenging. In addition, the development of gross and fine motor skills appears to be influenced differently by the home environment.

Multidrug-resistant pulmonary tuberculosis in Los Altos, Selva and Norte regions, Chiapas, Mexico.

PubMed

Sánchez-Pérez, H J; Díaz-Vázquez, A; Nájera-Ortiz, J C; Balandrano, S; Martín-Mateo, M

2010-01-01

To analyse the proportion of multidrug-resistant tuberculosis (MDR-TB) in cultures performed during the period 2000-2002 in Los Altos, Selva and Norte regions, Chiapas, Mexico, and to analyse MDR-TB in terms of clinical and sociodemographic indicators. Cross-sectional study of patients with pulmonary tuberculosis (PTB) from the above regions. Drug susceptibility testing results from two research projects were analysed, as were those of routine sputum samples sent in by health personnel for processing (n = 114). MDR-TB was analysed in terms of the various variables of interest using bivariate tests of association and logistic regression. The proportion of primary MDR-TB was 4.6% (2 of 43), that of secondary MDR-TB was 29.2% (7/24), while among those whose history of treatment was unknown the proportion was 14.3% (3/21). According to the logistic regression model, the variables most highly associated with MDR-TB were as follows: having received anti-tuberculosis treatment previously, cough of >3 years' duration and not being indigenous. The high proportion of MDR cases found in the regions studied shows that it is necessary to significantly improve the control and surveillance of PTB.

Frequency and clinical features of patients who attempted suicide by charcoal burning in Japan.

PubMed

Kato, Koji; Akama, Fumiaki; Yamada, Keigo; Maehara, Mizuki; Kimoto, Keitaro; Kimoto, Kousuke; Takahashi, Yuki; Sato, Reiko; Onishi, Yuichi; Matsumoto, Hideo

2013-02-15

To date, the clinical features between patients in Japan who have attempted suicide by charcoal burning and those who have attempted suicide by other methods in the context of a mental disorder diagnosis as assessed by structured interviews have not been reported. We enrolled 647 consecutive patients who attempted suicide and were hospitalized for inpatient treatment. Psychiatric diagnoses, frequency of suicide attempts, and clinical features were compared between charcoal burning and other suicide methods. Twenty of the 647 patients (3.1%) had attempted suicide by charcoal burning. The ratio of men to women was significantly higher by this method compared with that of other methods. The proportion of patients with mood disorders was significantly higher in the charcoal burning group than that in the other methods group. The occurrence of a psychiatric history in patients in the charcoal burning group was significantly lower than that in the other methods group. The study sample was limited to a single hospital. The results demonstrate the clinical characteristics of patients who attempted suicide by charcoal burning. Therefore, it is necessary to identify the clinical features of patients who have attempted suicide by charcoal burning in Japan. Copyright © 2012 Elsevier B.V. All rights reserved.

Cumulative trauma disorders in betel pepper leaf-cullers visiting a rehabilitation clinic: experience in Taitung.

PubMed

Wang, Lin-Yi; Pong, Ya-Ping; Wang, Her-Cherng; Su, Sheng-Hsiang; Tsai, Chang-Hsueh; Leong, Chau-Peng

2005-04-01

Betel pepper (Piper betle L.) cultivation is an important agricultural industry in Taitung, Taiwan, and culling leaves is very labor-intensive. This case study compares the proportion of cumulative trauma disorders (CTDs) between cullers and those with other occupations. Patients with musculoskeletal disorders in the rehabilitation clinic of a local hospital in Taitung were enrolled. This all female cohort was divided into a culler group (betel pepper cullers, n = 20), and a non-culler group (other occupations, n = 47). Three cullers were interviewed, and were also recorded to elucidate the related ergonomics. Patients were diagnosed using plain radiography and ultrasonography. The act of culling involves an overhead internal rotation of both shoulders with extended elbows while standing, followed by wrist flexion and forearm pronation. Flexing of the fingers is also required by the tools, 'iron nails' fitted onto both thumbs. The proportions of patients with shoulder impingement syndrome (SIS) and carpal tunnel syndrome (CTS) were significantly higher among cullers than non-cullers (0.45 vs. 0.15, p = 0.011 and 0.40 vs. 0.06, p = 0.002, respectively). Furthermore, the total frequency of CTDs displayed a positive linear correlation with employment duration (r = 0.618, p = 0.004). Proportions of occupational SIS and CTS were higher among betel pepper cullers than those with other occupations. These CTDs may have resulted from a prolonged static posture and repetitive motions during culling.

Is there still a place for emergency department thrombolysis following the introduction of the amended Joint Royal Colleges Ambulance Liaison Committee criteria for thrombolysis?

PubMed

Castle, N R; Owen, R C; Hann, M

2007-12-01

To apply the current (2004) and the amended (2006) Joint Royal Colleges Ambulance Liaison Committee (JRCALC) criteria for paramedic initiated thrombolysis to all patients who received thrombolytic treatment in an emergency department (ED) to determine if the amendments increase the proportion suitable for paramedic initiated thrombolysis. Retrospective descriptive analysis. The ED clinical notes, ambulance clinical record and the first recorded ECG (ED or ambulance) of all patients thrombolysed in the ED during a 12 month period were reviewed against the previous JRCALC guidelines (2004) and the amended JRCALC guidelines (2006) for thrombolysis. Using the JRCALC guidelines (2004), 26 of the 147 patients (17.7%) were eligible for paramedic initiated thrombolysis. Using the JRCALC guidelines (2006), this increased to 41 (27.9%). This difference was statistically significant (McNemar's I2 test with 1 degree of freedom = 15.00; p<0.001). The change to the blood pressure, age and pulse rate parameters has increased the percentage eligible for paramedic initiated thrombolysis by 10.2% (95% confidence interval 4.6% to 15.8%). The amended JRCALC guidelines (2006) for paramedic initiated thrombolysis have successfully increased the proportion of patients suitable for prehospital thrombolysis by approximately 10%, although the ED retains an important role in the provision of prompt thrombolytic treatment for a proportion of patients.

Clinical pharmacokinetics of Icotinib, an anti-cancer drug: evaluation of dose proportionality, food effect, and tolerability in healthy subjects.

PubMed

Liu, Dongyang; Jiang, Ji; Zhang, Li; Tan, Fenlai; Wang, Yingxiang; Zhang, Don; Hu, Pei

2014-04-01

Icotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, has proved effectiveness in xenografted nude mice. Purpose of the present studies was to investigate tolerability and pharmacokinetics of Icotinib in healthy subjects for the first time, including dose proportionality, food effect, and tolerability. Two studies were conducted in total of 22 healthy subjects: a randomized, two-Latin-square crossover, dose proportional study (n = 12) and a randomized two-way crossover food-effect study (n = 10). Plasma concentration of Icotinib reached peak at a median Tmax of 0.75-3.5 h after single dose and then declined with a mean t1/2β of 6.02-7.83 h. Over the dose range of 100-600 mg, AUC values were proportional to dose and Cmax showed a slight saturation when dose increases. Only 0.2 % of the dose was excreted through kidney in unchanged Icotinib. After dosing 400 mg of Icotinib with high-fat and high-calorie meal, mean Cmax and AUC were significantly increased by 59 and 79 %, respectively. Three subjects experienced four adverse events (rash, increase in AST and ALT, and external injury). Rash and increased levels of AST and ALT were considered as drug-related. No serious adverse events were reported. The current work demonstrated that Icotinib was well tolerated in healthy male subjects (n = 22) over the dose range of 100-600 mg with or without food. Icotinib exposure, expressed in AUC, was proportionally increased with dose over the above dose range. Food intake significantly increased the absorption and exposure of Icotinib in healthy subjects.

A bibliometric analysis assessing temporal changes in publication and authorship characteristics in The Knee from 1996 to 2016.

PubMed

Sheridan, G; Wisken, E; Hing, C B; Smith, T O

2018-03-01

Evidence-based practice is a foundation to clinical excellence. However there remains little evidence on the characteristics of authors who contribute to the evidence-base and whether these have changed over time. The purpose of this study was to explore these characteristics by undertaking a bibliometric analysis to explore publication and authorship characteristics in a leading sub-speciality orthopaedic journal (The Knee) over a 20-year period. All articles published in The Knee in 1996, 2006 and 2016 were identified. For each article, data collected included: highest academic award; profession; gender; continent of first and last author; total number of authors; the level of evidence; and funding source. We analysed temporal changes in these variables using appropriate statistical models. A total of 413 papers were analysed. Between 1996 to 2016 there has been a significant increase in the overall number of authors, the number of paper submitted from Asia, the proportion of Level 1 or 2 tiered evidence, the proportion of people with Bachelor or Master-level degrees as their highest level of educational award and the proportion of non-medically qualified authors (P<0.001). From 2006 to 2016 there was a significant increase in the proportion of articles whose first author was female (P=0.03), but no significant change in the number of females as last author (P=0.43). The findings indicate that there have been changes in publication and authorship characteristics in this sub-speciality orthopaedic journal during the past 20years. This provides encouraging indication of greater diversification and internationalisation of orthopaedic research. Copyright © 2018 Elsevier B.V. All rights reserved.

Persistence of impaired health status of Q fever patients 4 years after the first Dutch outbreak.

PubMed

Limonard, G J M; Peters, J B; Besselink, R; Groot, C A R; Dekhuijzen, P N R; Vercoulen, J H; Nabuurs-Franssen, M H

2016-04-01

A significant proportion of Q fever patients from the first Dutch Q fever outbreak in 2007 showed impairment in health status up to 1 year after infection. Interested in whether this decrease in health status persisted, we set out to determine the health status in the same cohort of patients, 4 years after primary infection and to compare health status scores at the individual patient level between 1 and 4 years follow-up. Health status was assessed with the Nijmegen Clinical Screening Instrument (NCSI). Patients were serologically tested to exclude patients with possible, probable or proven chronic Q fever. Results on the NCSI sub-domains at group level [2008 (n = 54) and 2011 (n = 46)] showed a persistent significant percentage of patients exhibiting clinically relevant ('severe') scores for all NCSI sub-domains. After 4 years, undue fatigue was present in 46% and exactly half of all patients experienced a severely impaired general quality of life. Patients with NCSI scores available in both 2008 and 2011 (n = 37) showed no difference in all sub-domain scores, except for a small decrease in dyspnoea emotions in 2011. In this group, a significant proportion of patients either improved or worsened in one or more sub-domains of health status. We conclude that at the group level, health status of Q fever patients remained impaired 4 years after primary infection. At the individual patient level, health status may change.

[The epidemiological relationship of periodontitis, intestinal dysbiosis, atherogenic dyslipidemia and metabolic syndrome].

PubMed

Petrukhina, N B; Zorina, O A; Rabinovich, I M; Shilov, A M

2015-01-01

The study of risk factors for cardio-vascular continuum (CVC), the influence of the digestive tract endobiosis on lipid-carbohydrate metabolism and clinical status, a retrospective analysis of 1000 medical records of patients, suffering from various diseases of internal organs (Gastrointestinal tract, coronary heart disease, type 2 diabetes, obesity) in combination with periodontitis of varying severity, aged 20 to 55 years. A statistically significant relationship is directly proportional to the severity of inflammation of periodontal tissues with body mass index (BMI), especially pronounced in patients with a BMI ≥225 kg/m2 which is the "calling card" of the metabolic syndrome - clinical model polymorbidity.

Primary Care Collaborative Memory Clinics: Building Capacity for Optimized Dementia Care.

PubMed

Lee, Linda; Hillier, Loretta M; Molnar, Frank; Borrie, Michael J

2017-01-01

Increasingly, primary care collaborative memory clinics (PCCMCs) are being established to build capacity for person-centred dementia care. This paper reflects on the significance of PCCMCs within the system of care for older adults, supported with data from ongoing evaluation studies. Results highlight timelier access to assessment with a high proportion of patients being managed in primary care within a person-centred approach to care. Enhancing primary care capacity for dementia care with interprofessional and collaborative care will strengthen the system's ability to respond to increasing demands for service and mitigate the growth of wait times to access geriatric specialist assessment.

Underreporting of liver transplant waitlist removals due to death or clinical deterioration: results at four major centers.

PubMed

Goldberg, David; French, Benjamin; Trotter, James; Shetty, Kirti; Schiano, Thomas; Reddy, K Rajender; Halpern, Scott D

2013-07-27

Few studies have evaluated the accuracy of United Network for Organ Sharing (UNOS) or Scientific Registry of Transplant Recipients data among patients listed for liver transplantation. Of particular importance for transplant policy and practice is whether patients' outcomes are coded properly. Using data from four transplant centers, we identified all liver transplant candidates removed from the waitlist from February 27, 2002 to July 24, 2010, with a specific focus the removal code of "other." Among nontransplanted patients at these centers, 2206 patients were removed for death or clinical deterioration. Of these, 8.6% (189 of 2206) were misclassified; they were assigned the UNOS removal code of "other." Among these 189 misclassified patients, 128 became medically unsuitable, 35 died, and 26 became too sick to transplant. Nearly one-half (46.8%) of misclassified patients were removed due to advanced hepatocellular carcinoma. Among true waitlist removals for death, only 35 of 1593 (2.2%) were misclassified. Conversely, of true removals for clinical deterioration, 154 of 612 (25.2%) were misclassified, with significant (P < 0.001) center variation: 4.4% (Baylor), 8.0% (Georgetown), 32.6% (University of Pennsylvania), and 45.0% (Mount Sinai). Extrapolating these data to the entire United States, if "other" patients who truly died or clinically deteriorated were recoded appropriately, there would be an additional 2525 (95% confidence interval, 2046-3102) patients removed from the waitlist due to death (331) or clinical deterioration (2194) since 2002. A substantial proportion of patients truly removed from the waitlist for death or clinical deterioration were misclassified as "other." Thus, analyses using the UNOS or the Scientific Registry of Transplant Recipients database may underestimate the true proportion of patients removed from the waitlist for clinical deterioration.

Anti-MDA5 autoantibodies in juvenile dermatomyositis identify a distinct clinical phenotype: a prospective cohort study

PubMed Central

2014-01-01

Introduction The aim of this study was to define the frequency and associated clinical phenotype of anti-MDA5 autoantibodies in a large UK based, predominantly Caucasian, cohort of patients with juvenile dermatomyositis (JDM). Methods Serum samples and clinical data were obtained from 285 patients with JDM recruited to the UK Juvenile Dermatomyositis Cohort and Biomarker Study. The presence of anti-MDA5 antibodies was determined by immunoprecipitation and confirmed by ELISA using recombinant MDA5 protein. Results were compared with matched clinical data, muscle biopsies (scored by an experienced paediatric neuropathologist) and chest imaging (reviewed by an experienced paediatric radiologist). Results Anti-MDA5 antibodies were identified in 7.4% of JDM patients and were associated with a distinct clinical phenotype including skin ulceration (P = 0.03) oral ulceration (P = 0.01), arthritis (P <0.01) and milder muscle disease both clinically (as determined by Childhood Myositis Assessment Score (P = 0.03)) and histologically (as determined by a lower JDM muscle biopsy score (P <0.01)) than patients who did not have anti-MDA5 antibodies. A greater proportion of children with anti-MDA5 autoantibodies achieved disease inactivity at two years post-diagnosis according to PRINTO criteria (P = 0.02). A total of 4 out of 21 children with anti-MDA5 had interstitial lung disease; none had rapidly progressive interstitial lung disease. Conclusions Anti-MDA5 antibodies can be identified in a small but significant proportion of patients with JDM and identify a distinctive clinical sub-group. Screening for anti-MDA5 autoantibodies at diagnosis would be useful to guide further investigation for lung disease, inform on prognosis and potentially confirm the diagnosis, as subtle biopsy changes could otherwise be missed. PMID:24989778

Immune response phenotype of allergic versus clinically tolerant pigs in a neonatal swine model of allergy.

PubMed

Schmied, Julie; Rupa, Prithy; Garvie, Sarah; Wilkie, Bruce

2013-07-15

The prevalence of childhood food allergy and the duration of these allergies, particularly those considered to be transient, like egg and milk allergy, are increasing. The identification of allergic individuals using minimally invasive, non-anaphylaxis-threatening methods is therefore of increasing importance. In this experiment, correlates were sought of an allergic immune response (IR) phenotype in pigs. Using pigs pre-treated with heat-killed bacteria or bacterial components before allergic sensitization with the egg white protein ovomucoid (Ovm), differences were determined in IR phenotype of pigs in the categories treated-allergic, treated-tolerant, control-allergic (CA) and control-tolerant. Phenotype was established by measuring immunoglobulin (Ig)-associated antibody activity (AbA), cytokine profiles and the proportion of blood T-regulatory cells (T-regs) and observing late-phase allergen-specific skin tests (ST). Although 100% of pigs became sensitized to Ovm, only 33% of pigs had clinical signs of allergy after oral challenge with egg white. Pigs without clinical signs were classified as clinically tolerant. Sixty-seven percent of allergic pigs had a positive, late-phase ST classified as very strong or strong, while 84% of clinically tolerant pigs did not have late-phase ST. Treated-allergic pigs and CA pigs had greater total antibody IgG (H+L), IgE and IgG1 AbA than clinically tolerant pigs. Cytokine profiles of allergic pigs and the proportion of circulating T-regs, did not differ significantly between allergic and clinically tolerant pigs. Therefore, measurement of allergen-specific IgG, IgG1 and/or IgE activity and evaluation of late-phase ID ST may be useful in identifying allergic IR phenotypes in swine models of food allergy, which may be extended toward human use. Copyright © 2013 Elsevier B.V. All rights reserved.

Secukinumab provides rapid and sustained pain relief in psoriatic arthritis over 2 years: results from the FUTURE 2 study.

PubMed

McInnes, Iain B; Mease, Philip J; Schett, Georg; Kirkham, Bruce; Strand, Vibeke; Williams, Nicole; Fox, Todd; Pricop, Luminita; Jugl, Steffen M; Gandhi, Kunal K

2018-06-07

Pain is one of the most important domains affecting health-related quality of life (HRQoL) in patients with psoriatic arthritis (PsA). Secukinumab has demonstrated rapid and sustained improvements in signs and symptoms, including HRQoL, among patients with active PsA. This analysis evaluates the effect of secukinumab on patient-reported pain in PsA through 104 weeks of treatment. Pain was assessed through week 104 using clinically relevant measures, including change from baseline in a pain visual analog scale (VAS) and Short Form-36 (SF-36) bodily domain scores; proportion of patients reporting improvements equal to or better than minimum clinically meaningful differences in the pain VAS and SF-36 bodily pain domain scores; and proportion of patients with no, moderate, or extreme pain/discomfort measured by the EuroQoL 5-Dimension 3-Level Questionnaire (EQ-5D-3 L) pain item scores. Correlations of pain measures were analyzed using Pearson's correlation coefficient. Pre-specified analyses of TNF-naïve patients and patients who stopped TNF-inhibitors (TNFis) due to inadequate responses or safety/tolerability (TNF-IR patients) were performed using "as-observed data." Mean improvements from baseline in pain VAS scores were greater with secukinumab versus placebo by week 3 (- 16.9; P < 0.0001 with secukinumab 300 mg and - 12.6; P < 0.05 with secukinumab 150 mg) and sustained through week 104. SF-36 bodily pain domain scores were significantly greater with 300 mg secukinumab and secukinumab 150 mg versus placebo by week 4 (16.2 and 16.3, respectively; P < 0.0001 for both), and these changes were maintained through week 104. With both secukinumab 300 mg and secukinumab 150 mg, improvements equal to or better than the minimum clinically meaningful differences in pain VAS and SF-36 bodily pain were significant versus placebo at week 3 and week 4, respectively. At week 4, 15%, 9%, and 5% of patients receiving secukinumab 300 mg, secukinumab 150 mg, and placebo, respectively, reported "no pain/discomfort" measured by EQ-5D-3 L; these proportions increased to week 104 with both secukinumab doses. Similarly, improvements in pain measures were significant in both TNF-naïve and TNF-IR patients. Secukinumab provided rapid and sustained pain relief in PsA over 2 years of treatment. Improvements in pain were reported regardless of prior exposure to TNFis. ClinicalTrials.gov, NCT01752634 . Registered on 19 December 2012.

Pilot study of medical-legal partnership to address social and legal needs of patients.

PubMed

Weintraub, Dana; Rodgers, Melissa A; Botcheva, Luba; Loeb, Anna; Knight, Rachael; Ortega, Karina; Heymach, Brooke; Sandel, Megan; Huffman, Lynne

2010-05-01

As a preliminary investigation of the effectiveness of medical-legal partnership in pediatrics, we conducted a 36-month prospective cohort study of the impact of clinic- and hospital-based legal services. We hypothesized that integration of legal services into pediatric settings would increase families' awareness of and access to legal and social services, decrease barriers to health care for children, and improve child health. Health care providers referred families with legal or social needs to the Peninsula Family Advocacy Program (FAP). Fifty four families completed both baseline and six-month follow-up assessments. Comparison of follow-up with baseline demonstrated significantly increased proportions of families who utilized food and income supports and significantly decreased proportions of families avoiding health care due to lack of health insurance or concerns about cost. Two-thirds of respondents reported improved child health and well-being. This study suggests that adding an attorney to the medical team increases awareness of and access to social and legal services.

Implementation of dextrose gel in the management of neonatal hypoglycaemia.

PubMed

Ter, Marene; Halibullah, Ikhwan; Leung, Laura; Jacobs, Susan

2017-04-01

The aim of this study was to evaluate dextrose gel in the management of neonatal hypoglycaemia in the postnatal wards at an Australian tertiary level perinatal centre. An audit was performed before and after implementation of dextrose gel. Pre-implementation, neonatal hypoglycaemia was managed with feed supplementation alone, and dextrose gel was used in addition to feed supplementation in the post-implementation phase. Outcomes included admission to neonatal intensive care unit (NICU) for management of hypoglycaemia, proportion of neonates who achieved normoglycaemia (defined as blood glucose ≥2.6 mmol/L, with no clinical signs after one or two treatment attempts) and proportion of neonates with hypoglycaemia recurrence after normoglycaemia and one or two treatment attempts. NICU admission for treatment of hypoglycaemia reduced significantly post-implementation of dextrose gel (29/100 (29%) vs. 14/100 (14%), P = 0.01). No significant difference was seen in the proportion of neonates achieving normoglycaemia (71/100 (71%) vs. 75/100 (75%), P = 0.52), but hypoglycaemia recurrence was higher in the post-implementation group (22/71 (31%) vs. 37/75 (49%), P = 0.02). Dextrose gel is effective in the management of neonatal hypoglycaemia in the postnatal ward setting, reducing admission to NICU and mother-infant separation. © 2016 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).

Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials

PubMed Central

Panés, Julian; Sandborn, William J; Schreiber, Stefan; Sands, Bruce E; Vermeire, Séverine; D'Haens, Geert; Panaccione, Remo; Higgins, Peter D R; Colombel, Jean-Frederic; Feagan, Brian G; Chan, Gary; Moscariello, Michele; Wang, Wenjin; Niezychowski, Wojciech; Marren, Amy; Healey, Paul; Maller, Eric

2017-01-01

Objective Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). Design We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. Results 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (p<0.0001) with 10 mg twice daily after both induction and maintenance treatments. Conclusions Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. No new safety signals were observed for tofacitinib. Trial registration numbers NCT01393626 and NCT01393899. PMID:28209624

Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians.

PubMed

Overby, Casey Lynnette; Devine, Emily Beth; Abernethy, Neil; McCune, Jeannine S; Tarczy-Hornoch, Peter

2015-06-01

To facilitate personalized drug dosing (PDD), this pilot study explored the communication effectiveness and clinical impact of using a prototype clinical decision support (CDS) system embedded in an electronic health record (EHR) to deliver pharmacogenomic (PGx) information to physicians. We employed a conceptual framework and measurement model to access the impact of physician characteristics (previous experience, awareness, relative advantage, perceived usefulness), technology characteristics (methods of implementation-semi-active/active, actionability-low/high) and a task characteristic (drug prescribed) on communication effectiveness (usefulness, confidence in prescribing decision), and clinical impact (uptake, prescribing intent, change in drug dosing). Physicians performed prescribing tasks using five simulated clinical case scenarios, presented in random order within the prototype PGx-CDS system. Twenty-two physicians completed the study. The proportion of physicians that saw a relative advantage to using PGx-CDS was 83% at the start and 94% at the conclusion of our study. Physicians used semi-active alerts 74-88% of the time. There was no association between previous experience with, awareness of, and belief in a relative advantage of using PGx-CDS and improved uptake. The proportion of physicians reporting confidence in their prescribing decisions decreased significantly after using the prototype PGx-CDS system (p=0.02). Despite decreases in confidence, physicians perceived a relative advantage to using PGx-CDS, viewed semi-active alerts on most occasions, and more frequently changed doses toward doses supported by published evidence. Specifically, sixty-five percent of physicians reduced their dosing, significantly for capecitabine (p=0.002) and mercaptopurine/thioguanine (p=0.03). These findings suggest a need to improve our prototype such that PGx CDS content is more useful and delivered in a way that improves physician's confidence in their prescribing decisions. The greatest increases in communication effectiveness and clinical impact of PGx-CDS are likely to be realized through continued focus on content, content delivery, and tailoring to physician characteristics. Copyright © 2015 Elsevier Inc. All rights reserved.

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.

PubMed

Kasivisvanathan, Veeru; Rannikko, Antti S; Borghi, Marcelo; Panebianco, Valeria; Mynderse, Lance A; Vaarala, Markku H; Briganti, Alberto; Budäus, Lars; Hellawell, Giles; Hindley, Richard G; Roobol, Monique J; Eggener, Scott; Ghei, Maneesh; Villers, Arnauld; Bladou, Franck; Villeirs, Geert M; Virdi, Jaspal; Boxler, Silvan; Robert, Grégoire; Singh, Paras B; Venderink, Wulphert; Hadaschik, Boris A; Ruffion, Alain; Hu, Jim C; Margolis, Daniel; Crouzet, Sébastien; Klotz, Laurence; Taneja, Samir S; Pinto, Peter; Gill, Inderbir; Allen, Clare; Giganti, Francesco; Freeman, Alex; Morris, Stephen; Punwani, Shonit; Williams, Norman R; Brew-Graves, Chris; Deeks, Jonathan; Takwoingi, Yemisi; Emberton, Mark; Moore, Caroline M

2018-05-10

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited. In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer. A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001). The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).

Randomized controlled trial of atorvastatin in clinically isolated syndrome

PubMed Central

Waubant, E.; Pelletier, D.; Mass, M.; Cohen, J.A.; Kita, M.; Cross, A.; Bar-Or, A.; Vollmer, T.; Racke, M.; Stüve, O.; Schwid, S.; Goodman, A.; Kachuck, N.; Preiningerova, J.; Weinstock-Guttman, B.; Calabresi, P.A.; Miller, A.; Mokhtarani, M.; Iklé, D.; Murphy, S.; Kopetskie, H.; Ding, L.; Rosenberg, E.; Spencer, C.; Zamvil, S.S.; Waubant, E.; Pelletier, D.; Mass, M.; Bourdette, D.; Egan, R.; Cohen, J.; Stone, L.; Kita, M.; Elliott, M.; Cross, A.; Parks, B.J.; Bar-Or, A.; Vollmer, T.; Campagnolo, D.; Racke, M.; Stüve, O.; Frohman, E.; Schwid, S.; Goodman, A.; Segal, B.; Kachuck, N.; Weiner, L.; Preiningerova, J.; Carrithers, M.; Weinstock-Guttman, B.; Calabresi, P.; Kerr, D.; Miller, A.; Lublin, F.; Sayre, Peter; Hayes, Deborah; Rosenberg, Ellen; Gao, Wendy; Ding, Linna; Adah, Steven; Mokhtarani, Masoud; Neuenburg, Jutta; Bromstead, Carolyn; Olinger, Lynn; Mullen, Blair; Jamison, Ross; Speth, Kelly; Saljooqi, Kerensa; Phan, Peter; Phippard, Deborah; Seyfert-Margolis, Vicki; Bourcier, Katarzyna; Debnam, Tracia; Romaine, Jennifer; Wolin, Stephanie; O'Dale, Brittany; Iklé, David; Murphy, Stacey; Kopetskie, Heather

2012-01-01

Objective: To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS). Methods: Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a). Results: Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at baseline. A total of 53.1% of atorvastatin recipients (n = 26/49) met PEP compared to 56.3% of placebo recipients (n = 18/32) (p = 0.82). Eleven atorvastatin subjects (22.4%) and 7 placebo subjects (21.9%) met the PEP by clinical criteria. Proportion of subjects who did not develop new T2 lesions up to month 12 or to starting IFNβ-1a was 55.3% in the atorvastatin and 27.6% in the placebo group (p = 0.03). Likelihood of remaining free of new T2 lesions was significantly greater in the atorvastatin group compared with placebo (odds ratio [OR] = 4.34, p = 0.01). Likelihood of remaining free of Gd lesions tended to be higher in the atorvastatin group (OR = 2.72, p = 0.11). Overall, atorvastatin was well tolerated. No clear antagonistic effect of atorvastatin plus IFNβ-1a was observed on MRI measures. Conclusion: Atorvastatin treatment significantly decreased development of new brain MRI T2 lesion activity, although it did not achieve the composite clinical and imaging PEP. Classification of Evidence: This study provided Class II evidence that atorvastatin did not reduce the proportion of patients with CIS meeting imaging and clinical criteria for starting immunomodulating therapy after 12 months, compared to placebo. In an analysis of a secondary endpoint (Class III), atorvastatin was associated with a reduced risk for developing new T2 lesions. PMID:22459680

The Genomic Ancestry of Individuals from Different Geographical Regions of Brazil Is More Uniform Than Expected

PubMed Central

Pena, Sérgio D. J.; Di Pietro, Giuliano; Fuchshuber-Moraes, Mateus; Genro, Julia Pasqualini; Hutz, Mara H.; Kehdy, Fernanda de Souza Gomes; Kohlrausch, Fabiana; Magno, Luiz Alexandre Viana; Montenegro, Raquel Carvalho; Moraes, Manoel Odorico; de Moraes, Maria Elisabete Amaral; de Moraes, Milene Raiol; Ojopi, Élida B.; Perini, Jamila A.; Racciopi, Clarice; Ribeiro-dos-Santos, Ândrea Kely Campos; Rios-Santos, Fabrício; Romano-Silva, Marco A.; Sortica, Vinicius A.; Suarez-Kurtz, Guilherme

2011-01-01

Based on pre-DNA racial/color methodology, clinical and pharmacological trials have traditionally considered the different geographical regions of Brazil as being very heterogeneous. We wished to ascertain how such diversity of regional color categories correlated with ancestry. Using a panel of 40 validated ancestry-informative insertion-deletion DNA polymorphisms we estimated individually the European, African and Amerindian ancestry components of 934 self-categorized White, Brown or Black Brazilians from the four most populous regions of the Country. We unraveled great ancestral diversity between and within the different regions. Especially, color categories in the northern part of Brazil diverged significantly in their ancestry proportions from their counterparts in the southern part of the Country, indicating that diverse regional semantics were being used in the self-classification as White, Brown or Black. To circumvent these regional subjective differences in color perception, we estimated the general ancestry proportions of each of the four regions in a form independent of color considerations. For that, we multiplied the proportions of a given ancestry in a given color category by the official census information about the proportion of that color category in the specific region, to arrive at a “total ancestry” estimate. Once such a calculation was performed, there emerged a much higher level of uniformity than previously expected. In all regions studied, the European ancestry was predominant, with proportions ranging from 60.6% in the Northeast to 77.7% in the South. We propose that the immigration of six million Europeans to Brazil in the 19th and 20th centuries - a phenomenon described and intended as the “whitening of Brazil” - is in large part responsible for dissipating previous ancestry dissimilarities that reflected region-specific population histories. These findings, of both clinical and sociological importance for Brazil, should also be relevant to other countries with ancestrally admixed populations. PMID:21359226

The relationship between adherence to clinic appointments and year-one mortality for newly enrolled HIV infected patients at a regional referral hospital in Western Kenya, January 2011–December 2012

PubMed Central

Kimeu, Muthusi; Burmen, Barbara; Audi, Beryl; Adega, Anne; Owuor, Karen; Arodi, Susan; Bii, Dennis; Zielinski-Gutiérrez, Emily

2016-01-01

This retrospective cohort analysis was conducted to describe the association between adherence to clinic appointments and mortality, one year after enrollment into HIV care. We examined appointment-adherence for newly enrolled patients between January 2011 and December 2012 at a regional referral hospital in western Kenya. The outcomes of interest were patient default, risk factors for repeat default, and year-one risk of death. Of 582 enrolled patients, 258 (44%) were defaulters. GEE revealed that once having been defaulters, patients were significantly more likely to repeatedly default (OR 1.4; 95% CI 1.12–1.77), especially the unemployed (OR 1.43; 95% CI 1.07–1.91), smokers (OR 2.22; 95% CI 1.31–3.76), and those with no known disclosure (OR 2.17; 95% CI 1.42–3.3). Nineteen patients (3%) died during the follow-up period. Cox proportional hazards revealed that the risk of death was significantly higher among defaulters (HR 3.12; 95% CI 1.2–8.0) and increased proportionally to the rate of patient default; HR was 4.05 (95% CI1.38–11.81) and 4.98 (95% CI 1.45–17.09) for a cumulative of 4–60 and ≥60 days elapsed between all scheduled and actual clinic appointment dates, respectively. Risk factors for repeat default suggest a need to deliver targeted adherence programs. PMID:26572059

Likely effect of the 2014 Ebola epidemic on HIV care in Liberia.

PubMed

Loubet, Paul; Mabileau, Guillaume; Baysah, Maima; Nuta, Cecilia; Taylor, Masietta; Jusu, Hawa; Weeks, Harry; Ingels, Anne; Perennec-Olivier, Marion; Chapplain, Jean-Marc; Cartier, Nathalie; Mendiharat, Pierre; Raguin, Gilles; Tattevin, Pierre; Yazdanpanah, Yazdan

2015-11-01

Liberia's health system has been severely struck by the 2014 Ebola epidemic. We aimed to assess the potential effect of this epidemic on the care of HIV patient in two clinics [John F. Kennedy (JFK) and Redemption Hospitals] in Monrovia, which stayed open throughout the epidemic. A preexisting electronic database of HIV patient's follow-up visits was used to estimate three weekly parameters from January 2012 to October 2014: number of visits, number of new patient, and proportion of patients with follow-up delay. We used segmented negative binomial regressions to assess trends before and after the week of the Ebola outbreak defined in June 2014 by WHO. The cumulative number of patients in care comprised 5948 patients with a total of 56 287 visits between January 2012 and October 2014. From June 2014, the number of visit per week, stable since 2012, abruptly decreased (59%) in Redemption (P < 0.001) and progressively decreased by 3% per week in JFK (P < 0.001). In both the clinics, the weekly proportion of patient with follow-up delay sharply increased after the point break from June 2014 (P value < 0.001). From June 2014, a significant decrease in new patients per week occurred in both the clinics: by 57% (P value < 0.001) in Redemption and by 4.6% per week (P value < 0.001) in JFK. The Ebola epidemic had a significant effect on HIV care in Monrovia. Given the particular impact on the rate of patients with follow-up delay, a long-term impact is feared.

Misleading reporting and interpretation of results in major infertility journals.

PubMed

Glujovsky, Demian; Sueldo, Carlos E; Borghi, Carolina; Nicotra, Pamela; Andreucci, Sara; Ciapponi, Agustín

2016-05-01

To evaluate the proportion of randomized controlled trials (RCTs) published in top infertility journals indexed on PubMed that reported their results with proper effect estimates and their precision estimation, while correctly interpreting both measures. Cross-sectional study evaluating all the RCTs published in top infertility journals during 2014. Not applicable. Not applicable. Not applicable. Proportion of RCTs that reported both relative and absolute effect size measures and its precision. Among the 32 RCTs published in 2014 in the top infertility journals reviewed, 37.5% (95% confidence interval [CI], 21.1-56.3) did not mention in their abstracts whether the difference among the study arms was statistically or clinically significant, and only 6.3% (95% CI, 0.8-20.8) used a CI of the absolute difference. Similarly, in the results section, these elements were observed in 28.2% (95% CI, 13.7-46.7) and 15.6% (95% CI, 5.3-32.8), respectively. Only one study clearly expressed the minimal clinically important difference in their methods section, but we found related proxies in 53% (95% CI, 34.7-70.9). None of the studies used CIs to draw conclusions about the clinical or statistical significance. We found 13 studies where the interpretation of the findings could be misleading. Recommended reporting items are underused in top infertility journals, which could lead to misleading interpretations. Authors, reviewers, and editorial boards should emphasize their use to improve reporting quality. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Previous radiographic experience of children referred for dental extractions under general anaesthesia in the U.K.

PubMed

Young, N L; Rodd, H D; Craig, S A

2009-03-01

To determine what proportion of children undergo radiographic assessment prior to referral to a dental hospital for extractions under general anaesthesia. This prospective survey was conducted over a 6-month period. A data sheet was used to record the following information: patient's age; referrer's name and place of work (general dental practice or community dental service); teeth to be extracted (primary dentition and/or permanent dentition) and reported previous radiographic examination. Patients were excluded from the study if, following a clinical examination, radiographs were not actually deemed necessary for diagnosis and treatment planning purposes. Clinical setting A paediatric dentistry clinic within a dental hospital in the North of England. Participants 161 patients with a mean age of six years (SD = 2.2, range = 3-14 years) who were referred to the dental hospital for extractions under general anaesthesia. Overall, 12.4% of children had reportedly undergone a previous radiographic assessment prior to hospital referral. A significantly greater proportion of children referred for permanent tooth extractions had been subject to radiographic examination compared to children referred for primary tooth extractions (46.2% as compared to 6.3%; P = 0.001 chi-squared test). Furthermore, patients referred from the community dental service were significantly more likely to have had previous dental radiographs than children referred from general dental practice (36.9% compared to 9.3%; P = 0.003 chi-squared test). Radiographs do not appear to be routinely employed for caries diagnosis and treatment planning in young children within general dental practice in the U.K.

An Australian general practice based strategy to improve chronic disease prevention, and its impact on patient reported outcomes: evaluation of the preventive evidence into practice cluster randomised controlled trial.

PubMed

Harris, Mark Fort; Parker, Sharon M; Litt, John; van Driel, Mieke; Russell, Grant; Mazza, Danielle; Jayasinghe, Upali W; Smith, Jane; Del Mar, Chris; Lane, Riki; Denney-Wilson, Elizabeth

2017-09-08

Implementing evidence-based chronic disease prevention with a practice-wide population is challenging in primary care. PEP Intervention practices received education, clinical audit and feedback and practice facilitation. Patients (40‑69 years) without chronic disease from trial and control practices were invited to participate in baseline and 12 month follow up questionnaires. Patient-recalled receipt of GP services and referral, and the proportion of patients at risk were compared over time and between intervention and control groups. Mean difference in BMI, diet and physical activity between baseline and follow up were calculated and compared using a paired t-test. Change in the proportion of patients meeting the definition for physical activity diet and weight risk was calculated using McNemar's test and multilevel analysis was used to determine the effect of the intervention on follow-up scores. Five hundred eighty nine patients completed both questionnaires. No significant changes were found in the proportion of patients reporting a BP, cholesterol, glucose or weight check in either group. Less than one in six at-risk patients reported receiving lifestyle advice or referral at baseline with little change at follow up. More intervention patients reported attempts to improve their diet and reduce weight. Mean score improved for diet in the intervention group (p = 0.04) but self-reported BMI and PA risk did not significantly change in either group. There was no significant change in the proportion of patients who reported being at-risk for diet, PA or weight, and no changes in PA, diet and BMI in multilevel linear regression adjusted for patient age, sex, practice size and state. There was good fidelity to the intervention but practices varied in their capacity to address changes. The lack of measurable effect within this trial may be attributable to the complexities around behaviour change and/or system change. This trial highlights some of the challenges in providing suitable chronic disease preventive interventions which are both scalable to whole practice populations and meet the needs of diverse practice structures. Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12612000578808 (29/5/2012). This trial registration is retrospective as our first patient returned their consent on the 21/5/2012. Patient recruitment was ongoing until 31/10/2012.

Effect of chronic kidney disease on warfarin management in a pharmacist-managed anticoagulation clinic.

PubMed

Kleinow, Megan E; Garwood, Candice L; Clemente, Jennifer L; Whittaker, Peter

2011-09-01

There is growing evidence that kidney disease affects hepatically cleared drugs. Accordingly, we hypothesized that chronic kidney disease (CKD) would disrupt anticoagulation of warfarin-treated patients and thereby increase the amount of management required to maintain appropriate anticoagulation. Specifically, we anticipated that more dose manipulations (both dose changes and transient dose adjustments) and shorter times between scheduled clinic visits would be required for anticoagulation patients with CKD. To determine how CKD affected warfarin maintenance dose, anticoagulation stability, the proportion of clinic visits that necessitated a dose manipulation (either a change in the prescribed weekly dose or a transient dose adjustment), and the length of time between scheduled visits in 2 pharmacist-managed anticoagulation clinics. Our retrospective, cohort chart review investigated warfarin response in anticoagulation clinic patients. From the clinic database of patients with an international normalized ratio (INR) target range of 2.0-3.0, we matched 20 of 24 patients with CKD (estimated creatinine clearance less than 60 mL per minute) to 20 comparison group patients (estimated creatinine clearance greater than 60 mL per minute) based on parameters demonstrated to affect warfarin dose: ethnicity, gender, age, body surface area, and simvastatin use. We calculated the average weekly dose used to maintain target INR (assessment period range=116-1,408 days). To evaluate anticoagulation stability and patient management, we quantified several parameters, including the percentage of total time in therapeutic range, the proportion of clinic visits that required a dose change, and the time between scheduled visits. We compared group means using t-tests, and categorical data were compared using Fisher's exact test. Our population was predominantly female (75%) and of African ancestry (95%); average age 60 years. Patients with CKD required a 24% lower dose than the comparison group (mean [SD]=35.9 [10.7] vs. 47.0 [11.2] mg per week, P=0.003) and spent less time in therapeutic range required increased clinic management versus the comparison group, as indicated by a significantly higher proportion of clinic visits at which dose changes occurred (22% vs. 12%, P<0.001) and a decreased time between scheduled visits (mean [SD] of 16.0 [3.2] days vs. 19.7 [3.4] days, respectively, P=0.001). CKD was associated with both decreased warfarin maintenance dose and decreased anticoagulation stability which, in turn, required more frequent and intensive anticoagulation clinic management.

The ability of four strains of Streptococcus uberis to induce clinical mastitis after intramammary inoculation in lactating cows.

PubMed

Notcovich, S; deNicolo, G; Williamson, N B; Grinberg, A; Lopez-Villalobos, N; Petrovski, K R

2016-07-01

To compare the ability of four strains of Streptococcus uberis at two doses to induce clinical mastitis in lactating dairy cows after intramammary inoculation in order to evaluate their usefulness for future experimental infection models. Four field strains of S. uberis (26LB, S418, and S523 and SR115) were obtained from cows with clinical mastitis in the Wairarapa and Waikato regions of New Zealand. Twenty-four crossbred lactating cows, with no history of mastitis and absence of major pathogens following culture of milk samples, were randomly allocated to four groups (one per strain) of six cows. Each cow was infused (Day 0) in one quarter with approximately 10(4) cfu and in the contralateral quarter with approximately 10(6) cfu of the same strain. The other two quarters remained unchallenged. All four quarters were then inspected for signs of clinical mastitis, by palpation and observation of the foremilk, twice daily from Days 0-9, and composite milk samples were collected from Days 0-8 for analysis of somatic cell counts (SCC). Quarters were treated with penicillin when clinical mastitis was observed. Duplicate milk samples were collected and cultured on presentation of each clinical case and on Day 4 from challenged quarters with no clinical signs. Clinical mastitis was diagnosed in 26/48 (54%) challenged quarters. Challenge with strain S418 resulted in more cases of mastitis (12/12 quarters) than strains SR115 (7/12), 26LB (6/12) or S523 (1/12), and the mean interval from challenge to first diagnosis of mastitis was shorter for S418 than the other strains (p<0.001). The proportion of quarters from which S. uberis could be isolated after challenge was less for strain 26LB (1/6) than SR115 (6/7) (p<0.05), and SCC following challenge was lower for strain S523 than the other strains (p<0.05). There were significant differences between the strains in the proportion of quarters developing clinical mastitis, the interval to mastitis onset, SCC following challenge and the proportion of clinical cases from which S. uberis could be isolated. These results illustrate the difference in the ability of S. uberis strains to cause mastitis and the severity of the infections caused. Experimental challenge models can be used to compare infectivity and pathogenicity of different strains of mastitis-causing bacteria, the efficacy of pharmaceutical products and host-responses in a cost-effective manner.

Symptoms of distress and posttraumatic stress among South African former political detainees.

PubMed

Kagee, Ashraf

2005-05-01

Considerable debate has centred on the question of traumatisation among individuals who have survived human rights violations in societies that have undergone political conflict. In order to gain an estimate of the extent of long-term traumatisation among political activists who experienced torture and abuse in detention during the apartheid era in South Africa, a sample of 148 survivors of such experiences were recruited in a cross-sectional study and asked to complete the Hopkins Symptom Checklist (HSCL), the Impact of Event Scale (IES), and the Trauma Symptoms section of the Harvard Trauma Questionnaire (HTQ). The proportions of the sample that scored above the clinical cut-points on these measures were calculated. On the HSCL, 14.19% of the sample scored above the cut-point for clinical significance of 44; on the IES, 17.57% scored above the clinical cut-point of 44; and on the HTQ, 37.83% scored above the cut-point of 75. Moreover, the sample's mean scores were significantly higher than the cut-point for clinically significant distress on the HSCL (p < 0.001); significantly lower than the cut-point for severe traumatisation on the IES (p < 0.001); and non-significantly lower than the cut-point for clinically significant traumatisation on the HTQ (p = 0.074). These results are considered in terms of current theoretical debates on the relevance and applicability of posttraumatic stress disorder as a circumscribed nosological entity in developing countries that are in the process of coming to terms with a history of political conflict.

First hundred cases of variant Creutzfeldt-Jakob disease: retrospective case note review of early psychiatric and neurological features

PubMed Central

Spencer, Michael D; Knight, Richard S G; Will, Robert G

2002-01-01

Objective To describe the early psychiatric and neurological features of variant Creutzfeldt-Jakob disease. Design Cohort study. Setting National surveillance system for Creutzfeldt-Jakob disease in the United Kingdom. Participants The first 100 cases of variant Creutzfeldt-Jakob disease identified in the United Kingdom. Main outcome measures The timing and nature of early psychiatric and neurological symptoms in variant Creutzfeldt-Jakob disease. Results The early stages of variant Creutzfeldt-Jakob disease are dominated by psychiatric symptoms, but neurological symptoms precede psychiatric symptoms in 15% of cases and are present in combination with psychiatric symptoms in 22% of cases from the onset of disease. Common early psychiatric features include dysphoria, withdrawal, anxiety, insomnia, and loss of interest. No common early neurological features exist, but a significant proportion of patients do exhibit neurological symptoms within 4 months of clinical onset, including poor memory, pain, sensory symptoms, unsteadiness of gait, and dysarthria. Conclusions Although the diagnosis of variant Creutzfeldt-Jakob disease may be impossible in the early stages of the illness, particular combinations of psychiatric and neurological features may allow early diagnosis in an appreciable proportion of patients. What is already known on this topicThe early stages of variant Creutzfeldt-Jakob disease are dominated by psychiatric symptomatologySome patients have early neurological features that might suggest the presence of an underlying neurological disorderWhat this study addsThis study provides a comprehensive description of the evolution of psychiatric and neurological features in variant Creutzfeldt-Jakob diseaseAn appreciable proportion of patients have early neurological symptomsA high proportion of patients have a combination of psychiatric and neurological features within four months of clinical onset that suggest the diagnosis of variant Creutzfeldt-Jakob disease PMID:12077031

Clinical assessment of the physical activity pattern of chronic fatigue syndrome patients: a validation of three methods.

PubMed

Scheeres, Korine; Knoop, Hans; Meer, van der Jos; Bleijenberg, Gijs

2009-04-01

Effective treatment of chronic fatigue syndrome (CFS) with cognitive behavioural therapy (CBT) relies on a correct classification of so called 'fluctuating active' versus 'passive' patients. For successful treatment with CBT is it especially important to recognise the passive patients and give them a tailored treatment protocol. In the present study it was evaluated whether CFS patient's physical activity pattern can be assessed most accurately with the 'Activity Pattern Interview' (API), the International Physical Activity Questionnaire (IPAQ) or the CFS-Activity Questionnaire (CFS-AQ). The three instruments were validated compared to actometers. Actometers are until now the best and most objective instrument to measure physical activity, but they are too expensive and time consuming for most clinical practice settings. In total 226 CFS patients enrolled for CBT therapy answered the API at intake and filled in the two questionnaires. Directly after intake they wore the actometer for two weeks. Based on receiver operating characteristic (ROC) curves the validity of the three methods were assessed and compared. Both the API and the two questionnaires had an acceptable validity (0.64 to 0.71). None of the three instruments was significantly better than the others. The proportion of false predictions was rather high for all three instrument. The IPAQ had the highest proportion of correct passive predictions (sensitivity 70.1%). The validity of all three instruments appeared to be fair, and all showed rather high proportions of false classifications. Hence in fact none of the tested instruments could really be called satisfactory. Because the IPAQ showed to be the best in correctly predicting 'passive' CFS patients, which is most essentially related to treatment results, it was concluded that the IPAQ is the preferable alternative for an actometer when treating CFS patients in clinical practice.

Orthotic treatment of positional brachycephaly associated with osteogenesis imperfecta.

PubMed

Matarazzo, Carolina G; Schreen, Gerd; Lago-Rizzardi, Camilla D do; Peccin, Maria Stella; Pinto, Fernando Cg

2017-12-01

Osteogenesis imperfecta is an inherited disorder of the connective tissue characterized primarily by fractures with no or small causal antecedents and extremely variable clinical presentation. The disorder requires a global and, therefore, multidisciplinary therapeutic approach that should aim, among other aspects, at the prevention and treatment of deformities resulting from osteogenesis imperfecta. Due to limitations related to bony deformities, it can be difficult to place these infants in a variety of positions that would help remediate skull deformities, so a cranial orthosis becomes the therapy of choice. The aim of this study was to demonstrate the results obtained during treatment with a cranial remolding orthosis (helmet) in babies with osteogenesis imperfecta. Case Description and Methods: For the first time in the scientific literature, this study describes the use of a cranial orthosis for the treatment of infants with osteogenesis imperfecta. Both children had severe asymmetrical brachycephaly documented by laser digital scanning and were submitted to treatment with a cranial remolding orthosis. Outcomes and Conclusion: The study showed that there was a significant improvement in cranial proportion and symmetry, with a reduction in the cephalic index at reevaluation. It is concluded that the orthotic therapy is an effective therapeutic modality to improve the proportion and minimize the asymmetry in children with osteogenesis imperfecta. Clinical relevance The clinical relevance of such a description is that children with osteogenesis imperfecta may have numerous deformities and minimizing them can be an important factor. This report showed a beneficial result as the orthotic therapy modality improved the proportions and minimized the asymmetry. This treatment offers too high levels of satisfaction to parents and brings these children closer to normal indices.

A Low-Effort, Clinic-Wide Intervention Improves Attendance for HIV Primary Care

PubMed Central

Gardner, Lytt I.; Marks, Gary; Craw, Jason A.; Wilson, Tracey E.; Drainoni, Mari-Lynn; Moore, Richard D.; Mugavero, Michael J.; Rodriguez, Allan E.; Bradley-Springer, Lucy A.; Holman, Susan; Keruly, Jeanne C.; Sullivan, Meg; Skolnik, Paul R.; Malitz, Faye; Metsch, Lisa R.; Raper, James L.; Giordano, Thomas P.

2012-01-01

Background. Retention in care for human immunodeficiency virus (HIV)–infected patients is a National HIV/AIDS Strategy priority. We hypothesized that retention could be improved with coordinated messages to encourage patients' clinic attendance. We report here the results of the first phase of the Centers for Disease Control and Prevention/Health Resources and Services Administration Retention in Care project. Methods. Six HIV-specialty clinics participated in a cross-sectionally sampled pretest-posttest evaluation of brochures, posters, and messages that conveyed the importance of regular clinic attendance. 10 018 patients in 2008–2009 (preintervention period) and 11 039 patients in 2009–2010 (intervention period) were followed up for clinic attendance. Outcome variables were the percentage of patients who kept 2 consecutive primary care visits and the mean proportion of all primary care visits kept. Stratification variables were: new, reengaging, and active patients, HIV RNA viral load, CD4 cell count, age, sex, race or ethnicity, risk group, number of scheduled visits, and clinic site. Data were analyzed by multivariable log-binomial and linear models using generalized estimation equation methods. Results. Clinic attendance for primary care was significantly higher in the intervention versus preintervention year. Overall relative improvement was 7.0% for keeping 2 consecutive visits and 3.0% for the mean proportion of all visits kept (P < .0001). Larger relative improvement for both outcomes was observed for new or reengaging patients, young patients and patients with elevated viral loads. Improved attendance among the new or reengaging patients was consistent across the 6 clinics, and less consistent across clinics for active patients. Conclusion. Targeted messages on staying in care, which were delivered at minimal effort and cost, improved clinic attendance, especially for new or reengaging patients, young patients, and those with elevated viral loads. PMID:22828593

Breed and maturity effects on Churra Galega Bragançana and Suffolk lamb carcass characteristics: Killing-out proportion and composition.

PubMed

Rodrigues, S; Cadavez, V; Teixeira, A

2006-02-01

The aim of this work was to study the carcass killing-out proportions and carcass composition of Churra Galega Bragançana (CGB) and Suffolk sheep at 20%, 25%, 30% and 35% of maturity. Forty-eight male lambs were used, 24 CGB and 24 Suffolks from the Bragança's School of Agriculture sheep flock. Suffolk lambs had greater proportions of leg, shoulder and breast joints, but lower proportions of rib, anterior rib and neck joints. Increasing maturity caused a significant decrease in leg and shoulder proportions and an increase in chump proportion. Suffolk lambs had significantly greater muscle and significantly less subcutaneous fat and kidney and pelvic fat percentages than CGB lambs. With the increase of maturity, a significant increase in intermuscular fat and a significant decrease in bone proportion were observed. It was concluded that, under the management conditions of this work, Suffolks were preferred for meat production, since at a comparable stage of maturity they had greater proportions of expensive cuts and greater carcass lean percentage.

The effect of cisatracurium and rocuronium on lung function in anesthetized children.

PubMed

Yang, Charles I; Fine, Gavin F; Jooste, Edmund H; Mutich, Rebecca; Walczak, Stephen A; Motoyama, Etsuro K

2013-12-01

Neuromuscular blocking drugs have been implicated in intraoperative bronchoconstrictive episodes. We examined the effects of clinically relevant doses of cisatracurium and rocuronium on the lung mechanics of pediatric subjects. We hypothesized that cisatracurium and rocuronium would have bronchoconstrictive effects. We studied ASA physical status I and II pediatric subjects having elective dental or urological procedures, requiring general anesthesia with endotracheal intubations with either cisatracurium or rocuronium. Pulmonary function tests were performed before and after neuromuscular blocking drug dosing and again after albuterol administration. Using forced deflation and passive deflation techniques, forced vital capacity (FVC) and maximum expiratory flow rate at 10% (MEF10) of FVC were obtained. Fractional changes from the baseline were used to compare subjects. Changes in MEF10 of >30% were considered clinically significant. A Shapiro-Wilk test, paired t test, and Wilcoxon rank sum test were used to analyze the data. Twenty-five subjects (median age = 5.25 years; range = 9 months-9.9 years) were studied; 12 subjects received cisatracurium and 13 subjects received rocuronium. Data are shown as mean proportional change ± SD or, in the case of not normally distributed, median proportional change (first, third quartile) with P values. In the cisatracurium group, there were no differences between baseline and postneuromuscular blocker administration in the fractional change from the baselines of FVC (1.00 ± 0.04, P = 0.5), but there was a significant decrease in MEF10 (0.80 ± 0.18, P = 0.002). In the rocuronium group, there were small yet significant decreases of FVC (0.99 [first quartile 0.97, third quartile 1], P = 0.02) and significant decreases in MEF10 (0.78 ± 0.26, P = 0.008). After administration of albuterol in the cisatracurium group, FVC increased slightly but significantly from baseline values (1.02 ± 0.02, P = 0.005). MEF10 increased significantly beyond baseline values (1.24 ± 0.43, P =0.04). In the rocuronium group, there were also significant differences between baseline and postalbuterol administration from the baseline value of FVC (1.02 ± 0.02, P = 0.004) and MEF10 (1.23 ± 0.29, P = 0.01). At clinically relevant doses, both cisatracurium and rocuronium caused changes in lung function, indicating constriction of smaller airways. In general, these changes were mild and not clinically detectable. However, in the rocuronium group, 3 of 13 patients showed more noticeable decreases in MEF10 (≤50%), demonstrating the potential for significant broncho-bronchiolar constriction in susceptible patients.

Cell and Gene Therapies: European View on Challenges in Translation and How to Address Them

PubMed Central

Rousseau, Cécile F.; Mačiulaitis, Romaldas; Śladowski, Dariusz; Narayanan, Gopalan

2018-01-01

Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs). The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development. In order to successfully overcome these challenges, a clear understanding of the requirements and expectations of all the stakeholders is critical. This article aims to cover the potential challenges related to such translation and suggested approaches to find solutions based on experience and learnings from the perspective of European Union. While commercial challenges have a significant impact on the ATMPs in general, it is considered outside the scope of this article. However, by adopting a strong scientific basis for translation as suggested in this article, it is likely such an approach would help rather than harm successful real world clinical use of ATMPs.

Phosphoproteomics reveals ALK promote cell progress via RAS/ JNK pathway in neuroblastoma.

PubMed

Chen, Kai; Lv, Fan; Xu, Guofeng; Zhang, Min; Wu, Yeming; Wu, Zhixiang

2016-11-15

Emerging evidence suggests receptor tyrosine kinase ALK as a promising therapeutic target in neuroblastoma. However, clinical trials reveal that a limited proportion of ALK-positive neuroblastoma patients experience clinical benefits from Crizotinib, a clinically approved specific inhibitor of ALK. The precise molecular mechanisms of aberrant ALK activity in neuroblastoma remain elusive, limiting the clinical application of ALK as a therapeutic target in neuroblastoma. Here, we describe a deep quantitative phosphoproteomic approach in which Crizotinib-treated neuroblastoma cell lines bearing aberrant ALK are used to investigate downstream regulated phosphoproteins. We identified more than 19,500-and quantitatively analyzed approximately 10,000-phosphorylation sites from each cell line, ultimately detecting 450-790 significantly-regulated phosphorylation sites. Multiple layers of bioinformatic analysis of the significantly-regulated phosphoproteins identified RAS/JNK as a downstream signaling pathway of ALK, independent of the ALK variant present. Further experiments demonstrated that ALK/JNK signaling could be inactivated by either ALK- or JNK-specific inhibitors, resulting in cell growth inhibition by induction of cell cycle arrest and cell apoptosis. Our study broadly defines the phosphoproteome in response to ALK inhibition and provides a resource for further clinical investigation of ALK as therapeutic target for the treatment of neuroblastoma.

BRCA1 and BRCA2 genetic testing—pitfalls and recommendations for managing variants of uncertain clinical significance

PubMed Central

Eccles, D. M.; Mitchell, G.; Monteiro, A. N. A.; Schmutzler, R.; Couch, F. J.; Spurdle, A. B.; Gómez-García, E. B.

2015-01-01

Background Increasing use of BRCA1/2 testing for tailoring cancer treatment and extension of testing to tumour tissue for somatic mutation is moving BRCA1/2 mutation screening from a primarily prevention arena delivered by specialist genetic services into mainstream oncology practice. A considerable number of gene tests will identify rare variants where clinical significance cannot be inferred from sequence information alone. The proportion of variants of uncertain clinical significance (VUS) is likely to grow with lower thresholds for testing and laboratory providers with less experience of BRCA. Most VUS will not be associated with a high risk of cancer but a misinterpreted VUS has the potential to lead to mismanagement of both the patient and their relatives. Design Members of the Clinical Working Group of ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles) global consortium (www.enigmaconsortium.org) observed wide variation in practices in reporting, disclosure and clinical management of patients with a VUS. Examples from current clinical practice are presented and discussed to illustrate potential pitfalls, explore factors contributing to misinterpretation, and propose approaches to improving clarity. Results and conclusion Clinicians, patients and their relatives would all benefit from an improved level of genetic literacy. Genetic laboratories working with clinical geneticists need to agree on a clinically clear and uniform format for reporting BRCA test results to non-geneticists. An international consortium of experts, collecting and integrating all available lines of evidence and classifying variants according to an internationally recognized system, will facilitate reclassification of variants for clinical use. PMID:26153499

Treatment of plaque psoriasis with an ointment formulation of the Janus kinase inhibitor, tofacitinib: a Phase 2b randomized clinical trial.

PubMed

Papp, Kim A; Bissonnette, Robert; Gooderham, Melinda; Feldman, Steven R; Iversen, Lars; Soung, Jennifer; Draelos, Zoe; Mamolo, Carla; Purohit, Vivek; Wang, Cunshan; Ports, William C

2016-10-03

Most psoriasis patients have mild to moderate disease, commonly treated topically. Current topical agents have limited efficacy and undesirable side effects associated with long-term use. Tofacitinib is a small molecule Janus kinase inhibitor investigated for the topical treatment of psoriasis. This was a 12-week, randomized, double-blind, parallel-group, vehicle-controlled Phase 2b study of tofacitinib ointment (2 % and 1 %) applied once (QD) or twice (BID) daily in adults with mild to moderate plaque psoriasis. Primary endpoint: proportion of patients with Calculated Physician's Global Assessment (PGA-C) clear or almost clear and ≥2 grade improvement from baseline at Weeks 8 and 12. Secondary endpoints: proportion of patients with PGA-C clear or almost clear; proportion achieving Psoriasis Area and Severity Index 75 (PASI75) response; percent change from baseline in PASI and body surface area; change from baseline in Itch Severity Item (ISI). Adverse events (AEs) were monitored and clinical laboratory parameters measured. Overall, 435 patients were randomized and 430 patients received treatment. The proportion of patients with PGA-C clear or almost clear and ≥2 grade improvement from baseline at Week 8 was 18.6 % for 2 % tofacitinib QD (80 % confidence interval [CI] for difference from vehicle: 3.8, 18.2 %) and 22.5 % for 2 % tofacitinib BID (80 % CI: 3.1, 18.5 %); this was significantly higher vs vehicle for both dosage regimens. No significant difference vs vehicle was seen at Week 12. Significantly more patients achieved PGA-C clear or almost clear with 2 % tofacitinib QD and BID and 1 % tofacitinib QD (not BID) at Week 8, and with 2 % tofacitinib BID at Week 12. Pruritus was significantly reduced vs vehicle with 2 % and 1 % tofacitinib BID (starting Day 2), and 2 % tofacitinib QD (starting Day 3). Overall, 44.2 % of patients experienced AEs, 8.1 % experienced application site AEs, and 2.3 % experienced serious AEs. The highest incidence of AEs (including application site AEs) was in the vehicle QD group. In adults with mild to moderate plaque psoriasis, 2 % tofacitinib ointment QD and BID showed greater efficacy than vehicle at Week 8, but not Week 12, with an acceptable safety and local tolerability profile. NCT01831466 registered March 28, 2013.

Patterns of alcohol consumption among male adults at a slum in Kolkata, India.

PubMed

Ghosh, Santanu; Samanta, Amrita; Mukherjee, Shuvankar

2012-03-01

Globally, alcohol-abuse is a major cause of mortality and morbidity. Consumption of alcohol has increased in India in the recent decades. It is imperative to know the patterns of alcohol consumption among different types of consumers to launch a well-planned nationwide programme for the prevention and control of this devastating social pathology. This community-based, cross-sectional study was undertaken to identify the patterns of alcohol intake among different types of alcohol consumers and to assess the clinical signs of chronic harmful alcohol-use. A predesigned, pretested, semi-structured alcohol-use disorders identification test (AUDIT) questionnaire was used for interviewing males, aged >18 years, selected by random sampling from an updated household list of a randomly-selected sector of the service area of the Urban Health Centre in Chetla, Kolkata, West Bengal, India. Written informed consents were obtained from all the respondents. Relevant clinical examination for chronic harmful alcohol-use was done according to the AUDIT clinical screening procedures. The results revealed that 65.8% (150/228) were current consumers of alcohol; 14% were alcohol-dependents; 8% were hazardous or harmful consumers, and 78% were non-hazardous non-harmful consumers. The mean age of the respondents at the initiation of drinking alcohol was 20.8+5.9 years. Eighty-six percent of dependents (n=21) took both Indian-made foreign liquor and locally-made alcoholic beverages. The proportions of alcohol consumers who drank alone among alcohol-dependents, hazardous or harmful consumers, and non-hazardous non-harmful consumers were 71.4%, 50%, and 7.7% respectively, and the difference was significant (p<0.01). Forty-one percent of the consumers drank at public places and workplaces, which may be socially harmful. About 38% of the dependents purchased alcohol from unlicensed liquor shops. Only 16% expressed concerns for their drinking habit mainly to the past illness. The proportion of the concerned respondents was higher in the hazardous and harmful drinking patterns than in the non-hazardous non-harmful drinking pattern, and the difference was significant (p<0.05). About 62% of the dependents had clinical signs of chronic alcohol consumption. The presence of a considerable proportion of alcohol-dependents, the low mean age at initiation of drinking alcohol, and the habit of drinking in public places and workplaces are the main areas that need special emphasis by intervention programmes.

Speed of Adoption of Immune Checkpoint Inhibitors of Programmed Cell Death 1 Protein and Comparison of Patient Ages in Clinical Practice vs Pivotal Clinical Trials.

PubMed

O'Connor, Jeremy M; Fessele, Kristen L; Steiner, Jean; Seidl-Rathkopf, Kathi; Carson, Kenneth R; Nussbaum, Nathan C; Yin, Emily S; Adelson, Kerin B; Presley, Carolyn J; Chiang, Anne C; Ross, Joseph S; Abernethy, Amy P; Gross, Cary P

2018-05-10

The US Food and Drug Administration (FDA) is increasing its pace of approvals for novel cancer therapeutics, including for immune checkpoint inhibitors of programmed cell death 1 protein (anti-PD-1 agents). However, little is known about how quickly anti-PD-1 agents reach eligible patients in practice or whether such patients differ from those studied in clinical trials that lead to FDA approval (pivotal clinical trials). To assess the speed with which anti-PD-1 agents reached eligible patients in practice and to compare the ages of patients treated in clinical practice with the ages of those treated in pivotal clinical trials. This retrospective cohort study, performed from January 1, 2011, through August 31, 2016, included patients from the Flatiron Health Network who were eligible for anti-PD-1 treatment of selected cancer types, which included melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma (RCC). Cumulative proportions of eligible patients receiving anti-PD-1 treatment and their age distributions. The study identified 3089 patients who were eligible for anti-PD-1 treatment (median age, 66 [interquartile range, 56-75] years for patients with melanoma, 66 [interquartile range, 58-72] years for patients with RCC, and 67 [interquartile range, 59-74] years for patients with NSCLC; 1742 male [56.4%] and 1347 [43.6%] female; 2066 [66.9%] white). Of these patients, 2123 (68.7%) received anti-PD-1 treatment, including 439 eligible patients with melanoma (79.1%), 1417 eligible patients with NSCLC (65.6%), and 267 eligible patients with RCC (71.2%). Within 4 months after FDA approval, greater than 60% of eligible patients in each cohort had received anti-PD-1 treatment. Overall, similar proportions of older and younger patients received anti-PD-1 treatment during the first 9 months after FDA approval. However, there were significant differences in age between clinical trial participants and patients receiving anti-PD-1 treatment in clinical practice, with more patients being older than 65 years in clinical practice (range, 327 of 1365 [60.6%] to 46 of 72 [63.9%]) than in pivotal clinical trials (range, 38 of 120 [31.7%] to 223 of 544 [41.0%]; all P < .001). Anti-PD-1 agents rapidly reached patients in clinical practice, and patients treated in clinical practice differed significantly from patients treated in pivotal clinical trials. Future actions are needed to ensure that rapid adoption occurs on the basis of representative trial evidence.

Clinical significance of preoperative carcinoembryonic antigen level in patients with clinical stage IA non-small cell lung cancer.

PubMed

Maeda, Ryo; Suda, Takashi; Hachimaru, Ayumi; Tochii, Daisuke; Tochii, Sachiko; Takagi, Yasushi

2017-01-01

The objective of this study was to assess the preoperative serum carcinoembryonic antigen (CEA) level in patients with clinical stage IA non-small cell lung cancer (NSCLC) and to evaluate its clinical significance. Between January 2005 and December 2014, a total of 378 patients with clinical stage IA NSCLC underwent complete resection with systematic node dissection. The survival rate was estimated starting from the date of surgery to the date of either death or the last follow-up by the Kaplan-Meier method. Univariate analyses by log-rank tests were used to determine prognostic factors. Cox proportional hazards ratios were used to identify independent predictors of poor prognosis. Clinicopathological predictors of lymph node metastases were evaluated by logistic regression analyses. The 5-year survival rate of patients with an elevated preoperative serum CEA level was significantly lower than that of patients with a normal CEA level (75.5% vs. 87.7%; P=0.02). However, multivariate analysis did not show the preoperative serum CEA level to be an independent predictor of poor prognosis. Postoperative pathological factors, including lymphatic permeation, visceral pleural invasion, and lymph node metastases, tended to be positive in patients with an elevated preoperative serum CEA level. In addition, the CEA level was a statistically significant independent clinical predictor of lymph node metastases. The preoperative serum CEA level was not an independent predictor of poor prognosis in patients with pathological stage IA NSCLC but was an important clinical predictor of tumor invasiveness and lymph node metastases in patients with clinical stage IA NSCLC. Therefore, measurement of the preoperative serum CEA level should be considered even for patients with early-stage NSCLC.

Home-based versus clinic-based specimen collection in the management of Chlamydia trachomatis and Neisseria gonorrhoeae infections.

PubMed

Fajardo-Bernal, Luisa; Aponte-Gonzalez, Johanna; Vigil, Patrick; Angel-Müller, Edith; Rincon, Carlos; Gaitán, Hernando G; Low, Nicola

2015-09-29

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the most frequent causes of bacterial sexually transmitted infections (STIs). Management strategies that reduce losses in the clinical pathway from infection to cure might improve STI control and reduce complications resulting from lack of, or inadequate, treatment. To assess the effectiveness and safety of home-based specimen collection as part of the management strategy for Chlamydia trachomatis and Neisseria gonorrhoeae infections compared with clinic-based specimen collection in sexually-active people. We searched the Cochrane Sexually Transmitted Infections Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS on 27 May 2015, together with the World Health Organization International Clinical Trials Registry (ICTRP) and ClinicalTrials.gov. We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies. Randomized controlled trials (RCTs) of home-based compared with clinic-based specimen collection in the management of C. trachomatis and N. gonorrhoeae infections. Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We contacted study authors for additional information. We resolved any disagreements through consensus. We used standard methodological procedures recommended by Cochrane. The primary outcome was index case management, defined as the number of participants tested, diagnosed and treated, if test positive. Ten trials involving 10,479 participants were included. There was inconclusive evidence of an effect on the proportion of participants with index case management (defined as individuals tested, diagnosed and treated for CT or NG, or both) in the group with home-based (45/778, 5.8%) compared with clinic-based (51/788, 6.5%) specimen collection (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.60 to 1.29; 3 trials, I² = 0%, 1566 participants, moderate quality). Harms of home-based specimen collection were not evaluated in any trial. All 10 trials compared the proportions of individuals tested. The results for the proportion of participants completing testing had high heterogeneity (I² = 100%) and were not pooled. We could not combine data from individual studies looking at the number of participants tested because the proportions varied widely across the studies, ranging from 30% to 96% in home group and 6% to 97% in clinic group (low-quality evidence). The number of participants with positive test was lower in the home-based specimen collection group (240/2074, 11.6%) compared with the clinic-based group (179/967, 18.5%) (RR 0.72, 95% CI 0.61 to 0.86; 9 trials, I² = 0%, 3041 participants, moderate quality). Home-based specimen collection could result in similar levels of index case management for CT or NG infection when compared with clinic-based specimen collection. Increases in the proportion of individuals tested as a result of home-based, compared with clinic-based, specimen collection are offset by a lower proportion of positive results. The harms of home-based specimen collection compared with clinic-based specimen collection have not been evaluated. Future RCTs to assess the effectiveness of home-based specimen collection should be designed to measure biological outcomes of STI case management, such as proportion of participants with negative tests for the relevant STI at follow-up.

Resistant Hypertension: Time to Consider the Best Fifth Anti-Hypertensive Treatment.

PubMed

Pio-Abreu, Andrea; Drager, Luciano F

2018-06-16

Resistant hypertension (RH) is a growing clinical condition worldwide associated with target-organ damage and poor prognosis compared to non-resistant counterparts. The purpose of this review is to perform a critical evaluation of preferable drug choices for managing RH highlighting the evidence that significant proportion of patients remained uncontrolled despite using four anti-hypertensive drugs. Until recently, the fourth drug therapy was main derived from personal opinion or small interventional studies. The recent data derived from two multicentric randomized trials, namely PATHWAY-2 and ReHOT, pointed spironolactone as the preferable fourth drug therapy in patients with confirmed RH as compared to bisoprolol and doxazosin (PATHWAY-2) as well as clonidine (ReHOT). However, significant proportion of patients (especially observed in ReHOT trial that used 24-h ambulatory blood pressure monitoring) did not achieve optimal blood pressure with the fourth drug. This finding underscores the need of new approaches and treatment options in this important research area. The current evidence pointed that significant proportion of RH patients are requiring more than four drugs for controlling BP. This statement is particularly true considering the new criteria proposed by the 2017 Guidelines for diagnosing RH (> 130 × 80 mmHg). New combinations, drugs, or treatments should be tested aiming to reduce the RH burden. Based on the aforementioned multicentric trials, we proposed the first five preferable anti-hypertensive classes in the overall context of RH.

Prescription practice of anti-tuberculosis drugs in Yunnan, China: A clinical audit.

PubMed

Xu, Lin; Chen, Jinou; Innes, Anh L; Li, Ling; Chiang, Chen-Yuan

2017-01-01

China has a high burden of drug-resistant tuberculosis (TB). As irrational use and inadequate dosing of anti-TB drugs may contribute to the epidemic of drug-resistant TB, we assessed the drug types and dosages prescribed in the treatment of TB cases in a representative sample of health care facilities in Yunnan. We applied multistage cluster sampling using probability proportion to size to select 28 counties in Yunnan. Consecutive pulmonary TB patients were enrolled from either the TB centers of Yunnan Center of Disease Control or designated TB hospitals. Outcomes of interest included the regimen used in the treatment of new and retreatment TB patients; and the proportion of patients treated with adequate dosing of anti-TB drugs. Furthermore, we assess whether there has been reduction in the use of fluoroquinolone and second line injectables in Tuberculosis Clinical Centre (TCC) after the training activity in late 2012. Of 2390 TB patients enrolled, 582 (24.4%) were prescribed second line anti-TB drugs (18.0% in new cases and 60.9% in retreatment cases); 363(15.2%) prescribed a fluoroquinolone. General hospitals (adjusted odds ratio (adjOR) 1.97, 95% confidence interval (CI) 1.47-2.66), retreatment TB cases (adjOR 4.75, 95% CI 3.59-6.27), smear positive cases (adjOR 1.69, 95% CI 1.22-2.33), and extrapulmonary TB (adjOR 2.59, 95% CI 1.66-4.03) were significantly associated with the use of fluoroquinolones. The proportion of patients treated with fluoroquinolones decreased from 41.4% before 2013 to 13.5% after 2013 (adjOR 0.19, 95% CI 0.12-0.28) in TCC. The proportion of patients with correct, under and over dosages of isoniazid was 88.2%, 1.5%, and 10.4%, respectively; of rifampicin was 50.2%, 46.8%, and 2.9%; of pyrazinamide was 67.6%, 31.7% and 0.7%; and of ethambutol was 41.4%, 57.5%, and 1.0%. The prescribing practice of anti-TB drugs was not standardized, findings with significant programmatic implication.

Directly Improving the Quality of Radiation Treatment Through Peer Review: A Cross-sectional Analysis of Cancer Centers Across a Provincial Cancer Program.

PubMed

Rouette, Julie; Gutierrez, Eric; O'Donnell, Jennifer; Reddeman, Lindsay; Hart, Margaret; Foxcroft, Sophie; Mitera, Gunita; Warde, Padraig; Brundage, Michael D

2017-07-01

To describe the outcomes of peer review across all 14 cancer centers in Ontario. We identified all peer-reviewed, curative treatment plans delivered in Ontario within a 3-month study period from 2013 to 2014 using a provincial cancer treatment database and collected additional data on the peer-review outcomes. Considerable variation was found in the proportion of peer-reviewed plans across the centers (average 70.2%, range 40.8%-99.2%). During the study period, 5561 curative plans underwent peer review. Of those, 184 plans (3.3%) had changes recommended. Of the 184 plans, the changes were major (defined as requiring repeat planning or having a major effect on planning or clinical outcomes, or both) in 40.2% and minor in 47.8%. For the remaining 12.0%, data were missing. The proportions of recommended changes varied among disease sites (0.0%-7.0%). The disease sites with the most recommended changes to treatment plans after peer review and with the greatest potential for benefit were the esophagus (7.0%), uterus (6.7%), upper limb (6.3%), cervix and lower limb (both 6.0%), head and neck and bilateral lung (both 5.9%), right supraclavicular lymph nodes (5.7%), rectum (5.3%), and spine (5.0%). Although the heart is an organ at risk in left-sided breast treatment plans, the proportions of recommended changes did not significantly differ between the left breast treatment plans (3.0%, 95% confidence interval 2.0%-4.5%) and right breast treatment plans (2.4%, 95% confidence interval 1.5%-3.8%). The recommended changes were more frequently made when peer review occurred before radiation therapy (3.8%) than during treatment (1.4%-2.8%; P=.0048). The proportion of plans with recommended changes was not significantly associated with patient volume (P=.23), peer-review performance (P=.36), or center academic status (P=.75). Peer review of treatment plans directly affects the quality of care by identifying important clinical and planning changes. Provincial strategies are underway to optimize its conduct in radiation oncology. Copyright © 2016. Published by Elsevier Inc.

Pediatric Orbital Fractures

PubMed Central

Oppenheimer, Adam J.; Monson, Laura A.; Buchman, Steven R.

2013-01-01

It is wise to recall the dictum “children are not small adults” when managing pediatric orbital fractures. In a child, the craniofacial skeleton undergoes significant changes in size, shape, and proportion as it grows into maturity. Accordingly, the craniomaxillofacial surgeon must select an appropriate treatment strategy that considers both the nature of the injury and the child's stage of growth. The following review will discuss the management of pediatric orbital fractures, with an emphasis on clinically oriented anatomy and development. PMID:24436730

Prospective Validation of ATA and ETA Sonographic Pattern Risk of Thyroid Nodules Selected for FNAC.

PubMed

Maino, Fabio; Forleo, Raffaella; Martinelli, Martina; Fralassi, Noemi; Barbato, Filomena; Pilli, Tania; Capezzone, Marco; Brilli, Lucia; Ciuoli, Cristina; Di Cairano, Giovanni; Nigi, Laura; Pacini, Furio; Castagna, Maria Grazia

2018-06-01

Recently, the American Thyroid Association (ATA) and the European Thyroid Association (ETA) have proposed that thyroid ultrasound (US) should be used to stratify the risk of malignancy in thyroid nodules and to aid decision-making about whether fine-needle aspiration cytology (FNAC) is indicated. To validate and to compare the ATA and ETA US risk stratification systems of thyroid nodules in a prospective series of thyroid nodules submitted to FNAC. We prospectively evaluated 432 thyroid nodules selected for FNAC from 340 patients. Cytology reports were based on the five categories according to the criteria of the British Thyroid Association. The proportion of Thy2 nodules decreased significantly, whereas the proportion of Thy4/Thy5 nodules significantly increased with increasing US risk class (P < 0.0001). The ability to identify benign and malignant nodules was similar between ATA and ETA systems. According to ATA and ETA US risk stratification systems, 23.7% and 56.0% nodules did not meet the criteria for FNAC, respectively. Considering only categories at lower risk of malignancy, the cumulative malignancy rate in these nodules was 1.2% for ATA and 1.7% for ETA US risk stratification systems. ETA and ATA US risk stratification systems provide effective malignancy risk stratification for thyroid nodules. In clinical practice, using this approach, we should be able to reduce the number of unnecessary FNAC without losing clinically relevant thyroid cancer.

3 alpha-Hydroxylated bile acid profiles in clinically normal cats, cats with severe hepatic lipidosis, and cats with complete extrahepatic bile duct occlusion.

PubMed

Center, S A; Thompson, M; Guida, L

1993-05-01

Concentrations of 3 alpha-hydroxylated bile acids were measured in serum and urine of clinically normal (healthy) cats (n = 6), cats with severe hepatic lipidosis (n = 9), and cats with complete bile duct occlusion (n = 4). Bile acid concentrations were measured by use of a gradient flow high-performance liquid chromatography procedure with an acetonitrile and ammonium phosphate mobile phase and an in-line postanalytic column containing 3 alpha-hydroxy-steroid dehydrogenase and a fluorescence detector. Specific identification of all bile acid peaks was not completed; unidentified moieties were represented in terms of their elution time (in minutes). Significant differences in serum and urine bile acid concentrations, quantitative and proportional, were determined among groups of cats. Cats with hepatic lipidosis and bile duct occlusion had significantly (P > or = 0.05) greater total serum and urine bile acids concentrations than did healthy cats. The proportion of hydrophobic bile acids in serum, those eluting at > or = 400 minutes, was 1.9% for healthy cats, 3.3% for cats with lipidosis, and 5.4% for bile duct-obstructed cats. Both groups of ill cats had a broader spectrum of unidentified late-eluting serum bile acids than did healthy cats; the largest spectrum developed in bile duct-occluded cats.(ABSTRACT TRUNCATED AT 250 WORDS)

The revised dengue fever classification in German travelers: clinical manifestations and indicators for severe disease.

PubMed

Hoffmeister, B; Suttorp, N; Zoller, T

2015-02-01

The number of dengue cases imported to Germany has increased significantly in recent years. Among returning travelers, dengue is now a frequent cause of hospitalization. The aim of this study was to determine the proportion of patients with severe disease hospitalized in a European, non-endemic country applying the revised 2009 WHO classification system and to determine predictors of severe disease. A retrospective single-center analysis of clinical data from 56 patients, 31 (55 %) women and 25 (45 %) men, between 14 and 70 years of age treated in a tertiary care hospital between 1996 and 2010 was conducted. Thirty-nine patients (69.6 %) presented with dengue fever without warning signs, 11 (19.6 %) with warning signs and 6 (10.7 %) with signs for severe dengue fever. Two patients (4 %) developed dengue shock syndrome. Non-European descent (p = 0.001), plasma protein level <6.5 mg/dl (p = 0.001), platelets <30/nl (p = 0.017) and activated partial thromboplastin time (aPTT) >44 s (p = 0.003) were associated with severe disease. A significant proportion of patients hospitalized with symptomatic imported dengue fever in Germany have evidence of severe disease. Simple routine laboratory parameters such as complete blood count, plasma protein level and aPTT are helpful tools for identifying adult patients at risk for severe disease.

Assessment of Reliable Change Using 95% Credible Intervals for the Differences in Proportions: A Statistical Analysis for Case-Study Methodology.

PubMed

Unicomb, Rachael; Colyvas, Kim; Harrison, Elisabeth; Hewat, Sally

2015-06-01

Case-study methodology studying change is often used in the field of speech-language pathology, but it can be criticized for not being statistically robust. Yet with the heterogeneous nature of many communication disorders, case studies allow clinicians and researchers to closely observe and report on change. Such information is valuable and can further inform large-scale experimental designs. In this research note, a statistical analysis for case-study data is outlined that employs a modification to the Reliable Change Index (Jacobson & Truax, 1991). The relationship between reliable change and clinical significance is discussed. Example data are used to guide the reader through the use and application of this analysis. A method of analysis is detailed that is suitable for assessing change in measures with binary categorical outcomes. The analysis is illustrated using data from one individual, measured before and after treatment for stuttering. The application of this approach to assess change in categorical, binary data has potential application in speech-language pathology. It enables clinicians and researchers to analyze results from case studies for their statistical and clinical significance. This new method addresses a gap in the research design literature, that is, the lack of analysis methods for noncontinuous data (such as counts, rates, proportions of events) that may be used in case-study designs.

Clinical Improvement by Switching to an Integrase Strand Transfer Inhibitor in Hemophiliac Patients with HIV: The Japan Cohort Study of HIV Patients Infected through Blood Products.

PubMed

Kawado, Miyuki; Hashimoto, Shuji; Oka, Shin-Ichi; Fukutake, Katsuyuki; Higasa, Satoshi; Yatsuhashi, Hiroshi; Ogane, Miwa; Okamoto, Manabu; Shirasaka, Takuma

2017-01-01

This study aimed to determine improvement in HIV RNA levels and the CD4 cell count by switching to an antiretroviral regimen with an integrase strand transfer inhibitor (INSTI) in patients with HIV. This study was conducted on Japanese patients with HIV who were infected by blood products in the 1980s. Data were collected between 2007 and 2014. Data of 564 male hemophiliac patients with HIV from the Japan Cohort Study of HIV Patients Infected through Blood Products were available. Changes in antiretroviral regimen use, HIV RNA levels, and the CD4 cell count between 2007 and 2014 were examined. From 2007 to 2014, the proportion of use of a regimen with an INSTI increased from 0.0% to 41.0%. For patients with HIV who used a regimen, including an INSTI, the proportion of HIV RNA levels <50 copies/mL significantly increased from 58.3% in 2007 to 90.6% in 2014. Additionally, the median CD4 cell count significantly increased from 380/μL to 438/μL. There is a large effect of switching to an antiretroviral regimen with an INSTI for Japanese patients with HIV who are infected by blood products. This suggests that performing this switch in clinical practice will lead to favorable effects.

Relationship between reflection ability and clinical performance: a cross-sectional and retrospective-longitudinal correlational cohort study in midwifery.

PubMed

Embo, M; Driessen, E; Valcke, M; van der Vleuten, C P M

2015-01-01

increasingly, reflection is highlighted as integral to core practice competencies but empirical research into the relationship between reflection and performance in the clinical workplace is scarce. this study investigated the relationship between reflection ability and clinical performance. we designed a cross-sectional and a retrospective-longitudinal cohort study. Data from first, second and third year midwifery students were collected to study the variables 'clinical performance' and 'reflection ability'. Data were analysed with SPSS for Windows, Release 20.0. Descriptive statistics, Pearson׳s Product Moment Correlation Coefficients (r) and r² values were computed to investigate associations between the research variables. the results showed a moderate observed correlation between reflection ability and clinical performance scores. When adopting a cross-sectional perspective, all correlation values were significant (p<0.01) and above 0.4, with the exception of the third year correlations. Assuming perfect reliability in the measurement, the adjusted correlations, for year 2 and year 3 indicated a high association between reflection ability and clinical performance (>0.6). The results based on the retrospective-longitudinal data set explained a moderate proportion of the variance after correction for attenuation. Finally, the results indicate that 'reflection ability' scores of earlier years are significant related with 'clinical performance' scores of subsequent years. These results suggest that (1) reflection ability is linked to clinical performance; (2) that written reflections are an important, but not the sole way to assess professional competence and that (3) reflection is a contributor to clinical performance improvement. the data showed a moderate but significant relationship between 'reflection ability' and 'clinical performance' scores in clinical practice of midwifery students. Reflection therefore seems an important component of professional competence. Copyright © 2014 Elsevier Ltd. All rights reserved.

Higher proportion of fast-twitch (type II) muscle fibres in idiopathic inflammatory myopathies - evident in chronic but not in untreated newly diagnosed patients.

PubMed

Loell, I; Helmers, S B; Dastmalchi, M; Alexanderson, H; Munters, L A; Nennesmo, I; Lindroos, E; Borg, K; Lundberg, I E; Esbjörnsson, M

2011-01-01

Polymyositis and dermatomyositis are idiopathic, inflammatory myopathies characterized by proximal muscle fatigue. Conventional immunosuppressive treatment gives a variable response. Biopsies from chronic patients display a low proportion type I and a high proportion of type II muscle fibres. This raised a suspicion that the low proportion of type I fibres might play a role in the muscle fatigue. To investigate whether the muscle fibre attributes evident in chronic myositis are characteristic for the polymyositis and dermatomyosistis diseases themselves. Muscle biopsies were obtained from thigh muscle from untreated patients (n = 18), treated responders (n = 14) and non-responders (n = 6) and from healthy controls (n = 11), respectively. For clinical evaluations, creatine kinase, functional index of myositis and cumulative dose of cortisone were established.   Chronic patients had a lower proportion of type I fibres and a higher proportion of type II fibres compared to untreated myositis patients and healthy controls. Fibre cross-sectional area (CSA) did not differ between patients and healthy individuals but all women had a 20% smaller type II fibre CSA compared to men. Untreated polymyositis and dermatomyositis patients and healthy controls have a different fibre type composition than chronic polymyositis and dermatomyositis patients. Fibre CSA did not differ between healthy controls or any of the patient groups. A low proportion of oxidative muscle fibres can therefore be excluded as a contributing factor causing muscle fatigue at disease onset and the gender difference should be taken into consideration when evaluating fibre CSA in myositis. © 2010 The Authors. Clinical Physiology and Functional Imaging © 2010 Scandinavian Society of Clinical Physiology and Nuclear Medicine.

C-A4-01: Computerized Clinical Decision Support During Drug Ordering for Long-term Care Residents With Renal Insufficiency

PubMed Central

Field, Terry S; Rochon, Paula; Lee, Monica; Gavendo, Linda; Baril, Joann L; Gurwitz, Jerry H

2010-01-01

Objective: To determine whether a computerized clinical decision support system (CDSS) providing patient specific recommendations in real- time improves the quality of prescribing for long-term care residents with renal insufficiency. Design: A randomized trial within the long-stay units of a large long-term care facility. Randomization was within blocks by unit type. Alerts related to medication prescribing for residents with renal insufficiency were displayed to prescribers in the intervention units and hidden but tracked in control units. Measurement: The proportions of final drug orders that were appropriate were compared between intervention and control units within alert categories: recommended medication doses; recommended administration frequencies; recommendations to avoid the drug; 4) warnings of missing information. Results: The rates of alerts were nearly equal in the intervention and control units: 2.5 per 1000 resident days in the intervention units and 2.4 in the control units. The proportions of dose alerts for which the final drug orders were appropriate were similar between the intervention and control units (relative risk 0.95, 95% confidence interval 0.83, 1.1). For the remaining alert categories significantly higher proportions of final drug orders were appropriate in the intervention units: relative risk 2.4 for maximum frequency (1.4, 4.4); 2.6 for drugs that should be avoided (1.4, 5.0); and 1.8 for alerts to acquire missing information (1.1, 3.4). Overall, final drug orders were appropriate significantly more often than a relative risk 1.2 (1.0, 1.4). By tracking personnel time and expenditures, we estimated the cost of developing the CDSS as $48,668.57. Drug costs saved during the 12 months of the trial are estimated at $2,137. Conclusion: Clinical decision support for physicians prescribing medications for long-term care residents with renal insufficiency can improve the quality of prescribing decisions. However, patient well-being and quality of care rather than the business case related to cost savings are likely to be the key drivers for adoption of this HIT application.

Brain-controlled functional electrical stimulation therapy for gait rehabilitation after stroke: a safety study.

PubMed

McCrimmon, Colin M; King, Christine E; Wang, Po T; Cramer, Steven C; Nenadic, Zoran; Do, An H

2015-07-11

Many stroke survivors have significant long-term gait impairment, often involving foot drop. Current physiotherapies provide limited recovery. Orthoses substitute for ankle strength, but they provide no lasting therapeutic effect. Brain-computer interface (BCI)-controlled functional electrical stimulation (FES) is a novel rehabilitative approach that may generate permanent neurological improvements. This study explores the safety and feasibility of a foot-drop-targeted BCI-FES physiotherapy in chronic stroke survivors. Subjects (n = 9) operated an electroencephalogram-based BCI-FES system for foot dorsiflexion in 12 one-hour sessions over four weeks. Gait speed, dorsiflexion active range of motion (AROM), six-minute walk distance (6MWD), and Fugl-Meyer leg motor (FM-LM) scores were assessed before, during, and after therapy. The primary safety outcome measure was the proportion of subjects that deteriorated in gait speed by ≥0.16 m/s at one week or four weeks post-therapy. The secondary outcome measures were the proportion of subjects that experienced a clinically relevant decrease in dorsiflexion AROM (≥2.5°), 6MWD (≥20 %), and FM-LM score (≥10 %) at either post-therapy assessment. No subjects (0/9) experienced a clinically significant deterioration in gait speed, dorsiflexion AROM, 6MWT distance, or FM-LM score at either post-therapy assessment. Five subjects demonstrated a detectable increase (≥0.06 m/s) in gait speed, three subjects demonstrated a detectable increase (≥2.5°) in dorsiflexion AROM, five subjects demonstrated a detectable increase (≥10 %) in 6MWD, and three subjects demonstrated a detectable increase (≥10 %) in FM-LM. Five of the six subjects that exhibited a detectable increase in either post-therapy gait speed or 6MWD also exhibited significant (p < 0.01 using a Mann-Whitney U test) increases in electroencephalogram event-related synchronization/desynchronization. Additionally, two subjects experienced a clinically important increase (≥0.16 m/s) in gait speed, and four subjects experienced a clinically important increase (≥20 %) in 6MWD. Linear mixed models of gait speed, dorsiflexion AROM, 6MWD, and FM-LM scores suggest that BCI-FES therapy is associated with an increase in lower motor performance at a statistically, yet not clinically, significant level. BCI-FES therapy is safe. If it is shown to improve post-stroke gait function in future studies, it could provide a new gait rehabilitation option for severely impaired patients. Formal clinical trials are warranted.

Effects of BRAF mutations and BRAF inhibition on immune responses to melanoma

PubMed Central

Ilieva, Kristina M.; Correa, Isabel; Josephs, Debra H.; Karagiannis, Panagiotis; Egbuniwe, Isioma U.; Cafferkey, Michiala J.; Spicer, James F.; Harries, Mark; Nestle, Frank O.; Lacy, Katie E.; Karagiannis, Sophia N.

2014-01-01

Malignant melanoma is associated with poor clinical prognosis; however, novel molecular and immune therapies are now improving patient outcomes. Almost 50% of melanomas harbor targetable activating mutations of BRAF which promote RAS-RAF-MEK-ERK pathway activation and melanoma proliferation. Recent evidence also indicates that melanomas bearing mutant BRAF may also have altered immune responses, suggesting additional avenues for treatment of this patient group. The small molecule inhibitors selective for mutant BRAF induce significant but short-lived clinical responses in a proportion of patients, but also lead to immune stimulatory bystander events, which then subside with the emergence of resistance to inhibition. Simultaneous BRAF and MEK inhibition, and especially combination of BRAF inhibitors with new immunotherapies such as checkpoint blockade antibodies, may further enhance immune activation, or counteract immunosuppressive signals. Pre-clinical evaluation and ongoing clinical trials should provide novel insights into the role of immunity in the therapy of BRAF-mutant melanoma. PMID:25385327

Outcome Measures in Myasthenia Gravis: Incorporation Into Clinical Practice.

PubMed

Muppidi, Srikanth

2017-03-01

The development of validated assessment tools for evaluating disease status and response to interventions in patients with myasthenia gravis (MG) has been driven by clinical studies of emerging MG therapies. However, only a small proportion of MG-focused neurology practices have adopted these assessment tools for routine clinical use. This article reviews the suitability of 5 assessment instruments for incorporation into clinical practice, which should be driven by their ability to contribute to improved patient outcomes, and to be implemented within practice personnel and resource constraints. It is recommended that assessments based on both physician-evaluated and patient-reported outcomes be selected, to adequately evaluate both point-in-time symptom load and functional impact of MG symptoms over time. Provider resource allocation and reimbursement issues may be the most significant roadblocks to successful ongoing use of these tools; to that end, the addition of regular assessments to MG standards of care is recommended.

Evaluation of clinical management of gonorrhoea using enhanced surveillance in South East Queensland.

PubMed

Field, Emma; Heel, Karen; Palmer, Cheryn; Vally, Hassan; Beard, Frank; McCall, Brad

2010-12-01

Gonorrhoea is the second most common notifiable sexually transmissible infection (STI) in Queensland. Notifications have been increasing since 2002. Enhanced surveillance was undertaken in this study in order to evaluate clinical management and add to understanding of the epidemiology of gonorrhoea and in South East Queensland. Information on clinical management and an enhanced surveillance form were faxed to clinicians who notified gonorrhoea in the Brisbane Southside Population Health Unit area from 2003 to 2008. Ceftriaxone was recommended for treatment of gonorrhoea cases, as was simultaneous treatment for chlamydia, testing for other STIs and management of sexual contacts. Enhanced surveillance focussed on collecting more detailed epidemiological and clinical management information. A total of 909 enhanced surveillance forms were returned (response rate 72.2%). The use of ceftriaxone increased significantly over the study period from 31.3% in 2003 to 68.4% in 2008 (P < 0.05). However, there remained a considerable proportion of cases that did not receive ceftriaxone (31.6% in 2008). Simultaneous treatment for chlamydia was reported for 70.5% of cases and did not increase over the study period. A high proportion of males were not screened for high risk co-infection such as HIV (49.6%) and syphilis (51.7%). Contact tracing was initiated for 76.5% of cases and did not increase during the study period. Continued education of clinicians on treatment guidelines is needed. Screening of other STIs such as HIV in males with gonorrhoea and increasing contact tracing were identified as aspects of clinical management for future improvement. Overall this study provides useful insights into the clinical management of gonorrhoea in South East Queensland.

Advanced Multi-Axis Spine Testing: Clinical Relevance and Research Recommendations

PubMed Central

Holsgrove, Timothy P.; Nayak, Nikhil R.; Welch, William C.

2015-01-01

Back pain and spinal degeneration affect a large proportion of the general population. The economic burden of spinal degeneration is significant, and the treatment of spinal degeneration represents a large proportion of healthcare costs. However, spinal surgery does not always provide improved clinical outcomes compared to non-surgical alternatives, and modern interventions, such as total disc replacement, may not offer clinically relevant improvements over more established procedures. Although psychological and socioeconomic factors play an important role in the development and response to back pain, the variation in clinical success is also related to the complexity of the spine, and the multi-faceted manner by which spinal degeneration often occurs. The successful surgical treatment of degenerative spinal conditions requires collaboration between surgeons, engineers, and scientists in order to provide a multi-disciplinary approach to managing the complete condition. In this review, we provide relevant background from both the clinical and the basic research perspectives, which is synthesized into several examples and recommendations for consideration in increasing translational research between communities with the goal of providing improved knowledge and care. Current clinical imaging, and multi-axis testing machines, offer great promise for future research by combining invivo kinematics and loading with in-vitro testing in six degrees of freedom to offer more accurate predictions of the performance of new spinal instrumentation. Upon synthesis of the literature, it is recommended that in-vitro tests strive to recreate as many aspects of the in-vivo environment as possible, and that a physiological preload is a critical factor in assessing spinal biomechanics in the laboratory. A greater link between surgical procedures, and the outcomes in all three anatomical planes should be considered in both the in-vivo and in-vitro settings, to provide data relevant to quality of motion, and stability. PMID:26273552

Contextual factors and clinical reasoning: differences in diagnostic and therapeutic reasoning in board certified versus resident physicians.

PubMed

McBee, Elexis; Ratcliffe, Temple; Picho, Katherine; Schuwirth, Lambert; Artino, Anthony R; Yepes-Rios, Ana Monica; Masel, Jennifer; van der Vleuten, Cees; Durning, Steven J

2017-11-15

The impact of context on the complex process of clinical reasoning is not well understood. Using situated cognition as the theoretical framework and videos to provide the same contextual "stimulus" to all participants, we examined the relationship between specific contextual factors on diagnostic and therapeutic reasoning accuracy in board certified internists versus resident physicians. Each participant viewed three videotaped clinical encounters portraying common diagnoses in internal medicine. We explicitly modified the context to assess its impact on performance (patient and physician contextual factors). Patient contextual factors, including English as a second language and emotional volatility, were portrayed in the videos. Physician participant contextual factors were self-rated sleepiness and burnout.. The accuracy of diagnostic and therapeutic reasoning was compared with covariates using Fisher Exact, Mann-Whitney U tests and Spearman Rho's correlations as appropriate. Fifteen board certified internists and 10 resident physicians participated from 2013 to 2014. Accuracy of diagnostic and therapeutic reasoning did not differ between groups despite residents reporting significantly higher rates of sleepiness (mean rank 20.45 vs 8.03, U = 0.5, p < .001) and burnout (mean rank 20.50 vs 8.00, U = 0.0, p < .001). Accuracy of diagnosis and treatment were uncorrelated (r = 0.17, p = .65). In both groups, the proportion scoring correct responses for treatment was higher than the proportion scoring correct responses for diagnosis. This study underscores that specific contextual factors appear to impact clinical reasoning performance. Further, the processes of diagnostic and therapeutic reasoning, although related, may not be interchangeable. This raises important questions about the impact that contextual factors have on clinical reasoning and provides insight into how clinical reasoning processes in more authentic settings may be explained by situated cognition theory.

Effects of vedolizumab on health-related quality of life in patients with ulcerative colitis: results from the randomised GEMINI 1 trial.

PubMed

Feagan, B G; Patel, H; Colombel, J-F; Rubin, D T; James, A; Mody, R; Lasch, K

2017-01-01

Health-related quality of life (HRQL) is often diminished in patients with ulcerative colitis. To evaluate the effects of vedolizumab on HRQL in patients with ulcerative colitis. Using maintenance phase data from the GEMINI 1 study, an analysis of covariance model was used to calculate mean differences between the vedolizumab and placebo groups in changes from baseline to week 52 for 3 HRQL instruments: The Inflammatory Bowel Disease Questionnaire (IBDQ), 36-Item Short Form Health Survey (SF-36), and EQ-5D. Proportions of patients meeting minimal clinically important difference (MCID) thresholds for changes on these instruments were compared between treatment groups for the overall population and for clinically important subgroups. Concordance between clinical remission and remission defined using IBDQ scores was examined. Compared with placebo-treated patients, vedolizumab-treated patients had greater improvements (152-201%) in IBDQ, EQ-5D visual analogue scale (VAS), and EQ-5D utility scores. Greater proportions (6.9-19.9%) of vedolizumab-treated patients than placebo-treated patients met MCID thresholds for all the instruments. Vedolizumab-treated patients with lower baseline disease activity and those without prior tumour necrosis factor (TNF) antagonist failure had greater HRQL improvements. Among 127 patients with clinical remission based on complete Mayo Clinic scores, >80% also had IBDQ remission; >70% of the 150 patients with IBDQ remission demonstrated clinical remission. Vedolizumab therapy was associated with significant improvements in HRQL measures compared with placebo. Benefits were greater in patients with lower disease activity and no prior TNF antagonist failure. © 2016 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.

Prevalence of primary outcome changes in clinical trials registered on ClinicalTrials.gov: a cross-sectional study.

PubMed

Ramagopalan, Sreeram; Skingsley, Andrew P; Handunnetthi, Lahiru; Klingel, Michelle; Magnus, Daniel; Pakpoor, Julia; Goldacre, Ben

2014-01-01

An important principle in the good conduct of clinical trials is that a summary of the trial protocol, with a pre-defined primary outcome, should be freely available before the study commences. The clinical trials registry ClinicalTrials.gov provides one method of doing this, and once the trial is registered, any changes made to the primary outcome are documented. The objectives of this study were: to assess the proportion of registered trials on ClinicalTrials.gov that had the primary outcome changed; to assess when the primary outcome was changed in relation to the listed study start and end dates and to assess whether the primary outcome change had any relation to the study sponsor. A cross-sectional analysis of all interventional clinical trials registered on ClinicalTrials.gov as of 25 October 2012 was performed. The main outcome was any change made to the initially listed primary outcome and the time of the change in relation to the trial start and end date. Our analysis showed that 28229 of 89204 (31.7%) registered studies had their primary outcome changed.  Industry funding was associated with all primary outcome changes, odds ratio (OR)= 1.36, 95% confidence interval (CI)=1.31-1.41, p<0.001; with primary outcome changes after study start date OR=1.37, 95% CI=1.32-1.42, p<0.001; with primary outcome changes after primary completion date OR=1.84, 95% CI=1.75-1.94, p<0.001 and with primary outcome changes after study completion date OR=1.82, 95% CI=1.73-1.91, p<0.001.  Conclusions A significant proportion of interventional trials registered on ClinicalTrials.gov have their primary outcomes altered after the listed study start and completion dates. These changes are associated with funding source.

A novel electronic algorithm using host biomarker point-of-care tests for the management of febrile illnesses in Tanzanian children (e-POCT): A randomized, controlled non-inferiority trial.

PubMed

Keitel, Kristina; Kagoro, Frank; Samaka, Josephine; Masimba, John; Said, Zamzam; Temba, Hosiana; Mlaganile, Tarsis; Sangu, Willy; Rambaud-Althaus, Clotilde; Gervaix, Alain; Genton, Blaise; D'Acremont, Valérie

2017-10-01

The management of childhood infections remains inadequate in resource-limited countries, resulting in high mortality and irrational use of antimicrobials. Current disease management tools, such as the Integrated Management of Childhood Illness (IMCI) algorithm, rely solely on clinical signs and have not made use of available point-of-care tests (POCTs) that can help to identify children with severe infections and children in need of antibiotic treatment. e-POCT is a novel electronic algorithm based on current evidence; it guides clinicians through the entire consultation and recommends treatment based on a few clinical signs and POCT results, some performed in all patients (malaria rapid diagnostic test, hemoglobin, oximeter) and others in selected subgroups only (C-reactive protein, procalcitonin, glucometer). The objective of this trial was to determine whether the clinical outcome of febrile children managed by the e-POCT tool was non-inferior to that of febrile children managed by a validated electronic algorithm derived from IMCI (ALMANACH), while reducing the proportion with antibiotic prescription. We performed a randomized (at patient level, blocks of 4), controlled non-inferiority study among children aged 2-59 months presenting with acute febrile illness to 9 outpatient clinics in Dar es Salaam, Tanzania. In parallel, routine care was documented in 2 health centers. The primary outcome was the proportion of clinical failures (development of severe symptoms, clinical pneumonia on/after day 3, or persistent symptoms at day 7) by day 7 of follow-up. Non-inferiority would be declared if the proportion of clinical failures with e-POCT was no worse than the proportion of clinical failures with ALMANACH, within statistical variability, by a margin of 3%. The secondary outcomes included the proportion with antibiotics prescribed on day 0, primary referrals, and severe adverse events by day 30 (secondary hospitalizations and deaths). We enrolled 3,192 patients between December 2014 and February 2016 into the randomized study; 3,169 patients (e-POCT: 1,586; control [ALMANACH]: 1,583) completed the intervention and day 7 follow-up. Using e-POCT, in the per-protocol population, the absolute proportion of clinical failures was 2.3% (37/1,586), as compared with 4.1% (65/1,583) in the ALMANACH arm (risk difference of clinical failure -1.7, 95% CI -3.0, -0.5), meeting the prespecified criterion for non-inferiority. In a non-prespecified superiority analysis, we observed a 43% reduction in the relative risk of clinical failure when using e-POCT compared to ALMANACH (risk ratio [RR] 0.57, 95% CI 0.38, 0.85, p = 0.005). The proportion of severe adverse events was 0.6% in the e-POCT arm compared with 1.5% in the ALMANACH arm (RR 0.42, 95% CI 0.20, 0.87, p = 0.02). The proportion of antibiotic prescriptions was substantially lower, 11.5% compared to 29.7% (RR 0.39, 95% CI 0.33, 0.45, p < 0.001). Using e-POCT, the most common indication for antibiotic prescription was severe disease (57%, 103/182 prescriptions), while it was non-severe respiratory infections using the control algorithm (ALMANACH) (70%, 330/470 prescriptions). The proportion of clinical failures among the 544 children in the routine care cohort was 4.6% (25/544); 94.9% (516/544) of patients received antibiotics on day 0, and 1.1% (6/544) experienced severe adverse events. e-POCT achieved a 49% reduction in the relative risk of clinical failure compared to routine care (RR 0.51, 95% CI 0.31, 0.84, p = 0.007) and lowered antibiotic prescriptions to 11.5% from 94.9% (p < 0.001). Though this safety study was an important first step to evaluate e-POCT, its true utility should be evaluated through future implementation studies since adherence to the algorithm will be an important factor in making use of e-POCT's advantages in terms of clinical outcome and antibiotic prescription. e-POCT, an innovative electronic algorithm using host biomarker POCTs, including C-reactive protein and procalcitonin, has the potential to improve the clinical outcome of children with febrile illnesses while reducing antibiotic use through improved identification of children with severe infections, and better targeting of children in need of antibiotic prescription. ClinicalTrials.gov NCT02225769.

Characteristics and the trajectory of psychotropic medication use in general and antipsychotics in particular among adults with an intellectual disability who exhibit aggressive behaviour.

PubMed

Deb, S; Unwin, G; Deb, T

2015-01-01

A high proportion of adults with an intellectual disability (ID) are known to receive psychotropic medications for the management of aggressive behaviour in the absence of any psychiatric diagnosis. Despite this widespread use of psychotropic medication in general and antipsychotic medication in particular, no study has reported the trajectory of psychotropic medication use using a prospective design. We have prospectively studied a community, clinic-based sample of 100 adults with ID and aggressive behaviour over a 6-month period for use of psychotropic medication in general and antipsychotics in particular, and compared them with demographic, psychiatric and behavioural variables. Psychotropic medications were used for 89% of patients at baseline (T1) and 90% at 6 months' (T2) follow-up. Risperidone was the most commonly used antipsychotic medication followed by chlorpromazine, haloperidol, olanzapine, zuclopenthixol and quetiapine. Other commonly used medications were SSRI antidepressants such as citalopram, paroxetine and fluoxetine followed by mood stabilisers such as carbamazepine and sodium valproate. Although in a high proportion of cases carbamazepine and sodium valproate were used to treat epilepsy per se. A high proportion (45%) received more than one (polypharmacy) psychotropic medication at T1; however, this proportion decreased slightly to 41% at T2. As for antipsychotic prescribing specifically, a similar proportion received them at T1 (75%) and T2 (73%), with polypharmacy of antipsychotics remaining similar at T1 (10%) and at T2 (9%). Twenty-three per cent and 20% of patients received over 300 mg/day of chlorpromazine equivalent dose of antipsychotics at T1 and T2 respectively. However, there was an overall significant reduction in the severity of aggressive behaviour between T1 and T2. Higher doses of antipsychotic prescribing were positively correlated with more severe aggressive behaviour, physical aggression towards objects, self-injurious behaviour and increasing age. There was no significant association with other demographic variables, physical health conditions or psychiatric diagnosis. Neither was there any significant correlation between mean aggression severity score change and antipsychotic daily dose change between T1 and T2. To our knowledge, this is the first ever comprehensive follow-up study of use of psychotropic medications in general but antipsychotics in particular over a 6-month period in adults with ID and aggressive behaviour, in a clinic-based community setting which also compared the trajectory of severity of aggressive behaviour with that of antipsychotic medication dose. Our study shows that not only the use of psychotropic medication is common among adults with ID who attend psychiatric clinics for aggressive behaviour, the use of polypharmacy of psychotropic medications in general and high dose of antipsychotics in particular are equally prevalent. However, in some cases two antipsychotics may have been prescribed simultaneously as the psychiatrist is in the process of switching from one to another. © 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005.

PubMed

Ridker, Paul M; Torres, Jose

2006-05-17

In surveys based on data available prior to 2000, clinical trials funded by for-profit organizations appeared more likely to report positive findings than those funded by not-for-profit organizations. Whether this situation has changed over the past 5 years or whether similar effects are present among jointly funded trials is unknown. To determine in contemporary randomized cardiovascular trials the association between funding source and the likelihood of reporting positive findings. We reviewed 324 consecutive superiority trials of cardiovascular medicine published between January 1, 2000, and July 30, 2005, in JAMA, The Lancet, and the New England Journal of Medicine. The proportion of trials favoring newer treatments over the standard of care was evaluated by funding source. Of the 324 superiority trials, 21 cited no funding source. Of the 104 trials funded solely by not-for-profit organizations, 51 (49%) reported evidence significantly favoring newer treatments over the standard of care, whereas 53 (51%) did not (P = .80). By contrast, 92 (67.2%) of 137 trials funded solely by for-profit organizations favored newer treatments over standard of care (P<.001). Among 62 jointly funded trials, 35 (56.5%), an intermediate proportion, favored newer treatments. For 205 randomized trials evaluating drugs, the proportions favoring newer treatments were 39.5%, not-for-profit; 54.4%, jointly funded; and 65.5%, for-profit trials (P for trend across groups = .002). For the 39 randomized trials evaluating cardiovascular devices, the proportions favoring newer treatments were 50.0%, not-for-profit; 69.2%, jointly funded; and 82.4%, for-profit trials (P for trend across groups = .07). Regardless of funding source, trials using surrogate end points, such as quantitative angiography, intravascular ultrasound, plasma biomarkers, and functional measures were more likely to report positive findings (67%) than trials using clinical end points (54.1%; P = .02). Recent cardiovascular trials funded by for-profit organizations are more likely to report positive findings than trials funded by not-for-profit organizations, as are trials using surrogate rather than clinical end points. Trials jointly funded by not-for-profit and for-profit organizations appear to report positive findings at a rate approximately midway between rates observed in trials supported solely by one or the other of these entities.

External quality assurance of HER2 fluorescence in situ hybridisation testing: results of a UK NEQAS pilot scheme

PubMed Central

Bartlett, John M S; Ibrahim, Merdol; Jasani, Bharat; Morgan, John M; Ellis, Ian; Kay, Elaine; Magee, Hilary; Barnett, Sarah; Miller, Keith

2007-01-01

Background and Aims Trastuzumab provides clinical benefit for advanced and early breast cancer patients whose tumours over‐express or have gene amplification of the HER2 oncogene. The UK National External Quality Assessment Scheme (NEQAS) for immunohistochemical testing was established to assess and improve the quality of HER2 immunohistochemical testing. However, until recently, no provision was available for HER2 fluorescence in situ hybridisation (FISH) testing. A pilot scheme was set up to review the performance of FISH testing in clinical diagnostic laboratories. Methods FISH was performed in 6 reference and 31 participating laboratories using a cell line panel with known HER2 status. Results Using results from reference laboratories as a criterion for acceptable performance, 60% of all results returned by participants were appropriate and 78% either appropriate or acceptable. However, 22.4% of results returned were deemed inappropriate, including 13 cases (4.2%) where a misdiagnosis would have been made had these been clinical specimens. Conclusions The results of three consecutive runs show that both reference laboratories and a proportion of routine clinical diagnostic (about 25%) centres can consistently achieve acceptable quality control of HER2 testing. Data from a significant proportion of participating laboratories show that further steps are required, including those taken via review of performance under schemes such as NEQAS, to improve quality of HER2 testing by FISH in the “real world”. PMID:16963466

Glaucoma and clinical characteristics in Vietnamese Americans.

PubMed

Peng, Pai-Huei; Manivanh, Richard; Nguyen, Ngoc; Weinreb, Robert N; Lin, Shan C

2011-08-01

To assess the proportions of glaucoma types and clinical characteristics in Vietnamese Americans in a single-center, retrospective study. Medical charts of Vietnamese-American patients who visited a single private practice in Northern California from 1998-2007 were reviewed. The main outcome measures included the distribution and characteristics of glaucoma types, and clinical parameters associated with the presence of various glaucomas. Data from 2247 patients aged 18-98 years were reviewed. Glaucoma was determined for 305 patients (13.6%). Among this group, 54.8% had primary open-angle glaucoma (POAG), 26.9% had primary angle-closure glaucoma (PACG), 13.4% had mixed mechanism glaucoma (MMG), and 4.9% had secondary glaucoma. In the MMG group (41 patients), 27 patients who initially had open angles developed narrow angles and underwent laser peripheral iridotomy (LPI) with a mean follow up of 6.4 years from the time of iridotomy. The other 13 patients had glaucoma progression with open angles after LPI. One POAG patient had neovascular glaucoma due to retinal vein occlusion several years later. Compared to the PACG group, the MMG group had significantly lower baseline intraocular pressure (25.0 vs. 20.2 mmHg, p = 0.007) but with no difference in biometry. POAG is the major type of glaucoma in this clinic-based Vietnamese population. However, Vietnamese appear to have a relatively higher proportion of PACG than Caucasians and those of African descent. It is recommended that gonioscopy be part of the regular eye check-up for adult Vietnamese patients.

Use of clinical practice guidelines by dentists: findings from the Japanese dental practice-based research network.

PubMed

Kakudate, Naoki; Yokoyama, Yoko; Sumida, Futoshi; Matsumoto, Yuki; Gordan, Valeria V; Gilbert, Gregg H

2017-02-01

The objectives of this study were to: (1) examine differences in the use of dental clinical practice guidelines among Japanese dentists, and (2) identify characteristics associated with the number of guidelines used by participating dentists. We conducted a cross-sectional study consisting of a questionnaire survey in Japan between July 2014 and May 2015. The study queried dentists working in outpatient dental practices who are affiliated with the Dental Practice-Based Research Network Japan (n = 148). They were asked whether they have used each of 15 Japanese dental clinical guidelines. Associations between the number of guidelines used by participants and specific characteristics were analysed via negative binomial regression analysis. The mean number of guidelines used by participating dentists was 2.5 ± 2.9 [standard deviation (SD)]. Rate of use of guidelines showed substantial variation, from 5% to 34% among dentists. The proportion of dentists that used guidelines was the highest among oral medicine specialists, who had the highest proportion for 10 of 15 guidelines. Negative binomial regression analysis identified three factors significantly associated with the number of guidelines used: 'years since graduation from dental school', 'specialty practice' and 'practice busyness'. These results suggest that the use of clinical practice guidelines by Japanese dentists may still be inadequate. Training in the use of the guidelines could be given to dental students as undergraduate education and to young clinicians as continuing education. © 2016 John Wiley & Sons, Ltd.

[ST-segment elevation myocardial infarction in the eastern urban China: from 2001 to 2011].

PubMed

Li, J; Li, X; Hu, S; Yu, Y; Yan, X F; Jiang, L X

2016-04-24

To assess trends in clinical characteristics, treatments, and outcomes for hospitalized patients with ST-segment elevation myocardial infarction(STEMI) in eastern urban China from 2001 to 2011. The data were obtained from the China PEACE-retrospective acute myocardial infarction study. Patients admitted to hospital in the eastern urban China for STEMI were selected via two-stage random sampling. The first phase was to identify participating hospitals via a simple random-sampling procedure. The second stage was to select patients admitted to each participating hospitals for acute myocardial infarction in the year of 2001, 2006 and 2011 with a systematic sampling approach. Then clinical information was obtained via central medical record abstraction for each patient. In all analyses, weight was calculated proportional to the inverse sampling fraction for each period. Multilevel logistic regression models with generalized estimating equations were used for analysis of patient outcomes. This analysis included 5 257 patients with STEMI from 32 hospitals. In 2001, 2006, and 2011, the median age of STEMI patients was 66(57, 72)、67(56, 74)and 63(53, 74)years(trend test P=0.008), the proportion of female was 30.3%, 29.5% and 29.2%(trend test P=0.530), respectively. The proportion of cardiovascular risk factors increased over time(trend test P<0.001); 45.6%, 55.6%, and 56.3% patients had hypertension(trend test P<0.001); 18.8%, 27.7% and 26.2% patients had diabetes(trend test P<0.001); 50.1%, 59.2% and 70.5% patients had dyslipidemia(trend test P<0.001); 30.5%, 35.1% and 44.1% patients are current smokers(trend test P<0.001) in 2001, 2006 and 2011, respectively. Between 2001 and 2011, there were significant increases in aspirin use(80.7% in 2001, 90.4% in 2006, and 91.5% in 2011, trend test P<0.001), clopidogrel use(2.9% in 2001, 64.2% in 2006, and 90.3% in 2011, trend test P<0.001) within 24 hours after admission, statins use rate was 45.8% in 2001, 83.4% in 2006, and 93.8% in 2011(trend test P<0.001), and rate of direct percutaneous coronary intervention(PCI) was 21.0% in 2001, 29.7% in 2006, and 40.3% in 2011(trend test P<0.001) in patients without documented contraindications. However, the rate of reperfusion therapy was non-significantly decreased: 58.5% in 2001, 58.0% in 2006, and 55.5% in 2011 (trend test P=0.230). The use of beta blockers also decreased: 62.4% in 2001, 64.3% in 2006 and 55.2% in 2011(trend test P=0.001). The mortality rate within 7 days following admission was 7.8%, 7.0%, 6.1%, and the proportion of death or treatment withdrawal because of terminal status was 8.3%, 8.6%, 7.4% in 2001, 2006 and 2011, respectively. Both parameters were similar among the 3 time points(trend test P>0.05). During the past decade, there has been a rapid increase in application of new technology and drug for STEMI in the eastern urban China. However, important gaps persist between clinical practice and guideline recommendations, and the outcomes of patients have not been significantly improved. Clinical Trail Registry: ClinicalTrials.gov, NCT01624883.

Analysis of polymorphisms in the promoter region and protein levels of interleukin-6 gene among gout patients.

PubMed

Tsai, P-C; Chen, C-J; Lai, H-M; Chang, S-J

2008-01-01

To explore the associations between the polymorphisms and protein levels of interleukin-6 (IL-6) gene and gout disease. A total of 120 male gout patients and 184 healthy controls were enrolled. Each patient was matched with 1-2 gout-free controls by age within three years. Four polymorphisms in the promoter of IL-6 gene, including -597G/A, -572C/G, -373A(m)T(n), and -174G/C, and the IL-6 levels were analyzed. The clinical characteristics and biochemical markers in plasma were measured, including age of gout onset, duration of gout history, tophus number, gout attack frequency, uric acid, total cholesterol, triglycerides and creatinine. The mean IL-6 level for gout patients was 9.80 (+/-11.76 pg/ml) which showed no significant difference from the controls (7.06+/-7.58 pg/ml, p=0.230). When the IL-6 levels were dichotomized according to the median value (5 pg/ml), there were significantly higher proportions of the gout patients (59.66%) than controls (44%) with high IL-6 levels (OR=1.88, 95% CI=1.17-3.02, p=0.008). Unique genotype was found at polymorphisms -174G/C and -597G/A. Neither the polymorphisms -572C/G nor -373A(m)T(n) in the genotype or allele distributions showed a significant association related to clinical characteristics, biochemical markers, IL-6 levels or gout disease (all p>0.05). Those with gout disease have greater proportions of high IL-6 levels in plasma than controls, and there is no significant association between the four polymorphisms in the promoter region of IL-6 gene and gout disease.

Perioperative supplementation with bifidobacteria improves postoperative nutritional recovery, inflammatory response, and fecal microbiota in patients undergoing colorectal surgery: a prospective, randomized clinical trial

PubMed Central

MIZUTA, Minoru; ENDO, Izuru; YAMAMOTO, Sumiharu; INOKAWA, Hidetoshi; KUBO, Masatoshi; UDAKA, Tetsunobu; SOGABE, Osanori; MAEDA, Hiroya; SHIRAKAWA, Kazutoyo; OKAZAKI, Eriko; ODAMAKI, Toshitaka; ABE, Fumiaki; XIAO, Jin-zhong

2015-01-01

The use of probiotics has been widely documented to benefit human health, but their clinical value in surgical patients remains unclear. The present study investigated the effect of perioperative oral administration of probiotic bifidobacteria to patients undergoing colorectal surgery. Sixty patients undergoing colorectal resection were randomized to two groups prior to resection. One group (n=31) received a probiotic supplement, Bifidobacterium longum BB536, preoperatively for 7–14 days and postoperatively for 14 days, while the other group (n=29) received no intervention as a control. The occurrences of postoperative infectious complications were recorded. Blood and fecal samples were collected before and after surgery. No significant difference was found in the incidence of postoperative infectious complications and duration of hospital stay between the two groups. In comparison to the control group, the probiotic group tended to have higher postoperative levels of erythrocytes, hemoglobin, lymphocytes, total protein, and albumin and lower levels of high sensitive C-reactive proteins. Postoperatively, the proportions of fecal bacteria changed significantly; Actinobacteria increased in the probiotic group, Bacteroidetes and Proteobacteria increased in the control group, and Firmicutes decreased in both groups. Significant correlations were found between the proportions of fecal bacteria and blood parameters; Actinobacteria correlated negatively with blood inflammatory parameters, while Bacteroidetes and Proteobacteria correlated positively with blood inflammatory parameters. In the subgroup of patients who received preoperative chemoradiotherapy treatment, the duration of hospital stay was significantly shortened upon probiotic intervention. These results suggest that perioperative oral administration of bifidobacteria may contribute to a balanced intestinal microbiota and attenuated postoperative inflammatory responses, which may subsequently promote a healthy recovery after colorectal resection. PMID:27200261

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-02-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Step training improves reaction time, gait and balance and reduces falls in older people: a systematic review and meta-analysis.

PubMed

Okubo, Yoshiro; Schoene, Daniel; Lord, Stephen R

2017-04-01

To examine the effects of stepping interventions on fall risk factors and fall incidence in older people. Electronic databases (PubMed, EMBASE, CINAHL, Cochrane, CENTRAL) and reference lists of included articles from inception to March 2015. Randomised (RCT) or clinical controlled trials (CCT) of volitional and reactive stepping interventions that included older (minimum age 60) people providing data on falls or fall risk factors. Meta-analyses of seven RCTs (n=660) showed that the stepping interventions significantly reduced the rate of falls (rate ratio=0.48, 95% CI 0.36 to 0.65, p<0.0001, I 2 =0%) and the proportion of fallers (risk ratio=0.51, 95% CI 0.38 to 0.68, p<0.0001, I 2 =0%). Subgroup analyses stratified by reactive and volitional stepping interventions revealed a similar efficacy for rate of falls and proportion of fallers. A meta-analysis of two RCTs (n=62) showed that stepping interventions significantly reduced laboratory-induced falls, and meta-analysis findings of up to five RCTs and CCTs (n=36-416) revealed that stepping interventions significantly improved simple and choice stepping reaction time, single leg stance, timed up and go performance (p<0.05), but not measures of strength. The findings indicate that both reactive and volitional stepping interventions reduce falls among older adults by approximately 50%. This clinically significant reduction may be due to improvements in reaction time, gait, balance and balance recovery but not in strength. Further high-quality studies aimed at maximising the effectiveness and feasibility of stepping interventions are required. CRD42015017357. 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/.

Spa therapy together with supervised self-mobilisation improves pain, function and quality of life in patients with chronic shoulder pain: a single-blind randomised controlled trial

NASA Astrophysics Data System (ADS)

Chary-Valckenaere, Isabelle; Loeuille, Damien; Jay, Nicolas; Kohler, François; Tamisier, Jean-Noë; Roques, Christian-François; Boulange, Michel; Gay, Gérard

2018-06-01

To determine whether spa therapy has a beneficial effect on pain and disability in patients with chronic shoulder pain, this single-blind randomised controlled clinical trial included patients with chronic shoulder pain due to miscellaneous conditions attending one of four spa centres as outpatients. Patients were randomised into two groups: spa therapy (18 days of standardised treatment combining thermal therapy together with supervised mobilisation in a thermal pool) and controls (spa therapy delayed for 6 months: `immediate versus delayed treatment' paradigm). All patients continued usual treatments during the 6-month follow-up period. The main endpoint was the mean change in the French-Quick DASH (F-QD) score at 6 months. The effect size of spa therapy was calculated, and the proportion of patients reaching minimal clinically important improvement (MCII) was compared. Secondary endpoints were the mean change in SF-36, treatment use and tolerance. One hundred eighty-six patients were included (94 patients as controls, 92 in the spa group) and analysed by intention to treat. At 6 months, the mean change in the F-QD score was statistically significantly greater among spa therapy patients than controls (- 32.6 versus - 8.15%; p < 0.001) with an effect size of 1.32 (95%CI: 0.97-1.68). A significantly greater proportion of spa therapy patients reached MCII (59.3 versus 17.9%). Spa therapy was well tolerated with a significant impact on SF-36 components but not on drug intake. Spa therapy provided a statistically significant benefit on pain, function and quality of life in patients with chronic shoulder pain after 6 months compared with usual care.

Diverse proportion in composite pheochromocytoma-ganglioneuroma may induce varied clinical symptom: comparison of two cases

PubMed Central

Zhang, Bu-Yi; Zhao, Mingfei; Li, Baizhou; Zhang, Jian-Min

2015-01-01

Composite pheochromocytoma-ganglioneuroma is extremely rare. We described two cases of composite pheochromocytomas in the adrenal medullar. Case 1 was a 70-year-old male presenting with lower abdominal pain and normal blood electrolytes. Case 2 was a 48-year-old female with palpitation and back tenderness. Biochemical investigations showed hypocalcium, hypokalemia and high level of vma. The histological images and the immunohistochemical staining demonstrated the two cases composed of pheochromocytoma and ganglioneuromoma components. Ganglioneuroma component in case 2 accounted for more proportion than that in case 1. We speculated that the varied clinical symptoms were related with the diverse proportions in composite pheochromocytome-ganglioneuroma. PMID:26823896

Categorical improvements in disease severity in patients with major depressive disorder treated with vilazodone: post hoc analysis of four randomized, placebo-controlled trials.

PubMed

Durgam, Suresh; Chen, Changzheng; Gommoll, Carl P; Edwards, John; Citrome, Leslie

2016-01-01

In three 8-week studies of vilazodone 40 mg/d (NCT00285376, NCT00683592, and NCT01473394) and a 10-week study of vilazodone 20 or 40 mg/d (NCT01473381), adults with major depressive disorder (MDD) showed significantly greater improvement with vilazodone versus placebo in global disease severity as measured by mean change from baseline in Clinical Global Impression of Severity (CGI-S) score. To assess the proportion of patients achieving clinically meaningful improvement, a post hoc pooled analysis was conducted using categorical shifts in disease severity based on CGI-S scores at baseline and end of treatment (EOT). Analyses were conducted in the pooled intent-to-treat population (N=2,218). Definitions of categorical shifts included CGI-S ≥4 (moderately ill or worse) at baseline to CGI-S ≤2 (normal or borderline ill) at EOT; CGI-S ≥5 (markedly ill or worse) at baseline to CGI-S ≤2 at EOT; and CGI-S ≥6 (severely ill or worse) at baseline to CGI-S ≤3 (mildly ill or better) at EOT. At baseline, 2,217 patients were moderately ill or worse. The percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (40.0% versus 27.8%; odds ratio [OR] =1.7, P <0.001; number needed to treat [NNT] =9). In the 979 patients who were markedly ill or worse at baseline, the percentage who improved to normal or borderline ill was significantly higher with vilazodone than with placebo (36.8% versus 25.5%; OR =1.7, P <0.001; NNT =9). The small number of severely ill patients at baseline (n =43) provided inadequate power to detect statistically significant between-group differences, but an NNT =5 was found for improvement to mildly ill or better. Categorical shift analyses, defined using baseline and EOT CGI-S scores, showed that significantly higher proportions of patients had clinically meaningful improvements in global disease severity with vilazodone 20-40 mg/d versus placebo. This type of analysis may be useful for evaluating the effects of antidepressant treatment in adults with MDD.

Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial.

PubMed

Maruani, Annabel; Boutron, Isabelle; Baron, Gabriel; Ravaud, Philippe

2014-09-19

To evaluate the impact of sending an email to responsible parties of completed trials that do not comply with the Food and Drug Administration Amendments Act 801 legislation, to remind them of the legal requirement to post results. Cohort embedded pragmatic randomized controlled trial. Trials registered on ClinicalTrials.gov. 190 out of 379 trials randomly selected by computer generated randomization list to receive the intervention (personalized emails structured as a survey and sent by one of us to responsible parties of the trials, indirectly reminding them of the legal requirement and potential penalties for non-compliance). The primary outcome was the proportion of results posted on ClinicalTrials.gov at three months. The secondary outcome was the proportion posted at six months. In a second step, two assessors blinded to the intervention group collected the date of the first results being received on ClinicalTrials.gov. A post hoc sensitivity analysis excluding trials wrongly included was performed. Among 379 trials included, 190 were randomized to receive the email intervention. The rate of posting of results did not differ at three months between trials with or without the intervention: 36/190 (19%) v 24/189 (13%), respectively (relative risk 1.5, 95% confidence interval 0.9 to 2.4, P=0.096) but did at six months: 46/190 (24%) v 27/189 (14%), 1.7, 1.1 to 2.6, P=0.014. In the sensitivity analysis, which excluded 48/379 trials (13%), 26/190 (14%) and 22/189 (12%), respectively, results were significant at three months (relative risk 5.1, 1.1 to 22.9, P=0.02) and at six months (4.1, 1.3 to 10.6, P=0.001). Sending email reminders about the FDA's legal requirement to post results at ClinicalTrials.gov improved significantly the posting rate at six months but not at three months.Trial registration ClinicalTrials.gov NCT01658254. © Maruani et al 2014.

Financial Incentives for Linkage to Care and Viral Suppression Among HIV-Positive Patients: A Randomized Clinical Trial (HPTN 065).

PubMed

El-Sadr, Wafaa M; Donnell, Deborah; Beauchamp, Geetha; Hall, H Irene; Torian, Lucia V; Zingman, Barry; Lum, Garret; Kharfen, Michael; Elion, Richard; Leider, Jason; Gordin, Fred M; Elharrar, Vanessa; Burns, David; Zerbe, Allison; Gamble, Theresa; Branson, Bernard

2017-08-01

Achieving linkage to care and viral suppression in human immunodeficiency virus (HIV)-positive patients improves their well-being and prevents new infections. Current gaps in the HIV care continuum substantially limit such benefits. To evaluate the effectiveness of financial incentives on linkage to care and viral suppression in HIV-positive patients. A large community-based clinical trial that randomized 37 HIV test and 39 HIV care sites in the Bronx, New York, and Washington, DC, to financial incentives or standard of care. Participants at financial incentive test sites who had positive test results for HIV received coupons redeemable for $125 cash-equivalent gift cards upon linkage to care. HIV-positive patients receiving antiretroviral therapy at financial incentive care sites received $70 gift cards quarterly, if virally suppressed. Linkage to care: proportion of HIV-positive persons at the test site who linked to care within 3 months, as indicated by CD4+ and/or viral load test results done at a care site. Viral suppression: proportion of established patients at HIV care sites with suppressed viral load (<400 copies/mL), assessed at each calendar quarter. Outcomes assessed through laboratory test results reported to the National HIV Surveillance System. A total of 1061 coupons were dispensed for linkage to care at 18 financial incentive test sites and 39 359 gift cards were dispensed to 9641 HIV-positive patients eligible for gift cards at 17 financial incentive care sites. Financial incentives did not increase linkage to care (adjusted odds ratio, 1.10; 95% CI, 0.73-1.67; P = .65). However, financial incentives significantly increased viral suppression. The overall proportion of patients with viral suppression was 3.8% higher (95% CI, 0.7%-6.8%; P = .01) at financial incentive sites compared with standard of care sites. Among patients not previously consistently virally suppressed, the proportion virally suppressed was 4.9% higher (95% CI, 1.4%-8.5%; P = .007) at financial incentive sites. In addition, continuity in care was 8.7% higher (95% CI, 4.2%-13.2%; P < .001) at financial incentive sites. Financial incentives, as used in this study (HPTN 065), significantly increased viral suppression and regular clinic attendance among HIV-positive patients in care. No effect was noted on linkage to care. Financial incentives offer promise for improving adherence to treatment and viral suppression among HIV-positive patients. clinicaltrials.gov Identifier: NCT01152918.

Simulation program for estimating statistical power of Cox's proportional hazards model assuming no specific distribution for the survival time.

PubMed

Akazawa, K; Nakamura, T; Moriguchi, S; Shimada, M; Nose, Y

1991-07-01

Small sample properties of the maximum partial likelihood estimates for Cox's proportional hazards model depend on the sample size, the true values of regression coefficients, covariate structure, censoring pattern and possibly baseline hazard functions. Therefore, it would be difficult to construct a formula or table to calculate the exact power of a statistical test for the treatment effect in any specific clinical trial. The simulation program, written in SAS/IML, described in this paper uses Monte-Carlo methods to provide estimates of the exact power for Cox's proportional hazards model. For illustrative purposes, the program was applied to real data obtained from a clinical trial performed in Japan. Since the program does not assume any specific function for the baseline hazard, it is, in principle, applicable to any censored survival data as long as they follow Cox's proportional hazards model.

[Clinical significance of autologous transplantation with hematopoietic stem cells in leukemia and solid tumors].

PubMed

Hinterberger, W; Adler, V; Bauer, K; Haberhauer, G; Habertheuer, K H; Höniger, S; Huber, K; Kier, P; Kittel, E; Ruckser, R

1995-01-01

Autologous Transplantation of hematopoietic tissue with frozen hematopoietic stem cells is increasingly used for leukemias and lymphomas, but also for some solid tumors. In the past, autotransplants have been performed with bone marrow as the source of hematopoietic stem cells. Circulating, blood derived hematopoietic stem cells, however, allow safe engraftment of all cell lines after supralethal chemo-radiotherapy. This survey describes the role of autologous stem cell transplantation in disorders that are currently in the center of clinical and scientific interest. This estimation is based on the proportion of protocols dealing with, and centering on, autologous stem cell transplantation in the context of treatment for leukemias and solid tumors ("Oncodisc", "PDQ").

Body habitus in heart failure: understanding the mechanisms and clinical significance of the obesity paradox.

PubMed

Parto, Parham; Lavie, Carl J; Arena, Ross; Bond, Samantha; Popovic, Dejana; Ventura, Hector O

2016-11-01

The prevalence of obesity among adults and children worldwide has reached epic proportions and has become a major independent risk factor for the development of heart failure (HF), in addition to a contributor of hypertension and cardiovascular disease. The implications of obesity in the development of HF involve adverse effects on cardiac structure and function. Despite all of this, in the setting of chronic HF, excess body mass is associated with improved clinical outcomes, demonstrating the presence of an obesity paradox. In this review, we will discuss the gender differences, global application, potential mechanisms and role of interventions based on fitness and purposeful weight loss as potential therapeutic strategies.

Long-term survival after childhood acute lymphoblastic leukaemia: population-based trends in cure and relapse by clinical characteristics.

PubMed

Smith, Lesley; Glaser, Adam W; Kinsey, Sally E; Greenwood, Darren C; Chilton, Lucy; Moorman, Anthony V; Feltbower, Richard G

2018-05-29

'Cure models' offer additional information to traditional epidemiological approaches to assess survival for cancer patients by simultaneously estimating the proportion cured and the survival of those 'uncured'. The proportion cured is a summary of long-term survival while the median survival time of the uncured provides important information on those who are not long-term survivors. Population-based trends in the cure proportion and survival of the uncured for childhood acute lymphoblastic leukaemia (ALL) by clinical prognostic risk factors were estimated using flexible parametric cure models, based on overall survival and event-free survival. Children aged 1-17 years diagnosed between 1990 and 2011 in Yorkshire, UK, were included (n = 492). The percentage cured increased from 77% (95% confidence interval 70-84%) in 1990-1997 to 89% (84-93%) in 2003-2011, while the median survival time of the uncured decreased from 3·2 years (2·2-4·1 years) to 0·7 years (0-1·5 years). Models based on event-free survival showed a similar trend. The 5-year cumulative incidence of relapse substantially decreased from 35% in 1990-97 to 9% in 2003-2011. These results show selective improvement in survival between 1990 and 2011 with a significant reduction in the risk of relapse alongside a reduced absolute duration of survival for those destined to be uncured. © 2018 John Wiley & Sons Ltd.

Management of supratentorial cavernous malformations: craniotomy versus gammaknife radiosurgery.

PubMed

Shih, Yang-Hsin; Pan, David Hung-Chi

2005-02-01

Although craniotomy is the preferred treatment for symptomatic solitary supratentorial cavernous malformation (CM), radiosurgery is also an option. Our aim was to see which of these strategies was the most effective and under what circumstances. Of the 46 patients with solitary supratentorial CM that we retrospectively studied, 24 presented with seizures, 16 with focal neurological deficits due to intracerebral hemorrhage, and 6 with both seizures and bleeding. Sixteen were treated with craniotomy and 30 with gammaknife radiosurgery (GKRS). The main outcome measures for comparing craniotomy with GKRS were the proportion of postoperative seizure-free patients and the proportion of patients in whom no rebleeding occurred. Of patients presenting with seizures with/without bleeding, a significantly higher proportion of the craniotomy group than the GKRS group became and remained seizure-free (11/14 [79%] versus 4/16 [25%]; P < 0.002), and of those presenting with bleeding with/without seizures, a somewhat (though nonsignificantly) higher proportion did not rebleed (4/4 [100%] versus 12/18 [67%]) after surgery. The remaining 2 of the 16 craniotomy patients did not rebleed and had no residual tumor at follow up. Twelve of the 30 GKRS patients had evidence of tumor regression at follow up. In the clinical management of solitary supratentorial CM, craniotomy for lesionectomy resulted in better seizure control and rebleeding avoidance than GKRS.

Caries and background factors in Swedish 4-year-old children with special reference to immigrant status.

PubMed

Stecksén-Blicks, Christina; Hasslöf, Pamela; Kieri, Catarina; Widman, Kjerstin

2014-11-01

This study assesses the prevalence of caries and some background factors in 4-year-old children in the city of Umeå, northern Sweden, and compares this with data from earlier studies to reveal changes over time. Children from the catchment areas of three Public Dental Health Service clinics in Umeå (n = 224) born during the third quarter of 2008 were invited to undergo a clinical dental examination. Decayed surfaces (including both dentine and enamel, except for enamel lesions on buccal and lingual surfaces), missing and filled surfaces (dmfs) were recorded using the same methods and criteria as in a series of earlier studies performed between 1980-2007. Background data were collected in a case-history and a questionnaire. Results. The proportion of children with caries significantly decreased from 2007 (38%) to 2012 (22%) (p < 0.05). In addition, the distribution of dmfs differed significantly between these years (p < 0.05). More immigrant children had caries (42%) than non-immigrant children (15%) (p < 0.05). For children with caries, there were no significant changes in the distribution of dmfs between 1980-2012 (p > 0.05). An immigrant background was associated with a lower frequency of tooth brushing and a higher intake of ice cream, sweets and chocolate drinks (p < 0.05). Although the proportion of children with caries declined between 2007-2012, this decline was limited to non-immigrant children. Since 1980 the distribution of dmfs remained unchanged among children with caries. More research on interventions for changing oral health behaviours is needed, specifically for immigrant children.

Outcome of liver transplantation for hepatocellular carcinoma -- a single center experience.

PubMed

Iacob, R; Iacob, S; Gheorghe, L; Gheorghe, C; Hrehoreţ, D; Brașoveanu, V; Croitoru, A; Herlea, V; Popescu, I

2013-01-01

Liver transplantation (LT) is a promising treatment for patients with liver cirrhosis associated with hepatocellular carcinoma (HCC). The aim of our study was to evaluate our experience regarding the clinical and pathological staging of HCC in patients who underwent LT, as well as recurrence free and overall survival. From January 2006 to December 2011, 38 patients with diagnosis of HCC, underwent LT in our Center. Demographic, clinical, imaging and pathologic information were recorded. A Cox proportional hazards survival analysis was performed in order to identify significant predictors of tumor recurrence and patient's death after LT. Eighteen patients (47.4%) in our study group were within Milan criteria. The mean follow-up was 22 months and the recurrence rate of HCC after LT was 13.2%. The 1, 3- year recurrence free survival rates were 85%, 74.3% respectively. The 1 and 3-year overall survival rates were 83.5% and 63.6% respectively. No significant predictor for HCC recurrence was identified in our study group by survival analysis, taking into account 13 different variables. As independent predictors of patient'ss death after LT for HCC however, the presence of diabetes mellitus (p=0.001), presence of more than 3 HCC nodules (p=0.03) and tumor recurrence after LT (p=0.03) were identified by multivariate Cox proportional hazards survival analysis. In our cohort HCC recurrence rate after LT was 13.2%. Diabetes mellitus, presence of more than 3 HCC nodules and HCC recurrence were significant predictors of poor overall survival after LT. Celsius.

Allergen immunotherapy: exploring areas for further inquiry.

PubMed

Ramsey, Tam; Lai, Wanda; Svider, Peter F; Hojjat, Houmehr; Eloy, Jean Anderson; Folbe, Adam J

2017-12-01

Allergy-related illness impacts millions of individuals worldwide. Our objectives were to characterize current trends of clinical trials research relating to allergen immunotherapy and to describe the landscape of allergen immunotherapy in National Institutes of Health (NIH)-supported research inquiry. On ClinicalTrials.gov, the following terms were searched: allergen immunotherapy OR allergy immunotherapy. Variables, including completion status, dates, design, study population, funder, location, and allergen were recorded. The NIH Research Portfolio Online Reporting Tools (RePORTER) system was also used to gather relevant variables. A total of 372 clinical trials met inclusion criteria. The proportion of industry-funded clinical trials has declined over 15 years. There has been a slow decline in pollen allergy immunotherapy research, with an increase in both food and animal allergy immunotherapy research. Otolaryngologists comprised only 6.4% of clinical trials principal investigators (PIs). There was a total adjusted NIH funding of $74,986,125 for the 118 total funding years. Despite an immense interest in allergen immunotherapy, this analysis demonstrates that otolaryngologists represented a small proportion of PIs leading associated clinical trials and basic science inquiry. The proportion of trials with industry sponsorship has declined considerably in recent decades. These trends could help direct future resource allocation for allergen immunotherapy. © 2017 ARS-AAOA, LLC.

Relations among behavioral inhibition, shame- and guilt-proneness, and anxiety disorders symptoms in non-clinical children.

PubMed

Muris, Peter; Meesters, Cor; Bouwman, Leanne; Notermans, Sabine

2015-04-01

This study examined relationships between the self-conscious emotions of shame and guilt, behavioral inhibition (as an index of anxiety proneness), and anxiety disorder symptoms in non-clinical children aged 8-13 years (N = 126), using children's self-report data. Results showed that there were positive and significant correlations between shame and guilt, behavioral inhibition, and anxiety disorders symptoms. When controlling for the overlap between shame and guilt, it was found that shame (but not guilt) remained significantly associated with higher levels of anxiety proneness and anxiety symptoms. Further, when controlling for the effect of behavioral inhibition, shame still accounted for a significant proportion of the variance of total anxiety and generalized anxiety scores. For these anxiety problems, support emerged for a model in which shame acted as a partial mediator in the relation between behavioral inhibition and anxiety. These results indicate that the self-conscious emotion of shame is a robust correlate of anxiety pathology in children.

Analysis of internet use behaviors among clinical medical students in China

PubMed Central

2014-01-01

Background The availability of internet-based information resources is increasing and the appropriate use of such resources is an important subject for clinical medical students. The aims of this study were to investigate the behaviors of clinical medical students regarding the use of internet-based activities, to analyze the behavior and characteristics of the students’ information demands, and to discuss the behaviors and time preferences related to internet use of students with different levels of education. Methods Librarians obtained real-time feedback from 999 clinical medical students to record online activities. The data was recorded in a standard form and then analyzed statistically. Results There were significant differences in the use of the internet for learning activities among the different groups of clinical medical students (P < 0.0001). Learning accounted for 73.5% of all internet use for doctoral candidates, 47.6% of internet use for master’s candidates, 28.7% of internet use for seven-year undergraduate students, and 14.1% of use for five-year undergraduate students. There was also a significant difference in the proportions of leisure and e-commerce activities among the student groups (P < 0.0001), with five-year students displaying the highest total proportion of these activities (59.4% and 18.8%). Internet use for entertainment activities was the same for all groups of clinical medical students. Time of day of internet use was consistent across all student groups, but internet use differed by day of the week (P < 0.01). There was no difference among the time of day of internet use for learning, leisure and entertainment activities during a single day (P > 0.05), but e-commerce activities varied according to time of day (P < 0.05). Learning and e-commerce activities by clinical medical students did not vary by day of the week (P > 0.05), but the distributions of leisure and entertainment activities were different according to day of the week (P < 0.05). Conclusions A stronger demand for learning is associated with a higher academic level of clinical medical students. Differences exist among student groups regarding internet use behaviors and internet use during different time periods. PMID:24690437

Once-daily USL255 as adjunctive treatment of partial-onset seizures: Randomized phase III study

PubMed Central

Chung, Steve S; Fakhoury, Toufic A; Hogan, R Edward; Nagaraddi, Venkatesh N; Blatt, Ilan; Lawson, Balduin; Arnold, Stephan; Anders, Bob; Clark, Annie M; Laine, Dawn; Meadows, R Shawn; Halvorsen, Mark B

2014-01-01

Objective To evaluate the efficacy and safety of USL255, Qudexy™ XR (topiramate) extended-release capsules, as an adjunctive treatment for refractory partial-onset seizures (POS) in adults taking one to three concomitant antiepileptic drugs. Methods In this global phase III study (PREVAIL; NCT01142193), 249 adults with POS were randomized 1:1 to once-daily USL255 (200 mg/day) or placebo. The primary and key secondary efficacy endpoints were median percent reduction in weekly POS frequency and responder rate (proportion of patients with ≥50% reduction in seizure frequency). Seizure freedom was also assessed. Safety (adverse events, clinical and laboratory findings), as well as treatment effects on quality of life (QOLIE-31-P) and clinical global impression of change (CGI-C), were evaluated. Results Across the entire 11-week treatment phase, USL255 significantly reduced the median percent seizure frequency and significantly improved responder rate compared with placebo. Efficacy over placebo was observed early in treatment, in patients with highly refractory POS, and in those with the most debilitating seizure types (i.e., complex partial, partial secondarily generalized). USL255 was safe and generally well tolerated with a low incidence of neurocognitive adverse events. USL255 was associated with significant clinical improvement without adversely affecting quality of life. Significance The PREVAIL phase III clinical study demonstrated that once-daily USL255 (200 mg/day) significantly improved seizure control and was safe and generally well tolerated with few neurocognitive side effects. PMID:24902983

The Affordable Care Act Decreased the Proportion of Uninsured Patients in a Safety Net Orthopaedic Clinic.

PubMed

Gil, Joseph A; Goodman, Avi D; Kleiner, Justin; Kamal, Robin N; Baker, Laurence C; Akelman, Edward

2018-05-01

The Patient Protection and Affordable Care Act (ACA) was approved in 2010, substantially altering the economics of providing and receiving healthcare services in the United States. One of the primary goals of this legislation was to expand insurance coverage for under- and uninsured residents. Our objective was to examine the effect of the ACA on the insurance status of patients at a safety net clinic. Our institution houses a safety net clinic that provides the dominant majority of orthopaedic care for uninsured patients in our state. Therefore, our study allows us to accurately examine the magnitude of the effect on insurance status in safety net orthopaedic clinics. (1) Did the ACA result in a decrease in the number of uninsured patients at a safety net orthopaedic clinic that provides the dominant majority of orthopaedic care for the uninsured in the state? (2) Did the proportion of patients insured after passage of the ACA differ across age or demographic groups in one state? We retrospectively examined our longitudinally maintained adult orthopaedic surgery clinic database from January 2009 to March 2015 and collected visit and demographic data, including zip code income quartile. Based on the data published by the Rhode Island Department of Health, our clinic provides the dominant majority of orthopaedic care for uninsured patients in our state. Therefore, examination of the changes in the proportion of insurance status in our clinic allows us to assess the effect of the ACA on the state level. Univariate and multivariable logistic regression analyses were used to determine the relationship between demographic variables and insurance status. Adjusted odds ratios and 95% CIs were calculated for the proportion of uninsured visits. The proportion of uninsured visits before and after implementation of the ACA was evaluated with an interrupted time-series analysis. The reduction in the proportion of patients without insurance between demographic groups (ie, race, gender, language spoken, and income level) also was compared using an interrupted time-series design. There was a 36% absolute reduction (95% CI, 35%-38%; p < 0.001) in uninsured visits (73% relative reduction; 95% CI, 71%-75%; p < 0.001). There was an immediate 28% absolute reduction (95% CI, 21%-34%; p < 0.001) at the time of ACA implementation, which continued to decline thereafter. After controlling for potential confounding variables such as gender, race, age, and income level, we found that patients who were white, men, younger than 65 years, and seen after January 2014 were more likely to have insurance than patients of other races, women, older patients, and patients treated before January 2014. After the ACA was implemented, the proportion of patients with health insurance at our safety net adult orthopaedic surgery clinic increased substantially. The reduction in uninsured patients was not equal across genders, races, ages, and incomes. Future studies may benefit from identifying barriers to insurance acquisition in these subpopulations. The results of this study could affect orthopaedic practices in the United States by guiding policy decisions regarding health care. Level III, therapeutic study.

Herbal medicines and veno-occlusive disease in India.

PubMed Central

Datta, D. V.; Khuroo, M. S.; Mattocks, A. R.; Aikat, B. K.; Chhuttani, P. N.

1978-01-01

Six cases are described of veno-occlusive disease (VOD) after medicinal herb ingestion. The herb Heliotropium eichwaldii, taken by three patients, was found to contain the toxic pyrrolizidine alkaloid, heliotrine. Two patients presented with fulminant hepatic failure while the other four patients had a clinical picture suggestive of decompensated cirrhosis. The medical use of this herb may possibly be responsible for a significant proportion of acute and chronic liver disease in India, making it of public health importance. Images Fig. 1 Fig. 2 Fig. 3 PMID:733681

The use of antifibrinolytics in pediatric patients with hypoproliferative thrombocytopenia.

PubMed

Delaney, Meghan; Matthews, Dana C; Gernsheimer, Terry B

2017-12-01

Despite the use of evidence-based platelet transfusion therapy during periods of hypoproliferative thrombocytopenia, a large proportion of pediatric hematology/oncology patients continue to suffer from clinically significant bleeding. Antifibrinolytic (AF) drugs have been shown in certain surgical and trauma settings to decrease bleeding, blood transfusion, and improve survival. We conducted a retrospective assessment of the safety of using AF drugs in pediatric patients with hypoproliferative thrombocytopenia at our center as well as the impact on bleeding occurrence and severity. © 2017 Wiley Periodicals, Inc.

The Relationship of Financial Pressures and Community Characteristics to Closure of Private Safety Net Clinics.

PubMed

Li, Suhui; Dor, Avi; Pines, Jesse M; Zocchi, Mark S; Hsia, Renee Y

2016-10-01

In order to better understand what threatens vulnerable populations' access to primary care, it is important to understand the factors associated with closing safety net clinics. This article examines how a clinic's financial position, productivity, and community characteristics are associated with its risk of closure. We examine patterns of closures among private-run primary care clinics (PCCs) in California between 2006 and 2012. We use a discrete-time proportional hazard model to assess relative hazard ratios of covariates, and a random-effect hazard model to adjust for unobserved heterogeneity among PCCs. We find that lower net income from patient care, smaller amount of government grants, and lower productivity were associated with significantly higher risk of PCC closure. We also find that federally qualified health centers and nonfederally qualified health centers generally faced the same risk factors of closure. These results underscore the critical role of financial incentives in the long-term viability of safety net clinics. © The Author(s) 2015.

Association between the findings on magnetic resonance imaging screening for syringomyelia in asymptomatic Cavalier King Charles spaniels and observation of clinical signs consistent with syringomyelia in later life.

PubMed

Ives, E J; Doyle, L; Holmes, M; Williams, T L; Vanhaesebrouck, A E

2015-01-01

A questionnaire-based study was used to investigate the association between the findings on magnetic resonance imaging (MRI) screening for syringomyelia (SM) in 79 asymptomatic Cavalier King Charles spaniels (CKCS) and the subsequent development of clinical signs consistent with SM in later life. Owners reported clinical signs consistent with SM in 13/79 (16%) dogs at the time of the questionnaire. A significantly greater proportion of CKCS with a syrinx visible on MRI screening showed clinical signs in later life (9/25, 36%) than dogs without a visible syrinx (4/54, 7%; odds ratio 6.9). Whether the findings of MRI screening can be used to indicate the likelihood of an asymptomatic CKCS developing clinical signs consistent with SM in later life warrants further prospective study in a larger cohort of dogs. Copyright © 2014 Elsevier Ltd. All rights reserved.

The Average Hazard Ratio - A Good Effect Measure for Time-to-event Endpoints when the Proportional Hazard Assumption is Violated?

PubMed

Rauch, Geraldine; Brannath, Werner; Brückner, Matthias; Kieser, Meinhard

2018-05-01

In many clinical trial applications, the endpoint of interest corresponds to a time-to-event endpoint. In this case, group differences are usually expressed by the hazard ratio. Group differences are commonly assessed by the logrank test, which is optimal under the proportional hazard assumption. However, there are many situations in which this assumption is violated. Especially in applications were a full population and several subgroups or a composite time-to-first-event endpoint and several components are considered, the proportional hazard assumption usually does not simultaneously hold true for all test problems under investigation. As an alternative effect measure, Kalbfleisch and Prentice proposed the so-called 'average hazard ratio'. The average hazard ratio is based on a flexible weighting function to modify the influence of time and has a meaningful interpretation even in the case of non-proportional hazards. Despite this favorable property, it is hardly ever used in practice, whereas the standard hazard ratio is commonly reported in clinical trials regardless of whether the proportional hazard assumption holds true or not. There exist two main approaches to construct corresponding estimators and tests for the average hazard ratio where the first relies on weighted Cox regression and the second on a simple plug-in estimator. The aim of this work is to give a systematic comparison of these two approaches and the standard logrank test for different time-toevent settings with proportional and nonproportional hazards and to illustrate the pros and cons in application. We conduct a systematic comparative study based on Monte-Carlo simulations and by a real clinical trial example. Our results suggest that the properties of the average hazard ratio depend on the underlying weighting function. The two approaches to construct estimators and related tests show very similar performance for adequately chosen weights. In general, the average hazard ratio defines a more valid effect measure than the standard hazard ratio under non-proportional hazards and the corresponding tests provide a power advantage over the common logrank test. As non-proportional hazards are often met in clinical practice and the average hazard ratio tests often outperform the common logrank test, this approach should be used more routinely in applications. Schattauer GmbH.

Tuberculosis cure rates and the ETR.Net: investigating the quality of reporting treatment outcomes from primary healthcare facilities in Mpumalanga province, South Africa.

PubMed

Dreyer, A W; Mbambo, D; Machaba, M; Oliphant, C E M; Claassens, M M

2017-03-10

Tuberculosis control programs rely on accurate collection of routine surveillance data to inform program decisions including resource allocation and specific interventions. The electronic TB register (ETR.Net) is dependent on accurate data transcription from both paperbased clinical records and registers at the facilities to report treatment outcome data. The study describes the quality of reporting of TB treatment outcomes from facilities in the Ehlanzeni District, Mpumalanga Province. A descriptive crossectional study of primary healthcare facilities in the district for the period 1 January - 31 December 2010 was performed. New smear positive TB cure rate data was obtained from the ETR.Net followed by verification of paperbased clinical records, both TB folders and the TB register, of 20% of all new smear positive cases across the district for correct reporting to the ETR.Net. Facilities were grouped according to high (>70%) and low cure rates (≤ 70%) as well as high (> 20%) and low (≤ 20%) error proportions in reporting. Kappa statistic was used to determine agreement between paperbased record, TB register and ETR.Net. Of the100 facilities (951 patient clinical records), 51(51%) had high cure rates and high error proportions, 14(14%) had a high cure rate and low error proportion whereas 30(30%) had low cure rates and high error proportions and five (5%) had a low cure rate with low error proportion. Fair agreement was observed (Kappa = 0.33) overall and between registers. Of the 473 patient clinical records which indicated cured, 383(81%) was correctly captured onto the ETR.Net, whereas 51(10.8%) was incorrectly captured and 39(8.2%) was not captured at all. Over reporting of treatment success of 12% occurred on the ETR.Net. The high error proportion in reporting onto the ETR.Net could result in a false sense of improvement in the TB control programme in the Ehlanzeni district.

Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics.

PubMed

Yoon, Jean; Lo, Jeanie; Gehlert, Elizabeth; Johnson, Erin E; O'Toole, Thomas P

2017-06-01

The study compared health care utilization and costs among homeless veterans randomly assigned to peer mentors or usual care and described contacts with peer mentors. Homeless patients at four Department of Veterans Affairs clinics were randomly assigned to a peer mentor (N=195) or to usual care (N=180). Administrative data on utilization and costs over a six-month follow-up were combined with peer mentors' reports of patient contacts. Most patients (87%) in the peer mentor group had at least one peer contact. Patients in this group spent the largest proportions of time discussing housing and health issues with peer mentors and had more outpatient encounters than those in usual care, although differences were not significant. No other between-group differences were found in utilization or costs. Although significant impacts of peer mentors on health care patterns or costs were not detected, some patients had frequent contact with peer mentors.

Metabolic Abnormalities and Clinical Lipodystrophy in Children With Human Immunodeficiency Virus Infection: A Report From a Tertiary Care Center in India.

PubMed

Kumar, Prasanna; Suri, Deepti; Vignesh, Pandiarajan; Verma Attri, Savita; Kumar Bhalla, Anil; Singh, Surjit

2017-12-01

A cross-sectional study from a tertiary care center in India was undertaken to assess and compare the prevalence of blood glucose and lipid profile aberrations in children who received first-line antiretroviral therapy (ART; n = 63) and in children who were naïve to ART (n = 46). Impaired fasting blood glucose values were found in 7 children in ART-experienced group but none in ART-naïve group (P = 0.02). Low concentrations of high-density lipoprotein cholesterol were more prevalent in the ART-naïve group compared with ART-experienced group (54.3% vs. 22.2%; P = 0.001). Hypertriglyceridemia was noted in a significant proportion of both ART-naïve (43.5%) and ART-experienced children (39.7%). Incidence of clinical lipodystrophy was 47.7%, and there was no significant association noted between lipid profile abnormalities and lipodystrophy.

High rates of PTSD treatment dropout: A possible red herring?

PubMed

Szafranski, Derek D; Smith, Brian N; Gros, Daniel F; Resick, Patricia A

2017-04-01

Few studies have examined symptom change among dropouts from posttraumatic stress disorder (PTSD) treatment. However, dropout is widely considered a negative event needing to be addressed. The present study investigated PTSD and depression symptom change in patients with PTSD who discontinued psychotherapy. Female civilians (n=321) diagnosed with PTSD participated in two randomized clinical trials examining PTSD treatment outcomes. Of those, 53 were identified as dropouts and included in this study. Symptom change was assessed by clinically significant change (CSC) criteria and symptom end-state criteria. Results demonstrated that considerable proportions of participants (35.85-55.56%) displayed significant improvement and/or met good end-state criteria for PTSD and depression. Results also revealed that participants who displayed symptom improvement were younger, attended more treatment sessions, were married or partnered, and had higher annual household income. Although preliminary, these findings contradict belief that treatment dropouts do not display symptom improvement. Published by Elsevier Ltd.

High-Performance 3D Compressive Sensing MRI Reconstruction Using Many-Core Architectures.

PubMed

Kim, Daehyun; Trzasko, Joshua; Smelyanskiy, Mikhail; Haider, Clifton; Dubey, Pradeep; Manduca, Armando

2011-01-01

Compressive sensing (CS) describes how sparse signals can be accurately reconstructed from many fewer samples than required by the Nyquist criterion. Since MRI scan duration is proportional to the number of acquired samples, CS has been gaining significant attention in MRI. However, the computationally intensive nature of CS reconstructions has precluded their use in routine clinical practice. In this work, we investigate how different throughput-oriented architectures can benefit one CS algorithm and what levels of acceleration are feasible on different modern platforms. We demonstrate that a CUDA-based code running on an NVIDIA Tesla C2050 GPU can reconstruct a 256 × 160 × 80 volume from an 8-channel acquisition in 19 seconds, which is in itself a significant improvement over the state of the art. We then show that Intel's Knights Ferry can perform the same 3D MRI reconstruction in only 12 seconds, bringing CS methods even closer to clinical viability.

Patient-level clinically meaningful improvements in activities of daily living and pain after total hip arthroplasty: data from a large US institutional registry.

PubMed

Singh, Jasvinder A; Lewallen, David G

2013-06-01

To characterize patient-level clinically meaningful improvements in pain and limitation of key activities of daily living (ADLs) after primary or revision total hip arthroplasty (THA). We analysed prospectively collected data from the Mayo Clinic Total Joint Registry to study clinically meaningful improvements in index hip pain severity and limitation in seven key ADLs (walking, climbing stairs, putting on shoes/socks, picking up objects, getting in/out of car, rising from a chair and sitting), from preoperative to 2- and 5-year post-THA. The primary THA cohort consisted of 6168 responders preoperatively, 5707 at 2 years and 3289 at 5 years postoperatively. The revision THA cohort consisted of 2063 responders preoperatively, 2682 at 2 years and 1627 at 5 years postoperatively. In the primary THA cohort, clinically meaningful pain reduction to mild or no hip pain at 2 years was reported by 94% with moderate and 91% with severe preoperative pain; respective proportions were 91% and 89% at 5-year follow-up. For revision THA, respective proportions were 84% and 77% at 2 years and 80% and 78% at 5 years. In the primary THA cohort, up to 4% with moderate and 17% with severe preoperative ADL limitation reported severe limitation in the respective activity 2 years post-primary THA; at 5 years, the respective proportions were up to 7% and 20%. Respective proportions for revision THA were up to 10% and 26% at 2 years and 13% and 30% at 5 years. These comprehensive data for patient-level clinically meaningful improvements in pain and seven key ADLs can help patients set realistic goals for improvement after THA.

[Clinical manifestation and cytogenetic analysis of 607 patients with Turner syndrome].

PubMed

Zheng, Jiemei; Liu, Zhiying; Xia, Pei; Lai, Yi; Wei, Yangjun; Liu, Yanyan; Chen, Jiurong; Qin, Li; Xie, Liangyu; Wang, He

2017-02-10

To explore the correlation between cytogenetic findings and clinical manifestations of Turner syndrome. 607 cases of cytogenetically diagnosed Turner syndrome, including those with a major manifestation of Turner syndrome, were analyzed with conventional G-banding. Correlation between the karyotypes and clinical features were analyzed. Among the 607 cases, there were 154 cases with monosomy X (25.37%). Mosaicism monosomy X was found in 240 patients (39.54%), which included 194 (80.83%) with a low proportion of 45,X (3 ≤ the number of 45, X ≤5, while the normal cells ≥ 30). Structural X chromosome abnormalities were found in 173 patients (28.50%). A supernumerary marker chromosome was found in 40 cases (6.59%). Most patients with typical manifestations of Turner syndrome were under 11 years of age and whose karyotypes were mainly 45,X. The karyotype of patients between 11 and 18 years old was mainly 45,X, 46,X,i(X)(q10) and mos45,X/46,X,i(X)(q10), which all had primary amenorrhea in addition to the typical clinical manifestations. The karyotype of patients over 18 years of age were mainly mosaicism with a low proportion of 45,X, whom all had primary infertility. 53 patients had a history of pregnancy, which included 48 with non-structural abnormalities of X chromosome and 5 with abnormal structure of X chromosome. Generally, the higher proportion of cells with an abnormal karyotype, the more severe were the clinical symptoms and the earlier clinical recognition. Karyotyping analysis can provide guidance for the early diagnosis of Turner syndrome, especially those with a low proportion of 45,X.

Association between type 2 diabetes mellitus and anthropometric measurements - a case control study in South India.

PubMed

Awasthi, A; Rao, C R; Hegde, D S; Rao N, K

2017-03-01

Obesity is a major risk factor for type 2 diabetes mellitus (T2DM). Clinical evidence indicates a stronger association of diabetes with central obesity than general obesity. The present study aimed to compare the association between type 2 diabetes mellitus and different anthropometric measurements and evaluate the usefulness of these measurements in clinical practice. A case-control study was done among 102 individuals; of whom 51 cases included diagnosed T2DM (≥ 20 years age) patients attending the Medicine out-patient consultation of a tertiary care hospital and 51 controls who were screen negative for T2DM and recruited from the local community. Various anthropometric measurements were used according to standard World Health Organization (WHO) protocols. Data was entered and analyzed using Statistical Package for Social Sciences (SPSS) version 15. The proportion of cases with Body Mass Index (BMI) ≥ 25 kg/m 2 was 55% as compared to 22% of controls and this association was statistically significant (p < 0.05). The proportion of cases with high waist circumference cut-offs (WC) was 74.5% as compared to 45.1% healthy individuals and this association was also statistically significant (p < 0.05, OR = 3.56). A Receiver Operating Characteristic (ROC) curve for both gender revealed highest area under the curve for body mass index (area = 0.787). Body mass index had the best discriminatory power. Waist to hip ratio was not a sensitive marker especially for females. A strong association between obesity indices and diabetes was identified. BMI and WC could be used in clinical practice for suggesting life style modifications.

[An analysis of the clinical and epidemiological characteristics of acute poisoning patients in a general hospital].

PubMed

Hou, Y H; Zhao, Q; Wu, Y X; Hu, T T; Chen, Y; You, Y T; Kang, X W; Hong, G L; Lu, Z Q

2016-07-20

Objective: To analyze the clinical and epidemiological characteristics of acute poisoning patients in a general hospital, then to provide a reference for the prevention and treatment of acute poisoning in the future. Methods: A retrospective analysis was made on the clinical data of 660 patients with acute poisoning admitted in emergency medical center of the First Affiliated Hospital of Wenzhou Medical University from July 2009 to May 2015. Results: More men than women in 660 cases with acute poisoning(the ratio of male to female was 1.36∶1) ; ≥30 years old was the high incidence age (78.79%) ; The top occupation was farmers (39.70%) ; Most were life poisoning (88.18%) , suicide was the main reason (62.42%) especially happened in women, and the main cause of suicide was family conflicts; Toxic species dominated by pesticide (67.58%) , most were severe poisoning (81.82%) ; The top two pesticide poisoning were organic phosphorus and paraquat, and the proportion of blood purification in paraquat was significantly higher (χ 2 =105.21, P =0.00) ; There were 212 cases with organ dysfunction, main were pesticide poisoning patients, and the proportionof organ dysfunction in paraquat was significantly higher than the rest allpesticide poisoning (χ 2 =45.09, P =0.00) ; The general fatal rate of acute poisoning was 2.27%, and the proportion in paraquat poisoning was .higher than the rest pesticide poisoning who were death and give up when discharged (χ 2 =56.83, P =0.00) . Conclusion: The focus of acute poisoning in the general hospital is still pesticide (especially organic phosphorus and paraquat) , and most were severe poisoning.

Analysis of evidence within the AUA's clinical practice guidelines.

PubMed

Antoine, Samuel G; Small, Alexander C; McKiernan, James M; Shah, Ojas

2018-02-01

Surgical subspecialty societies release clinical practice guidelines (CPGs) to provide topic-specific recommendations to healthcare providers. We hypothesize that there may be significant differences in statement strength and evidence quality both within the American Urological Association (AUA) guidelines and compared to those published by the American Academy of Orthopedic Surgeons (AAOS) and American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). CPGs issued through 2017 were extracted from the AUAnet.org. Statements were characterized by evidence basis, strength, and evidence quality. CPGs were compared among urologic subspecialties and to those from the AAOS and AAO-HNS. Analysis used Fisher's exact tests and Student's t-tests with significance p < 0.05. A total of 25 AUA CPGs (672 statements) were reviewed and 34.6% were non-evidence based with the highest proportions in pediatrics (47.5%) and sexual medicine (46.5%). The AUA has published over twice as many statements as the AAOS and quadruple that of the AAO-HNS. A smaller proportion of the AUA statements were evidence-based (65.4%) compared to the AAOS (80.5%, p < 0.001) and AAO-HNS (99.8%, p < 0.001), and fewer used "high" quality evidence (AUA 7.2% versus AAOS 21.2%, p < 0.001; versus AAO-HNS 16.1%, p < 0.001). The AUA has published broad CPGs that far exceed those from the AAOS and AAO-HNS. The AUA has utilized extensive resources to provide guidance to help standardize care among urologists. The AAOS and AAO-HNS may not provide guidelines when evidence is limited. With the continued increase of high quality clinical trials, the AUA will be able to continue improving its robust set of evidence-based CPGs.

Prognostic value of Ki-67 index in adult medulloblastoma after accounting for molecular subgroup: a retrospective clinical and molecular analysis.

PubMed

Zhao, Fu; Zhang, Jing; Li, Peng; Zhou, Qiangyi; Zhang, Shun; Zhao, Chi; Wang, Bo; Yang, Zhijun; Li, Chunde; Liu, Pinan

2018-04-23

Medulloblastoma (MB) is a rare primary brain tumor in adults. We previously evaluated that combining both clinical and molecular classification could improve current risk stratification for adult MB. In this study, we aimed to identify the prognostic value of Ki-67 index in adult MB. Ki-67 index of 51 primary adult MBs was reassessed using a computer-based image analysis (Image-Pro Plus). All patients were followed up ranging from 12 months up to 15 years. Gene expression profiling and immunochemistry were used to establish the molecular subgroups in adult MB. Combined risk stratification models were designed based on clinical characteristics, molecular classification and Ki-67 index, and identified by multivariable Cox proportional hazards analysis. In our cohort, the mean Ki-67 value was 30.0 ± 11.3% (range 6.56-63.55%). The average Ki-67 value was significantly higher in LC/AMB than in CMB and DNMB (P = .001). Among three molecular subgroups, Group 4-tumors had the highest average Ki-67 value compared with WNT- and SHH-tumors (P = .004). Patients with Ki-67 index large than 30% displayed poorer overall survival (OS) and progression free survival (PFS) than those with Ki-67 less than 30% (OS: P = .001; PFS: P = .006). Ki-67 index (i.e. > 30%, < 30%) was identified as an independent significant prognostic factor (OS: P = .017; PFS: P = .024) by using multivariate Cox proportional hazards model. In conclusion, Ki-67 index can be considered as a valuable independent prognostic biomarker for adult patients with MB.

[Analysis of Relationship between Serum Total Light Chain κ/λ Ratio and Proportion of Bone Marrow Plasma Cells in Patients with IgG type and IgA type Multiple Myeloma].

PubMed

Zhu, An-You; Zhu, Fang-Bing; Wang, Feng-Chao; Zhang, Lun-Jun; Ma, Yue; Hu, Jian-Guo

2017-10-01

To explore the relationship between serum total light chain κ/λ ratio (sTLC-κ/λ) and proportion of bone marrow plasma cells (BMPC) in patients with IgG type and IgA type multiple myeloma (MM) and its clinical significance. The levels of serum IgG, IgA, κ type and λ type total light chain were detected in 79 newly diagnosed patients with IgG type (n=52) and IgA type (n=27) MM by immuno-nephelometric assay and the sTLC-κ/λ ratio was calculated. The proportion of BMPC was determined by bone marrow smears in the corresponding period, and the changes in sTLC-κ/λ ratio and the proportion of BMPC were observed in 19 patients with IgG type(n=16) and IgA type (n=3) MM undergoing treatment, 26 cases of non-phasmocytic proliferative diseases were enrolled in control group. In MM patients with IgGκ type and IgAκ type, the sTLC-κ/λ ratio was significantly higher than that in the control group (P<0.01), while in MM patients with IgGλ type and IgAλ type, the sTLC-κ/λ ratio was significantly lower than that in the control group (P<0.01). In MM patients with IgGκ, the sTLC-κ/λ ratio was significantly higher than that in MM patients with IgAκ(P<0.01), while the sTLC-κ/λ ratio in MM patients with IgGλ was significantly lower than that in MM patients with IgAλ. The sTLC-κ/λ ratios in MM patients with IgGκ and IgAκ were positively correlated with the concentrations of IgG (r=0.778,P=0.000) and IgA (r=0.601,P=0.039), while the sTLC-κ/λ ratios of patients with IgGλ and IgAλ were negativily correlated with the IgG(r=-0.586,P=0.01) and IgA level(r=-0.718,P=0.003). In addition, a correlation between each type MM was not found except the IgGκ type MM which had a positive correlation between the sTLC-κ/λ ratio and proportion of BMPC (r=0.579,P=0.002). Nonetheless, 18 of 19 patients with IgG type and IgA type MM undergoing treatment showed concordance between the sTLC-κ/λ ratio and proportion of BMPC change. There is a lower correlation between the sTLC-κ/λ ratio and the proportion of BMPC in MM patients with IgG type and IgA type, but there is a high concordance between the sTLC-κ/λ ratio and the proportion of BMPC change in the same patient and it suggests that the sTLC-κ/λ ratio plays an important role in the diagnosis and monitoring of IgG type and IgA type MM.

Expanding access to high-cost medicines through the E2 access program in Thailand: effects on utilisation, health outcomes and cost using an interrupted time-series analysis.

PubMed

Sruamsiri, Rosarin; Wagner, Anita K; Ross-Degnan, Dennis; Lu, Christine Y; Dhippayom, Teerapon; Ngorsuraches, Surachat; Chaiyakunapruk, Nathorn

2016-03-17

In 2008, the Thai government introduced the 'high-cost medicines E2 access program' as a part of the National List of Essential Medicines to increase patient access to medicines, improve clinical outcomes and make medicines more affordable. Our objective was to examine whether the 'high-cost medicines E2 access program' achieved its goals. Interrupted time-series design study. 3 tertiary hospitals in different regions of Thailand, January 2006 to December 2012. Patients with target acute and chronic disease diagnoses who newly met E2 program criteria for selected study medicines. High-cost medicines E2 access program. Level and trend changes over time in the proportions of eligible patients who received the indicated E2 medicines and who improved clinically, as well as in costs of treatment. A total of 2024 patients were included in utilisation analyses and 1375 patients with selected acute diseases contributed to analyses of clinical outcome. After 1 year of the E2 program implementation, the percentage of eligible patients receiving the indicated E2 program medicines increased significantly (relative change 12.7% (95% CI 4.4% to 21.0%), especially among those insured by the government's universal coverage scheme (relative change 19.9% (95% CI 9.5% to 30.5%)). The increase in the proportion of clinically improved patients with acute conditions was not significant (relative change 6.2% (95% CI -1.9% to 15.1%)). Quarterly healthcare costs per patient dropped significantly (relative change -13.5% (95% CI -26.9% to -1.7%)). In the study hospitals, the E2 access program seems to have facilitated patient access to specialty medicines, may have contributed to improved health outcomes, and decreased treatment costs. Routine monitoring is needed to assess effects of expanding the programme, including effects on quality of care and financial sustainability. 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/

Comparison of Clinical Efficacy Between Interlaminar and Transforaminal Epidural Injection in Patients With Axial Pain due to Cervical Disc Herniation.

PubMed

Lee, Jung Hwan; Lee, Sang-Ho

2016-01-01

Transforaminal (TF) approach is preferred by physician to interlaminar (IL) approach because it can deliver injectates directly around nerve root and dorsal root ganglion, which is regarded as main pain sources. Axial neck pain is originated from sinuvertebral nerve located in ventral epidural spaces, which has been described to be related to central or paramedian disc herniation. It is very questionable that TF injection is also more effective than IL injection in the patients with axial neck or interscapular pain. This study was to evaluate clinical efficacy of cervical epidural injection in patients with axial pain due to cervical disc herniation and to compare the clinical outcomes between TF and IL approaches. Fifty-six and 52 patients who underwent IL and TF epidural injections, respectively, for axial neck/interscapular pain due to central or paramedian cervical disc herniation were included. Numeric Rating Scale (NRS) and Neck Disability Index (NDI) were compared between both groups at 2 and 8 weeks after treatment. Successful pain relief was defined if a 50% or more reduction of NRS score was achieved in comparison with pretreatment one. Successful functional improvement was defined if at least a 40% reduction of NDI was obtained. Overall, 79 (73.1%) and 57 (52.8%) among 108 patients showed successful pain relief at 2 and 8 weeks, respectively. Seventy-six (70.4%) and 52 (48.1%) had successful functional improvement at 2 and 8 weeks, respectively. The IL and TF groups showed no significant difference in proportion of successful results of NRS 2 weeks (73.2% vs 67.3%) and 8 weeks (48.2% vs 48.1%). Also, no significant difference was obtained in proportion of successful NDI between 2 groups at 2 weeks (75.0% vs 71.2%) and 8 weeks (53.6% vs 51.9%). Cervical epidural injection showed favorable results in 2 weeks and moderate results in 8 weeks in patients with axial pain due to cervical disc herniation. IL and TF showed no significant difference in clinical efficacy. Considering TF was relevant to more serious side effects, IL was more recommendable in these patients.

Last-observation-carried-forward imputation method in clinical efficacy trials: review of 352 antidepressant studies.

PubMed

Woolley, Stephen B; Cardoni, Alex A; Goethe, John W

2009-12-01

To determine the prevalence, over 40 years, of using the last-observation-carried-forward (LOCF) imputation method in clinical trials, the association between use of LOCF and how the trials were conducted, and the extent of information about attrition and LOCF use in published reports. Retrospective analysis of the reports of randomized antidepressant efficacy trials published over a 40-year period (1965-2004). MEDLINE database, Cochrane reviews, reference- and bibliography-based manual search, and publication list services. A total of 352 trials met the following criteria for analysis: antidepressant comparative efficacy trial, randomized design, patients with major depressive disorder, English-language article, published during 1965-2004, and first report of a trial. Design, attrition, and data analysis characteristics were recorded by investigators and trained assistants. Analyses included descriptive statistics of the trial size, duration, and number of patients who dropped out in LOCF versus non-LOCF studies, as well as the extent to which dropouts and the potential bias associated with attrition was discussed in the published report. The frequency of published antidepressant clinical trials increased from less than 1 trial/year (1965-1974) to 19 trials/year (1990-1994). Trials using the LOCF method were significantly larger than non-LOCF trials (p<0.01), and the proportion of subjects dropping out was significantly greater (p<0.05) in LOCF versus non-LOCF trials. The proportion of subjects dropping out remained relatively constant over time (approximately 30%) but was significantly greater among LOCF (30.9%) than non-LOCF (28.8%) trials (p<0.01). The LOCF study articles were more likely to report dropouts, but only 7% of these articles reported outcomes recorded for subjects before they dropped out. Less than 16% of articles discussed bias associated with dropouts, 6.8% discussed the direction of bias, and only about 2% suggested the magnitude of the bias. The percentage of clinical antidepressant trials using the LOCF method and the percentage of study subjects' data imputed by using LOCF increased many-fold during 1965-2004. Published reports of trials provided little information to allow readers to assess possible bias introduced by use of the LOCF method.

Fever as an initial manifestation of spondyloarthritis: A retrospective study.

PubMed

Byun, Se Jin; Bae, William Han; Jung, Seung Min; Lee, Sang-Won; Park, Yong-Beom; Song, Jason Jungsik

2017-01-01

We aimed to evaluate a wide spectrum of clinical features of adult patients with spondyloarthritis (SpA) whose initial manifestation was fever, using the Assessment of SpondyloArthritis international Society (ASAS) classification criteria. We retrospectively collected the electronic medical records of hospitalized SpA patients who initially presented to the Severance Hospital (Seoul, Korea) with fever from January 2010 to May 2016. As a control group, we also recruited one-hundred consecutive patients who were diagnosed with SpA in our outpatient clinic. Clinical features and laboratory findings were compared in two patient groups. There were 26 patients who had fever as initial presentation of SpA (reactive arthritis 50%, undifferentiated SpA 26.9%, ankylosing spondylitis 15.4%, enteropathic arthritis 3.8%, psoriatic arthritis 3.8%). Peripheral SpA was more common in febrile SpA patients than in control SpA patients (65.4% vs 24.0%, p<0.001). Febrile SpA patients were less frequently HLA-B27 positive than control SpA patients (52.2% vs 77.0%, p<0.05). At baseline, systemic inflammatory markers were significantly higher in the febrile SpA patients (white blood cell count, 11.57 vs 7.81 cells/μL, p<0.001; erythrocyte sedimentation rate, 69.2 vs 41.0 mm/h, p<0.001; C-reactive protein, 109.6 vs 15.3 mg/L, p<0.001). The proportion of patients treated with systemic steroids was significantly higher in febrile SpA patients (57.7% vs. 11.0%, p<0.001). The proportion of patients who visited rheumatology specialty was significantly lower in febrile SpA patients than in control SpA patients (7.7% vs 59.0%, p<0.001). Various subgroups of SpA can be presented with fever as an initial manifestation. Febrile SpA patients demonstrated higher systemic inflammation and a lower chance to visit rheumatology in early stage. When evaluating febrile patients with any clinical features of SpA, clinicians are advised to consider performing SpA-focused evaluation including HLA-B27 or a simple sacroiliac joint radiograph.

Optimizing information technology to improve sexual health-care delivery: public and patient preferences.

PubMed

Ross, J D C; Copas, A; Stephenson, J; Fellows, L; Gilleran, G

2007-07-01

Information and communication technology (ICT) has the potential to improve the quality of care and efficiency in sexual health clinics, but its introduction requires input not only from health-care professionals and ICT specialists but also from service users and potential future users. In this study, views on ICT in relation to the delivery of sexual health services were assessed using a structured interview in two groups - a community sample of young people and a clinic sample of existing patients. In all, 542 community interviewees and 202 clinic patients participated. About 75% of respondents had access to the Internet and overall 60% reported that the self-collection of a sexual history on an electronic form was acceptable. Black Caribbean individuals had significantly less access to the Internet and a lower acceptance of electronic data collection. For booking an appointment, the majority of patients reported the telephone (community sample 93%, clinic sample 96%) or attending in person (community sample 77%, clinic sample 54%) to be acceptable, with a smaller proportion choosing email (community sample 10%, clinic sample 27%) or the Internet (community sample 7%, clinic sample 11%). Electronic booking was significantly less acceptable to Black Caribbean respondents. Although new technologies offer the opportunity to improve the quality of sexual health services, patient preferences and differences between groups in access to technology also need to be considered when services are reconfigured.

Uterine fibroid treatment patterns in a population of insured women.

PubMed

Lee, David W; Gibson, Teresa B; Carls, Ginger S; Ozminkowski, Ronald J; Wang, Shaohung; Stewart, Elizabeth A

2009-02-01

To profile women treated for uterine leiomyomas who are covered by commercial insurance from large, self-insured employers in the United States. Retrospective, observational study. Inpatient, outpatient, and prescription drug experience of women with employer-sponsored insurance in the United States. Data were obtained from the MarketScan insurance databases for 1999 through 2004 and weighted to represent the population of women with employer-sponsored health insurance in the United States. None. The proportion of women with clinically significant leiomyomas was determined in each year, based on inpatient and outpatient medical claims with diagnostic codes indicating leiomyoma. Patient characteristics, comorbidities, prescription drug treatments, and surgical interventions were profiled in 2004. Approximately 1% of women had clinically significant leiomyomas. Comorbid genital or menstrual conditions were common and much more prevalent for women with leiomyomas. Of women with leiomyomas, 18.4% received no surgical or prescription drug treatment, whereas 16.8% received only surgical treatment, 22.4% received only prescription drug treatment, and 42.4% received both. Hysterectomy was the most common surgical treatment. Generalizing from this sample, we estimate that 443,445 women with employer-sponsored insurance in the United States had clinically significant leiomyomas in 2004.

Morphological and clinical risk factors for posterior communicating artery aneurysm rupture.

PubMed

Matsukawa, Hidetoshi; Fujii, Motoharu; Akaike, Gensuke; Uemura, Akihiro; Takahashi, Osamu; Niimi, Yasunari; Shinoda, Masaki

2014-01-01

Recent studies have shown that posterior circulation aneurysms, specifically posterior communicating artery (PCoA) aneurysms, are more likely to rupture than other aneurysms. To date, few studies have investigated the factors contributing to PCoA aneurysm rupture. The authors aimed to identify morphological and clinical characteristics predisposing to PCoA aneurysm rupture. The authors retrospectively reviewed 134 consecutive patients with PCoA aneurysms managed at their facility between July 2003 and December 2012. The authors divided patients into groups of those with aneurysmal rupture (n = 39) and without aneurysmal rupture (n = 95) and compared morphological and clinical characteristics. Morphological characteristics were mainly evaluated by 3D CT angiography and included diameter of arteries (anterior cerebral artery, middle cerebral artery, and internal carotid artery), size of the aneurysm, dome-to-neck ratio, neck direction of the aneurysmal dome around the PCoA (medial, lateral, superior, inferior, and posterior), aneurysm bleb formation, whether the PCoA was fetal type, and the existence of other intracranial unruptured aneurysm(s). Patients with ruptured PCoA aneurysms were significantly younger (a higher proportion were < 60 years of age) and a significantly higher proportion of patients with ruptured PCoA aneurysms showed a lateral direction of the aneurysmal dome around the PCoA, had bleb formation, and the aneurysm was > 7 mm in diameter and/or the dome-to-neck ratio was > 2.0. Multivariate logistic regression analysis showed age < 60 years (OR 4.3, p = 0.011), history of hypertension (OR 5.1, p = 0.008), lateral direction of the aneurysmal dome around the PCoA (OR 6.7, p = 0.0001), and bleb formation (OR 11, p < 0.0001) to be significantly associated with PCoA aneurysm rupture. The present results demonstrated that lateral projection of a PCoA aneurysm may be related to rupture.

Effect of a simple dose-escalation schedule on tramadol tolerability : assessment in the clinical setting.

PubMed

Tagarro, I; Herrera, J; Barutell, C; Díez, M C; Marín, M; Samper, D; Busquet, C; Rodríguez, M J

2005-01-01

To assess the effect of a very simple dose-escalation schedule on tramadol tolerability in clinical practice. This schedule consists of starting treatment with sustained-release tramadol 50mg twice daily, and escalating the dose around 7 days later to 100mg twice daily. Data from 1925 outpatients with non-malignant chronic pain were collected in this multicentre, prospective, comparative, non-randomised, open, observational study. A total of 1071 patients (55.6%) were included in the dose-escalation group (50mg group) and 854 patients (44.4%) in the control group (sustained-release tramadol 100mg twice daily; 100mg group). The proportion of patients who interrupted tramadol treatment due to the occurrence of adverse reactions was significantly lower in the 50mg group (5.6%) than in the 100mg group (12.6%) [p = 0.001]. In line with this, the proportion of patients who experienced at least one adverse reaction was significantly lower in the 50mg group (18.4%) than in the 100mg group (30.4%) [p = 0.001] and, interestingly, the two most frequently reported adverse reactions, nausea and dizziness, were found with a significantly lower frequency in the 50mg group (p < 0.001). Multivariate analysis showed that the risk of safety-related treatment cessations was 2.3 times higher in the 100mg group than in the 50mg group, and 2.2 times higher in females than in males. The two treatments were equally effective in reducing pain intensity (p = 0.121), measured as a reduction in pain score obtained by means of a visual analogue scale. The instauration of tramadol treatment, starting with sustained-release 50mg capsules twice daily and escalating the dose some days later to 100mg twice daily, was shown to be an effective and easy way to improve tramadol tolerability in clinical practice, whilst maintaining its analgesic efficacy.

Kinematics effectively delineate accomplished users of endovascular robotics with a physical training model.

PubMed

Duran, Cassidy; Estrada, Sean; O'Malley, Marcia; Lumsden, Alan B; Bismuth, Jean

2015-02-01

Endovascular robotics systems, now approved for clinical use in the United States and Europe, are seeing rapid growth in interest. Determining who has sufficient expertise for safe and effective clinical use remains elusive. Our aim was to analyze performance on a robotic platform to determine what defines an expert user. During three sessions, 21 subjects with a range of endovascular expertise and endovascular robotic experience (novices <2 hours to moderate-extensive experience with >20 hours) performed four tasks on a training model. All participants completed a 2-hour training session on the robot by a certified instructor. Completion times, global rating scores, and motion metrics were collected to assess performance. Electromagnetic tracking was used to capture and to analyze catheter tip motion. Motion analysis was based on derivations of speed and position including spectral arc length and total number of submovements (inversely proportional to proficiency of motion) and duration of submovements (directly proportional to proficiency). Ninety-eight percent of competent subjects successfully completed the tasks within the given time, whereas 91% of noncompetent subjects were successful. There was no significant difference in completion times between competent and noncompetent users except for the posterior branch (151 s:105 s; P = .01). The competent users had more efficient motion as evidenced by statistically significant differences in the metrics of motion analysis. Users with >20 hours of experience performed significantly better than those newer to the system, independent of prior endovascular experience. This study demonstrates that motion-based metrics can differentiate novice from trained users of flexible robotics systems for basic endovascular tasks. Efficiency of catheter movement, consistency of performance, and learning curves may help identify users who are sufficiently trained for safe clinical use of the system. This work will help identify the learning curve and specific movements that translate to expert robotic navigation. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Can education improve clinical practice concerning delirium in older hospitalised patients? Results of a pre-test post-test study on an educational intervention for nursing staff.

PubMed

van Velthuijsen, Eveline L; Zwakhalen, Sandra M G; Warnier, Ron M J; Ambergen, Ton; Mulder, Wubbo J; Verhey, Frans R J; Kempen, Gertrudis I J M

2018-04-02

Delirium is a common and serious complication of hospitalisation in older adults. It can lead to prolonged hospital stay, institutionalisation, and even death. However, it often remains unrecognised or is not managed adequately. The aim of this study was to evaluate the effects of an educational intervention for nursing staff on three aspects of clinical practice concerning delirium in older hospitalised patients: the frequency and correctness of screening for delirium using the 13-item Delirium Observation Screening score (DOS), and the frequency of geriatric consultations requested for older patients. The a priori expectations were that there would be an increase in all three of these outcomes. We designed an educational intervention and implemented this on two inpatient hospital units. Before providing the educational session, the nursing staff was asked to fill out two questionnaires about delirium in older hospitalised patients. The educational session was then tailored to each unit based on the results of these questionnaires. Additionally, posters and flyers with information on the screening and management of delirium were provided and participants were shown where to find additional information. Relevant data (outcomes, demographics and background patient data) were collected retrospectively from digital medical files. Data was retrospectively collected for four different time points: three pre-test and one post-test. There was a significant increase in frequency of delirium screening (P = 0.001), and both units showed an increase in the correctness of the screening. No significant effect of the educational intervention was found for the proportion of patients who received a geriatric consultation (P = 0.083). The educational intervention was fairly successful in making positive changes in clinical practice: after the educational session an improvement in the frequency and correctness of screening for delirium was observed. A trend, though not significant, towards an increase in the proportion of geriatric consultations for older hospitalised patients was also observed.

Associations of renal function at 1-year after kidney transplantation with subsequent return to dialysis, mortality, and healthcare costs.

PubMed

Schnitzler, Mark A; Johnston, Karissa; Axelrod, David; Gheorghian, Adrian; Lentine, Krista L

2011-06-27

Improved early kidney transplant outcomes limit the contemporary utility of standard clinical endpoints. Quantifying the relationship of renal function at 1 year after transplant with subsequent clinical outcomes and healthcare costs may facilitate cost-benefit evaluations among transplant recipients. Data for Medicare-insured kidney-only transplant recipients (1995-2003) were drawn from the United States Renal Data System. Associations of estimated glomerular filtration rate (eGFR) level at the first transplant anniversary with subsequent death-censored graft failure and patient death in posttransplant years 1 to 3 and 4 to 7 were examined by parametric survival analysis. Associations of eGFR with total health care costs defined by Medicare payments were assessed with multivariate linear regression. Among 38,015 participants, first anniversary eGFR level demonstrated graded associations with subsequent outcomes. Compared with patients with 12-month eGFR more than or equal to 60 mL/min/1.73 m, the adjusted relative risk of death-censored graft failure in years 1 to 3 was 31% greater for eGFR 45 to 59 mL/min/1.73 m (P<0.0001) and 622% greater for eGFR 15 to 30 mL/min/1.73 m (P<0.0001). Associations of first anniversary eGFR level with graft failure and mortality remained significant in years 4 to 7. The proportions of recipients expected to return to dialysis or die attributable to eGFR less than 60 mL/min/1.73 m over 10 years were 23.1% and 9.4%, respectively, and were significantly higher than proportions attributable to delayed graft function or acute rejection. Reduced eGFR was associated with graded and significant increases in health care spending during years 2 and 3 after transplant (P<0.0001). eGFR is strongly associated with clinical and economic outcomes after kidney transplantation.

Pathological and Biochemical Outcomes among African-American and Caucasian Men with Low Risk Prostate Cancer in the SEARCH Database: Implications for Active Surveillance Candidacy.

PubMed

Leapman, Michael S; Freedland, Stephen J; Aronson, William J; Kane, Christopher J; Terris, Martha K; Walker, Kelly; Amling, Christopher L; Carroll, Peter R; Cooperberg, Matthew R

2016-11-01

Racial disparities in the incidence and risk profile of prostate cancer at diagnosis among African-American men are well reported. However, it remains unclear whether African-American race is independently associated with adverse outcomes in men with clinical low risk disease. We retrospectively analyzed the records of 895 men in the SEARCH (Shared Equal Access Regional Cancer Hospital) database in whom clinical low risk prostate cancer was treated with radical prostatectomy. Associations of African-American and Caucasian race with pathological biochemical recurrence outcomes were examined using chi-square, logistic regression, log rank and Cox proportional hazards analyses. We identified 355 African-American and 540 Caucasian men with low risk tumors in the SEARCH cohort who were followed a median of 6.3 years. Following adjustment for relevant covariates African-American race was not significantly associated with pathological upgrading (OR 1.33, p = 0.12), major upgrading (OR 0.58, p = 0.10), up-staging (OR 1.09, p = 0.73) or positive surgical margins (OR 1.04, p = 0.81). Five-year recurrence-free survival rates were 73.4% in African-American men and 78.4% in Caucasian men (log rank p = 0.18). In a Cox proportional hazards analysis model African-American race was not significantly associated with biochemical recurrence (HR 1.11, p = 0.52). In a cohort of patients at clinical low risk who were treated with prostatectomy in an equal access health system with a high representation of African-American men we observed no significant differences in the rates of pathological upgrading, up-staging or biochemical recurrence. These data support continued use of active surveillance in African-American men. Upgrading and up-staging remain concerning possibilities for all men regardless of race. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

A double-blind, randomized, placebo-controlled, single-dose study of the cyclooxygenase-2 inhibitor, GW406381, as a treatment for acute migraine.

PubMed

Wentz, A L; Jimenez, T B; Dixon, R M; Aurora, S K; Gold, M

2008-04-01

The objective of the present study was to explore the clinical efficacy and tolerability of GW406381, a cyclooxygenase-2 (COX-2) inhibitor with relatively high CNS penetration, in acute migraine. This was a double-blind, single-dose study of GW406381 compared with placebo and naproxen sodium compared with placebo (protocol number CXA20008). Three hundred and thirty-seven subjects were randomized 1:1:1 to GW406381 (70 mg), naproxen sodium (825 mg), or placebo for the treatment of one migraine headache of moderate or severe intensity in a potential 8-week period. The primary end-point was the proportion of subjects with headache relief [reduction in headache severity score from pre-dose 2 (moderate) or 3 (severe) to 0 (no pain) or 1 (mild)] at 2 h post-dose for GW406381 compared with placebo. Significantly higher proportions of subjects treated with GW406381 (50%, P = 0.032) or naproxen sodium (56%, P = 0.005) than with placebo (35%) reported headache relief at 2 h post-dose. Additional significant benefits were observed on many secondary outcomes, including proportions of subjects pain-free, for both GW406381 and naproxen sodium treatment compared with placebo. Both active treatments were well tolerated. Single-dose GW406381 (70 mg) and naproxen sodium (825 mg) were effective and well tolerated in the treatment of acute migraine.

Mental Disorder Symptoms among Public Safety Personnel in Canada.

PubMed

Carleton, R Nicholas; Afifi, Tracie O; Turner, Sarah; Taillieu, Tamara; Duranceau, Sophie; LeBouthillier, Daniel M; Sareen, Jitender; Ricciardelli, Rose; MacPhee, Renee S; Groll, Dianne; Hozempa, Kadie; Brunet, Alain; Weekes, John R; Griffiths, Curt T; Abrams, Kelly J; Jones, Nicholas A; Beshai, Shadi; Cramm, Heidi A; Dobson, Keith S; Hatcher, Simon; Keane, Terence M; Stewart, Sherry H; Asmundson, Gordon J G

2018-01-01

Canadian public safety personnel (PSP; e.g., correctional workers, dispatchers, firefighters, paramedics, police officers) are exposed to potentially traumatic events as a function of their work. Such exposures contribute to the risk of developing clinically significant symptoms related to mental disorders. The current study was designed to provide estimates of mental disorder symptom frequencies and severities for Canadian PSP. An online survey was made available in English or French from September 2016 to January 2017. The survey assessed current symptoms, and participation was solicited from national PSP agencies and advocacy groups. Estimates were derived using well-validated screening measures. There were 5813 participants (32.5% women) who were grouped into 6 categories (i.e., call center operators/dispatchers, correctional workers, firefighters, municipal/provincial police, paramedics, Royal Canadian Mounted Police). Substantial proportions of participants reported current symptoms consistent with 1 (i.e., 15.1%) or more (i.e., 26.7%) mental disorders based on the screening measures. There were significant differences across PSP categories with respect to proportions screening positive based on each measure. The estimated proportion of PSP reporting current symptom clusters consistent with 1 or more mental disorders appears higher than previously published estimates for the general population; however, direct comparisons are impossible because of methodological differences. The available data suggest that Canadian PSP experience substantial and heterogeneous difficulties with mental health and underscore the need for a rigorous epidemiologic study and category-specific solutions.

Argentine references for the assessment of body proportions from birth to 17 years of age.

PubMed

Del Pino, Mariana; Orden, Alicia B; Arenas, María A; Fano, Virginia

2017-06-01

Abnormal body proportions may indicate skeletal disorders; therefore, their detection has great clinical significance. To estimate centiles for head circumference/height (HC/H) and sitting height/height (SH/H) ratios, and assess their diagnostic usefulness among a group of children with skeletal dysplasia. Centiles 3, 10, 25, 50, 75, 90 and 97 for HC/H and SH/H ratios were estimated with the LMS method using Box-Cox transformation to normalize data distribution for each age. Q-Q plot tests were applied to evaluate normality of residuals and the Q test to calculate goodness-of-fit. The sample included 4818 girls and4803 boys, all healthy, between 0-17 years old. The median of the SH/H ratio for each age decreased from 0.67 at birth to 0.57 at age 4. At 12 years of age, values reached 0.52 and 0.53 for males and females, respectively, remaining unchanged until age 17. The median of the HC/H ratio decreased from 0.45 at 6 years old to 0.34 at 17 years old for both sexes. Z-scores for SH/H among 20 children diagnosed with hypochondroplasia were better at showing abnormal proportions than the SH/H ratio not adjusted by age. Estimated centiles for HC/H and SH/H ratios show that the most dramatic changes in body proportions occur in the prepubertal period. These references allow an earlier detection of abnormal body proportions in children with skeletal dysplasia.

BRCA1 and BRCA2 genetic testing-pitfalls and recommendations for managing variants of uncertain clinical significance.

PubMed

Eccles, D M; Mitchell, G; Monteiro, A N A; Schmutzler, R; Couch, F J; Spurdle, A B; Gómez-García, E B

2015-10-01

Increasing use of BRCA1/2 testing for tailoring cancer treatment and extension of testing to tumour tissue for somatic mutation is moving BRCA1/2 mutation screening from a primarily prevention arena delivered by specialist genetic services into mainstream oncology practice. A considerable number of gene tests will identify rare variants where clinical significance cannot be inferred from sequence information alone. The proportion of variants of uncertain clinical significance (VUS) is likely to grow with lower thresholds for testing and laboratory providers with less experience of BRCA. Most VUS will not be associated with a high risk of cancer but a misinterpreted VUS has the potential to lead to mismanagement of both the patient and their relatives. Members of the Clinical Working Group of ENIGMA (Evidence-based Network for the Interpretation of Germline Mutant Alleles) global consortium (www.enigmaconsortium.org) observed wide variation in practices in reporting, disclosure and clinical management of patients with a VUS. Examples from current clinical practice are presented and discussed to illustrate potential pitfalls, explore factors contributing to misinterpretation, and propose approaches to improving clarity. Clinicians, patients and their relatives would all benefit from an improved level of genetic literacy. Genetic laboratories working with clinical geneticists need to agree on a clinically clear and uniform format for reporting BRCA test results to non-geneticists. An international consortium of experts, collecting and integrating all available lines of evidence and classifying variants according to an internationally recognized system, will facilitate reclassification of variants for clinical use. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Advances in the management of multiple sclerosis spasticity: recent clinical trials.

PubMed

Fernández, Oscar

2014-01-01

Most patients with multiple sclerosis (MS) experience spasticity as the clinical course evolves. Associated symptoms include (often painful) spasms, urinary dysfunction and sleep disturbances. THC:CBD oromucosal spray (Sativex®) is approved for symptom improvement in adult patients with moderate to severe MS-related spasticity who have not responded adequately to other antispasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In pivotal clinical trials of THC:CBD oromucosal spray, a meaningful proportion of patients with treatment-resistant MS spasticity achieved clinically relevant improvement with active treatment versus placebo. The utility of a 4-week trial of therapy to identify patients who respond to treatment was demonstrated in an enriched-design study. THC:CBD oromucosal spray was well tolerated in these studies, with no evidence of effects typically associated with recreational cannabis use. In a subsequent post approval clinical trial, THC:CBD oromucosal spray had no statistically significant effect on cognition and mood compared with placebo. Moreover, after 50 weeks' treatment, approximately two-thirds of patients, physicians and caregivers reported improvement from baseline in spasticity based on global impressions of change. Key Messages: In phase III clinical trials, approximately one-third of MS patients with treatment-resistant spasticity had a clinically relevant and statistically significant response to THC:CBD oromucosal spray. In addition to a reduction in spasticity, responders experienced meaningful relief from associated symptoms. THC:CBD oromucosal spray was generally well tolerated and efficacy was maintained over the longer term. A post-approval clinical trial indicated no effect of THC:CBD oromucosal spray on cognition or mood after 50 weeks of use. © 2014 S. Karger AG, Basel.

Reliability at the lower limits of HIV-1 RNA quantification in clinical samples: a comparison of RT-PCR versus bDNA assays.

PubMed

Lubelchek, Ronald J; Max, Blake; Sandusky, Caroline J; Hota, Bala; Barker, David E

2009-06-23

To explore whether an assay change was responsible for an increasing proportion of patients with undetectable HIV viral loads at our urban HIV clinic, we selected highly stable patients, examining their viral loads before and after changing assays. We compared the proportion with detectable viremia during RT-PCR vs. bDNA periods. We selected patients with > or =1 viral loads assessed during both RT-PCR and bDNA periods. We included patients with stable CD4 counts, excluding patients with viral loads > or =1,000 copies/ml or any significant changes in therapy. Out of 4500 clinic patients, 419 patients (1588 viral loads) were included. 39% of viral loads were reported as detectable by RT-PCR vs. 5% reported as detectable by bDNA. The mean coefficient of variation was higher before vs. after assay change. We found an odds' ratio of 16.7 for having a viral load >75 copies/ml during the RT-PCR vs. bDNA periods. These data support previous reports, suggesting that bDNA may more reliably discriminate between viral suppression and low level viremia in stable patients on therapy. Low-level viremia, noted more with RT-PCR, may promote unneeded testing, while differences in viral load reliability may impact antiretroviral trial and quality assurance endpoints. Commonly used plasma separator tubes may differentially affect RT-PCR and bDNA results.

Audit of Orthopaedic Audits in an English Teaching Hospital: Are We Closing the Loop?

PubMed Central

Iqbal, H.J; Pidikiti, P

2010-01-01

Background: Clinical audit is an important tool to improve patient care and outcomes in health service. A significant proportion of time and economic resources are spent on activities related to clinical audit. Completion of audit cycle is essential to confirm the improvements in healthcare delivery. We aimed this study to evaluate audits carried out within trauma and orthopaedic unit of a teaching hospital over the last 4 years, and establish the proportions which were re-audited as per recommendations. Methods: Data was collected from records of the clinical audit department. All orthopaedic audit projects from 2005 to 2009 were included in this study. The projects were divided in to local, regional and national audits. Data regarding audit lead clinicians, completion and presentation of projects, recommendations and re-audits was recorded. Results: Out of 61 audits commenced during last four years, 19.7% (12) were abandoned, 72.1% (44) were presented and 8.2 % (5) were still ongoing. The audit cycle was completed in only 29% (13) projects. Conclusion: Change of junior doctors every 4~6 months is related to fewer re-audits. Active involvement by supervising consultant, reallocation of the project after one trainee has finished, and full support of audit department may increase the ratio of completion of audit cycles, thereby improving the patient care. PMID:20721318

A virologic pilot study of valacyclovir in infectious mononucleosis.

PubMed

Balfour, Henry H; Hokanson, Kristin M; Schacherer, Robyn M; Fietzer, Christine M; Schmeling, David O; Holman, Carol J; Vezina, Heather E; Brundage, Richard C

2007-05-01

Infectious mononucleosis decreases the productivity of many college students and Epstein-Barr virus (EBV) infection may result in long-term immune damage. Evaluate the antiviral effect of valacyclovir during EBV-related acute infectious mononucleosis and explore potential clinical benefits. University students who presented during the first 7 days of illness were randomized to receive valacyclovir 3g/day for 14 days or not. The quantity of Epstein-Barr virus (EBV) DNA in oral and whole blood samples was determined by real-time (TaqMan) PCR. The primary outcome was the proportion of subjects with laboratory-confirmed primary EBV infection who had >or=2 log10 decrease in EBV copies/mL in oral washes during the treatment period. Secondary outcomes included clinical effects. Twenty subjects were studied. The proportion of valacyclovir recipients versus control subjects who had >or=2 log10 decrease in EBV copies was significantly greater for both oral wash fluid-derived cell pellet (P=0.03) and supernatant (P=0.001) samples. At the end of the treatment period, the number of reported symptoms (P=0.03) and the severity of illness (P=0.049) were reduced among valacyclovir recipients as compared with controls. Valacyclovir therapy caused a reduction of EBV excretion and possibly produced a clinical benefit in infectious mononucleosis. Because our study was small and not placebo-controlled, these results must be confirmed by a larger, placebo-controlled trial.

Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial

PubMed Central

2012-01-01

Background IVF is a costly treatment option for women, their partners, and the public. Therefore new therapies that improve reproductive and health outcomes are highly desirable. There is a growing body of research evaluating the effect of acupuncture administered during IVF, and specifically on the day of embryo transfer (ET). Many trials are heterogeneous and results inconsistent. There remains insufficient evidence to determine if acupuncture can enhance live birth rates when used as an adjunct to IVF treatment. The study will determine the clinical effectiveness of acupuncture with improving the proportion of women undergoing IVF having live births. Other objectives include: determination of the cost effectiveness of IVF with acupuncture; and examination of the personal and social context of acupuncture in IVF patients, and examining the reasons why the acupuncture may or may not have worked. Methods We will conduct a randomized controlled trial of acupuncture compared to placebo acupuncture. Inclusion criteria include: women aged less than 43 years; undergoing a fresh IVF or ICSI cycle; and restricted to women with the potential for a lower live birth rate defined as two or more previous unsuccessful ETs; and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria. Women will be randomized to acupuncture or placebo acupuncture. Treatment is administered on days 6 to 8 of the stimulated cycle and two treatments on the day of ET. A non-randomized cohort of women not using acupuncture will be recruited to the study. The primary study outcome is the proportion of women reporting a live birth. Secondary outcomes include the proportion of women reporting a clinical pregnancy miscarriage prior to 12 weeks, quality of life, and self-efficacy. The sample size of the study is 1,168 women, with the aim of detecting a 7% difference in live births between groups (P = 0.05, 80% power). Discussion There remains a need for further research to add significant new knowledge to defining the exact role of certain acupuncture protocols in the management of infertility requiring IVF from a clinical and cost-effectiveness perspective. Clinical Trial Registration Australian and New Zealand Clinical Trial Registry ACTRN12611000226909 PMID:22607192

Care of adolescent parents and their children.

PubMed

Pinzon, Jorge L; Jones, Veronnie F

2012-12-01

Teen pregnancy and parenting remain an important public health issue in the United States and the world, and many children live with their adolescent parents alone or as part of an extended family. A significant proportion of teen parents reside with their family of origin, significantly affecting the multigenerational family structure. Repeated births to teen parents are also common. This clinical report updates a previous policy statement on care of the adolescent parent and their children and addresses medical and psychosocial risks specific to this population. Challenges unique to teen parents and their children are reviewed, along with suggestions for the pediatrician on models for intervention and care.

[Current epidemiological status of causes of disease among patients with liver disease hospitalized in Department of Infectious Diseases in a large general hospital within the past 20 years].

PubMed

Zhao, R H; Ma, K; Hu, J; Chen, C X; Qi, J Y

2018-02-20

Objective: To investigate the causes of disease among patients with liver disease hospitalized in Department of Infectious Diseases in our hospital and the changes in such causes within the past 20 years. Methods: A retrospective analysis was performed for the clinical data of 7570 patients who were admitted to our hospital from January 1995 to December 2015. The chi-square test was used for the statistical analysis of constituent ratio. Results: Of all 7570 patients with liver disease, 4930 (65.13%) had viral hepatitis, 332 (4.39%) had immune disease, 215 (2.84%) had drug-induced liver injury, 192 (2.54%) had fatty liver disease, 88 (1.16%) had schistosome-induced liver disease, 160 (2.11%) had inherited metabolic diseases, and 20 (0.13%) had vascular disease; 689 (9.1%) still had no clear cause of disease at discharge. The proportion of patients with viral hepatitis was 77.61% in the first 10 years and 59.19% in the last 10 years ( P < 0.01). As for liver disease caused by hepatotropic virus, there were significant increases in the proportion of patients with hepatitis C or hepatitis E from the first to the last 10 years (hepatitis C: 2.24% vs 15.56%, P < 0.01; hepatitis E: 18.61% vs 23.07%, P < 0.05), while there were significant reductions in the proportion of patients with hepatitis B (68.14% vs 60.01%, P < 0.05) or hepatitis A (10.7% vs 1.36%, P < 0.05). The proportion of patients with immune diseases was 0.82% in the first 10 years and 6.08% in the last 10 years ( P < 0.01). There were also certain changes in the proportion of patients with liver disease caused by other reasons. Conclusion: There is a large proportion of patients with viral hepatitis among patients with liver disease hospitalized in Department of Infectious Diseases in a large general hospital, especially hepatitis B and E caused by hepatotropic virus. There is a certain change in the epidemiology of liver disease within the past 20 years, with a reduction in the proportion of patients with viral hepatitis and an increase in the proportion of patients with non-infectious liver diseases. There is a large proportion of patients with unknown causes of liver disease.

Effect of automated ultraviolet C-emitting device on decontamination of hospital rooms with and without real-time observation of terminal room disinfection.

PubMed

Penno, Katie; Jandarov, Roman A; Sopirala, Madhuri M

2017-11-01

We studied the effectiveness of an ultraviolet C (UV-C) emitter in clinical settings and compared it with observed terminal disinfection. We cultured 22 hospital discharge rooms at a tertiary care academic medical center. Phase 1 (unobserved terminal disinfection) included cultures of 11 high-touch environmental surfaces (HTSs) after terminal room disinfection (AD) and after the use of a UV-C-emitting device (AUV). Phase 2 (observed terminal disinfection) included cultures before terminal room disinfection (BD), AD, and AUV. Zero-inflated Poisson regression compared mean colony forming units (CFU) between the groups. Two-sample proportion tests identified significance of the observed differences in proportions of thoroughly cleaned HTSs (CFU < 5). Significant P value was determined using the Bonferroni corrected threshold of α = .05/12 = .004. We obtained 594 samples. Risk of overall contamination was 0.48 times lower in the AUV group than in the AD group (P < .001), with 1.04 log 10 reduction. During phase 1, overall proportion of HTSs with <5 CFUs increased in AUV versus AD by 0.12 (P = .001). During phase 2, it increased in AD versus BD by 0.45 (P < .001), with no significant difference between AD and AUV (P = .02). Use of UV-C with standard cleaning significantly reduced microbial burden and improved the thoroughness of terminal disinfection. We found no further benefit to UV-C use if standard terminal disinfection was observed. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Return to Play after Cervical Spine Injuries: A Consensus of Opinion

PubMed Central

France, John C.; Karsy, Michael; Harrop, James S.; Dailey, Andrew T.

2016-01-01

Study Design Survey. Objective Sports-related spinal cord injury (SCI) represents a growing proportion of total SCIs but lacks evidence or guidelines to guide clinical decision-making on return to play (RTP). Our objective is to offer the treating physician a consensus analysis of expert opinion regarding RTP that can be incorporated with the unique factors of a case for clinical decision-making. Methods Ten common clinical scenarios involving neurapraxia and stenosis, atlantoaxial injury, subaxial injury, and general cervical spine injury were presented to 25 spine surgeons from level 1 trauma centers for whom spine trauma is a significant component of their practice. We evaluated responses to questions about patient RTP, level of contact, imaging required for a clinical decision, and time to return for each scenario. The chi-square test was used for statistical analysis, with p < 0.05 considered significant. Results Evaluation of the surgeons' responses to these cases showed significant consensus regarding return to high-contact sports in cases of cervical cord neurapraxia without symptoms or stenosis, surgically repaired herniated disks, and nonoperatively healed C1 ring or C2 hangman's fractures. Greater variability was found in recommendations for patients showing persistent clinical symptomatology. Conclusion This survey suggests a consensus among surgeons for allowing patients with relatively normal imaging and resolution of symptoms to return to high-contact activities; however, patients with cervical stenosis or clinical symptoms continue to be a challenge for management. This survey may serve as a basis for future clinical trials and consensus guidelines. PMID:27853664

Modest rise in chlamydia and gonorrhoea testing did not increase case detection in a clinical HIV cohort in Ontario, Canada

PubMed Central

Burchell, Ann N; Grewal, Ramandip; Allen, Vanessa G; Gardner, Sandra L; Moravan, Veronika; Bayoumi, Ahmed M; Kaul, Rupert; McGee, Frank; Millson, Margaret (Peggy) E; Remis, Robert S; Raboud, Janet; Mazzulli, Tony; Rourke, Sean B

2014-01-01

Objectives We described patterns of testing for chlamydia and gonorrhoea infection among persons in specialty HIV care in Ontario, Canada, from 2008 to 2011. Methods We analysed data from 3165 participants in the OHTN Cohort Study attending one of seven specialty HIV care clinics. We obtained chlamydia and gonorrhoea test results via record linkage with the provincial public health laboratory. We estimated the proportion of participants who underwent testing annually, the positivity rate among those tested and the proportion diagnosed with chlamydia or gonorrhoea among all under observation. We explored risk factors for testing and diagnosis using multiple logistic regression analysis. Results The proportion tested annually rose from 15.2% (95% CI 13.6% to 16.7%) in 2008 to 27.0% (95% CI 25.3% to 28.6%) in 2011 (p<0.0001). Virtually all were urine-based nucleic acid amplification tests. Testing was more common among men who have sex with men (MSM), younger adults, Toronto residents, persons attending primary care clinics and persons who had tested in the previous year or who had more clinic visits in the current year. We observed a decrease in test positivity rates over time. However, the annual proportion diagnosed remained stable and in 2011 this was 0.97% (95% CI 0.61% to 1.3%) and 0.79% (95% CI 0.46% to 1.1%) for chlamydia and gonorrhoea, respectively. Virtually all cases were among MSM. Conclusions Chlamydia and gonorrhoea testing increased over time while test positivity rates declined and the overall proportion diagnosed remained stable, suggesting that the modest increase in testing did not improve case detection. PMID:25178285

Clinical and Radiographic Predictors of GOLD–Unclassified Smokers in the COPDGene Study

PubMed Central

Hokanson, John E.; Murphy, James R.; Regan, Elizabeth A.; Make, Barry J.; Lynch, David A.; Crapo, James D.; Silverman, Edwin K.

2011-01-01

Rationale: A significant proportion of smokers have lung function impairment characterized by a reduced FEV1 with a preserved FEV1/FVC ratio. These smokers are a poorly characterized group due to their systematic exclusion from chronic obstructive pulmonary disease (COPD) studies. Objectives: To characterize the clinical, functional, and radiographic features of Global Initiative for Chronic Obstructive Lung Disease (GOLD)-Unclassified (FEV1/FVC ≥ 0.7 and FEV1 < 80% predicted) and lower limits of normal (LLN)-unclassified (FEV1/FVC ≥ LLN and FEV1 < LLN) subjects compared to smokers with normal lung function and subjects with COPD. Methods: Data from the first 2,500 subjects enrolled in the COPDGene study were analyzed. All subjects had 10 or more pack-years of smoking and were between the ages of 45 and 80 years. Multivariate regression models were constructed to determine the clinical and radiological variables associated with GOLD-Unclassified (GOLD-U) and LLN-Unclassified status. Separate multivariate regressions were performed in the subgroups of subjects with complete radiologic measurement variables available. Measurements and Main Results: GOLD-U smokers account for 9% of smokers in COPDGene and have increased body mass index (BMI), a disproportionately reduced total lung capacity, and a higher proportion of nonwhite subjects and subjects with diabetes. GOLD-U subjects exhibit increased airway wall thickness compared to smoking control subjects and decreased gas trapping and bronchodilator responsiveness compared to subjects with COPD. When LLN criteria were used to define the “unclassified” group, African American subjects were no longer overrepresented. Both GOLD-U and LLN-Unclassified subjects demonstrated a wide range of lung function impairment, BMI, and percentage of total lung emphysema. Conclusions: Subjects with reduced FEV1 and a preserved FEV1/FVC ratio are a heterogeneous group with significant symptoms and functional limitation who likely have a variety of underlying etiologies beyond increased BMI. Clinical trial registered with www.clinicaltrials.gov (NCT000608764). PMID:21493737

Increased use of catheters as vascular access: is it justified by patients' clinical conditions?

PubMed

Di Benedetto, A; Basci, A; Cesare, S; Marcelli, D; Ponce, P; Richards, N

2007-01-01

Over the last years many technical improvements have been made in hemodialysis treatment. Vascular access (VA) still remains an important problem. Although the use of indwelling vascular catheters is discouraged, in Europe there is an increasing use of them. The K/DOQI Guidelines recommend a native arteriovenous fistula (AVF) as VA of choice. As reported by DOPPS, there is considerable geographic variation in the distribution of type of VA used amongst hemodialysis patients. The aim of this study was to evaluate the time patients in four European countries have to wait before undergoing their first surgery for VA (AVF or graft). All incident patients admitted to HD clinics located in Turkey, Italy, the UK and Portugal of the European FME clinics network between October 1, 2002 and September 30, 2004 were considered. Data were gained from the Clinical Database EuCliD. 2,152 patients (males 55.9%, mean age 62.5+/-15.7 years, diabetics 27%) were selected. Italy and Portugal had a higher proportion of elderly patients. At time of admission, the proportion of patients starting dialysis with AVF ranged between 23% and 60% from Turkey to Italy respectively. Patients with an indwelling catheter at admission are expected to undergo VA surgery as soon as possible. After 3 months of follow-up, about 75% of all patients had undergone surgery, however in the UK less than 50% of the patients had had a VA procedure. Overall, males have significantly higher probability of undergoing surgery, whilst elderly patients have a lower probability (27% and 14% respectively). Significant differences exist between countries in the time interval from referral to creation of VA. Health care system related problems seem to be the major reason to explain such differences. Patients in the UK have longer waiting times than the other countries studied.

Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM)

PubMed Central

Heller, Simon R.; Pratley, Richard E.; Sinclair, Alan; Festa, Andreas; Brusko, Cynthia S.; Duan, Ran; Heine, Robert J.

2017-01-01

Aims To compare the glycaemic outcomes of 2 glucose‐lowering treatment strategies in vulnerable (moderately ill and/or frail) patients aged ≥65 years with type 2 diabetes whose individual HbA1c targets were not met with diet/exercise and/or oral anti‐hyperglycaemic medications (OAMs). Methods The primary endpoint of this study was a composite of achieving/maintaining individualized HbA1c targets without “clinically significant” hypoglycaemia (severe hypoglycaemia or repeated hypoglycaemia causing interruption of patients’ activities or blood glucose <54 mg/dL). Strategy‐A comprised glucose‐dependent therapies (n = 99) with a non‐sulphonylurea OAM and a glucagon‐like peptide‐1 receptor agonist as the first injectable. Strategy‐B comprised non‐glucose‐dependent therapies (n = 93) with sulphonylurea as the preferred OAM and insulin glargine as the first injectable. Results There was no significant difference between Strategy‐A and Strategy‐B in percentages of patients achieving the primary endpoint (64.5% vs 54.9%; P = .190). Mean incidences (A vs B) of total (10.2% vs 53.8%), documented symptomatic (5.1% vs 36.6%), and asymptomatic (8.2% vs 32.3%) hypoglycaemia were lower for Strategy‐A (P < .001 each). Proportions of patients achieving/maintaining HbA1c target (A, 63.3% vs B, 55.9%) were similar. Conclusion Similar proportions of older, vulnerable aged ≥65 years patients with type 2 diabetes achieved/maintained glycaemic treatment goals without clinically significant hypoglycaemia with Strategies A or B. However, Strategy‐A resulted in lower risk of total, documented symptomatic, and asymptomatic hypoglycaemia. These results identify an approach of potential clinical benefit in this age group and will inform future clinical research in older patients with type 2 diabetes. PMID:28671753

Efficacy of Indigo Naturalis in a Multicenter Randomized Controlled Trial of Patients With Ulcerative Colitis.

PubMed

Naganuma, Makoto; Sugimoto, Shinya; Mitsuyama, Keiichi; Kobayashi, Taku; Yoshimura, Naoki; Ohi, Hidehisa; Tanaka, Shinji; Andoh, Akira; Ohmiya, Naoki; Saigusa, Keiichiro; Yamamoto, Takayuki; Morohoshi, Yuichi; Ichikawa, Hitoshi; Matsuoka, Katsuyoshi; Hisamatsu, Tadakazu; Watanabe, Kenji; Mizuno, Shinta; Suda, Wataru; Hattori, Masahira; Fukuda, Shinji; Hirayama, Akiyoshi; Abe, Takayuki; Watanabe, Mamoru; Hibi, Toshifumi; Suzuki, Yasuo; Kanai, Takanori

2018-03-01

Indigo naturalis (IN) is a traditional Chinese medicine that contains ligands for the aryl hydrocarbon receptor and promotes regeneration of the mucosa by inducing production of interleukin 22. IN might induce mucosal healing in patients with ulcerative colitis (UC). We performed a randomized controlled trial to investigate the safety and efficacy of IN in patients with UC. We performed a multicenter, double-blind trial evaluating the safety of 86 patients in Japan with active UC (Mayo scores of 6 or more), enrolled from March 30 through December 27, 2016. Patients were randomly assigned to groups and given a daily dose of 0.5, 1.0, or 2.0 g IN or placebo (1:1:1:1 ratio) for 8 weeks. The primary endpoint was the rate of clinical response at week 8, defined as a 3-point decrease in the Mayo score and a decrease of at least 30% from baseline, with a decrease of at least 1 point for the rectal bleeding subscore or absolute rectal bleeding score of 0-1. The main secondary endpoint was the rate of clinical remission at week 8, defined as a Mayo score or ≤2 and no subscores with a value >1. Mucosal healing was also assessed at week 8. The trial was terminated because of an external reason: a report of pulmonary arterial hypertension in a patient who used self-purchased IN for 6 months. In the intent-to-treat analysis, we observed a significant, dose-dependent linear trend in proportions of patients with clinical responses (13.6% with a clinical response to placebo; 69.6% to 0.5 g IN; 75.0% to 1.0 g IN; and 81.0% to 2.0 g IN) (Cochran-Armitage trend test P < .0001 compared with placebo). Proportions of patients in clinical remission at week 8 were significantly higher in the 1.0 g IN group (55.0%, P = .0004) and the 2.0 g IN group (38.1%, (P = .0093) than in the placebo group (4.5%). Proportions of patients with mucosal healing were 13.6% in the placebo group, 56.5% in the 0.5 g IN group, 60.0% in the 1.0 g IN group, and 47.6% in the 2.0 g IN group (P = .0278 compared with placebo). Although mild liver dysfunction was observed in 10 patients who received IN, no serious adverse events were observed. In a randomized, placebo-controlled trial, we found 8 weeks of IN (0.5-2.0 g per day) to be effective in inducing a clinical response in patients with UC. However, IN should not yet be used because of the potential for adverse effects, including pulmonary arterial hypertension. Clinical Trials Registry no: UMIN000021439 (http://www.umin.ac.jp/ctr/). Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.

The renin-angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril in clinical trials versus routine practice: insights from the prospective EARLY registry.

PubMed

Bramlage, Peter; Schmieder, Roland E; Gitt, Anselm K; Baumgart, Peter; Mahfoud, Felix; Buhck, Hartmut; Ouarrak, Taoufik; Ehmen, Martina; Potthoff, Sebastian A

2015-12-19

Patient characteristics and blood pressure-related outcomes in randomized clinical trials (RCTs) differ from clinical practice because of stringent selection criteria. The present study aimed to explore the relationship between clinical trials and clinical practice. We analyzed data from patients enrolled in the "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry comparing blood pressure (BP) effects of the angiotensin receptor blocker (ARB) azilsartan medoxomil (AZL-M) with the angiotensin-converting enzyme (ACE) inhibitor ramipril between patients who met the eligibility criteria of a previous RCT and those who did not. Patients with primary arterial hypertension were consecutively enrolled from primary care offices in Germany into the EARLY registry in a 7:3 ratio for treatment with AZL-M or an ACE inhibitor, provided that they met the following criteria at baseline: 1) no antihypertensive treatment prior to inclusion or a non-renin-angiotensin system (RAS) based monotherapy; 2) initiation of treatment with either AZL-M or an ACE inhibitor alone. Analyses were performed to evaluate BP effects for patients in the EARLY registry who met the selection criteria of a prior RCT (RCT+) versus those who did not (RCT-). Out of 3,698 patients considered, 1,644 complied with the RCT criteria (RCT+) while 2,054 did not (RCT-). RCT- patients (55.5%) displayed a higher risk profile in terms of age and comorbidities, and a wider spectrum of BP values at baseline, as highlighted by the grades of hypertension and mean BP values. The proportion of patients who achieved target blood pressure control in the RCT+ group was significantly higher for AZL-M versus ramipril (64.1 versus 56.1%; P<0.01), in accordance with the result of the clinical trial. In the RCT- AZL-M group, the proportion of patients who met BP targets was lower (58.1%) than in the RCT+ AZL-M group (64.1%), whereas the proportion of patients with target BP values in the RCT- ramipril and the RCT+ ramipril groups was similar (57.7 versus 56.1%). Thus, in contrast to results for the RCT+ group, in the RCT- group, the target BP attainment rate for AZL-M was not significantly superior to that for ramipril. However, the tolerability profile of AZL-M and ramipril was comparable in both populations. At the 12-month follow-up, death and stroke rates were low (≤0.5%) and adverse events did not differ between the AZL-M and ramipril groups, irrespective of RCT eligibility. These data confirm that the EARLY population comprised a broader spectrum of hypertensive patients than RCTs, and the differences in patient characteristics were accompanied by disparate rates of blood pressure goal attainment. Overall, the validity of the RCT was demonstrated and confirmed in clinical practice with a broader range of patients with various comorbidities.

Immunological alterations and associated diseases in mandrills (Mandrillus sphinx) naturally co-infected with SIV and STLV.

PubMed

Souquière, Sandrine; Makuwa, Maria; Sallé, Bettina; Lepelletier, Yves; Mortreux, Franck; Hermine, Olivier; Kazanji, Mirdad

2014-04-01

Mandrills are naturally infected with simian T-cell leukaemia virus type 1 (STLV-1) and simian immunodeficiency virus (SIV)mnd. In humans, dual infection with human immunodeficiency virus (HIV) and human T-cell lymphotropic virus type 1 (HTLV-1) may worsen their clinical outcome. We evaluated the effect of co-infection in mandrills on viral burden, changes in T-cell subsets and clinical outcome. The SIV viral load was higher in SIV-infected mandrills than in co-infected animals, whereas the STLV-1 proviral load was higher in co-infected than in mono-infected groups. Dually infected mandrills had a statistically significantly lower CD4+ T-cell count, a lower proportion of naive CD8+ T cells and a higher proportion of central memory cells. CD4(+) and CD8(+) T cells from SIV-infected animals had a lower percentage of Ki67 than those from the other groups. Co-infected monkeys had higher percentages of activated CD4(+) and CD8(+) T cells. Two co-infected mandrills with high immune activation and clonal integration of STLV provirus showed pathological manifestations (infective dermatitis and generalised scabies) rarely encountered in nonhuman primates. Copyright © 2014 Elsevier Inc. All rights reserved.

Gender Dysphoria and Autism Spectrum Disorder: A Systematic Review of the Literature.

PubMed

Glidden, Derek; Bouman, Walter Pierre; Jones, Bethany A; Arcelus, Jon

2016-01-01

There is a growing clinical recognition that a significant proportion of patients with gender dysphoria have concurrent autism spectrum disorder (ASD). The purpose of this review is to systematically appraise the current literature regarding the co-occurrence of gender dysphoria and ASD. A systematic literature search using Medline and PubMed, PsycINFO, and Embase was conducted from 1966 to July 2015. Fifty-eight articles were generated from the search. Nineteen of these publications met the inclusion criteria. The literature investigating ASD in children and adolescents with gender dysphoria showed a higher prevalence rate of ASD compared with the general population. There is a limited amount of research in adults. Only one study showed that adults attending services for gender dysphoria had increased ASD scores. Another study showed a larger proportion of adults with atypical gender identity and ASD. Although the research is limited, especially for adults, there is an increasing amount of evidence that suggests a co-occurrence between gender dysphoria and ASD. Further research is vital for educational and clinical purposes. Copyright © 2016 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Prognostic value of continuous electroencephalography monitoring in children with severe brain damage.

PubMed

Lan, Yan-huai; Zhu, Xiao-mei; Zhou, Yuan-feng; Qiu, Peng-ling; Lu, Guo-ping; Sun, Dao-kai; Wang, Yi

2015-06-01

The purpose of this study is to determine whether there is a relationship between continuous electroencephalography (EEG) monitoring patterns and prognosis for children with severe brain damage. Patients and The different patterns of EEG were analyzed for 103 children (Glasgow Coma Scale [GCS] score < 8) who were monitored with continuous video-EEG (CVEEG) within 72 hours after the onset of coma. The clinical outcomes were scored and evaluated at hospital discharge by the modified Pediatric Cerebral and Overall Performance Category Scale (PCOPCS). EEG parameters of the different prognosis groups were compared and risk factors for prognosis were identified. Of the 103 children, 36 were in the good prognosis group (PCOPCS scores 1 and 2) and 67 were in the poor prognosis group (PCOPCS scores 3-6). The poor prognosis group had the lower proportion of events in reactive EEG patterns and sleep architecture, and a higher proportion of low-voltage events. Multivariate analyses showed that the lower GCS score and no sleep architecture were significantly associated with poor prognosis. Comatose children with higher GCS score and sleep architecture have better clinical outcomes in terms of morbidity and mortality. Georg Thieme Verlag KG Stuttgart · New York.

Research projects in the Surgeon-Scientist and Clinician-Investigator programs at the University of Toronto (1987-2016): a cohort study.

PubMed

Goldenberg, Neil M; Steinberg, Benjamin E; Rutka, James T; Chen, Robert; Cabral, Val; Rosenblum, Norman D; Kapus, Andras; Lee, Warren L

2016-01-01

Physicians have traditionally been at the forefront of medical research, bringing clinical questions to the laboratory and returning with ideas for treatment. However, we have anecdotally observed a decline in the popularity of basic science research among trainees. We hypothesized that fewer resident physicians have been pursuing basic science research training over time. We examined records from residents in the Surgeon-Scientist and Clinician-Investigator programs at the University of Toronto (1987-2016). Research by residents was categorized independently by 2 raters as basic science, clinical epidemiology or education-related based on the title of the project, the name of the supervisor and Pubmed searches. The study population was divided into quintiles of time, and the proportion pursuing basic science training in each quintile was calculated. Agreement between the raters was 100%; the categorization of the research topic remained unclear in 9 cases. The proportion of trainees pursuing basic science training dropped by 60% from 1987 to 2016 ( p = 0.005). Significantly fewer residents in the Surgeon-Scientist and Clinician-Investigator Programs at the University of Toronto are pursuing training in the basic sciences as compared with previous years.

Linear and nonlinear regression techniques for simultaneous and proportional myoelectric control.

PubMed

Hahne, J M; Biessmann, F; Jiang, N; Rehbaum, H; Farina, D; Meinecke, F C; Muller, K-R; Parra, L C

2014-03-01

In recent years the number of active controllable joints in electrically powered hand-prostheses has increased significantly. However, the control strategies for these devices in current clinical use are inadequate as they require separate and sequential control of each degree-of-freedom (DoF). In this study we systematically compare linear and nonlinear regression techniques for an independent, simultaneous and proportional myoelectric control of wrist movements with two DoF. These techniques include linear regression, mixture of linear experts (ME), multilayer-perceptron, and kernel ridge regression (KRR). They are investigated offline with electro-myographic signals acquired from ten able-bodied subjects and one person with congenital upper limb deficiency. The control accuracy is reported as a function of the number of electrodes and the amount and diversity of training data providing guidance for the requirements in clinical practice. The results showed that KRR, a nonparametric statistical learning method, outperformed the other methods. However, simple transformations in the feature space could linearize the problem, so that linear models could achieve similar performance as KRR at much lower computational costs. Especially ME, a physiologically inspired extension of linear regression represents a promising candidate for the next generation of prosthetic devices.

Meta-Analysis of the Changes of Peripheral Blood T Cell Subsets in Patients with Brucellosis

PubMed Central

Zheng, Rongjiong; Xie, Songsong; Niyazi, Shaniya; Lu, Xiaobo; Zhou, Yan

2018-01-01

Brucellosis is one of the most prevalent zoonotic diseases in the world, but its pathogenesis is not very clear. At present, it is thought that it may be related to the immunity of T cells. The conclusions of related studies are inconsistent, and its clinical significance is not explicit. We searched published articles in electronic databases up to December 2017 identified as relating to the clinical features of human brucellosis in China. Only eight studies had sufficient quality for data extraction. Meta-analysis showed a significantly decreased proportion of CD4+ T cells in human brucellosis patients compared to healthy subject individuals. The frequency of CD8+ T cells was significantly higher in human brucellosis patients than that in the healthy control group. The pooled analysis presented a significant decrease of the CD4+/CD8+ ratio in human brucellosis patients compared to healthy subjects. There is immunologic dysfunction of T lymphocyte in patients with human brucellosis, the CD4+ and CD8+ T cells might be the important factors affecting the progress of brucellosis. PMID:29888294

Foot care and footwear practices among patients attending a specialist diabetes clinic in Jamaica

PubMed Central

Gayle, Krystal A.T.; Tulloch Reid, Marshall K.; Younger, Novie O.; Francis, Damian K.; McFarlane, Shelly R.; Wright-Pascoe, Rosemarie A.; Boyne, Michael S.; Wilks, Rainford J.; Ferguson, Trevor S.

2012-01-01

This study aimed to estimate the proportion of patients at the University Hospital of the West Indies (UHWI) Diabetes Clinic who engage in recommended foot care and footwear practices. Seventy-two participants from the UHWI Diabetes Clinic completed an interviewer-administered questionnaire on foot care practices and types of footwear worn. Participants were a subset of a sex-stratified random sample of clinic attendees and were interviewed in 2010. Data analysis included frequency estimates of the various foot care practices and types of footwear worn. Participants had a mean age of 57.0±14.3 years and mean duration of diabetes of 17.0±10.3 years. Fifty-three percent of participants reported being taught how to care for their feet, while daily foot inspection was performed by approximately 60% of participants. Most participants (90%) reported daily use of moisturizing lotion on the feet but almost 50% used lotion between the toes. Approximately 85% of participants reported wearing shoes or slippers both indoors and outdoors but over 40% reported walking barefoot at some time. Thirteen percent wore special shoes for diabetes while over 80% wore shoes without socks at some time. Although much larger proportions reported wearing broad round toe shoes (82%) or leather shoes (64%), fairly high proportions reported wearing pointed toe shoes (39%), and 43% of women wore high heel shoes. In conclusion, approximately 60% of patients at the UHWI diabetic clinic engage in daily foot inspection and other recommended practices, but fairly high proportions reported foot care or footwear choices that should be avoided. PMID:24765484

A clinical trial design using the concept of proportional time using the generalized gamma ratio distribution.

PubMed

Phadnis, Milind A; Wetmore, James B; Mayo, Matthew S

2017-11-20

Traditional methods of sample size and power calculations in clinical trials with a time-to-event end point are based on the logrank test (and its variations), Cox proportional hazards (PH) assumption, or comparison of means of 2 exponential distributions. Of these, sample size calculation based on PH assumption is likely the most common and allows adjusting for the effect of one or more covariates. However, when designing a trial, there are situations when the assumption of PH may not be appropriate. Additionally, when it is known that there is a rapid decline in the survival curve for a control group, such as from previously conducted observational studies, a design based on the PH assumption may confer only a minor statistical improvement for the treatment group that is neither clinically nor practically meaningful. For such scenarios, a clinical trial design that focuses on improvement in patient longevity is proposed, based on the concept of proportional time using the generalized gamma ratio distribution. Simulations are conducted to evaluate the performance of the proportional time method and to identify the situations in which such a design will be beneficial as compared to the standard design using a PH assumption, piecewise exponential hazards assumption, and specific cases of a cure rate model. A practical example in which hemorrhagic stroke patients are randomized to 1 of 2 arms in a putative clinical trial demonstrates the usefulness of this approach by drastically reducing the number of patients needed for study enrollment. Copyright © 2017 John Wiley & Sons, Ltd.

Caseload midwifery care versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial.

PubMed

Tracy, Sally K; Hartz, Donna L; Tracy, Mark B; Allen, Jyai; Forti, Amanda; Hall, Bev; White, Jan; Lainchbury, Anne; Stapleton, Helen; Beckmann, Michael; Bisits, Andrew; Homer, Caroline; Foureur, Maralyn; Welsh, Alec; Kildea, Sue

2013-11-23

Women at low risk of pregnancy complications benefit from continuity of midwifery care, but no trial evidence exists for women with identified risk factors. We aimed to assess the clinical and cost outcomes of caseload midwifery care for women irrespective of risk factors. In this unblinded, randomised, controlled, parallel-group trial, pregnant women at two metropolitan teaching hospitals in Australia were randomly assigned to either caseload midwifery care or standard maternity care by a telephone-based computer randomisation service. Women aged 18 years and older were eligible if they were less than 24 weeks pregnant at the first booking visit. Those who booked with another care provider, had a multiple pregnancy, or planned to have an elective caesarean section were excluded. Women allocated to caseload care received antenatal, intrapartum, and postnatal care from a named caseload midwife (or back-up caseload midwife). Controls received standard care with rostered midwives in discrete wards or clinics. The participant and the clinician were not masked to assignment. The main primary outcome was the proportion of women who had a caesarean section. The other primary maternal outcomes were the proportions who had an instrumental or unassisted vaginal birth, and the proportion who had epidural analgesia during labour. Primary neonatal outcomes were Apgar scores, preterm birth, and admission to neonatal intensive care. We analysed all outcomes by intention to treat. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000349246. Publicly insured women were screened at the participating hospitals between Dec 8, 2008, and May 31, 2011. 1748 pregnant women were randomly assigned, 871 to caseload and 877 to standard care. The proportion of caesarean sections did not differ between the groups (183 [21%] in the caseload group vs 204 [23%] in the standard care group; odds ratio [OR] 0·88, 95% CI 0·70-1·10; p=0·26). The proportion of women who had elective caesarean sections (before onset of labour) differed significantly between caseload and standard care (69 [8%] vs 94 [11%]; OR 0·72, 95% CI 0·52-0·99; p=0·05). Proportions of instrumental birth were similar (172 [20%] vs 171 [19%]; p=0·90), as were the proportions of unassisted vaginal births (487 [56%] vs 454 [52%]; p=0·08) and epidural use (314 [36%] vs 304 [35%]; p=0·54). Neonatal outcomes did not differ between the groups. Total cost of care per woman was AUS$566·74 (95% 106·17-1027·30; p=0·02) less for caseload midwifery than for standard maternity care. Our results show that for women of any risk, caseload midwifery is safe and cost effective. National Health and Medical Research Council (Australia). Copyright © 2013 Elsevier Ltd. All rights reserved.

Evaluation of fatty proportion in fatty liver using least squares method with constraints.

PubMed

Li, Xingsong; Deng, Yinhui; Yu, Jinhua; Wang, Yuanyuan; Shamdasani, Vijay

2014-01-01

Backscatter and attenuation parameters are not easily measured in clinical applications due to tissue inhomogeneity in the region of interest (ROI). A least squares method(LSM) that fits the echo signal power spectra from a ROI to a 3-parameter tissue model was used to get attenuation coefficient imaging in fatty liver. Since fat's attenuation value is higher than normal liver parenchyma, a reasonable threshold was chosen to evaluate the fatty proportion in fatty liver. Experimental results using clinical data of fatty liver illustrate that the least squares method can get accurate attenuation estimates. It is proved that the attenuation values have a positive correlation with the fatty proportion, which can be used to evaluate the syndrome of fatty liver.

Blast injury research models

PubMed Central

Kirkman, E.; Watts, S.; Cooper, G.

2011-01-01

Blast injuries are an increasing problem in both military and civilian practice. Primary blast injury to the lungs (blast lung) is found in a clinically significant proportion of casualties from explosions even in an open environment, and in a high proportion of severely injured casualties following explosions in confined spaces. Blast casualties also commonly suffer secondary and tertiary blast injuries resulting in significant blood loss. The presence of hypoxaemia owing to blast lung complicates the process of fluid resuscitation. Consequently, prolonged hypotensive resuscitation was found to be incompatible with survival after combined blast lung and haemorrhage. This article describes studies addressing new forward resuscitation strategies involving a hybrid blood pressure profile (initially hypotensive followed later by normotensive resuscitation) and the use of supplemental oxygen to increase survival and reduce physiological deterioration during prolonged resuscitation. Surprisingly, hypertonic saline dextran was found to be inferior to normal saline after combined blast injury and haemorrhage. New strategies have therefore been developed to address the needs of blast-injured casualties and are likely to be particularly useful under circumstances of enforced delayed evacuation to surgical care. PMID:21149352

Proportions of maxillary anterior teeth relative to each other and to golden standard in tabriz dental faculty students.

PubMed

Parnia, Fereydoun; Hafezeqoran, Ali; Mahboub, Farhang; Moslehifard, Elnaz; Koodaryan, Rodabeh; Moteyagheni, Rosa; Saleh Saber, Fariba

2010-01-01

Various methods are used to measure the size and form of the teeth, including the golden pro-portion, and the width-to-length ratio of central teeth, referred to as the golden standard. The aim of this study was to eval-uate the occurrence of golden standard values and golden proportion in the anterior teeth. Photographs of 100 dentistry students (50 males and 50 females) were taken under standard conditions. The visible widths and lengths of maxillary right and left incisors were calculated and the ratios were compared with golden standard. Data was analyzed using SPSS 14 software. Review of the results of the means showed statistically significant differences between the width ratio of right lateral teeth to the central teeth width with golden proportion (P<0.001). Likewise, the difference was significant for the left side, too (P<0.001). Test results of mean differences showed that the mean difference between proportion of right laterals to centrals with golden proportion was significant (P<0.001). The difference was significant for the left side, too (P<0.001). As a result, there is no golden proportion among maxillary incisors. The review of results of mean differences for single samples showed that the mean differences between the proportion of width-to-length of left and right central teeth was statistically significant by golden standard (P<0.001). Therefore, considering the width-to-length proportion of maxillary central teeth, no golden standard exists. In the evaluation of the width-to-width and width-to-length proportions of maxillary incisors no golden proportions and standards were detected, respectively.

Do mobile clinics provide high-quality antenatal care? A comparison of care delivery, knowledge outcomes and perception of quality of care between fixed and mobile clinics in central Haiti.

PubMed

Phillips, Erica; Stoltzfus, Rebecca J; Michaud, Lesly; Pierre, Gracia Lionel Fils; Vermeylen, Francoise; Pelletier, David

2017-10-16

Antenatal care (ANC) is an important health service for women in developing countries, with numerous proven benefits. Global coverage of ANC has steadily increased over the past 30 years, in part due to increased community-based outreach. However, commensurate improvements in health outcomes such as reductions in the prevalence of maternal anemia and infants born small-for-gestational age have not been achieved, even with increased coverage, indicating that quality of care may be inadequate. Mobile clinics are one community-based strategy used to further improve coverage of ANC, but their quality of care delivery has rarely been evaluated. To determine the quality of care of ANC in central Haiti, we compared adherence to national guidelines between fixed and mobile clinics by performing direct observations of antenatal care consultations and exit interviews with recipients of care using a multi-stage random sampling procedure. Outcome variables were eight components of care, and women's knowledge and perception of care quality. There were significant differences in the predicted proportion or probability of recommended services for four of eight care components, including intake, laboratory examinations, infection control, and supplies, iron folic acid supplements and Tetanus Toxoid vaccine provided to women. These care components were more likely performed in fixed clinics, except for distribution of supplies, iron-folic acid supplements, and Tetanus Toxoid vaccine, more likely provided in mobile clinics. There were no differences between clinic type for the proportion of total physical exam procedures performed, health and communication messages delivered, provider communication or documentation. Women's knowledge about educational topics was poor, but women perceived extremely high quality of care in both clinic models. Although adherence to guidelines differed by clinic type for half of the care components, both clinics had a low percentage of overall services delivered. Efforts to improve provider performance and quality are therefore needed in both models. Mobile clinics must deliver high-quality ANC to improve health and nutrition outcomes.

Tuberculosis detection and the challenges of integrated care in rural China: A cross-sectional standardized patient study.

PubMed

Sylvia, Sean; Xue, Hao; Zhou, Chengchao; Shi, Yaojiang; Yi, Hongmei; Zhou, Huan; Rozelle, Scott; Pai, Madhukar; Das, Jishnu

2017-10-01

Despite recent reductions in prevalence, China still faces a substantial tuberculosis (TB) burden, with future progress dependent on the ability of rural providers to appropriately detect and refer TB patients for further care. This study (a) provides a baseline assessment of the ability of rural providers to correctly manage presumptive TB cases; (b) measures the gap between provider knowledge and practice and; (c) evaluates how ongoing reforms of China's health system-characterized by a movement toward "integrated care" and promotion of initial contact with grassroots providers-will affect the care of TB patients. Unannounced standardized patients (SPs) presenting with classic pulmonary TB symptoms were deployed in 3 provinces of China in July 2015. The SPs successfully completed 274 interactions across all 3 tiers of China's rural health system, interacting with providers in 46 village clinics, 207 township health centers, and 21 county hospitals. Interactions between providers and standardized patients were assessed against international and national standards of TB care. Using a lenient definition of correct management as at least a referral, chest X-ray or sputum test, 41% (111 of 274) SPs were correctly managed. Although there were no cases of empirical anti-TB treatment, antibiotics unrelated to the treatment of TB were prescribed in 168 of 274 interactions or 61.3% (95% CI: 55%-67%). Correct management proportions significantly higher at county hospitals compared to township health centers (OR 0.06, 95% CI: 0.01-0.25, p < 0.001) and village clinics (OR 0.02, 95% CI: 0.0-0.17, p < 0.001). Correct management in tests of knowledge administered to the same 274 physicians for the same case was 45 percentage points (95% CI: 37%-53%) higher with 24 percentage points (95% CI: -33% to -15%) fewer antibiotic prescriptions. Relative to the current system, where patients can choose to bypass any level of care, simulations suggest that a system of managed referral with gatekeeping at the level of village clinics would reduce proportions of correct management from 41% to 16%, while gatekeeping at the level of the township hospital would retain correct management close to current levels at 37%. The main limitations of the study are 2-fold. First, we evaluate the management of a one-time new patient presenting with presumptive TB, which may not reflect how providers manage repeat patients or more complicated TB presentations. Second, simulations under alternate policies require behavioral and statistical assumptions that should be addressed in future applications of this method. There were significant quality deficits among village clinics and township health centers in the management of a classic case of presumptive TB, with higher proportions of correct case management in county hospitals. Poor clinical performance does not arise only from a lack of knowledge, a phenomenon known as the "know-do" gap. Given significant deficits in quality of care, reforms encouraging first contact with lower tiers of the health system can improve efficiency only with concomitant improvements in appropriate management of presumptive TB patients in village clinics and township health centers.

The proportionate value of proportionality in palliative sedation.

PubMed

Berger, Jeffrey T

2014-01-01

Proportionality, as it pertains to palliative sedation, is the notion that sedation should be induced at the lowest degree effective for symptom control, so that the patient's consciousness may be preserved. The pursuit of proportionality in palliative sedation is a widely accepted imperative advocated in position statements and guidelines on this treatment. The priority assigned to the pursuit of proportionality, and the extent to which it is relevant for patients who qualify for palliative sedation, have been overstated. Copyright 2014 The Journal of Clinical Ethics. All rights reserved.

Clinical performance and patient outcome after simulation-based training in prevention and management of postpartum haemorrhage: an educational intervention study in a low-resource setting.

PubMed

Nelissen, Ellen; Ersdal, Hege; Mduma, Estomih; Evjen-Olsen, Bjørg; Twisk, Jos; Broerse, Jacqueline; van Roosmalen, Jos; Stekelenburg, Jelle

2017-09-11

Postpartum haemorrhage (PPH) is a major cause of maternal mortality. Prevention and adequate treatment are therefore important. However, most births in low-resource settings are not attended by skilled providers, and knowledge and skills of healthcare workers that are available are low. Simulation-based training effectively improves knowledge and simulated skills, but the effectiveness of training on clinical behaviour and patient outcome is not yet fully understood. The aim of this study was to assess the effect of obstetric simulation-based training on the incidence of PPH and clinical performance of basic delivery skills and management of PPH. A prospective educational intervention study was performed in a rural referral hospital in Tanzania. Sixteen research assistants observed all births with a gestational age of more than 28 weeks from May 2011 to June 2013. In March 2012 a half-day obstetric simulation-based training in management of PPH was introduced. Observations before and after training were compared. The main outcome measures were incidence of PPH (500-1000 ml and >1000 ml), use and timing of administration of uterotonic drugs, removal of placenta by controlled cord traction, uterine massage, examination of the placenta, management of PPH (>500 ml), and maternal and neonatal mortality at 24 h. Three thousand six hundred twenty two births before and 5824 births after intervention were included. The incidence of PPH (500-1000 ml) significantly reduced from 2.1% to 1.3% after training (effect size Cohen's d = 0.07). The proportion of women that received oxytocin (87.8%), removal of placenta by controlled cord traction (96.5%), and uterine massage after birth (93.0%) significantly increased after training (to 91.7%, 98.8%, 99.0% respectively). The proportion of women who received oxytocin as part of management of PPH increased significantly (before training 43.0%, after training 61.2%). Other skills in management of PPH improved (uterine massage, examination of birth canal, bimanual uterine compression), but these were not statistically significant. The introduction of obstetric simulation-based training was associated with a 38% reduction in incidence of PPH and improved clinical performance of basic delivery skills and management of PPH.

Patterns of Hamstring Muscle Tears in the General Population: A Systematic Review

PubMed Central

Kuske, Barbara; Hamilton, David F.; Pattle, Sam B.; Simpson, A. Hamish R. W.

2016-01-01

Background Hamstring tears are well recognised in the sporting population. Little is known about these injuries in the general population. Purpose Evaluating the rates, patterns and risk factors of non-sporting hamstring tears, compared to sporting related hamstring tears. Data Sources MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials (1989–2015). Study Selection Studies reporting patients with a grade 2 or 3 hamstring muscle tear, identified clinically, confirmed by MRI imaging or direct visualisation during surgical exploration. Data Synthesis 144 sets of linked data were extracted for analysis. Most injuries were in males (81.3%), where mean age at injury was lower (30.2, 95% CI 29.1–31.3) than in females (35.4, 95% CI 32.4–38.4) p = 0.06. Key differences were found in the proportion of non-sporting injuries in patients under and over the age 40 (p = 0.001). The proportion of non-sporting injuries was significantly higher in females compared to males (25.9% female non-sporting injuries, versus 8.5% male; p = 0.02). Avulsions were more frequently reported in non-sporting activities (70.5%). The proportion of such injuries was notably higher in females, though this failed to meet significance (p = 0.124). Grouped by age category a bimodal distribution was noted, with the proportion of avulsions greater in younger (age <15) and older patients (age > 40) (p = 0.008). 86.8% of patients returned to pre-injury activity levels with a similar frequency across all study variables; age, activity (sporting vs non-sporting) and injury type (avulsion vs tear). Conclusion This review highlights a proportion of adults suffering grade 2 or 3 hamstring injuries from activities other than the classic sports trauma. The majority of these non-sporting injuries were avulsion injuries that clustered in older female and skeletally immature patients suggesting a potential link to bone mineral density. PMID:27144648

Patterns of Hamstring Muscle Tears in the General Population: A Systematic Review.

PubMed

Kuske, Barbara; Hamilton, David F; Pattle, Sam B; Simpson, A Hamish R W

2016-01-01

Hamstring tears are well recognised in the sporting population. Little is known about these injuries in the general population. Evaluating the rates, patterns and risk factors of non-sporting hamstring tears, compared to sporting related hamstring tears. MEDLINE, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials (1989-2015). Studies reporting patients with a grade 2 or 3 hamstring muscle tear, identified clinically, confirmed by MRI imaging or direct visualisation during surgical exploration. 144 sets of linked data were extracted for analysis. Most injuries were in males (81.3%), where mean age at injury was lower (30.2, 95% CI 29.1-31.3) than in females (35.4, 95% CI 32.4-38.4) p = 0.06. Key differences were found in the proportion of non-sporting injuries in patients under and over the age 40 (p = 0.001). The proportion of non-sporting injuries was significantly higher in females compared to males (25.9% female non-sporting injuries, versus 8.5% male; p = 0.02). Avulsions were more frequently reported in non-sporting activities (70.5%). The proportion of such injuries was notably higher in females, though this failed to meet significance (p = 0.124). Grouped by age category a bimodal distribution was noted, with the proportion of avulsions greater in younger (age <15) and older patients (age > 40) (p = 0.008). 86.8% of patients returned to pre-injury activity levels with a similar frequency across all study variables; age, activity (sporting vs non-sporting) and injury type (avulsion vs tear). This review highlights a proportion of adults suffering grade 2 or 3 hamstring injuries from activities other than the classic sports trauma. The majority of these non-sporting injuries were avulsion injuries that clustered in older female and skeletally immature patients suggesting a potential link to bone mineral density.

An evaluation of rabies vaccination rates among canines and felines involved in biting incidents within the Wellington-Dufferin-Guelph Public Health Department.

PubMed

Bottoms, K; Trotz-Williams, L; Hutchison, S; MacLeod, J; Dixon, J; Berke, O; Poljak, Z

2014-11-01

The objectives of this study were to determine the rate of animal bite incidents occurring in the human population of a local health department, and to determine the proportion of these canines and felines that were not up to date on their rabies vaccination at the time the incident occurred. Data were obtained from animal bite incidents reported to Wellington-Dufferin-Guelph Public Health during 2010 and 2011. Descriptive statistics of 718 eligible reports revealed the average rate of animal biting was 1.55 bites per 1000 residents per year. Approximately 54% of these animals were vaccinated against rabies, 32% were not up to date with their rabies vaccination, and the remaining 14.5% were of unknown status. The unit of analysis was the municipality, and the four outcomes of interest were: (i) number of animal bite incidents per 1000 residents, (ii) number of dog bite incidents per 1000 residents, (iii) proportion of animals involved in bite incidents that were not up to date with their rabies vaccination, and (iv) proportion of dogs that were not up to date. Associations between the outcomes and selected demographic variables were investigated using regression analysis. The number of veterinary clinics per 10,000 residents, and whether the municipality was urban or rural were identified as significant predictors for the number of animal bites per 1000 residents, and the number of dog bites. There were no significant predictors for the proportion of unvaccinated animals or dogs. Spatial clustering and the location of spatial clusters were assessed using the empirical Bayes index and spatial scan test. This analysis identified five municipalities within the health department that have a high rate of biting incidents and a high proportion of animals that were not up to date on their rabies vaccination. Such municipalities are ideal for targeted educational campaigns regarding the importance of vaccination in pets. © 2014 Blackwell Verlag GmbH.

A prospective comparison between stabilized glutaraldehyde and chlorhexidine gluconate for preoperative skin antisepsis in dogs.

PubMed

Lambrechts, Nicolaas E; Hurter, Karin; Picard, Jackie A; Goldin, Jeremy P; Thompson, Peter N

2004-01-01

To compare the efficacy of 0.3% stabilized glutaraldehyde and alcohol (SG+A), 0.3% SG and water (SG+W), and 4% chlorhexidine gluconate tincture (CG+A), as skin disinfectants in dogs undergoing ovariohysterectomy. Prospective, blinded clinical study. One hundred and twenty-one dogs. Cutaneous bacterial colony forming units (CFU) from the perioperative site after skin preparation, after antisepsis, and after surgery (incisional and paramedian), were quantified. The influence of high initial bacterial counts (> or =150 CFU) and surgical time on antibacterial efficacy was examined and the proportion of dogs from which Staphylococcus intermedius was cultured, determined. Perioperative skin reactions and wound infections were documented. All 3 antiseptic solutions significantly and equally reduced CFU to all post-antisepsis sampling levels irrespective of surgical duration (mean surgical times 151.6, 136.2, and 149.6 minutes for CG+A, SG+A and SG+W, respectively). Median percentage reductions in CFU ranged between 99.3% and 100%. In dogs with initial high counts and disinfected with CG+A and SG+W, the incisional samples had significantly higher counts than the post-antisepsis samples. In the CG+A and SG+W groups, the proportion of post-surgery samples yielding S. intermedius was significantly higher at the incisional than the paramedian sites. Eight mild cutaneous reactions were recorded in equal proportions for the 3 solutions. There were no recorded infections. All 3 preparations had an equal ability to reduce and maintain low CFU counts, with minimal cutaneous reactions. SG solutions are safe and effective preoperative skin antiseptics for elective clean-contaminated surgical procedures.

Future enhanced clinical role of pharmacists in Emergency Departments in England: multi-site observational evaluation.

PubMed

Hughes, Elizabeth; Terry, David; Huynh, Chi; Petridis, Konstantinos; Aiello, Matthew; Mazard, Louis; Ubhi, Hirminder; Terry, Alex; Wilson, Keith; Sinclair, Anthony

2017-08-01

Background There are concerns about maintaining appropriate clinical staffing levels in Emergency Departments. Pharmacists may be one possible solution. Objective To determine if Emergency Department attendees could be clinically managed by pharmacists with or without advanced clinical practice training. Setting Prospective 49 site cross-sectional observational study of patients attending Emergency Departments in England. Method Pharmacist data collectors identified patient attendance at their Emergency Department, recorded anonymized details of 400 cases and categorized each into one of four possible options: cases which could be managed by a community pharmacist; could be managed by a hospital pharmacist independent prescriber; could be managed by a hospital pharmacist independent prescriber with additional clinical training; or medical team only (unsuitable for pharmacists to manage). Impact indices sensitive to both workload and proportion of pharmacist manageable cases were calculated for each clinical group. Main outcome measure Proportion of cases which could be managed by a pharmacist. Results 18,613 cases were observed from 49 sites. 726 (3.9%) of cases were judged suitable for clinical management by community pharmacists, 719 (3.9%) by pharmacist prescribers, 5202 (27.9%) by pharmacist prescribers with further training, and 11,966 (64.3%) for medical team only. Impact Indices of the most frequent clinical groupings were general medicine (13.18) and orthopaedics (9.69). Conclusion The proportion of Emergency Department cases that could potentially be managed by a pharmacist was 36%. Greatest potential for pharmacist management was in general medicine and orthopaedics (usually minor trauma). Findings support the case for extending the clinical role of pharmacists.

Validation of the 'United Registries for Clinical Assessment and Research' [UR-CARE], a European Online Registry for Clinical Care and Research in Inflammatory Bowel Disease.

PubMed

Burisch, Johan; Gisbert, Javier P; Siegmund, Britta; Bettenworth, Dominik; Thomsen, Sandra Bohn; Cleynen, Isabelle; Cremer, Anneline; Ding, Nik John Sheng; Furfaro, Federica; Galanopoulos, Michail; Grunert, Philip Christian; Hanzel, Jurij; Ivanovski, Tamara Knezevic; Krustins, Eduards; Noor, Nurulamin; O'Morain, Neil; Rodríguez-Lago, Iago; Scharl, Michael; Tua, Julia; Uzzan, Mathieu; Ali Yassin, Nuha; Baert, Filip; Langholz, Ebbe

2018-04-27

The 'United Registries for Clinical Assessment and Research' [UR-CARE] database is an initiative of the European Crohn's and Colitis Organisation [ECCO] to facilitate daily patient care and research studies in inflammatory bowel disease [IBD]. Herein, we sought to validate the database by using fictional case histories of patients with IBD that were to be entered by observers of varying experience in IBD. Nineteen observers entered five patient case histories into the database. After 6 weeks, all observers entered the same case histories again. For each case history, 20 key variables were selected to calculate the accuracy for each observer. We assumed that the database was such that ≥ 90% of the entered data would be correct. The overall proportion of correctly entered data was calculated using a beta-binomial regression model to account for inter-observer variation and compared to the expected level of validity. Re-test reliability was assessed using McNemar's test. For all case histories, the overall proportion of correctly entered items and their confidence intervals included the target of 90% (Case 1: 92% [88-94%]; Case 2: 87% [83-91%]; Case 3: 93% [90-95%]; Case 4: 97% [94-99%]; Case 5: 91% [87-93%]). These numbers did not differ significantly from those found 6 weeks later [NcNemar's test p > 0.05]. The UR-CARE database appears to be feasible, valid and reliable as a tool and easy to use regardless of prior user experience and level of clinical IBD experience. UR-CARE has the potential to enhance future European collaborations regarding clinical research in IBD.

Trends in Occupations and Work Sectors Among Patients With Work-Related Asthma at a Canadian Tertiary Care Clinic.

PubMed

Gotzev, Simeon; Lipszyc, Joshua C; Connor, Dale; Tarlo, Susan M

2016-10-01

Work-related asthma (WRA) is the most common chronic occupational lung disease in the developed world. Several factors including sociodemographic status and occupation/industry increase the risks of developing WRA. In this study, we sought to identify changes in patterns and characteristics among patients with WRA over a 15-year period in an occupational lung disease clinic. We performed a retrospective analysis of patients with WRA charts at the Occupational Lung Disease Clinic of a University Hospital in Toronto, Canada. Patients were divided into two periods classified by first attendance at the clinic 2000 through 2007 and 2008 through 2015. Comparisons between the two periods included: sociodemographic characteristics, smoking status, occupations, exposures, and submitted workers' compensation claims. Fewer occupational asthma cases were seen in the more recent period vs the earlier period (40 vs 74 cases), with a smaller reduction in work-exacerbated asthma cases (40 vs 58). The recent period included a significantly smaller proportion employed in the manufacturing industry and isocyanate-induced cases compared with the earlier period. An increased proportion were employed in health-care and education industries (primarily cleaners and teachers) in the recent period, consistent with a corresponding increased frequency of cleaning agents and dust exposures. The changes observed in work sectors in the patients with WRA in this clinic in Toronto are consistent with reductions reported in Ontario workers' compensation claims for occupational asthma and may relate to preventive measures. Cleaners and teachers should be a focus of further intervention measures for work-related asthma. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Antineutrophil cytoplasmic autoantibodies and myeloperoxidase autoantibodies in clinical expression of Churg-Strauss syndrome.

PubMed

Healy, Bridget; Bibby, Susan; Steele, Richard; Weatherall, Mark; Nelson, Harold; Beasley, Richard

2013-02-01

The clinical significance of antineutrophil cytoplasmic antibodies (ANCAs) in the phenotypic expression of Churg-Strauss syndrome (CSS) is uncertain. We sought to investigate the relationship between ANCA status and the clinical expression of CSS in a case series derived from the US Food and Drug Administration's adverse events database. All cases of CSS reported to the US Food and Drug Administration from 1997 to April 2003 were reviewed. Information about basic demographics, suspect medication use, clinical manifestations, histologic findings, ANCA staining patterns, and the presence of antibodies to myeloperoxidase (anti-MPO) or proteinase 3 (anti-PR3) was recorded when available. There were 93 case reports of CSS with sufficient documentation, including ANCA status. There were 38 (40.9%) of 93 cases with positive ANCA results, of which 15 cases reported a positive ELISA, all of which were positive for anti-MPO. ANCA negativity was associated with an increased proportion of cardiac involvement (risk difference [RD], 38.2%; 95% CI, 25.3% to 51.0%), gastrointestinal involvement (RD, 25.5%; 95% CI, 13.9% to 37.0%), pulmonary infiltrates (odds ratio, 4.9; 95% CI, 1.5-16.2), and the outcome of a life-threatening event or death (RD, 30.9%; 95% CI, 18.7% to 43.1%) when compared with anti-MPO-positive cases. ANCA negativity was associated with a decreased proportion of peripheral neuropathy (odds ratio, 0.3; 95% CI, 0.07-0.9). These findings support the hypothesis that the presence or absence of autoantibodies influences the clinical expression and severity of CSS. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

Electroencephalography for diagnosis and prognosis of acute encephalitis.

PubMed

Sutter, Raoul; Kaplan, Peter W; Cervenka, Mackenzie C; Thakur, Kiran T; Asemota, Anthony O; Venkatesan, Arun; Geocadin, Romergryko G

2015-08-01

To confirm the previously identified EEG characteristics for HSV encephalitis and to determine the diagnostic and predictive value of electroencephalography (EEG) features for etiology and outcome of acute encephalitis in adults. In addition, we sought to investigate their independence from possible clinical confounders. This study was performed in the Intensive Care Units of two academic tertiary care centers. From 1997 to 2011, all consecutive patients with acute encephalitis who received one or more EEGs were included. Examination of the diagnostic and predictive value of EEG patterns regarding etiology, clinical conditions, and survival was performed. The main outcome measure was in-hospital death. Of 103 patients with encephalitis, EEGs were performed in 76 within a median of 1 day (inter quartile range 0.5-3) after admission. Mortality was 19.7%. Higher proportions of periodic discharges (PDs) (p=0.029) and focal slowing (p=0.017) were detected in Herpes Simplex virus (HSV) encephalitis as compared to non-HSV encephalitis, while clinical characteristics did not differ. Normal EEG remained the strongest association with a low relative risk for death in multivariable analyses (RR<0.001, p<0.001) adjusting for confounders as coma, global cerebral edema and mechanical ventilation. None of the patients with a normal EEG had a GCS of 15. Normal EEG predicted survival independently from possible confounders, highlighting the prognostic value of EEG in evaluating patients with encephalitis. EEG revealed higher proportions of PDs along with focal slowing in HSV encephalitis as compared to other etiologies. EEG significantly adds to clinical, diagnostic and prognostic information in patients with acute encephalitis. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

The landscape of precision cancer medicine clinical trials in the United States.

PubMed

Roper, Nitin; Stensland, Kristian D; Hendricks, Ryan; Galsky, Matthew D

2015-05-01

Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective "precision cancer medicine" clinical trials in the U.S. We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as "precision cancer medicine" if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. Of the initial 18,797 trials identified, 9094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), p<0.001], multi-center [RR 1.18 (1.11-1.26), p<0.001], open-label [RR 1.04 (1.02-1.07), p=0.005] and involve breast [RR 4.03 (3.49-4.52), p<0.001], colorectal [RR 1.62 (1.22-2.14), p=0.002] and skin [RR 1.98 (1.55-2.54), p<0.001] cancers. Precision medicine trials required 38 unique genomic alterations for enrollment. The proportion of precision cancer medicine trials compared to the total number of trials increased from 3% in 2006 to 16% in 2013. The proportion of adult cancer clinical trials in the U.S. requiring a genomic alteration for enrollment has increased substantially over the past several years. However, such trials still represent a small minority of studies performed within the cancer clinical trials enterprise and include a small subset of putatively "actionable" alterations. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

PubMed

Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-10-01

While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient's body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial

PubMed Central

Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

2017-01-01

Background While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this “Treatment of Early Neuropathy in Leprosy” (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. Methods In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (<6 months) were allocated to a prednisolone treatment regimen of either 20 weeks or 32 weeks. Prednisolone was started at either 45 or 60 mg/day, depending on the patient’s body weight, and was then tapered. Throughout follow up, NFI was assessed by voluntary muscle testing and monofilament testing. The primary outcome was the proportion of patients with improved or restored nerve function at week 78. As secondary outcomes, we analysed improvements between baseline and week 78 on the Reaction Severity Scale, the SALSA Scale and the Participation Scale. Serious Adverse Events and the need for additional prednisolone treatment were monitored and reported. Results We included 868 patients in the study, 429 in the 20-week arm and 439 in the 32-week arm. At 78 weeks, the proportion of patients with improved or restored nerve function did not differ significantly between the groups: 78.1% in the 20-week arm and 77.5% in the 32-week arm (p = 0.821). Nor were there any differences in secondary outcomes, except for a significant higher proportion of Serious Adverse Events in the longer treatment arm. Conclusion In our study, a 20-week course of prednisolone was as effective as a 32-week course in improving and restoring recent clinical NFI in leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment. PMID:28976976

Controlled trials in children: quantity, methodological quality and descriptive characteristics of pediatric controlled trials published 1948-2006.

PubMed

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P

2010-09-30

The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials.

A systematic review and meta-analysis of factors that relate to aggression perpetrated against nurses by patients/relatives or staff.

PubMed

Edward, Karen-leigh; Stephenson, John; Ousey, Karen; Lui, Steve; Warelow, Philip; Giandinoto, Jo-Ann

2016-02-01

The aim of this meta-analysis was to identify the factors that related to aggression (verbal abuse or physical abuse/assault) perpetrated against the nurse or other health professionals by patients/relatives or staff. In the light of the paucity of systematic reviews on this common issue in nursing, the objective was to present a comprehensive systematic review and meta-analysis of these papers. Aggression towards nurses is common around the world and can be the impetus for nurses leaving the profession or developing anxiety when working in particular settings. Systematic review with meta-analysis. Meta-analyses were conducted to assess the effect of the factors of gender and context (dichotomised as mental health/psychiatric or nonmental health/psychiatric). The databases of Medline (1966-2015), CINAHL (1982-2015) and PsychInfo (1920-2015). A total of 1571 papers were screened by two reviewers. At the final decision 14 were selected for analysis. A higher proportion of female nurses than male nurses were reported to be the victims of verbal abuse, with the difference in proportions being statistically significant. A statistically significant higher proportion of male nurses than female nurses were reported to be the victims of physical abuse. There was a significantly higher proportion of mental health nurses reported experiencing physical abuse as compared to nonmental health nurses. The analysis reveal female nurses have greater odds of verbal abuse than male nurses and male nurses have greater odds of physical abuse than female nurses. Overall mental health nurses had three times higher odds of physical assault than other nurses. In the light of the findings it is recommended organisational support improve in high aggression potential clinical areas and for nursing curriculums to incorporate education about the management of challenging behaviours in undergraduate programmes. © 2015 John Wiley & Sons Ltd.

CoAIMs: A Cost-Effective Panel of Ancestry Informative Markers for Determining Continental Origins

PubMed Central

Londin, Eric R.; Keller, Margaret A.; Maista, Cathleen; Smith, Gretchen; Mamounas, Laura A.; Zhang, Ran; Madore, Steven J.; Gwinn, Katrina; Corriveau, Roderick A.

2010-01-01

Background Genetic ancestry is known to impact outcomes of genotype-phenotype studies that are designed to identify risk for common diseases in human populations. Failure to control for population stratification due to genetic ancestry can significantly confound results of disease association studies. Moreover, ancestry is a critical factor in assessing lifetime risk of disease, and can play an important role in optimizing treatment. As modern medicine moves towards using personal genetic information for clinical applications, it is important to determine genetic ancestry in an accurate, cost-effective and efficient manner. Self-identified race is a common method used to track and control for population stratification; however, social constructs of race are not necessarily informative for genetic applications. The use of ancestry informative markers (AIMs) is a more accurate method for determining genetic ancestry for the purposes of population stratification. Methodology/Principal Findings Here we introduce a novel panel of 36 microsatellite (MSAT) AIMs that determines continental admixture proportions. This panel, which we have named Continental Ancestry Informative Markers or CoAIMs, consists of MSAT AIMs that were chosen based upon their measure of genetic variance (Fst), allele frequencies and their suitability for efficient genotyping. Genotype analysis using CoAIMs along with a Bayesian clustering method (STRUCTURE) is able to discern continental origins including Europe/Middle East (Caucasians), East Asia, Africa, Native America, and Oceania. In addition to determining continental ancestry for individuals without significant admixture, we applied CoAIMs to ascertain admixture proportions of individuals of self declared race. Conclusion/Significance CoAIMs can be used to efficiently and effectively determine continental admixture proportions in a sample set. The CoAIMs panel is a valuable resource for genetic researchers performing case-control genetic association studies, as it can control for the confounding effects of population stratification. The MSAT-based approach used here has potential for broad applicability as a cost effective tool toward determining admixture proportions. PMID:20976178

A survey of general practitioners' views on autopsy reports.

PubMed Central

Karunaratne, S; Benbow, E W

1997-01-01

AIMS: To study the views of general practitioners on the quality and utility of autopsy reports, and on autopsies in general. METHODS: For a period of six months, a questionnaire was enclosed with each autopsy report sent to a general practitioner from the mortuary at Manchester Royal Infirmary. RESULTS: Most (93.3%) general practitioners found the autopsy report useful, and many (66.7%) thought the bereaved relatives would do so too. However, only a minority (25.2%) would discuss the report with the relatives. A considerable proportion (20.0%) found the cause of death surprising, and a significant number (10.4%) felt the report would modify their future clinical practice. There was approval of autopsies in general, with most (88.6%) agreeing that autopsies reveal lesions not detected in life, and many (74.4%) indicating that loss of the autopsy would impair severely the monitoring of clinical standards. CONCLUSIONS: General practitioners appreciate autopsy reports, which may have a significant impact on clinical practice. Autopsy reports provide both case audit and information for relatives. PMID:9306932

Rapid assessment breast clinics--evolution through audit.

PubMed

Toomey, D P; Cahill, R A; Birido, N; Jeffers, M; Loftus, B; McInerney, D; Rothwell, J; Geraghty, J G

2006-11-01

This observational, cohort study aimed to examine the potential utility of Rapid Assessment Breast Clinics (RABC) beyond cancer detection at presentation. One thousand four hundred and twenty nine women were studied over an 18 month period. 154 (10.7%) had breast cancer - 87.7% of whom were seen expediently with 92.9% being diagnosed at one attendance. One hundred and forty three (10%) of those with a benign diagnosis were found by routine questioning to have significant familial risk separate to their reason for referral. Despite careful triage, considerable contamination of appointment allotment occurred with many who were correctly triaged as non-urgent being seen 'urgently'. One hundred and seventy six attendees (12.3%) had neither the symptom that triggered referral, nor breast lump, nipple discharge nor family history of breast cancer, while 283 (19.8%) had no objective clinical or radiological abnormality. Although RABC reliably categorise malignant versus non-malignant diagnoses despite cluttering by low risk women, a significant proportion of non-cancer patients still require address of future risk rather than reassurance of their present status alone.

Epidemiology of clinical feline herpesvirus infection in zoo-housed cheetahs (Acinonyx jubatus).

PubMed

Witte, Carmel L; Lamberski, Nadine; Rideout, Bruce A; Vaida, Florin; Citino, Scott B; Barrie, Michael T; Haefele, Holly J; Junge, Randall E; Murray, Suzan; Hungerford, Laura L

2017-10-15

OBJECTIVE To determine the incidence of and risk factors for clinical feline herpesvirus (FHV) infection in zoo-housed cheetahs and determine whether dam infection was associated with offspring infection. DESIGN Retrospective cohort study. ANIMALS 144 cheetah cubs born in 6 zoos from 1988 through 2007. PROCEDURES Data were extracted from the health records of cheetahs and their dams to identify incident cases of clinical FHV infection and estimate incidence from birth to 18 months of age. Univariate and multivariable Cox proportional hazards models, controlling for correlations among cheetahs with the same dam, were used to identify risk factors for incident FHV infection. RESULTS Cumulative incidence of FHV infection in cheetah cubs was 35% (50/144). No significant association between dam and offspring infection was identified in any model. Factors identified as significant through multivariable analysis varied by age group. For cheetahs up to 3 months of age, the most important predictor of FHV infection was having a dam that had received a preparturition FHV vaccine regimen that included a modified-live virus vaccine versus a dam that had received no preparturition vaccine. Other risk factors included being from a small litter, being born to a primiparous dam, and male sex. CONCLUSIONS AND CLINICAL RELEVANCE This study provided the first population-level characterization of the incidence of and risk factors for FHV infection in cheetahs, and findings confirmed the importance of this disease. Recognition that clinical FHV infection in the dam was not a significant predictor of disease in cubs and identification of other significant factors have implications for disease management.

Coenzyme Q10 and vitamin E deficiency in Friedreich's ataxia: predictor of efficacy of vitamin E and coenzyme Q10 therapy.

PubMed

Cooper, J M; Korlipara, L V P; Hart, P E; Bradley, J L; Schapira, A H V

2008-12-01

A pilot study of high dose coenzyme Q(10) (CoQ(10))/vitamin E therapy in Friedreich's ataxia (FRDA) patients resulted in significant clinical improvements in most patients. This study investigated the potential for this treatment to modify clinical progression in FRDA in a randomized double blind trial. Fifty FRDA patients were randomly divided into high or low dose CoQ(10)/ vitamin E groups. The change in International Co-operative Ataxia Ratings Scale (ICARS) was assessed over 2 years as the primary end-point. A post hoc analysis was made using cross-sectional data. At baseline serum CoQ(10) and vitamin E levels were significantly decreased in the FRDA patients (P < 0.001). During the trial CoQ(10) and vitamin E levels significantly increased in both groups (P < 0.01). The primary and secondary end-points were not significantly different between the therapy groups. When compared to cross-sectional data 49% of all patients demonstrated improved ICARS scores. This responder group had significantly lower baseline serum CoQ(10) levels. A high proportion of FRDA patients have a decreased serum CoQ(10) level which was the best predictor of a positive clinical response to CoQ(10)/vitamin E therapy. Low and high dose CoQ(10)/vitamin E therapies were equally effective in improving ICARS scores.

A survey of occupational skin disease in UK health care workers.

PubMed

Campion, K M

2015-01-01

Occupational skin disease is a common problem among health care workers (HCWs). The prevalence of occupational skin disease in HCWs has been reported in several international studies, but not in the UK. To estimate the prevalence of occupational skin disease in a population of UK HCWs and to explore possible causative factors. Clinical and non-clinical HCWs attending for an influenza vaccine during October and November 2013 were invited to complete a brief skin questionnaire. Data from staff who stated their skin had suffered as a result of work were compared with data from staff who did not, to explore differences in potential causative factors. A total of 2762 questionnaires were analysed. The estimated prevalence of occupational skin disease was 20% for clinical and 7% for non-clinical staff. In total, 424 clinical staff stated their skin had been made worse by work. There were statistically significant differences between clinical staff with and without reported skin symptoms regarding a history of eczema, frequent hand washing and moisturizer use but no statistically significant difference in the relative proportions of soap and alcohol hand gel use. Non-clinical staff reported significantly more use of soap relative to alcohol gel than clinical staff. This study demonstrated the prevalence of occupational skin disease in a population of UK HCWs. More work is indicated to explore if the ratio of soap and alcohol gel reported in this study are typical and whether this has any impact on the development of occupational skin disease. © The Author 2014. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Anemia and Red Blood Cell Abnormalities in HIV-Infected and HIV-Exposed Breastfed Infants: A Secondary Analysis of the Kisumu Breastfeeding Study.

PubMed

Odhiambo, Collins; Zeh, Clement; Ondoa, Pascale; Omolo, Paul; Akoth, Benta; Lwamba, Humphrey; Lando, Richard; Williamson, John; Otieno, Juliana; Masaba, Rose; Weidle, Paul; Thomas, Timothy

2015-01-01

Anemia results in increased morbidity and mortality, underscoring the need to better understand its pathophysiology amongst HIV-exposed and infected children in sub-Saharan Africa, the region where most infant HIV exposure and infections occur. This analysis used samples obtained from children in the Kisumu Breastfeeding Study (KiBS). KiBS was a longitudinal phase IIB, open-label, one-arm clinical trial, designed to investigate the safety, tolerability and effectiveness of a maternal triple-antiretroviral (ARV) regimen for prevention of mother-to-child transmission (PMTCT) of HIV, during late pregnancy and early infancy while breastfeeding. Blood samples from 482 children were obtained at birth, 2, 6, 10 and 14 weeks and 6, 9, 12, 18 and 24 months. Severity of anemia was graded using the NIH Division of AIDS (DAIDS) toxicity tables. We describe the proportion of children with anemia and anomalies in red blood cell parameters at various time points over 24 months and compare rates of anemia between HIV-infected and HIV-uninfected children and by mothers' ARV regimen and infant malaria infection. The proportion of children with anemia significantly increased after the breastfeeding period in both HIV-infected and HIV-uninfected children with higher proportion among HIV-infected children compared to HIV-uninfected children (RR: 1.72; CI: 1.22-2.44, p = 0.002). Maternal triple-antiretroviral regimen was not associated with infant anemia (p = 0.11). There was no significant difference in mean hemoglobin between HIV-uninfected children with and without malaria at each time point except at 24 months. A relatively lower proportion of children with severe anemia during the breastfeeding period suggest that exposure to mother's triple antiretroviral combinations through breast milk, posed minimal risk of hematologic toxicity.

Laser-assisted subepithelial keratectomy versus epipolis laser in situ keratomileusis for myopia: a meta-analysis of clinical outcomes.

PubMed

Wen, Daizong; Huang, Jinhai; Li, Xuexi; Savini, Giacomo; Feng, Yifan; Lin, Qiaoya; Wang, Qinmei

2014-01-01

To identify possible differences between laser-assisted subepithelial keratectomy and epipolis laser in situ keratomileusis for myopia. Meta-analysis. Patients from previously reported comparative studies treated by laser-assisted subepithelial keratectomy versus epipolis laser in situ keratomileusis. A systematic literature retrieval was conducted in the MEDLINE, EMBASE and Cochrane Library, up to January 2013. The included studies were subject to a meta-analysis using a RevMan 5.1 version software. The differences in efficacy, predictability, safety, epithelial healing time, pain perception and corneal haze formation. A total of six studies involving 517 eyes were included. There were no statistically significant differences in the final proportion of eyes with uncorrected visual acuity of 6/6 or better (P = 0.43), mean postoperative uncorrected visual acuity (P = 0.53), final proportion of eyes with refraction within ± 0.50 D (P = 0.62) and ± 1.00 D (P = 0.16) of target, final proportion of eyes losing two or more lines of best spectacle-corrected visual acuity (P = 1.00), healing time of corneal epithelium (P = 0.58), final proportion of eyes with corneal haze grade 0.5 or higher (P = 0.26), and corneal haze levels (P = 0.36). There were no significant differences in efficacy, predictability, safety, epithelial healing time and corneal haze formation between laser-assisted subepithelial keratectomy and epipolis laser in situ keratomileusis, but the result was limited. Future more data are required to detect the potential differences between the two procedures. © 2013 Royal Australian and New Zealand College of Ophthalmologists.

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers.

PubMed

Walters, Jodi; Cazzell, Shawn; Pham, Hau; Vayser, Dean; Reyzelman, Alexander

2016-01-01

The purpose of this 16-week, multicenter, randomized, controlled trial was to assess the healed ulcer rate of a human acellular dermal matrix, DermACELL, compared with conventional care and a second acellular dermal matrix, Graftjacket, in the treatment of full-thickness diabetic foot ulcers. One hundred sixty-eight patients were randomized into DermACELL, conventional care, and Graftjacket treatment arms in a 2:2:1 ratio. Patients in the acellular dermal matrix groups received either 1 or 2 applications of the graft at the discretion of the investigator. Weekly follow-up visits were conducted until the ulcer healed or the endpoint was reached. At 16 weeks, the DermACELL arm had a significantly higher proportion of completely healed ulcers than the conventional care arm (67.9% vs 48.1%; P = .0385) and a nonsignificantly higher proportion than the Graftjacket arm (67.9% vs 47.8%; P = .1149). The DermACELL arm also exhibited a greater average percent reduction in wound area than the conventional care arm (91.4% vs 80.3%; P = .0791) and the Graftjacket arm (91.4% vs 73.5%; P = .0762). The proportion of severe adverse events and the proportion of overall early withdrawals were similar among the 3 groups based on relative population size (P ≥ .05). The results presented here indicate that DermACELL is an appropriate clinical option in the treatment of diabetic foot ulcers, with significant increases in healing rates and rate of percentage wound closure as compared with conventional care options.

The Effect of Metformin Therapy for Preventing Gestational Diabetes Mellitus in Women with Polycystic Ovary Syndrome: A Meta-Analysis.

PubMed

Zhao, Jing; Liu, Xiaoyan; Zhang, Wenhua

2018-06-11

This study was to analyze the efficacy of metformin intervention in preventing gestational diabetes mellitus (GDM). A systematic review and meta-analysis of clinical trials or observational studies of metformin intervention in preventing symptoms of GDM during pregnancy were performed. Medline, Embase, and Cochrane Library were searched through to now. The main evaluated primary outcomes were incident of GDM, miscarriage, preterm delivery, and neonatal mortality. The evaluated secondary outcomes were mean difference of gestational age at birth and birth weight between metformin group and control group. We included 6 studies including 3 randomized clinical trials (RCTs), 2 observational studies, and 1 non-RCT in our meta-analysis. A total of 643 patients were enrolled for a follow-up study with continued metformin therapy (n=341) or not (n=302) during pregnancy. Metformin therapy reduced the proportion of patients developing GDM (log Odds Ratio: -1.27; 95%CI: -2.24 to -0.30) but had no significant effect on reducing the proportion of abortion, preterm delivery, and neonatal death in pregnant women with polycystic ovary syndrome (PCOS). Also, it did not cause a significant difference in gestational age at birth and birth weight in metformin group versus control/placebo group. Metformin was associated with less frequent GDM development than control diets, suggesting that it is the appropriate intervention to be prescribed to prevent GDM in patients with PCOS. © Georg Thieme Verlag KG Stuttgart · New York.

Stent Retriever Thrombectomy in Different Thrombus Locations of Anterior Cerebral Circulation

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

Protto, Sara; Sillanpää, Niko, E-mail: niko.sillanpaa@pshp.fi; Pienimäki, Juha-Pekka

BackgroundMechanical thrombectomy (MT) is a safe and efficient treatment for acute ischemic stroke in patients with proximal anterior occlusion and large penumbra. We evaluated the technical and clinical success of MT in relation to the location of the occlusion (internal carotid artery, M1 and M2 segments of the middle cerebral artery).MethodsWe prospectively reviewed 130 patients of whom 105 met the inclusion criteria. Baseline clinical, procedural and imaging variables, technical outcome (TICI, thrombolysis in cerebral infarction), 24 h imaging outcome and three-month clinical outcome (mRS, modified Rankin Scale) were recorded. Differences between the groups were studied with statistical tests according to themore » type of the variable.ResultsThere were 37, 46 and 22 patients in the internal carotid artery (ICA), M1 and M2 groups, respectively. TICI 2b or 3 was achieved in 92 cases (88 %) with a non-significant trend towards a better recanalization outcome in the ICA and M1 groups. Overall, 57 of the 105 patients (55 %) experienced favorable clinical outcome (mRS ≤ 2) with no significant differences between the groups. Excellent outcome (mRS ≤ 1) was seen in 40 patients (39 %) and there proportionally more patients with excellent outcome in the ICA and M1 groups (ICA: 44 %, M1: 41 %, M2: 23 % of patients, p = 0.22).ConclusionsThere were no statistically significant differences in the technical or clinical outcomes between the different sites of occlusion (ICA, M1 or M2). There was a non-significant trend towards achieving excellent clinical outcome (3-month mRS ≤ 1) more often and better recanalization results in the two more proximal locations.« less

Delta-9-tetrahydrocannabinol/cannabidiol (Sativex®): a review of its use in patients with moderate to severe spasticity due to multiple sclerosis.

PubMed

Syed, Yahiya Y; McKeage, Kate; Scott, Lesley J

2014-04-01

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) [Sativex®] is an oromucosal spray formulation that contains principally THC and CBD at an approximately 1:1 fixed ratio, derived from cloned Cannabis sativa L. plants. The main active substance, THC, acts as a partial agonist at human cannabinoid receptors (CB1 and CB2), and thus, may modulate the effects of excitatory (glutamate) and inhibitory (gamma-aminobutyric acid) neurotransmitters. THC/CBD is approved in a number of countries, including Germany and the UK, as an add-on treatment for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. In the largest multinational clinical trial that evaluated the approved THC/CBD regimen in this population, 12 weeks' double-blind treatment with THC/CBD significantly reduced spasticity severity (primary endpoint) compared with placebo in patients who achieved a clinically significant improvement in spasticity after 4 weeks' single-blind THC/CBD treatment, as assessed by a patient-rated numerical rating scale. A significantly greater proportion of THC/CBD than placebo recipients achieved a ≥ 30% reduction (a clinically relevant reduction) in spasticity severity. The efficacy of THC/CBD has been also shown in at least one everyday clinical practice study (MOVE 2). THC/CBD was generally well tolerated in clinical trials. Dizziness and fatigue were reported most frequently during the first 4 weeks of treatment and resolved within a few days even with continued treatment. Thus, add-on THC/CBD is a useful symptomatic treatment option for its approved indication.

Influence of Information Framing on Patient Decisions to Treat Actinic Keratosis.

PubMed

Berry, Katherine; Butt, Melissa; Kirby, Joslyn S

2017-05-01

Actinic keratosis (AK) is a skin growth induced by UV light exposure that requires long-term management because a small proportion of the disease can progress to squamous cell carcinoma. The influence of how clinicians frame or present information to patients may affect decision making about AK. To evaluate the differences in patients' decisions on whether to receive treatment for AK related to information presentation or choice framing. A prospective survey study was performed from June 1 to July 31, 2016, in participants who were able to read English. Participants were recruited through the Penn State Milton S. Hershey Dermatology Clinic and an online survey site. The survey was conducted through an online portal. A total of 571 individuals were recruited. Regression analysis, correlation coefficient analysis, and test-retest validation were conducted. The proportions of patients choosing to receive treatment for AK. Analyses were performed to adjust for age, sex, educational level, history of skin cancer, and history of AK. Of the 571 recruited participants, 539 (94.4%) returned completed surveys. The mean (SD) age of respondents was 42.9 (17.8) years; 306 (56.8%) were women. The decision to receive treatment for AK varied from 57.7% (n = 311) to 92.2% (n = 497) for the 5 scenarios presented in the questions (P < .001). The question that presented AK as a "precancer" had the highest proportion of participants who preferred treatment (497 [92.2%]). Two questions that presented the risk of AK as not progressing to cancer had the lowest proportion of individuals who chose treatment (311 [57.7%] and 328 [60.9%]). Participants from the clinic and from the online portal were significantly different in age (mean [SD] age, 56.1 [17.6] vs 33.3 [10.0] years), sex (145 [63.6%] vs 161 [51.8%] were females), educational level (40 [17.5%] vs 80 [25.7%] had completed some graduate school), history of AK (46 [20.2%] vs 19 [6.1%] answered yes), and history of skin cancer (76 [33.3%] vs 15 [4.8%] answered yes) (all P ≤ .001). Based on a regression analysis, age, sex, and previous diagnosis of skin cancer were not significantly associated with the participants' responses. This study found that patients' decisions on whether to receive treatment for AK is significantly affected by physician wording, especially with alterations in the presentation of risk of malignant transformation.

Influence of Information Framing on Patient Decisions to Treat Actinic Keratosis

PubMed Central

Berry, Katherine; Butt, Melissa

2017-01-01

Importance Actinic keratosis (AK) is a skin growth induced by UV light exposure that requires long-term management because a small proportion of the disease can progress to squamous cell carcinoma. The influence of how clinicians frame or present information to patients may affect decision making about AK. Objective To evaluate the differences in patients’ decisions on whether to receive treatment for AK related to information presentation or choice framing. Design, Setting, and Participants A prospective survey study was performed from June 1 to July 31, 2016, in participants who were able to read English. Participants were recruited through the Penn State Milton S. Hershey Dermatology Clinic and an online survey site. The survey was conducted through an online portal. A total of 571 individuals were recruited. Regression analysis, correlation coefficient analysis, and test-retest validation were conducted. Main Outcomes and Measures The proportions of patients choosing to receive treatment for AK. Analyses were performed to adjust for age, sex, educational level, history of skin cancer, and history of AK. Results Of the 571 recruited participants, 539 (94.4%) returned completed surveys. The mean (SD) age of respondents was 42.9 (17.8) years; 306 (56.8%) were women. The decision to receive treatment for AK varied from 57.7% (n = 311) to 92.2% (n = 497) for the 5 scenarios presented in the questions (P < .001). The question that presented AK as a “precancer” had the highest proportion of participants who preferred treatment (497 [92.2%]). Two questions that presented the risk of AK as not progressing to cancer had the lowest proportion of individuals who chose treatment (311 [57.7%] and 328 [60.9%]). Participants from the clinic and from the online portal were significantly different in age (mean [SD] age, 56.1 [17.6] vs 33.3 [10.0] years), sex (145 [63.6%] vs 161 [51.8%] were females), educational level (40 [17.5%] vs 80 [25.7%] had completed some graduate school), history of AK (46 [20.2%] vs 19 [6.1%] answered yes), and history of skin cancer (76 [33.3%] vs 15 [4.8%] answered yes) (all P ≤ .001). Based on a regression analysis, age, sex, and previous diagnosis of skin cancer were not significantly associated with the participants’ responses. Conclusions and Relevance This study found that patients’ decisions on whether to receive treatment for AK is significantly affected by physician wording, especially with alterations in the presentation of risk of malignant transformation. PMID:28114674

A new modeling and inference approach for the Systolic Blood Pressure Intervention Trial outcomes.

PubMed

Yang, Song; Ambrosius, Walter T; Fine, Lawrence J; Bress, Adam P; Cushman, William C; Raj, Dominic S; Rehman, Shakaib; Tamariz, Leonardo

2018-06-01

Background/aims In clinical trials with time-to-event outcomes, usually the significance tests and confidence intervals are based on a proportional hazards model. Thus, the temporal pattern of the treatment effect is not directly considered. This could be problematic if the proportional hazards assumption is violated, as such violation could impact both interim and final estimates of the treatment effect. Methods We describe the application of inference procedures developed recently in the literature for time-to-event outcomes when the treatment effect may or may not be time-dependent. The inference procedures are based on a new model which contains the proportional hazards model as a sub-model. The temporal pattern of the treatment effect can then be expressed and displayed. The average hazard ratio is used as the summary measure of the treatment effect. The test of the null hypothesis uses adaptive weights that often lead to improvement in power over the log-rank test. Results Without needing to assume proportional hazards, the new approach yields results consistent with previously published findings in the Systolic Blood Pressure Intervention Trial. It provides a visual display of the time course of the treatment effect. At four of the five scheduled interim looks, the new approach yields smaller p values than the log-rank test. The average hazard ratio and its confidence interval indicates a treatment effect nearly a year earlier than a restricted mean survival time-based approach. Conclusion When the hazards are proportional between the comparison groups, the new methods yield results very close to the traditional approaches. When the proportional hazards assumption is violated, the new methods continue to be applicable and can potentially be more sensitive to departure from the null hypothesis.

Variability in antibiotic use across Ontario acute care hospitals.

PubMed

Tan, Charlie; Vermeulen, Marian; Wang, Xuesong; Zvonar, Rosemary; Garber, Gary; Daneman, Nick

2017-02-01

Antibiotic stewardship is a required organizational practice for Canadian acute care hospitals, yet data are scarce regarding the quantity and composition of antibiotic use across facilities. We sought to examine the variability, and risk-adjusted variability, in antibiotic use across acute care hospitals in Ontario, Canada's most populous province. Antibiotic purchasing data from IMS Health, previously demonstrated to correlate strongly with internal antibiotic dispensing data, were acquired for 129 Ontario hospitals from January to December 2014 and linked to patient day (PD) denominator data from administrative datasets. Hospital variation in DDDs/1000 PDs was determined for overall antibiotic use, class-specific use and six practices of clinical or ecological significance. Multivariable risk adjustment for hospital and patient characteristics was used to compare observed versus expected utilization. There was 7.4-fold variability in the quantity of antibiotic use across the 129 acute care hospitals, from 253 to 1873 DDDs/1000 PDs. Variation was evident within hospital subtypes, exceeded that explained by hospital and patient characteristics, and included wide variability in proportion of broad-spectrum antibiotics (IQR 36%-48%), proportion of fluoroquinolones among respiratory antibiotics (IQR 40%-62%), proportion of ciprofloxacin among urinary anti-infectives (IQR 44%-60%), proportion of antibiotics with highest risk for Clostridium difficile (IQR 29%-40%), proportion of 'reserved-use' antibiotics (IQR 0.8%-3.5%) and proportion of anti-pseudomonal antibiotics among antibiotics with Gram-negative coverage (IQR 26%-40%). There is extensive variability in antibiotic use, and risk-adjusted use, across acute care hospitals. This could motivate, focus and benchmark antibiotic stewardship efforts. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Physician medical direction and clinical performance at an established emergency medical services system.

PubMed

Munk, Marc-David; White, Shaun D; Perry, Malcolm L; Platt, Thomas E; Hardan, Mohammed S; Stoy, Walt A

2009-01-01

Few developed emergency medical services (EMS) systems operate without dedicated medical direction. We describe the experience of Hamad Medical Corporation (HMC) EMS, which in 2007 first engaged an EMS medical director to develop and implement medical direction and quality assurance programs. We report subsequent changes to system performance over time. Over one year, changes to the service's clinical infrastructure were made: Policies were revised, paramedic scopes of practice were adjusted, evidence-based clinical protocols were developed, and skills maintenance and education programs were implemented. Credentialing, physician chart auditing, clinical remediation, and online medical command/hospital notification systems were introduced. Following these interventions, we report associated improvements to key indicators: Chart reviews revealed significant improvements in clinical quality. A comparison of pre- and post-intervention audited charts reveals a decrease in cases requiring remediation (11% to 5%, odds ratio [OR] 0.43 [95% confidence interval (CI) 0.20-0.85], p = 0.01). The proportion of charts rated as clinically acceptable rose from 48% to 84% (OR 6 [95% CI 3.9-9.1], p < 0.001). The proportion of misplaced endotracheal tubes fell (3.8% baseline to 0.6%, OR 0.16 [95% CI 0.004-1.06], (exact) p = 0.05), corresponding to improved adherence to an airway placement policy mandating use of airway confirmation devices and securing devices (0.7% compliance to 98%, OR 714 [95% CI 64-29,334], (exact) p < 0.001). Intravenous catheter insertion in unstable cases increased from 67% of cases to 92% (OR 1.31 [95% CI 1.09-1.71], p = 0.004). EMS administration of aspirin to patients with suspected ischemic chest pain improved from 2% to 77% (OR 178 [95% CI 35-1,604], p < 0.001). We suggest that implementation of a physician medical direction is associated with improved clinical indicators and overall quality of care at an established EMS system.

[Studies of prognostic factor and chemotherapeutic effect of epithelial ovarian cancer using Cox's proportional hazard model].

PubMed

Umesaki, N; Sugawa, T; Yajima, A; Satoh, S; Terashima, Y; Ochiai, K; Tomoda, Y; Kanoh, T; Noda, K; Yakushiji, M

1993-12-01

To make clear the prognostic factor and chemotherapeutic effect of epithelial ovarian cancer, a multiple-center study involving 22 hospitals in Japan was conducted using Cox's proportional hazard model. A total of 1,181 cases were reviewed. Clinical stage, histologic type, and residual tumor diameter were significant prognostic factors, but the degree of tissue differentiation was not. The effect of remission induction chemotherapy was assessed with or without CDDP, and a distinct prognostic difference was noted. Among the patients receiving CDDP + ADM + other chemotherapeutic agents (PA group), CDDP + other chemotherapeutic agents (PO group) and CDDP only (P group), the prognosis of the PO group was better than for the P group. The long-term prognosis improving effect of chemotherapy was assessed. Neither maintenance chemotherapy based on oral administration of pyrimidine fluoride nor immunotherapy had any long-term prognosis improving effect, while intermittent chemotherapy based on CDDP resulted in improved prognosis.

Metabolic syndrome risk factors among a sample of overweight and obese Mexican children.

PubMed

Elizondo-Montemayor, Leticia; Serrano-González, Mónica; Ugalde-Casas, Patricia A; Cuello-García, Carlos; Borbolla-Escoboza, José R

2010-05-01

The objective of this study was to estimate the prevalence and correlations of components of the metabolic syndrome (MetS) using the International Diabetes Federation (IDF) pediatric definition in a cross-sectional study of 215 overweight/obese Mexican children aged 6 to 12. There are no previous studies of this kind in Mexican children. Clinical, anthropometric, and laboratory measurements were performed. The prevalence of MetS using the pediatric IDF criteria was 6.7% (95% confidence interval, 4.0-11.1). A higher proportion of children in the younger age group had waist circumference above the cutoff, while a higher proportion in the older age group had hyperglycemia. Children with MetS had higher percentages of body fat, body mass index, total cholesterol, and low-density lipoprotein cholesterol. Increased triglycerides, decreased high-density lipoprotein cholesterol, and waist circumference were most highly associated with MetS. This has significant implications for public health.

Hospital budget increase for information technology during phase 1 meaningful use.

PubMed

Neumeier, Harold; Berner, Eta S; Burke, Darrell E; Azuero, Andres

2015-01-01

Federal policies have a significant effect on how businesses spend money. The 2009 HITECH (Health Information Technology for Economic and Clinical Health Act) authorized incentive payments through Medicare and Medicaid to clinicians and hospitals when they use certified electronic health records privately and securely to achieve specified improvements in care delivery. Federal incentive payments were offered in 2011 for hospitals that had satisfied "meaningful use" criteria. A longitudinal study of nonfederal hospital information technology (IT) budgets (N = 493) during the years 2009 to 2011 found increases in the percentage of hospital annual operating budgets allocated to IT in the years leading up to these federal incentives. This increase was most pronounced among hospitals receiving high proportions of their reimbursements from Medicaid, followed by hospitals receiving high proportions of their reimbursements from Medicare, possibly indicating a budget shift during this period to more IT spending to achieve meaningful-use policy guidelines.

Effectiveness of a multidisciplinary critical pathway based on a computerised physician order entry system for ST-segment elevation myocardial infarction management in the emergency department: a retrospective observational study.

PubMed

Park, Yoo Seok; Chung, Sung Phil; You, Je Sung; Kim, Min Joung; Chung, Hyun Soo; Hong, Jung Hwa; Lee, Hye Sun; Wang, Jinwon; Park, Incheol

2016-08-16

The purpose of this study was to investigate whether a multidisciplinary organised critical pathway (CP) for ST-segment elevation myocardial infarction (STEMI) management can significantly attenuate differences in the duration from emergency department (ED) arrival to evaluation and treatment, regardless of the arrival time, by eliminating off-hour and weekend effects. Retrospective observational cohort study. 2 tertiary academic hospitals. Consecutive patients in the Fast Interrogation Rule for STEMI (FIRST) program. A study was conducted on patients in the FIRST program, which uses a computerised physician order entry (CPOE) system. The patient demographics, time intervals and clinical outcomes were analysed based on the arrival time at the ED: group 1, normal working hours on weekdays; group 2, off-hours on weekdays; group 3, normal working hours on weekends; and group 4, off-hours on weekends. Clinical outcomes categorised according to 30-day mortality, in-hospital mortality and the length of stay. The duration from door-to-data or FIRST activation did not differ significantly among the 4 groups. The median duration between arrival and balloon placement during percutaneous coronary intervention did not significantly exceed 90 min, and the proportions (89.6-95.1%) of patients with door-to-balloon times within 90 min did not significantly differ among the 4 groups, regardless of the ED arrival time (p=0.147). Moreover, no differences in the 30-day (p=0.8173) and in-hospital mortality (p=0.9107) were observed in patients with STEMI. A multidisciplinary CP for STEMI based on a CPOE system can effectively decrease disparities in the door-to-data duration and proportions of patients with door-to-balloon times within 90 min, regardless of the ED arrival time. The application of a multidisciplinary CP may also help attenuate off-hour and weekend effects in STEMI clinical outcomes. 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/

A novel Internet-based blended learning programme providing core competency in clinical research.

PubMed

Tsugihashi, Yukio; Kakudate, Naoki; Yokoyama, Yoko; Yamamoto, Yosuke; Mishina, Hiroki; Fukumori, Norio; Nakamura, Fumiaki; Takegami, Misa; Ohno, Shinya; Wakita, Takafumi; Watanabe, Kazuhiro; Yamaguchi, Takuhiro; Fukuhara, Shunichi

2013-04-01

We developed a novel Internet-based blended learning programme that allows busy health care professionals to attain core competency in clinical research. This study details the educational strategies and learning outcomes of the programme. This study was conducted at Kyoto University and seven satellite campuses from September 2009 to March 2010. A total of 176 health care professionals who had never attempted to attain core competency in clinical research were enrolled. The participants were supplied with a novel programme comprising the following four strategies: online live lectures at seven satellite campuses, short examinations after each lecture, an Internet-based feedback system and an end-of-course examination. We assessed the proportion of attendance at the lectures as the main outcome. In addition, we evaluated interaction via the feedback system and scores for end-of-course examination. Of the 176 participants, 134 (76%) reported working more than 40 hours per week. The mean proportion of attendance over all 23 lectures was 82%. A total of 156 (89%) participants attended more than 60% of all lectures and were eligible for the end-of-course examination. A total of the participants accessed the feedback system 3564 times and asked 284 questions. No statistically significant differences were noted in the end-of-course scores among medical doctors, pharmacists, registered nurses and other occupations. We developed an Internet-based blended learning programme providing core competency in clinical research. Most busy health care professionals completed the programme successfully. In addition, the participants could attain the core competency effectively, regardless of their occupation. © 2011 Blackwell Publishing Ltd.

Variability in CKD stage in outpatients followed in two large renal clinics.

PubMed

Sikaneta, Tabo; Abdolell, Mohamed; Taskapan, Hulya; Roscoe, Janet; Fung, Jason; Nagai, Gordon; Ting, Robert H; Ng, Paul; Wu, George; Oreopoulos, Dimitrios; Tam, Paul Y

2012-10-01

Chronic kidney disease (CKD) is staged by glomerular filtration rate (GFR). CKD stages sometimes vary between routine office visits, and it is unknown if this impacts renal and patient survival separately from a cross-sectional CKD stage value. We quantified and categorized CKD stage variability in a large group of outpatients and correlated this with clinical and demographic features and with renal and patient survival. All estimated GFRs were staged in the first observation period. CKD stages were then categorized as static, improving, worsening, or fluctuating. Logistic regression analysis was performed to identify clinical variables associated with CKD stage variability. Death and dialysis progression rates were then collected and analyzed using Cox proportional regression. During a 1.1-year observation period, 1,262 patients (mean age 71.25 years) had a mean 5 eGFR's. CKD stages were static in 60.4%, worsened in 14.4%, improved in 7.4%, and fluctuated in 17.2% of patients. Secondary analysis revealed heavy proteinuria and East Asian ethnicity to be negatively, and diabetes mellitus and previous acute kidney injury to be positively associated with improving CKD stages. Cox proportional regression of 902 patients analyzed 2.3 years later revealed a negative association with improving CKD stage and subsequent need for dialysis. CKD stage changed in 40% of 1,262 elderly patients when determined 5 times in just over 1 year. Improving CKD stage was the only variability pattern significantly associated with any of the clinical outcomes when assessed 2.3 years later, being unlikely to be linked with subsequent need for dialysis.

Association of tumor growth on nude mice and poor clinical outcome in soft tissue sarcoma patients.

PubMed

Budach, W; Budach, V

2001-09-01

Permanent growth in nude mice (PGNM) may be associated with poor clinical outcome. We tested this hypothesis in a group of soft tissue sarcoma (STS) patients. Small chunks from fresh tumor biopsies of 81 patients with STS were transplanted subcutaneously into NMRI-nu/nu nude mice. Tumor cell lines exhibiting growth in nude mice for more than three tumor passages were considered as permanently established. Clinical outcome of all patients was monitored with a median follow-up of 38 months. 39/81 (48%) STSs exhibited PGNM. High grade, high S-phase proportion, and aneuploidy were significant predictors of PGNM. Overall survival (OS) at 3 years was 21% (+7% standard error of median) for STS patients with PGNM and 53% (+/-8%) for patients without PGNM (P<0.01). Considering only patients without distant metastasis at the time of biopsy (n = 49), 3-year-OS was 25% (+/-10%) and 71% (+/-9%) for STS with PGNM and without PGNM, respectively (P<0.01). In the univariate analysis, PGNM, aneuploidy high S-phase proportion, tumor location at the trunk, high tumor grade, and non-liposarcoma histology were associated with reduced survival time. In the multivariate analysis, aneuploidy and tumor location at the trunk were the only independent predictors of overall survival. Permanent growth of STS on nude mice is associated with poor clinical outcome in the univariate analysis, but is not an independent predictor of survival in the multivariate analysis due to a strong co-correlation to other known adverse prognostic factors.

Outcomes of a Clinic-Based, Surveillance-Informed Intervention to Relink Patients to HIV Care

PubMed Central

Bove, Joanna; Golden, Matthew R.; Dhanireddy, Shireesha; Harrington, Robert D.; Dombrowski, Julia C.

2015-01-01

Background Improving patient retention in HIV care is crucial to improving the HIV care continuum. We instituted and evaluated a relinkage program that uses clinical data to identify potentially out-of-care patients, matches those data to public health surveillance, and employs a linkage specialist (LS) to coordinate care relinkage. Methods The intervention began November 1, 2012 in the largest HIV clinic in Washington State. We evaluated program outcomes and compared patient outcomes in the year following initiation of the intervention to a historical control cohort of patients. Cox proportional hazard ratios were used to compare time to relinkage to care between cohorts, and regression models using generalized estimated equations were preformed to examine secondary outcomes of relinkage to care, engagement in care, and viral suppression. Results 753 patients were identified as “out of care” on 11/1/12. Matching with surveillance data and initial LS investigations found that 596 (79%) of these patients had moved, transferred care or were incarcerated. Of the 157 remaining patients: 40 (25%) relinked to care before LS contact, and the LS successfully contacted 38 (24%). A total of 116 (15%) patients in the intervention cohort relinked to care and 24 (20%) were contacted by the LS. Compared to the historical cohort, the time to relinkage was shorter among patients in the intervention cohort [adjusted HR=1.7 (1.2-2.3)] and a greater proportion relinked [15% vs. 10%]. Conclusions This clinic-based, surveillance-informed relinkage intervention showed statistically significant but modest effectiveness in returning out-of-care patients to HIV care compared to historical controls. PMID:26068720

Friend or foe? Mogamulizumab in allogeneic hematopoietic stem cell transplantation for adult T-cell leukemia/lymphoma

PubMed Central

Shindo, Takero

2016-01-01

Adult T-cell leukemia/lymphoma (ATL/ATLL) is a peripheral T-cell neoplasm associated with human T-lymphotropic virus type-1 (HTLV-1). Even the currently most intensive chemotherapy regimen modified LSG15 (mLSG15, VCAP-AMP-VECP) results in a dismal clinical outcome, with a median overall survival of only around 1 year. Although allogeneic hematopoietic stem cell transplantation (allo-HSCT) may lead to long-term remission in a proportion of patients with aggressive ATL, the clinical outcome in patients with refractory or relapsed ATL is unsatisfactory. The anti-CCR4 antibody mogamulizumab (moga) has been recently approved for ATL in Japan, and it is effective in a significant proportion of patients with refractory or relapsed ATL. However, there are major concerns about the harmful influences of pretransplant moga on the immune reconstitution after allo-HSCT. Specifically, moga depletes regulatory T cells (Tregs) for at least a few months, which may increase the risk of graft-versus-host disease (GVHD) after allo-HSCT. A recent retrospective study from Japan clearly showed that pretransplant moga increased the risk of severe and steroid-refractory GVHD, which led to increases in non-relapse mortality and overall mortality. To improve the overall clinical outcome in patients with relapsed or refractory ATL, more studies are needed to incorporate moga without increasing adverse effects on the clinical outcome after allo-HSCT. In this review, we aim to provide an updated summary of the research related to moga and allo-HSCT. PMID:27868052

Clinical significance of cigarette smoking and dust exposure in pulmonary alveolar proteinosis: a Korean national survey.

PubMed

Hwang, Ji An; Song, Joo Han; Kim, Jung Hoon; Chung, Man Pyo; Kim, Dong Soon; Song, Jin Woo; Kim, Young Whan; Choi, Sun Mi; Cha, Seung Ick; Uh, Soo Taek; Park, Choon-Sik; Jeong, Sung Hwan; Park, Yong Bum; Lee, Hong Lyeol; Shin, Jong Wook; Lee, Eun Joo; Jegal, Yangjin; Lee, Hyun Kyung; Park, Jong Sun; Park, Moo Suk

2017-11-21

This study aimed to investigate clinical characteristics of Korean PAP patients and to examine the potential risk factors of PAP. We retrospectively reviewed medical records of 78 Korean PAP patients diagnosed between 1993 and 2014. Patients were classified into two groups according to the presence/absence of treatment (lavage). Clinical and laboratory features were compared between the two groups. Of the total 78 PAP patients, 60% were male and median age at diagnosis was 47.5 years. Fifty three percent were ever smokers (median 22 pack-years) and 48% had a history of dust exposure (metal 26.5%, stone or sand 20.6%, chemical or paint 17.7%, farming dust 14.7%, diesel 14.7%, textile 2.9%, and wood 2.9%). A history of cigarette smoking or dust exposure was present in 70.5% of the total PAP patients, with 23% having both of them. Patients who underwent lavage (n = 38) presented symptoms more frequently (38/38 [100%] vs. 24/40 [60%], P < 0.001) and had significantly lower PaO 2 and DL CO with higher D(A-a)O 2 at the onset of disease than those without lavage (n = 40) (P = 0.006, P < 0.001, and P = 0.036, respectively). Correspondingly, the distribution of disease severity score (DSS) differed significantly between the two groups (P = 0.001). Based on these, when the total patients were categorized according to DSS (low DSS [DSS 1-2] vs. high DSS [DSS 3-5]), smoking status differed significantly between the two groups with the proportion of current smokers significantly higher in the high DSS group (11/22 [50%] vs. 7/39 [17.9%], P = 0.008). Furthermore, current smokers had meaningfully higher DSS and serum CEA levels than non-current smokers (P = 0.011 and P = 0.031), whereas no difference was found between smokers and non-smokers. Regarding type of exposed dust, farming dust was significantly associated with more severe form of PAP (P = 0.004). A considerable proportion of PAP patients had a history of cigarette smoking and/or dust exposure, suggestive of their possible roles in the development of PAP. Active cigarette smoking at the onset of PAP is associated with the severity of PAP.

The influence of individual socioeconomic status on the clinical outcomes in ischemic stroke patients with different neighborhood status in Shanghai, China

PubMed Central

Yan, Han; Liu, Baoxin; Meng, Guilin; Shang, Bo; Jie, Qiqiang; Wei, Yidong; Liu, Xueyuan

2017-01-01

Objective: Socioeconomic status (SES) is being recognized as an important factor in both social and medical problems. The aim of present study is to examine the relationship between SES and ischemic stroke and investigate whether SES is a predictor of clinical outcomes among patients with different neighborhood status from Shanghai, China. Methods: A total of 471 first-ever ischemic stroke patients aged 18-80 years were enrolled in this retrospective study. The personal SES of each patient was evaluated using a summed score derived from his or her educational level, household income, occupation, and medical reimbursement rate. Clinical adverse events and all-cause mortality were analyzed to determine whether SES was a prognostic factor, its prognostic impact was then assessed based on different neighborhood status using multivariable Cox proportional hazard models after adjusting for other covariates. Results: The individual SES showed a significant positive correlation with neighborhood status (r = 0.370; P < 0.001). The incidence of clinical adverse events and mortality were significantly higher in low SES patients compared with middle and high SES patients (P = 0.001 and P = 0.037, respectively). After adjusting other risk factors and neighborhood status, Kaplan-Meier analysis showed clinical adverse events and deaths were still higher in the low SES patients (all P < 0.05). Multivariate Cox regression analysis demonstrated that both personal SES and neighborhood status are independent prognostic factors for ischemic stroke (all P < 0.05). Besides, among patients with low and middle neighborhood status, lower individual SES was significantly associated with clinical adverse events and mortality (all P < 0.05). Conclusion: Both individual SES and neighborhood status are significantly associated with the prognosis after ischemic stroke. A lower personal SES as well as poorer neighborhood status may significantly increase risk for adverse clinical outcomes among ischemic stroke patients. PMID:28138313

Effect of a Game-Based Intervention Designed to Enhance Social Incentives to Increase Physical Activity Among Families: The BE FIT Randomized Clinical Trial.

PubMed

Patel, Mitesh S; Benjamin, Emelia J; Volpp, Kevin G; Fox, Caroline S; Small, Dylan S; Massaro, Joseph M; Lee, Jane J; Hilbert, Victoria; Valentino, Maureen; Taylor, Devon H; Manders, Emily S; Mutalik, Karen; Zhu, Jingsan; Wang, Wenli; Murabito, Joanne M

2017-11-01

Gamification, the application of game design elements such as points and levels in nongame contexts, is often used in digital health interventions, but evidence on its effectiveness is limited. To test the effectiveness of a gamification intervention designed using insights from behavioral economics to enhance social incentives within families to increase physical activity. The Behavioral Economics Framingham Incentive Trial (BE FIT) was a randomized clinical trial with a 12-week intervention period and a 12-week follow-up period. The investigation was a community-based study between December 7, 2015, and August 14, 2016. Participants in the modified intent-to-treat analysis were adults enrolled in the Framingham Heart Study, a long-standing cohort of families. All participants tracked daily step counts using a wearable device or a smartphone, established a baseline, selected a step goal increase, and received daily individual feedback on goal performance by text message or email for 24 weeks. Families in the gamification arm could earn points and progress through levels based on physical activity goal achievement during the 12-week intervention. The game design was meant to enhance collaboration, accountability, and peer support. The primary outcome was the proportion of participant-days that step goals were achieved during the intervention period. Secondary outcomes included the proportion of participant-days that step goals were achieved during the follow-up period and the change in the mean daily steps during the intervention and follow-up periods. Among 200 adults comprising 94 families, the mean age was 55.4 years, and 56.0% (n = 112) were female. During the intervention period, participants in the gamification arm achieved step goals on a significantly greater proportion of participant-days (0.53 vs 0.32; adjusted difference, 0.27; 95% CI, 0.20-0.33; P < .001) and had a significantly greater increase in the mean daily steps compared with baseline (1661 vs 636; adjusted difference, 953; 95% CI, 505-1401; P < .001) than the control arm. During the follow-up period, physical activity in the gamification arm declined but remained significantly greater than that in the control arm for the proportion of participant-days achieving step goals (0.44 vs 0.33; adjusted difference, 0.12; 95% CI, 0.05-0.19; P < .001) and the mean daily steps compared with baseline (1385 vs 798; adjusted difference, 494; 95% CI, 170-818; P < .01). Gamification designed to leverage insights from behavioral economics to enhance social incentives significantly increased physical activity among families in the community. clinicaltrials.gov Identifier: NCT02531763.

Adjusted Clinical Groups: Predictive Accuracy for Medicaid Enrollees in Three States

PubMed Central

Adams, E. Kathleen; Bronstein, Janet M.; Raskind-Hood, Cheryl

2002-01-01

Actuarial split-sample methods were used to assess predictive accuracy of adjusted clinical groups (ACGs) for Medicaid enrollees in Georgia, Mississippi (lagging in managed care penetration), and California. Accuracy for two non-random groups—high-cost and located in urban poor areas—was assessed. Measures for random groups were derived with and without short-term enrollees to assess the effect of turnover on predictive accuracy. ACGs improved predictive accuracy for high-cost conditions in all States, but did so only for those in Georgia's poorest urban areas. Higher and more unpredictable expenses of short-term enrollees moderated the predictive power of ACGs. This limitation was significant in Mississippi due in part, to that State's very high proportion of short-term enrollees. PMID:12545598

Is cost-effective healthcare compatible with publicly financed academic medical centres?

PubMed

Chia, Whay Kuang; Toh, Han Chong

2013-01-01

Probably more than any country, Singapore has made significant investment into the biomedical enterprise as a proportion of its economy and size. This focus recently witnessed a shift towards a greater emphasis on translational and clinical development. Key to the realisation of this strategy will be Academic Medical Centres (AMCs), as a principal tool to developing and applying useful products for the market and further improving health outcomes. Here, we explore the principal value proposition of the AMC to Singapore society and its healthcare system. We question if the values inherent within academic medicine--that of inquiry, innovation, pedagogy and clinical exceptionalism--can be compatible with the seemingly paradoxical mandate of providing cost-effective or rationed healthcare.

Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials.

PubMed

Panés, Julian; Sandborn, William J; Schreiber, Stefan; Sands, Bruce E; Vermeire, Séverine; D'Haens, Geert; Panaccione, Remo; Higgins, Peter D R; Colombel, Jean-Frederic; Feagan, Brian G; Chan, Gary; Moscariello, Michele; Wang, Wenjin; Niezychowski, Wojciech; Marren, Amy; Healey, Paul; Maller, Eric

2017-06-01

Tofacitinib is an oral, small-molecule Janus kinase inhibitor that is being investigated for IBD. We evaluated the efficacy and safety of tofacitinib for induction and maintenance treatment in patients with moderate-to-severe Crohn's disease (CD). We conducted two randomised, double-blind, placebo-controlled, multicentre phase IIb studies. Adult patients with moderate-to-severe CD were randomised to receive induction treatment with placebo, tofacitinib 5 or 10 mg twice daily for 8 weeks. Those achieving clinical response-100 or remission were re-randomised to maintenance treatment with placebo, tofacitinib 5 or 10 mg twice daily for 26 weeks. Primary endpoints were clinical remission at the end of the induction study, and clinical response-100 or remission at the end of the maintenance study. 180/280 patients randomised in the induction study were enrolled in the maintenance study. At week 8 of induction, the proportion of patients with clinical remission was 43.5% and 43.0% with 5 and 10 mg twice daily, respectively, compared with 36.7% in the placebo group (p=0.325 and 0.392 for 5 and 10 mg twice daily vs placebo). At week 26 of maintenance, the proportion of patients with clinical response-100 or remission was 55.8% with tofacitinib 10 mg twice daily compared with 39.5% with tofacitinib 5 mg twice daily and 38.1% with placebo (p=0.130 for 10 mg twice daily vs placebo). Compared with placebo, the change in C-reactive protein from baseline was statistically significant (p<0.0001) with 10 mg twice daily after both induction and maintenance treatments. Primary efficacy endpoints were not significantly different from placebo, although there was evidence of a minor treatment effect. No new safety signals were observed for tofacitinib. NCT01393626 and NCT01393899. 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/.

Cognitive Behavioural Analysis System of Psychotherapy (CBASP) for chronic depression: clinical characteristics and six month clinical outcomes in an open case series.

PubMed

Swan, John S; Macvicar, Robert; Christmas, David; Durham, Rob; Rauchhaus, Petra; McCullough, James P; Matthews, Keith

2014-01-01

Evidence-based guidance on how best to treat chronic depression is limited. Cognitive Behavioural Analysis System of Psychotherapy (CBASP) has shown some promise with this 'difficult-to-treat' clinical group. This case series was designed to assess the acceptability and utility of this novel treatment in routine clinical practice within the U.K. National Health Service. We offered an open trial of CBASP to a cohort of 115 referred patients within primary and secondary care. Diagnostic interview and standardised outcome measures were administered before and after 6 months of CBASP with a trained, accredited therapist. Seventy-four patients entered therapy, with 46 completing. 30% met criteria for remission (≤ 8 HRSD-24 score) and a further 30% met criteria for clinically significant change (> 8 and ≤15 HRSD-24 plus 50% reduction in baseline score). Thirty-nine per cent made "No change". Group measures of quality of life, social functioning and interpersonal functioning also improved. This was an open study design with a moderate sample size and no control group. Ratings were not completed using a blinded procedure. CBASP is an acceptable therapy for a large proportion of patients with chronic depression and was associated with clinically significant change in 60% of completers. © 2013 Published by Elsevier B.V.

[Autoimmune insulitis in patients with type 2 diabetes mellitus A randomized clinical trial in hospitalized patients].

PubMed

Martinka, Emil; Rončáková, Mariana; Mišániková, Michaela; Davani, Arash

It is not always easy to classify diabetes (DM) diagnosed in adults, with a significant group of patients initially classified and treated for type 2 diabetes mellitus (DM2T) presenting signs indicating the presence of autoimmune insulitis (AI), which is characteristic of type 1 diabetes mellitus (DM1T), or latent autoimmune diabetes mellitus in adults (LADA). Identify the proportion of patients entered with DM2T who present AI signs, and the number of patients of that proportion, who at the same time present low insulin secretion, and what clinical and laboratory manifestations could be used to differentiate between these patients.Cohort and methods: A randomized clinical trial with a pre-determined set of assessed parameters for n = 625 patients, who were hospitalized during the first 6 months of 2016 at the National Endocrinology and Diabetology Institute (NEDU), Lubochna. Apart from the standard parameters, C-peptide (CP) and autoantibodies to glutamic acid decarboxylase (GADA) were examined for each patient. GADA positive (GADA+) patients were compared to GADA negative (GADA-) patients in the following parameters: gender, age, age at the time of dia-gnosing DM, duration of DM, HbA1c, incidence of hypoglycemia, lipidogram, fasting C-peptide levels, BMI, waist circumference, incidence of hypoglycemias, presence of microvascular and macrovascular complications, treatment of dia-betes and incidence of other endocrinopathies. GADA+ with low CP were subsequently compared to GADA+ patients with normal CP. Of 625 patients originally classified and treated as DM2T, 13 % were GADA+. 31 % of them had low CP (< 0.2 nmol/l) and 28 % had CP levels within the intermediary range (0.2-0.4 nmol/l). Females made up a larger proportion of GADA+ patients, with a lower BMI, smaller waist circumference, lower CP, higher HDL cholesterol levels, a greater incidence of hypoglycemias and lower total daily dose of insulin. GADA+ patients with low CP differed from GADA+ patients with normal CP in higher HDL cholesterol levels, lower triglyceride levels and earlier need of insulin thera-py. The testing for GADA and CP levels with regard to the other relevant characteristics led to re-classification, or more precisely adding of DM1T/LADA (as the main, or parallel cause of DM) for 2.9 % of all the patients included and a clinically significant proportion of AI could be assumed in 6.1 % of the patients. The results of our study show that the pathogenesis of DM in patients initially diagnosed and registered with DM2T and with concurrent presence of GADA includes mechanisms characteristic of both DM2T (insulin resistance) and DM1T (autoimmune insulitis) acting in parallel, with different intensity, in differing proportions and time sequence as a fluid continuum, which also accounts for the differences between individual patients. The characteristics highlighting the presence and role of AI based on our results include high titre of GADA+, low CP levels, early need of insulin therapy, presence of thyroid disorder, higher HDL cholesterol levels and lower triglyceride levels. The characteristics highlighting the dominance of mechanisms characteristic of DM2T (insulin resistance) included higher BMI and waist circumference values, normal CP levels, low HDL cholesterol levels, higher triglyceride levels, higher blood pressure and borderline titre of GADA. autoimmune diabetes mellitus - C-peptide - GADA - HDL-cholesterol - classification.

Association of Asian ethnicity with disease activity in SLE: an observational study from the Monash Lupus Clinic.

PubMed

Golder, V; Connelly, K; Staples, M; Morand, E; Hoi, A

2013-11-01

Systemic lupus erythematosus (SLE), an autoimmune condition with diverse clinical manifestations, is reported to have different expression in populations of different ancestry. Most previous studies compared patients of different ethnic groups from geographically distinct cohorts. In our study, we aimed to characterize disease manifestations in patients of different ethnic groups from a single centre, and studied patterns of disease activity over time. Demographics, baseline disease characteristics and autoantibody profiles, and disease activity (SLEDAI) measured at each visit, were captured from all consenting patients prospectively followed between 2007 and 2011 in an urban teaching hospital lupus clinic. Ethnicity was self-reported. Asian ethnicity was significantly associated with more clinically severe SLE. Time-adjusted mean SLEDAI (p = 0.01) and maximum SLEDAI (p = 0.0018) were significantly higher in Asian patients. Asians were more likely to have renal disease (OR 2.9, 95% CI 1.4-5.98; p = 0.004) and persistently active disease (PAD) (OR 2.14, 95% CI 1.05-4.38, p = 0.04). Asian lupus patients also had a significantly higher proportion of autoantibody positivity to anti-dsDNA, anti-RNP, anti-Sm, anti-Ro and anti-La, as well as increased likelihood of hypocomplementaemia and immunosuppressant use. In this single-cohort study, Asian ethnicity was found to be associated with increased SLE disease activity. This suggests significant inter-ethnic genetic contributions to the regulation of autoimmune responses and disease severity in SLE.

Effectiveness of an intervention to facilitate the implementation of healthy eating and physical activity policies and practices in childcare services: a randomised controlled trial.

PubMed

Jones, Jannah; Wyse, Rebecca; Finch, Meghan; Lecathelinais, Christophe; Wiggers, John; Marshall, Josephine; Falkiner, Maryann; Pond, Nicole; Yoong, Sze Lin; Hollis, Jenna; Fielding, Alison; Dodds, Pennie; Clinton-McHarg, Tara; Freund, Megan; McElduff, Patrick; Gillham, Karen; Wolfenden, Luke

2015-10-25

The primary aim of this study was to evaluate the effectiveness of an intervention to increase the implementation of healthy eating and physical activity policies and practices by centre-based childcare services. The study also sought to determine if the intervention was effective in improving child dietary intake and increasing child physical activity levels while attending childcare. A parallel group, randomised controlled trial was conducted in a sample of 128 childcare services. Intervention strategies included provision of implementation support staff, securing executive support, staff training, consensus processes, academic detailing visits, tools and resources, performance monitoring and feedback and a communications strategy. The primary outcome of the trial was the proportion of services implementing all seven healthy eating and physical activity policies and practices targeted by the intervention. Outcome data were collected via telephone surveys with nominated supervisors and room leaders at baseline and immediately post-intervention. Secondary trial outcomes included the differences between groups in the number of serves consumed by children for each food group within the Australian Guide to Healthy Eating and in the proportion of children engaged in sedentary, walking or very active physical activity assessed via observation in a random subsample of 36 services at follow-up. There was no significant difference between groups for the primary trial outcome (p = 0.44). Relative to the control group, a significantly larger proportion of intervention group services reported having a written nutrition and physical activity policy (p = 0.05) and providing adult-guided activities to develop fundamental movement skills (p = 0.01). There were no significant differences between groups at follow-up on measures of child dietary intake or physical activity. The findings of the trial were equivocal. While there was no significant difference between groups for the primary trial outcome, the intervention did significantly increase the proportion of intervention group services implementing two of the seven healthy eating and physical activity policies and practices. High levels of implementation of a number of policies and practices at baseline, significant obesity prevention activity in the study region and higher than previously reported intra-class correlation of child behaviours may, in part, explain the trial findings. Australian Clinical Trials Registry (reference ACTRN12612000927820 ).

Computerized Dental Injection Fear Treatment

PubMed Central

Heaton, L.J.; Leroux, B.G.; Ruff, P.A.; Coldwell, S.E.

2013-01-01

One in four adults reports a clinically significant fear of dental injections, leading many to avoid dental care. While systematic desensitization is the most common therapeutic method for treating specific phobias such as fear of dental injections, lack of access to trained therapists, as well as dentists’ lack of training and time in providing such a therapy, means that most fearful individuals are not able to receive the therapy needed to be able to receive necessary dental treatment. Computer Assisted Relaxation Learning (CARL) is a self-paced computerized treatment based on systematic desensitization for dental injection fear. This multicenter, block-randomized, dentist-blind, parallel-group study conducted in 8 sites in the United States compared CARL with an informational pamphlet in reducing fear of dental injections. Participants completing CARL reported significantly greater reduction in self-reported general and injection-specific dental anxiety measures compared with control individuals (p < .001). Twice as many CARL participants (35.3%) as controls (17.6%) opted to receive a dental injection after the intervention, although this was not statistically significant. CARL, therefore, led to significant changes in self-reported fear in study participants, but no significant differences in the proportion of participants having a dental injection (ClinicalTrials.gov, NCT00609648). PMID:23690352

Effect of surgical safety checklists on pediatric surgical complications in Ontario

PubMed Central

O’Leary, James D.; Wijeysundera, Duminda N.; Crawford, Mark W.

2016-01-01

Background: In health care, most preventable adverse events occur in the operating room. Surgical safety checklists have become a standard of care for safe operating room practice, but there is conflicting evidence for the effectiveness of checklists to improve perioperative outcomes in some populations. Our objective was to determine whether surgical safety checklists are associated with a reduction in the proportion of children who had perioperative complications. Methods: We conducted a retrospective cohort study using administrative health care databases housed at the Institute for Clinical Evaluative Sciences to compare the risk of perioperative complications in children undergoing common types of surgery before and after the mandated implementation of surgical safety checklists in 116 acute care hospitals in Ontario. The primary outcome was a composite outcome of 30-day all-cause mortality and perioperative complications. Results: We identified 14 458 and 14 314 surgical procedures in pre- and postchecklist groups, respectively. The proportion of children who had perioperative complications was 4.08% (95% confidence interval [CI] 3.76%–4.40%) before the implementation of the checklist and 4.12% (95% CI 3.80%–4.45%) after implementation. After we adjusted for confounding factors, we found no significant difference in the odds of perioperative complications after the introduction of surgical safety checklists (adjusted odds ratio 1.01, 95% CI 0.90–1.14, p = 0.9). Interpretation: The implementation of surgical safety checklists for pediatric surgery in Ontario was not associated with a reduction in the proportion of children who had perioperative complications. Trial registration: ClinicalTrials.gov, no. NCT02419053 PMID:26976960

Validation of the omega-3 fatty acid intake measured by a web-based food frequency questionnaire against omega-3 fatty acids in red blood cells in men with prostate cancer.

PubMed

Allaire, J; Moreel, X; Labonté, M-È; Léger, C; Caron, A; Julien, P; Lamarche, B; Fradet, V

2015-09-01

The objective of this study was to evaluate the ability of a web-based self-administered food frequency questionnaire (web-FFQ) to assess the omega-3 (ω-3) fatty acids (FAs) intake of men affected with prostate cancer (PCa) against a biomarker. The study presented herein is a sub-study from a phase II clinical trial. Enrolled patients afflicted with PCa were included in the sub-study analysis if the FA profiles from the red blood cell (RBC) membranes and FA intakes at baseline were both determined at the time of the data analysis (n=60). Spearman's correlation coefficients were calculated to estimate the correlations between FA intakes and their proportions in the RBC membranes. Intakes of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) were highly correlated with their respective proportions in the RBC membranes (both rs=0.593, P<0.0001). Correlation between alpha-linolenic acid (ALA) intake and its proportion in RBC was not significant (rs=0.130, P=0.332). Correlations were observed between fatty fish intake and total ω-3 FAs (rs=0.304, P=0.02), total long-chain ω-3 FAs (rs=0.290, P=0.03) and DHA (rs=0.328, P=0.01) in RBC membranes. This study has shown that the web-FFQ is an accurate tool to assess total long-chain ω-3 FAs, EPA and DHA but not ALA intake in clinical trials and epidemiological studies carried out in men with PCa.

The Role of Genetic Ancestry in Brazilian Patients With Primary Congenital Glaucoma.

PubMed

Rolim, Hévila; Cronemberger, Sebastião; Rangel, Hayana; Batista, Wagner D; Bastos-Rodrigues, Luciana; De Marco, Luiz

2016-01-01

The relationship between clinical data and genetic ancestry in Brazilian patients with primary congenital glaucoma (PCG) was studied. Thirty patients with PCG and 60 unrelated controls underwent a complete ophthalmological examination. The PCG inclusion criterion was prior surgery with a minimum follow-up of 6 months after the last surgical procedure. Clinical data were recorded and DNA from each individual was extracted and genotyped for a panel of 40 validated ancestry-informative insertion-deletion DNA polymorphisms (indels). Eighteen (60%) children had bilateral disease and 16 (53.3%) were male. The mean age at diagnosis was 6.3 months and surgical follow-up time varied from 8 to 85 months. For the PCG group, the proportion of Europeans, Africans, and Amerindians was 0.784±0.044 (mean±SEM), 0.149±0.035, and 0.067±0.023, respectively, whereas for the control group was 0.730±0.048, 0.132±0.034, and 0.138±0.032, respectively. An increased proportion of African indels was associated with worse surgical prognosis (P=0.036). There was also a statistically significant (P<0.05) positive correlation between axial length and African component (initial: R=0.625; final: R=0.567). An increased proportion of African indels was associated with worse prognosis for PCG in a mixed population. Genetic ancestry markers may be helpful in assessing risk factors for surgical outcomes in PCG. Further studies are needed to unveil the role of ancestry in heterogeneous populations such as Brazilians with PCG.

Obstacles to the implementation of the treat-to-target strategy for rheumatoid arthritis in clinical practice in Japan.

PubMed

Kaneko, Yuko; Koike, Takao; Oda, Hiromi; Yamamoto, Kazuhiko; Miyasaka, Nobuyuki; Harigai, Masayoshi; Yamanaka, Hisashi; Ishiguro, Naoki; Tanaka, Yoshiya; Takeuchi, Tsutomu

2015-01-01

To clarify the obstacles preventing the implementation of the treat-to-target (T2T) strategy for rheumatoid arthritis (RA) in clinical practice. A total of 301 rheumatologists in Japan completed a questionnaire. In the first section, participants were indirectly questioned on the implementation of basic components of T2T, and in the second section, participants were directly questioned on their level of agreement and application. Although nearly all participants set treatment targets for the majority of RA patients with moderate to high disease activity, the proportion who set clinical remission as their target was 59%, with only 45% of these using composite measures. The proportion of participants who monitored X-rays and Health Assessment Questionnaires for all their patients was 44% and 14%, respectively. The proportion of participants who did not discuss treatment strategies was 44%, with approximately half of these reasoning that this was due to a proportion of patients having a lack of understanding of the treatment strategy or inability to make decisions. When participants were directly questioned, there was a high level of agreement with the T2T recommendations. Although there was a high level of agreement with the T2T recommendations, major obstacles preventing its full implementation still remain.

Controlled Trials in Children: Quantity, Methodological Quality and Descriptive Characteristics of Pediatric Controlled Trials Published 1948-2006

PubMed Central

Thomson, Denise; Hartling, Lisa; Cohen, Eyal; Vandermeer, Ben; Tjosvold, Lisa; Klassen, Terry P.

2010-01-01

Background The objective of this study was to describe randomized controlled trials (RCTs) and controlled clinical trials (CCTs) in child health published between 1948 and 2006, in terms of quantity, methodological quality, and publication and trial characteristics. We used the Trials Register of the Cochrane Child Health Field for overall trends and a sample from this to explore trial characteristics in more detail. Methodology/Principal Findings We extracted descriptive data on a random sample of 578 trials. Ninety-six percent of the trials were published in English; the percentage of child-only trials was 90.5%. The most frequent diagnostic categories were infectious diseases (13.2%), behavioural and psychiatric disorders (11.6%), neonatal critical care (11.4%), respiratory disorders (8.9%), non-critical neonatology (7.9%), and anaesthesia (6.5%). There were significantly fewer child-only studies (i.e., more mixed child and adult studies) over time (P = 0.0460). The proportion of RCTs to CCTs increased significantly over time (P<0.0001), as did the proportion of multicentre trials (P = 0.002). Significant increases over time were found in methodological quality (Jadad score) (P<0.0001), the proportion of double-blind studies (P<0.0001), and studies with adequate allocation concealment (P<0.0001). Additionally, we found an improvement in reporting over time: adequate description of withdrawals and losses to follow-up (P<0.0001), sample size calculations (P<0.0001), and intention-to-treat analysis (P<0.0001). However, many trials still do not describe their level of blinding, and allocation concealment was inadequately reported in the majority of studies across the entire time period. The proportion of studies with industry funding decreased slightly over time (P = 0.003), and these studies were more likely to report positive conclusions (P = 0.028). Conclusions/Significance The quantity and quality of pediatric controlled trials has increased over time; however, much work remains to be done, particularly in improving methodological issues around conduct and reporting of trials. PMID:20927344

Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data.

PubMed

Ali, Hammad; Donovan, Basil; Wand, Handan; Read, Tim R H; Regan, David G; Grulich, Andrew E; Fairley, Christopher K; Guy, Rebecca J

2013-04-18

To measure the effect on genital warts of the national human papillomavirus vaccination programme in Australia, which started in mid-2007. Trend analysis of national surveillance data. Data collated from eight sexual health services from 2004 to 2011; the two largest clinics also collected self reported human papillomavirus vaccination status from 2009. Between 2004 and 2011, 85,770 Australian born patients were seen for the first time; 7686 (9.0%) were found to have genital warts. Rate ratios comparing trends in proportion of new patients diagnosed as having genital warts in the pre-vaccination period (2004 to mid-2007) and vaccination period (mid-2007 to the end of 2011). Large declines occurred in the proportions of under 21 year old (92.6%) and 21-30 year old (72.6%) women diagnosed as having genital warts in the vaccination period-from 11.5% in 2007 to 0.85% in 2011 (P<0.001) and from 11.3% in 2007 to 3.1% in 2011 (P<0.001), respectively. No significant decline in wart diagnoses was seen in women over 30 years of age. Significant declines occurred in proportions of under 21 year old (81.8%) and 21-30 year old (51.1%) heterosexual men diagnosed as having genital warts in the vaccination period-from 12.1% in 2007 to 2.2% in 2011 (P<0.001) and from 18.2% in 2007 to 8.9% in 2011 (P<0.001), respectively. No significant decline in genital wart diagnoses was seen in heterosexual men over 30 years of age. In 2011 no genital wart diagnoses were made among 235 women under 21 years of age who reported prior human papillomavirus vaccination. The significant declines in the proportion of young women found to have genital warts and the absence of genital warts in vaccinated women in 2011 suggests that the human papillomavirus vaccine has a high efficacy outside of the trial setting. Large declines in diagnoses of genital warts in heterosexual men are probably due to herd immunity.

Impact of lopinavir/ritonavir use on antiretroviral resistance in recent clinical practice.

PubMed

Lambert-Niclot, Sidonie; Masquelier, Bernard; Cohen Codar, Isabelle; Soulie, Cathia; Delaugerre, Constance; Morand-Joubert, Laurence; Charpentier, Charlotte; Ferre, Virginie; Plantier, Jean-Christophe; Montes, Brigitte; Carret, Sophie; Perrot, Valerie; Peytavin, Gilles; Costagliola, Dominique; Calvez, Vincent; Marcelin, Anne-Geneviève

2012-10-01

This observational study was requested by French health authorities to determine the impact of lopinavir/ritonavir (Kaletra(®)) on antiretroviral resistance in clinical practice. Virological failures of lopinavir/ritonavir and their effects on the resistance to protease inhibitors and reverse transcriptase inhibitors were evaluated in protease inhibitor-experienced patients. Virological failure was defined as an HIV-1 plasma viral load >50 copies/mL after at least 3 months of lopinavir/ritonavir-containing antiretroviral therapy. For all patients, a resistance genotypic test was available at failure and before lopinavir/ritonavir treatment. Data from 72 patients with inclusion criteria were studied. The mean viral load at baseline was 4 log(10) copies/mL (1.6-6.5). Mutations in the protease gene significantly selected between baseline and failure were L10V, K20R, L33F, M36I, I47V, I54V, A71V and I85V (P < 0.05). Patients who had more than seven protease inhibitor mutations at baseline showed a significantly increased risk of occurrence of protease inhibitor mutations. The proportion of viruses susceptible to atazanavir, fosamprenavir and darunavir decreased significantly between baseline and failure (P < 0.05). Among patients with a virus susceptible to atazanavir at day 0, 26% (n = 14) exhibited a virus resistant or possibly resistant at the time of failure. This proportion was 32% (n = 16) for fosamprenavir and 16% (n = 7) for darunavir. A darunavir-based regimen appears to be a sequential option in the case of lopinavir/ritonavir failure. To compare and determine the best treatment sequencing, similar studies should be performed for darunavir/ritonavir and atazanavir/ritonavir.

Active Rheumatoid Arthritis in Central Africa: A Comparative Study Between Sudan and Sweden.

PubMed

Elshafie, Amir I; Elkhalifa, Abdalla D; Elbagir, Sahwa; Aledrissy, Mawahib I E; Elagib, Elnour M; Nur, Musa A M; Weitoft, Tomas; Rönnelid, Johan

2016-10-01

To compare clinical characteristics and treatment between simultaneously investigated Sudanese and Swedish outpatients with rheumatoid arthritis (RA). Outpatients with RA from Sudan (n = 281) and Sweden (n = 542) diagnosed according to the 1987 American College of Rheumatology criteria were recruited between December 2008 and September 2010 and compared concerning clinical presentation, treatment, and laboratory findings, including immunoglobulin M with rheumatoid factor (IgM-RF). Sudanese patients had lower inclusion age (median 49 vs 68 yrs), disease duration (48 vs 107 mos), and disease onset age (43 vs 56 yrs) as compared with Swedish patients (p < 0.0001 for all). When stratified concerning the age of inclusion, Swedish patients between 41-50 years had, however, a significantly lower age of onset, with a similar trend for all age groups above 30 years. The female preponderance was higher among Sudanese patients (89.3% vs 72.5%, p < 0.0001), and smoking was nonexistent among Sudanese female patients (p < 0.0001). Erythrocyte sedimentation rate levels and number of tender joints were significantly higher among Sudanese patients. The proportion of IgM-RF positivity was lower among Sudanese patients with RA (52.4% vs 75.5%, p < 0.0001). Higher proportions of Sudanese patients with RA were treated with methotrexate (MTX) and disease-modifying antirheumatic drug combinations, but none of them used biologics. Sudanese patients used lower doses of MTX and sulfasalazine (p < 0.0001) and higher doses of prednisolone (p < 0.0001) than Swedish patients. Sudanese patients with RA have significantly higher disease activity and are often IgM-RF-seronegative. Together with reports from Uganda and Cameroon, our data indicate a cluster of highly active and often seronegative RA in central Africa.

Does outpatient physical therapy with the aim of improving health-related physical fitness influence the level of physical activity in patients with long-term musculoskeletal conditions?

PubMed

Holm, I; Tveter, A T; Moseng, T; Dagfinrud, H

2015-09-01

To evaluate any change in self-reported level of physical activity in patients receiving a general physical exercise programme in addition to disease-specific physiotherapy treatment. Pre-post-intervention study. Outpatient physiotherapy clinics. One hundred and ninety patients with long-term musculoskeletal conditions attending outpatient physiotherapy were recruited from seven physiotherapy clinics. Physiotherapy including disease-specific modalities and a general individually tailored exercise programme. Patients were evaluated at baseline and at the end of the programme. International Physical Activity Questionnaire short form (IPAQ-sf) and COOP WONCA functional assessment charts. Forty-two patients were excluded from the analysis because they did not complete the IPAQ-sf correctly or dropped out during the treatment period. There was a significant increase in the number of metabolic equivalent task (MET)-min/week for vigorous and moderate-intensity activities, walking and total physical activity. The number of exercise sessions per week increased from 1.8 [standard deviation (SD) 0.9] to 2.2 (SD 1.2) (P=0.001). The proportion of patients with a low level of physical activity decreased by 12%, and the proportion of the participants who did not/could not exercise decreased from 26% to 8%. The COOP WONCA charts showed significant improvements in the physical fitness, feelings, daily activities and social activities items. A significant increase was found in the number of MET-min/week for all activity levels. Therefore, a general physical exercise programme initiated by a physiotherapist led to a positive change in level of physical activity. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Impact of a Clinical Therapeutic Intervention on Pain Assessment, Management, and Nursing Practices in an Intensive Care Unit: A before-and-after Study.

PubMed

Damico, Vincenzo; Cazzaniga, Flavio; Murano, Liana; Ciceri, Rita; Nattino, Giuseppe; Dal Molin, Alberto

2018-04-18

Accurate pain assessment and management constitute a major challenge for medical and nursing staff in intensive care units (ICUs). A distinct recollection of pain is reported by high proportions of ICU patients. A clinical therapeutic intervention directed at improving pain assessment and management in critically ill patients who are unable to communicate was implemented at an Italian ICU. In this before-and-after study, data were collected before (T 0 ) and after (T 1 ) the adoption of a protocol involving pain assessment with an ad hoc behavioral pain scale and the administration of analgesics, rather than sedatives, to patients with intermediate to high pain scores. The main outcome measure was pain recollection a year after discharge; secondary outcome measures were the use and doses of sedatives and analgesics. A significantly (p = .037) smaller proportion of patients treated after protocol adoption recollected feeling severe pain compared with patients treated before the protocol was introduced. This group also received significantly (p < .001) fewer sedatives and significantly (p = .0028) more anti-inflammatory drugs and analgesics on an "as needed" basis. The administration of strong analgesics was similar in the two groups. The intervention was implemented in 70.5% of patients with intermediate to high pain scores. Appropriately trained ICU nurses have the potential to help adopt pain relief and prevention measures during nursing care and to contribute to the successful management of sedation and analgesia. Further studies of larger patient samples are needed to monitor the stability of results over time and to explore the efficacy of the approach in other populations, such as pediatric and neonatal ICU patients. Published by Elsevier Inc.

Pre-existing diabetes mellitus in patients with multiple myeloma.

PubMed

Chou, Yi-Sheng; Yang, Ching-Fen; Chen, Harn-Shen; Yang, Sheng-Hsiang; Yu, Yuan-Bin; Hong, Ying-Chung; Liu, Chun-Yu; Gau, Jyh-Pyng; Liu, Jin-Hwang; Chen, Po-Min; Chiou, Tzeon-Jye; Tzeng, Cheng-Hwai; Hsiao, Liang-Tsai

2012-10-01

Type 2 diabetes mellitus is present in approximately 10% of patients at diagnosis of multiple myeloma (MM) and is associated with increased risks of adverse events caused by novel antimyeloma agents. However, the impact of type 2 diabetes on the survival of patients with MM has not been studied. We enrolled newly diagnosed patients with MM in Taipei Veterans General Hospital between 1999 and 2007 and identified those with pre-existing diabetes. The impact of pre-existing diabetes on patients with MM was evaluated by comparing clinical features, treatments and adverse reactions related to glycaemic control and overall survival (OS) of patients with and without pre-existing diabetes. Of 310 patients with MM, 73% were men and 40 (12.9%) had pre-existing diabetes. Compared with their non-diabetic counterparts, MM patients with pre-existing diabetes had a significantly higher proportion of renal impairment [(RI), serum creatinine ≥ 2.0 mg/dL] and International Staging System stage III at diagnosis, and a significantly lower proportion of bisphosphonate use and a lower rate of RI reversal (P = 0.087). During the course of the disease, hyperglycaemia and hypoglycaemia of any grade were noted in 23 (67.6%) and 6 (17.6%) of these patients, respectively. Antidiabetic therapy was changed in 10 (29.4%) of 34 evaluable patients. MM patients with pre-existing diabetes had a significantly higher all-cause mortality risk (hazard ratio, 1.509; 95% confidence interval, 1.023-2.225, P = 0.037) compared with their non-diabetic counterparts. Our study demonstrated the impact of pre-existing diabetes on clinical features and OS in patients with MM. © 2012 John Wiley & Sons A/S.

Trends in Mortality After Primary Cytoreductive Surgery for Ovarian Cancer: A Systematic Review and Metaregression of Randomized Clinical Trials and Observational Studies.

PubMed

Di Donato, Violante; Kontopantelis, Evangelos; Aletti, Giovanni; Casorelli, Assunta; Piacenti, Ilaria; Bogani, Giorgio; Lecce, Francesca; Benedetti Panici, Pierluigi

2017-06-01

Primary cytoreductive surgery (PDS) followed by platinum-based chemotherapy is the cornerstone of treatment and the absence of residual tumor after PDS is universally considered the most important prognostic factor. The aim of the present analysis was to evaluate trend and predictors of 30-day mortality in patients undergoing primary cytoreduction for ovarian cancer. Literature was searched for records reporting 30-day mortality after PDS. All cohorts were rated for quality. Simple and multiple Poisson regression models were used to quantify the association between 30-day mortality and the following: overall or severe complications, proportion of patients with stage IV disease, median age, year of publication, and weighted surgical complexity index. Using the multiple regression model, we calculated the risk of perioperative mortality at different levels for statistically significant covariates of interest. Simple regression identified median age and proportion of patients with stage IV disease as statistically significant predictors of 30-day mortality. When included in the multiple Poisson regression model, both remained statistically significant, with an incidence rate ratio of 1.087 for median age and 1.017 for stage IV disease. Disease stage was a strong predictor, with the risk estimated to increase from 2.8% (95% confidence interval 2.02-3.66) for stage III to 16.1% (95% confidence interval 6.18-25.93) for stage IV, for a cohort with a median age of 65 years. Metaregression demonstrated that increased age and advanced clinical stage were independently associated with an increased risk of mortality, and the combined effects of both factors greatly increased the risk.

Analytical validation of BRAF mutation testing from circulating free DNA using the amplification refractory mutation testing system.

PubMed

Aung, Kyaw L; Donald, Emma; Ellison, Gillian; Bujac, Sarah; Fletcher, Lynn; Cantarini, Mireille; Brady, Ged; Orr, Maria; Clack, Glen; Ranson, Malcolm; Dive, Caroline; Hughes, Andrew

2014-05-01

BRAF mutation testing from circulating free DNA (cfDNA) using the amplification refractory mutation testing system (ARMS) holds potential as a surrogate for tumor mutation testing. Robust assay validation is needed to establish the optimal clinical matrix for measurement and cfDNA-specific mutation calling criteria. Plasma- and serum-derived cfDNA samples from 221 advanced melanoma patients were analyzed for BRAF c.1799T>A (p.V600E) mutation using ARMS in two stages in a blinded fashion. cfDNA-specific mutation calling criteria were defined in stage 1 and validated in stage 2. cfDNA concentrations in serum and plasma, and the sensitivities and specificities of BRAF mutation detection in these two clinical matrices were compared. Sensitivity of BRAF c.1799T>A (p.V600E) mutation detection in cfDNA was increased by using mutation calling criteria optimized for cfDNA (these criteria were adjusted from those used for archival tumor biopsies) without compromising specificity. Sensitivity of BRAF mutation detection in serum was 44% (95% CI, 35% to 53%) and in plasma 52% (95% CI, 43% to 61%). Specificity was 96% (95% CI, 90% to 99%) in both matrices. Serum contains significantly higher total cfDNA than plasma, whereas the proportion of tumor-derived mutant DNA was significantly higher in plasma. Using mutation calling criteria optimized for cfDNA improves sensitivity of BRAF c.1799T>A (p.V600E) mutation detection. The proportion of tumor-derived cfDNA in plasma was significantly higher than in serum. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Decisional conflict in asthma patients: a cross sectional study.

PubMed

Des Cormiers, Annick; Légaré, France; Simard, Serge; Boulet, Louis-Philippe

2015-01-01

This study aimed at determining the level of decisional conflict in asthmatic individuals facing recommendation-based decisions provided to improve asthma control. This was a cross-sectional study performed on a convenience sample of 50 adults aged between 18 and 65 years with a diagnosis of asthma. They completed a decisional conflict scale (possible range of 0-100%), asthma knowledge and control questionnaires (both 0% and 100%), and a general questionnaire on socio-demographic characteristics. A decisional conflict was considered clinically significant with a score greater than 37.5%. Simple descriptive statistics were used to investigate associations with decisional conflict. Participants were mainly women (76%) and diagnosed with mild asthma (72%). The median age (1st and 3rd quartile) was 25 years (22 and 42). The median score (1st and 3rd quartile) of decisional conflict was 33% (24 and 44). A clinically significant score (>37.5%) was obtained in 36% of subjects. A statistically significant negative correlation between the knowledge score and the decisional conflict score (r(p) = -0.38; p = 0.006) was observed. The level of knowledge was the only statistically independent variable associated with the decisional conflict score (p = 0.0043). A considerable proportion of patients with asthma have a clinically significant level of decisional conflict when facing decisions aimed at improving asthma control. Patients with poor knowledge of asthma are more at risk of clinically significant level of decisional conflict. These findings support the relevance of providing asthmatic patients with relevant information in decision aids.

The use of the Bayley Scales of Infant and Toddler Development III with clinical populations: a preliminary exploration.

PubMed

Milne, Susan; McDonald, Jenny; Comino, Elizabeth J

2012-02-01

In response to concerns that the Bayley Scales of Infant and Toddler Development III (BSIDIII) underestimate delay in clinical populations, this study explores developmental quotient scores as an alternative to composite scores for these children. One hundred and twenty-two children aged ≤42 months, referred for diagnosis of developmental disability from January 2007 to May 2010, were assessed, and their composite and developmental quotient scores on each scale were compared. Composite scores identified only 22% (cognitive), 27% (motor), and 47.5% (language) of children as having a developmental disability. Developmental quotient scores were significantly lower than composite scores, giving rates of developmental disability of 56.6% (cognitive), 48.4% (motor), and 74.6% (language) and more closely matching both clinical impressions of delay and the proportions of those children who were also delayed on standardized tests of adaptive function.

Occult thyrotoxicosis: a correctable cause of idiopathic atrial fibrillation

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

Forfar, J.C.; Miller, H.C.; Toft, A.D.

1979-07-01

Serum total thyroxine, triiodothyronine and thyrotropin response to thyrotropin-releasing hormone were measured in 75 consecutive patients presenting to a cardiology clinic with atrial fibrillation with no obvious cardiovascular cause. A lack of response of serum thyrotropin to thyrotropin-releasing hormone, indicative of thyrotoxicosis, was found in 10 patients (13%), not all whom had raised serum thyroid hormone levels. These 10 patients were predominantly male, had no clinical signs of thyrotoxicosis and a relative excess of nonpalpable autonomous thyroid nodules demonstrated with scintigraphy. Eight of the 10 patients had reversion to stable sinus rhythm after treatment with iodine-131 or carbimazole, either spontaneouslymore » or after direct current cardioversion. It would appear that clinically occult thyrotoxicosis can be identified consistently only with the thyrotropin-releasing hormone test and is the cause of idiopathic atrial fibrillation in a significant proportion of patients.« less

Adolescent identity development and distress in a clinical sample.

PubMed

Wiley, Rachel E; Berman, Steven L

2013-12-01

The purpose of this study was to examine the relationships of identity development and identity distress to psychological adjustment within adolescents affected by psychological problems. Participants included 88 adolescents (43.2% female) ranging from 11 to 20 years of age who were receiving services from a community mental health center. A high proportion of the participants (22.7%) met the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision criteria for Identity Problem. Regression analyses found psychopathology symptom score was associated with identity distress, identity exploration, and identity commitment, while identity distress was only related to psychopathology symptom score and not the other two identity variables. Adolescents with a clinical diagnosis may report significant levels of identity distress. Given that the relationship between psychopathology and identity distress may be reciprocal, assessing for identity issues might be prudent when conducting clinical diagnostic interviews and useful in treatment planning. © 2013 Wiley Periodicals, Inc.

Delivering preference for place of death in a specialist palliative care setting.

PubMed

Oxenham, David; Finucane, Anne; Arnold, Elizabeth; Russell, Papiya

2013-01-01

Over the last 10 years, one of the key themes of public policy in palliative care has been achievement of choice in place of death. In Marie Curie Hospice Edinburgh a baseline audit conducted in 2006 showed that only a small proportion (18%) of patients referred to hospice services died at home. The audit also revealed that only 31% of those who expressed a preference to die at home were able to do so, whereas 91% of those who chose a setting other than home achieved their preference. Overall achievement of preferred place of death was 56%. However a significant number of patients (29%) did not have a recorded preference. A programme of quality improvement has continued over the last 7 years to improve identification, communication and achievement of preferred place of death for all patients. The mechanisms to change practice have been: changes to documentation; changes to clinical systems to support use of documentation; support for clinical staff to recognise the value of discussing preferences; and support for clinical staff to develop new skills. In addition the programme has been incorporated into local clinical strategy and this has enabled gaps in service to be addressed with a new service to support early discharge of those patients who wish to die at home. A recent audit showed that all patients had a recorded preference or a documented reason why their preference was unclarified. One third of patients died at home - nearly double the proportion that died at home in the baseline audit. Seventy one per cent of patients who wished to die at home actually died at home - a substantial increase from 31% at baseline. Achievement of preferred place of death for patients wishing to die in the hospice remained high at 88%. The focus on assessment of preference for place of death has led to substantial improvements in the identification and achievement of preference for patients dying under the care of the hospice. Furthermore, it has been associated with an increase in the overall proportion of patients who die at home.

Characteristics of clients who access mobile compared to clinic HIV counselling and testing services: a matched study from Cape Town, South Africa.

PubMed

Meehan, Sue-Ann; Naidoo, Pren; Claassens, Mareli M; Lombard, Carl; Beyers, Nulda

2014-12-20

Studies within sub-Saharan African countries have shown that mobile services increase uptake of HIV counselling and testing (HCT) services when compared to clinics and are able to access different populations, but these have included provider-initiated HCT in clinics. This study aimed to compare the characteristics of clients who self-initiated HCT at either a mobile or a clinic service in terms of demographic and socio-economic variables, also comparing reasons for accessing a particular health service provider. This study took place in eight areas around Cape Town. A matched design was used with one mobile HCT service matched with one or more clinics (offering routine HCT services) within each of the eight areas. Adult clients who self-referred for an HIV test within a specified time period at either a mobile or clinic service were invited to participate in the study. Data were collected between February and April 2011 using a questionnaire. Summary statistics were calculated for each service type within a matched pair and differences of outcomes from pairs were used to calculate effect sizes and 95% confidence intervals. 1063 participants enrolled in the study with 511 from mobile and 552 from clinic HCT services. The proportion of males accessing mobile HCT significantly exceeded that of clinic HCT (p < 0.001). The mean age of participants attending mobile HCT was higher than clinic participants (p = 0.023). No significant difference was found for socio-economic variables between participants, with the exception of access to own piped water (p = 0.029). Participants who accessed mobile HCT were significantly more likely to report that they were just passing, deemed an "opportunistic" visit (p = 0.014). Participants who accessed clinics were significantly more likely to report the service being close to home or work (p = 0.035). An HCT strategy incorporating a mobile HCT service, has a definite role to play in reaching those population groups who do not typically access HCT services at a clinic, especially males and those who take advantage of the opportunity to test. Mobile HCT services can complement clinic services.

Loss-To-Follow-Up on Multidrug Resistant Tuberculosis Treatment in Gujarat, India: The WHEN and WHO of It

PubMed Central

Shringarpure, Kalpita S.; Isaakidis, Petros; Sagili, Karuna D.; Baxi, R. K.

2015-01-01

Background Multidrug-resistant Tuberculosis (MDR-TB) is a rising global threat to public health and concerted efforts for its treatment are diluted if the outcomes are not successful, loss to follow up (LFU) being one of them. It is therefore necessary to know the proportion and the associated reasons for LFU and devise effective patient-centered strategies to improve retention in care. Methods A retrospective cohort study was conducted at the MDR-TB treatment site (DR-TB Site)in Central Gujarat among all patients registered from February 2010 to June 2013.LFU patients were defined as those whose treatment was interrupted for two or more consecutive months for any reason. Descriptive statistics, survival analysis and multivariate modeling were used to determine the proportion of patients LFU and to assess associations between LFU and selected demographic and clinical factors. Results A total of 796 patients were enrolled during the study period; 71.9% were male and the median age was 35 years [Interquartile range (IQR) 27-45].The overall proportion of LFU patients was 153/796 (19.2%).The majority of LFU patients (133/153 i.e.87%) were lost within the first 6 months of treatment. Ambulatory treatment initiation (adjusted Hazards ratio aHR=2.63, CI:1.01-6.86), different providers in IP and CP ( aHR=1.27, CI:1.18-1.38)and culture conversion after more than 4 months of treatment(aHR=1.34, CI: 1.21-1.49)were found to be significantly associated with LFU in multivariate models. Conclusions A high proportion of LFU among patients on MDR-TB treatment was found in a programmatic setting in India. Clinical but equally important programmatic factors were associated with LFU, accounting for one-fifth of all the outcomes of MDR-TB treatment. Proper training for DOT providers and aggressive counseling and health system strengthening with patient friendly follow up services may help reduce LFU. PMID:26167891

Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer.

PubMed

Cha, Eugene K; Eastham, James A

2015-05-01

Although both surgery and radiation are potential curative options for men with clinically localized prostate cancer, a significant proportion of men with high-risk and locally advanced disease will demonstrate biochemical and potentially clinical progression of their disease. Neoadjuvant systemic therapy before radical prostatectomy (RP) is a logical strategy to improve treatment outcomes for men with clinically localized high-risk prostate cancer. Furthermore, delivery of chemotherapy and other systemic agents before RP affords an opportunity to explore the efficacy of these agents with pathologic end points. Neoadjuvant chemotherapy, primarily with docetaxel (with or without androgen deprivation therapy), has demonstrated feasibility and safety in men undergoing RP, but no study to date has established the efficacy of neoadjuvant chemotherapy or neoadjuvant chemohormonal therapies. Other novel agents, such as those targeting the vascular endothelial growth factor receptor, epidermal growth factor receptor, platelet-derived growth factor receptor, clusterin, and immunomodulatory therapeutics, are currently under investigation. Copyright © 2015 Elsevier Inc. All rights reserved.

Provider-related barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs) and hospitals.

PubMed

Bogart, Laura M; Howerton, Devery; Lange, James; Setodji, Claude Messan; Becker, Kirsten; Klein, David J; Asch, Steven M

2010-06-01

We examined provider-reported barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs), and hospitals. 12 primary metropolitan statistical areas (PMSAs; three per region) were sampled randomly, with sampling weights proportional to AIDS case reports. Across PMSAs, all 671 hospitals and a random sample of 738 clinics/CBOs were telephoned for a survey on rapid HIV test availability. Of the 671 hospitals, 172 hospitals were randomly selected for barriers questions, for which 158 laboratory and 136 department staff were eligible and interviewed in 2005. Of the 738 clinics/CBOs, 276 were randomly selected for barriers questions, 206 were reached, and 118 were eligible and interviewed in 2005-2006. In multivariate models, barriers regarding translation of administrative/quality assurance policies into practice were significantly associated with rapid HIV testing availability. For greater rapid testing diffusion, policies are needed to reduce administrative barriers and provide quality assurance training to non-laboratory staff.

Interventions for improving research productivity in clinical radiology.

PubMed

Akhtar, Waseem; Arain, Mubashir Aslam; Ali, Arif; Sajjad, Zafar

2012-07-01

The purpose of this study was to evaluate the effects of research promotion activities on overall quality and quantity of research output in a clinical department of a teaching tertiary care hospital. Simple research enhancing strategies including regular journal club, research hour, basic research skills training, hiring of research faculty, research awards, and annual research retreat and research board to increase research production were implemented in the Department of Radiology of a teaching hospital in Pakistan. A total of 77 papers were produced by the Department of Radiology before the intervention, which increased to 92 after the introduction of research initiatives. There was a significant increase in the overall proportion of publications in the international journals after the intervention (p < 0.001) with an increasing trend towards indexed journals (p < 0.001). The research enhancing interventions had a positive effect on increasing clinical research output by the Department of Radiology. Such interventions can also be replicated in other clinical departments to increase their research productivity.

Joint model-based clustering of nonlinear longitudinal trajectories and associated time-to-event data analysis, linked by latent class membership: with application to AIDS clinical studies.

PubMed

Huang, Yangxin; Lu, Xiaosun; Chen, Jiaqing; Liang, Juan; Zangmeister, Miriam

2017-10-27

Longitudinal and time-to-event data are often observed together. Finite mixture models are currently used to analyze nonlinear heterogeneous longitudinal data, which, by releasing the homogeneity restriction of nonlinear mixed-effects (NLME) models, can cluster individuals into one of the pre-specified classes with class membership probabilities. This clustering may have clinical significance, and be associated with clinically important time-to-event data. This article develops a joint modeling approach to a finite mixture of NLME models for longitudinal data and proportional hazard Cox model for time-to-event data, linked by individual latent class indicators, under a Bayesian framework. The proposed joint models and method are applied to a real AIDS clinical trial data set, followed by simulation studies to assess the performance of the proposed joint model and a naive two-step model, in which finite mixture model and Cox model are fitted separately.

Clinical and Virological Study of Dengue Cases and the Members of Their Households: The Multinational DENFRAME Project

PubMed Central

Dussart, Philippe; Baril, Laurence; Petit, Laure; Beniguel, Lydie; Quang, Luong Chan; Ly, Sowath; Azevedo, Raimunda do Socorro Silva; Meynard, Jean-Baptiste; Vong, Sirenda; Chartier, Loïc; Diop, Aba; Sivuth, Ong; Duong, Veasna; Thang, Cao Minh; Jacobs, Michael; Sakuntabhai, Anavaj; Nunes, Marcio Roberto Teixeira; Huong, Vu Ti Que; Buchy, Philippe; Vasconcelos, Pedro Fernando da Costa

2012-01-01

Background Dengue has emerged as the most important vector-borne viral disease in tropical areas. Evaluations of the burden and severity of dengue disease have been hindered by the frequent lack of laboratory confirmation and strong selection bias toward more severe cases. Methodology A multinational, prospective clinical study was carried out in South-East Asia (SEA) and Latin America (LA), to ascertain the proportion of inapparent dengue infections in households of febrile dengue cases, and to compare clinical data and biological markers from subjects with various dengue disease patterns. Dengue infection was laboratory-confirmed during the acute phase, by virus isolation and detection of the genome. The four participating reference laboratories used standardized methods. Principal Findings Among 215 febrile dengue subjects—114 in SEA and 101 in LA—28 (13.0%) were diagnosed with severe dengue (from SEA only) using the WHO definition. Household investigations were carried out for 177 febrile subjects. Among household members at the time of the first home visit, 39 acute dengue infections were detected of which 29 were inapparent. A further 62 dengue cases were classified at early convalescent phase. Therefore, 101 dengue infections were found among the 408 household members. Adding these together with the 177 Dengue Index Cases, the overall proportion of dengue infections among the study participants was estimated at 47.5% (278/585; 95% CI 43.5–51.6). Lymphocyte counts and detection of the NS1 antigen differed significantly between inapparent and symptomatic dengue subjects; among inapparent cases lymphocyte counts were normal and only 20% were positive for NS1 antigen. Primary dengue infection and a specific dengue virus serotype were not associated with symptomatic dengue infection. Conclusion Household investigation demonstrated a high proportion of household members positive for dengue infection, including a number of inapparent cases, the frequency of which was higher in SEA than in LA. PMID:22292098

Distance and utilisation of out-of-hours services in a Norwegian urban/rural district: an ecological study

PubMed Central

2013-01-01

Background Long travel distances limit the utilisation of health services. We wanted to examine the relationship between the utilisation of a Norwegian out-of-hours service and the distance from the municipality population centroid to the associated casualty clinic. Methods All first contacts from ten municipalities in Arendal out-of-hours district were registered from 2007 through 2011. The main outcomes were contact and consultation rates for each municipality for each year. The associations between main outcomes and distance from the population centroid of the participating municipalities to the casualty clinic and were examined by linear regression. Demographic and socioeconomic factors were included in multivariate linear regression. Secondary endpoints include association between distance and rates of different first actions taken and priority grades assessed by triage nurses. Age and gender specific subgroup analyses were performed. Results 141 342 contacts were included in the analyses. Increasing distance was associated with marked lower rates of all contact types except telephone consultations by doctor. Moving 43 kilometres away from the casualty clinic led to a 50 per cent drop in the rate of face-to-face consultations with a doctor. Availability of primary care doctors and education level contributed to a limited extent to the variance in consultation rate. The rates of all priority grades decreased significantly with increasing distance. The rate of acute events was reduced by 22 per cent when moving 50 kilometres away. The proportion of patients above 66 years increased with increasing distance, while the proportion of 13- to 19 year olds decreased. The proportion of female patients decreased with increasing distance. Conclusions The results confirm that increasing distance is associated with lower utilisation of out-of-hours services, even for the most acute cases. Extremely long distances might compromise patient safety. This must be taken into consideration when organising future out-of-hours districts. PMID:23773207

Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers.

PubMed

Chen, Ruijun; Desai, Nihar R; Ross, Joseph S; Zhang, Weiwei; Chau, Katherine H; Wayda, Brian; Murugiah, Karthik; Lu, Daniel Y; Mittal, Amit; Krumholz, Harlan M

2016-02-17

To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States. Cross sectional analysis. Academic medical centers in the United States. Academic medical centers with 40 or more completed interventional trials registered on ClinicalTrials.gov. Using the Aggregate Analysis of ClinicalTrials.gov database and manual review, we identified all interventional clinical trials registered on ClinicalTrials.gov with a primary completion date between October 2007 and September 2010 and with a lead investigator affiliated with an academic medical center. The proportion of trials that disseminated results, defined as publication or reporting of results on ClinicalTrials.gov, overall and within 24 months of study completion. We identified 4347 interventional clinical trials across 51 academic medical centers. Among the trials, 1005 (23%) enrolled more than 100 patients, 1216 (28%) were double blind, and 2169 (50%) were phase II through IV. Overall, academic medical centers disseminated results for 2892 (66%) trials, with 1560 (35.9%) achieving this within 24 months of study completion. The proportion of clinical trials with results disseminated within 24 months of study completion ranged from 16.2% (6/37) to 55.3% (57/103) across academic medical centers. The proportion of clinical trials published within 24 months of study completion ranged from 10.8% (4/37) to 40.3% (31/77) across academic medical centers, whereas results reporting on ClinicalTrials.gov ranged from 1.6% (2/122) to 40.7% (72/177). Despite the ethical mandate and expressed values and mission of academic institutions, there is poor performance and noticeable variation in the dissemination of clinical trial results across leading academic medical centers. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Does training practice nurses to carry out physical health checks for people with severe mental illness increase the level of screening for cardiovascular risk?

PubMed

Hardy, Sheila; Hinks, Philippa; Gray, Richard

2014-05-01

Compared to the general population, people with severe mental illness (SMI) have a higher risk of developing cardiovascular disease (CVD). Authors of clinical guidelines advise annual screening for CVD risk factors with appropriate lifestyle counselling. There are seven recommended elements of this health check: blood pressure, body mass index (or waist circumference), blood glucose, serum cholesterol, diet advice, exercise recommendations and smoking cessation guidance. To establish whether training practice nurses increases the proportion of patients with SMI who are screened for CVD risk factors and given lifestyle advice in primary care. A before-and-after audit of 400 patients on the SMI registers in five primary care centres in Northampton, England. Following the training, the proportion of patients with SMI who received all elements of the health check significantly increased (pre-training: n = 33, 8%, 95% CI = 6-11; post-training: n = 60, 15%, 95% CI = 12-19; RR = 1.82, 95% CI = 1.22-2.72, p = .01). Training practice nurses about CVD prevention in people with SMI may be effective in increasing the proportion of patients in this group who receive a comprehensive health check.

Clinical Muscle Testing Compared with Whole-Body Magnetic Resonance Imaging in Facio-scapulo-humeral Muscular Dystrophy.

PubMed

Regula, J U; Jestaedt, L; Jende, F; Bartsch, A; Meinck, H-M; Weber, M-A

2016-12-01

The objective of this study was to evaluate the clinical usefulness of whole-body magnetic resonance imaging (MRI) in facio-scapulo-humeral muscular dystrophy (FSHD). In 20 patients with genetically proven FSHD1, we prospectively assessed muscular involvement and correlated the results of semi-quantitative manual muscle testing and other parameters such as disease duration, creatine kinase (CK) levels and repeat length of the D4Z4 locus with whole-body MRI. Clinical muscle testing revealed the trapezius, pectoralis and infraspinatus as the most severely affected muscles in the shoulder, and the knee flexors and gluteus medius in the hip girdle. MRI revealed the trapezius and serratus anterior muscles in the shoulder, and the hamstrings and adductor muscles in the hip girdle, as the most severely affected muscle groups. Overall, degrees of fatty degeneration on MRI scans correlated significantly with clinical weakness. Moreover, we could detect clear affection of the trunk muscles. Corresponding to earlier reports, asymmetric involvement was frequent in both clinical examination and MRI scoring. Moreover, MRI revealed inhomogeneous muscle degeneration in a considerable proportion of both, muscles and patients. Both clinical and MRI scores significantly correlated to disease duration, but not to fragment size or CK levels. Fatty degeneration in whole-body MRI correlates well to clinical muscle testing of the extremities but gives more information on deeper or trunk muscles. It shows structural changes in muscular disorders and may become an excellent tool for assessment of muscle involvement and follow-up studies.

The effect of Zataria multiflora extract on the clinical endometritis and reproductive indices in lactating Holstein dairy cows.

PubMed

Hajibemani, Abolfazl; Mirzaei, Abdolah; Rowshan Ghasrodashti, Abbas; Memarzadeh, Mohammad Reza

2016-01-01

In the present study, the effect of intrauterine infusion of Zataria multiflora extract on the clinical endometritis was investigated. Vaginal examination, transrectal palpation and ultrasonography were used to inspect the genital tract at 30-40 days in milk and two weeks later the same approach was applied. Cows with clinical endometritis were randomly divided into three treatment groups: Z. multiflora extract (n = 56), penicillin + streptomycin (pen + strep, n = 55), and placebo (n = 20). Cervical cytology, reagent strip test and cell counting by means of Neubauer hemocytometer were carried out in both examinations. Clinical cure rate of cows with endometritis of score 1 were 45.5, 34.5 and 53.6% in placebo, pen + strep and Z. multiflora , respectively. Clinical cure rate of cows with endometritis of score 2, 3 were 66.7, 84.6 and 56.0% in placebo, pen + strep and Z. multiflora , respectively. Overall, proportions of successfully treated cows were 55.0, 58.2 and 54.7% in placebo, pen + strep and Z. multiflora , respectively ( p > 0.05). In placebo, none of the parameters were significantly different between first and second examination, while we found the significant differences in percentage of neutrophils and leukocyte esterase activity in other groups ( p < 0.05). First service conception rate of cows was higher in Z. multiflora compared to other groups; however, this difference was not significant. In conclusion, pen + strep and Z. multiflora extract can be effective on the clinical endometritis and may improve reproductive performance. The extract of Z. multiflora can be useful as an alternative therapy for treatment of clinical endometritis in lactating dairy cows.

The effect of Zataria multiflora extract on the clinical endometritis and reproductive indices in lactating Holstein dairy cows

PubMed Central

Hajibemani, Abolfazl; Mirzaei, Abdolah; Rowshan Ghasrodashti, Abbas; Memarzadeh, Mohammad Reza

2016-01-01

In the present study, the effect of intrauterine infusion of Zataria multiflora extract on the clinical endometritis was investigated. Vaginal examination, transrectal palpation and ultrasonography were used to inspect the genital tract at 30-40 days in milk and two weeks later the same approach was applied. Cows with clinical endometritis were randomly divided into three treatment groups: Z. multiflora extract (n = 56), penicillin + streptomycin (pen + strep, n = 55), and placebo (n = 20). Cervical cytology, reagent strip test and cell counting by means of Neubauer hemocytometer were carried out in both examinations. Clinical cure rate of cows with endometritis of score 1 were 45.5, 34.5 and 53.6% in placebo, pen + strep and Z. multiflora, respectively. Clinical cure rate of cows with endometritis of score 2, 3 were 66.7, 84.6 and 56.0% in placebo, pen + strep and Z. multiflora, respectively. Overall, proportions of successfully treated cows were 55.0, 58.2 and 54.7% in placebo, pen + strep and Z. multiflora, respectively (p > 0.05). In placebo, none of the parameters were significantly different between first and second examination, while we found the significant differences in percentage of neutrophils and leukocyte esterase activity in other groups (p < 0.05). First service conception rate of cows was higher in Z. multiflora compared to other groups; however, this difference was not significant. In conclusion, pen + strep and Z. multiflora extract can be effective on the clinical endometritis and may improve reproductive performance. The extract of Z. multiflora can be useful as an alternative therapy for treatment of clinical endometritis in lactating dairy cows. PMID:28144422

Proton Radiotherapy for Solid Tumors of Childhood

PubMed Central

Cotter, Shane E.; McBride, Sean M.; Yock, Torunn I.

2012-01-01

The increasing efficacy of pediatric cancer therapy over the past four decades has produced many long-term survivors that now struggle with serious treatment related morbidities affecting their quality of life. Radiation therapy is responsible for a significant proportion of these late effects, but a relatively new and emerging modality, proton radiotherapy hold great promise to drastically reduce these treatment related late effects in long term survivors by sparing dose to normal tissues. Dosimetric studies of proton radiotherapy compared with best available photon based treatment show significant dose sparing to developing normal tissues. Furthermore, clinical data are now emerging that begin to quantify the benefit in decreased late treatment effects while maintaining excellent cancer control rates. PMID:22417062

Current Treatment Strategies in Pediatric Alopecia Areata

PubMed Central

Wang, Etienne; Lee, Joyce SS; Tang, Mark

2012-01-01

Alopecia areata (AA) is a non-scarring autoimmune disease of the hair follicle that can present at any age. Pediatric cases are commonly seen in a dermatology clinic, and management can potentially be challenging, with a small proportion of cases experiencing a chronic relapsing course marked by distressing hair loss that can bring about significant psychosocial morbidity. We review the established treatments for pediatric alopecia areata, alongside second and third line therapies that have shown to be efficacious. We also offer a treatment algorithm as a guide to the treatment of pediatric AA. PMID:23248364

When silence is not golden: an integrated approach to selective mutism.

PubMed

McInnes, Alison; Manassis, Katharina

2005-08-01

Selective mutism (SM) is a rare disorder that is associated with both anxiety and communication impairments. Preliminary evidence suggests that educational attainment and development of social skills and self-esteem may be affected by SM in a significant proportion of cases. There is a critical need for cross-disciplinary research from the fields of speech-language pathology, psychiatry, and clinical psychology to develop protocols for assessing language and cognitive functioning in children with SM and developing interventions that address psychiatric, communicative, and social aspects of this disorder.

Sex differences in the significance of isolated reactive treponemal chemiluminescence immunoassay results.

PubMed

Bopage, Rohan I; Vollmer-Conna, Ute; Shand, Antonia W; Post, Jeffrey John

2018-05-01

The significance of sera with isolated reactive treponemal chemiluminescence immunoassay (IRTCIA) results is unclear. Women have this phenotype more commonly than men. Most cohorts examining this phenotype have included predominantly men and have demonstrated evidence of past or subsequently confirmed syphilis infection in a significant proportion of cases. We hypothesised that a proportion of sera with IRTCIA results would be positive on immunoblot testing and that sera from women with IRTCIA would have different results in immunoblot testing than men. IRTCIA sera from a tertiary referral serology laboratory serving multiple clinical sites were analysed with a syphilis line immunoblot assay (LIA) and analysed by sex. Logistic regression was undertaken to assess factors associated with LIA status. Medical record review and descriptive analysis of a separate cohort of women with the IRTCIA phenotype from a single campus was also undertaken. Overall, 19/63 (30.1%) subjects with the IRTCIA phenotype were positive in the LIA, including 13 men and 6 women. Women were significantly less likely to have definitive results (positive or negative) than men (p=0.015). Pregnant women were less likely than non-pregnant women to have a negative LIA result (OR 0.57; p=0.03). Record review of 22 different women with IRTCIA reactivity showed that 2/22 (9.1%) had HIV and previous syphilis infection, 15/22 (68.2%) were pregnant and 3 (13.6%) had autoimmune disease. A significant proportion of sera with IRTCIA results on serological tests are reactive on LIA testing and some may not be false positive results. The interpretation of IRTCIA results should be undertaken in conjunction with an assessment of factors such as sex, pregnancy, a history of syphilis and other STIs and syphilis risk. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Health-Related Quality of Life After Single-Fraction High-Dose-Rate Brachytherapy and Hypofractionated External Beam Radiotherapy for Prostate Cancer

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

Morton, Gerard C., E-mail: gerard.morton@sunnybrook.ca; Loblaw, D. Andrew; Chung, Hans

Purpose: To investigate the change in health-related quality of life for men after high-dose-rate brachytherapy and external beam radiotherapy for prostate cancer and the factors associated with this change. Methods and Materials: Eligible patients had clinically localized intermediate-risk prostate cancer. The patients received high-dose-rate brachytherapy as a single 15-Gy implant, followed by external beam radiotherapy to 37.5 Gy in 15 fractions. The patients were monitored prospectively for toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and health-related quality of life (Expanded Prostate Cancer Index Composite [EPIC]). The proportion of patients developing a clinically significant difference in the EPIC domainmore » score (minimally important difference of >0.5 standard deviation) was determined and correlated with the baseline clinical and dosimetric factors. The study accrued 125 patients, with a median follow-up of 24 months. Results: By 24 months, 23% had Grade 2 urinary toxicity and only 5% had Grade 2 bowel toxicity, with no Grade 3 toxicity. The proportion of patients reporting a significant decrease in EPIC urinary, bowel, sexual, and hormonal domain scores was 53%, 51%, 45%, and 40% at 12 months and 57%, 65%, 51%, and 30% at 24 months, respectively. The proportion with a >1 standard deviation decrease in the EPIC urinary, bowel, sexual, and hormonal domain scores was 38%, 36%, 24%, and 20% at 12 months and 46%, 48%, 19%, and 8% at 24 months, respectively. On multivariate analysis, the dose to 10% of the urethra was associated with a decreasing EPIC urinary domain score (p = .0089) and, less strongly (p = .0312) with a decreasing hormonal domain score. No association was found between the prostate volume, bladder dose, or high-dose volume and urinary health-related quality of life. A high baseline International Index of Erectile Function score was associated (p = .0019) with a decreasing sexual domain score. The optimal maximal dose to 10% of the urethra cutpoint for urinary health-related quality of life was 120% of the prescription dose. Conclusion: EPIC was a more sensitive tool for detecting the effects on function and bother than were the generic toxicity scales. The urethral dose had the strongest association with a deteriorating urinary quality of life.« less

Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial.

PubMed

Smith, Caroline A; de Lacey, Sheryl; Chapman, Michael; Ratcliffe, Julie; Norman, Robert J; Johnson, Neil; Sacks, Gavin; Lyttleton, Jane; Boothroyd, Clare

2012-05-18

IVF is a costly treatment option for women, their partners, and the public. Therefore new therapies that improve reproductive and health outcomes are highly desirable. There is a growing body of research evaluating the effect of acupuncture administered during IVF, and specifically on the day of embryo transfer (ET). Many trials are heterogeneous and results inconsistent. There remains insufficient evidence to determine if acupuncture can enhance live birth rates when used as an adjunct to IVF treatment.The study will determine the clinical effectiveness of acupuncture with improving the proportion of women undergoing IVF having live births. Other objectives include: determination of the cost effectiveness of IVF with acupuncture; and examination of the personal and social context of acupuncture in IVF patients, and examining the reasons why the acupuncture may or may not have worked. We will conduct a randomized controlled trial of acupuncture compared to placebo acupuncture.Inclusion criteria include: women aged less than 43 years; undergoing a fresh IVF or ICSI cycle; and restricted to women with the potential for a lower live birth rate defined as two or more previous unsuccessful ETs; and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria. Women will be randomized to acupuncture or placebo acupuncture. Treatment is administered on days 6 to 8 of the stimulated cycle and two treatments on the day of ET. A non-randomized cohort of women not using acupuncture will be recruited to the study. The primary study outcome is the proportion of women reporting a live birth. Secondary outcomes include the proportion of women reporting a clinical pregnancy miscarriage prior to 12 weeks, quality of life, and self-efficacy. The sample size of the study is 1,168 women, with the aim of detecting a 7% difference in live births between groups (P = 0.05, 80% power). There remains a need for further research to add significant new knowledge to defining the exact role of certain acupuncture protocols in the management of infertility requiring IVF from a clinical and cost-effectiveness perspective. Australian and New Zealand Clinical Trial Registry ACTRN12611000226909.

The incidence of cervical spondylosis decreases with aging in the elderly, and increases with aging in the young and adult population: a hospital-based clinical analysis

PubMed Central

Wang, Chuanling; Tian, Fuming; Zhou, Yingjun; He, Wenbo; Cai, Zhiyou

2016-01-01

Background and purpose Cervical spondylosis is well accepted as a common degenerative change in the cervical spine. Compelling evidence has shown that the incidence of cervical spondylosis increases with age. However, the relationship between age and the incidence of cervical spondylosis remains obscure. It is essential to note the relationship between age and the incidence of cervical spondylosis through more and more clinical data. Methods In the case-controlled study reported here, retrospective clinical analysis of 1,276 cases of cervical spondylosis has been conducted. We analyzed the general clinical data, the relationship between age and the incidence of cervical spondylosis, and the relationship between age-related risk factors and the incidence of cervical spondylosis. A chi-square test was used to analyze the associations between different variables. Statistical significance was defined as a P-value of less than 0.05. Results The imaging examination demonstrated the most prominent characteristic features of cervical spondylosis: bulge or herniation at C3-C4, C4-C5, and C5-C6. The incidence of cervical spondylosis increased with aging before age 50 years and decreased with aging after age 50 years, especially in the elderly after 60 years old. The occurrence rate of bulge or herniation at C3-C4, C4-C5, C5-C6, and C6-C7 increased with aging before age 50 years and decreased with aging after age 50 years, especially after 60 years. Moreover, the incidence of hyperosteogeny and spinal stenosis increased with aging before age 60 years and decreased with aging after age 60 years, although there was no obvious change in calcification. The age-related risk factors, such as hypertension, hyperlipidemia, diabetes, cerebral infarct, cardiovascular diseases, smoking, and drinking, have no relationship with the incidence of cervical spondylosis. Conclusion A decreasing proportion of cervical spondylosis with aging occurs in the elderly, while the proportion of cervical spondylosis increases with aging in the young and the adults. This investigation implicates that aging is not only a contributor to the clinical performance of cervical spondylosis in the elderly, although the incidence of cervical spondylosis is proportional to the progress of age. PMID:26834465

Splenectomy Causes 10-Fold Increased Risk of Portal Venous System Thrombosis in Liver Cirrhosis Patients.

PubMed

Qi, Xingshun; Han, Guohong; Ye, Chun; Zhang, Yongguo; Dai, Junna; Peng, Ying; Deng, Han; Li, Jing; Hou, Feifei; Ning, Zheng; Zhao, Jiancheng; Zhang, Xintong; Wang, Ran; Guo, Xiaozhong

2016-07-19

BACKGROUND Portal venous system thrombosis (PVST) is a life-threatening complication of liver cirrhosis. We conducted a retrospective study to comprehensively analyze the prevalence and risk factors of PVST in liver cirrhosis. MATERIAL AND METHODS All cirrhotic patients without malignancy admitted between June 2012 and December 2013 were eligible if they underwent contrast-enhanced CT or MRI scans. Independent predictors of PVST in liver cirrhosis were calculated in multivariate analyses. Subgroup analyses were performed according to the severity of PVST (any PVST, main portal vein [MPV] thrombosis >50%, and clinically significant PVST) and splenectomy. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported. RESULTS Overall, 113 cirrhotic patients were enrolled. The prevalence of PVST was 16.8% (19/113). Splenectomy (any PVST: OR=11.494, 95%CI=2.152-61.395; MPV thrombosis >50%: OR=29.987, 95%CI=3.247-276.949; clinically significant PVST: OR=40.415, 95%CI=3.895-419.295) and higher hemoglobin (any PVST: OR=0.974, 95%CI=0.953-0.996; MPV thrombosis >50%: OR=0.936, 95%CI=0.895-0.980; clinically significant PVST: OR=0.935, 95%CI=0.891-0.982) were the independent predictors of PVST. The prevalence of PVST was 13.3% (14/105) after excluding splenectomy. Higher hemoglobin was the only independent predictor of MPV thrombosis >50% (OR=0.952, 95%CI=0.909-0.997). No independent predictors of any PVST or clinically significant PVST were identified in multivariate analyses. Additionally, PVST patients who underwent splenectomy had a significantly higher proportion of clinically significant PVST but lower MELD score than those who did not undergo splenectomy. In all analyses, the in-hospital mortality was not significantly different between cirrhotic patient with and without PVST. CONCLUSIONS Splenectomy may increase by at least 10-fold the risk of PVST in liver cirrhosis independent of severity of liver dysfunction.

Splenectomy Causes 10-Fold Increased Risk of Portal Venous System Thrombosis in Liver Cirrhosis Patients

PubMed Central

Qi, Xingshun; Han, Guohong; Ye, Chun; Zhang, Yongguo; Dai, Junna; Peng, Ying; Deng, Han; Li, Jing; Hou, Feifei; Ning, Zheng; Zhao, Jiancheng; Zhang, Xintong; Wang, Ran; Guo, Xiaozhong

2016-01-01

Background Portal venous system thrombosis (PVST) is a life-threatening complication of liver cirrhosis. We conducted a retrospective study to comprehensively analyze the prevalence and risk factors of PVST in liver cirrhosis. Material/Methods All cirrhotic patients without malignancy admitted between June 2012 and December 2013 were eligible if they underwent contrast-enhanced CT or MRI scans. Independent predictors of PVST in liver cirrhosis were calculated in multivariate analyses. Subgroup analyses were performed according to the severity of PVST (any PVST, main portal vein [MPV] thrombosis >50%, and clinically significant PVST) and splenectomy. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported. Results Overall, 113 cirrhotic patients were enrolled. The prevalence of PVST was 16.8% (19/113). Splenectomy (any PVST: OR=11.494, 95%CI=2.152–61.395; MPV thrombosis >50%: OR=29.987, 95%CI=3.247–276.949; clinically significant PVST: OR=40.415, 95%CI=3.895–419.295) and higher hemoglobin (any PVST: OR=0.974, 95%CI=0.953–0.996; MPV thrombosis >50%: OR=0.936, 95%CI=0.895–0.980; clinically significant PVST: OR=0.935, 95%CI=0.891–0.982) were the independent predictors of PVST. The prevalence of PVST was 13.3% (14/105) after excluding splenectomy. Higher hemoglobin was the only independent predictor of MPV thrombosis >50% (OR=0.952, 95%CI=0.909–0.997). No independent predictors of any PVST or clinically significant PVST were identified in multivariate analyses. Additionally, PVST patients who underwent splenectomy had a significantly higher proportion of clinically significant PVST but lower MELD score than those who did not undergo splenectomy. In all analyses, the in-hospital mortality was not significantly different between cirrhotic patient with and without PVST. Conclusions Splenectomy may increase by at least 10-fold the risk of PVST in liver cirrhosis independent of severity of liver dysfunction. PMID:27432511

Maternal perception of fetal movements in late pregnancy is affected by type and duration of fetal movement.

PubMed

Brown, Rebecca; Higgins, Lucy E; Johnstone, Edward D; Wijekoon, Jayawan H; Heazell, Alexander E P

2016-01-01

A reduction in fetal movements has been proposed to identify pregnancies at risk of stillbirth. The utility of this approach is limited by variability in maternal perception of fetal movements. We aimed to determine the proportion of fetal movements observed by ultrasound that were maternally perceived and identify factors that affected maternal perception. During 30-min recordings, women (n = 21) depressed a trigger upon perception of a fetal movement, while an ultrasound operator recorded observed movements according to the fetal parts involved. Women perceived between 2.4% and 81.0% (median 44.8%) of movements observed on scan. Synchronous movement of the fetal trunk and limbs was more likely to be recognized than either part in isolation (60.5% versus 37.5% and 30%, respectively). The ultrasound operator judged the fetus to be moving for a significantly greater proportion of the time than mothers (median 1.5% of total recording time versus 0.7%). There was no significant relationship between the ability to perceive fetal activity and placental site, parity, amniotic fluid index or maternal body mass index. Variations in maternal perception of fetal movements may affect detection of a clinically significant reduction in fetal movements for some women.

The common characteristics and outcomes of multidisciplinary collaboration in primary health care: a systematic literature review

PubMed Central

Schepman, Sanneke; Hansen, Johan; de Putter, Iris D.; Batenburg, Ronald S.; de Bakker, Dinny H.

2015-01-01

Introduction Research on collaboration in primary care focuses on specific diseases or types of collaboration. We investigate the effects of such collaboration by bringing together the results of scientific studies. Theory and methods We conducted a systematic literature review of PubMed, CINAHL, Cochrane and EMBASE. The review was restricted to publications that test outcomes of multidisciplinary collaboration in primary care in high-income countries. A conceptual model is used to structure the analysis. Results Fifty-one studies comply with the selection criteria about collaboration in primary care. Approximately half of the 139 outcomes in these studies is non-significant. Studies among older patients, in particular, report non-significant outcomes (p < .05). By contrast, a higher proportion of significant results were found in studies that report on clinical outcomes. Conclusions and discussion This review shows a large diversity in the types of collaboration in primary care; and also thus a large proportion of outcomes do not seem to be positively affected by collaboration. Both the characteristics of the structure of the collaboration and the collaboration processes themselves affect the outcomes. More research is necessary to understand the mechanism behind the success of collaboration, especially on the exact nature of collaboration and the context in which collaboration takes place. PMID:26150765