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Sample records for clinical cohort studies

  1. A clinical research analytics toolkit for cohort study.

    PubMed

    Yu, Yiqin; Zhu, Yu; Sun, Xingzhi; Tao, Ying; Zhang, Shuo; Xu, Linhao; Pan, Yue

    2012-01-01

    This paper presents a clinical informatics toolkit that can assist physicians to conduct cohort studies effectively and efficiently. The toolkit has three key features: 1) support of procedures defined in epidemiology, 2) recommendation of statistical methods in data analysis, and 3) automatic generation of research reports. On one hand, our system can help physicians control research quality by leveraging the integrated knowledge of epidemiology and medical statistics; on the other hand, it can improve productivity by reducing the complexities for physicians during their cohort studies.

  2. Cerebral palsy and clinical negligence litigation: a cohort study.

    PubMed

    Greenwood, Catherine; Newman, Sally; Impey, Lawrence; Johnson, Ann

    2003-01-01

    To compare the prevalence of criteria suggesting acute intrapartum hypoxia in children with cerebral palsy who have and have not been the subjects of clinical negligence legal claims. Nested cohort study within a geographically defined cohort. The former Oxfordshire Health Authority. Singleton children with cerebral palsy born between 1984 and 1993, excluding cases with a recognised postnatal cause for cerebral palsy. Retrospective review of medical records by blinded observer. Three 'essential' criteria defined by the International Cerebral Palsy Task Force which identify acute intrapartum hypoxia. One-fifth (27/138) of all singleton cerebral palsy children were the subject of a legal claim. The presence of all three criteria was significantly more likely to lead to a legal claim (P < 0.01), but in 74% (20/27) of claims, all three were not fulfilled and 36% (4/11) of those satisfying all three criteria did not claim. At least one of the three criteria was met in 82% (91/111) of the cases where there was no claim. Data on fetal or neonatal arterial blood gases were available in only 57% (78/138). Of the 27 claims, 12 were discontinued, 8 were settled and in 7 the legal process is still pending. The presence of the three essential criteria for acute intrapartum hypoxia did not increase the likelihood of a legal claim being settled. The prevalence of the 'template essential' criteria is high in all cases of cerebral palsy. Although the presence of all three essential criteria was more likely in the claims group, this did not appear to influence the outcome of a claim. It remains to be seen whether the existence of the template leads to change in the pattern of decisions made by the courts.

  3. The UK clinical aptitude test and clinical course performance at Nottingham: a prospective cohort study

    PubMed Central

    2013-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course. The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Methods Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. Results The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). Conclusions This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools. PMID:23442227

  4. The UK Clinical Aptitude Test and clinical course performance at Nottingham: a prospective cohort study.

    PubMed

    Yates, Janet; James, David

    2013-02-26

    The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Verbal Reasoning, Quantitative Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admission panels in advance of the selection process. Our first study showed little evidence of any predictive validity for performance in the first two years of the Nottingham undergraduate course.The study objective was to determine whether the UKCAT scores had any predictive value for the later parts of the course, largely delivered via clinical placements. Students entering the course in 2007 and who had taken the UKCAT were asked for permission to use their anonymised data in research. The UKCAT scores were incorporated into a database with routine pre-admission socio-demographics and subsequent course performance data. Correlation analysis was followed by hierarchical multivariate linear regression. The original study group comprised 204/254 (80%) of the full entry cohort. With attrition over the five years of the course this fell to 185 (73%) by Year 5. The Verbal Reasoning score and the UKCAT Total score both demonstrated some univariate correlations with clinical knowledge marks, and slightly less with clinical skills. No parts of the UKCAT proved to be an independent predictor of clinical course marks, whereas prior attainment was a highly significant predictor (p <0.001). This study of one cohort of Nottingham medical students showed that UKCAT scores at admission did not independently predict subsequent performance on the course. Whilst the test adds another dimension to the selection process, its fairness and validity in selecting promising students remains unproven, and requires wider investigation and debate by other schools.

  5. Design and Cohort Characteristics of the Social Spectrum Study: A Multicenter Study of the Autism Spectrum among Clinically Referred Children

    ERIC Educational Resources Information Center

    Duvekot, Jorieke; Hoopen, Leontine W.; Slappendel, Geerte; van der Ende, Jan; Verhulst, Frank C.; van der Sijde, Ad; Greaves-Lord, Kirstin

    2017-01-01

    This paper provides an overview of the design and cohort characteristics of the Social Spectrum Study: a clinical cohort study that used a two-phase sampling design to identify children at risk for ASD. After screening 1281 children aged 2.5-10 years who had been consecutively referred to one of six mental health services in the Netherlands,…

  6. [Down with odds ratios: risk ratios in cohort studies and randomised clinical trials].

    PubMed

    Knol, Mirjam J

    2012-01-01

    Various effect measures are available for quantifying the relationship between an intervention or a risk factor and an outcome, such as the risk ratio and the odds ratio. Odds ratios are intended for use in case-control studies in which they are an appropriate measure for estimating the relative risk; however, this measure is also often presented in cohort studies and in randomized clinical trials. When used for cohort studies and randomized clinical trials, the odds ratio is often incorrectly interpreted as the risk ratio; the odds ratio then provides an overestimation of the risk ratio, especially when the outcome is frequent. The use of logistic regression to adjust for confounding is one of the reasons that odds ratios are presented. For cohort studies and randomized clinical trials, however, there are methods to estimate adjusted risk ratios; these include the Mantel-Haenszel method, log-binomial regression, Poisson regression with robust standard error, and 'doubling of cases' method with robust standard error. To avoid misinterpretation of odds ratios, risk ratios should be calculated in cohort studies and randomized clinical trials.

  7. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  8. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    ERIC Educational Resources Information Center

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  9. Socioeconomic inequality in clinical outcome among hip fracture patients: a nationwide cohort study.

    PubMed

    Kristensen, P K; Thillemann, T M; Pedersen, A B; Søballe, K; Johnsen, S P

    2017-04-01

    The evidence is limited regarding the association between socioeconomic status and the clinical outcome among patients with hip fracture. In this nationwide, population-based cohort study, higher education and higher family income were associated with a substantially lower 30-day mortality and risk of unplanned readmission after hip fracture.

  10. Are prospective cohort studies an appropriate tool to answer clinical nutrition questions?

    PubMed

    Vincent, Jean-Louis; Preiser, Jean-Charles

    2013-03-01

    Randomized controlled trials can be difficult to conduct in critically ill patients and may not always be the most appropriate type of study. Cohort studies can provide valuable information in large complete populations of patients without strict exclusion criteria and without the need for informed consent, thus potentially being more representative of and applicable to daily practice. Recent cohort studies have evaluated the various aspects of the epidemiology and practice of nutrition in critically ill patients, including the proportions of patients receiving different types of nutritional support, the potential benefits of supplementary parenteral nutrition, the importance of meeting nutrition targets especially for protein, and the beneficial effects of feeding protocols on outcomes. Results from some of these cohort studies have provided an indication of how nutrition guidelines have been applied in clinical practice and which areas need to be improved. Others have generated hypotheses that will be (or are already being) tested in randomized studies.

  11. Clinical progression and outcome of dysphagia following thermal burn injury: a prospective cohort study.

    PubMed

    Rumbach, Anna F; Ward, Elizabeth C; Cornwell, Petrea L; Bassett, Lynell V; Muller, Michael J

    2012-01-01

    The objectives of this study were 1) to establish clinical profiles of dysphagic and nondysphagic individuals following thermal burn injury and 2) to provide a clinical profile of the progression and outcome of dysphagia resolution by hospital discharge for a dysphagic cohort. A total of 438 consecutively admitted patients with thermal burns were included. All patients underwent a clinical swallowing examination. Medical parameters regarding burn presentation and its treatment and speech-language pathology specific variables from admission to discharge were collected for each participant. Dysphagia was identified in 49 patients via clinical assessment, and their course of recovery was followed up until the point of dysphagia resolution or discharge. No significant difference was observed between the dysphagic and nondysphagic groups in age, gender, and injury etiology. However, the dysphagic cohort was significantly different from the nondysphagic group in all variables pertaining to injury presentation and medical management. Individuals with dysphagia took significantly longer to start, and maintain, oral intake and required nonoral supplementation for three and a half times longer than those who were nondysphagic. Length of speech-language pathology intervention averaged 1 month for the dysphagics and increased with dysphagia severity. Return to normal fluid consistencies occurred in >75% of dysphagic individuals by week 7 after injury, although resumption of normal diet textures was more protracted, with 75% resuming normal oral intake by week 9. Dysphagia had resolved in 50% of the cohort by week 6, and by hospital discharge, 85% of the dysphagic individuals had resumed normal oral intake of thin fluids and a general diet. This is the first large prospective cohort study to establish clinical profiles of dysphagic and nondysphagic cohorts and document the nature of dysphagia and patterns of recovery within the thermal burn population. These current data will

  12. Understanding Heterogeneity in Clinical Cohorts Using Normative Models: Beyond Case-Control Studies.

    PubMed

    Marquand, Andre F; Rezek, Iead; Buitelaar, Jan; Beckmann, Christian F

    2016-10-01

    Despite many successes, the case-control approach is problematic in biomedical science. It introduces an artificial symmetry whereby all clinical groups (e.g., patients and control subjects) are assumed to be well defined, when biologically they are often highly heterogeneous. By definition, it also precludes inference over the validity of the diagnostic labels. In response, the National Institute of Mental Health Research Domain Criteria proposes to map relationships between symptom dimensions and broad behavioral and biological domains, cutting across diagnostic categories. However, to date, Research Domain Criteria have prompted few methods to meaningfully stratify clinical cohorts. We introduce normative modeling for parsing heterogeneity in clinical cohorts, while allowing predictions at an individual subject level. This approach aims to map variation within the cohort and is distinct from, and complementary to, existing approaches that address heterogeneity by employing clustering techniques to fractionate cohorts. To demonstrate this approach, we mapped the relationship between trait impulsivity and reward-related brain activity in a large healthy cohort (N = 491). We identify participants who are outliers within this distribution and show that the degree of deviation (outlier magnitude) relates to specific attention-deficit/hyperactivity disorder symptoms (hyperactivity, but not inattention) on the basis of individualized patterns of abnormality. Normative modeling provides a natural framework to study disorders at the individual participant level without dichotomizing the cohort. Instead, disease can be considered as an extreme of the normal range or as-possibly idiosyncratic-deviation from normal functioning. It also enables inferences over the degree to which behavioral variables, including diagnostic labels, map onto biology. Copyright © 2016 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  13. Clinical disorders in a post war British cohort reaching retirement: evidence from the First National Birth Cohort study.

    PubMed

    Pierce, Mary B; Silverwood, Richard J; Nitsch, Dorothea; Adams, Judith E; Stephen, Alison M; Nip, Wing; Macfarlane, Peter; Wong, Andrew; Richards, Marcus; Hardy, Rebecca; Kuh, Diana

    2012-01-01

    The medical needs of older people are growing because the proportion of the older population is increasing and disease boundaries are widening. This study describes the distribution and clustering of 15 common clinical disorders requiring medical treatment or supervision in a representative British cohort approaching retirement, and how health tracked across adulthood. The data come from a cohort of 2661 men and women, 84% of the target sample, followed since birth in England, Scotland and Wales in 1946, and assessed at 60-64 years for: cardio and cerebro-vascular disease, hypertension, raised cholesterol, renal impairment, diabetes, obesity, hypothyroidism, hyperthyroidism, anaemia, respiratory disease, liver disease, psychiatric problems, cancers, atrial fibrillation on ECG and osteoporosis. We calculated the proportions disorder-free, with one or more disorders, and the level of undiagnosed disorders; and how these disorders cluster into latent classes and relate to health assessed at 36 years. Participants had, on average, two disorders (range 0-9); only 15% were disorder-free. The commonest disorders were hypertension (54.3%, 95% CI 51.8%-56.7%), obesity (31.1%, 28.8%-33.5%), raised cholesterol (25.6%, 23.1-28.26%), and diabetes or impaired fasting glucose (25.0%, 22.6-27.5%). A cluster of one in five individuals had a high probability of cardio-metabolic disorders and were twice as likely than others to have been in the poorest health at 36 years. The main limitations are that the native born sample is entirely white, and a combination of clinical assessments and self reports were used. Most British people reaching retirement already have clinical disorders requiring medical supervision. Widening disease definitions and the move from a disease-based to a risk-based medical model will increase pressure on health services. The promotion of healthy ageing should start earlier in life and consider the individual's ability to adapt to and self manage changes in

  14. [International cohort studies].

    PubMed

    Ahrens, W; Pigeot, I

    2012-06-01

    Among observational studies, cohort studies, i.e. longitudinal observations of selected population groups, provide the highest possible evidence of a causal association between specific risk factors (exposure) and the occurrence of disease in populations. Besides the fact that many exposures cannot be investigated in experimental designs, cohort studies have the advantage over randomized clinical trials that they are conducted in free living populations and not in restrictive, clinical settings. In this paper we describe the aims and features of international cohorts that have been selected because of their impact, their size or their endpoints. We do not only present the study designs and survey instruments used but we also highlight some of the most important results gained by these studies. Most of these prospective studies investigated common chronic diseases in the elderly, such as cancer, diabetes, cardiovascular or neurodegenerative diseases, osteoporosis and ophthalmologic disorders. Newer cohorts and recent reassessments of existing cohorts almost always include the collection and storage of biological samples. In recent years technological developments allowed the implementation of cutting edge measurement procedures, such as imaging techniques for phenotyping. Finally, we discuss on the one hand whether these designs can be transferred to the German situation and on the other hand to what degree the results obtained from foreign cohorts can be generalized for the German population. We conclude with recommendations for future cohort studies.

  15. The BioFIND study: Characteristics of a clinically typical Parkinson's disease biomarker cohort

    PubMed Central

    Goldman, Jennifer G.; Alcalay, Roy N.; Xie, Tao; Tuite, Paul; Henchcliffe, Claire; Hogarth, Penelope; Amara, Amy W.; Frank, Samuel; Rudolph, Alice; Casaceli, Cynthia; Andrews, Howard; Gwinn, Katrina; Sutherland, Margaret; Kopil, Catherine; Vincent, Lona; Frasier, Mark

    2016-01-01

    ABSTRACT Background Identifying PD‐specific biomarkers in biofluids will greatly aid in diagnosis, monitoring progression, and therapeutic interventions. PD biomarkers have been limited by poor discriminatory power, partly driven by heterogeneity of the disease, variability of collection protocols, and focus on de novo, unmedicated patients. Thus, a platform for biomarker discovery and validation in well‐characterized, clinically typical, moderate to advanced PD cohorts is critically needed. Methods BioFIND (Fox Investigation for New Discovery of Biomarkers in Parkinson's Disease) is a cross‐sectional, multicenter biomarker study that established a repository of clinical data, blood, DNA, RNA, CSF, saliva, and urine samples from 118 moderate to advanced PD and 88 healthy control subjects. Inclusion criteria were designed to maximize diagnostic specificity by selecting participants with clinically typical PD symptoms, and clinical data and biospecimen collection utilized standardized procedures to minimize variability across sites. Results We present the study methodology and data on the cohort's clinical characteristics. Motor scores and biospecimen samples including plasma are available for practically defined off and on states and thus enable testing the effects of PD medications on biomarkers. Other biospecimens are available from off state PD assessments and from controls. Conclusion Our cohort provides a valuable resource for biomarker discovery and validation in PD. Clinical data and biospecimens, available through The Michael J. Fox Foundation for Parkinson's Research and the National Institute of Neurological Disorders and Stroke, can serve as a platform for discovering biomarkers in clinically typical PD and comparisons across PD's broad and heterogeneous spectrum. © 2016 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society PMID:27113479

  16. Clinical Disorders in a Post War British Cohort Reaching Retirement: Evidence from the First National Birth Cohort Study

    PubMed Central

    Pierce, Mary B.; Silverwood, Richard J.; Nitsch, Dorothea; Adams, Judith E.; Stephen, Alison M.; Nip, Wing; Macfarlane, Peter; Wong, Andrew; Richards, Marcus; Hardy, Rebecca; Kuh, Diana

    2012-01-01

    Background The medical needs of older people are growing because the proportion of the older population is increasing and disease boundaries are widening. This study describes the distribution and clustering of 15 common clinical disorders requiring medical treatment or supervision in a representative British cohort approaching retirement, and how health tracked across adulthood. Methods and Findings The data come from a cohort of 2661 men and women, 84% of the target sample, followed since birth in England, Scotland and Wales in 1946, and assessed at 60–64 years for: cardio and cerebro-vascular disease, hypertension, raised cholesterol, renal impairment, diabetes, obesity, hypothyroidism, hyperthyroidism, anaemia, respiratory disease, liver disease, psychiatric problems, cancers, atrial fibrillation on ECG and osteoporosis. We calculated the proportions disorder-free, with one or more disorders, and the level of undiagnosed disorders; and how these disorders cluster into latent classes and relate to health assessed at 36 years. Participants had, on average, two disorders (range 0–9); only 15% were disorder-free. The commonest disorders were hypertension (54.3%, 95% CI 51.8%–56.7%), obesity (31.1%, 28.8%–33.5%), raised cholesterol (25.6%, 23.1–28.26%), and diabetes or impaired fasting glucose (25.0%, 22.6–27.5%). A cluster of one in five individuals had a high probability of cardio-metabolic disorders and were twice as likely than others to have been in the poorest health at 36 years. The main limitations are that the native born sample is entirely white, and a combination of clinical assessments and self reports were used. Conclusions Most British people reaching retirement already have clinical disorders requiring medical supervision. Widening disease definitions and the move from a disease-based to a risk-based medical model will increase pressure on health services. The promotion of healthy ageing should start earlier in life and consider the

  17. Clinical features to identify urinary tract infection in nursing home residents: a cohort study.

    PubMed

    Juthani-Mehta, Manisha; Quagliarello, Vincent; Perrelli, Eleanor; Towle, Virginia; Van Ness, Peter H; Tinetti, Mary

    2009-06-01

    To identify clinical features associated with bacteriuria plus pyuria in noncatheterized nursing home residents with clinically suspected urinary tract infection (UTI). Prospective, observational cohort study from 2005 to 2007. Five New Haven, Connecticut area nursing homes. Five hundred fifty-one nursing home residents each followed for 1 year for the development of clinically suspected UTI. The combined outcome of bacteriuria (>100,000 colony forming units from urine culture) plus pyuria (>10 white blood cells from urinalysis). After 178,914 person-days of follow-up, 228 participants had 399 episodes of clinically suspected UTI with a urinalysis and urine culture performed; 147 episodes (36.8%) had bacteriuria plus pyuria. The clinical features associated with bacteriuria plus pyuria were dysuria (relative risk (RR)=1.58, 95% confidence interval (CI)=1.10-2.03), change in character of urine (RR=1.42, 95% CI=1.07-1.79), and change in mental status (RR=1.38, 95% CI=1.03-1.74). Dysuria, change in character of urine, and change in mental status were significantly associated with the combined outcome of bacteriuria plus pyuria. Absence of these clinical features identified residents at low risk of having bacteriuria plus pyuria (25.5%), whereas presence of dysuria plus one or both of the other clinical features identified residents at high risk of having bacteriuria plus pyuria (63.2%). Diagnostic uncertainty still remains for the vast majority of residents who meet only one clinical feature. If validated in future cohorts, these clinical features with bacteriuria plus pyuria may serve as an evidence-based clinical definition of UTI to assist in management decisions.

  18. Clinical Features to Identify UTI in Nursing Home Residents: A Cohort Study

    PubMed Central

    Juthani-Mehta, Manisha; Quagliarello, Vincent; Perrelli, Eleanor; Towle, Virginia; Van Ness, Peter H.; Tinetti, Mary

    2009-01-01

    Objective To identify, among non-catheterized nursing home residents with clinically suspected UTI, clinical features associated with bacteriuria plus pyuria. Design Prospective, observational cohort study from 2005 to 2007. Setting Five New Haven, CT area nursing homes. Participants 551 nursing home residents each followed for one year for the development of clinically suspected UTI. Measurements The combined outcome of bacteriuria (>100,000 colony forming units on urine culture) plus pyuria (>10 white blood cells on urinalysis). Results After 178,914 person-days of follow-up, 228 participants had 399 episodes of clinically suspected UTI with a urinalysis and urine culture performed; 147 episodes (37%) had bacteriuria plus pyuria. The clinical features associated with bacteriuria plus pyuria were dysuria (relative risk [RR]=1.58, 95% confidence interval [CI] 1.10, 2.03), change in character of urine (RR=1.42, 95% CI 1.07, 1.79), and change in mental status (RR=1.38, 95% CI 1.03, 1.74). Conclusions Dysuria, change in character of urine, and change in mental status were significantly associated with the combined outcome of bacteriuria plus pyuria. Absence of these clinical features identified residents at low risk of having bacteriuria plus pyuria (25%), while presence of dysuria plus one or both of the other clinical features identified residents at high risk of having bacteriuria plus pyuria (63%). Diagnostic uncertainty still remains for the vast majority of residents who meet only one clinical feature. If validated in future cohorts, these clinical features with bacteriuria plus pyuria may serve as an evidence-based clinical definition of UTI to assist in management decisions. PMID:19490243

  19. Uptake of clinical trials in a palliative care setting: a retrospective cohort study.

    PubMed

    Eastman, Peter; Le, Brian; McCarthy, Gillian; Watt, James; Rosenthal, Mark

    2015-03-01

    There has been growth in the number of clinical trials conducted in the palliative care setting. However, issues exist regarding patient acceptance and vulnerability as well as the appropriateness of conducting trials in the dying patient. This study aimed to investigate the uptake of palliative care clinical trials at the Royal Melbourne Hospital, evaluate patient demographics for those enrolled onto study and assess the proportion of patients who died within 28 days of enrolling on a palliative care clinical trial. A retrospective cohort study of all patients prescreened and enrolled onto palliative care clinical trials by the Palliative Care Clinical Trials Team (PCCTT) at the Royal Melbourne Hospital over a 27-month period was undertaken. Of 515 patients referred to the PCCTT for consideration of trial enrollment, 64 (12.4%) were subsequently enrolled onto one of six clinical trials open during the study period. About 62.5% were non-cancer patients; 81.3% of all patients completed the trial intervention and 65.6% completed trial follow-up; 28.1% of patients enrolled died within 28 days of trial commencement. More than 500 patients were referred for assessment of clinical trial participation perhaps reflecting clinician acceptance of palliative care clinical trials. A number of enrolled patients were involved in trials during their terminal phase, indicating a willingness of participants to be involved, despite poor prognosis. © 2014 Wiley Publishing Asia Pty Ltd.

  20. Clinical Effect of Rebound Hyperthermia After Cooling Postcardiac Arrest: A Retrospective Cohort Study.

    PubMed

    Makker, Parth; Shimada, Yuichi J; Misra, Deepika; Kanei, Yumiko

    2016-10-26

    Therapeutic hypothermia is used in select patients after out-of-hospital cardiac arrest (OHCA) to improve neurologic outcome. Rebound hyperthermia (RH) is commonly observed post-treatment. Previous studies analyzing the association of RH with clinical outcome have reported conflicting results. The purpose of this study is to examine the impact of RH after completion of therapeutic hypothermia in patients postcardiac arrest. We analyzed a retrospective cohort from our institution. All adults who underwent therapeutic hypothermia post-OHCA were divided into two cohorts depending on the presence/absence of fever (T > 38°C) within 24 hours of completing hypothermia protocol. Clinical outcomes were analyzed at hospital discharge or death. Among 306 patients admitted with OHCA, 117 underwent hypothermia, 97 survived 24 hours postrewarming. Twenty-seven patients (50%) with RH died compared with 20 (47%) without RH (OR, 1.15; 95% CI, 0.52-2.57). Twenty-six patients (67%) with RH had a poor neurologic outcome compared with 27 (63%) without RH (OR 1.19, 95% CI, 0.51-2.74). RH is common after completion of therapeutic hypothermia in comatose patients due to cardiac arrest and is associated with poor neurologic outcomes. We found no significant clinical impact of rebound hypothermia on neurologic outcome or mortality, but our study was underpowered to reveal such impact if it exists.

  1. Dengue Infection in Children in Ratchaburi, Thailand: A Cohort Study. II. Clinical Manifestations

    PubMed Central

    Sirivichayakul, Chukiat; Limkittikul, Kriengsak; Chanthavanich, Pornthep; Jiwariyavej, Vithaya; Chokejindachai, Watcharee; Pengsaa, Krisana; Suvannadabba, Saravudh; Dulyachai, Wut; Letson, G. William; Sabchareon, Arunee

    2012-01-01

    Background Dengue infection is one of the most important mosquito-borne diseases. More data regarding the disease burden and the prevalence of each clinical spectrum among symptomatic infections and the clinical manifestations are needed. This study aims to describe the incidence and clinical manifestations of symptomatic dengue infection in Thai children during 2006 through 2008. Study Design This study is a school-based prospective open cohort study with a 9,448 person-year follow-up in children aged 3–14 years. Active surveillance for febrile illnesses was done in the studied subjects. Subjects who had febrile illness were asked to visit the study hospital for clinical and laboratory evaluation, treatment, and serological tests for dengue infection. The clinical data from medical records, diary cards, and data collection forms were collected and analyzed. Results Dengue infections were the causes of 12.1% of febrile illnesses attending the hospital, including undifferentiated fever (UF) (49.8%), dengue fever (DF) (39.3%) and dengue hemorrhagic fever (DHF) (10.9%). Headache, anorexia, nausea/vomiting and myalgia were common symptoms occurring in more than half of the patients. The more severe dengue spectrum (i.e., DHF) had higher temperature, higher prevalence of nausea/vomiting, abdominal pain, rash, diarrhea, petechiae, hepatomegaly and lower platelet count. DHF cases also had significantly higher prevalence of anorexia, nausea/vomiting and abdominal pain during day 3–6 and diarrhea during day 4–6 of illness. The absence of nausea/vomiting, abdominal pain, diarrhea, petechiae, hepatomegaly and positive tourniquet test may predict non-DHF. Conclusion Among symptomatic dengue infection, UF is most common followed by DF and DHF. Some clinical manifestations may be useful to predict the more severe disease (i.e., DHF). This study presents additional information in the clinical spectra of symptomatic dengue infection. PMID:22389735

  2. Effect of clinical and social risk factors on hospital profiling for stroke readmission: a cohort study.

    PubMed

    Keyhani, Salomeh; Myers, Laura J; Cheng, Eric; Hebert, Paul; Williams, Linda S; Bravata, Dawn M

    2014-12-02

    The Centers for Medicare & Medicaid Services (CMS) and Veterans Health Administration (VA) will report 30-day stroke readmission rates as a measure of hospital quality. A national debate on whether social risk factors should be included in models developed for hospital profiling is ongoing. To compare a CMS-based model of 30-day readmission with a more comprehensive model that includes measures of social risk (such as homelessness) or clinical factors (such as stroke severity and functional status). Data from a retrospective cohort study were used to develop a CMS-based 30-day readmission model that included age and comorbid conditions based on codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (model 1). This model was then compared with one that included administrative social risk factors (model 2). Finally, the CMS model (model 1) was compared with a model that included social risk and clinical factors from chart review (model 3). These 3 models were used to rank hospitals by 30-day risk-standardized readmission rates and examine facility rankings among the models. Hospitals in the VA. Patients hospitalized with stroke in 2007. 30-day readmission rates. The 30-day readmission rate was 12.8%. The c-statistics for the 3 models were 0.636, 0.646, and 0.661, respectively. All hospitals were classified as performing "as expected" using all 3 models (that is, performance did not differ from the VA national average); therefore, the addition of detailed clinical information or social risk factors did not alter assessment of facility performance. A predominantly male veteran cohort limits the generalizability of these findings. In the VA, more comprehensive models that included social risk and clinical factors did not affect hospital comparisons based on 30-day readmission rates. U.S. Department of Veterans Affairs.

  3. Randomized controlled trials 5: Determining the sample size and power for clinical trials and cohort studies.

    PubMed

    Greene, Tom

    2015-01-01

    Performing well-powered randomized controlled trials is of fundamental importance in clinical research. The goal of sample size calculations is to assure that statistical power is acceptable while maintaining a small probability of a type I error. This chapter overviews the fundamentals of sample size calculation for standard types of outcomes for two-group studies. It considers (1) the problems of determining the size of the treatment effect that the studies will be designed to detect, (2) the modifications to sample size calculations to account for loss to follow-up and nonadherence, (3) the options when initial calculations indicate that the feasible sample size is insufficient to provide adequate power, and (4) the implication of using multiple primary endpoints. Sample size estimates for longitudinal cohort studies must take account of confounding by baseline factors.

  4. Predictors of Undergraduate and Postgraduate Clinical Performance: A Longitudinal Cohort Study.

    PubMed

    Kim, Taeyeon; Chang, Ji-Young; Myung, Sun Jung; Chang, Yerim; Park, Kyung Duk; Park, Wan Beom; Shin, Chan Soo

    2016-01-01

    Though many medical schools applied various admission criteria in the selection process, the evidence of using those criteria is unclear. This study examined the predictive validity of each admission criterion for student competency. We conducted a prospective cohort study of all students who matriculated to Seoul National University School of Medicine from 2002 to 2008. Demographic characteristics, admission criteria scores, and clinical competencies based on grade point average (GPA), objective structured clinical examination score, and internship score were obtained for each student to analyze the predictive validity of admission criteria. Graduate GPA at the end of 4 years positively correlated with preadmission GPA (p < 0.0001) and written test score (p = 0.012) but negatively correlated with essay test (p = 0.049). Internship score significantly correlated with preadmission GPA and graduate GPA. Regression analysis revealed that the preadmission GPA of the affiliated college and young age at admission could predict GPA, and preadmission GPA and graduate GPA could predict the internship score, which indicates postgraduate clinical performance. These findings suggest that preadmission GPA is a reliable predictor of academic achievement during medical school and postgraduate clinical performance. For assessing nonacademic competencies, further research is needed. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  5. Novel molecular subgroups for clinical classification and outcome prediction in childhood medulloblastoma: a cohort study.

    PubMed

    Schwalbe, Edward C; Lindsey, Janet C; Nakjang, Sirintra; Crosier, Stephen; Smith, Amanda J; Hicks, Debbie; Rafiee, Gholamreza; Hill, Rebecca M; Iliasova, Alice; Stone, Thomas; Pizer, Barry; Michalski, Antony; Joshi, Abhijit; Wharton, Stephen B; Jacques, Thomas S; Bailey, Simon; Williamson, Daniel; Clifford, Steven C

    2017-07-01

    International consensus recognises four medulloblastoma molecular subgroups: WNT (MBWNT), SHH (MBSHH), group 3 (MBGrp3), and group 4 (MBGrp4), each defined by their characteristic genome-wide transcriptomic and DNA methylomic profiles. These subgroups have distinct clinicopathological and molecular features, and underpin current disease subclassification and initial subgroup-directed therapies that are underway in clinical trials. However, substantial biological heterogeneity and differences in survival are apparent within each subgroup, which remain to be resolved. We aimed to investigate whether additional molecular subgroups exist within childhood medulloblastoma and whether these could be used to improve disease subclassification and prognosis predictions. In this retrospective cohort study, we assessed 428 primary medulloblastoma samples collected from UK Children's Cancer and Leukaemia Group (CCLG) treatment centres (UK), collaborating European institutions, and the UKCCSG-SIOP-PNET3 European clinical trial. An independent validation cohort (n=276) of archival tumour samples was also analysed. We analysed samples from patients with childhood medulloblastoma who were aged 0-16 years at diagnosis, and had central review of pathology and comprehensive clinical data. We did comprehensive molecular profiling, including DNA methylation microarray analysis, and did unsupervised class discovery of test and validation cohorts to identify consensus primary molecular subgroups and characterise their clinical and biological significance. We modelled survival of patients aged 3-16 years in patients (n=215) who had craniospinal irradiation and had been treated with a curative intent. Seven robust and reproducible primary molecular subgroups of childhood medulloblastoma were identified. MBWNT remained unchanged and each remaining consensus subgroup was split in two. MBSHH was split into age-dependent subgroups corresponding to infant (<4·3 years; MBSHH-Infant; n=65) and

  6. Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study

    PubMed Central

    Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

    2015-01-01

    Study Objectives: To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Design: Cross-sectional cohort study. Setting: Sleep laboratory. Patients: Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Interventions: Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). Measurements and Results: The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m2. No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P < 0.02). UHMDRS correlated positively with the ESS score (P < 0.005), and negatively with the percentage of REM sleep. Conclusions: Patients with Huntington disease showed a severe sleep disruption and a high prevalence of periodic limb movements, but no evidence of sleep disordered breathing or REM sleep behavior disorder. Citation: Piano C, Losurdo A, Della Marca G, Solito M

  7. Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study

    PubMed Central

    SELLE, FRÉDÉRIC; EMILE, GEORGE; PAUTIER, PATRICIA; ASMANE, IRÈNE; SOARES, DANIELE G.; KHALIL, AHMED; ALEXANDRE, JEROME; LHOMMÉ, CATHERINE; RAY-COQUARD, ISABELLE; LOTZ, JEAN-PIERRE; GOLDWASSER, FRANÇOIS; TAZI, YOUSSEF; HEUDEL, PIERRE; PUJADE-LAURAINE, ERIC; GOUY, SÉBASTIEN; TREDAN, OLIVIER; BARBAZA, MARIE O.; ADY-VAGO, NORA; DUBOT, CORALINE

    2016-01-01

    The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease. PMID:26998090

  8. Safety of bevacizumab in clinical practice for recurrent ovarian cancer: A retrospective cohort study.

    PubMed

    Selle, Frédéric; Emile, George; Pautier, Patricia; Asmane, Irène; Soares, Daniele G; Khalil, Ahmed; Alexandre, Jerome; Lhommé, Catherine; Ray-Coquard, Isabelle; Lotz, Jean-Pierre; Goldwasser, François; Tazi, Youssef; Heudel, Pierre; Pujade-Lauraine, Eric; Gouy, Sébastien; Tredan, Olivier; Barbaza, Marie O; Ady-Vago, Nora; Dubot, Coraline

    2016-03-01

    The poor outcome of patients with recurrent ovarian cancer constitutes a continuous challenge for decision-making in clinical practice. In this setting, molecular targets have recently been identified, and novel compounds are now available. Bevacizumab has been introduced for the treatment of patients with ovarian cancer and is, to date, the most extensively investigated targeted therapy in this setting. However, potential toxicities are associated with the use of this monoclonal antibody. These toxicities have been reported in clinical trials, and can also be observed outside of trials. As limited data is currently available regarding the safety of bevacizumab treatment in daily clinical practice, the current retrospective study was designed to evaluate this. Data from 156 patients with recurrent ovarian cancer who had received bevacizumab treatment between January 2006 and June 2009 were retrospectively identified from the institutional records of five French centers. In contrast to clinical trials, the patients in the present study were not selected and had a heterogeneous profile according to their prior medical history, lines of treatment prior to bevacizumab introduction and number of relapses. The results first confirm the effect of heavy pretreatment on the occurrence of serious and fatal adverse events in clinical practice, as previously reported for clinical trials and for other retrospective cohort studies. Importantly, the data also demonstrates, for the first time, that medical history of hypertension is an independent predictive risk factor for the development of high-grade hypertension during bevacizumab treatment. These results thus suggest that treating physicians must consider all risk factors for managing bevacizumab toxicity prior to its introduction. Such risk factors include the time of bevacizumab introduction, a patient's history of hypertension and a low incidence of pre-existing obstructive disease.

  9. Clinical utility of corpus callosum measurements in head sonograms of preterm infants: a cohort study

    PubMed Central

    Perenyi, Agnes; Amodio, John; Katz, Joanne S; Stefanov, Dimitre G

    2013-01-01

    Objective To assess the clinical usefulness of measurement of corpus callosum (CC) size in head ultrasound (HUS) to predict short-term neurodevelopmental (ND) outcomes in preterm infants. We hypothesised that including CC measurements in routine HUS will be an additional tool for early identification of infants at risk of adverse short-term ND outcome, over and above the predictive power of perinatal morbidities. Design Retrospective cohort study. Setting Level III neonatal intensive care unit (NICU) and outpatient NICU follow-up clinic of an academic medical centre in New York City. Participants 929 HUS of 502 infants with gestational age of 23–36 weeks in African-American infants were initially studied. Exclusion criteria included those who died, had gross abnormalities in HUS, infants with race other than African-American, infants with suboptimal quality of HUS, late preterm infants and infants who did not participate in ND follow-up. A total of 173 infants completed the study. Interventions CC size (length and thickness) was measured in a subset of 87 infants who had routine HUS between 23 and 29 weeks (0–6 postnatal weeks). Relevant clinical variables were collected from chart reviews. ND assessments were completed in outpatient follow-up clinics. A statistical model was developed to assess the clinical utility and possible predictive value of CC measurements for adverse short-term ND outcome, while adjusting for perinatal morbidities. Primary and secondary outcome measures CC size and ND status. Results Measurements of CC size did not add substantial predictive power to predict short-term ND outcome beyond the information provided by the presence of morbidities related to prematurity. Conclusions No association was found between morbidities related to prematurity and short-term ND outcome and CC size in preterm infants. CC measurements in HUS early in life did not have an additional value in predicting short-term ND outcome, therefore did not seem to

  10. Productivity and Time Use during Occupational Therapy and Nutrition/Dietetics Clinical Education: A Cohort Study

    PubMed Central

    Rodger, Sylvia; Stephens, Elizabeth; Clark, Michele; Ash, Susan; Hurst, Cameron; Graves, Nicholas

    2012-01-01

    Background Currently in the Australian higher education sector higher productivity from allied health clinical education placements is a contested issue. This paper will report results of a study that investigated output changes associated with occupational therapy and nutrition/dietetics clinical education placements in Queensland, Australia. Supervisors’ and students’ time use during placements and how this changes for supervisors compared to when students are not present in the workplace is also presented. Methodology/Principal Findings A cohort design was used with students from four Queensland universities, and their supervisors employed by Queensland Health. There was an increasing trend in the number of occasions of service delivered when the students were present, and a statistically significant increase in the daily mean length of occasions of service delivered during the placement compared to pre-placement levels. Conclusions/Significance A novel method for estimating productivity and time use changes during clinical education programs for allied health disciplines has been applied. During clinical education placements there was a net increase in outputs, suggesting supervisors engage in longer consultations with patients for the purpose of training students, while maintaining patient numbers. Other activities were reduced. This paper is the first time these data have been shown in Australia and form a sound basis for future assessments of the economic impact of student placements for allied health disciplines. PMID:22952964

  11. HIV and cancer: a comparative retrospective study of Brazilian and U.S. clinical cohorts.

    PubMed

    Castilho, Jessica L; Luz, Paula M; Shepherd, Bryan E; Turner, Megan; Ribeiro, Sayonara R; Bebawy, Sally S; Netto, Juliana S; McGowan, Catherine C; Veloso, Valdiléa G; Engels, Eric A; Sterling, Timothy R; Grinsztejn, Beatriz

    2015-01-01

    With successful antiretroviral therapy, non-communicable diseases, including malignancies, are increasingly contributing to morbidity and mortality among HIV-infected persons. The epidemiology of AIDS-defining cancers (ADCs) and non-AIDS-defining cancers (NADCs) in HIV-infected populations in Brazil has not been well described. It is not known if cancer trends in HIV-infected populations in Brazil are similar to those of other countries where antiretroviral therapy is also widely available. We performed a retrospective analysis of clinical cohorts at Instituto Nacional de Infectologia Evandro Chagas (INI) in Rio de Janeiro and Vanderbilt Comprehensive Care Clinic (VCCC) in Nashville from 1998 to 2010. We used Poisson regression and standardized incidence ratios (SIRs) to examine incidence trends. Clinical and demographic predictors of ADCs and NADCs were examined using Cox proportional hazards models. This study included 2,925 patients at INI and 3,927 patients at VCCC. There were 57 ADCs at INI (65% Kaposi sarcoma), 47 at VCCC (40% Kaposi sarcoma), 45 NADCs at INI, and 82 at VCCC. From 1998 to 2004, incidence of ADCs remained statistically unchanged at both sites. From 2005 to 2010, ADC incidence decreased in both cohorts (INI incidence rate ratio per year = 0.74, p < 0.01; VCCC = 0.75, p < 0.01). Overall Kaposi sarcoma incidence was greater at INI than VCCC (3.0 vs. 1.2 cases per 1,000 person-years, p < 0.01). Incidence of NADCs remained constant throughout the study period (overall INI incidence 3.6 per 1,000 person-years and VCCC incidence 5.3 per 1,000 person-years). Compared to general populations, overall risk of NADCs was increased at both sites (INI SIR = 1.4 [95% CI 1.1-1.9] and VCCC SIR = 1.3 [1.0-1.7]). After non-melanoma skin cancers, the most frequent NADCs were anal cancer at INI (n = 7) and lung cancer at VCCC (n = 11). In multivariate models, risk of ADC was associated with male sex and immunosuppression. Risk of

  12. Lifestyle and clinical determinants of skin autofluorescence in a population-based cohort study.

    PubMed

    van Waateringe, Robert P; Slagter, Sandra N; van der Klauw, Melanie M; van Vliet-Ostaptchouk, Jana V; Graaff, Reindert; Paterson, Andrew D; Lutgers, Helen L; Wolffenbuttel, Bruce H R

    2016-05-01

    Skin autofluorescence (SAF) is a noninvasive marker of advanced glycation end products (AGEs). In diabetes, higher SAF levels have been positively associated with long-term complications, cardiovascular morbidity and mortality. Because little is known about the factors that influence SAF in nondiabetic individuals, we assessed the association of clinical and lifestyle parameters with SAF as well as their interactions in a large-scale, nondiabetic population and performed the same analysis in a type 2 diabetic subgroup. In a cross-sectional study in participants from the LifeLines Cohort Study, extensive clinical and biochemical phenotyping, including SAF measurement, was assessed in 9009 subjects of whom 314 (3·5%) subjects with type 2 diabetes. Mean SAF was 2·04 ± 0·44 arbitrary units (AU) in nondiabetic individuals and 2·44 ± 0·55 AU in type 2 diabetic subjects (P < 0·0001). Multivariate backward regression analysis showed that in the nondiabetic population, SAF was significantly and independently associated with age, BMI, HbA1c, creatinine clearance, genetic polymorphism in NAT2 (rs4921914), current smoking, pack-years of smoking and coffee consumption. In the type 2 diabetic group, a similar set of factors was associated with SAF, except for coffee consumption. In addition to the established literature on type 2 diabetes, we have demonstrated that SAF levels are associated with several clinical and lifestyle factors in the nondiabetic population. These parameters should be taken into consideration when using SAF as a screening or prediction tool for populations at risk for cardiovascular disease and diabetes. © 2016 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.

  13. Polysomnographic Findings and Clinical Correlates in Huntington Disease: A Cross-Sectional Cohort Study.

    PubMed

    Piano, Carla; Losurdo, Anna; Della Marca, Giacomo; Solito, Marcella; Calandra-Buonaura, Giovanna; Provini, Federica; Bentivoglio, Anna Rita; Cortelli, Pietro

    2015-09-01

    To evaluate the sleep pattern and the motor activity during sleep in a cohort of patients affected by Huntington disease (HD). Cross-sectional cohort study. Sleep laboratory. Thirty HD patients, 16 women and 14 men (mean age 57.3 ± 12.2 y); 30 matched healthy controls (mean age 56.5 ± 11.8 y). Subjective sleep evaluation: Epworth Sleepiness Scale (ESS); Berlin's Questionnaire, interview for restless legs syndrome (RLS), questionnaire for REM sleep behavior disorder (RBD). Clinical evaluation: disease duration, clinical severity (unified Huntington disease motor rating scale [UHDMRS]), genetic tests. Laboratory-based full-night attended video-polysomnography (V-PSG). The duration of the disease was 9.4 ± 4.4 y, UHMDRS score was 55.5 ± 23.4, CAG repeats were 44.3 ± 4.1. Body mass index was 21.9 ± 4.0 kg/m(2). No patients or caregivers reported poor sleep quality. Two patients reported symptoms of RLS. Eight patients had an ESS score ≥ 9. Eight patients had high risk of obstructive sleep apnea. At the RBD questionnaire, two patients had a pathological score. HD patients, compared to controls, showed shorter sleep, reduced sleep efficiency index, and increased arousals and awakenings. Four patients presented with sleep disordered breathing (SDB). Periodic limb movements (PLMs) during wake and sleep were observed in all patients. No episode of RBD was observed in the V-PSG recordings, and no patients showed rapid eye movement (REM) sleep without atonia. The disease duration correlated with ESS score (P < 0.02). UHMDRS correlated positively with the ESS score (P < 0.005), and negatively with the percentage of REM sleep. Patients with Huntington disease showed a severe sleep disruption and a high prevalence of periodic limb movements, but no evidence of sleep disordered breathing or REM sleep behavior disorder. © 2015 Associated Professional Sleep Societies, LLC.

  14. What we learnt from randomized clinical trials and cohort studies of antioxidant vitamin? Focus on vitamin E and cardiovascular disease.

    PubMed

    Ueda, Shinichiro; Yasunari, Kenichi

    2006-04-01

    There is no doubt that oxidative stress is pivotally involved in the process of atherosclerosis. Thus antioxidants, particularly vitamin E, have been expected to retard the development of atherosclerosis. In fact, several cohort studies suggested reduced cardiovascular risk in persons taking vitamin E supplements. However, randomized clinical trials of vitamin E did not show any benefit of vitamin E supplementation in terms of prevention of coronary heart disease and death. Discrepancy between cohort studies and randomized clinical trials may be partly explained by difference in coronary risk in study participant. However, use of vitamin E supplementation in low risk population has not been justified yet.

  15. Diabetes Is Associated with Worse Clinical Presentation in Tuberculosis Patients from Brazil: A Retrospective Cohort Study

    PubMed Central

    Hickson, Lucas S.; Daltro, Carla; Castro, Simone; Kornfeld, Hardy; Netto, Eduardo M.; Andrade, Bruno B.

    2016-01-01

    Background The rising prevalence of diabetes mellitus (DM) worldwide, especially in developing countries, and the persistence of tuberculosis (TB) as a major public health issue in these same regions, emphasize the importance of investigating this association. Here, we compared the clinical profile and disease outcomes of TB patients with or without coincident DM in a TB reference center in Brazil. Methods We performed a retrospective analysis of a TB patient cohort (treatment naïve) of 408 individuals recruited at a TB primary care center in Brazil between 2004 and 2010. Data on diagnosis of TB and DM were used to define the groups. The study groups were compared with regard to TB disease presentation at diagnosis as well as to clinical outcomes such as cure and mortality rates upon anti-tuberculosis therapy (ATT) initiation. A composite score utilizing clinical, radiological and microbiological parameters was used to compare TB severity between the groups. Results DM patients were older than non-diabetic TB patients. In addition, diabetic individuals more frequently presented with cough, night sweats, hemoptysis and malaise than those without DM. The overall pattern of lung lesions assessed by chest radiographic examination was similar between the groups. Compared to non-diabetic patients, those with TB-diabetes exhibited positive acid-fast bacilli in sputum samples more frequently at diagnosis and at 30 days after ATT initiation. Notably, higher values of the TB severity score were significantly associated with TB-diabetes comorbidity after adjustment for confounding factors. Moreover, during ATT, diabetic patients required more frequent transfers to TB reference hospitals for complex clinical management. Nevertheless, overall mortality and cure rates were indistinguishable between the study groups. Conclusions These findings reinforce the idea that diabetes negatively impacts pulmonary TB severity. Our study argues for the systematic screening for DM in TB

  16. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection.

    PubMed

    Delaney, Conor P; Craver, Christopher; Gibbons, Melinda M; Rachfal, Amy W; VandePol, Christine J; Cook, Suzanne F; Poston, Sara A; Calloway, Michael; Techner, Lee

    2012-04-01

    To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment. Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan--a peripherally acting μ-opioid receptor antagonist--accelerated gastrointestinal recovery after open BR. A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population). Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P ≤ 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P ≤ 0.0008 for each). On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved

  17. High risk clinical characteristics for subarachnoid haemorrhage in patients with acute headache: prospective cohort study.

    PubMed

    Perry, Jeffrey J; Stiell, Ian G; Sivilotti, Marco L A; Bullard, Michael J; Lee, Jacques S; Eisenhauer, Mary; Symington, Cheryl; Mortensen, Melodie; Sutherland, Jane; Lesiuk, Howard; Wells, George A

    2010-10-28

    To identify high risk clinical characteristics for subarachnoid haemorrhage in neurologically intact patients with headache. Multicentre prospective cohort study over five years. Six university affiliated tertiary care teaching hospitals in Canada. Data collected from November 2000 until November 2005. Neurologically intact adults with a non-traumatic headache peaking within an hour. Subarachnoid haemorrhage, as defined by any of subarachnoid haemorrhage on computed tomography of the head, xanthochromia in the cerebrospinal fluid, or red blood cells in the final sample of cerebrospinal fluid with positive results on angiography. Physicians completed data collection forms before investigations. In the 1999 patients enrolled there were 130 cases of subarachnoid haemorrhage. Mean (range) age was 43.4 (16-93), 1207 (60.4%) were women, and 1546 (78.5%) reported that it was the worst headache of their life. Thirteen of the variables collected on history and three on examination were reliable and associated with subarachnoid haemorrhage. We used recursive partitioning with different combinations of these variables to create three clinical decisions rules. All had 100% (95% confidence interval 97.1% to 100.0%) sensitivity with specificities from 28.4% to 38.8%. Use of any one of these rules would have lowered rates of investigation (computed tomography, lumbar puncture, or both) from the current 82.9% to between 63.7% and 73.5%. Clinical characteristics can be predictive for subarachnoid haemorrhage. Practical and sensitive clinical decision rules can be used in patients with a headache peaking within an hour. Further study of these proposed decision rules, including prospective validation, could allow clinicians to be more selective and accurate when investigating patients with headache.

  18. Complex fibroadenoma and breast cancer risk: a Mayo Clinic Benign Breast Disease Cohort Study.

    PubMed

    Nassar, Aziza; Visscher, Daniel W; Degnim, Amy C; Frank, Ryan D; Vierkant, Robert A; Frost, Marlene; Radisky, Derek C; Vachon, Celine M; Kraft, Ruth A; Hartmann, Lynn C; Ghosh, Karthik

    2015-09-01

    The purpose of this study is to examine the breast cancer risk overall among women with simple fibroadenoma or complex fibroadenoma and to examine the association of complex fibroadenoma with breast cancer through stratification of other breast cancer risks. The study included women aged 18-85 years from the Mayo Clinic Benign Breast Disease Cohort who underwent excisional breast biopsy from 1967 through 1991. Within this cohort, women who had fibroadenoma were compared to women who did not have fibroadenoma. Breast cancer risk (observed versus expected) across fibroadenoma levels was assessed through standardized incidence ratios (SIRs) by using age- and calendar-stratified incidence rates from the Iowa Surveillance, Epidemiology, and End Results registry. Analyses were performed overall, within subgroups of involution status, with other demographic characteristics (age, year of biopsy, indication for biopsy, and family history), and with histologic characteristics, including overall impression [nonproliferative disease, proliferative disease without atypia (PDWA), or atypical hyperplasia]. Fibroadenoma was identified in 2136 women [noncomplex, 1835 (85.9%); complex, 301 (14.1%)]. SIR for noncomplex fibroadenoma was 1.49 (95% CI 1.26-1.74); for complex fibroadenoma, it was 2.27 (95% CI 1.63-3.10) (test for heterogeneity in SIR, P = .02). However, women with complex fibroadenoma were more likely to have other, concomitant high-risk histologic characteristics (e.g., incomplete involution and PDWA). In analyses stratified by involution status and PDWA, complex fibroadenoma was not an independent risk marker for breast cancer. Complex fibroadenoma does not confer increased breast cancer risk beyond other established histologic characteristics.

  19. Microscopic colitis: a descriptive clinical cohort study of 795 patients with collagenous and lymphocytic colitis.

    PubMed

    Mellander, Marie-Rose; Ekbom, Anders; Hultcrantz, Rolf; Löfberg, Robert; Öst, Åke; Björk, Jan

    2016-01-01

    Microscopic colitis is a common cause of chronic diarrhoea in the Scandinavian countries. This report comprises demographic data, clinical and endoscopic features, and occurrence of coeliac and inflammatory bowel disease (IBD) in a large urban cohort of patients with lymphocytic colitis (LC) and collagenous colitis (CC). A total of 795 patients with microscopic colitis from two hospitals in Stockholm were included. Medical records were reviewed and clinical data, including endoscopic and histological findings, were compiled. Forty-three percent had CC (female:male ratio 3.7:1) and 57% had LC (female:male ratio 2.7:1). The mean age at diagnosis of CC was 63 years and of LC was 59 years (p = 0.005). Clinical features were similar in both entities, but the intensity of symptoms differed. Watery diarrhoea was reported in 55% in CC patients versus in 43% in LC patients (p = 0.0014), and nocturnal diarrhoea in 28% versus 18% (p = 0.002). Subtle endoscopic mucosal findings were reported in 37% of the CC patients and in 25% of the LC patients (p = 0.0011). Colorectal adenomatous polyps were found in 5.3% of all patients. Coeliac disease occurred in 6% and IBD occurred in 2.1% of all patients. Clinical features of LC and CC are similar but not identical. CC seems to be a more severe type of bowel inflammation and LC tends to occur earlier in life. Both forms might indeed feature endoscopic findings despite the designation 'microscopic'. Our study confirms the strong association with coeliac disease.

  20. Cost and clinical consequences of smoking cessation in outpatients after cardiovascular disease: a retrospective cohort study

    PubMed Central

    Sicras-Mainar, Antoni; Díaz-Cerezo, Silvia; de Burgoa, Verónica Sanz; Navarro-Artieda, Ruth

    2013-01-01

    This cohort retrospective study explored the cost and clinical consequences of smoking cessation in outpatients after cardiovascular events (CVEs), in Spain. A total of 2,540 patients (68.1 years; 60.7% male; 8.4% smokers, 52.9% ex-smokers, and 38.7% never smokers) fulfilling the selection criteria and followed up throughout a period of 36 months after the event were considered eligible for analysis. Total costs were higher among current smokers in comparison with ex-smokers and never smokers (€7,981 versus [vs] €7,322 and €5,619, respectively) (P < 0.001). Both health care costs (€6,273 vs €5,673 and €4,823, respectively) (P < 001) and loss of productivity at work costs (€1,708 vs €1,650 and €796, respectively) (P < 001) accounted for such differences. There was also a difference in CVE recurrence rates (18.6% vs 16.5% and 9.6%, respectively) (P < 01). Smoking cessation in CVE outpatients was associated with lower cost and risk of CVE recurrence compared with smokers, and their health status was similar to that of never smokers, in routine clinical practice in Spain. PMID:23983479

  1. Medical students' communication skills in clinical education: Results from a cohort study.

    PubMed

    Bachmann, Cadja; Roschlaub, Silke; Harendza, Sigrid; Keim, Rebecca; Scherer, Martin

    2017-10-01

    To assess students' communication skills during clinical medical education and at graduation. We conducted an observational cohort study from 2007 to 2011 with 26 voluntary undergraduate medical students at Hamburg University based on video-taped consultations in year four and at graduation. 176 consultations were analyzed quantitatively with validated and non-validated context-independent communication observation instruments (interrater reliability ≥0.8). Based on observational protocols each consultation was also documented in free-text comments, salient topics were extracted afterwards. 26 students, seven males, were enrolled in the survey. On average, graduates scored higher in differential-diagnostic questioning and time management but showed deficiencies in taking systematic and complete symptom-oriented histories, in communication techniques, in structuring consultations and in gathering the patients' perspectives. Patient-centeredness and empathy were rather low at graduation. Individual deficiencies could barely be eliminated. Medical students were able to enhance their clinical reasoning skills and their time management. Still, various communication deficiencies in final year students became evident regarding appropriate history taking, communication skills, empathy and patient-centeredness. The necessity of developing a longitudinal communication curriculum with enhanced communication trainings and assessments became evident. A curriculum should ensure that students' communication competencies are firmly achieved at graduation. Copyright © 2017. Published by Elsevier B.V.

  2. Cost and clinical consequences of smoking cessation in outpatients after cardiovascular disease: a retrospective cohort study.

    PubMed

    Sicras-Mainar, Antoni; Díaz-Cerezo, Silvia; de Burgoa, Verónica Sanz; Navarro-Artieda, Ruth

    2013-01-01

    This cohort retrospective study explored the cost and clinical consequences of smoking cessation in outpatients after cardiovascular events (CVEs), in Spain. A total of 2,540 patients (68.1 years; 60.7% male; 8.4% smokers, 52.9% ex-smokers, and 38.7% never smokers) fulfilling the selection criteria and followed up throughout a period of 36 months after the event were considered eligible for analysis. Total costs were higher among current smokers in comparison with ex-smokers and never smokers (€7,981 versus [vs] €7,322 and €5,619, respectively) (P < 0.001). Both health care costs (€6,273 vs €5,673 and €4,823, respectively) (P < 001) and loss of productivity at work costs (€1,708 vs €1,650 and €796, respectively) (P < 001) accounted for such differences. There was also a difference in CVE recurrence rates (18.6% vs 16.5% and 9.6%, respectively) (P < 01). Smoking cessation in CVE outpatients was associated with lower cost and risk of CVE recurrence compared with smokers, and their health status was similar to that of never smokers, in routine clinical practice in Spain.

  3. Clinical features and hospital outcomes in thyroid storm: a retrospective cohort study.

    PubMed

    Angell, Trevor E; Lechner, Melissa G; Nguyen, Caroline T; Salvato, Victoria L; Nicoloff, John T; LoPresti, Jonathan S

    2015-02-01

    Thyroid storm (TS) is a rare but life-threatening manifestation of thyrotoxicosis. Predictive features and outcomes remain incompletely understood, in part because studies comparing TS with hospitalized thyrotoxic patients have rarely been performed. Our objectives were to compare the diagnosis and outcomes in TS versus hospitalized compensated thyrotoxic (CT) patients and to assess differences in diagnostic classification using the Burch-Wartofsky scores (BWSs) or Akamizu (Ak) criteria for identifying TS. This was a retrospective cohort study of hospitalized patients during a 6-year period at an academic tertiary hospital, with age ≥ 18 years, TSH <0.01 mIU/L, and clinically diagnosed TS or CT. In-patient mortality, hospital and intensive care unit length of stay, intubation, and ventilator duration were assessed. Twenty-five TS and 125 CT patients were identified and analyzed. All but 1 TS patient received thionamides, β-blockade, glucocorticoids, and iodides within 24 hours of diagnosis. CT patients received thionamides and β-blockade alone. In the acute hospital setting, rates of fever (>100.4 °F), heart rate (>100 beats/min), altered mentation, and a precipitating event were all higher for TS than for CT patients. Altered mentation was the only clinical feature significantly different between TS and the subset of CT patients defined as TS by BWS or Ak criteria (P < .001). TS patients had greater in-patient mortality, hospital and intensive care unit length of stay, and ventilation requirements than CT patients. In acutely hospitalized thyrotoxic patients, the presence of central nervous system dysfunction distinguished clinically diagnosed TS from patients with BWS- or Ak-defined TS. Because TS patients had significantly worse outcomes in this study, thyrotoxic patients with possible TS and central nervous system dysfunction may derive the greatest benefit from aggressive supportive and TS-specific treatments.

  4. Clinical teaching performance improvement of faculty in residency training: A prospective cohort study.

    PubMed

    Van Der Leeuw, Renée M; Boerebach, Benjamin C M; Lombarts, Kiki M J M H; Heineman, Maas Jan; Arah, Onyebuchi A

    2016-05-01

    The purpose of this study is to investigate how aspects of a teaching performance evaluation system may affect faculty's teaching performance improvement as perceived by residents over time. Prospective multicenter cohort study conducted in The Netherlands between 1 September 2008 and 1 February 2013. Nine hundred and one residents and 1068 faculty of 65 teaching programs in 16 hospitals were invited to annually (self-) evaluate teaching performance using the validated, specialty-specific System for Evaluation of Teaching Qualities (SETQ). We used multivariable adjusted generalized estimating equations to analyze the effects of (i) residents' numerical feedback, (ii) narrative feedback, and (iii) faculty's participation in self-evaluation on residents' perception of faculty's teaching performance improvement. The average response rate over three years was 69% for faculty and 81% for residents. Higher numerical feedback scores were associated with residents rating faculty as having improved their teaching performance one year following the first measurement (regression coefficient, b: 0.077; 95% CI: 0.002-0.151; p = 0.045), but not after the second wave of receiving feedback and evaluating improvement. Receiving more suggestions for improvement was associated with improved teaching performance in subsequent years. Evaluation systems on clinical teaching performance appear helpful in enhancing teaching performance in residency training programs. High performing teachers also appear to improve in the perception of the residents.

  5. Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study.

    PubMed

    Thomas, Kim S; Ormerod, Anthony D; Craig, Fiona E; Greenlaw, Nicola; Norrie, John; Mitchell, Eleanor; Mason, James M; Johnston, Graham A; Wahie, Shyamal; Williams, Hywel C

    2016-11-01

    Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a prospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confidence interval, 96 days to ∞). Initial ulcer size was a significant predictor of time to healing (hazard ratio, 0.94 [95% confidence interval, 0.88-1.00); P = .043). Four patients (15%) had a recurrence. Our study did not include a randomized comparator. Topical therapy is potentially an effective first-line treatment for PG that avoids the possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  6. Reporting of clinically diagnosed dementia on death certificates: retrospective cohort study

    PubMed Central

    Perera, Gayan; Stewart, Robert; Higginson, Irene J.; Sleeman, Katherine E.

    2016-01-01

    Background: mortality statistics are a frequently used source of information on deaths in dementia but are limited by concerns over accuracy. Objective: to investigate the frequency with which clinically diagnosed dementia is recorded on death certificates, including predictive factors. Methods: a retrospective cohort study assembled using a large mental healthcare database in South London, linked to Office for National Statistics mortality data. People with a clinical diagnosis of dementia, aged 65 or older, who died between 2006 and 2013 were included. The main outcome was death certificate recording of dementia. Results: in total, 7,115 people were identified. Dementia was recorded on 3,815 (53.6%) death certificates. Frequency of dementia recording increased from 39.9% (2006) to 63.0% (2013) (odds ratio (OR) per year increment 1.11, 95% CI 1.07–1.15). Recording of dementia was more likely if people were older (OR per year increment 1.02, 95% CI 1.01–1.03), and for those who died in care homes (OR 1.89, 95% CI 1.50–2.40) or hospitals (OR 1.14, 95% CI 1.03–1.46) compared with home, and less likely for people with less severe cognitive impairment (OR 0.95, 95% CI 0.94–0.96), and if the diagnosis was Lewy body (OR 0.30, 95% CI 0.15–0.62) or vascular dementia (OR 0.79, 95% CI 0.68–0.93) compared with Alzheimer's disease. Conclusions: changes in certification practices may have contributed to the rise in recorded prevalence of dementia from mortality data. However, mortality data still considerably underestimate the population burden of dementia. Potential biases affecting recording of dementia need to be taken into account when interpreting mortality data. PMID:27146301

  7. Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study

    PubMed Central

    Little, Paul; Hobbs, FD Richard; Mant, David; McNulty, Cliodna AM; Mullee, Mark

    2012-01-01

    Background Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs. Aim To assess the incidence and clinical variables associated with streptococcal infections. Design and setting Prospective diagnostic cohort study in UK primary care. Method The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat. Results Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient’s assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors’ assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42). Conclusion Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting. PMID:23211183

  8. Incidence and clinical variables associated with streptococcal throat infections: a prospective diagnostic cohort study.

    PubMed

    Little, Paul; Hobbs, F D Richard; Mant, David; McNulty, Cliodna A M; Mullee, Mark

    2012-11-01

    Management of pharyngitis is commonly based on features which are thought to be associated with Lancefield group A beta-haemolytic streptococci (GABHS) but it is debatable which features best predict GABHS. Non-group A strains share major virulence factors with group A, but it is unclear how commonly they present and whether their presentation differs. To assess the incidence and clinical variables associated with streptococcal infections. Prospective diagnostic cohort study in UK primary care. The presence of pathogenic streptococci from throat swabs was assessed among patients aged ≥5 years presenting with acute sore throat. Pathogenic streptococci were found in 204/597 patients (34%, 95% CI = 31 to 38%): 33% (68/204) were non-group A streptococci, mostly C (n = 29), G (n = 18) and B (n = 17); rarely D (n = 3) and Streptococcus pneumoniae (n = 1). Patients presented with similar features whether the streptococci were group A or non-group A. The features best predicting A, C or G beta-haemolytic streptococci were patient's assessment of severity (odds ratio [OR] for a bad sore throat 3.31, 95% CI = 1.24 to 8.83); doctors' assessment of severity (severely inflamed tonsils OR 2.28, 95% CI = 1.39 to 3.74); absence of a bad cough (OR 2.73, 95% CI = 1.56 to 4.76), absence of a coryza (OR 1.54, 95% CI = 0.99 to 2.41); and moderately bad or worse muscle aches (OR 2.20, 95% CI = 1.41 to 3.42). Non-group A strains commonly cause streptococcal sore throats, and present with similar symptomatic clinical features to group A streptococci. The best features to predict streptococcal sore throat presenting in primary care deserve revisiting.

  9. Clinical and social outcomes of adolescent self harm: population based birth cohort study

    PubMed Central

    Heron, Jon; Crane, Catherine; Hawton, Keith; Lewis, Glyn; Macleod, John; Tilling, Kate; Gunnell, David

    2014-01-01

    Objectives To investigate the mental health, substance use, educational, and occupational outcomes of adolescents who self harm in a general population sample, and to examine whether these outcomes differ according to self reported suicidal intent. Design Population based birth cohort study. Setting Avon Longitudinal Study of Parents and Children (ALSPAC), a UK birth cohort of children born in 1991-92. Participants Data on lifetime history of self harm with and without suicidal intent were available for 4799 respondents who completed a detailed self harm questionnaire at age 16 years. Multiple imputation was used to account for missing data. Main outcome measures Mental health problems (depression and anxiety disorder), assessed using the clinical interview schedule-revised at age 18 years, self reported substance use (alcohol, cannabis, cigarette smoking, and illicit drugs) at age 18 years, educational attainment at age 16 and 19 years, occupational outcomes at age 19 years, and self harm at age 21 years. Results Participants who self harmed with and without suicidal intent at age 16 years were at increased risk of developing mental health problems, future self harm, and problem substance misuse, with stronger associations for suicidal self harm than for non-suicidal self harm. For example, in models adjusted for confounders the odds ratio for depression at age 18 years was 2.21 (95% confidence interval 1.55 to 3.15) in participants who had self harmed without suicidal intent at age 16 years and 3.94 (2.67 to 5.83) in those who had self harmed with suicidal intent. Suicidal self harm, but not self harm without suicidal intent, was also associated with poorer educational and employment outcomes. Conclusions Adolescents who self harm seem to be vulnerable to a range of adverse outcomes in early adulthood. Risks were generally stronger in those who had self harmed with suicidal intent, but outcomes were also poor among those who had self harmed without suicidal

  10. Predicting clinical instability of older patients in post-acute care units: a nationwide cohort study.

    PubMed

    Lee, Wei-Ju; Chou, Ming-Yueh; Peng, Li-Ning; Liang, Chih-Kuang; Liu, Li-Kuo; Liu, Chien-Liang; Chen, Liang-Kung; Wu, Yung-Hung

    2014-04-01

    Although patients admitted to post-acute care (PAC) units are usually clinically stable, unexpected medical conditions requiring acute ward readmissions still occur and can jeopardize the clinical effectiveness of PAC services. The main purpose of the present study was to evaluate predictive factors for clinical instability of patients in PAC units to improve the quality of PAC services. This was a nationwide multicenter cohort study that recruited patients from five PAC units in Taiwan between July 2007 and June 2009. All patients received the comprehensive geriatric assessment (CGA) within 72 h of PAC unit admissions. Conditions requiring acute ward re-admissions from PAC units were defined as clinical instability. Causes of clinical instability for all patients and data of CGA were collected for analysis. Of 918 enrolled participants, 119 (12.9%) experienced acute ward readmissions, including 106 (89.1%) admissions related to medical conditions and 13 (10.9%) for surgical causes. Common conditions included diseases of the respiratory system (n = 32, 26.9%), genitourinary system (n = 24, 20.2%) and digestive system (n = 14, 11.8%). Surgical conditions, mainly fractures and dislocation of upper limbs, were significantly more likely to occur later (P = 0.05) in the PAC unit admissions than medical conditions. Compared with the non-readmission group, the readmission group was leaner (mean body mass index 21.1 ± 2.8 vs 22.0 ± 3.8 kg/m(2) , P = 0.007), having poorer functional status (mean Barthel Index 41.0 ± 19.4 vs 45.4 ± 20.3, P = 0.02; mean IADL: 1.3 ± 1.6 vs 1.7 ± 1.8, P = 0.016), poorer cognitive function (mean Mini-Mental State Examination: 16.8 ± 6.4 vs 18.3 ± 6.4, P = 0.022), poorer ambulation (mean Timed Up & Go test 32.7 ± 18.7 vs 26.6 ± 11.7 s, P = 0.039) and poorer nutritional status (mean Mini-Nutrition Assessment 13.3 ± 5.7 vs 15.4 ± 5.8, P < 0

  11. Clinically relevant quality measures for risk factor control in primary care: a retrospective cohort study.

    PubMed

    Weiler, Stefan; Gemperli, Armin; Collet, Tinh-Hai; Bauer, Douglas C; Zimmerli, Lukas; Cornuz, Jacques; Battegay, Edouard; Gaspoz, Jean-Michel; Kerr, Eve A; Aujesky, Drahomir; Rodondi, Nicolas

    2014-07-15

    Assessment of the proportion of patients with well controlled cardiovascular risk factors underestimates the proportion of patients receiving high quality of care. Evaluating whether physicians respond appropriately to poor risk factor control gives a different picture of quality of care. We assessed physician response to control cardiovascular risk factors, as well as markers of potential overtreatment in Switzerland, a country with universal healthcare coverage but without systematic quality monitoring, annual report cards on quality of care or financial incentives to improve quality. We performed a retrospective cohort study of 1002 randomly selected patients aged 50-80 years from four university primary care settings in Switzerland. For hypertension, dyslipidemia and diabetes mellitus, we first measured proportions in control, then assessed therapy modifications among those in poor control. "Appropriate clinical action" was defined as a therapy modification or return to control without therapy modification within 12 months among patients with baseline poor control. Potential overtreatment of these conditions was defined as intensive treatment among low-risk patients with optimal target values. 20% of patients with hypertension, 41% with dyslipidemia and 36% with diabetes mellitus were in control at baseline. When appropriate clinical action in response to poor control was integrated into measuring quality of care, 52 to 55% had appropriate quality of care. Over 12 months, therapy of 61% of patients with baseline poor control was modified for hypertension, 33% for dyslipidemia, and 85% for diabetes mellitus. Increases in number of drug classes (28-51%) and in drug doses (10-61%) were the most common therapy modifications. Patients with target organ damage and higher baseline values were more likely to have appropriate clinical action. We found low rates of potential overtreatment with 2% for hypertension, 3% for diabetes mellitus and 3-6% for dyslipidemia. In

  12. Clinical features and prognostic factors of listeriosis: the MONALISA national prospective cohort study.

    PubMed

    Charlier, Caroline; Perrodeau, Élodie; Leclercq, Alexandre; Cazenave, Benoît; Pilmis, Benoît; Henry, Benoît; Lopes, Amanda; Maury, Mylène M; Moura, Alexandra; Goffinet, François; Dieye, Hélène Bracq; Thouvenot, Pierre; Ungeheuer, Marie-Noëlle; Tourdjman, Mathieu; Goulet, Véronique; de Valk, Henriette; Lortholary, Olivier; Ravaud, Philippe; Lecuit, Marc

    2017-05-01

    Listeriosis is a severe foodborne infection and a notifiable disease in France. We did a nationwide prospective study to characterise its clinical features and prognostic factors. MONALISA was a national prospective observational cohort study. We enrolled eligible cases declared to the National Reference Center for Listeria (all microbiologically proven) between Nov 3, 2009, and July 31, 2013, in the context of mandatory reporting. The outcomes were analysis of clinical features, characterisation of Listeria isolates, and determination of predictors of 3-month mortality or persisting impairment using logistic regression. A hierarchical clustering on principal components was also done for neurological and bacteraemic cases. The study is registered at ClinicalTrials.gov, number NCT01520597. We enrolled 818 cases from 372 centres, including 107 maternal-neonatal infections, 427 cases of bacteraemia, and 252 cases of neurolisteriosis. Only five (5%) of 107 pregnant women had an uneventful outcome. 26 (24%) of 107 mothers experienced fetal loss, but never after 29 weeks of gestation or beyond 2 days of admission to hospital. Neurolisteriosis presented as meningoencephalitis in 212 (84%) of 252 patients; brainstem involvement was only reported in 42 (17%) of 252 patients. 3-month mortality was higher for bacteraemia than neurolisteriosis (hazard ratio [HR] 0·54 [95% CI 0·41-0·69], p<0·0001). For both bacteraemia and neurolisteriosis, the strongest mortality predictors were ongoing cancer (odds ratio [OR] 5·19 [95% CI 3·01-8·95], p<0·0001), multi-organ failure (OR 7·98 [4·32-14·72], p<0·0001), aggravation of any pre-existing organ dysfunction (OR 4·35 [2·79-6·81], p<0·0001), and monocytopenia (OR 3·70 [1·82-7·49], p=0·0003). Neurolisteriosis mortality was higher in blood-culture positive patients (OR 3·67 [1·60-8·40], p=0·002) or those receiving adjunctive dexamethasone (OR 4·58 [1·50-13·98], p=0·008). The severity of listeriosis is higher than

  13. Publication bias: evidence of delayed publication in a cohort study of clinical research projects.

    PubMed Central

    Stern, J. M.; Simes, R. J.

    1997-01-01

    OBJECTIVES: To determine the extent to which publication is influenced by study outcome. DESIGN: A cohort of studies submitted to a hospital ethics committee over 10 years were examined retrospectively by reviewing the protocols and by questionnaire. The primary method of analysis was Cox's proportional hazards model. SETTING: University hospital, Sydney, Australia. STUDIES: 748 eligible studies submitted to Royal Prince Alfred Hospital Ethics Committee between 1979 and 1988. MAIN OUTCOME MEASURES: Time to publication. RESULTS: Response to the questionnaire was received for 520 (70%) of the eligible studies. Of the 218 studies analysed with tests of significance, those with positive results (P < 0.05) were much more likely to be published than those with negative results (P > or = 0.10) (hazard ratio 2.32 (95% confidence interval 1.47 to 3.66), P = 0.0003), with a significantly shorter time to publication (median 4.8 v 8.0 years). This finding was even stronger for the group of 130 clinical trials (hazard ratio 3.13 (1.76 to 5.58). P = 0.0001), with median times to publication of 4.7 and 8.0 years respectively. These results were not materially changed after adjusting for other significant predictors of publication. Studies with indefinite conclusions (0.05 < or = P < 0.10) tended to have an even lower publication rate and longer time to publication than studies with negative results (hazard ratio 0.39 (0.13 to 1.12), P = 0.08). For the 103 studies in which outcome was rated qualitatively, there was no clear cut evidence of publication bias, although the number of studies in this group was not large. CONCLUSIONS: This study confirms the evidence of publication bias found in other studies and identifies delay in publication as an additional important factor. The study results support the need for prospective registration of trials to avoid publication bias and also support restricting the selection of trials to those started before a common date in undertaking

  14. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study.

    PubMed

    Saloom, H F; Papageorgiou, S N; Carpenter, G H; Cobourne, M T

    2017-05-01

    Obesity is a widespread chronic inflammatory disorder characterized by an increased overall disease burden and significant association with periodontitis. The aim of this prospective clinical cohort study was to investigate the effect of obesity on orthodontic tooth movement. Fifty-five adolescent patients (27 males, 28 females) with a mean (SD) age of 15.1 (1.7) years and mean (SD) body mass index (BMI) of 30.2 (3.5) kg/m(2) in obese and 19.4 (2.2) kg/m(2) in normal-weight groups were followed from start of treatment to completion of tooth alignment with fixed orthodontic appliances. Primary outcome was time taken to complete tooth alignment, while secondary outcomes included rate of tooth movement and change in clinical parameters (plaque/gingival indices, unstimulated whole-mouth salivary flow rate, gingival crevicular fluid biomarkers). Data collection took place at baseline (start of treatment: appliance placement), 1 h and 1 wk following appliance placement, and completion of alignment. Results were analyzed by descriptive statistics followed by generalized estimating equation regression modeling. There were no significant differences between groups in time taken to achieve tooth alignment (mean [SD] 158.7 [75.3] d; P = 0.486). However, at 1 wk, initial tooth displacement was significantly increased in the obese group ( P < 0.001), and after adjusting for confounders, obese patients had a significantly higher rate of tooth movement compared with normal-weight patients (+0.017 mm/d; 95% confidence interval, 0.008-0.025; P < 0.001) over the period of alignment. Explorative analyses indicated that levels of the adipokines leptin and resistin, the inflammatory marker myeloperoxidase (MPO), and the cytokine receptor for nuclear factor kappa-B ligand (RANKL) were significantly different between obese- and normal-weight patients and associated with observed rates of tooth movement. This represents the first prospective data demonstrating a different response in

  15. Chlamydia trachomatis re-infection in Spain: A STI clinic-based cohort study.

    PubMed

    López-de-Munain, Josefina; Cámara-Pérez, Maria Del Mar; Imaz-Pérez, Manuel; Pereda-Berroeta, Javier; López-Azcarreta, Iñigo; Muñoz-Sánchez, Josefa; Cisterna-Cáncer, Ramón; Ferrero-Beneitez, Oscar Luis; Ibarra-Ugarte, Sofia; Zubero-Sulibarria, Zuriñe; Baraia-Etxaburu Artetxe, Josu Mirena

    2017-03-01

    Chlamydia trachomatis (C. trachomatis) is the most frequently reported sexually transmitted infection (STI) in developed countries, but there is a lack data on its incidence and population dynamics in Spain. The objectives of this study were to estimate the incidence of C. trachomatis in patients seeking medical attention in an STI clinic with a defined population catchment area, to identify factors associated with this infection, and to explore differences between factors associated with new infections and re-infections. A retrospective study was conducted on a cohort of patients from a STI clinic who underwent chlamydia testing at least twice between 2007 and 2015. Of the 2633 patients who met study selection criteria, 795 (30.2%) tested positive for C. trachomatis at baseline (baseline Chlamydia). The overall incidence was 7.97/100 person-years (95% CI: 7.2-8.8): 5.9/100 person-years (95% CI: 5.2-6.7) among patients testing negative for C. trachomatis at baseline, and 18.3 person-years (95% CI: 15.6-21.5) among those testing positive at baseline. In multivariate analysis, the factors independently associated with overall incidence were a history of infection with C. trachomatis in the previous 6 months (hazard ratio=3.6; 95% CI: 2.3-5.4), younger age (HR <20 vs ≥35 years=5.5; 95% CI: 3.2-9.5), male sex, 2 or more sexual partners in the previous month and year, and inconsistent condom use. Guidelines should be established for C. trachomatis in Spain, including recommendations on the need for follow-up and re-testing, independently of age. Though data concerning the optimal timing of re-testing are inconclusive, our findings support the establishment of a 3-6 month interval. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

  16. Clinical and molecular characterisation of hereditary dopamine transporter deficiency syndrome: an observational cohort and experimental study.

    PubMed

    Kurian, Manju A; Li, Yan; Zhen, Juan; Meyer, Esther; Hai, Nebula; Christen, Hans-Jürgen; Hoffmann, Georg F; Jardine, Philip; von Moers, Arpad; Mordekar, Santosh R; O'Callaghan, Finbar; Wassmer, Evangeline; Wraige, Elizabeth; Dietrich, Christa; Lewis, Timothy; Hyland, Keith; Heales, Simon; Sanger, Terence; Gissen, Paul; Assmann, Birgit E; Reith, Maarten E A; Maher, Eamonn R

    2011-01-01

    dopamine transporter deficiency syndrome is the first identified parkinsonian disorder caused by genetic alterations of the dopamine transporter. We describe a cohort of children with mutations in the gene encoding the dopamine transporter (SLC6A3) with the aim to improve clinical and molecular characterisation, reduce diagnostic delay and misdiagnosis, and provide insights into the pathophysiological mechanisms. 11 children with a biochemical profile suggestive of dopamine transporter deficiency syndrome were enrolled from seven paediatric neurology centres in the UK, Germany, and the USA from February, 2009, and studied until June, 2010. The syndrome was characterised by detailed clinical phenotyping, biochemical and neuroradiological studies, and SLC6A3 mutation analysis. Mutant constructs of human dopamine transporter were used for in-vitro functional analysis of dopamine uptake and cocaine-analogue binding. children presented in infancy (median age 2·5 months, range 0·5-7) with either hyperkinesia (n=5), parkinsonism (n=4), or a mixed hyperkinetic and hypokinetic movement disorder (n=2). Seven children had been initially misdiagnosed with cerebral palsy. During childhood, patients developed severe parkinsonism-dystonia associated with an eye movement disorder and pyramidal tract features. All children had raised ratios of homovanillic acid to 5-hydroxyindoleacetic acid in cerebrospinal fluid, of range 5·0-13·2 (normal range 1·3-4·0). Homozygous or compound heterozygous SLC6A3 mutations were detected in all cases. Loss of function in all missense variants was recorded from in-vitro functional studies, and was supported by the findings of single photon emission CT DaTSCAN imaging in one patient, which showed complete loss of dopamine transporter activity in the basal nuclei. dopamine transporter deficiency syndrome is a newly recognised, autosomal recessive disorder related to impaired dopamine transporter function. Careful characterisation of patients

  17. Clinical and molecular characterisation of hereditary dopamine transporter deficiency syndrome: an observational cohort and experimental study

    PubMed Central

    Kurian, Manju A; Li, Yan; Zhen, Juan; Meyer, Esther; Hai, Nebula; Christen, Hans-Jürgen; Hoffmann, Georg F; Jardine, Philip; von Moers, Arpad; Mordekar, Santosh R; O'Callaghan, Finbar; Wassmer, Evangeline; Wraige, Elizabeth; Dietrich, Christa; Lewis, Timothy; Hyland, Keith; Heales, Simon JR; Sanger, Terence; Gissen, Paul; Assmann, Birgit E; Reith, Maarten EA; Maher, Eamonn R

    2010-01-01

    Summary Background Dopamine transporter deficiency syndrome is the first identified parkinsonian disorder caused by genetic alterations of the dopamine transporter. We describe a cohort of children with mutations in the gene encoding the dopamine transporter (SLC6A3) with the aim to improve clinical and molecular characterisation, reduce diagnostic delay and misdiagnosis, and provide insights into the pathophysiological mechanisms. Methods 11 children with a biochemical profile suggestive of dopamine transporter deficiency syndrome were enrolled from seven paediatric neurology centres in the UK, Germany, and the USA from February, 2009, and studied until June, 2010. The syndrome was characterised by detailed clinical phenotyping, biochemical and neuroradiological studies, and SLC6A3 mutation analysis. Mutant constructs of human dopamine transporter were used for in-vitro functional analysis of dopamine uptake and cocaine-analogue binding. Findings Children presented in infancy (median age 2·5 months, range 0·5–7) with either hyperkinesia (n=5), parkinsonism (n=4), or a mixed hyperkinetic and hypokinetic movement disorder (n=2). Seven children had been initially misdiagnosed with cerebral palsy. During childhood, patients developed severe parkinsonism-dystonia associated with an eye movement disorder and pyramidal tract features. All children had raised ratios of homovanillic acid to 5-hydroxyindoleacetic acid in cerebrospinal fluid, of range 5·0–13·2 (normal range 1·3–4·0). Homozygous or compound heterozygous SLC6A3 mutations were detected in all cases. Loss of function in all missense variants was recorded from in-vitro functional studies, and was supported by the findings of single photon emission CT DaTSCAN imaging in one patient, which showed complete loss of dopamine transporter activity in the basal nuclei. Interpretation Dopamine transporter deficiency syndrome is a newly recognised, autosomal recessive disorder related to impaired dopamine

  18. Relevance of anxiety in clinical practice of Guillain-Barre syndrome: a cohort study.

    PubMed

    Sharshar, Tarek; Polito, Andrea; Porcher, Raphaël; Merhbene, Takoua; Blanc, Morgane; Antona, Marion; Durand, Marie-Christine; Friedman, Diane; Orlikowski, David; Annane, Djillali; Marcadet, Marie-Hélène

    2012-01-01

    Illness is often associated with anxiety, but few data exist about the prognostic significance of this phenomenon. To address this issue, we assessed whether patient anxiety is associated with subsequent need for intubation in Guillain-Barré syndrome (GBS). Incident case-cohort study. Acute secondary care in a teaching hospital (France) from 2006 to 2010. 110 adult GBS patients. Either language barrier or cognitive decline that precluded understanding was considered as exclusion criteria. Acute respiratory failure. At admission, anxiety and clinical factors (including known predictors of respiratory failure: delay between GBS onset and admission, inability to lift head, vital capacity (VC)) were assessed and related to subsequent need for mechanical ventilation (MV). Anxiety was assessed using a Visual Analogical Scale (VAS), the State Anxiety Inventory form Y1 (STAI-Y1) score and a novel-specific questionnaire, evaluating fears potentially triggered by GBS. Patients were asked to choose which they found most stressful from weakness, pain, breathlessness and uncertainty. 23 (22%) were subsequently ventilated. Mean STAI-Y1 was 47.2 (range 22-77) and anxiety VAS 5.2 (range 0-10). STAI was above 60/80 in 22 (21%) patients and anxiety VAS above 7/10 in 28 (27%) patients. Fear of remaining paralysed, uncertainty as to how the disease would progress and fear of intubation were the most stressful. Factors significantly associated with anxiety were weakness and bulbar dysfunction. STAI-Y1 was higher and uncertainty more frequent in subsequently ventilated patients, who had shorter onset-admission delay and greater weakness but not a lower VC. Uncertainty was independently associated with subsequent MV. Early management of patients with GBS should evaluate anxiety and assess its causes both to adjust psychological support and to anticipate subsequent deterioration.

  19. Relevance of anxiety in clinical practice of Guillain-Barré syndrome: a cohort study

    PubMed Central

    Sharshar, Tarek; Polito, Andrea; Porcher, Raphaël; Merhbene, Takoua; Blanc, Morgane; Antona, Marion; Durand, Marie-Christine; Friedman, Diane; Orlikowski, David; Annane, Djillali; Marcadet, Marie-Hélène

    2012-01-01

    Objectives Illness is often associated with anxiety, but few data exist about the prognostic significance of this phenomenon. To address this issue, we assessed whether patient anxiety is associated with subsequent need for intubation in Guillain-Barré syndrome (GBS). Design Incident case-cohort study. Setting Acute secondary care in a teaching hospital (France) from 2006 to 2010. Participants 110 adult GBS patients. Either language barrier or cognitive decline that precluded understanding was considered as exclusion criteria. Primary outcome Acute respiratory failure. Interventions At admission, anxiety and clinical factors (including known predictors of respiratory failure: delay between GBS onset and admission, inability to lift head, vital capacity (VC)) were assessed and related to subsequent need for mechanical ventilation (MV). Anxiety was assessed using a Visual Analogical Scale (VAS), the State Anxiety Inventory form Y1 (STAI-Y1) score and a novel-specific questionnaire, evaluating fears potentially triggered by GBS. Patients were asked to choose which they found most stressful from weakness, pain, breathlessness and uncertainty. Results 23 (22%) were subsequently ventilated. Mean STAI-Y1 was 47.2 (range 22–77) and anxiety VAS 5.2 (range 0–10). STAI was above 60/80 in 22 (21%) patients and anxiety VAS above 7/10 in 28 (27%) patients. Fear of remaining paralysed, uncertainty as to how the disease would progress and fear of intubation were the most stressful. Factors significantly associated with anxiety were weakness and bulbar dysfunction. STAI-Y1 was higher and uncertainty more frequent in subsequently ventilated patients, who had shorter onset-admission delay and greater weakness but not a lower VC. Uncertainty was independently associated with subsequent MV. Conclusions Early management of patients with GBS should evaluate anxiety and assess its causes both to adjust psychological support and to anticipate subsequent deterioration. PMID:22923622

  20. Early sedation and clinical outcomes of mechanically ventilated patients: a prospective multicenter cohort study

    PubMed Central

    2014-01-01

    Introduction Sedation overuse is frequent and possibly associated with poor outcomes in the intensive care unit (ICU) patients. However, the association of early oversedation with clinical outcomes has not been thoroughly evaluated. The aim of this study was to assess the association of early sedation strategies with outcomes of critically ill adult patients under mechanical ventilation (MV). Methods A secondary analysis of a multicenter prospective cohort conducted in 45 Brazilian ICUs, including adult patients requiring ventilatory support and sedation in the first 48 hours of ICU admissions, was performed. Sedation depth was evaluated after 48 hours of MV. Multivariate analysis was used to identify variables associated with hospital mortality. Results A total of 322 patients were evaluated. Overall, ICU and hospital mortality rates were 30.4% and 38.8%, respectively. Deep sedation was observed in 113 patients (35.1%). Longer duration of ventilatory support was observed (7 (4 to 10) versus 5 (3 to 9) days, P = 0.041) and more tracheostomies were performed in the deep sedation group (38.9% versus 22%, P = 0.001) despite similar PaO2/FiO2 ratios and acute respiratory distress syndrome (ARDS) severity. In a multivariate analysis, age (Odds Ratio (OR) 1.02; 95% confidence interval (CI) 1.00 to 1.03), Charlson Comorbidity Index >2 (OR 2.06; 95% CI, 1.44 to 2.94), Simplified Acute Physiology Score 3 (SAPS 3) score (OR 1.02; CI 95%, 1.00 to 1.04), severe ARDS (OR 1.44; CI 95%, 1.09 to 1.91) and deep sedation (OR 2.36; CI 95%, 1.31 to 4.25) were independently associated with increased hospital mortality. Conclusions Early deep sedation is associated with adverse outcomes and constitutes an independent predictor of hospital mortality in mechanically ventilated patients. PMID:25047960

  1. Immune thrombocytopenia in adults: a prospective cohort study of clinical features and predictors of outcome

    PubMed Central

    Grimaldi-Bensouda, Lamiae; Nordon, Clémentine; Michel, Marc; Viallard, Jean-François; Adoue, Daniel; Magy-Bertrand, Nadine; Durand, Jean-Marc; Quittet, Philippe; Fain, Olivier; Bonnotte, Bernard; Morin, Anne-Sophie; Morel, Nathalie; Costedoat-Chalumeau, Nathalie; Pan-Petesch, Brigitte; Khellaf, Mehdi; Perlat, Antoinette; Sacre, Karim; Lefrere, François; Abenhaim, Lucien; Godeau, Bertrand

    2016-01-01

    This prospective observational cohort study aimed to explore the clinical features of incident immune thrombocytopenia in adults and predictors of outcome, while determining if a family history of autoimmune disorder is a risk factor for immune thrombocytopenia. All adults, 18 years of age or older, recently diagnosed with immune thrombocytopenia were consecutively recruited across 21 hospital centers in France. Data were collected at diagnosis and after 12 months. Predictors of chronicity at 12 months were explored using logistic regression models. The association between family history of autoimmune disorder and the risk of developing immune thrombocytopenia was explored using a conditional logistic regression model after matching each case to 10 controls. One hundred and forty-three patients were included: 63% female, mean age 48 years old (Standard Deviation=19), and 84% presented with bleeding symptoms. Median platelet count was 10×109/L. Initial treatment was required in 82% of patients. After 12 months, only 37% of patients not subject to disease-modifying interventions achieved cure. The sole possible predictor of chronicity at 12 months was a higher platelet count at baseline [Odds Ratio 1.03; 95%CI: 1.00, 1.06]. No association was found between outcome and any of the following features: age, sex, presence of either bleeding symptoms or antinuclear antibodies at diagnosis. Likewise, family history of autoimmune disorder was not associated with incident immune thrombocytopenia. Immune thrombocytopenia in adults has been shown to progress to a chronic form in the majority of patients. A lower platelet count could be indicative of a more favorable outcome. PMID:27229715

  2. Adherence to physiotherapy clinical guideline acute ankle injury and determinants of adherence: a cohort study

    PubMed Central

    van der Wees, Philip J; Hendriks, Erik JM; Jansen, Mariette J; van Beers, Hans; de Bie, Rob A; Dekker, Joost

    2007-01-01

    Background Clinical guidelines are considered important instruments to improve quality in health care. In physiotherapy, insight in adherence to guidelines is limited. Knowledge of adherence is important to identify barriers and to enhance implementation. Purpose of this study is to investigate the ability to adherence to recommendations of the guideline Acute ankle injury, and to identify patient characteristics that determine adherence to the guideline. Methods Twenty-two physiotherapists collected data of 174 patients in a prospective cohort study, in which the course of treatment was systematically registered. Indicators were used to investigate adherence to recommendations. Patient characteristics were used to identify prognostic factors that may determine adherence to the guideline. Correlation between patient characteristics and adherence to outcome-indicators (treatment sessions, functioning of patient, accomplished goals) was calculated using univariate logistic regression. To calculate explained variance of combined patient characteristics, multivariate analysis was performed. Results Adherence to individual recommendations varied from 71% to 100%. In 99 patients (57%) the physiotherapists showed adherence to all indicators. Adherence to preset maximum of six treatment sessions for patients with severe ankle injury was 81% (132 patients). The odds to receive more than six sessions were statistically significant for three patient characteristics: females (OR:3.89; 95%CI: 1.41–10.72), recurrent sprain (OR: 6.90; 95%CI: 2.34 – 20.37), co-morbidity (OR: 25.92; 95% CI: 6.79 – 98.93). All factors together explained 40% of the variance. Inclusion of physiotherapist characteristics in the regression model showed that work-experience reduced the odds to receive more than six sessions (OR: 0.2; 95%CI: 0.06 – 0.77), and increased explained variance to 45%. Conclusion Adherence to the clinical guideline Acute ankle sprain showed that the guideline is

  3. Shunting outcomes in posthemorrhagic hydrocephalus: results of a Hydrocephalus Clinical Research Network prospective cohort study.

    PubMed

    Wellons, John C; Shannon, Chevis N; Holubkov, Richard; Riva-Cambrin, Jay; Kulkarni, Abhaya V; Limbrick, David D; Whitehead, William; Browd, Samuel; Rozzelle, Curtis; Simon, Tamara D; Tamber, Mandeep S; Oakes, W Jerry; Drake, James; Luerssen, Thomas G; Kestle, John

    2017-07-01

    OBJECTIVE Previous Hydrocephalus Clinical Research Network (HCRN) retrospective studies have shown a 15% difference in rates of conversion to permanent shunts with the use of ventriculosubgaleal shunts (VSGSs) versus ventricular reservoirs (VRs) as temporization procedures in the treatment of hydrocephalus due to high-grade intraventricular hemorrhage (IVH) of prematurity. Further research in the same study line revealed a strong influence of center-specific decision-making on shunt outcomes. The primary goal of this prospective study was to standardize decision-making across centers to determine true procedural superiority, if any, of VSGS versus VR as a temporization procedure in high-grade IVH of prematurity. METHODS The HCRN conducted a prospective cohort study across 6 centers with an approximate 1.5- to 3-year accrual period (depending on center) followed by 6 months of follow-up. Infants with premature birth, who weighed less than 1500 g, had Grade 3 or 4 IVH of prematurity, and had more than 72 hours of life expectancy were included in the study. Based on a priori consensus, decisions were standardized regarding the timing of initial surgical treatment, upfront shunt versus temporization procedure (VR or VSGS), and when to convert a VR or VSGS to a permanent shunt. Physical examination assessment and surgical technique were also standardized. The primary outcome was the proportion of infants who underwent conversion to a permanent shunt. The major secondary outcomes of interest included infection and other complication rates. RESULTS One hundred forty-five premature infants were enrolled and met criteria for analysis. Using the standardized decision rubrics, 28 infants never reached the threshold for treatment, 11 initially received permanent shunts, 4 were initially treated with endoscopic third ventriculostomy (ETV), and 102 underwent a temporization procedure (36 with VSGSs and 66 with VRs). The 2 temporization cohorts were similar in terms of sex, race

  4. Clinical deterioration in older adults with delirium during early hospitalisation: a prospective cohort study.

    PubMed

    Hsieh, S Jean; Madahar, Purnema; Hope, Aluko A; Zapata, Jennifer; Gong, Michelle N

    2015-09-09

    To measure the prevalence and incidence of delirium in older adults as they transition from the emergency department (ED) to the inpatient ward, and to determine the association between delirium during early hospitalisation and subsequent clinical deterioration. Prospective cohort study. Urban tertiary care hospital in Bronx, New York. Adults aged 65 years or older admitted to the inpatient ward from the ED (n=260). Beginning in the ED, delirium was assessed daily for 3 days, using the Confusion Assessment Method for the Intensive Care Unit. (1) Clinical deterioration, defined as unanticipated intensive care unit (ICU) admission or in-hospital death (primary outcome); (2) decline in discharge status, defined as discharge to higher level of care, hospice or in-hospital death. 38 of 260 participants (15%) were delirious at least once during the first 3 days of hospitalisation. Of the 29 (11%) patients with delirium in the ED (ie, hospital day 1), delirium persisted into hospital day 2 in 72% (n=21), and persisted for all 3 days in 52% (n=15). In multivariate analyses, as little as 1 episode of delirium during the first 3 days was associated with increased odds of unanticipated ICU admission or in-hospital death (adjusted OR 8.07 (95% CI 1.91 to 34.14); p=0.005). Delirium that persisted for all 3 days was associated with a decline in discharge status, even after adjusting for factors such as severity of illness and baseline cognitive impairment (adjusted OR 4.70 (95% CI 1.41 to 15.63); p=0.012). Delirium during the first few days of hospitalisation was associated with poor outcomes in older adults admitted from the ED to the inpatient ward. These findings suggest the need for serial delirium monitoring that begins in the ED to identify a high-risk population that may benefit from closer follow-up and intervention. 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.

  5. Clinical deterioration in older adults with delirium during early hospitalisation: a prospective cohort study

    PubMed Central

    Hsieh, S Jean; Madahar, Purnema; Hope, Aluko A; Zapata, Jennifer; Gong, Michelle N

    2015-01-01

    Objectives To measure the prevalence and incidence of delirium in older adults as they transition from the emergency department (ED) to the inpatient ward, and to determine the association between delirium during early hospitalisation and subsequent clinical deterioration. Design Prospective cohort study. Setting Urban tertiary care hospital in Bronx, New York. Participants Adults aged 65 years or older admitted to the inpatient ward from the ED (n=260). Measurements Beginning in the ED, delirium was assessed daily for 3 days, using the Confusion Assessment Method for the Intensive Care Unit. Outcomes (1) Clinical deterioration, defined as unanticipated intensive care unit (ICU) admission or in-hospital death (primary outcome); (2) decline in discharge status, defined as discharge to higher level of care, hospice or in-hospital death. Results 38 of 260 participants (15%) were delirious at least once during the first 3 days of hospitalisation. Of the 29 (11%) patients with delirium in the ED (ie, hospital day 1), delirium persisted into hospital day 2 in 72% (n=21), and persisted for all 3 days in 52% (n=15). In multivariate analyses, as little as 1 episode of delirium during the first 3 days was associated with increased odds of unanticipated ICU admission or in-hospital death (adjusted OR 8.07 (95% CI 1.91 to 34.14); p=0.005). Delirium that persisted for all 3 days was associated with a decline in discharge status, even after adjusting for factors such as severity of illness and baseline cognitive impairment (adjusted OR 4.70 (95% CI 1.41 to 15.63); p=0.012). Conclusions Delirium during the first few days of hospitalisation was associated with poor outcomes in older adults admitted from the ED to the inpatient ward. These findings suggest the need for serial delirium monitoring that begins in the ED to identify a high-risk population that may benefit from closer follow-up and intervention. PMID:26353866

  6. A prospective cohort study of treatment decision-making for prostate cancer following participation in a multidisciplinary clinic.

    PubMed

    Hurwitz, Lauren M; Cullen, Jennifer; Elsamanoudi, Sally; Kim, Daniel J; Hudak, Jane; Colston, Maryellen; Travis, Judith; Kuo, Huai-Ching; Porter, Christopher R; Rosner, Inger L

    2016-05-01

    Patients diagnosed with prostate cancer (PCa) are presented with several treatment options of similar efficacy but varying side effects. Understanding how and why patients make their treatment decisions, as well as the effect of treatment choice on long-term outcomes, is critical to ensuring effective, patient-centered care. This study examined treatment decision-making in a racially diverse, equal-access, contemporary cohort of patients with PCa counseled on treatment options at a multidisciplinary clinic. A prospective cohort study was initiated at the Walter Reed National Military Medical Center (formerly Walter Reed Army Medical Center) in 2006. Newly diagnosed patients with PCa were enrolled before attending a multidisciplinary clinic. Patients completed surveys preclinic and postclinic to assess treatment preferences, reasons for treatment choice, and decisional regret. As of January 2014, 925 patients with PCa enrolled in this study. Surgery (54%), external radiation (20%), and active surveillance (12%) were the most common primary treatments for patients with low- and intermediate-risk PCa, whereas patients with high-risk PCa chose surgery (34%) or external radiation with neoadjuvant hormones (57%). Treatment choice differed by age at diagnosis, race, comorbidity status, and calendar year in both univariable and multivariable analyses. Patients preferred to play an active role in the decision-making process and cited doctors at the clinic as the most helpful source of treatment-related information. Almost all patients reported satisfaction with their decision. This is one of the first prospective cohort studies to examine treatment decision-making in an equal-access, multidisciplinary clinic setting. Studies of this cohort would aid in understanding and improving the PCa decision-making process. Published by Elsevier Inc.

  7. Clinical features of CKD-MBD in Japan: cohort studies and registry.

    PubMed

    Hamano, Takayuki; Sakaguchi, Yusuke; Fujii, Naohiko; Isaka, Yoshitaka

    2017-03-01

    Randomized controlled trials (RCTs) are essential for evidence-based medicine; however, cohort studies and registries provide an important information about risk factors and, hence, shed light on the target of laboratory parameters. The uniqueness of the current Japanese CKD-MBD guidelines lies in the lower target range of intact parathyroid hormone levels than those used in other countries, which is based on analyses of the nationwide Japan Renal Data Registry. Cohort studies were also useful in exploring risk factors of renal outcome in predialysis patients. It was revealed that low vitamin D status (very prevalent in Japan) and high fibroblast growth factor 23 (FGF23) levels predict poor renal outcome. The reported association of FGF23 levels with left ventricular hypertrophy (LVH) and heart failure observed in cohort studies may support the idea of adding the 4th component of CKD-MBD, namely, "LVH" to the three original components. When it is not feasible to conduct RCTs regarding intervention, we have no choice but to rely on observational studies with sophisticated analysis methods, such as facility-level analysis and marginal structural model minimizing indication bias. Observational studies conducted in Japan revealed that the side effects of medications for CKD-MBD, resultant compliance, and effective doses in terms of hard outcome in Japanese patients were found to be different from those in other countries. For example, the MBD-5D study confirmed the benefit of cinacalcet in terms of mortality despite its median dose of only 25 mg/day. These data are very helpful for future guidelines specific to Japanese patients with CKD.

  8. Demographic and clinical predictors of unplanned hospital utilisation among chronically ill patients: a prospective cohort study.

    PubMed

    Mallitt, Kylie-Ann; Kelly, Patrick; Plant, Natalie; Usherwood, Tim; Gillespie, James; Boyages, Steven; Jan, Stephen; Leeder, Stephen

    2015-04-03

    In urban Australia, patients with serious and continuing illnesses make frequent use of hospital emergency department (ED) services. However, the risk factors for hospital utilisation among the broad population of people with chronic illness are not well known. The aim of this study was to assess the predictors of hospital utilisation (either inpatient admissions or ED visits) in a cohort of 308 patients with chronic illness. We studied patients with serious and continuing chronic illnesses presenting to an ED in a large periurban hospital in western Sydney, Australia, between 2010 and 2013. ED presentations and hospital admissions were observed over two years. Multivariate negative-binomial regression analyses were used to identify risk factors for the number of presentations to hospital. The main risk factors for hospital utilisation were having a live-in carer, and a history of hospital utilisation. Having a live-in carer was associated with an increase in number of ED presentations by 88% (RR 1.88; 95% CI 1.41-2.51), and of admissions by 116% (RR 2.16; 95% CI 1.61-2.92). Seventy-seven percent of hospital utilisation in the cohort was attributable to carer status. Each additional ED presentation that a person had in the 12 months prior to the study led to an increased risk of an ED presentation in the follow-up period by 6% (RR = 1.06, 95% CI = 1.03-1.08). Between 20% and 25% of variability in hospital utilisation in the cohort was attributable to the number of hospital admissions or ED presentations in the previous 12 months. Patients with a live-in carer and with a history of hospital utilisation are at high risk for future hospital use.

  9. Comparative Effectiveness of Initial Antiretroviral Therapy Regimens: ACTG 5095 and 5142 Clinical Trials Relative to ART-CC Cohort Study

    PubMed Central

    Mugavero, Michael J.; May, Margaret; Ribaudo, Heather J.; Gulick, Roy M.; Riddler, Sharon A.; Haubrich, Richard; Napravnik, Sonia; Abgrall, Sophie; Phillips, Andrew; Harris, Ross; Gill, M. John; de Wolf, Frank; Hogg, Robert; Günthard, Huldrych F.; Chêne, Geneviève; D'Arminio Monforte, Antonella; Guest, Jodie L.; Smith, Colette; Murillas, Javier; Berenguer, Juan; Wyen, Christoph; Domingo, Pere; Kitahata, Mari M.; Sterne, Jonathan A. C.; Saag, Michael S.

    2011-01-01

    Background The generalizability of antiretroviral therapy (ART) clinical trial efficacy findings to routine care settings is not well studied. We compared the relative effectiveness of initial ART regimens estimated in AIDS Clinical Trial Group (ACTG) randomized controlled trials with that among patients receiving ART at Antiretroviral Therapy Cohort Collaboration (ART-CC) study sites. Methods Treatment-naive HIV-infected patients initiating identical ART regimens in ACTG trials (A5095 and A5142) and at 15 ART-CC cohort study sites were included. Virological failure (HIV-1 RNA >200 copies/ml) at 24- and 48-weeks, incident AIDS-defining events and mortality were measured according to study design (ART-CC cohort vs. ACTG trial) and stratified by 3rd drug [Abacavir (ABC), Efavirenz (EFV), and Lopinavir/r (LPV/r)]. We used logistic regression to estimate and compare odds ratios for virological failure between different regimens and study designs, and used Cox models to estimate and compare hazard ratios for AIDS and death. Results Compared with patients receiving ABC, those receiving EFV had roughly half the odds of 24-week virologic failure (>200 copies/mL) in both ACTG 5095 (OR=0.53, 95% CI 0.36–0.79) and ART-CC (0.46, 0.37–0.57). Virologic superiority of EFV (vs. ABC) appeared comparable in ART-CC and ACTG 5095 (ratio of ORs 0.86, 95% CI 0.54–1.35). Odds ratios for 48-week virologic failure, comparing EFV with LPV/r, were also comparable in ACTG 5142 and ART-CC (ratio of ORs 0.87, 0.45–1.69). Conclusions Between ART regimen virologic efficacy of 3rd drugs ABC, EFV, and LPV/r observed in the ACTG 5095 and 5142 trials appear generalizable to the routine care setting of ART-CC clinical cohorts. PMID:21857357

  10. Multiple Treatments of Pediatric Constraint-Induced Movement Therapy (pCIMT): A Clinical Cohort Study

    PubMed Central

    Ramey, Sharon Landesman; Trucks, Mary Rebekah; Wallace, Dorian Ainsworth

    2015-01-01

    Pediatric constraint-induced movement therapy (pCIMT) is one of the most efficacious treatments for children with cerebral palsy (CP). Distinctive components of pCIMT include constraint of the less impaired upper extremity (UE), high-intensity therapy for the more impaired UE (≥3 hr/day, many days per week, for multiple weeks), use of shaping techniques combined with repetitive task practice, and bimanual transfer. A critical issue is whether multiple treatments of pCIMT produce additional benefit. In a clinical cohort (mean age = 31 mo) of 28 children with asymmetrical CP whose parents sought multiple pCIMT treatments, the children gained a mean of 13.2 (standard deviation [SD] = 4.2) new functional skills after Treatment 1; Treatment 2 produced a mean of 7.3 (SD = 4.7) new skills; and Treatment 3, 6.5 (SD = 4.2). These findings support the conclusion that multiple pCIMT treatments can produce clinically important functional gains for children with hemiparetic CP. PMID:26565094

  11. Prevalence, clinical features and risk assessment of pre-diabetes in Spain: the prospective Mollerussa cohort study.

    PubMed

    Vilanova, María Belén; Falguera, Mireia; Marsal, Josep Ramon; Rubinat, Esther; Alcubierre, Núria; Catelblanco, Esmeralda; Granado-Casas, Minerva; Miró, Neus; Molló, Àngels; Mata-Cases, Manel; Franch-Nadal, Josep; Mauricio, Didac

    2017-06-11

    The Mollerussa prospective cohort was created to study pre-diabetes in a population-based sample from the primary care setting in the semirural area of Pla d'Urgell in Catalonia (Spain). The aims of the study were to assess the prevalence of pre-diabetes in our population, the likelihood to develop overt diabetes over time and to identify risk factors associated with the progression of the condition. The cohort includes 594 subjects randomly selected between March 2011 and July 2014 from our primary care population, who were older than 25 years, consented to participate and did not have a recorded diagnosis of diabetes. At baseline, we performed a clinical interview to collect demographic, clinical and lifestyle (including a nutritional survey) characteristics; carotid ultrasound imaging to assess subclinical cardiovascular disease was also performed, and a blood sample was collected, with an overall <5% rate of missing data. An additional blood draw was performed 12 months after initial recruitment to reassess laboratory results in patients initially identified as having pre-diabetes, with an 89.6% retention rate. Several studies investigating various hypotheses are currently ongoing. All subjects recruited during the cohort creation will be followed long-term through annual extraction of data from health records stored in the electronic Clinical station in Primary Care database. The Mollerussa cohort will thus be a sound population-based sample for multiple future research projects to generate insights into the epidemiology and natural history of pre-diabetes in Spain. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study.

    PubMed

    Alobaid, Adel S; Cortes, Lina M; Lo, Jeffery; Nguyen, Thuan T; Albert, Jeffery; Abu-Melha, Abdulaziz S; Lin, Louis M; Gibbs, Jennifer L

    2014-08-01

    This retrospective cohort study compared clinical and radiographic outcomes of endodontic treatment performed in immature nonvital permanent teeth by apexification (calcium hydroxide or apical barrier with mineral trioxide aggregate) versus revascularization. A comprehensive chart review was performed to obtain a cohort of previously completed cases with recalls. Clinical and radiographic data were collected for 31 treated teeth (19 revascularization and 12 apexification) with an average follow-up time of 17 months and a recall rate of 63%. Tooth survival, success rate, and adverse events were analyzed. Changes in radiographic root length, width, and area were quantified. The majority of treated teeth survived throughout the study period, with 30 of 31 (97%) teeth surviving (18/19 [95%] revascularization and 12/12 apexification). Most cases were also clinically successful, with 27 of 31 (87%) meeting criteria for success (15/19 [78%] revascularization and 12/12 apexification; nonsignificant difference). A greater incidence of adverse events was observed in the revascularization group (8/19 [42%] vs 1/12 [11%] in apexification) (risk ratio = 5.1; P = .04; 95% confidence interval, 0.719-35.48). Although more revascularization cases than apexification cases showed an increase in radiographic root area and width, the effect was not statistically significant. In this study, revascularization was not superior to other apexification techniques in either clinical or radiographic outcomes. Studies with large subject cohorts and long follow-up periods are needed to evaluate outcomes of revascularization and apexification while accounting for important covariants relevant to clinical success. Copyright © 2014 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  13. Radiographic and Clinical Outcomes of the Treatment of Immature Permanent Teeth by Revascularization or Apexification: A Pilot Retrospective Cohort Study

    PubMed Central

    Alobaid, Adel S.; Cortes, Lina M.; Lo, Jeffery; Nguyen, Thuan T.; Albert, Jeffery; Abu-Melha, Abdulaziz S; Lin, Louis M.; Gibbs, Jennifer L.

    2014-01-01

    Introduction This retrospective cohort study compared clinical and radiographic outcomes of endodontic treatment performed in immature non-vital permanent teeth, by apexification (calcium hydroxide or apical barrier with Mineral Trioxide Aggregate (MTA)), versus revascularization. Methods A comprehensive chart review was performed to obtain a cohort of sequential previously completed cases with recalls. Clinical and radiographic data were collected for 31 treated teeth (19 revascularization and 12 apexification) with an average follow up time of 17 months and a recall rate of 63%. Tooth survival, success rate, and adverse events were analyzed. Changes in radiographic root length, width and area were quantified. Results The majority of treated teeth survived throughout the study period with 30/31 (97%) teeth surviving (18/19 (95%) revascularization, 12/12 apexification). Most cases were also clinically successful with 27/31 (87%) meeting criteria for success, (15/19 (78%) revascularization and 12/12 apexification; non-significant difference). A greater incidence of adverse events was observed in the revascularization group (8/19 (42%) versus 1/12 (11%) in apexification (Risk Ratio= 5.1, p=0.04, 95%CI (0.719, 35.48)). Although more revascularization cases than apexification cases demonstrated an increase in radiographic root area and width, the effect was not statistically significant. Conclusion In this study, revascularization was not superior to other apexification techniques in either clinical or radiographic outcomes. Studies with large subject cohorts, and long follow up periods are needed to evaluate outcomes of revascularization and apexification, while accounting for important co-variants relevant to clinical success. PMID:25069909

  14. Birch pollen influence the severity of atopic eczema - prospective clinical cohort pilot study and ex vivo penetration study.

    PubMed

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route.

  15. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    PubMed Central

    Fölster-Holst, Regina; Galecka, Jagoda; Weißmantel, Sigo; Dickschat, Ute; Rippke, Frank; Bohnsack, Kerstin; Werfel, Thomas; Wichmann, Katja; Buchner, Matthias; Schwarz, Thomas; Vogt, Annika; Lademann, Jürgen; Meinke, Martina C

    2015-01-01

    There is little clinical evidence for a correlation between the severity of atopic eczema (AE) and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD) score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. PMID:26604810

  16. Bariatric Surgery in the United Kingdom: A Cohort Study of Weight Loss and Clinical Outcomes in Routine Clinical Care

    PubMed Central

    Douglas, Ian J.; Bhaskaran, Krishnan; Batterham, Rachel L.; Smeeth, Liam

    2015-01-01

    Background Bariatric surgery is becoming a more widespread treatment for obesity. Comprehensive evidence of the long-term effects of contemporary surgery on a broad range of clinical outcomes in large populations treated in routine clinical practice is lacking. The objective of this study was to measure the association between bariatric surgery, weight, body mass index, and obesity-related co-morbidities. Methods and Findings This was an observational retrospective cohort study using data from the United Kingdom Clinical Practice Research Datalink. All 3,882 patients registered in the database and with bariatric surgery on or before 31 December 2014 were included and matched by propensity score to 3,882 obese patients without surgery. The main outcome measures were change in weight and body mass index over 4 y; incident diagnoses of type 2 diabetes mellitus (T2DM), hypertension, angina, myocardial infarction (MI), stroke, fractures, obstructive sleep apnoea, and cancer; mortality; and resolution of hypertension and T2DM. Weight measures were available for 3,847 patients between 1 and 4 mo, 2,884 patients between 5 and 12 mo, and 2,258 patients between 13 and 48 mo post-procedure. Bariatric surgery patients exhibited rapid weight loss for the first four postoperative months, at a rate of 4.98 kg/mo (95% CI 4.88–5.08). Slower weight loss was sustained to the end of 4 y. Gastric bypass (6.56 kg/mo) and sleeve gastrectomy (6.29 kg/mo) were associated with greater initial weight reduction than gastric banding (2.77 kg/mo). Protective hazard ratios (HRs) were detected for bariatric surgery for incident T2DM, 0.68 (95% CI 0.55–0.83); hypertension, 0.35 (95% CI 0.27–0.45); angina, 0.59 (95% CI 0.40–0.87);MI, 0.28 (95% CI 0.10–0.74); and obstructive sleep apnoea, 0.55 (95% CI 0.40–0.87). Strong associations were found between bariatric surgery and the resolution of T2DM, with a HR of 9.29 (95% CI 6.84–12.62), and between bariatric surgery and the resolution of

  17. Clinical presentation, diagnosis and long‐term outcome of Wilson's disease: a cohort study

    PubMed Central

    Merle, U; Schaefer, M; Ferenci, P; Stremmel, W

    2007-01-01

    Background Wilson's disease is a rare inborn disease related to copper storage, leading to liver cirrhosis and neuropsychological deterioration. Clinical data on larger cohorts are limited owing to low disease frequency. Objective and methods We performed a retrospective analysis of 163 patients with Wilson's disease, examined at the University of Heidelberg, Heidelberg, Germany, to determine clinical presentation, diagnostic course and long‐term outcome. Results Diagnostic criteria for non‐caeruloplasmin‐bound serum copper, serum caeruloplasmin, 24‐h urinary copper excretion, liver copper content, presence of Kayser–Fleischer rings and histological signs of chronic liver damage were reached in 86.6%, 88.2%, 87.1%, 92.7%, 66.3% and 73% of patients, respectively. By analysis of the coding region of ATP7B (except exons 2, 3 and 21), disease‐causing mutations were detected in 57% and 29% of patients with Wilson's disease on both chromosomes and on one chromosome, respectively. No mutations were detected in 15% of patients with Wilson's disease. No significant differences were found in clinical parameters or initial presentation between patients grouped according to their mutations. The patients with neurological symptoms were significantly older at the onset of symptoms than patients with hepatitic symptoms (20.2 v 15.5 years of age, p<0.05), and the neurological symptoms were associated with a significantly longer time from onset to diagnosis than hepatic symptoms (44.4 v 14.4 months, p<0.05). After initiating treatment, 76.1% of the patients had a stable or improved course of the disease. Disease progression under treatment was more likely for neuropsychiatric than for hepatic symptoms. Side effects of treatment occurred in 74.4% of patients. Conclusions Patients with Wilson's disease having predominantly neuropsychiatric symptoms manifest symptoms later, have a longer time delay from onset of symptoms until definitive diagnosis and have a poorer

  18. Clinical effectiveness of school screening for adolescent idiopathic scoliosis: a large population-based retrospective cohort study.

    PubMed

    Luk, Keith D K; Lee, C F; Cheung, Kenneth M C; Cheng, Jack C Y; Ng, Bobby K W; Lam, T P; Mak, K H; Yip, Paul S F; Fong, Daniel Y T

    2010-08-01

    Retrospective cohort study. To evaluate the clinical effectiveness of school scoliosis screening using a large and long-term-followed cohort of students in Hong Kong. School screening for adolescent idiopathic scoliosis has been criticized as resulting in over-referrals for radiography and having low predictive values. Indeed, all but one previous retrospective cohort studies had no follow-up assessments of students until their skeletal maturity, leaving any late-developed curves undetected. The one study that completed this follow-up was well conducted but had low precisions due to its small sample size. A total of 157,444 students were eligible for a biennial scoliosis screening, and their screening results and medical records up to 19 years of age were available. Students first had forward bending test and angle of trunk rotation (ATR) performed. Those with ATR between 5 degrees and 14 degrees or signs of adolescent idiopathic scoliosis were assessed by moiré topography regularly. Students with an ATR >or=15 degrees , >or=2 moiré lines, or significant clinical signs were referred for radiography and had their Cobb angle measured. Of the 115,190 screened students in the cohort, 3228 (2.8%, 95% confidence interval [CI] = 2.7%-2.9%) were referred for radiography. At the final follow-up, the positive predictive values were 43.6% (41.8%-45.3%) for a Cobb angle >or=20 degrees and 9.4% (8.4%-10.5%) for needing treatment, while the sensitivities were 88.1% (86.4%-89.6%) and 80.0% (75.6%-83.9%), respectively. This is the largest study that has demonstrated that school scoliosis screening in Hong Kong is predictive and sensitive with a low referral rate. Screening should thus be continued in order to facilitate early administration of conservative treatments.

  19. The Mayo Clinic cohort study of personality and aging: design and sampling, reliability and validity of instruments, and baseline description.

    PubMed

    Rocca, Walter A; Grossardt, Brandon R; Peterson, Brett J; Bower, James H; Trenerry, Max R; Ahlskog, J Eric; Sanft, Kevin R; de Andrade, Mariza; Maraganore, Demetrius M

    2006-01-01

    We established a historical cohort of 7,216 subjects who completed the Minnesota Multiphasic Personality Inventory (MMPI) at the Mayo Clinic from 1962 through 1965 for research (not clinical indication), and who resided within a 120-mile radius centered in Rochester, Minnesota. We describe here the overall cohort design and sampling, we report results concerning reliability and validity, and we describe age and sex patterns at baseline for four MMPI scores of primary interest (depression, anxiety, social introversion, and negativity). Subjects excluded from the cohort because of missing data had MMPI scores similar to subjects included (after appropriate rescaling). A cut-off specific for age and sex at the 75th percentile of the distribution of raw scores was valid compared with the traditional clinical cut-off (T scores plus one standard deviation). Baseline scores for all four scales were higher in women than in men at all ages (all p < 0.0001). Depression and social introversion scores showed an increasing trend with age in both sexes (Spearman rank correlation, rho = 0.05 and 0.08, respectively, p < 0.0001 for both). Baseline scores on the anxiety scale showed a decreasing trend with age in both sexes (rho = -0.06, p < 0.0001). Negativity scores remained relatively stable with age in both sexes (rho = 0.03, p = 0.01). We found a high correlation between the anxiety score and the negativity score (rho = 0.90, p < 0.0001) even after the exclusion of overlapping items (rho = 0.68, p < 0.0001). This newly established historical cohort study provides opportunities to test hypotheses regarding the link between personality and aging, aging-related diseases, and overall mortality.

  20. Clinical outcomes of vertebroplasty or kyphoplasty for patients with vertebral compression fractures: a nationwide cohort study.

    PubMed

    Tsai, Yi-Wen; Hsiao, Fei-Yuan; Wen, Yu-Wen; Kao, Yu-Hsiang; Chang, Li-Chuan; Huang, Weng-Foung; Peng, Li-Ning; Liu, Chien-Liang; Chen, Liang-Kung

    2013-01-01

    To evaluate the outcome of vertebroplasty or kyphoplasty (VK), in comparison with non-VK treatment, among patients hospitalized for first-ever vertebral compression fractures (VCFs). A population-based retrospective cohort study. Taiwan' s National Health Insurance claims data. All individuals aged ≥ 60 years who were newly discharged after hospitalization for a primary VCF diagnosis. Percutaneous vertebroplasty or kyphoplasty. Study outcomes were discharge outcome (re-hospitalization within 1 week, 1 month or 6 months, categorized by diagnosis) and the prescription of anti-osteoporosis medication for secondary fracture prevention. Potential selection bias was adjusted by using propensity score matching to select one conservatively treated patient (e.g. lumbar brace, analgesics, or physical therapy) matched to one patient receiving VK. The study cohort consisted of 9238 patients who had been discharged after hospitalization for a first-ever VCF between 2004 and 2007. During the index hospitalization, 1018 patients received VK, compared with 8,220 patients who did not receive VK. Patients receiving percutaneous procedure group had a consistently lower incidence of 7-day re-hospitalization for any of the three outcomes (OR = 0.48; 95% CI: 0.32-0.72). Considering the cause of re-hospitalization separately, the vertebroplasty/kyphoplasty group had a significantly lower risk of 7-day re-hospitalization for fracture-related diagnosis (OR = 0.28, 95% CI: 0.12-0.68) and musculoskeletal diagnosis (OR = 0.08, 95% CI: 0.01-0.88) as well as a significantly lower risk of 1-month re-hospitalization (OR = 0.74; 95% CI: 0.59-0.93). VK may protect patients with VCFs from short-term re-hospitalization and a greater need exists for anti-osteoporosis medication as secondary prevention for this at-risk patient group. Copyright © 2013 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

  1. Predictors of suppurative complications for acute sore throat in primary care: prospective clinical cohort study

    PubMed Central

    Stuart, Beth; Hobbs, F D Richard; Butler, Chris C; Hay, Alastair D; Campbell, John; Delaney, Brendan; Broomfield, Sue; Barratt, Paula; Hood, Kerenza; Everitt, Hazel; Mullee, Mark; Williamson, Ian; Mant, David; Moore, Michael

    2013-01-01

    Objective To document whether elements of a structured history and examination predict adverse outcome of acute sore throat. Design Prospective clinical cohort. Setting Primary care. Participants 14 610 adults with acute sore throat (≤2 weeks’ duration). Main outcome measures Common suppurative complications (quinsy or peritonsillar abscess, otitis media, sinusitis, impetigo or cellulitis) and reconsultation with new or unresolving symptoms within one month. Results Complications were assessed reliably (inter-rater κ=0.95). 1.3% (177/13 445) of participants developed complications overall and 14.2% (1889/13 288) reconsulted with new or unresolving symptoms. Independent predictors of complications were severe tonsillar inflammation (documented among 13.0% (1652/12 717); odds ratio 1.92, 95% confidence interval 1.28 to 2.89) and severe earache (5% (667/13 323); 3.02, 1.91 to 4.76), but the model including both variables had modest prognostic utility (bootstrapped area under the receiver operator curve 0.61, 0.57 to 0.65), and 70% of complications (124/177) occurred when neither was present. Clinical prediction rules for bacterial infection (Centor criteria and FeverPAIN) also predicted complications, but predictive values were also poor and most complications occurred with low scores (67% (118/175) scoring ≤2 for Centor; 126/173 (73%) scoring ≤2 for FeverPAIN). Previous medical problems, sex, temperature, and muscle aches were independently but weakly associated with reconsultation with new or unresolving symptoms. Conclusion Important suppurative complications after an episode of acute sore throat in primary care are uncommon. History and examination and scores to predict bacterial infection cannot usefully identify those who will develop complications. Clinicians will need to rely on strategies such as safety netting or delayed prescription in managing the uncertainty and low risk of complications. PMID:24277339

  2. Clinical epidemiology of laboratory-confirmed Buruli ulcer in Benin: a cohort study.

    PubMed

    Vincent, Quentin B; Ardant, Marie-Françoise; Adeye, Ambroise; Goundote, Aimé; Saint-André, Jean-Paul; Cottin, Jane; Kempf, Marie; Agossadou, Didier; Johnson, Christian; Abel, Laurent; Marsollier, Laurent; Chauty, Annick; Alcaïs, Alexandre

    2014-07-01

    Buruli ulcer, caused by Mycobacterium ulcerans, was identified as a neglected emerging infectious disease by WHO in 1998. Although Buruli ulcer is the third most common mycobacterial disease worldwide, understanding of the disease is incomplete. We analysed a large cohort of laboratory-confirmed cases of Buruli ulcer from Pobè, Benin, to provide a comprehensive description of the clinical presentation of the disease, its variation with age and sex, and its effect on the occurrence of permanent functional sequelae. Between Jan 1, 2005, and Dec 31, 2011, we prospectively collected clinical and laboratory data from all patients with Buruli ulcer diagnosed at the Centre de Dépistage et de Traitement de l'Ulcère de Buruli in Pobè, Benin. We followed up patients to assess the frequency of permanent functional sequelae. All analyses were done on cases that were laboratory confirmed. 1227 cases of laboratory-confirmed Buruli ulcer were included in the analysis. Typically, patients with Buruli ulcer were children (median age at diagnosis 12 years) presenting with a unique (1172 [96%]) large (≥15 cm, 444 [36%]) ulcerative (805 [66%]) lesion of the lower limb (733 [60%]). Atypical clinical presentation of Buruli ulcer included Buruli ulcer osteomyelitis with no identifiable present or past Buruli ulcer skin lesions, which was recorded in at least 14 patients. The sex ratio of Buruli ulcer widely varied with age, with male patients accounting for 57% (n=427) of patients aged 15 years and younger, but only 33% (n=158) of those older than 15 years (odds ratio [OR] 2·59, 95% CI 2·04-3·30). Clinical presentation of Buruli ulcer was significantly dependent on age and sex. 54 (9%) male patients had Buruli ulcer osteomyelitis, whereas only 28 (4%) of female patients did (OR 2·21, 95% CI 1·39-3·59). 1 year after treatment, 229 (22% of 1043 with follow-up information) patients presented with permanent functional sequelae. Presentation with oedema, osteomyelitis, or large (

  3. Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study.

    PubMed

    Sheppard, James P; Holder, Roger; Nichols, Linda; Bray, Emma; Hobbs, F D Richard; Mant, Jonathan; Little, Paul; Williams, Bryan; Greenfield, Sheila; McManus, Richard J

    2014-11-01

    Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. This study used an observational cohort design and included 220 individuals aged 35-84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice.

  4. Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study

    PubMed Central

    Sheppard, James P.; Holder, Roger; Nichols, Linda; Bray, Emma; Hobbs, F.D. Richard; Mant, Jonathan; Little, Paul; Williams, Bryan; Greenfield, Sheila; McManus, Richard J.

    2014-01-01

    Objectives: Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. Methods: This study used an observational cohort design and included 220 individuals aged 35–84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. Results: The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. Conclusion: Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice. PMID:25144295

  5. Cohort study on maternal cytomegalovirus seroprevalence and prevalence and clinical manifestations of congenital infection in China

    PubMed Central

    Wang, Shiwen; Wang, Tongzhan; Zhang, Wenqiang; Liu, Xiaolin; Wang, Xiaofang; Wang, Haiyan; He, Xiaozhou; Zhang, Shunxian; Xu, Shuhui; Yu, Yang; Jia, Xingbing; Wang, Maolin; Xu, Aiqiang; Ma, Wei; Amin, Minal M.; Bialek, Stephanie R.; Dollard, Sheila C.; Wang, Chengbin

    2017-01-01

    Abstract Congenital cytomegalovirus (CMV) infection is the leading viral cause of birth defects and developmental disabilities in developed countries. However, CMV seroprevalence and burden of congenital CMV infection are not well defined in China. Cohort of newborns from 5 birthing hospitals in 2 counties of Shandong Province, China, were enrolled from March 2011 to August 2013. Dried blood spots (DBS) and saliva were collected within 4 days after birth for IgG testing for maternal seroprevalence and real-time PCR testing for congenital CMV infection, respectively. Among 5020 newborns tested for CMV IgG, 4827 were seropositive, resulting in CMV maternal seroprevalence of 96.2% (95% confidence interval [CI]:95.6%–96.7%). Of the 10,933 newborns screened for congenital CMV infection, 75 had CMV detected, resulting in an overall prevalence of 0.7% (95% CI: 0.5%–0.9%), with prevalences of 0.4% (14/3995), 0.6% (66/10,857), and 0.7% (52/7761) for DBS, wet saliva, and dried saliva specimens screened, respectively. Prevalence of congenital CMV infection decreased with increasing maternal age (0.9%, 0.6%, and 0.3% among newborns delivered from mothers aged 16–25, 26–35, and >35 years, respectively; P = 0.03), and was higher among preterm infants than full term infants (1.3% vs 0.6%, P = 0.04), infants with intrauterine growth restriction (IUGR) than those without (1.8% vs 0.7%, P = 0.03), and twins or triplets than singleton pregnancies (2.8% vs 0.7%, P = 0.04). None of the 75 newborns exhibited symptomatic congenital CMV infection, and there was no difference in clinical characteristics and newborn hearing screening results between infants with and without congenital CMV infection at birth. Congenital CMV infection prevalence was lower and the clinical manifestations were milder in this relatively developed region of China compared to populations from other countries with similarly high maternal seroprevalence. Follow-up on children with congenital

  6. Cohort study on maternal cytomegalovirus seroprevalence and prevalence and clinical manifestations of congenital infection in China.

    PubMed

    Wang, Shiwen; Wang, Tongzhan; Zhang, Wenqiang; Liu, Xiaolin; Wang, Xiaofang; Wang, Haiyan; He, Xiaozhou; Zhang, Shunxian; Xu, Shuhui; Yu, Yang; Jia, Xingbing; Wang, Maolin; Xu, Aiqiang; Ma, Wei; Amin, Minal M; Bialek, Stephanie R; Dollard, Sheila C; Wang, Chengbin

    2017-02-01

    Congenital cytomegalovirus (CMV) infection is the leading viral cause of birth defects and developmental disabilities in developed countries. However, CMV seroprevalence and burden of congenital CMV infection are not well defined in China.Cohort of newborns from 5 birthing hospitals in 2 counties of Shandong Province, China, were enrolled from March 2011 to August 2013. Dried blood spots (DBS) and saliva were collected within 4 days after birth for IgG testing for maternal seroprevalence and real-time PCR testing for congenital CMV infection, respectively.Among 5020 newborns tested for CMV IgG, 4827 were seropositive, resulting in CMV maternal seroprevalence of 96.2% (95% confidence interval [CI]:95.6%-96.7%). Of the 10,933 newborns screened for congenital CMV infection, 75 had CMV detected, resulting in an overall prevalence of 0.7% (95% CI: 0.5%-0.9%), with prevalences of 0.4% (14/3995), 0.6% (66/10,857), and 0.7% (52/7761) for DBS, wet saliva, and dried saliva specimens screened, respectively. Prevalence of congenital CMV infection decreased with increasing maternal age (0.9%, 0.6%, and 0.3% among newborns delivered from mothers aged 16-25, 26-35, and >35 years, respectively; P = 0.03), and was higher among preterm infants than full term infants (1.3% vs 0.6%, P = 0.04), infants with intrauterine growth restriction (IUGR) than those without (1.8% vs 0.7%, P = 0.03), and twins or triplets than singleton pregnancies (2.8% vs 0.7%, P = 0.04). None of the 75 newborns exhibited symptomatic congenital CMV infection, and there was no difference in clinical characteristics and newborn hearing screening results between infants with and without congenital CMV infection at birth.Congenital CMV infection prevalence was lower and the clinical manifestations were milder in this relatively developed region of China compared to populations from other countries with similarly high maternal seroprevalence. Follow-up on children with congenital CMV infection will

  7. 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

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

    PubMed

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

    2017-01-31

    Atypical hyperplasia (AH) and mammographic breast density (MBD) are established risk factors for breast cancer (BC), but their joint contributions are not well understood. We examine associations of MBD and BC by histologic impression, including AH, in a subcohort of women from the Mayo Clinic Benign Breast Disease Cohort. Women with a diagnosis of BBD and mammogram between 1985 and 2001 were eligible. Histologic impression was assessed via pathology review and coded as non-proliferative disease (NP), proliferative disease without atypia (PDWA) and AH. MBD was assessed clinically using parenchymal pattern (PP) or BI-RADS criteria and categorized as low, moderate or high. Percent density (PD) was also available for a subset of women. BC and clinical information were obtained by questionnaires, medical records and the Mayo Clinic Tumor Registry. Women were followed from date of benign biopsy to BC, death or last contact. Standardized incidence ratios (SIRs) compared the observed number of BCs to expected counts. Cox regression estimated multivariate-adjusted MBD hazard ratios. Of the 6271 women included in the study, 1132 (18.0%) had low MBD, 2921 (46.6%) had moderate MBD, and 2218 (35.4%) had high MBD. A total of 3532 women (56.3%) had NP, 2269 (36.2%) had PDWA and 470 (7.5%) had AH. Over a median follow-up of 14.3 years, 528 BCs were observed. The association of MBD and BC risk differed by histologic impression (p-interaction = 0.03), such that there was a strong MBD and BC association among NP (p < 0.001) but non-significant associations for PDWA (p = 0.27) and AH (p = 0.96). MBD and BC associations for AH women were not significant within subsets defined by type of MBD measure (PP vs. BI-RADS), age at biopsy, number of foci of AH, type of AH (lobular vs. ductal) and body mass index, and after adjustment for potential confounding variables. Women with atypia who also had high PD (>50%) demonstrated marginal evidence of increased BC risk (SIR 4

  9. 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

  10. Subtyping Somatic Tinnitus: A Cross-Sectional UK Cohort Study of Demographic, Clinical and Audiological Characteristics

    PubMed Central

    Ward, Jamie; Vella, Claire; Hoare, Derek J.; Hall, Deborah A.

    2015-01-01

    Somatic tinnitus is the ability to modulate the psychoacoustic features of tinnitus by somatic manoeuvres. The condition is still not fully understood and further identification of this subtype is essential, particularly for the purpose of establishing protocols for both its diagnosis and treatment. This study aimed to investigate the characteristics of somatic tinnitus within a large UK cohort using a largely unselected sample. We believe this to be relatively unique in comparison to current literature on the topic. This was investigated by using a total of 608 participant assessments from a set of recognised tinnitus and audiology measures. Results from a set of chi-square tests of association found that amongst the individuals with somatic tinnitus, a higher proportion had pulsatile tinnitus (different from heartbeat), were under the age of 40, reported variation in the loudness of their tinnitus and reported temporomandibular joint (TMJ) disorder. The same pattern of results was confirmed using a multivariate analysis of the data based on logistic regression. These findings have strong implications towards the profiling of somatic tinnitus as a distinct subtype of general tinnitus. PMID:25996779

  11. Baseline serum albumin and other common clinical markers are prognostic factors in colorectal carcinoma: A retrospective cohort study.

    PubMed

    González-Trejo, Sagrario; Carrillo, José F; Carmona-Herrera, D Darlene; Baz-Gutiérrez, Patricia; Herrera-Goepfert, Roberto; Núñez, Gloria; Ochoa-Carrillo, Francisco J; Gallardo-Rincón, Dolores; Aiello-Crocifoglio, Vincenzo; Oñate-Ocaña, Luis F

    2017-04-01

    The aim of the present study was to define the prognostic role of baseline serum albumin (BSA) in colorectal cancer (CRC) across tumor-node-metastasis (TNM) stages and other well defined prognostic factors. Many prognostic models in medicine employ BSA to define or refine treatments in very specific settings; in CRC, BSA has been found to be a prognostic factor as well. A retrospective cohort study of consecutive patients with CRC demonstrated by biopsy, who attended a cancer center during a 7-year period. Multivariate analysis was utilized to define prognostic factors associated with overall survival (OS) employing the Cox model. In this retrospective cohort study, 1465 patients were included; 46.6% were females and 53.4% males (mean age, 59.1 years). Mean BSA was inversely correlated with TNM stages. By multivariate analysis, it was an independent explanatory variable. TNM stages, "R" classification, age, lymphocyte count, neutrophil/platelet ratio, neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, postoperative morbidity, and BSA were independently associated with OS. Morbidities, surgery type, chemotherapy, and radiotherapy were considered confounders after adjusting by TNM stages. BSA is a significant and independent prognostic factor in patients with CRC, and its effect is maintained across TNM strata and other well known clinical prognostic factors. It can be easily used in prognostic models and should be employed to stratify prognosis in therapeutic randomized clinical trials.

  12. A Cohort Study of Pediatric Shock: Frequency of Corticosteriod Use and Association with Clinical Outcomes.

    PubMed

    Menon, Kusum; McNally, J Dayre; Choong, Karen; Lawson, Margaret L; Ramsay, Tim; Hutchison, James S; Foster, Jennifer; Wong, Hector R

    2015-11-01

    Pediatric shock is associated with significant morbidity and limited evidence suggests treatment with corticosteroids. The objective of this study was to describe practice patterns and outcomes associated with corticosteroid use in children with shock. We conducted a retrospective, cohort study in four pediatric intensive care units (PICU) in Canada. Patients aged newborn to 17 years admitted to PICU with shock between January 2010 and June 2011 were eligible. 364 patients were included. The frequency of hydrocortisone administration was 22.3% overall (95% CI: 18.0, 26.5) and 59.4% in patients who received at least 60 cc/kg of fluid and were on two or more vasoactive agents. Patients administered hydrocortisone had higher PRISM scores (19, IQR 11-24 versus 9, IQR 5-16; P < 0.0001), higher inotrope scores (15, IQR 10-25 versus 7.5, IQR 3.3-10.6, P < 0.0001) and were more likely to have received 60 cc/kg of fluid resuscitation (59.3% versus 33.6%, OR 2.88, 95% CI: 2.09, 3.96). In an adjusted analysis, patients who received hydrocortisone spent more time on vasoactive infusions (64 versus 34  hours, hazard ratio 0.72, 95% CI: 0.62, 0.84) and had a higher incidence of positive cultures between day 4 and day 28 post admission (24.7% versus 14.5%, OR 1.79, 95% CI: 1.58, 2.04). Hydrocortisone administration was associated with longer time on vasopressors and increased incidence of positive cultures even after correcting for illness severity. Caution should be exercised in administering hydrocortisone for shock until there is clear evidence for benefit in this patient population.

  13. Gender differences in clinical outcomes among HIV-positive individuals on antiretroviral therapy in Canada: a multisite cohort study.

    PubMed

    Cescon, Angela; Patterson, Sophie; Chan, Keith; Palmer, Alexis K; Margolese, Shari; Burchell, Ann N; Cooper, Curtis; Klein, Marina B; Machouf, Nima; Montaner, Julio S G; Tsoukas, Chris; Hogg, Robert S; Raboud, Janet M; Loutfy, Mona R

    2013-01-01

    Cohort data examining differences by gender in clinical responses to combination antiretroviral therapy (ART) remain inconsistent and have yet to be explored in a multi-province Canadian setting. This study investigates gender differences by injection drug use (IDU) history in virologic responses to ART and mortality. Data from the Canadian Observational Cohort (CANOC) collaboration, a multisite cohort study of HIV-positive individuals initiating ART after January 1, 2000, were included. This analysis was restricted to participants with a follow-up HIV-RNA plasma viral load measure and known IDU history. Weibull hazard regression evaluated time to virologic suppression (2 consecutive measures <50 copies/mL), rebound (>1000 copies/mL after suppression), and all-cause mortality. Sensitivity analyses explored the impact of presumed ART use in pregnancy on virologic outcomes. At baseline, women (1120 of 5442 participants) were younger (median 36 vs. 41 years) and more frequently reported IDU history (43.5% vs. 28.8%) (both p<0.001). Irrespective of IDU history, in adjusted multivariable analyses women were significantly less likely to virologically suppress after ART initiation and were at increased risk of viral load rebound. In adjusted time to death analysis, no differences by gender were noted. After adjusting for presumed ART use in pregnancy, observed gender differences in time to virologic suppression for non-IDU, and time to virologic rebound for IDU, became insignificant. HIV-positive women in CANOC are at heightened risk for poor clinical outcomes. Further understanding of the intersections between gender and other factors augmenting risk is needed to maximize the benefits of ART.

  14. Gender Differences in Clinical Outcomes among HIV-Positive Individuals on Antiretroviral Therapy in Canada: A Multisite Cohort Study

    PubMed Central

    Cescon, Angela; Patterson, Sophie; Chan, Keith; Palmer, Alexis K.; Margolese, Shari; Burchell, Ann N.; Cooper, Curtis; Klein, Marina B.; Machouf, Nima; Montaner, Julio S. G.; Tsoukas, Chris; Hogg, Robert S.; Raboud, Janet M.; Loutfy, Mona R.

    2013-01-01

    Background Cohort data examining differences by gender in clinical responses to combination antiretroviral therapy (ART) remain inconsistent and have yet to be explored in a multi-province Canadian setting. This study investigates gender differences by injection drug use (IDU) history in virologic responses to ART and mortality. Methods Data from the Canadian Observational Cohort (CANOC) collaboration, a multisite cohort study of HIV-positive individuals initiating ART after January 1, 2000, were included. This analysis was restricted to participants with a follow-up HIV-RNA plasma viral load measure and known IDU history. Weibull hazard regression evaluated time to virologic suppression (2 consecutive measures <50 copies/mL), rebound (>1000 copies/mL after suppression), and all-cause mortality. Sensitivity analyses explored the impact of presumed ART use in pregnancy on virologic outcomes. Results At baseline, women (1120 of 5442 participants) were younger (median 36 vs. 41 years) and more frequently reported IDU history (43.5% vs. 28.8%) (both p<0.001). Irrespective of IDU history, in adjusted multivariable analyses women were significantly less likely to virologically suppress after ART initiation and were at increased risk of viral load rebound. In adjusted time to death analysis, no differences by gender were noted. After adjusting for presumed ART use in pregnancy, observed gender differences in time to virologic suppression for non-IDU, and time to virologic rebound for IDU, became insignificant. Conclusions HIV-positive women in CANOC are at heightened risk for poor clinical outcomes. Further understanding of the intersections between gender and other factors augmenting risk is needed to maximize the benefits of ART. PMID:24391803

  15. Impact of ascites volume on clinical outcomes in ovarian cancer: A cohort study.

    PubMed

    Szender, J Brian; Emmons, Tiffany; Belliotti, Sarah; Dickson, Danielle; Khan, Aalia; Morrell, Kayla; Khan, A N M Nazmul; Singel, Kelly L; Mayor, Paul C; Moysich, Kirsten B; Odunsi, Kunle; Segal, Brahm H; Eng, Kevin H

    2017-09-01

    To investigate the impact of ascites volume on ovarian cancer outcomes. Clinicopathologic features of a cohort of patients with ovarian cancer were obtained from a curated database at a single institution. Progression free survival (PFS) and overall survival (OS) were recorded. Ascites volume at primary surgery was dichotomized at 2000mL and comparisons for high and low volume ascites were made. Additionally, to elucidate interactions between ascites and ovarian tumor progression, we evaluated the effect of intraperitoneal administrations of murine cell-free ascites versus saline in a syngeneic mouse model of epithelial ovarian cancer. Out of 685 patients identified, 58% had ascites present at the time of initial surgery. Considering the volume of ascites continuously, each liter of ascites was associated with shorter PFS (HR=1.12, 95% CI: 1.07-1.17) and OS (HR=1.12, 95%CI: 1.07-1.17). Patients with ascites greater than the median of 2000mL had significantly shorter PFS (14.5months vs. 22.7months; p<0.001) and OS (27.7months vs. 42.9months; p<0.001). After adjusting for stage, presence of ascites was inversely associated with ability to achieve optimal cytoreductive surgery. Consistent with these correlative results in patients, intraperitoneal administrations of murine cell-free ascites accelerated ovarian cancer progression in mice. The volume of ascites at initial diagnosis of ovarian cancer correlated with worse PFS and OS. The effect of large volume on prognosis is likely to be in part related to reduced likelihood for complete resection of tumor (R0). If these findings are confirmed in independent studies, consideration should be made to add the presence of large volume ascites at diagnosis to the staging criteria for ovarian cancer. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. The Hotel Study-Clinical and Health Service Effectiveness in a Cohort of Homeless or Marginally Housed Persons.

    PubMed

    Honer, William G; Cervantes-Larios, Alejandro; Jones, Andrea A; Vila-Rodriguez, Fidel; Montaner, Julio S; Tran, Howard; Nham, Jimmy; Panenka, William J; Lang, Donna J; Thornton, Allen E; Vertinsky, Talia; Barr, Alasdair M; Procyshyn, Ric M; Smith, Geoffrey N; Buchanan, Tari; Krajden, Mel; Krausz, Michael; MacEwan, G William; Gicas, Kristina M; Leonova, Olga; Langheimer, Verena; Rauscher, Alexander; Schultz, Krista

    2017-07-01

    The Hotel Study was initiated in Vancouver's Downtown East Side (DTES) neighborhood to investigate multimorbidity in homeless or marginally housed people. We evaluated the clinical effectiveness of existing, illness-specific treatment strategies and assessed the effectiveness of health care delivery for multimorbid illnesses. For context, we mapped the housing locations of patients presenting for 552,062 visits to the catchment hospital emergency department (2005-2013). Aggregate data on 22,519 apprehensions of mentally ill people were provided by the Vancouver Police Department (2009-2015). The primary strategy was a longitudinal cohort study of 375 people living in the DTES (2008-2015). We analysed mortality and evaluated the clinical and health service delivery effectiveness for infection with human immunodeficiency virus or hepatitis C virus, opioid dependence, and psychosis. Mapping confirmed the association between poverty and greater number of emergency visits related to substance use and mental illness. The annual change in police apprehensions did not differ between the DTES and other policing districts. During 1581 person-years of cohort observation, the standardized mortality ratio was 8.43 (95% confidence interval, 6.19 to 11.50). Physician visits were common (84.3% of participants over 6 months). Clinical treatment effectiveness was highest for HIV/AIDS, intermediate for opioid dependence, and lowest for psychosis. Health service delivery mechanisms provided examples of poor access, poor treatment adherence, and little effect on multimorbid illnesses. Clinical effectiveness was variable, and illness-specific service delivery appeared to have little effect on multimorbidity. New models of care may need to be implemented.

  17. Clinical outcomes and resource utilisation in Medicare patients with chronic liver disease: a historical cohort study.

    PubMed

    Younossi, Zobair M; Zheng, Li; Stepanova, Maria; Venkatesan, Chapy; Mishra, Alita

    2014-05-16

    The aim of this study is to assess recent trends in health resource utilisation and patient outcomes of Medicare beneficiaries with chronic liver disease (CLD). Liver-related mortality is the 10th leading cause of death in the USA, and hepatitis C virus (HCV) and obesity-related non-alcoholic fatty liver disease are the major causes of CLD. As the US population ages and becomes more obese, the impact of CLD is expected to become more prominent for the Medicare population. This is a retrospective cohort study of Medicare beneficiaries with a diagnosis of CLD based on inpatient (N=21 576; 14 977 unique patients) and outpatient (N=515 990; 244 196 patients) claims from 2005 to 2010. The study outcomes included hospital length of stay (LOS) and inpatient mortality as well as inpatient and outpatient inflation-adjusted payments. Between 2005 and 2010, there was an annual decrease in LOS of 3.17% for CLD-related hospitalisations. Risk-adjusted in-hospital mortality decreased (OR 0.90, 95% CI 0.87 to 0.94), while short-term postdischarge mortality remained stable (1.00, 0.98 to 1.03). Inpatient per-claim payment increased from $11 769 in 2005 to $12 347 in 2010 (p=0.0006). Similarly, the average yearly payments for outpatient care increased from $366 to $404 (p<0.0001). This change in payment was observed together with a consistent decrease in the proportion of beneficiary-paid amount (25.4-20%, p<0.0001) as opposed to Medicare-paid amount (73.1-80%, p<0.0001). The major predictors of higher outpatient payments were younger age, Asian race or Hispanic ethnicity, living in California, and having more diagnoses and outpatient procedures per claim. The predictors of inpatient spending also included younger age, location and the number of inpatient procedures. Length of inpatient stay and inpatient mortality among Medicare beneficiaries with CLD decreased, while inpatient and outpatient spending increased. Published by the BMJ Publishing Group Limited. For

  18. The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School

    PubMed Central

    2010-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown. The study objective was to determine whether UKCAT scores predict performance during the first two years of the 5-year undergraduate medical course at Nottingham. Methods We studied a single cohort of students, who entered Nottingham Medical School in October 2007 and had taken the UKCAT. We used linear regression analysis to identify independent predictors of marks for different parts of the 2-year preclinical course. Results Data were available for 204/260 (78%) of the entry cohort. The UKCAT total score had little predictive value. Quantitative Reasoning was a significant independent predictor of course marks in Theme A ('The Cell'), (p = 0.005), and Verbal Reasoning predicted Theme C ('The Community') (p < 0.001), but otherwise the effects were slight or non-existent. Conclusion This limited study from a single entry cohort at one medical school suggests that the predictive value of the UKCAT, particularly the total score, is low. Section scores may predict success in specific types of course assessment. The ultimate test of validity will not be available for some years, when current cohorts of students graduate. However, if this test of mental ability does not predict preclinical performance, it is arguably less likely to predict the outcome in the clinical years. Further research from medical schools with different types of curriculum and assessment is needed, with longitudinal studies throughout the course. PMID:20667093

  19. The value of the UK Clinical Aptitude Test in predicting pre-clinical performance: a prospective cohort study at Nottingham Medical School.

    PubMed

    Yates, Janet; James, David

    2010-07-28

    The UK Clinical Aptitude Test (UKCAT) was introduced in 2006 as an additional tool for the selection of medical students. It tests mental ability in four distinct domains (Quantitative Reasoning, Verbal Reasoning, Abstract Reasoning, and Decision Analysis), and the results are available to students and admissions panels in advance of the selection process. As yet the predictive validity of the test against course performance is largely unknown.The study objective was to determine whether UKCAT scores predict performance during the first two years of the 5-year undergraduate medical course at Nottingham. We studied a single cohort of students, who entered Nottingham Medical School in October 2007 and had taken the UKCAT. We used linear regression analysis to identify independent predictors of marks for different parts of the 2-year preclinical course. Data were available for 204/260 (78%) of the entry cohort. The UKCAT total score had little predictive value. Quantitative Reasoning was a significant independent predictor of course marks in Theme A ('The Cell'), (p = 0.005), and Verbal Reasoning predicted Theme C ('The Community') (p < 0.001), but otherwise the effects were slight or non-existent. This limited study from a single entry cohort at one medical school suggests that the predictive value of the UKCAT, particularly the total score, is low. Section scores may predict success in specific types of course assessment.The ultimate test of validity will not be available for some years, when current cohorts of students graduate. However, if this test of mental ability does not predict preclinical performance, it is arguably less likely to predict the outcome in the clinical years. Further research from medical schools with different types of curriculum and assessment is needed, with longitudinal studies throughout the course.

  20. Cohort Profile Update: The GAZEL Cohort Study.

    PubMed

    Goldberg, Marcel; Leclerc, Annette; Zins, Marie

    2015-02-01

    The original GAZEL cohort was composed of 20 625 employees of the French national gas and electricity companies (15 011 male employees then aged 40 to 50 years and 5614 women between 35 and 50 years old) at its inception in 1989. A Cohort Profile article was published in 2007. By the end of 2013, participants were aged 60-75, and almost all of them retired during follow-up. Accordingly, the main focus of research in the past decade was devoted to the study of the persistent, long-term effects of occupational exposures after retirement; of the transition between professionally active life and retirement; and on determinants of early ageing. Accordingly, in addition to the health, behavioural and social data collected yearly since the beginning of the follow-up, new data were thus collected on cognitive complaints, cognitive and physical functioning, limitations in daily activities, time use and social relationships of retirees. This update presents the main findings of research within the GAZEL Cohort Study during the past 7 years. Any research group, in France or elsewhere, can submit a research proposal to work on the GAZEL cohort. To do this, interested researchers should contact one of the principal investigators of the GAZEL Cohort Study.

  1. Growth Patterns of HIV Infected Indian Children in Response to ART: A Clinic Based Cohort Study.

    PubMed

    Parchure, Ritu S; Kulkarni, Vinay V; Darak, Trupti S; Mhaskar, Rahul; Miladinovic, Branko; Emmanuel, Patricia J

    2015-06-01

    To describe catch-up growth after antiretroviral therapy (ART) initiation among children living with human immunodeficiency virus (CLHIV), attending a private clinic in India. This is a retrospective analysis of data of CLHIV attending Prayas clinic, Pune, India. Height and weight z scores (HAZ, WAZ) were calculated using WHO growth charts. Catch-up growth post-ART was assessed using a mixed method model in cases where baseline and at least one subsequent follow-up HAZ/WAZ were available. STATA 12 was used for statistical analysis. During 1998 to 2011, 466 children were enrolled (201 girls and 265 boys; median age = 7 y). A total of 302 children were ever started on ART; of which 73 and 76 children were included for analysis for catch up growth in WAZ and HAZ respectively. Median WAZ and HAZ increased from -2.14 to -1.34 (p = 0.007) and -2.42 to -1.94 (p = 0.34), respectively, 3 y post ART. Multivariable analysis using mixed model (adjusted for gender, guardianship, baseline age, baseline WAZ/HAZ, baseline and time varying WHO clinical stage) showed gains in WAZ (coef = 0.2, 95 % CI: -0.06 to 0.46) and HAZ (coef = 0.49, 95 % CI: 0.21 to 0.77) with time on ART. Lower baseline WAZ/HAZ and older age were associated with impaired catch-up growth. Children staying in institutions and with baseline advanced clinical stage showed higher gain in WAZ. The prevalence of stunting and underweight was high at ART initiation. Sustained catch-up growth was seen with ART. The study highlights the benefit of early ART in achieving normal growth in CLHIV.

  2. Topical distribution of initial paresis of the limbs to predict clinically relevant spasticity after ischemic stroke: a retrospective cohort study.

    PubMed

    Picelli, A; Tamburin, S; Dambruoso, F; Midiri, A; Girardi, P; Santamato, A; Fiore, P; Smania, N

    2014-10-01

    The degree of initial paresis relates to spasticity development in stroke patients. However, the importance of proximal and distal paresis in predicting spasticity after stroke is unclear. To investigate the role of topical distribution of initial limb paresis to predict clinically relevant spasticity in adults with stroke. Retrospective cohort study Seventy-two first-ever ischemic stroke patients were examined. At the acute phase of illness, demographics and the European Stroke Scale motor items (maintenance of outstretched arm position, arm raising, wrist extension, grip strength, maintenance of outstretched leg position, leg flexion, foot dorsiflexion) were evaluated. At six months after the stroke onset, spasticity was assessed at the upper and lower limb with the modified Ashworth Scale. Clinically relevant spasticity was defined as modified Ashworth Scale ≥3 (0-5). The degree of initial paresis of the proximal muscles of the upper limb and the distal muscles of the lower limb showed the strongest association and the best profile of sensitivity-specificity in predicting clinically relevant spasticity at the upper and lower limb, respectively. Younger age showed higher risk for developing clinically relevant spasticity in the upper limb. Our findings support the hypothesis that the initial degree of proximal paresis of the upper limb and distal paresis of the lower limb as well as age may be considered early predictors of clinically relevant spasticity in adults with ischemic stroke. Our findings further improve the role of initial paresis as predictor of spasticity after stroke.

  3. How well are journal and clinical article characteristics associated with the journal impact factor? a retrospective cohort study

    PubMed Central

    Lokker, Cynthia; Haynes, R. Brian; Chu, Rong; McKibbon, K. Ann; Wilczynski, Nancy L; Walter, Stephen D

    2012-01-01

    Objective: Journal impact factor (JIF) is often used as a measure of journal quality. A retrospective cohort study determined the ability of clinical article and journal characteristics, including appraisal measures collected at the time of publication, to predict subsequent JIFs. Methods: Clinical research articles that passed methods quality criteria were included. Each article was rated for relevance and newsworthiness by 3 to 24 physicians from a panel of more than 4,000 practicing clinicians. The 1,267 articles (from 103 journals) were divided 60∶40 into derivation (760 articles) and validation sets (507 articles), representing 99 and 88 journals, respectively. A multiple regression model was produced determining the association of 10 journal and article measures with the 2007 JIF. Results: Four of the 10 measures were significant in the regression model: number of authors, number of databases indexing the journal, proportion of articles passing methods criteria, and mean clinical newsworthiness scores. With the number of disciplines rating the article, the 5 variables accounted for 61% of the variation in JIF (R2 = 0.607, 95% CI 0.444 to 0.706, P<0.001). Conclusion: For the clinical literature, measures of scientific quality and clinical newsworthiness available at the time of publication can predict JIFs with 60% accuracy. PMID:22272156

  4. How well are journal and clinical article characteristics associated with the journal impact factor? a retrospective cohort study.

    PubMed

    Lokker, Cynthia; Haynes, R Brian; Chu, Rong; McKibbon, K Ann; Wilczynski, Nancy L; Walter, Stephen D

    2012-01-01

    Journal impact factor (JIF) is often used as a measure of journal quality. A retrospective cohort study determined the ability of clinical article and journal characteristics, including appraisal measures collected at the time of publication, to predict subsequent JIFs. Clinical research articles that passed methods quality criteria were included. Each article was rated for relevance and newsworthiness by 3 to 24 physicians from a panel of more than 4,000 practicing clinicians. The 1,267 articles (from 103 journals) were divided 60∶40 into derivation (760 articles) and validation sets (507 articles), representing 99 and 88 journals, respectively. A multiple regression model was produced determining the association of 10 journal and article measures with the 2007 JIF. Four of the 10 measures were significant in the regression model: number of authors, number of databases indexing the journal, proportion of articles passing methods criteria, and mean clinical newsworthiness scores. With the number of disciplines rating the article, the 5 variables accounted for 61% of the variation in JIF (R(2) = 0.607, 95% CI 0.444 to 0.706, P<0.001). For the clinical literature, measures of scientific quality and clinical newsworthiness available at the time of publication can predict JIFs with 60% accuracy.

  5. Sorafenib treatment of radioiodine-refractory advanced thyroid cancer in daily clinical practice: a cohort study from a single center.

    PubMed

    Gallo, Marco; Michelon, Federica; Castiglione, Anna; Felicetti, Francesco; Viansone, Alessandro Adriano; Nervo, Alice; Zichi, Clizia; Ciccone, Giovannino; Piovesan, Alessandro; Arvat, Emanuela

    2015-08-01

    Treatment options for recurrent or metastatic differentiated thyroid cancer (DTC) refractory to radioactive iodine (RAI) are inadequate. Multitargeted kinase inhibitors have recently shown promising results in phase 2-3 studies. This retrospective study aimed to document our clinical experience on the effects of sorafenib in the setting of daily clinical practice. Retrospective study evaluating the efficacy and safety of sorafenib in a cohort of patients consecutively treated with sorafenib at a single center. Twenty patients with advanced RAI-refractory thyroid carcinoma were enrolled (March 2011-March 2014). Patients generally started with 400 mg of sorafenib twice daily, tapering the dose in case of side effects. Radiological response and toxicity were measured during follow-up, together with safety parameters. CT scans were performed by a single experienced radiologist every 3-4 months. Five patients stopped sorafenib within 90 days due to severe toxicities. Median progression-free survival was 248 days. Five patients had a partial response (PR), achieved in all cases within 3 months, whereas 5 had stable disease (SD) at 12 months. Durable response rate (PR plus SD) for at least 6 months was 50 %, among those who received sorafenib for at least 3 months. Commonest adverse events included skin toxicity, gastrointestinal and constitutional symptoms. In our cohort of patients with advanced RAI-refractory thyroid carcinoma, sorafenib confirmed antitumor activity leading to SD or PR in the majority of cases, at the expense of clinically relevant side effects. More effective and tolerable agents are still needed in the treatment of RAI-refractory DTC.

  6. The clinical characteristics of sarcoid arthropathy based on a prospective cohort study

    PubMed Central

    Kobak, Senol; Sever, Fidan; Usluer, Ozan; Goksel, Tuncay; Orman, Mehmet

    2016-01-01

    Background: Sarcoidosis is known as a Th1-mediated disease, which can mimic many primary rheumatologic diseases or sometimes co-exist with them. Clinical characteristics of sarcoid arthropathy are not well described and the studies reported in the literature so far are mostly based on data from referrals. The aim of this study was to evaluate the incidence and clinical characteristics of sarcoid arthropathy. Methods: All our patients were prospectively evaluated in our rheumatology outpatient center from 2011 to 2015. A total of 114 (32 male) patients with sarcoidosis who were admitted to our clinic were included in the study. Clinical, demographical, laboratory, radiological and histological data of these patients obtained during 4-year follow-up and treatment period were compiled and analyzed. Results: The mean patient age was 48.1 years (range, 20–82 years), and the mean disease duration was 40.5 months (range, 1–300 months). Sarcoid arthritis was observed in 71 (62.3%), and arthralgia in 106 (92.9%) patients. Out of the 71 patients with arthritis, 61 (85.9%) had involvement of ankle, 7 (9.8%) knee, 2 (2.8%) wrist, MCP and PIP joints, and 1 (1.4%) had shoulder periarthritis. Oligoarthritis (two to four joints) was the most common pattern followed by monoarthritis and polyarthritis. Arthritis and erytjhema nodosum and arthritis and female sex was found to be correlated (p = 0.03 and p = 0.001). Again, in patients with arthritis, even higher levels of CRP/ESR as well as ANA and RF positivity were observed (p = 0.03, p = 0.01, p = 0.01, and p = 0.02, respectively). A total of 11 patients had another rheumatic pathology concurrent with sarcoidosis. Conclusions: Inflammatory arthritis occurs in a majority of patients with sarcoidosis. Acute arthritis with bilateral ankle involvement is the most common pattern of sarcoid arthropathy. Sarcoidosis can mimic many primary rheumatic diseases or may coexist with them. Sarcoidosis should be considered not only as a

  7. Association between rheumatic diseases and cancer: results from a clinical practice cohort study.

    PubMed

    Bellan, Mattia; Boggio, Enrico; Sola, Daniele; Gibbin, Antonello; Gualerzi, Alessandro; Favretto, Serena; Guaschino, Giulia; Bonometti, Ramona; Pedrazzoli, Roberta; Pirisi, Mario; Sainaghi, Pier Paolo

    2017-02-08

    The association between cancer and immune-mediated rheumatic conditions is controversial, especially as far as polymyalgia rheumatica (PMR) is concerned. Furthermore, no clinical feature has been shown to be suggestive of a paraneoplastic rheumatic syndrome. With the present study, we aim to address both these issues. The study population comprised N = 1750 patients, including N = 100 with PMR, who attended our tertiary immuno-rheumatology clinic between January 1, 2005 and November 30, 2012. A rheumatic disease was deemed paraneoplastic if cancer had been diagnosed in the 2 years preceding or following its onset. The probability of a significant association between a specific rheumatic disease and cancer was evaluated by computing the odds ratio (OR): N = 702 patients with osteoarthritis serving as controls. Furthermore, clinical features distinguishing paraneoplastic rheumatic diseases were searched for by univariate and multivariate analysis. Sjogren's syndrome (SS) [OR 3.6 (CI 95% 1.7-7.5)], PMR (OR 5.1 CI 95% 2.9-8.9), dermatomyositis/polymyositis [OR 12.09 (CI 95% 2.6-55.8)] and vasculitis [OR 3.70 (CI 95% 1.81-7.52)] are associated with cancer. At multivariate analysis, older age is associated with cancer among SS patients (p = 0.03), while in the PMR group, older age, male gender, and ≥6 tender joints are independent predictors of paraneoplastic PMR (p < 0.0004). Cancer frequently either heralds or follows rheumatic manifestations, including PMR. Older age, male gender and a more extensive joint involvement should be considered red flags for paraneoplastic PMR.

  8. Identification of clinical predictors of flare in systemic lupus erythematosus patients: a 24-month prospective cohort study.

    PubMed

    Inês, Luís; Duarte, Cátia; Silva, Rosário Santos; Teixeira, Ana Sofia; Fonseca, Fernando Pereira; da Silva, José António P

    2014-01-01

    SLE has a relapsing-remitting course with disease activity flares over time. This study aims to identify clinical predictors of SLE flares. This prospective cohort study over 24 months included all SLE patients on follow-up at one academic lupus clinic. Flare was defined as an increase in SLEDAI-2K score ≥4 points. Baseline clinical and demographic parameters were compared using survival analysis for time-to-flare outcome with univariate log-rank tests. Variables with significant differences were further evaluated as predictors with multivariate Cox regression models adjusting for potential confounding or contributing factors and hazard ratio (HR) calculation. A total of 202 SLE patients were included. Over the follow-up period, 1083 visits were documented and 16.8% of patients presented with flares. In multivariate analysis, the following parameters emerged as flare predictors: SLE diagnosis up to 25 years of age (HR = 2.14, P = 0.03), lupus nephritis previous to baseline visit (HR = 4.78, P < 0.0001) and immunosuppressor treatment for severe SLE (HR = 3.22, P < 0.001). Baseline disease activity, disease duration and treatment with prednisone or HCQ were not predictive factors. Patients with an SLE diagnosis before age 25 years, lupus nephritis or immunosuppressor treatment for severe SLE present greater HRs for flares, suggesting the need for tighter clinical monitoring. Current immunosuppressive strategies seem to be inefficient in providing flare prevention.

  9. Clinical and neuropsychological features of violence in schizophrenia: A prospective cohort study.

    PubMed

    Bulgari, Viola; Iozzino, Laura; Ferrari, Clarissa; Picchioni, Marco; Candini, Valentina; De Francesco, Alessandra; Maggi, Paolo; Segalini, Beatrice; de Girolamo, Giovanni

    2017-03-01

    The increased risk of violence in schizophrenia has been linked to several environmental, clinical and neuropsychological factors, including executive dysfunction. However, data about the nature of these effects are mixed and controversial. The main aim of this study was to investigate the relationship between clinical and neuropsychological factors with violence risk in patients with schizophrenia, taking into account current psychopathology and lifetime alcohol use. We compared a sample of patients living in Residential Facilities (RFs) with schizophrenia and a past history of interpersonal violence (vSZ, N=50) to patients with schizophrenia matched on age, gender and alcohol abuse/dependence but with no violence history (nvSZ, N=37). We then established the association between the clinical and neuropsychological factors that predicted violence over a 1year follow-up period. The results revealed that vSZ patients living in RFs were characterized by greater compulsory hospital admissions, higher anger and less negative symptoms as compared to nvSZ patients. vSZ patients performed better on executive and motor tasks than nvSZ; however, these differences appeared to be explained by the lower negative psychotic symptom in the vSZ group. Both groups were involved in episodes of violence during the follow-up period; among the two, the vSZ patients were more likely to be violent. Negative symptoms predicted less verbal aggression at 1year follow-up. Overall, these findings support a key role of negative rather than positive symptoms in driving violence risk among SZ patients living in RFs, in a manner that negative symptoms are linked to a lower risk of violence.

  10. Optimism and recovery after acute coronary syndrome: a clinical cohort study.

    PubMed

    Ronaldson, Amy; Molloy, Gerard J; Wikman, Anna; Poole, Lydia; Kaski, Juan-Carlos; Steptoe, Andrew

    2015-04-01

    Optimism is associated with reduced cardiovascular mortality, but its impact on recovery after acute coronary syndrome (ACS) is poorly understood. We hypothesized that greater optimism would lead to more effective physical and emotional adaptation after ACS and would buffer the impact of persistent depressive symptoms on clinical outcomes. This prospective observational clinical study took place in an urban general hospital and involved 369 patients admitted with a documented ACS. Optimism was assessed with a standardized questionnaire. The main outcomes were physical health status, depressive symptoms, smoking, physical activity, and fruit and vegetable consumption measured 12 months after ACS, and composite major adverse cardiac events (cardiovascular death, readmission with reinfarction or unstable angina, and coronary artery bypass graft surgery) assessed over an average of 45.7 months. We found that optimism predicted better physical health status 12 months after ACS independently of baseline physical health, age, sex, ethnicity, social deprivation, and clinical risk factors (B = 0.65, 95% confidence interval [CI] = 0.10-1.20). Greater optimism also predicted reduced risk of depressive symptoms (odds ratio = 0.82, 95% CI = 0.74-0.90), more smoking cessation, and more fruit and vegetable consumption at 12 months. Persistent depressive symptoms 12 months after ACS predicted major adverse cardiac events over subsequent years (odds ratio = 2.56, 95% CI = 1.16-5.67), but only among individuals low in optimism (optimism × depression interaction; p = .014). Optimism predicts better physical and emotional health after ACS. Measuring optimism may help identify individuals at risk. Pessimistic outlooks can be modified, potentially leading to improved recovery after major cardiac events.

  11. Optimism and Recovery After Acute Coronary Syndrome: A Clinical Cohort Study

    PubMed Central

    Ronaldson, Amy; Molloy, Gerard J.; Wikman, Anna; Poole, Lydia; Kaski, Juan-Carlos; Steptoe, Andrew

    2015-01-01

    ABSTRACT Objective Optimism is associated with reduced cardiovascular mortality, but its impact on recovery after acute coronary syndrome (ACS) is poorly understood. We hypothesized that greater optimism would lead to more effective physical and emotional adaptation after ACS and would buffer the impact of persistent depressive symptoms on clinical outcomes. Methods This prospective observational clinical study took place in an urban general hospital and involved 369 patients admitted with a documented ACS. Optimism was assessed with a standardized questionnaire. The main outcomes were physical health status, depressive symptoms, smoking, physical activity, and fruit and vegetable consumption measured 12 months after ACS, and composite major adverse cardiac events (cardiovascular death, readmission with reinfarction or unstable angina, and coronary artery bypass graft surgery) assessed over an average of 45.7 months. Results We found that optimism predicted better physical health status 12 months after ACS independently of baseline physical health, age, sex, ethnicity, social deprivation, and clinical risk factors (B = 0.65, 95% confidence interval [CI] = 0.10–1.20). Greater optimism also predicted reduced risk of depressive symptoms (odds ratio = 0.82, 95% CI = 0.74–0.90), more smoking cessation, and more fruit and vegetable consumption at 12 months. Persistent depressive symptoms 12 months after ACS predicted major adverse cardiac events over subsequent years (odds ratio = 2.56, 95% CI = 1.16–5.67), but only among individuals low in optimism (optimism × depression interaction; p = .014). Conclusions Optimism predicts better physical and emotional health after ACS. Measuring optimism may help identify individuals at risk. Pessimistic outlooks can be modified, potentially leading to improved recovery after major cardiac events. PMID:25738438

  12. Longitudinal assessment of neuroimaging and clinical markers in autosomal dominant Alzheimer's disease: a prospective cohort study.

    PubMed

    Yau, Wai-Ying Wendy; Tudorascu, Dana L; McDade, Eric M; Ikonomovic, Snezana; James, Jeffrey A; Minhas, Davneet; Mowrey, Wenzhu; Sheu, Lei K; Snitz, Beth E; Weissfeld, Lisa; Gianaros, Peter J; Aizenstein, Howard J; Price, Julie C; Mathis, Chester A; Lopez, Oscar L; Klunk, William E

    2015-08-01

    The biomarker model of Alzheimer's disease postulates a dynamic sequence of amyloidosis, neurodegeneration, and cognitive decline as an individual progresses from preclinical Alzheimer's disease to dementia. Despite supportive evidence from cross-sectional studies, verification with long-term within-individual data is needed. For this prospective cohort study, carriers of autosomal dominant Alzheimer's disease mutations (aged ≥21 years) were recruited from across the USA through referrals by physicians or from affected families. People with mutations in PSEN1, PSEN2, or APP were assessed at the University of Pittsburgh Alzheimer's Disease Research Center every 1-2 years, between March 23, 2003, and Aug 1, 2014. We measured global cerebral amyloid β (Aβ) load using (11)C-Pittsburgh Compound-B PET, posterior cortical metabolism with (18)F-fluorodeoxyglucose PET, hippocampal volume (age and sex corrected) with T1-weighted MRI, verbal memory with the ten-item Consortium to Establish a Registry for Alzheimer's Disease Word List Learning Delayed Recall Test, and general cognition with the Mini Mental State Examination. We estimated overall biomarker trajectories across estimated years from symptom onset using linear mixed models, and compared these estimates with cross-sectional data from cognitively normal control individuals (age 65-89 years) who were negative for amyloidosis, hypometabolism, and hippocampal atrophy. In the mutation carriers who had the longest follow-up, we examined the within-individual progression of amyloidosis, metabolism, hippocampal volume, and cognition to identify progressive within-individual changes (a significant change was defined as an increase or decrease of more than two Z scores standardised to controls). 16 people with mutations in PSEN1, PSEN2, or APP, aged 28-56 years, completed between two and eight assessments (a total of 83 assessments) over 2-11 years. Significant differences in mutation carriers compared with controls (p<0

  13. The respective roles of controlled clinical trials and cohort monitoring studies in the pre- and postmarketing assessment of drugs.

    PubMed

    Vray, Muriel; Hamelin, Bernard; Jaillon, Patrice

    2005-01-01

    The respective roles of controlled clinical trials and observational studies (cohort or case-control studies) in evaluating the efficacy, safety and usefulness of a drug were analysed. A randomised, controlled, double-blind study is the best method of estimating the efficacy of a treatment. It provides the least biased and most robust estimate of the causal relationship. In certain situations and on the basis of certain criteria, observational studies can have a proof-of-efficacy value. Randomised, controlled, pre- and postmarketing authorisation (MA) clinical studies identify the rarer adverse effects and compare them with those resulting from the reference treatment. Before the MA, the pooled safety data from different controlled trials can provide an estimation of relatively frequent adverse events and subjects at risk. However, an observational study is the most appropriate method of evaluating the safety of a drug in the currently used conditions. By definition, a drug influences the health of a population if it directly or indirectly improves its health. A drug would have a major role in public health if it reduced mortality or morbidity related to a particular disease or if it improved the quality of life of patients with this disease. Prior to marketing a product, modelling is the approach of choice to quantify the expected effect. Pragmatic, postmarketing trials and observational studies are the reference methods used to define the population affected, the efficacy and safety of the drug in a real situation and its usefulness for public health. In conclusion, randomised clinical trials remain the reference approach for evaluating efficacy, while observational studies have a confirmatory value. Observational studies are the most appropriate way of evaluating safety in the currently used conditions, as the clinical trial has limited indications. In the interests of public health, modelling is the pre-marketing approach of choice, while pragmatic trials and

  14. Clinical procedures and practices used in the perioperative treatment of female genital fistula during a prospective cohort study

    PubMed Central

    2014-01-01

    Background Treatment and care for female genital fistula have become increasingly available over the last decade in countries across Africa and South Asia. Before the International Federation of Gynaecology and Obstetrics (FIGO) and partners published a global fistula training manual in 2011 there was no internationally recognized, standardized training curriculum, including perioperative care. The community of fistula care practitioners and advocates lacks data about the prevalence of various perioperative clinical procedures and practices and their potential programmatic implications are lacking. Methods Data presented here are from a prospective cohort study conducted between September 2007 and September 2010 at 11 fistula repair facilities supported by Fistula Care in five countries. Clinical procedures and practices used in the routine perioperative management of over 1300 women are described. Results More than two dozen clinical procedures and practices were tabulated. Some of them were commonly used at all sites (e.g., vaginal route of repair, 95.3% of cases); others were rare (e.g., flaps/grafts, 3.4%) or varied widely depending on site (e.g. for women with urinary fistula, the inter-quartile range for median duration of post-repair bladder catheterization was 14 to 29 days). Conclusions These findings show a wide range of clinical procedures and practices with different program implications for safety, efficacy, and cost-effectiveness. The variability indicates the need for further research so as to strengthen the evidence base for fistula treatment in developing countries. PMID:24996561

  15. STroke imAging pRevention and treatment (START): A longitudinal stroke cohort study: Clinical trials protocol.

    PubMed

    Carey, Leeanne M; Crewther, Sheila; Salvado, Olivier; Lindén, Thomas; Connelly, Alan; Wilson, William; Howells, David W; Churilov, Leonid; Ma, Henry; Tse, Tamara; Rose, Stephen; Palmer, Susan; Bougeat, Pierrick; Campbell, Bruce C V; Christensen, Soren; Macaulay, S Lance; Favaloro, Jenny; O' Collins, Victoria; McBride, Simon; Bates, Susan; Cowley, Elise; Dewey, Helen; Wijeratne, Tissa; Gerraty, Richard; Phan, Thanh G; Yan, Bernard; Parsons, Mark W; Bladin, Chris; Barber, P Alan; Read, Stephen; Wong, Andrew; Lee, Andrew; Kleinig, Tim; Hankey, Graeme J; Blacker, David; Markus, Romesh; Leyden, James; Krause, Martin; Grimley, Rohan; Mahant, Neil; Jannes, Jim; Sturm, Jonathan; Davis, Stephen M; Donnan, Geoffrey A

    2015-06-01

    Stroke and poststroke depression are common and have a profound and ongoing impact on an individual's quality of life. However, reliable biological correlates of poststroke depression and functional outcome have not been well established in humans. Our aim is to identify biological factors, molecular and imaging, associated with poststroke depression and recovery that may be used to guide more targeted interventions. In a longitudinal cohort study of 200 stroke survivors, the START-STroke imAging pRevention and Treatment cohort, we will examine the relationship between gene expression, regulator proteins, depression, and functional outcome. Stroke survivors will be investigated at baseline, 24 h, three-days, three-months, and 12 months poststroke for blood-based biological associates and at days 3-7, three-months, and 12 months for depression and functional outcomes. A sub-group (n = 100), the PrePARE: Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke cohort, will also be investigated for functional and structural changes in putative depression-related brain networks and for additional cognition and activity participation outcomes. Stroke severity, diet, and lifestyle factors that may influence depression will be monitored. The impact of depression on stroke outcomes and participation in previous life activities will be quantified. Clinical significance lies in the identification of biological factors associated with functional outcome to guide prevention and inform personalized and targeted treatments. Evidence of associations between depression, gene expression and regulator proteins, functional and structural brain changes, lifestyle and functional outcome will provide new insights for mechanism-based models of poststroke depression. © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

  16. Clinical inertia causing new or progression of diabetic retinopathy in type 2 diabetes: A retrospective cohort study.

    PubMed

    Osataphan, Soravis; Chalermchai, Thep; Ngaosuwan, Kanchana

    2017-03-01

    Clinical inertia is a failure to intensify treatment according to evidence-based guidelines, and can have both short- and long-term adverse effects for type 2 diabetes (T2D). The aim of the present study was to demonstrate the effects of clinical inertia on glycemic control and diabetes-related complications. A retrospective cohort study was conducted at a university-based hospital in Thailand. Medical records were evaluated retrospectively from January 2010 to December 2014. Patients were classified into two groups: clinical inertia and non-inertia. Clinical inertia was defined as failure to initiate insulin within 3 months in patients with HbA1c ≥9 % who were already taking two oral antidiabetic agents. From 1206 records, 98 patients with mean HbA1c of 10.3 % were identified and enrolled in the study. The median follow-up time of these patients was 29.5 months and 68.4 % were classified into the clinical inertia group. The mean (± SD) HbA1c decrement in the clinical inertia and non-inertia groups was 0.82 ± 1.50 % and 3.02 ± 1.80 %, respectively, at 6 months (P < 0.001) and 1.46 ± 1.85 % and 3.04 ± 1.76 %, respectively, at the end of study (P < 0.001). Clinical inertia was associated with a significantly shorter median time to progression of diabetic retinopathy (DR); log rank test, P = 0.02 and a higher incidence of DR progression (10 vs 2.2 cases per 1000 person-months; P = 0.003). The adjusted incidence rate ratio for DR progression in the clinical inertia group was 4.92 (95 % confidence interval 1.11-21.77; P = 0.036). Being treated by general practitioners was the strongest risk factor associated with clinical inertia. Clinical inertia can cause persistently poor glycemic control and speed up the progression of DR in T2D. © 2016 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

  17. Cohort profile: UK Millennium Cohort Study (MCS).

    PubMed

    Connelly, Roxanne; Platt, Lucinda

    2014-12-01

    The UK Millennium Cohort Study (MCS) is an observational, multidisciplinary cohort study that was set up to follow the lives of children born at the turn of the new century. The MCS is nationally representative and 18 552 families (18 827 children) were recruited to the cohort in the first sweep. There have currently been five main sweeps of data collection, at ages 9 months and 3, 5, 7 and 11 years. A further sweep of data collection is planned for age 14 years. A range of health-related data have been collected as well as measures concerning child development, cognitive ability and educational attainment. The data also include a wealth of information describing the social, economic and demographic characteristics of the cohort members and their families. In addition, the MCS data have been linked to administrative data resources including health records. The MCS provides a unique and valuable resource for the analysis of health outcomes and health inequalities. The MCS data are freely available to bona fide researchers under standard access conditions via the UK Data Service (http://ukdataservice.ac.uk) and the MCS website provides detailed information on the study (http://www.cls.ioe.ac.uk/mcs).

  18. Clinical Characteristics and Outcomes in a Population With Disseminated Herpes Zoster: A Retrospective Cohort Study.

    PubMed

    Bollea-Garlatti, M L; Bollea-Garlatti, L A; Vacas, A S; Torre, A C; Kowalczuk, A M; Galimberti, R L; Ferreyro, B L

    2017-03-01

    Shingles is the cutaneous expression of the reactivation of latent varicella zoster virus infection in sensory ganglia. It presents as vesicles in the corresponding dermatome. The condition is called disseminated herpes zoster (DHZ) when more than 2 contiguous dermatomes are affected, more than 20 vesicles are observed outside the initial dermatome, or involvement is systemic. DHZ is rare and most frequently occurs in immunocompromised patients. To describe the epidemiology, predisposing factors, clinical presentation, laboratory findings, and clinical course of patients with DHZ, and to compare the findings in immunocompromised and immunocompetent patients. We analyzed a retrospective case series of adults hospitalized between February 2010 and October 2015. Forty-one patients with virologically confirmed manifestations of DHZ were included. Stress as a trigger factor was detected in 39% and immunodepression in 58.5%. Immunocompromised patients were younger than the immunocompetent patients (mean ages, 60.5 vs 82 years, P<.01). The 8 immunocompetent patients with no detectable trigger factors were older (mean age, 85 years). In 95% of cases, DHZ was initially limited to a single dermatome and then spread to other dermatomes or became disseminated. Thrombocytopenia was detected in 56% of cases. Complication rates were similar in immunocompromised and immunocompetent patients (54% vs 59%, P>.01). Six patients died; there was no difference in mortality between the 2 groups. This study provides evidence on the relationship between DHZ, the presence of underlying immunodepression, and complications. Immunosenescence may play an important role in the onset of this disease in older immunocompetent patients. Copyright © 2016 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  19. Clinic continuity of care, clinical outcomes and direct costs for COPD in Sweden: a population based cohort study

    PubMed Central

    Sveréus, Sofia; Larsson, Kjell; Rehnberg, Clas

    2017-01-01

    ABSTRACT Introduction: In this study we investigate whether clinic level continuity of care (COC) for individuals with chronic obstructive pulmonary disease (COPD) is associated with better health care outcomes and lower costs in a Swedish setting. Methods: Individuals with COPD (N = 20,187) were identified through ICD-10 codes in all Stockholm County health care registries in 2007–2011 (59% female, 40% in the age group 65–74 years). We followed the individuals prospectively for 365 days after their first outpatient visit in 2012. Individual associations between COC and incidence of any hospitalization or emergency department visit and total costs for health care and pharmaceuticals were quantified by regression analysis, controlling for age, sex, comorbidity and number of visits. Clinic level COC was measured through the Bice–Boxerman COC index, grouped into quintiles. Results: At baseline, 26% of the individuals had been hospitalized at least once and 73% had dispensed at least seven prescription drugs (23% at least 16) in the last year. Patients in the lowest COC quintile (Q1) had higher probabilities of any hospitalization and any emergency department visit compared to those in Q5 (odds ratio 2.17 [95% CI 1.95–2.43] and 2.06 [1.86–2.28], respectively). Patients in Q1 also on average had 58% [95% CI: 52–64] higher costs. Conclusion: The findings show robust associations between clinic level COC and outcomes. These results verify the importance of COC, and suggest that clinic level COC is of relevance to both better outcomes for COPD patients and more efficient use of resources. PMID:28326179

  20. Clinical Characteristics and Current Interventions in Shock Patients in Chinese Emergency Departments: A Multicenter Prospective Cohort Study

    PubMed Central

    Guo, Shu-Bin; Chen, Yun-Xia; Yu, Xue-Zhong

    2017-01-01

    Background: Shock is a life-threatening condition in emergency departments (EDs) and is associated with a high mortality; however, its clinical characteristics and current interventions in China are seldom reported. This study investigated the clinical characteristics and current interventions of shock patients in Chinese EDs. Methods: This multicenter prospective cohort study was conducted in the EDs of 33 academic hospitals in 16 Chinese provinces. Adult shock patients were enrolled from December 2013 to April 2014. Age, sex, comorbidities, shock subtype, and vital signs were recorded on ED arrival; details of subsequent interventions and treatments were added. We compared those data between survivors and nonsurvivors. All patients were followed up for 3 days. The primary outcome was 3-day mortality. Binary logistic regression analysis identified the independent predictors of that mortality. Results: We enrolled 1095 shock patients. The 3-day mortality was 27.5%, 36.3%, and 29.0%, respectively, in the whole cohort and for cardiogenic and septic shock. Within the first 24 h, 1039 patients (94.9%) were admitted to the Intensive Care Unit. Use of bicarbonate, epinephrine, and dopamine is an independent predictor for mortality. Hemorrhage and trauma (39.1%), along with sepsis (40.4%) were the most commonly observed causes of shock in the ED. In nondiabetic patients with cardiogenic shock, 3-day mortality was 69.2% for patients needing glucose control — much higher than in those not needing glucose control (30.0%, P = 0.01). Hydroxyethyl starch (HES) was applied in 29.6% of septic shock patients, and the mortality of septic patients who received HES was much higher than those who did not (38.2% vs. 25.1%, P = 0.006). Conclusions: In China, short-term mortality of shock patients in EDs is still high, especially among those with cardiogenic and septic shock. HES application needs to be restricted — particularly in septic shock patients. PMID:28485313

  1. The role and functions of Clinical Nurse Consultants, an Australian advanced practice role: a descriptive exploratory cohort study.

    PubMed

    Baldwin, Richard; Duffield, Christine Margaret; Fry, Margaret; Roche, Michael; Stasa, Helen; Solman, Annette

    2013-03-01

    The NSW Health Policy Directive (NSW Department of Health, 2000) lists clinical service and consultancy; clinical leadership; research; education; clinical services planning and management as the five domains of practice for nurses appointed as Clinical Nurse Consultants (CNCs), an Australian advanced practice nurse (APN) role. However, there is no clear definition of what is meant by advanced practice in the Australian nursing context. Nowhere is this more evident than in differentiating between the roles of Clinical Nurse Consultants (CNCs) and Nurse Practitioners (NP) in NSW. To date, limited empirical research has been done to characterise or delineate CNC role activity and responsibility. To investigate (i) the nature of CNC roles, activities and responsibilities, (ii) differentiate between CNCs by their work patterns and activities, and (iii) empirically conceptualize and differentiate ways CNCs practice in terms of an APN typology. The study sample was 56 CNCs at one tertiary level public hospital in Australia. A descriptive exploratory cohort study was conducted to explore CNC role characteristics and patterns of activity. Data were triangulated using an online survey, a follow-up survey, and semi-structured interviews. The data were analysed using descriptive statistics to examine differences between CNC work patterns and role activities. The survey data and the individual reports were thematically analysed to investigate for difference across the population of CNCs. Interpretation of survey and interview data led to an analyst-developed CNC typology of four CNC categories based on the work patterns and activities of Sole Practitioner, Clinic Coordinator, Clinical Team Coordinator and Clinical Leader. The typology was based on the themes interprofessional, role focus, clinical focus and setting as these themes distinguished and differentiated CNC roles. The study provides evidence of great diversity and prioritization within CNC roles. The CNC typology

  2. Clinical and Immunological Markers of Dengue Progression in a Study Cohort from a Hyperendemic Area in Malaysia

    PubMed Central

    Rathakrishnan, Anusyah; Klekamp, Benjamin; Wang, Seok Mui; Komarasamy, Thamil Vaani; Natkunam, Santha Kumari; Sathar, Jameela; Azizan, Azliyati; Sanchez-Anguiano, Aurora; Manikam, Rishya; Sekaran, Shamala Devi

    2014-01-01

    Background With its elusive pathogenesis, dengue imposes serious healthcare, economic and social burden on endemic countries. This study describes the clinical and immunological parameters of a dengue cohort in a Malaysian city, the first according to the WHO 2009 dengue classification. Methodology and Findings This longitudinal descriptive study was conducted in two Malaysian hospitals where patients aged 14 and above with clinical symptoms suggestive of dengue were recruited with informed consent. Among the 504 participants, 9.3% were classified as non-dengue, 12.7% without warning signs, 77.0% with warning signs and 1.0% with severe dengue based on clinical diagnosis. Of these, 37% were misdiagnosed as non-dengue, highlighting the importance of both clinical diagnosis and laboratory findings. Thrombocytopenia, prolonged clotting time, liver enzymes, ALT and AST served as good markers for dengue progression but could not distinguish between patients with and without warning signs. HLA-A*24 and -B*57 were positively associated with Chinese and Indians patients with warning signs, respectively, whereas A*03 may be protective in the Malays. HLA-A*33 was also positively associated in patients with warning signs when compared to those without. Dengue NS1, NS2A, NS4A and NS4B were found to be important T cell epitopes; however with no apparent difference between with and without warning signs patients. Distinction between the 2 groups of patients was also not observed in any of the cytokines analyzed; nevertheless, 12 were significantly differentially expressed at the different phases of illness. Conclusion The new dengue classification system has allowed more specific detection of dengue patients, however, none of the clinical parameters allowed distinction of patients with and without warning signs. While the HLA-A*33 may be predictive marker for development of warning signs; larger studies will be needed to support this findings. PMID:24647042

  3. Clinical and immunological markers of dengue progression in a study cohort from a hyperendemic area in Malaysia.

    PubMed

    Rathakrishnan, Anusyah; Klekamp, Benjamin; Wang, Seok Mui; Komarasamy, Thamil Vaani; Natkunam, Santha Kumari; Sathar, Jameela; Azizan, Azliyati; Sanchez-Anguiano, Aurora; Manikam, Rishya; Sekaran, Shamala Devi

    2014-01-01

    With its elusive pathogenesis, dengue imposes serious healthcare, economic and social burden on endemic countries. This study describes the clinical and immunological parameters of a dengue cohort in a Malaysian city, the first according to the WHO 2009 dengue classification. This longitudinal descriptive study was conducted in two Malaysian hospitals where patients aged 14 and above with clinical symptoms suggestive of dengue were recruited with informed consent. Among the 504 participants, 9.3% were classified as non-dengue, 12.7% without warning signs, 77.0% with warning signs and 1.0% with severe dengue based on clinical diagnosis. Of these, 37% were misdiagnosed as non-dengue, highlighting the importance of both clinical diagnosis and laboratory findings. Thrombocytopenia, prolonged clotting time, liver enzymes, ALT and AST served as good markers for dengue progression but could not distinguish between patients with and without warning signs. HLA-A*24 and -B*57 were positively associated with Chinese and Indians patients with warning signs, respectively, whereas A*03 may be protective in the Malays. HLA-A*33 was also positively associated in patients with warning signs when compared to those without. Dengue NS1, NS2A, NS4A and NS4B were found to be important T cell epitopes; however with no apparent difference between with and without warning signs patients. Distinction between the 2 groups of patients was also not observed in any of the cytokines analyzed; nevertheless, 12 were significantly differentially expressed at the different phases of illness. The new dengue classification system has allowed more specific detection of dengue patients, however, none of the clinical parameters allowed distinction of patients with and without warning signs. While the HLA-A*33 may be predictive marker for development of warning signs; larger studies will be needed to support this findings.

  4. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study.

    PubMed

    Friedl, Katrin; Hiller, Karl-Anton; Friedl, Karl-Heinz

    2011-10-01

    This retrospective clinical study evaluated the suitability of a glass ionomer system as a permanent restoration material in posterior cavities. 26 Class I (1-surface (S1)) and 125 Class II (84 2-surface (S2), 41 3- and 4-surface (S3+)) restorations were placed in permanent molars (n=94) and premolars (n=57) in 43 patients in 6 dental practices. Restorations were evaluated at 4.5× magnification using modified USPHS criteria. Statistical analysis was performed using the Pearson's Chi-square-test (p ≤ 0.05). The median age of the restorations was 24 months. No failures were observed. The original volume of the restoration was retained in 88.5% of the S1, in 64.2% of the S2 and in 53.7% of the S3+ restorations. A distinct volume loss in S1 restorations was evident in 3.8%. A visible and perceptible roughness was shown in 11.5% of the S1, in 14.3% of the S2 and in 24.4% of the S3+ restorations. Marginal disintegrities occurred in none of the S1, in 1.2% of the S2 and in 7.3% of the S3+ restorations. A distinct marginal discoloration was found less than 1%. Within the limitations of this study it can be concluded that EQUIA can be used as a permanent restoration material for any sized Class I and in smaller Class II cavities. However, results of ongoing prospective studies shall provide a more exact indication definition in Class II situations. Modern glass ionomer systems may not only serve as long-term temporaries, but also as permanent restorations in posterior teeth. Copyright © 2011 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  5. Risk of tuberculosis in patients with diabetes: population based cohort study using the UK Clinical Practice Research Datalink.

    PubMed

    Pealing, Louise; Wing, Kevin; Mathur, Rohini; Prieto-Merino, David; Smeeth, Liam; Moore, David A J

    2015-06-05

    Previous cohort studies demonstrate diabetes as a risk factor for tuberculosis (TB) disease. Public Health England has identified improved TB control as a priority area and has proposed a primary care-based screening program for latent TB. We investigated the association between diabetes and risk of tuberculosis in a UK General Practice cohort in order to identify potential high-risk groups appropriate for latent TB screening. Using data from the UK Clinical Practice Research Datalink we constructed a cohort of patients with incident diabetes. We included 222,731 patients with diabetes diagnosed from 1990-2013 and 1,218,616 controls without diabetes at index date who were matched for age, sex and general practice. The effect of diabetes was explored using a Poisson analysis adjusted for age, ethnicity, body mass index, socioeconomic status, alcohol intake and smoking. We explored the effects of age, diabetes duration and severity. The effects of diabetes on risk of incident TB were explored across strata of chronic disease care defined by cholesterol and blood pressure measurement and influenza vaccination rates. During just under 7 million person-years of follow-up, 969 cases of TB were identified. The incidence of TB was higher amongst patients with diabetes compared with the unexposed group: 16.2 and 13.5 cases per 100,000 person-years, respectively. After adjustment for potential confounders the association between diabetes and TB remained (adjusted RR 1.30, 95 % CI 1.01 to 1.67, P = 0.04). There was no evidence that age, time since diagnosis and severity of diabetes affected the association between diabetes and TB. Diabetes patients with the lowest and highest rates of chronic disease management had a higher risk of TB (P <0.001 for all comparisons). Diabetes as an independent risk factor is associated with only a modest overall increased risk of TB in our UK General Practice cohort and is unlikely to be sufficient cause to screen for latent TB. Across

  6. Can We Reduce Negative Blood Cultures With Clinical Scores and Blood Markers? Results From an Observational Cohort Study.

    PubMed

    Laukemann, Svenja; Kasper, Nina; Kulkarni, Prasad; Steiner, Deborah; Rast, Anna Christina; Kutz, Alexander; Felder, Susan; Haubitz, Sebastian; Faessler, Lukas; Huber, Andreas; Fux, Christoph A; Mueller, Beat; Schuetz, Philipp

    2015-12-01

    Only a small proportion of blood cultures routinely performed in emergency department (ED) patients is positive. Multiple clinical scores and biomarkers have previously been examined for their ability to predict bacteremia. Conclusive clinical validation of these scores and biomarkers is essential.This observational cohort study included patients with suspected infection who had blood culture sampling at ED admission. We assessed 5 clinical scores and admission concentrations of procalcitonin (PCT), C-reactive protein (CRP), lymphocyte and white blood cell counts, the neutrophil-lymphocyte count ratio (NLCR), and the red blood cell distribution width (RDW). Two independent physicians assessed true blood culture positivity. We used logistic regression models with area under the curve (AUC) analysis.Of 1083 patients, 104 (9.6%) had positive blood cultures. Of the clinical scores, the Shapiro score performed best (AUC 0.729). The best biomarkers were PCT (AUC 0.803) and NLCR (AUC 0.700). Combining the Shapiro score with PCT levels significantly increased the AUC to 0.827. Limiting blood cultures only to patients with either a Shapiro score of ≥4 or PCT > 0.1 μg/L would reduce negative sampling by 20.2% while still identifying 100% of positive cultures. Similarly, a Shapiro score ≥3 or PCT >0.25 μg/L would reduce cultures by 41.7% and still identify 96.1% of positive blood cultures.Combination of the Shapiro score with admission levels of PCT can help reduce unnecessary blood cultures with minimal false negative rates.The study was registered on January 9, 2013 at the 'ClinicalTrials.gov' registration web site (NCT01768494).

  7. Can We Reduce Negative Blood Cultures With Clinical Scores and Blood Markers? Results From an Observational Cohort Study

    PubMed Central

    Laukemann, Svenja; Kasper, Nina; Kulkarni, Prasad; Steiner, Deborah; Rast, Anna Christina; Kutz, Alexander; Felder, Susan; Haubitz, Sebastian; Faessler, Lukas; Huber, Andreas; Fux, Christoph A.; Mueller, Beat; Schuetz, Philipp

    2015-01-01

    Abstract Only a small proportion of blood cultures routinely performed in emergency department (ED) patients is positive. Multiple clinical scores and biomarkers have previously been examined for their ability to predict bacteremia. Conclusive clinical validation of these scores and biomarkers is essential. This observational cohort study included patients with suspected infection who had blood culture sampling at ED admission. We assessed 5 clinical scores and admission concentrations of procalcitonin (PCT), C-reactive protein (CRP), lymphocyte and white blood cell counts, the neutrophil-lymphocyte count ratio (NLCR), and the red blood cell distribution width (RDW). Two independent physicians assessed true blood culture positivity. We used logistic regression models with area under the curve (AUC) analysis. Of 1083 patients, 104 (9.6%) had positive blood cultures. Of the clinical scores, the Shapiro score performed best (AUC 0.729). The best biomarkers were PCT (AUC 0.803) and NLCR (AUC 0.700). Combining the Shapiro score with PCT levels significantly increased the AUC to 0.827. Limiting blood cultures only to patients with either a Shapiro score of ≥4 or PCT > 0.1 μg/L would reduce negative sampling by 20.2% while still identifying 100% of positive cultures. Similarly, a Shapiro score ≥3 or PCT >0.25 μg/L would reduce cultures by 41.7% and still identify 96.1% of positive blood cultures. Combination of the Shapiro score with admission levels of PCT can help reduce unnecessary blood cultures with minimal false negative rates. The study was registered on January 9, 2013 at the ‘ClinicalTrials.gov’ registration web site (NCT01768494). PMID:26656373

  8. Effect of Dialysis Initiation Timing on Clinical Outcomes: A Propensity-Matched Analysis of a Prospective Cohort Study in Korea

    PubMed Central

    Lee, Jeonghwan; An, Jung Nam; Hwang, Jin Ho; Kim, Yong-Lim; Kang, Shin-Wook; Yang, Chul Woo; Kim, Nam-Ho; Oh, Yun Kyu; Lim, Chun Soo; Kim, Yon Su; Lee, Jung Pyo

    2014-01-01

    Background Controversy persists regarding the appropriate initiation timing of renal replacement therapy for patients with end-stage renal disease. We evaluated the effect of dialysis initiation timing on clinical outcomes. Initiation times were classified according to glomerular filtration rate (GFR). Methods We enrolled a total of 1691 adult patients who started dialysis between August 2008 and March 2013 in a multi-center, prospective cohort study at the Clinical Research Center for End Stage Renal Disease in the Republic of Korea. The patients were classified into the early-start group or the late-start group according to the mean estimated GFR value, which was 7.37 ml/min/1.73 m2. The primary outcome was patient survival, and the secondary outcomes were hospitalization, cardiovascular events, vascular access complications, change of dialysis modality, and peritonitis. The two groups were compared before and after matching with propensity scores. Results Before propensity score matching, the early-start group had a poor survival rate (P<0.001). Hospitalization, cardiovascular events, vascular access complications, changes in dialysis modality, and peritonitis were not different between the groups. A total of 854 patients (427 in each group) were selected by propensity score matching. After matching, neither patient survival nor any of the other outcomes differed between groups. Conclusions There was no clinical benefit after adjustment by propensity scores comparing early versus late initiation of dialysis. PMID:25137235

  9. Clinical and radiographic predictors of acute compartment syndrome in the treatment of tibial plateau fractures: a retrospective cohort study.

    PubMed

    Gamulin, Axel; Lübbeke, Anne; Belinga, Patrick; Hoffmeyer, Pierre; Perneger, Thomas V; Zingg, Matthieu; Cunningham, Gregory

    2017-07-18

    The aim of the study was to evaluate the relation between demographic, injury-related, clinical and radiological factors of patients with tibial plateau fractures and the development of acute compartment syndrome. All consecutive adult patients with intra-articular tibial plateau fractures admitted in our urban academic medical centre between January 2005 and December 2009 were included in this retrospective cohort study. The main outcome measurement was the development of acute compartment syndrome. The charts of 265 patients (mean age 48.6 years) sustaining 269 intra-articular tibial plateau fractures were retrospectively reviewed. Acute compartment syndrome occurred in 28 fractures (10.4%). Four patients presented bilateral tibial plateau fractures; of them, 2 had unilateral, but none had bilateral acute compartment syndrome. Non-contiguous tibia fracture or knee dislocation and higher AO/OTA classification (type 41-C) were statistically significantly associated with the development of acute compartment syndrome in multivariable regression analysis, while younger age (<45 years), male sex, higher Schatzker grade (IV-V-VI), higher tibial widening ratio (≥1.05) and higher femoral displacement ratio (≥0.08) were significantly associated in the analysis adjusted for age and sex. Two parameters related to the occurrence of ACS in tibial plateau fractures were highlighted in this study: the presence of a non-contiguous tibia fracture or knee dislocation, and higher AO/OTA classification. They may be especially useful when clinical findings are difficult to assess (doubtful clinical signs, obtunded, sedated or intubated patients), and should rise the suspicion level of the treating surgeon. In these cases, regular clinical examinations and/or intra-compartmental pressure measurements should be performed before and after surgery, even if acute compartment syndrome seemed unlikely during initial assessment. However, larger studies are mandatory to confirm and

  10. Impact of Aspiration Pneumonia on the Clinical Course of Progressive Supranuclear Palsy: A Retrospective Cohort Study

    PubMed Central

    Tomita, Satoshi; Oeda, Tomoko; Umemura, Atsushi; Kohsaka, Masayuki; Park, Kwiyoung; Yamamoto, Kenji; Sugiyama, Hiroshi; Mori, Chiaki; Inoue, Kimiko; Fujimura, Harutoshi; Sawada, Hideyuki

    2015-01-01

    Introduction Although aspiration pneumonia is the most common complication of progressive supranuclear palsy (PSP), the clinical impact of aspiration pneumonia on disease course and survival has not been fully estimated. Thus, we retrospectively analyzed the prognostic factors and clinical consequences of pneumonia in PSP. Methods The clinical course of patients with aspiration pneumonia was surveyed. The association between baseline clinical features (2 years from disease onset) and latency to the initial development of pneumonia was investigated using survival time and Cox regression analyses. Results Ninety patients with a clinical diagnosis of PSP were observed for 5.1±3.8 years (mean±SD), and 22 had aspiration pneumonia. Subsequently, 20 patients (91%) had to discontinue oral feeding entirely and 13 (59%) died, whereas, of 68 patients without pneumonia, only three patients (4%) died. Time to initial development of pneumonia was strongly correlated with survival time (Spearman R = 0.92, P<0.001), with a mean latency of 2.3 years to death. Among baseline clinical features, early fall episodes and cognitive decline were significant predictors of pneumonia (P = 0.001 and P<0.001, respectively, log rank test). Cox regression analysis demonstrated that early fall episodes (adjusted hazard ratio: 3.9, 95% confidence interval: 1.2–12.5, P = 0.03) and cognitive decline (adjusted hazard ratio: 5.2, 95% confidence interval: 1.4–19.3, P = 0.02) independently predicted pneumonia. By contrast, dysphagia was not associated with pneumonia (P = 0.2, log rank test). Conclusion Initial development of pneumonia indicates an unfavorable clinical course and predicts survival time (mean survival time 2.3 years). Patients with early falls and cognitive decline were at high risk of early development of pneumonia. PMID:26270456

  11. Clinical significance of putative markers of cancer stem cells in gastric cancer: A retrospective cohort study

    PubMed Central

    He, Du; Lu, Zheng-Hao; Liu, Kai; Zhang, Wei-Han; Wang, Wei; Li, Chang-Chun; Xue, Lian; Zhao, Lin-Yong; Yang, Kun; Liu, Jian-Ping; Zhou, Zong-Guang; Hu, Jian-Kun; Mo, Xian-Ming

    2016-01-01

    Cancer stem cells (CSCs) are thought as the source of tumor maintaining and many CSCs markers have been identified. Regarding the heterogeneity in gastric cancer (GC), TNM stage is not enough to accurately predict the prognosis. The aim of this study was to investigate the clinical significance of CSCs markers (Lgr5, Oct4, CD133, EpCAM, CD54 and Sox2) and establish a new model based on these markers to accurately predict prognosis of GC. We retrospectively enrolled 377 GC tissues from January 2006 to October 2012 to perform immunohistochemistry (IHC), and 93 pairs of GC tissues and corresponding adjacent normal gastric tissues to perform quantitative PCR (qPCR) from December 2011 to October 2012. The clinicopathological and follow-up characteristics were collected. In IHC, Oct4, CD133 and EpCAM were independently related to tumor progression, while Sox2 were associated with well or moderate differentiation (all p<0.05). Cox regression showed that Oct4-EpCAM was an independently prognostic factor, indicating that double low expression of Oct4-EpCAM group had significantly better prognosis than control group (p=0.035). Regarding qPCR, CD133 was an independent prognostic factor, showing that the prognosis of patients with CD133 high expression was significantly worse than that of patients with CD133 low expression (p<0.001). The prognostic prediction accuracy of nomogram based on Oct4-EpCAM expression in IHC was significantly better than TNM stage alone (p=0.003). Low expressions of Oct4-EpCAM in IHC and CD133 in qPCR were favorable prognostic factors in GC. The nomogram based on Oct4-EpCAM was valuable in prognostic prediction of GC patients. PMID:27557490

  12. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study

    PubMed Central

    Salman, Rustam Al-Shahi; Hall, Julie M; Horne, Margaret A; Moultrie, Fiona; Josephson, Colin B; Bhattacharya, Jo J; Counsell, Carl E; Murray, Gordon D; Papanastassiou, Vakis; Ritchie, Vaughn; Roberts, Richard C; Sellar, Robin J; Warlow, Charles P

    2012-01-01

    Summary Background Cerebral cavernous malformations (CCMs) are prone to bleeding but the risk of intracranial haemorrhage and focal neurological deficits, and the factors that might predict their occurrence, are unclear. We aimed to quantify these risks and investigate whether they are affected by sex and CCM location. Methods We undertook a population-based study using multiple overlapping sources of case ascertainment (including a Scotland-wide collaboration of neurologists, neurosurgeons, stroke physicians, radiologists, and pathologists, as well as searches of registers of hospital discharges and death certificates) to identify definite CCM diagnoses first made in Scottish residents between 1999 and 2003, which study neuroradiologists independently validated. We used multiple sources of prospective follow-up both to identify outcome events (which were assessed by use of brain imaging, by investigators masked to potential predictive factors) and to assess adults' dependence. The primary outcome was a composite of intracranial haemorrhage or focal neurological deficits (not including epileptic seizure) that were definitely or possibly related to CCM. Findings 139 adults had at least one definite CCM and 134 were alive at initial presentation. During 1177 person-years of follow-up (completeness 97%), for intracranial haemorrhage alone the 5-year risk of a first haemorrhage was lower than the risk of recurrent haemorrhage (2·4%, 95% CI 0·0–5·7 vs 29·5%, 4·1–55·0; p<0·0001). For the primary outcome, the 5-year risk of a first event was lower than the risk of recurrence (9·3%, 3·1–15·4 vs 42·4%, 26·8–58·0; p<0·0001). The annual risk of recurrence of the primary outcome declined from 19·8% (95% CI 6·1–33·4) in year 1 to 5·0% (0·0–14·8) in year 5 and was higher for women than men (p=0·01) but not for adults with brainstem CCMs versus CCMs in other locations (p=0·17). Interpretation The risk of recurrent intracranial haemorrhage or

  13. Untreated clinical course of cerebral cavernous malformations: a prospective, population-based cohort study.

    PubMed

    Al-Shahi Salman, Rustam; Hall, Julie M; Horne, Margaret A; Moultrie, Fiona; Josephson, Colin B; Bhattacharya, Jo J; Counsell, Carl E; Murray, Gordon D; Papanastassiou, Vakis; Ritchie, Vaughn; Roberts, Richard C; Sellar, Robin J; Warlow, Charles P

    2012-03-01

    Cerebral cavernous malformations (CCMs) are prone to bleeding but the risk of intracranial haemorrhage and focal neurological deficits, and the factors that might predict their occurrence, are unclear. We aimed to quantify these risks and investigate whether they are affected by sex and CCM location. We undertook a population-based study using multiple overlapping sources of case ascertainment (including a Scotland-wide collaboration of neurologists, neurosurgeons, stroke physicians, radiologists, and pathologists, as well as searches of registers of hospital discharges and death certificates) to identify definite CCM diagnoses first made in Scottish residents between 1999 and 2003, which study neuroradiologists independently validated. We used multiple sources of prospective follow-up both to identify outcome events (which were assessed by use of brain imaging, by investigators masked to potential predictive factors) and to assess adults' dependence. The primary outcome was a composite of intracranial haemorrhage or focal neurological deficits (not including epileptic seizure) that were definitely or possibly related to CCM. 139 adults had at least one definite CCM and 134 were alive at initial presentation. During 1177 person-years of follow-up (completeness 97%), for intracranial haemorrhage alone the 5-year risk of a first haemorrhage was lower than the risk of recurrent haemorrhage (2·4%, 95% CI 0·0-5·7 vs 29·5%, 4·1-55·0; p<0·0001). For the primary outcome, the 5-year risk of a first event was lower than the risk of recurrence (9·3%, 3·1-15·4 vs 42·4%, 26·8-58·0; p<0·0001). The annual risk of recurrence of the primary outcome declined from 19·8% (95% CI 6·1-33·4) in year 1 to 5·0% (0·0-14·8) in year 5 and was higher for women than men (p=0·01) but not for adults with brainstem CCMs versus CCMs in other locations (p=0·17). The risk of recurrent intracranial haemorrhage or focal neurological deficit from a CCM is greater than the risk of a

  14. Predictive validity of the UK clinical aptitude test in the final years of medical school: a prospective cohort study

    PubMed Central

    2014-01-01

    Background The UK Clinical Aptitude Test (UKCAT) was designed to address issues identified with traditional methods of selection. This study aims to examine the predictive validity of the UKCAT and compare this to traditional selection methods in the senior years of medical school. This was a follow-up study of two cohorts of students from two medical schools who had previously taken part in a study examining the predictive validity of the UKCAT in first year. Methods The sample consisted of 4th and 5th Year students who commenced their studies at the University of Aberdeen or University of Dundee medical schools in 2007. Data collected were: demographics (gender and age group), UKCAT scores; Universities and Colleges Admissions Service (UCAS) form scores; admission interview scores; Year 4 and 5 degree examination scores. Pearson’s correlations were used to examine the relationships between admissions variables, examination scores, gender and age group, and to select variables for multiple linear regression analysis to predict examination scores. Results Ninety-nine and 89 students at Aberdeen medical school from Years 4 and 5 respectively, and 51 Year 4 students in Dundee, were included in the analysis. Neither UCAS form nor interview scores were statistically significant predictors of examination performance. Conversely, the UKCAT yielded statistically significant validity coefficients between .24 and .36 in four of five assessments investigated. Multiple regression analysis showed the UKCAT made a statistically significant unique contribution to variance in examination performance in the senior years. Conclusions Results suggest the UKCAT appears to predict performance better in the later years of medical school compared to earlier years and provides modest supportive evidence for the UKCAT’s role in student selection within these institutions. Further research is needed to assess the predictive validity of the UKCAT against professional and behavioural

  15. Predictive validity of the UK clinical aptitude test in the final years of medical school: a prospective cohort study.

    PubMed

    Husbands, Adrian; Mathieson, Alistair; Dowell, Jonathan; Cleland, Jennifer; MacKenzie, Rhoda

    2014-04-23

    The UK Clinical Aptitude Test (UKCAT) was designed to address issues identified with traditional methods of selection. This study aims to examine the predictive validity of the UKCAT and compare this to traditional selection methods in the senior years of medical school. This was a follow-up study of two cohorts of students from two medical schools who had previously taken part in a study examining the predictive validity of the UKCAT in first year. The sample consisted of 4th and 5th Year students who commenced their studies at the University of Aberdeen or University of Dundee medical schools in 2007. Data collected were: demographics (gender and age group), UKCAT scores; Universities and Colleges Admissions Service (UCAS) form scores; admission interview scores; Year 4 and 5 degree examination scores. Pearson's correlations were used to examine the relationships between admissions variables, examination scores, gender and age group, and to select variables for multiple linear regression analysis to predict examination scores. Ninety-nine and 89 students at Aberdeen medical school from Years 4 and 5 respectively, and 51 Year 4 students in Dundee, were included in the analysis. Neither UCAS form nor interview scores were statistically significant predictors of examination performance. Conversely, the UKCAT yielded statistically significant validity coefficients between .24 and .36 in four of five assessments investigated. Multiple regression analysis showed the UKCAT made a statistically significant unique contribution to variance in examination performance in the senior years. Results suggest the UKCAT appears to predict performance better in the later years of medical school compared to earlier years and provides modest supportive evidence for the UKCAT's role in student selection within these institutions. Further research is needed to assess the predictive validity of the UKCAT against professional and behavioural outcomes as the cohort commences working life.

  16. Clinically meaningful reduction in pain severity in children treated by paramedics: a retrospective cohort study.

    PubMed

    Jennings, Paul A; Lord, Bill; Smith, Karen

    2015-11-01

    Pediatric pain is a common presenting symptom in the prehospital setting; however, there is a lack of data identifying factors associated with effective pain management in this population. We sought to identify the factors associated with clinically meaningful pain reduction in children. An analysis of electronic patient care records of all patients younger than 15 years presenting with pain to the emergency medical service of Victoria, Australia, over a 4-year period (2008-2011). Data were analyzed using descriptive statistics and multivariate regression to assess predictors of clinically meaningful pain reduction. Clinically meaningful pain reduction was defined as a reduction of 2 or more points on an 11-point scale. A total of 92378 children were transported, of whom 15016 (16.3%) met the inclusion criteria. The median age was 11 (interquartile range, 9-13) years, and 59.2% were male. Patients older than 9 years were less likely (adjusted odds ratio [AOR], 0.5; 95% confidence interval [CI], 0.4-0.6) and boys were more likely (adjusted odds ratio, 1.1; 95% CI, 1.0-1.3) to have a clinically meaningful reduction in pain. Patients with pain classified as musculoskeletal were more likely to achieve a reduction in pain score of 2 or more when compared with pain due to other medical causes (AOR, 1.7; 95% CI, 1.5-1.9). Factors other than the type of analgesia are important determinants of prehospital pain relief and are likely to impact on clinical care and research. Clinical audit and research projects should stratify patients according to patient as well as management factors to maximize service improvement. Copyright © 2015 Elsevier Inc. All rights reserved.

  17. High progesterone levels in women with high ovarian response do not affect clinical outcomes: a retrospective cohort study

    PubMed Central

    2014-01-01

    Background The potentially detrimental role of progesterone during the follicular phase has been a matter of controversy for several years; however, few studies have analyzed the effects of combined raised estradiol and progesterone levels on pregnancy outcomes. The aim of the present study was to determine the influence of high progesterone levels on clinical outcomes in the context of high ovarian response. Methods We performed a retrospective cohort study that included 2850 women classified as high responders. The women were subdivided into six groups depending on their progesterone concentration on the day of human chorionic gonadotropin (hCG) administration: <0.5 ng/ml (1.81 ng/ml (>p90). Ovarian response was classified as high when > =20 oocytes were retrieved or when estradiol was > =3000 pg/ml. Clinical outcomes of each subgroup were analyzed. We also examined data from frozen-thawed embryo transfers. Results were analyzed with Student’s t- test to compare continuous variables and chi-squared test to compare proportions. A p-value of < =0.05 was considered statistically significant. Results The progesterone concentration increased with ovarian response, and elevated progesterone did not show a significant clinical impact on implantation rate and pregnancy rates. These data provide evidence that progesterone levels higher than 1.8 ng/ml do not have detrimental effect on oocyte quality or endometrial receptivity. Conclusions These data allow us to conclude that high progesterone levels correlate significantly with high estradiol levels and that in high responder women; progesterone levels do not show a significant clinical impact on results. PMID:25064138

  18. Clinical, physiologic, and radiographic factors contributing to development of hypoxemia in moderate to severe COPD: a cohort study.

    PubMed

    Wells, J Michael; Estepar, Raul San Jose; McDonald, Merry-Lynn N; Bhatt, Surya P; Diaz, Alejandro A; Bailey, William C; Jacobson, Francine L; Dransfield, Mark T; Washko, George R; Make, Barry J; Casaburi, Richard; van Beek, Edwin J R; Hoffman, Eric A; Sciurba, Frank C; Crapo, James D; Silverman, Edwin K; Hersh, Craig P

    2016-12-01

    Hypoxemia is a major complication of COPD and is a strong predictor of mortality. We previously identified independent risk factors for the presence of resting hypoxemia in the COPDGene cohort. However, little is known about characteristics that predict onset of resting hypoxemia in patients who are normoxic at baseline. We hypothesized that a combination of clinical, physiologic, and radiographic characteristics would predict development of resting hypoxemia after 5-years of follow-up in participants with moderate to severe COPD METHODS: We analyzed 678 participants with moderate-to-severe COPD recruited into the COPDGene cohort who completed baseline and 5-year follow-up visits and who were normoxic by pulse oximetry at baseline. Development of resting hypoxemia was defined as an oxygen saturation ≤88% on ambient air at rest during follow-up. Demographic and clinical characteristics, lung function, and radiographic indices were analyzed with logistic regression models to identify predictors of the development of hypoxemia. Forty-six participants (7%) developed resting hypoxemia at follow-up. Enrollment at Denver (OR 8.30, 95%CI 3.05-22.6), lower baseline oxygen saturation (OR 0.70, 95%CI 0.58-0.85), self-reported heart failure (OR 6.92, 95%CI 1.56-30.6), pulmonary artery (PA) enlargement on computed tomography (OR 2.81, 95%CI 1.17-6.74), and prior severe COPD exacerbation (OR 3.31, 95%CI 1.38-7.90) were independently associated with development of resting hypoxemia. Participants who developed hypoxemia had greater decline in 6-min walk distance and greater 5-year decline in quality of life compared to those who remained normoxic at follow-up. Development of clinically significant hypoxemia over a 5-year span is associated with comorbid heart failure, PA enlargement and severe COPD exacerbation. Further studies are needed to determine if treatments targeting these factors can prevent new onset hypoxemia. COPDGene is registered at ClinicalTrials.gov: NCT00608764

  19. Clinical effectiveness of posaconazole versus fluconazole as antifungal prophylaxis in hematology-oncology patients: a retrospective cohort study.

    PubMed

    Kung, Hsiang-Chi; Johnson, Melissa D; Drew, Richard H; Saha-Chaudhuri, Paramita; Perfect, John R

    2014-06-01

    In preventing invasive fungal disease (IFD) in patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), clinical trials demonstrated efficacy of posaconazole over fluconazole and itraconazole. However, effectiveness of posaconazole has not been investigated in the United States in real-world setting outside the environment of controlled clinical trial. We performed a single-center, retrospective cohort study of 130 evaluable patients ≥18 years of age admitted to Duke University Hospital between 2004 and 2010 who received either posaconazole or fluconazole as prophylaxis during first induction or first reinduction chemotherapy for AML or MDS. The primary endpoint was possible, probable, or definite breakthrough IFD. Baseline characteristics were well balanced between groups, except that posaconazole recipients received reinduction chemotherapy and cytarabine more frequently. IFD occurred in 17/65 (27.0%) in the fluconazole group and in 6/65 (9.2%) in the posaconazole group (P = 0.012). Definite/probable IFDs occurred in 7 (10.8%) and 0 patients (0%), respectively (P = 0.0013). In multivariate analysis, fluconazole prophylaxis and duration of neutropenia were predictors of IFD. Mortality was similar between groups. This study demonstrates superior effectiveness of posaconazole over fluconazole as prophylaxis of IFD in AML and MDS patients. Such superiority did not translate to reductions in 100-day all-cause mortality.

  20. Suicidal ideation and suicide plans or attempts in adults with Asperger's syndrome attending a specialist diagnostic clinic: a clinical cohort study.

    PubMed

    Cassidy, Sarah; Bradley, Paul; Robinson, Janine; Allison, Carrie; McHugh, Meghan; Baron-Cohen, Simon

    2014-07-01

    Asperger's syndrome in adulthood is frequently associated with depression, but few studies have explored the lifetime experience of self-reported suicidal ideation and suicide plans or attempts in this clinical group. We aimed to assess this prevalence in a clinical cohort of patients in the UK. In a clinical cohort study, we undertook a retrospective analysis of clinical survey data from adults newly diagnosed with Asperger's syndrome at a specialist diagnostic clinic between Jan 23, 2004, and July 8, 2013, in England. Patients completed a self-report questionnaire before clinical assessment, recording lifetime experience of depression, suicidal ideation, and suicide plans or attempts, along with self-reported measures of autistic traits and empathy. We compared the rate of suicidal ideation in the sample with published rates of suicidal ideation in the general population and other clinical groups. We also assessed associations between depression, autistic traits, empathy, and likelihood of suicidal ideation and suicide plans or attempts. 374 adults (256 men and 118 women) were diagnosed with Asperger's syndrome in the study period. 243 (66%) of 367 respondents self-reported suicidal ideation, 127 (35%) of 365 respondents self-reported plans or attempts at suicide, and 116 (31%) of 368 respondents self-reported depression. Adults with Asperger's syndrome were significantly more likely to report lifetime experience of suicidal ideation than were individuals from a general UK population sample (odds ratio 9·6 [95% CI 7·6-11·9], p<0·0001), people with one, two, or more medical illnesses (p<0·0001), or people with psychotic illness (p=0·019). Compared with people diagnosed with Asperger's syndrome without depression, people with Asperger's syndrome and depression were more likely to report suicidal ideation (p<0·0001) and suicide plans or attempts (p<0·0001). Our findings lend support to anecdotal reports of increased rates of suicidal ideation in adults with

  1. Admixture Mapping of Subclinical Atherosclerosis and Subsequent Clinical Events Among African Americans in 2 Large Cohort Studies.

    PubMed

    Shendre, Aditi; Wiener, Howard; Irvin, Marguerite R; Zhi, Degui; Limdi, Nita A; Overton, Edgar T; Wassel, Christina L; Divers, Jasmin; Rotter, Jerome I; Post, Wendy S; Shrestha, Sadeep

    2017-04-01

    Local ancestry may contribute to the disproportionate burden of subclinical and clinical cardiovascular disease among admixed African Americans compared with other populations, suggesting a rationale for admixture mapping. We estimated local European ancestry (LEA) using Local Ancestry inference in adMixed Populations using Linkage Disequilibrium method (LAMP-LD) and evaluated the association with common carotid artery intima-media thickness (cCIMT) using multivariable linear regression analysis among 1554 African Americans from MESA (Multi-Ethnic Study of Atherosclerosis). We conducted secondary analysis to examine the significant cCIMT-LEA associations with clinical cardiovascular disease events. We observed genome-wide significance in relation to cCIMT association with the SERGEF gene (secretion-regulating guanine nucleotide exchange factor; β=0.0137; P=2.98×10(-)(4)), also associated with higher odds of stroke (odds ratio=1.71; P=0.02). Several regions, in particular CADPS gene (Ca(2+)-dependent secretion activator 1) region identified in MESA, were also replicated in the ARIC cohort (Atherosclerosis Risk in Communities). We observed other cCIMT-LEA regions associated with other clinical events, most notably the regions harboring CKMT2 gene (creatine kinase, mitochondrial 2) and RASGRF2 gene (Ras protein-specific guanine nucleotide-releasing factor 2) with all clinical events except stroke, the LRRC3B gene (leucine-rich repeat containing 3B) with myocardial infarction, the PRMT3 gene (protein arginine methyltransferase 3) with stroke, and the LHFPL2 gene (lipoma high mobility group protein I-C fusion partner-like 2) with hard and all coronary heart disease. We identified several novel LEA regions, in addition to previously identified genetic variations, associated with cCIMT and cardiovascular disease events among African Americans. © 2017 American Heart Association, Inc.

  2. Nailfold Videocapillaroscopic Features and Other Clinical Risk Factors for Digital Ulcers in Systemic Sclerosis: A Multicenter, Prospective Cohort Study

    PubMed Central

    Herrick, Ariane L.; Distler, Oliver; Becker, Mike O.; Beltran, Emma; Carpentier, Patrick; Ferri, Clodoveo; Inanç, Murat; Vlachoyiannopoulos, Panayiotis; Chadha‐Boreham, Harbajan; Cottreel, Emmanuelle; Pfister, Thomas; Rosenberg, Daniel; Torres, Juan V.; Cutolo, Maurizio; Herrick, Ariane L.; Distler, Oliver; Becker, Mike; Beltran, Emma; Carpentier, Patrick; Ferri, Clodoveo; Inanç, Murat; Vlachoyiannopoulos, Panayiotis; Smith, Vanessa; Erlacher, L; Hirschl, M; Kiener, HP; Pilger, E; Smith, V; Blockmans, D; Wautrecht, J‐C; Becvár, R; Carpentier, P; Frances, C; Lok, C; Sparsa, A; Hachulla, E; Quere, I; Allanore, Y; Agard, C; Riemekasten, G; Hunzelmann, N; Stücker, M; Ahmadi‐Simab, K; Sunderkötter, C; Wohlrab, J; Müller‐Ladner, U; Schneider, M; Vlachoyianopoulos, P; Vassilopoulos, D; Drosos, A; Antonopoulos, A; Balbir‐Gurman, A; Langevitz, P; Rosner, I; Levy, Y; Cutolo, M; Bombardieri, S; Ferraccioli, G; Mazzuca, S; Grassi, W; Lunardi, C; Airó, P; Riccieri, V; Voskuyl, AE; Schuerwegh, A; Santos, L; Rodrigues, AC; Grilo, A; Amaral, MC; Román Ivorra, JA; Castellvi, I; Distler, O; Spertini, F; Müller, R; Inanç, M; Oksel, F; Turkcapar, N; Herrick, A; Denton, C; McHugh, N; Chattopadhyay, C; Hall, F; Buch, M

    2016-01-01

    Objective To identify nailfold videocapillaroscopic features and other clinical risk factors for new digital ulcers (DUs) during a 6‐month period in patients with systemic sclerosis (SSc). Methods In this multicenter, prospective, observational cohort study, the videoCAPillaroscopy (CAP) study, we evaluated 623 patients with SSc from 59 centers (14 countries). Patients were stratified into 2 groups: a DU history group and a no DU history group. At enrollment, patients underwent detailed nailfold videocapillaroscopic evaluation and assessment of demographic characteristics, DU status, and clinical and SSc characteristics. Risk factors for developing new DUs were assessed using univariable and multivariable logistic regression (MLR) analyses. Results Of the 468 patients in the DU history group (mean ± SD age 54.0 ± 13.7 years), 79.5% were female, 59.8% had limited cutaneous SSc, and 22% developed a new DU during follow‐up. The strongest risk factors for new DUs identified by MLR in the DU history group included the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs (categorized as 0, 1, 2, or ≥3), and the presence of critical digital ischemia. The receiver operating characteristic (ROC) of the area under the curve (AUC) of the final MLR model was 0.738 (95% confidence interval [95% CI] 0.681–0.795). Internal validation through bootstrap generated a ROC AUC of 0.633 (95% CI 0.510–0.756). Conclusion This international prospective study, which included detailed nailfold videocapillaroscopic evaluation and extensive clinical characterization of patients with SSc, identified the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs at enrollment, and the presence of critical digital ischemia at enrollment as risk factors for the development of new DUs. PMID:27111549

  3. Nailfold Videocapillaroscopic Features and Other Clinical Risk Factors for Digital Ulcers in Systemic Sclerosis: A Multicenter, Prospective Cohort Study.

    PubMed

    Cutolo, Maurizio; Herrick, Ariane L; Distler, Oliver; Becker, Mike O; Beltran, Emma; Carpentier, Patrick; Ferri, Clodoveo; Inanç, Murat; Vlachoyiannopoulos, Panayiotis; Chadha-Boreham, Harbajan; Cottreel, Emmanuelle; Pfister, Thomas; Rosenberg, Daniel; Torres, Juan V; Smith, Vanessa

    2016-10-01

    To identify nailfold videocapillaroscopic features and other clinical risk factors for new digital ulcers (DUs) during a 6-month period in patients with systemic sclerosis (SSc). In this multicenter, prospective, observational cohort study, the videoCAPillaroscopy (CAP) study, we evaluated 623 patients with SSc from 59 centers (14 countries). Patients were stratified into 2 groups: a DU history group and a no DU history group. At enrollment, patients underwent detailed nailfold videocapillaroscopic evaluation and assessment of demographic characteristics, DU status, and clinical and SSc characteristics. Risk factors for developing new DUs were assessed using univariable and multivariable logistic regression (MLR) analyses. Of the 468 patients in the DU history group (mean ± SD age 54.0 ± 13.7 years), 79.5% were female, 59.8% had limited cutaneous SSc, and 22% developed a new DU during follow-up. The strongest risk factors for new DUs identified by MLR in the DU history group included the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs (categorized as 0, 1, 2, or ≥3), and the presence of critical digital ischemia. The receiver operating characteristic (ROC) of the area under the curve (AUC) of the final MLR model was 0.738 (95% confidence interval [95% CI] 0.681-0.795). Internal validation through bootstrap generated a ROC AUC of 0.633 (95% CI 0.510-0.756). This international prospective study, which included detailed nailfold videocapillaroscopic evaluation and extensive clinical characterization of patients with SSc, identified the mean number of capillaries per millimeter in the middle finger of the dominant hand, the number of DUs at enrollment, and the presence of critical digital ischemia at enrollment as risk factors for the development of new DUs. © 2016, American College of Rheumatology.

  4. Characterisation of Patients Receiving Moxifloxacin for Acute Bacterial Rhinosinusitis in Clinical Practice: Results from an International, Observational Cohort Study

    PubMed Central

    Mösges, Ralph; Desrosiers, Martin; Arvis, Pierre; Heldner, Stephanie

    2013-01-01

    We conducted a prospective, non-controlled, multi-centre Phase IV observational cohort study of patients with acute bacterial rhinosinusitis who were treated with moxifloxacin in clinical practice in 19 countries in Asia Pacific, Europe and the Middle East. With the data collected we evaluated the presentation and course of the current disease episode, particularly in terms of the principal clinical signs and symptoms of acute rhinosinusitis and diagnostic procedures. A final assessment of moxifloxacin therapy was made to evaluate the impact of the sinusitis episode on activities of daily life and on sleep disturbance, and to evaluate the clinical outcome of treatment. A total of 7,090 patients were enrolled, of whom 3909 (57.6%) were included in the valid for clinical outcome and safety population. Regional differences were observed in the main symptoms of acute rhinosinusitis and, according to several characteristics, disease episodes appeared to be more severe in patients in Europe than in the Asia Pacific or Middle East regions. The sinusitis episode impacted on daily living for mean (SD) periods of 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) days and disturbed sleep for 3.6 (3.2), 4.6 (3.9) and 3.1 (3.0) nights in the Asia Pacific, Europe and Middle East regions, respectively. With moxifloxacin treatment, the mean (SD) time to improvement of symptoms was 3.0 (1.5), 3.4 (1.6) and 3.2 (1.5) days, and the time to resolution of symptoms was 4.8 (2.6) days, 5.7 (2.4) days and 5.5 (2.5) days, in the Asia Pacific, Europe and Middle East regions, respectively. In conclusion, acute rhinosinusitis remains a substantial health burden with significant impact on patients’ quality of life, and there are differences between global regions in the clinical presentation, diagnosis and clinical course of disease episodes. Moxifloxacin was an effective and well-tolerated treatment option in the overall population. Registration: ClinicalTrials.gov Identifier: NCT00930488 PMID:23626752

  5. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study.

    PubMed

    Koorevaar, Rinco C T; van 't Riet, Esther; Gerritsen, Marleen J J; Madden, Kim; Bulstra, Sjoerd K

    2016-01-01

    Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression and somatisation were

  6. Clinical Characteristics and Outcomes of Hospitalized Older Patients with Distinct Risk Profiles for Functional Decline: A Prospective Cohort Study

    PubMed Central

    Buurman, Bianca M.; Hoogerduijn, Jita G.; van Gemert, Elisabeth A.; de Haan, Rob J.; Schuurmans, Marieke J.; de Rooij, Sophia E.

    2012-01-01

    Background The aim of this research was to study the clinical characteristics and mortality and disability outcomes of patients who present distinct risk profiles for functional decline at admission. Methods Multicenter, prospective cohort study conducted between 2006 and 2009 in three hospitals in the Netherlands in consecutive patients of ≥65 years, acutely admitted and hospitalized for at least 48 hours. Nineteen geriatric conditions were assessed at hospital admission, and mortality and functional decline were assessed until twelve months after admission. Patients were divided into risk categories for functional decline (low, intermediate or high risk) according to the Identification of Seniors at Risk-Hospitalized Patients. Results A total of 639 patients were included, with a mean age of 78 years. Overall, 27%, 33% and 40% of the patients were at low, intermediate or high risk, respectively, for functional decline. Low-risk patients had fewer geriatric conditions (mean 2.2 [standard deviation [SD] 1.3]) compared with those at intermediate (mean 3.8 [SD 2.1]) or high risk (mean 5.1 [SD 1.8]) (p<0.001). Twelve months after admission, 39% of the low-risk group had an adverse outcome, compared with 50% in the intermediate risk group and 69% in the high risk group (p<0.001). Conclusion By using a simple risk assessment instrument at hospital admission, patients at low, intermediate or high risk for functional decline could be identified, with distinct clinical characteristics and outcomes. This approach should be tested in clinical practice and research and might help appropriately tailor patient care. PMID:22238628

  7. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study

    PubMed Central

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes. PMID:27606617

  8. Clinical and endoscopic aspects in the evolution of patients with bleeding peptic ulcer--a cohort study.

    PubMed

    Segal, F; Prolla, J C; Maguilnik, I; Wolff, F H

    2000-01-01

    Bleeding ulcers are a major problem in public health and represent approximately half of all the cases of upper gastrointestinal hemorrhage in the United States. This study aims to determine the prognostic value of factors such as clinical history, laboratory and endoscopic findings in the occurrence of new episodes of bleeding in patients who have upper gastrointestinal hemorrhage caused by gastric or duodenal peptic ulcer. A cohort study with 94 patients was designed to investigate prognostic factors to the occurrence of new episodes of bleeding. From the 94 patients studied, 88 did not present a new bleeding episode in the 7 days following hospital admission. The incidence of rebleeding was significantly higher in those patients with hemoglobin < 6 g/dL at the admission (P = 0.03, RR = 6.2). The localization of the ulcers in bulb was positively associated to rebleeding (P = 0.003). The rebleeding group needed a greater number of units transfunded (P = 0.03) and the time of hospitalization was longer than the time of the hemostasia group (P = 0.0349). The identification of patients with risk of death by bleeding peptic ulcer remains as a challenge, once few factors are capable of predicting the severity of the evolution. The identification of such factors will allow the choice of the better therapeutic conduct improving the diagnosis and decreasing the rate of rebleeding and the mortality.

  9. Comparison of energy consumption in different clinical forms multiple sclerosis with normal subjects (cohort study).

    PubMed

    Marvi-Esfahani, Mahnaz; Karimi, Mohammad Taghi; Etemadifar, Masoud; Fatoye, Francis

    2016-03-01

    Multiple sclerosis (MS) is one of the most common joint disorders that influence walking performance. The objectives are to determine if energy consumption of three different clinical forms of MS differs from each other. Is there any difference between MS and normal subjects? Is there an association between the Physiological Cost Index (PCI) and the Expanded Disability States Scale (EDSS)? MS subjects (EDSS>4) were separated in three groups based on the Ashworth and Ataxia scales, including ataxic (n=16), spastic (n=15) and ataxic-spastic (n=14). In addition, 13 age-and-gender-matched healthy subjects were used as the control group. A Heart Rate (HR) Polar Electro Finland was used to record the heart rate during resting and walking. The energy consumption was measured based on PCI. ANOVA, MANOVA, Post-hoc Tukey analysis and Pearson correlations were used for statistical analysis (P<0.05). There was a significant difference between the walking speeds of normal (76.05±5.70m/min) with ataxic (36.78±12.68m/min), spastic (34.45±16.32m/min) and ataxic-spastic (27.21±14.76m/min) groups (P<0.001). There were no significant differences between the resting HR and walking HR of four groups, and no significant difference between the PCI of ataxic, spastic and normal groups (P>0.1). The correlation between PCI and EDSS was 0.65 (P<0.001). The performance of the cardiovascular system in MS subjects was the same as normal subjects. Their energy consumption increased significantly due to a decrease in their walking speed. It seems that the weakness of muscles of the lower extremity and spasticity of knee extensors play a significant role in this regard. Copyright © 2016 Elsevier B.V. All rights reserved.

  10. Associations between weather conditions and clinical symptoms in patients with hip osteoarthritis: a 2-year cohort study.

    PubMed

    Dorleijn, Desirée M J; Luijsterburg, Pim A J; Burdorf, Alex; Rozendaal, Rianne M; Verhaar, Jan A N; Bos, Pieter K; Bierma-Zeinstra, Sita M A

    2014-04-01

    The goal of this study was to assess whether there is an association between ambient weather conditions and patients' clinical symptoms in patients with hip osteoarthritis (OA). The design was a cohort study with a 2-year follow-up and 3-monthly measurements and prospectively collected data on weather variables. The study population consisted of 222 primary care patients with hip OA. Weather variables included temperature, wind speed, total amount of sun hours, precipitation, barometric pressure, and relative humidity. The primary outcomes were severity of hip pain and hip disability as measured with the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) pain and function subscales. Associations between hip pain and hip disability and the weather variables were assessed using crude and multivariate adjusted linear mixed-model analysis for repeated measurements. On the day of questionnaire completion, mean relative humidity was associated with WOMAC pain (estimate 0.1; 95% confidence interval=0.0-0.2; P=.02). Relative humidity contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC pain score. Mean barometric pressure was associated with WOMAC function (estimate 0.1; 95% confidence interval=0.0-0.1; P=.02). Barometric pressure contributed < or = 1% to the explained within-patient variance and between-patient variance of the WOMAC function score. The other weather variables were not associated with the WOMAC pain or function score. Our results support the general opinion of OA patients that barometric pressure and relative humidity influence perceived OA symptoms. However, the contribution of these weather variables (< or = 1%) to the severity of OA symptoms is not considered to be clinically relevant. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  11. Clinical and Demographic Characteristics of Erosion-free and Erosion-present Status in Psoriatic Arthritis in a Cohort Study.

    PubMed

    Touma, Zahi; Thavaneswaran, Arane; Chandran, Vinod; Pellett, Fawnda; Cook, Richard J; Gladman, Dafna D

    2016-06-01

    Psoriatic arthritis (PsA) has been recognized as a severe erosive disease. However, some patients do not develop erosions. We aimed to determine the prevalence, characteristics, and predictors of erosion-free patients (EFP) as compared with erosion-present patients (EPP) among patients with PsA followed prospectively. This is a retrospective analysis conducted on patients from the Toronto PsA cohort. Patients with at least 10 years of followup and radiographs were analyzed. Radiographs were scored with the modified Steinbrocker method. Baseline (first visit to clinic) characteristics were used to predict the development of erosions with logistic regression models. To examine the effect of time-varying covariates, Cox regression models were fit for the time to development of erosions from baseline. Among 290 patients, 12.4% were EFP and 87.6% were EPP over the study period. The mean time to development of erosion in the EPP over the course of followup was 6.8 ± 6.1 years. EFP were diagnosed with psoriasis at a younger age compared with EPP. In both models, actively inflamed joints and clinically damaged joints were predictive of the development of erosion, whereas a longer duration of psoriasis at baseline decreased the odds of developing erosion. EPP had a higher percentage of unemployment as compared with EFP at baseline and followup visits. Among patients with PsA followed for at least 10 years, 12.4% never develop erosions. The clinical and radiographic findings can ultimately assist in the stratification of a patient's prognosis regarding the development of erosions.

  12. Financial barriers and adverse clinical outcomes among patients with cardiovascular-related chronic diseases: a cohort study.

    PubMed

    Campbell, David J T; Manns, Braden J; Weaver, Robert G; Hemmelgarn, Brenda R; King-Shier, Kathryn M; Sanmartin, Claudia

    2017-02-15

    Some patients with cardiovascular-related chronic diseases such as diabetes and heart disease report financial barriers to achieving optimal health. Previous surveys report that the perception of having a financial barrier is associated with self-reported adverse clinical outcomes. We sought to confirm these findings using linked survey and administrative data to determine, among patients with cardiovascular-related chronic diseases, if there is an association between perceived financial barriers and the outcomes of: (1) disease-related hospitalizations, (2) all-cause mortality and (3) inpatient healthcare costs. We used ten cycles of the nationally representative Canadian Community Health Survey (administered between 2000 and 2011) to identify a cohort of adults aged 45 and older with hypertension, diabetes, heart disease or stroke. Perceived financial barriers to various aspects of chronic disease care and self-management were identified (including medications, healthful food and home care) from the survey questions, using similar questions to those used in previous studies. The cohort was linked to administrative data sources for outcome ascertainment (Discharge Abstract Database, Canadian Mortality Database, Patient Cost Estimator). We utilized Poisson regression techniques, adjusting for potential confounding variables (age, sex, education, multimorbidity, smoking status), to assess for associations between perceived financial barriers and disease-related hospitalization and all-cause mortality. We used gross costing methodology and a variety of modelling approaches to assess the impact of financial barriers on hospital costs. We identified a cohort of 120,752 individuals over the age of 45 years with one or more of the following: hypertension, diabetes, heart disease or stroke. One in ten experienced financial barriers to at least one aspect of their care, with the two most common being financial barriers to accessing medications and healthful food. Even

  13. Clinical and financial implications of disease-related malnutrition in a department of Internal Medicine: prospective cohort study.

    PubMed

    Ballesteros-Pomar, M D; Calleja-Fernández, A; González-Valdés, M; Pintor-de la Maza, B; Villar Taibo, R; Vidal-Casariego, A; Urioste-Fondo, A; Torres-Torres, B; de Luis-Román, D; Cano-Rodríguez, I

    2016-12-01

    Disease-related malnutrition is a challenge for Spanish hospitals. Our objective was to assess the feasibility and importance of establishing a nutritional screening strategy in our community. A prospective cohort study was conducted in a department of internal medicine for 3 months. The nutritional screening was conducted at admission and was repeated weekly using the Malnutrition Universal Screening Tool. We analysed the clinical data, mean stay and expenses. The study included 330 patients (53.9% men), with a mean age of 77.8 years. The mean stay was 7 days, and the Charlson comorbidity index was 5.4. At admission, the Malnutrition Universal Screening Tool detected 26.9% of patients with a risk of malnutrition. Eighteen percent of the patients with a good nutritional state developed malnutrition during the hospitalisation. The patients with initially severe malnutrition had a longer mean stay. The patients whose nutritional state worsened during the hospitalisation had a significantly longer stay (2.5 days) compared with those whose state did not worsen. These cases of malnutrition caused a cost overrun of €767 per hospitalisation (35% greater), which entailed a malnutrition-related excess expenditure of €646,419.93 annually in the studied department. The appropriate coding resulted in an increase in mean weight from 2.11 to 2.81, which represented €82,568.52 and has not been previously quantified. The high prevalence and clinical and financial implications of Disease-related malnutrition in patients hospitalised in internal medicine warrants establishing protocols for its early detection and treatment. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  14. A cohort study assessing difficult patient encounters in a walk-in primary care clinic, predictors and outcomes.

    PubMed

    Hinchey, Sherri A; Jackson, Jeffrey L

    2011-06-01

    Previous studies have found that up to 15% of clinical encounters are experienced as difficult by clinicians. Explore patient and physician characteristics associated with being considered "difficult" and assess the impact on patient outcomes. Prospective cohort study. Seven hundred fifty adults presenting to a primary care walk-in clinic with a physical symptom. Pre-visit surveys assessed symptom characteristics, expectations, functional status (Medical Outcome Study SF-6) and the presence of mental disorders [Primary Care Evaluation of Mental Disorders, (PRIME-MD)]. Post-visit surveys assessed satisfaction (Rand-9), unmet expectations and trust. Two-week assessment included symptom outcome (gone, better, same, worse), functional status and satisfaction. After each visit, clinicians rated encounter difficulty using the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ). Clinicians also completed the Physician's Belief Scale, a measure of psychosocial orientation. Among the 750 subjects, 133 (17.8%) were perceived as difficult. "Difficult" patients were less likely to fully trust (RR = 0.88, 95% CI: 0.77-0.99) or be fully satisfied (RR = 0.78, 95% CI: 0.62-0.98) with their clinician, and were more likely to have worsening of symptoms at 2 weeks (RR = 0.75, 95% CI: 0.57-0.97). Patients involved in "difficult encounters" had more than five symptoms (RR = 1.8, 95% CI: 1.3-2.3), endorsed recent stress (RR = 1.9, 95% CI: 1.4-3.2) and had a depressive or anxiety disorder (RR = 2.3, 95% CI: 1.3-4.2). Physicians involved in difficult encounters were less experienced (12 years vs. 9 years, p = 0.0002) and had worse psychosocial orientation scores (77 vs. 67, p < 0.005). Both patient and physician characteristics are associated with "difficult" encounters, and patients involved in such encounters have worse short-term outcomes.

  15. A longitudinal cohort study of Finnish patients with primary Sjögren's syndrome: clinical, immunological, and epidemiological aspects

    PubMed Central

    Pertovaara, M; Pukkala, E; Laippala, P; Miettinen, A; Pasternack, A

    2001-01-01

    OBJECTIVE—To evaluate outcome in a cohort of Finnish patients with primary Sjögren's syndrome (pSS).
METHODS—Clinical and laboratory data from the time of diagnosis and follow up were collected from 110 patients with pSS (107 women, three men) diagnosed in 1977-1992 in central Finland. The standardised incidence ratio for cancers was determined as the ratio of the observed number of cases to the expected number based on regional population rates. Eighty one of the 93 patients still alive were interviewed, and clinical and laboratory examinations performed in 1994-1997.
RESULTS—The mean (SD) erythrocyte sedimentation rate (33 (22) v 45 (28) mm/1st h), serum IgG (18.8 (7.4) v 22.5 (8.5) g/l), and serum IgM (1.6 (1.1) v 2.0 (1.2) g/l) at the control visit were significantly (p<0.0001) lower than those at baseline. A similar change was observed in a subgroup of patients never treated with glucocorticosteroids or disease modifying antirheumatic drugs. Three non-Hodgkin's lymphomas were diagnosed (standardised incidence ratio 13; 95% confidence interval 2.7 to 38). In a logistic regression model, the patients with pSS with subsequent lymphoma were found to have higher baseline levels of serum β2 microglobulin than the others (odds ratio 1.9; 95% confidence interval 1.1 to 3.4).
CONCLUSION—The results suggest that mean concentrations of serum IgG and IgM in patients with pSS decline with time, possibly reflecting diminishing inflammatory activity. As in previous studies, the incidence of non-Hodgkin's lymphomas in this cohort of patients with pSS was significantly higher than in the reference population.

 PMID:11302868

  16. The clinical, occupational and financial outcomes associated with a bespoke specialist clinic for military aircrew—a cohort study

    PubMed Central

    Pavitt, A.J.; Pavitt, C.W.; Harron, K.; Jones, M.; Timperley, A.C.; Reid, A.N.C.; Mcloughlin, D.; d'Arcy, J.

    2016-01-01

    Objectives: To assess the clinical, occupational and financial outcomes of a new Clinical Aviation Medicine Service (CAMS) for UK military personnel. Methods: Consecutive patients over a 2 year period were included. Predictors of flying restrictions at referral and final outcome following consultation were modelled using logistic regression. National Health Service (NHS) Payment by Results tariffs and Defence capitation data were used to assess the financial impact of the service. Results: Eight hundred and sixteen new referrals (94.5% male, median age 45 years (range 19–75)) were received and 1025 consultations performed. Cardiovascular disease was the commonest reason for referral. CAMS clinical activity cost at NHS tariff was £453 310 representing a saving of £316 173 (£137 137 delivery cost). In total, 310/816 (38%) patients had employment restrictions on referral and 49.0% of this group returned to full employment following their initial consultation. Compared with cardiology, general medicine and respiratory patients were more likely to have been occupationally restricted prior to referral (50 vs. 35%, OR 1.81; 95% CI 1.18–2.76, P values=0.006 and 53 vs. 35%, OR 2.12; 95% CI 1.15–3.90, P values = 0.016, respectively). Overall 581/816 (71.2%) of patients returned to unrestricted employment while 98/816 (12.0%) were unable to continue in any aircrew role. The service saved 7000 lost working days per year at an estimated occupational saving of ∼£1 million per annum. Conclusions: This bespoke service has allowed rapid, occupationally relevant clinical care to be delivered with both time and financial savings. The model may have significant occupational and financial relevance for other environmental and occupational medical organizations. PMID:26424788

  17. Incidence and prevalence of clinically relevant pituitary adenomas: retrospective cohort study in a Health Management Organization in Buenos Aires, Argentina.

    PubMed

    Day, Patricia Fainstein; Loto, Monica Graciela; Glerean, Mariela; Picasso, María Fabiana Russo; Lovazzano, Soledad; Giunta, Diego Hernán

    2016-01-01

    The main purpose of this study was to estimate the incidence rate and prevalence of clinically relevant pituitary adenomas (PAs) within the Hospital Italiano Medical Care Program (HIMCP), a well-defined population of 150,000 members living in the urban and suburban area of the city of Buenos Aires. We defined clinically relevant PAs as those associated with endocrine dysfunction and/or mass effect. A retrospective open cohort study was conducted, including all members of the HIMCP over 18 years old, with active memberships during the period of the study, from January 1st 2003, to January 1, 2014. The incidence rates (IRs) were standardized (SIR) to the World Health Organization (WHO) 2000 standard population and were expressed per 100,000 members/year. Prevalence was estimated at January 1, 2014, and was expressed per 100,000 persons. The clinical records have been electronically managed since 2001. All lab and imaging studies were done in-house. The overall SIR was 7.39/100,000/year (95% CI 4.47-10.31). Female patients had a specific IR significantly higher than male patients (5.85 vs.1.54) and represented 73% of the affected members. Regarding tumor size, 61.4% were microadenomas, and the mean age at diagnosis was 46.4 years. Prolactinomas had the highest SIR (5.41), followed by acromegaly (Acro) and non-functioning adenomas (NFAs) with overlapping 95% CIs (0.44-1.41 and 0.31-0.99, respectively). Microprolactinomas were more frequent in female (72.6%) (p < 0.01) and younger members (38 vs.60 years; p < 0.04). The overall prevalence rate was 97.76/100,000. Prolactinomas had the highest prevalence (56.29), followed by NFAs (21.48), Acro (14.07) and CD (5.93). Our results demonstrate that clinically relevant PAs are more common than usually suspected, especially prolactinomas and growth-hormone secreting PAs. These data highlight the need to increase the awareness of PAs, thereby enabling early diagnosis and treatment.

  18. Four weeks of functional electrical stimulated cycling after spinal cord injury: a clinical cohort study.

    PubMed

    Kuhn, Daniel; Leichtfried, Veronika; Schobersberger, Wolfgang

    2014-09-01

    The aim of this study was to determine the efficacy and the effects of functional electrical stimulated cycling (FES cycling) in patients with spinal cord injury during their rehabilitation in a special acute care unit. Thirty patients [10 with American Spinal Injury Association Impairment Scale (AIS) grade A, three with AIS grade B, 15 with AIS grade C, two with AIS grade D] aged 44±15.5 years and 2 (median) (interquartile range, 1.0-4.25) months after spinal cord injury were included in the study. The patients participated in a 20-min FES-cycling program 2 days per week for 4 weeks during their acute inpatient rehabilitation. The influence on muscle cross-section, muscle and leg circumference, spasticity, and the walking ability parameter (distance, time, aids) was measured. Muscle stimulation intensity and output parameters (pedalling time and distance) were also recorded. Spasticity decreased during hip abduction and adduction (70 and 98.1%, respectively). Spasticity during knee flexion and knee extension decreased by 66.8 and 76.6%, and a decrease was found during dorsal foot extension (67.8%; for all, P<0.05). Presession-postsession comparisons showed that after 4 weeks of FES cycling, an increase in the circumference of the cross-sectional area of 15.3% on the left and of 17% on the right m. rectus femoris could be observed in group AIS A+B. In the AIS C+D group, the circumference of the left m. rectus femoris increased by 25% and that of the right m. rectus femoris by 21% (for all, P<0.05). The results of the study show that FES cycling in combination with function-oriented physiotherapy and occupational therapy can have a positive influence on spasticity, walking ability, and muscular reactivation. It seems to support circulatory processes within the rehabilitation of paraplegics already after a 4-week intervention.

  19. Clinical features and outcome of subacute thyroiditis in an incidence cohort: Olmsted County, Minnesota, study.

    PubMed

    Fatourechi, Vahab; Aniszewski, Jaroslaw P; Fatourechi, Guiti Z Eghbali; Atkinson, Elizabeth J; Jacobsen, Steven J

    2003-05-01

    Subacute thyroiditis (SAT), or granulomatous thyroiditis, is an inflammatory thyroid condition associated with pain and systemic symptoms. Few community studies are available. We studied the 160 patients with SAT in Olmsted County, Minnesota, seen between January 1, 1960, and December 30, 1997. Subjects were identified through the medical diagnostic index of the Rochester Epidemiology Project. The overall age- and sex-adjusted incidence from 1960 through 1997 was 4.9 cases per 100,000/yr. In the most recent 28-yr period (1970-1997), 94 patients were identified. In this group, pain was the presenting symptom in 96%. SAT recurred in 4% of the patients 6-21 yr after the initial episode. Corticosteroid therapy was given to 36%. Early-onset hypothyroidism occurred both in patients receiving corticosteroid therapy (29%) and in those not receiving corticosteroid therapy (37%). At latest follow-up, significantly more patients who had received corticosteroid therapy had a diagnosis of hypothyroidism than the group without corticosteroid therapy (25% vs. 10%, P < 0.05; overall rate of hypothyroidism, 15%). Early transient hypothyroidism is common in SAT. Permanent hypothyroidism is less common, and only 15% of the patients are receiving T(4) therapy after 28 yr of follow-up. Symptomatic relief is achieved with corticosteroid therapy, but such therapy does not prevent early- and late-onset thyroid dysfunction.

  20. Predicting and reducing cranioplasty infections by clinical, radiographic and operative parameters - A historical cohort study.

    PubMed

    Kimchi, Gil; Stlylianou, Petros; Wohl, Anton; Hadani, Moshe; Cohen, Zvi R; Zauberman, Jacob; Feldman, Zeev; Spiegelmann, Roberto; Nissim, Ouzi; Zivly, Zion; Penn, Mark; Harnof, Sagi

    2016-12-01

    Cranioplasty is a relatively straightforward and common procedure, yet it carries a substantial rate of infection that causes major morbidity and mortality. The authors' objective was to assess the effect of various variables on the risk of developing post-cranioplasty infections, and to enable the prediction and reduction of its incidence, contributing to an improved patient-selection. The medical records, microbiologic cultures, imaging studies and operative reports of patients who have undergone cranioplasty between the years 2008-2014 at Sheba Medical Center, a tertiary care teaching hospital in Tel-Hashomer, Israel, were reviewed and evaluated for potential predictive factors of infection. Cox regression was applied for uni- as well as multi-variate analyses, and a Kaplan-Meier curve and Log-Rank test were used to describe the association between neurological deficit prior to operation and occurrence of infection. Eighty-eight patients who had undergone cranioplasties using autologous as well as various artificial materials were included in the study. The overall rate of infection was 13.6%; median time to infection was 30.5 days (interquartile range: 17.35-43.5). Pre-operative degree of neurological disability was the strongest predictor for infection in both uni- and multi-variate analyses (Hazard ratio [HR]=18.9, 95% confidence interval [CI]: 1.9-187 p=0.014). Patients admitted due to trauma (HR=7.04 CI: 0.9-54.6, p=0.062) and autologous graft material (HR=2.88, 95% CI: 0.92-9.09, p=0.07) were associated with a trend toward a higher risk for infection. In conclusion, careful patient selection is a key concept in avoiding harmful post-cranioplasty infections. Modified Rankin Score yields a well-established tool that predicts the risk of infection.

  1. Diagnostic accuracy of a clinical diagnosis of idiopathic pulmonary fibrosis: an international case–cohort study

    PubMed Central

    Maher, Toby M.; Kolb, Martin; Poletti, Venerino; Nusser, Richard; Richeldi, Luca; Vancheri, Carlo; Wilsher, Margaret L.; Antoniou, Katerina M.; Behr, Jüergen; Bendstrup, Elisabeth; Brown, Kevin; Calandriello, Lucio; Corte, Tamera J.; Crestani, Bruno; Flaherty, Kevin; Glaspole, Ian; Grutters, Jan; Inoue, Yoshikazu; Kokosi, Maria; Kondoh, Yasuhiro; Kouranos, Vasileios; Kreuter, Michael; Johannson, Kerri; Judge, Eoin; Ley, Brett; Margaritopoulos, George; Martinez, Fernando J.; Molina-Molina, Maria; Morais, António; Nunes, Hilario; Raghu, Ganesh; Ryerson, Christopher J.; Selman, Moises; Spagnolo, Paolo; Taniguchi, Hiroyuki; Tomassetti, Sara; Valeyre, Dominique; Wijsenbeek, Marlies; Wuyts, Wim; Hansell, David; Wells, Athol

    2017-01-01

    We conducted an international study of idiopathic pulmonary fibrosis (IPF) diagnosis among a large group of physicians and compared their diagnostic performance to a panel of IPF experts. A total of 1141 respiratory physicians and 34 IPF experts participated. Participants evaluated 60 cases of interstitial lung disease (ILD) without interdisciplinary consultation. Diagnostic agreement was measured using the weighted kappa coefficient (κw). Prognostic discrimination between IPF and other ILDs was used to validate diagnostic accuracy for first-choice diagnoses of IPF and were compared using the C-index. A total of 404 physicians completed the study. Agreement for IPF diagnosis was higher among expert physicians (κw=0.65, IQR 0.53–0.72, p<0.0001) than academic physicians (κw=0.56, IQR 0.45–0.65, p<0.0001) or physicians with access to multidisciplinary team (MDT) meetings (κw=0.54, IQR 0.45–0.64, p<0.0001). The prognostic accuracy of academic physicians with >20 years of experience (C-index=0.72, IQR 0.0–0.73, p=0.229) and non-university hospital physicians with more than 20 years of experience, attending weekly MDT meetings (C-index=0.72, IQR 0.70–0.72, p=0.052), did not differ significantly (p=0.229 and p=0.052 respectively) from the expert panel (C-index=0.74 IQR 0.72–0.75). Experienced respiratory physicians at university-based institutions diagnose IPF with similar prognostic accuracy to IPF experts. Regular MDT meeting attendance improves the prognostic accuracy of experienced non-university practitioners to levels achieved by IPF experts. PMID:28860269

  2. Diagnostic accuracy of a clinical diagnosis of idiopathic pulmonary fibrosis: an international case-cohort study.

    PubMed

    Walsh, Simon L F; Maher, Toby M; Kolb, Martin; Poletti, Venerino; Nusser, Richard; Richeldi, Luca; Vancheri, Carlo; Wilsher, Margaret L; Antoniou, Katerina M; Behr, Jüergen; Bendstrup, Elisabeth; Brown, Kevin; Calandriello, Lucio; Corte, Tamera J; Cottin, Vincent; Crestani, Bruno; Flaherty, Kevin; Glaspole, Ian; Grutters, Jan; Inoue, Yoshikazu; Kokosi, Maria; Kondoh, Yasuhiro; Kouranos, Vasileios; Kreuter, Michael; Johannson, Kerri; Judge, Eoin; Ley, Brett; Margaritopoulos, George; Martinez, Fernando J; Molina-Molina, Maria; Morais, António; Nunes, Hilario; Raghu, Ganesh; Ryerson, Christopher J; Selman, Moises; Spagnolo, Paolo; Taniguchi, Hiroyuki; Tomassetti, Sara; Valeyre, Dominique; Wijsenbeek, Marlies; Wuyts, Wim; Hansell, David; Wells, Athol

    2017-08-01

    We conducted an international study of idiopathic pulmonary fibrosis (IPF) diagnosis among a large group of physicians and compared their diagnostic performance to a panel of IPF experts.A total of 1141 respiratory physicians and 34 IPF experts participated. Participants evaluated 60 cases of interstitial lung disease (ILD) without interdisciplinary consultation. Diagnostic agreement was measured using the weighted kappa coefficient (κw). Prognostic discrimination between IPF and other ILDs was used to validate diagnostic accuracy for first-choice diagnoses of IPF and were compared using the C-index.A total of 404 physicians completed the study. Agreement for IPF diagnosis was higher among expert physicians (κw=0.65, IQR 0.53-0.72, p<0.0001) than academic physicians (κw=0.56, IQR 0.45-0.65, p<0.0001) or physicians with access to multidisciplinary team (MDT) meetings (κw=0.54, IQR 0.45-0.64, p<0.0001). The prognostic accuracy of academic physicians with >20 years of experience (C-index=0.72, IQR 0.0-0.73, p=0.229) and non-university hospital physicians with more than 20 years of experience, attending weekly MDT meetings (C-index=0.72, IQR 0.70-0.72, p=0.052), did not differ significantly (p=0.229 and p=0.052 respectively) from the expert panel (C-index=0.74 IQR 0.72-0.75).Experienced respiratory physicians at university-based institutions diagnose IPF with similar prognostic accuracy to IPF experts. Regular MDT meeting attendance improves the prognostic accuracy of experienced non-university practitioners to levels achieved by IPF experts. Copyright ©ERS 2017.

  3. Social consequences of multiple sclerosis: clinical and demographic predictors - a historical prospective cohort study.

    PubMed

    Pfleger, C C H; Flachs, E M; Koch-Henriksen, N

    2010-11-01

    Time to disability pension is one of the endpoints to be used to determine the prognosis of multiple sclerosis (MS) in prospective studies.   To assess the time to cessation of work and receiving disability pension in MS, and how it may depend on gender, type of work and age and symptom at onset. A total of 2240 Danes with onset of definite/probable MS 1980-1989, identified from the Danish MS-Registry, were included. Information on social endpoints was retrieved from Statistics Denmark. Cox regression analyses were used with onset as starting point. Afferent onset symptoms [hazard ratio (HR 0.57)] and non-physical type of work (HR 0.70) were favourable prognostic factors compared with high age at onset, physical work and efferent symptoms at onset. The mean time to disability pension was 13 years for patients with afferent/brainstem onset symptom but 8.7 years for those with efferent onset symptoms (P < 0.0001). The effect of onset symptom was reduced and the effect of sex became significant when all covariates and age at onset were included in multivariate Cox regression. Onset age, type of onset symptom and work are robust predictors of disability pension in MS. Disability pension proves to be a reliable milestone in estimation of the prognosis of MS. © 2010 The Author(s). Journal compilation © 2010 EFNS.

  4. Clinical characteristics and survival of pulmonary arterial hypertension associated with three major connective tissue diseases: A cohort study in China.

    PubMed

    Zhao, Jiuliang; Wang, Qian; Liu, Yongtai; Tian, Zhuang; Guo, Xiaoxiao; Wang, Hui; Lai, Jinzhi; Huang, Can; Yang, Xiaoxi; Li, Mengtao; Zeng, Xiaofeng

    2017-06-01

    Pulmonary arterial hypertension (PAH) is a major cause of death in connective tissue disease patients. This study investigated the clinical characteristics and survival of CTD-PAH in Chinese patients. This cohort study enrolled 190 consecutive PAH patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or primary Sjögren's syndrome (pSS) who visited our referral center between May 2006 and December 2014. Baseline demographics, clinical features, laboratory results, and hemodynamic assessments were analyzed. Cox proportional hazards regression analysis was used to identify independent factors associated with increased risk of mortality. The PAH patients were more likely to have SLE (58.4%) as the underlying CTD than SSc (26.3%) or pSS (15.3%). Mean age was 37.8±10.4years, and patients with SLE were youngest at the time of PAH diagnosis. The most prevalent autoantibody was anti-U1RNP antibody (55.8%). The three groups did not differ significantly regarding World Health Organization functional class or hemodynamic results. The overall 1-, 3-, and 5-year survival rates were 87.1%, 79.1%, and 62.9%, respectively. The 3-year survival rate of 81.3% for those with SLE-PAH was significantly better than that for patients with SSc-PAH (63.6%, P<0.05). Independent predictors of mortality were 6-minute walk distance (6MWD) ≤380m (HR 3.222, 95% CI 1.485-6.987, P=0.003) and underlying CTD (HR 1.684; 95CI% 1.082-2.622, P=0.021). Independent predictors of mortality for CTD-PAH were 6MWD <380m and SSc as the underlying CTD. Increased awareness of pSS-PAH is needed because of its worse prognosis compared to SLE-PAH. Copyright © 2016. Published by Elsevier B.V.

  5. The predictive value of the borderline ankle-brachial index for long-term clinical outcomes: An observational cohort study.

    PubMed

    Tanaka, Shingo; Kaneko, Hidehiro; Kano, Hiroto; Matsuno, Shunsuke; Suzuki, Shinya; Takai, Hideaki; Otsuka, Takayuki; Uejima, Tokuhisa; Oikawa, Yuji; Nagashima, Kazuyuki; Kirigaya, Hajime; Sagara, Koichi; Yajima, Junji; Sawada, Hitoshi; Aizawa, Tadanori; Yamashita, Takeshi

    2016-07-01

    Low ankle-brachial index (ABI) is associated with increased mortality and an increased incidence of cardiovascular events. The purpose of this study was to investigate the value of borderline ABI in predicting clinical outcomes. The data were derived from the Shinken Database 2004-2012, from a single hospital-based cohort study (N = 19,994). ABI was measured in 5205 subjects; 4756 subjects whose ABI was 0.91-1.39 and having no history of peripheral artery disease were enrolled. The subjects were classified into two groups as follows: borderline ABI (0.91-1.00; n = 324) and normal ABI (1.01-1.39; n = 4432). Subjects in the borderline ABI group had more comorbidities, including diabetes mellitus, aortic disease, and stroke. Moreover, the borderline ABI group was associated with higher levels of hemoglobin A1c and brain natriuretic peptide, larger diameters of left atrium and left ventricle, and lower levels of estimated glomerular filtration rate and left ventricular ejection fraction. All-cause death and cardiovascular death occurred in 9.3% and 4.6% of subjects in the borderline ABI group, and in 2.0% and 0.8% of subjects in the normal ABI group, respectively. An adjusted Cox regression model showed that borderline ABI was associated with a higher incidence of all-cause death (hazard ratio [HR] 2.27, p = 0.005) and cardiovascular death (HR 3.47, p = 0.003). A borderline ABI was independently associated with worse clinical outcomes in relatively high risk population. Our data should be confirmed in larger populations including those with low risk profiles. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Clinical and laboratory associations of severity in a Sri Lankan cohort of patients with serologically confirmed leptospirosis: a prospective study.

    PubMed

    Rajapakse, Senaka; Weeratunga, Praveen; Niloofa, M J Roshan; Fernando, Narmada; Rodrigo, Chathuraka; Maduranga, Sachith; de Silva, Nipun Lakshitha; Fernando, Nipun Lakshitha; de Silva, H Janaka; Karunanayake, Lilani; Handunnetti, Shiroma

    2015-11-01

    Leptospirosis results in significant morbidity and mortality. This study elucidates markers of severity in a cohort of Sri Lankan patients. Patients presenting to three healthcare institutions in the Western province of Sri Lanka with leptospirosis serological confirmed by the microscopic agglutination test (MAT) were included. Prospective data regarding demographic, clinical and laboratory parameters was extracted. Univariate associations and subsequent multivariate logistic regression models were constructed. The study included 232 patients, with 68.5% (159) demonstrating severe disease. Significant associations of severe disease at a significance level of p<0.05 were fever >38.8°C on presentation, age >40 years, muscle tenderness, tachycardia on admission, highest white cell count >12 350/mm(3) and <7900/mm(3), highest neutrophil percentage >84%, haemoglobin >11.2 g/dL and <10.2 g/dL, packed cell volume (PCV) >33.8% and <29.8%, lowest platelet count <63 500/mm(3), highest alanine transaminase (ALT) >70 IU/L and hyponatremia with sodium <131 mEq/L. On multivariate analysis, PCV <29.8% (p=0.011; OR 3.750; CI: 1.394-10.423), ALT >70 IU/L (p=0.044; OR 2.639; CI: 1.028-6.774) and hyponatremia <131 mEq/L (p=0.019; OR 6.413; CI: 1.353-30.388) were independent associations of severe disease. Severity associations were demonstrated with both clinical and laboratory parameters. There is a need for novel biomarkers for prediction of severity in leptospirosis. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  7. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study.

    PubMed

    Martos-Benítez, Frank Daniel; Gutiérrez-Noyola, Anarelys; Echevarría-Víctores, Adisbel

    2016-01-01

    This study sought to determine the influence of postoperative complications on the clinical outcomes of patients who underwent thoracic and gastrointestinal cancer surgery. A prospective cohort study was conducted regarding 179 consecutive patients who received thorax or digestive tract surgery due to cancer and were admitted to an oncological intensive care unit. The Postoperative Morbidity Survey was used to evaluate the incidence of postoperative complications. The influence of postoperative complications on both mortality and length of hospital stay were also assessed. Postoperative complications were found for 54 patients (30.2%); the most common complications were respiratory problems (14.5%), pain (12.9%), cardiovascular problems (11.7%), infectious disease (11.2%), and surgical wounds (10.1%). A multivariate logistic regression found that respiratory complications (OR = 18.68; 95%CI = 5.59 - 62.39; p < 0.0001), cardiovascular problems (OR = 5.06, 95%CI = 1.49 - 17.13; p = 0.009), gastrointestinal problems (OR = 26.09; 95%CI = 6.80 - 100.16; p < 0.0001), infectious diseases (OR = 20.55; 95%CI = 5.99 - 70.56; p < 0.0001) and renal complications (OR = 18.27; 95%CI = 3.88 - 83.35; p < 0.0001) were independently associated with hospital mortality. The occurrence of at least one complication increased the likelihood of remaining hospitalized (log-rank test, p = 0.002). Postoperative complications are frequent disorders that are associated with poor clinical outcomes; thus, structural and procedural changes should be implemented to reduce postoperative morbidity and mortality.

  8. Clinical Features and Outcomes of IPF Patients Hospitalized for Pulmonary Infection: A Japanese Cohort Study

    PubMed Central

    Yamazaki, Ryo; Nishiyama, Osamu; Sano, Hiroyuki; Iwanaga, Takashi; Higashimoto, Yuji; Kume, Hiroaki; Tohda, Yuji

    2016-01-01

    Many patients with idiopathic pulmonary fibrosis (IPF) undergo hospitalizations due to pulmonary infections. We retrospectively investigated the characteristics of hospitalizations due to pulmonary infection in patients with IPF to elucidate causative pathogens and mortality. We reviewed patients with IPF who were admitted between January 2008 and December 2014 for pulmonary infections including pneumonia and bronchitis. The causative pathogen, the relationship between the site of pneumonia and existing IPF radiological patterns on high-resolution chest CT, and predictors of mortality were evaluated. Forty-eight IPF patients were hospitalized a totally of 81 times due to pulmonary infection during the study period. In the 48 first-time admissions after IPF diagnosis, causative pathogens were detected in 20 patients (41.6%). The most common pathogen was Haemophilus influenzae (14.5%) followed by Pseudomonas aeruginosa (4.1%), Staphylococcus aureus (4.1%), Branhamella catarrhalis (4.1%), and Klebsiella pneumoniae (4.1%). Among all 81 admissions, the most common pathogen was P. aeruginosa (12.3%), followed by H. influenzae (8.6%), S. aureus (6.1%) and Escherichia coli (4.9%). No relationship was observed between the detected pathogen and the site of pneumonia. The 30-day and hospital mortality rates were 14.5% and 18.7%, respectively. Pneumonia severity index on admission was significantly associated with both 30-day and hospital mortality. In conclusion, IPF patients hospitalized for pulmonary infections had high 30-day and hospital mortality. In contrast to community-acquired pneumonia, the causative pathogens mainly consisted of gram-negative bacteria. The PSI score may be a significant predictor of mortality. These results provide information for empiric antibiotic selection when treating IPF patients with pulmonary infections. PMID:27959904

  9. Clinical impact of sarcopenia on prognosis in pancreatic ductal adenocarcinoma: A retrospective cohort study.

    PubMed

    Ninomiya, Go; Fujii, Tsutomu; Yamada, Suguru; Yabusaki, Norimitsu; Suzuki, Kojiro; Iwata, Naoki; Kanda, Mitsuro; Hayashi, Masamichi; Tanaka, Chie; Nakayama, Goro; Sugimoto, Hiroyuki; Koike, Masahiko; Fujiwara, Michitaka; Kodera, Yasuhiro

    2017-03-01

    To investigate the impact of the body composition such as skeletal muscle, visceral fat and body mass index (BMI) on patients with resected pancreatic ductal adenocarcinoma (PDAC). A total of 265 patients who underwent curative surgery for PDAC were examined in this study. The total skeletal muscle and fat tissue areas were evaluated in a single image obtained at the third lumber vertebra during a preoperative computed tomography (CT) scan. The patients were assigned to either the sarcopenia or non-sarcopenia group based on their skeletal muscle index (SMI) and classified into high visceral fat area (H-VFA) or low VFA (L-VFA) groups. The association of clinicopathological features and prognosis with the body composition were statistically analyzed. There were 170 patients (64.2%) with sarcopenia. The median survival time (MST) was 23.7 months for sarcopenia patients and 25.8 months for patients without sarcopenia. The MST was 24.4 months for H-VFA patients and 25.8 months for L-VFA patients. However, sarcopenia patients with BMI ≥22 exhibited significantly poorer survival than patients without sarcopenia (MST: 19.2 vs. 35.4 months, P = 0.025). There was a significant difference between patients with and without sarcopenia who did not receive chemotherapy (5-year survival rate: 0% vs. 68.3%, P = 0.003). The multivariate analysis revealed that tumor size, positive dissected peripancreatic tissue margin, and sarcopenia were independent prognostic factors. Sarcopenia is an independent prognostic factor in PDAC patients with a BMI ≥22. Therefore, evaluating skeletal muscle mass may be a simple and useful approach for predicting patient prognosis. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  10. [Clinical courses and risk factors for progression of smoldering multiple myeloma: a nationwide cohort study in Japan].

    PubMed

    Takamatsu, Yasushi; Muta, Tsuyoshi

    2015-08-01

    We carried out a cohort study of smoldering multiple myeloma (SMM) in Japan. The clinical data of 207 patients with SMM, median age 69 years (range: 27-90), were collected from 63 institutions. The subtype of myeloma was IgG type in 168, IgA type in 30, and Bence Jones type in 9 patients. At a median follow-up of 39 months, 53% of the patients had progressed to symptomatic MM (within 5 years of the initial diagnosis). As previously described, a serum free light chain ratio>8 or <0.125, along with the number of bone marrow plasma cells being 10% or more and the serum M-protein level being at least 3 g/dl, was a significant predictor of rapid progression. We found that the rate of increase in serum M-protein levels correlated negatively with the risk of progression. The probability of progression within 5 years was 100% in patients whose rate of serum M-protein level increase was 2 mg/dl/day or higher. This indicates that the serum M-protein level increase rate might be a useful predictor of disease progression in SMM.

  11. Pessimistic, Anxious, and Depressive Personality Traits Predict All-Cause Mortality: The Mayo Clinic Cohort Study of Personality and Aging

    PubMed Central

    Grossardt, Brandon R.; Bower, James H.; Geda, Yonas E.; Colligan, Robert C.; Rocca, Walter A.

    2011-01-01

    Objective To study the association between several personality traits and all-cause mortality. Methods We established a historical cohort of 7216 subjects who completed the Minnesota Multiphasic Personality Inventory (MMPI) for research at the Mayo Clinic from 1962 to 1965, and who resided within a 120-mile radius centered in Rochester, MN. A total of 7080 subjects (98.1%) were followed over four decades either actively (via a direct or proxy telephone interview) or passively (via review of medical records or by obtaining their death certificates). We examined the association of pessimistic, anxious, and depressive personality traits (as measured using MMPI scales) with all-cause mortality. Results A total of 4634 subjects (65.5%) died during follow-up. Pessimistic, anxious, and depressive personality traits were associated with increased all-cause mortality in both men and women. In addition, we observed a linear trend of increasing risk from the first to the fourth quartile for all three scales. Results were similar in additional analyses considering the personality scores as continuous variables, in analyses combining the three personality traits into a composite neuroticism score, and in several sets of sensitivity analyses. These associations remained significant even when personality was measured early in life (ages 20 to 39 years). Conclusions Our findings suggest that personality traits related to neuroticism are associated with an increased risk of all-cause mortality even when they are measured early in life. PMID:19321849

  12. The Italian dementia with Lewy bodies study group (DLB-SINdem): toward a standardization of clinical procedures and multicenter cohort studies design.

    PubMed

    Bonanni, L; Cagnin, A; Agosta, F; Babiloni, C; Borroni, B; Bozzali, M; Bruni, A C; Filippi, M; Galimberti, D; Monastero, R; Muscio, C; Parnetti, L; Perani, D; Serra, L; Silani, V; Tiraboschi, P; Padovani, A

    2017-01-01

    Dementia with Lewy bodies (DLB) causes elevated outlays for the National Health Systems due to high institutionalization rate and patients' reduced quality of life and high mortality. Furthermore, DLB is often misdiagnosed as Alzheimer's disease. These data motivate harmonized multicenter longitudinal cohort studies to improve clinical management and therapy monitoring. The Italian DLB study group of the Italian Neurological Society for dementia (SINdem) developed and emailed a semi-structured questionnaire to 572 national dementia centers (from primary to tertiary) to prepare an Italian large longitudinal cohort. The questionnaire surveyed: (1) prevalence and incidence of DLB; (2) clinical assessment; (3) relevance and availability of diagnostic tools; (4) pharmacological management of cognitive, motor, and behavioural disturbances; (5) causes of hospitalization, with specific focus on delirium and its treatment. Overall, 135 centers (23.6 %) contributed to the survey. Overall, 5624 patients with DLB are currently followed by the 135 centers in a year (2042 of them are new patients). The percentage of DLB patients was lower (27 ± 8 %) than that of Alzheimer's disease and frontotemporal dementia (56 ± 27 %) patients. The majority of the centers (91 %) considered the clinical and neuropsychological assessments as the most relevant procedure for a DLB diagnosis. Nonetheless, most of the centers has availability of magnetic resonance imaging (MRI; 95 %), electroencephalography (EEG; 93 %), and FP-CIT single photon emission-computerized tomography (SPECT; 75 %) scan for clinical applications. It will be, therefore, possible to recruit a large harmonized Italian cohort of DLB patients for future cross-sectional and longitudinal multicenter studies.

  13. The Oxfordshire Community Stroke Project classification system predicts clinical outcomes following intravenous thrombolysis: a prospective cohort study

    PubMed Central

    Yang, Yuling; Wang, Anxin; Zhao, Xingquan; Wang, Chunxue; Liu, Liping; Zheng, Huaguang; Wang, Yongjun; Cao, Yibin; Wang, Yilong

    2016-01-01

    Background The Oxfordshire Community Stroke Project (OCSP) classification system is a simple stroke classification system that can be used to predict clinical outcomes. In this study, we compare the safety and efficacy of intravenous thrombolysis in Chinese stroke patients categorized using the OCSP classification system. Patients and methods We collected data from the Thrombolysis Implementation and Monitoring of Acute Ischemic Stroke in China registry. A total of 1,115 patients treated with intravenous thrombolysis with alteplase within 4.5 hours of stroke onset were included. Symptomatic intracranial hemorrhage (SICH), mortality, and 90-day functional outcomes were compared between the stroke patients with different stroke subtypes. Results Of the 1,115 patients included in the cohort, 197 (17.67%) were classified with total anterior circulation infarct (TACI), 700 (62.78%) with partial anterior circulation infarct, 153 (13.72%) with posterior circulation infarct, and 65 (5.83%) with lacunar infarct. After multivariable adjustment, compared to the patients with non-TACI, those with TACI had a significantly increased risk of SICH (odds ratio [OR] 8.80; 95% confidence interval [CI] 2.84–27.25, P<0.001), higher mortality (OR 5.24; 95% CI 3.19–8.62; P<0.001), and poor functional independence (OR 0.38; 95% CI 0.26–0.56; P<0.001) at 3-month follow-up. Conclusion After thrombolysis, the patients with TACI exhibited greater SICH, a higher mortality rate, and worse 3-month clinical outcomes compared with the patients with non-TACI. The OCSP classification system may help clinicians predict the safety and efficacy of thrombolysis. PMID:27418829

  14. Cohort Profile Update: The 1982 Pelotas (Brazil) Birth Cohort Study.

    PubMed

    Horta, Bernardo Lessa; Gigante, Denise P; Gonçalves, Helen; dos Santos Motta, JanainaVieira; Loret de Mola, Christian; Oliveira, Isabel O; Barros, Fernando C; Victora, Cesar G

    2015-04-01

    In this manuscript, we update the profile of the 1982 Pelotas Birth Cohort Study.In 1982, 5914 live births whose families lived in the urban are of Pelotas were enrolled in the cohort. In 2012-13, we tried to locate the whole original cohort; 3701 participants were interviewed who, added to the 325 known deaths, represented a follow-up rate of 68.1%. In contrast to the previous home interviews, in this wave all participants were invited to visit the research clinic to be interviewed and examined. The visit was carried out at a mean age of 30.2 years and mainly focused on four categories of outcomes: (i) mental health; (ii) body composition; (iii) precursors of complex chronic diseases; and (iv) human capital. Requests for collaboration by outside researchers are welcome.

  15. Cohort Profile Update: The 1982 Pelotas (Brazil) Birth Cohort Study

    PubMed Central

    Horta, Bernardo Lessa; Gigante, Denise P; Gonçalves, Helen; dos Santos Motta, JanainaVieira; Loret de Mola, Christian; Oliveira, Isabel O; Barros, Fernando C; Victora, Cesar G

    2015-01-01

    In this manuscript, we update the profile of the 1982 Pelotas Birth Cohort Study.In 1982, 5914 live births whose families lived in the urban are of Pelotas were enrolled in the cohort. In 2012–13, we tried to locate the whole original cohort; 3701 participants were interviewed who, added to the 325 known deaths, represented a follow-up rate of 68.1%. In contrast to the previous home interviews, in this wave all participants were invited to visit the research clinic to be interviewed and examined. The visit was carried out at a mean age of 30.2 years and mainly focused on four categories of outcomes: (i) mental health; (ii) body composition; (iii) precursors of complex chronic diseases; and (iv) human capital. Requests for collaboration by outside researchers are welcome. PMID:25733577

  16. Innovative measures to combat rare diseases in China: The national rare diseases registry system, larger-scale clinical cohort studies, and studies in combination with precision medicine research

    PubMed Central

    Song, Peipei; He, Jiangjiang; Li, Fen; Jin, Chunlin

    2017-01-01

    Summary China is facing the great challenge of treating the world's largest rare disease population, an estimated 16 million patients with rare diseases. One effort offering promise has been a pilot national project that was launched in 2013 and that focused on 20 representative rare diseases. Another government-supported special research program on rare diseases – the “Rare Diseases Clinical Cohort Study” – was launched in December 2016. According to the plan for this research project, the unified National Rare Diseases Registry System of China will be established as of 2020, and a large-scale cohort study will be conducted from 2016 to 2020. The project plans to develop 109 technical standards, to establish and improve 2 national databases of rare diseases – a multi-center clinical database and a biological sample library, and to conduct studies on more than 50,000 registered cases of 50 different rare diseases. More importantly, this study will be combined with the concept of precision medicine. Chinese population-specific basic information on rare diseases, clinical information, and genomic information will be integrated to create a comprehensive predictive model with a follow-up database system and a model to evaluate prognosis. This will provide the evidence for accurate classification, diagnosis, treatment, and estimation of prognosis for rare diseases in China. Numerous challenges including data standardization, protecting patient privacy, big data processing, and interpretation of genetic information still need to be overcome, but research prospects offer great promise. PMID:28357175

  17. Ten-year incidence and prevalence of clinically diagnosed blepharitis in South Korea: a nationwide population-based cohort study.

    PubMed

    Rim, Tyler Hyungtaek; Kang, Min Jae; Choi, Moonjung; Seo, Kyoung Yul; Kim, Sung Soo

    2017-07-01

    Blepharitis is one of the most common conditions. However, no study has yet evaluated the epidemiology by evaluating a large population-based sample. To evaluate the incidence and prevalence of clinically diagnosed blepharitis in South Korea. Nationwide population-based study. We investigated the Korean National Health Insurance Service-National Sample Cohort, a representative one million-sample of the Korean population, for patients diagnosed with blepharitis according to the Korean Classification of Diseases. Annual and overall incidence and prevalence of blepharitis during the study period (2004-2013) were estimated after excluding chronic blepharitis patients, diagnosed during 2002-2003. Sociodemographic factors and comorbidities associated with blepharitis were evaluated using Cox proportional hazard regression. The first occurrence of blepharitis. A total of 1 116 363 individuals over 9 698 118 person-years were evaluated (mean follow up: 8.7 years) from 2004 to 2013. The overall incidence was 1.1 (95% confidence interval, 1.1-1.1) per 100 person-years. The incidence increased with time (0.9 vs. 1.3 per 100 person-years, in 2004 and 2013, respectively) and was higher in female patients (1.3 vs. 0.9 per 100 person-years, respectively). The overall prevalence was 8.1% (95% confidence interval: 8.0-8.1) among subjects aged 40 years or older. Chalazion, gastritis, Sjögren's syndrome, pterygium, rosacea, prostatic hypertrophy, atopy, irritable bowel disease and peptic ulcer were associated with an increased incidence of blepharitis in the multivariable Cox model. We found that blepharitis was a relatively common disease and is associated with various ocular and systemic conditions. © 2017 Royal Australian and New Zealand College of Ophthalmologists.

  18. Clinical prediction of violence among inpatients with schizophrenia using the Chinese modified version of Violence Scale: a prospective cohort study.

    PubMed

    Chen, Shing-Chia; Hwu, Hai-Gwo; Hu, Fu-Chang

    2014-02-01

    A standard measure to assess and predict violence is important for psychiatric services. No prospective study has examined the history of violence and heterogeneity of violence in predicting specific types of violence among inpatient with schizophrenia. This study aimed to prospectively examine the accuracy of prediction of types of violence using the Chinese modified version of Violence Scale (VS-CM) among inpatients with schizophrenia based on their past history of violence and the real occurrence of violence during hospitalization. A prospective cohort study design. A total of 107 adult patients with schizophrenia spectrum disorders, consecutively admitted to an acute psychiatric ward of a university hospital in Taiwan, were recruited. In addition to data about demographics and clinical illness, count records of the history of violence within one month prior to admission by interview and the actual occurrence of violence during the whole course of hospitalization by participant observation were collected using the VS-CM. Multivariate logistic analysis and area under the Receiver Operating Characteristic curve (AUC) analysis were applied to examine the predictive ability of the VS-CM. A patient's history of violence assessed by the VS-CM predicted the actual occurrence of violence during hospitalization with the Odds Ratio of 17.5 (p=0.001). The predictive accuracy of the VS-CM had high sensitivity (97.0%), moderate positive predictive value (71.4%), and high negative predictive value (87.5%); however, the specificity was relatively low (35.0%). The AUC was 79.5% using the total scale of the VS-CM and 70.7-74.5% using the subscales in predicting corresponding types of violence. The VS-CM is a valid and reliable measure of potential violence. It can be applied to assess and predict specific types of violence among inpatient with schizophrenia. Copyright © 2013 Elsevier Ltd. All rights reserved.

  19. The Influence of Preoperative and Postoperative Psychological Symptoms on Clinical Outcome after Shoulder Surgery: A Prospective Longitudinal Cohort Study

    PubMed Central

    Koorevaar, Rinco C. T.; van ‘t Riet, Esther; Gerritsen, Marleen J. J.; Madden, Kim; Bulstra, Sjoerd K.

    2016-01-01

    Background Psychological symptoms are highly prevalent in patients with shoulder complaints. Psychological symptoms in patients with shoulder complaints might play a role in the aetiology, perceived disability and pain and clinical outcome of treatment. The aim of this study was to assess whether preoperative symptoms of distress, depression, anxiety and somatisation were associated with a change in function after shoulder surgery and postoperative patient perceived improvement of pain and function. In addition, the change of psychological symptoms after shoulder surgery was analyzed and the influence of postoperative symptoms of psychological disorders after surgery on the change in function after shoulder surgery and perceived postoperative improvement of pain and function. Methods and Findings A prospective longitudinal cohort study was performed in a general teaching hospital. 315 consecutive patients planned for elective shoulder surgery were included. Outcome measures included change of Disabilities of the Arm, Shoulder and Hand (DASH) score and anchor questions about improvement in pain and function after surgery. Psychological symptoms were identified before and 12 months after surgery with the validated Four-Dimensional Symptom Questionnaire (4DSQ). Psychological symptoms were encountered in all the various shoulder diagnoses. Preoperative symptoms of psychological disorders persisted after surgery in 56% of patients, 10% of patients with no symptoms of psychological disorders before surgery developed new psychological symptoms. Preoperative symptoms of psychological disorders were not associated with the change of DASH score and perceived improvement of pain and function after shoulder surgery. Patients with symptoms of psychological disorders after surgery were less likely to improve on the DASH score. Postoperative symptoms of distress and depression were associated with worse perceived improvement of pain. Postoperative symptoms of distress, depression

  20. A 13-year cohort study of musculoskeletal disorders treated in an autoplant, on-site physiotherapy clinic.

    PubMed

    Sadi, Jackie; MacDermid, Joy C; Chesworth, Bert; Birmingham, Trevor

    2007-12-01

    The purpose of this study was to describe the rate and distribution of treatment visits provided in an on-site, automotive plant, physiotherapy clinic over a 13-year period. A retrospective cohort study was conducted using data collected at an on-site physiotherapy clinic (1990-2002, 65,977 visits; n = 2,636 workers). The average age of workers was 43 +/- 9 years; most remained at work (85%) when treated. Disorders most commonly affected the shoulder, lumbar, and cervical regions; the median number of visits for these was 7, 6, and 5, respectively. Elbow disorders occurred commonly only for work-related complaints and required a median of eight visits. Rate of utilization was higher for women, with 47% of the plant's female workers attending physiotherapy in 1 year. Women had higher rates of cervical spine (12 vs. 22%) and wrist (5 vs. 10%) disorders. The two most common causes of injury reported by workers with an industrial injury were "frank injury arising out of normal employment" (51%) and "gradual onset/no frank injury" (37%). The diagnosis most often reported by the physiotherapist after initial assessment was "strain" which was similar for both industrial (43%) and non-industrial (49%) injuries. The six main departments in this automotive plant account for 93% of all industrial injuries reported. Final Assembly accounted for the largest number and highest rate of injury, although shift variability was noted in utilization rates (13 vs. 26%), despite the same tasks, shift schedules, and demographics. Although there was no control group, the number of visits to discharge was lower than reported in the literature for off-site physical therapy; there was a large reduction in claims (441-275) following introduction of the clinic and reduced duration/costs of lost time were identified by the employer as a rationale to continue and enhance the service over time. On-site physiotherapy services can provide early, cost-effective management of WRMSD in the automotive

  1. Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials.

    PubMed

    Dwan, Kerry; Altman, Douglas G; Clarke, Mike; Gamble, Carrol; Higgins, Julian P T; Sterne, Jonathan A C; Williamson, Paula R; Kirkham, Jamie J

    2014-06-01

    Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs). A systematic review was conducted and included cohort studies that assessed any aspect of the reporting of analyses of RCTs by comparing different trial documents, e.g., protocol compared to trial report, or different sections within a trial publication. The Cochrane Methodology Register, Medline (Ovid), PsycInfo (Ovid), and PubMed were searched on 5 February 2014. Two authors independently selected studies, performed data extraction, and assessed the methodological quality of the eligible studies. Twenty-two studies (containing 3,140 RCTs) published between 2000 and 2013 were included. Twenty-two studies reported on discrepancies between information given in different sources. Discrepancies were found in statistical analyses (eight studies), composite outcomes (one study), the handling of missing data (three studies), unadjusted versus adjusted analyses (three studies), handling of continuous data (three studies), and subgroup analyses (12 studies). Discrepancy rates varied, ranging from 7% (3/42) to 88% (7/8) in statistical analyses, 46% (36/79) to 82% (23/28) in adjusted versus unadjusted analyses, and 61% (11/18) to 100% (25/25) in subgroup analyses. This review is limited in that none of the included studies investigated the evidence for bias resulting from selective reporting of analyses. It was not possible to combine studies to provide overall summary estimates, and so the results of studies are discussed narratively. Discrepancies in analyses between publications and other study documentation were

  2. Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials

    PubMed Central

    Dwan, Kerry; Altman, Douglas G.; Clarke, Mike; Gamble, Carrol; Higgins, Julian P. T.; Sterne, Jonathan A. C.; Williamson, Paula R.; Kirkham, Jamie J.

    2014-01-01

    Background Most publications about selective reporting in clinical trials have focussed on outcomes. However, selective reporting of analyses for a given outcome may also affect the validity of findings. If analyses are selected on the basis of the results, reporting bias may occur. The aims of this study were to review and summarise the evidence from empirical cohort studies that assessed discrepant or selective reporting of analyses in randomised controlled trials (RCTs). Methods and Findings A systematic review was conducted and included cohort studies that assessed any aspect of the reporting of analyses of RCTs by comparing different trial documents, e.g., protocol compared to trial report, or different sections within a trial publication. The Cochrane Methodology Register, Medline (Ovid), PsycInfo (Ovid), and PubMed were searched on 5 February 2014. Two authors independently selected studies, performed data extraction, and assessed the methodological quality of the eligible studies. Twenty-two studies (containing 3,140 RCTs) published between 2000 and 2013 were included. Twenty-two studies reported on discrepancies between information given in different sources. Discrepancies were found in statistical analyses (eight studies), composite outcomes (one study), the handling of missing data (three studies), unadjusted versus adjusted analyses (three studies), handling of continuous data (three studies), and subgroup analyses (12 studies). Discrepancy rates varied, ranging from 7% (3/42) to 88% (7/8) in statistical analyses, 46% (36/79) to 82% (23/28) in adjusted versus unadjusted analyses, and 61% (11/18) to 100% (25/25) in subgroup analyses. This review is limited in that none of the included studies investigated the evidence for bias resulting from selective reporting of analyses. It was not possible to combine studies to provide overall summary estimates, and so the results of studies are discussed narratively. Conclusions Discrepancies in analyses between

  3. Cohort Study of ECG Left Ventricular Hypertrophy Trajectories: Ethnic Disparities, Associations With Cardiovascular Outcomes, and Clinical Utility.

    PubMed

    Iribarren, Carlos; Round, Alfred D; Lu, Meng; Okin, Peter M; McNulty, Edward J

    2017-10-05

    ECG left ventricular hypertrophy (LVH) is a well-known predictor of cardiovascular disease. However, no prior study has characterized patterns of presence/absence of ECG LVH ("ECG LVH trajectories") across the adult lifespan in both sexes and across ethnicities. We examined: (1) correlates of ECG LVH trajectories; (2) the association of ECG LVH trajectories with incident coronary heart disease, transient ischemic attack, ischemic stroke, hemorrhagic stroke, and heart failure; and (3) reclassification of cardiovascular disease risk using ECG LVH trajectories. We performed a cohort study among 75 412 men and 107 954 women in the Northern California Kaiser Permanente Medical Care Program who had available longitudinal exposures of ECG LVH and covariates, followed for a median of 4.8 (range <1-9.3) years. ECG LVH was measured by Cornell voltage-duration product. Adverse trajectories of ECG LVH (persistent, new development, or variable pattern) were more common among blacks and Native American men and were independently related to incident cardiovascular disease with hazard ratios ranging from 1.2 for ECG LVH variable pattern and transient ischemic attack in women to 2.8 for persistent ECG LVH and heart failure in men. ECG LVH trajectories reclassified 4% and 7% of men and women with intermediate coronary heart disease risk, respectively. ECG LVH trajectories were significant indicators of coronary heart disease, stroke, and heart failure risk, independently of level and change in cardiovascular disease risk factors, and may have clinical utility. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

  4. Clinical and laboratory profiles of patients with early spontaneous healing in cutaneous localized leishmaniasis: a historical cohort study.

    PubMed

    Oliveira-Ribeiro, Carla; Pimentel, Maria Inês Fernandes; Oliveira, Raquel de Vasconcellos Carvalhaes; Fagundes, Aline; Madeira, Maria de Fatima; Mello, Cintia Xavier; Mouta-Confort, Eliame; Valete-Rosalino, Claudia Maria; Vasconcellos, Erica de Camargo Ferreira; Lyra, Marcelo Rosandiski; Quintella, Leonardo Pereira; Fatima Antonio, Liliane de; Schubach, Armando; Conceição-Silva, Fatima

    2017-08-10

    Skin ulcers in American cutaneous leishmaniasis (ACL) may heal spontaneously after months/years. However, few cases may present quick heal even during diagnosis procedure (early spontaneous healing- ESH). The main objective of this study was to compare ESH patients with cases requiring specific treatment [non-ESH (NESH)]. A historical cohort study of ACL patients (n = 445) were divided into 2 groups: ESH - spontaneously healed patients (n = 13; 2.90%), and NESH- treated patients (n = 432; 97.10%). We compared clinical and laboratorial findings at diagnosis, including the lesion healing process. ESH patients had a higher percentage of single lesions (p = 0.027), epithelialized lesion on initial examination (p = 0.001), lesions located in the dorsal trunk (p = 0.017), besides earlier healing (p < 0.001). NESH presents higher frequency of ulcerated lesions (p = 0.002), amastigotes identified in histopathology exams (p = 0.005), positive cultures (p = 0.001), and higher positivity in ≥3 parasitological exams (p = 0.030). All ESH cases were positive in only a single exam, especially in PCR. ESH group apparently presented a lower parasitic load evidenced by the difficulty of parasitological confirmation and its positivity only by PCR method. The absence or deficiency of specific treatment is commonly identified as predisposing factors for recurrence and metastasis in ACL. However, due to the drugs toxicity, the treatment of cases which progress to early spontaneous healing is controversial. ESH patients were followed for up to 5 years after cure, with no evidence of recrudescence, therefore suggesting that not treating these patients is justifiable, but periodic dermatological and otorhinolaryngological examinations are advisable to detect a possible relapse.

  5. Clinical variables and biomarkers in prediction of cognitive impairment in patients with newly diagnosed Parkinson's disease: a cohort study.

    PubMed

    Schrag, Anette; Siddiqui, Uzma Faisal; Anastasiou, Zacharias; Weintraub, Daniel; Schott, Jonathan M

    2017-01-01

    Parkinson's disease is associated with an increased incidence of cognitive impairment and dementia. Predicting who is at risk of cognitive decline early in the disease course has implications for clinical prognosis and for stratification of participants in clinical trials. We assessed the use of clinical information and biomarkers as predictive factors for cognitive decline in patients with newly diagnosed Parkinson's disease. The Parkinson's Progression Markers Initiative (PPMI) study is a cohort study in patients with newly diagnosed Parkinson's disease. We evaluated cognitive performance (Montreal Cognitive Assessment [MoCA] scores), demographic and clinical data, APOE status, and biomarkers (CSF and dopamine transporter [DAT] imaging results). Using change in MoCA scores over 2 years, MoCA scores at 2 years' follow-up, and a diagnosis of cognitive impairment (combined mild cognitive impairment or dementia) at 2 years as outcome measures, we assessed the predictive values of baseline clinical variables and separate or combined additions of APOE status, DAT imaging, and CSF biomarkers. We did univariate and multivariate linear analyses with MoCA change scores between baseline and 2 years, and with MoCA scores at 2 years as dependent variables, using backwards linear regression analysis. Additionally, we constructed a prediction model for diagnosis of cognitive impairment using logistic regression analysis. 390 patients with Parkinson's disease recruited between July 1, 2010, and May 31, 2013, and for whom data on MoCA scores at baseline and 2 years were available. In multivariate analyses, baseline age, University of Pennsylvania Smell Inventory Test (UPSIT) scores, CSF amyloid - (Aβ42) to t-tau ratio, and APOE status were associated with change in MoCA scores over time. Baseline age, MoCA and UPSIT scores, and CSF Aβ42 to t-tau ratio were associated with MoCA score at 2 years (using a backwards p-removal threshold of 0·1). Accuracy of prediction of cognitive

  6. Clinical outcomes of first-line antiretroviral therapy in Latin America: analysis from the LATINA retrospective cohort study.

    PubMed

    Angriman, Federico; Belloso, Waldo H; Sierra-Madero, Juan; Sánchez, Jorge; Moreira, Ronaldo Ismerio; Kovalevski, Leandro O; Orellana, Liliana C; Cardoso, Sandra Wagner; Crabtree-Ramirez, Brenda; La Rosa, Alberto; Losso, Marcelo H

    2016-02-01

    Nearly 2 million people are infected with human immunodeficiency virus (HIV) in Latin America. However, information regarding population-scale outcomes from a regional perspective is scarce. We aimed to describe the baseline characteristics and therapeutic outcomes of newly-treated individuals with HIV infection in Latin America. A Retrospective cohort study was undertaken. The primary explanatory variable was combination antiretroviral therapy based on either a protease inhibitor (PI) or a non-nucleoside reverse transcriptase inhibitor (NNRTI). The main outcome was defined as the composite of all-cause mortality and the occurrence of an AIDS-defining clinical event or a serious non-AIDS-defining event during the first year of therapy. The secondary outcomes included the time to a change in treatment strategy. All analyses were performed according to the intention to treat principle. A total of 937 treatment-naive patients from four participating countries were included (228 patients with PI therapy and 709 with NNRTI-based treatment). At the time of treatment initiation, the patients had a mean age of 37 (SD: 10) years and a median CD4 + T-cell count of 133 cells/mm(3) (interquartile range: 47.5-216.0). Patients receiving PI-based regimens had a significantly lower CD4 + count, a higher AIDS prevalence at baseline and a shorter time from HIV diagnosis until the initiation of treatment. There was no difference in the hazard ratio for the primary outcome between groups. The only covariates associated with the latter were CD4 + cell count at baseline, study site and age. The estimated hazard ratio for the time to a change in treatment (NNRTI vs PI) was 0.61 (95% CI 0.47-0.80, p < 0.01). This study concluded that patients living with HIV in Latin America present with similar clinical outcomes regardless of the choice of initial therapy. Patients treated with PIs are more likely to require a treatment change during the first year of follow up.

  7. Clinical spectrum and features of activated phosphoinositide 3-kinase δ syndrome: A large patient cohort study.

    PubMed

    Coulter, Tanya I; Chandra, Anita; Bacon, Chris M; Babar, Judith; Curtis, James; Screaton, Nick; Goodlad, John R; Farmer, George; Steele, Cathal Laurence; Leahy, Timothy Ronan; Doffinger, Rainer; Baxendale, Helen; Bernatoniene, Jolanta; Edgar, J David M; Longhurst, Hilary J; Ehl, Stephan; Speckmann, Carsten; Grimbacher, Bodo; Sediva, Anna; Milota, Tomas; Faust, Saul N; Williams, Anthony P; Hayman, Grant; Kucuk, Zeynep Yesim; Hague, Rosie; French, Paul; Brooker, Richard; Forsyth, Peter; Herriot, Richard; Cancrini, Caterina; Palma, Paolo; Ariganello, Paola; Conlon, Niall; Feighery, Conleth; Gavin, Patrick J; Jones, Alison; Imai, Kohsuke; Ibrahim, Mohammad A A; Markelj, Gašper; Abinun, Mario; Rieux-Laucat, Frédéric; Latour, Sylvain; Pellier, Isabelle; Fischer, Alain; Touzot, Fabien; Casanova, Jean-Laurent; Durandy, Anne; Burns, Siobhan O; Savic, Sinisa; Kumararatne, D S; Moshous, Despina; Kracker, Sven; Vanhaesebroeck, Bart; Okkenhaug, Klaus; Picard, Capucine; Nejentsev, Sergey; Condliffe, Alison M; Cant, Andrew James

    2017-02-01

    Activated phosphoinositide 3-kinase δ syndrome (APDS) is a recently described combined immunodeficiency resulting from gain-of-function mutations in PIK3CD, the gene encoding the catalytic subunit of phosphoinositide 3-kinase δ (PI3Kδ). We sought to review the clinical, immunologic, histopathologic, and radiologic features of APDS in a large genetically defined international cohort. We applied a clinical questionnaire and performed review of medical notes, radiology, histopathology, and laboratory investigations of 53 patients with APDS. Recurrent sinopulmonary infections (98%) and nonneoplastic lymphoproliferation (75%) were common, often from childhood. Other significant complications included herpesvirus infections (49%), autoinflammatory disease (34%), and lymphoma (13%). Unexpectedly, neurodevelopmental delay occurred in 19% of the cohort, suggesting a role for PI3Kδ in the central nervous system; consistent with this, PI3Kδ is broadly expressed in the developing murine central nervous system. Thoracic imaging revealed high rates of mosaic attenuation (90%) and bronchiectasis (60%). Increased IgM levels (78%), IgG deficiency (43%), and CD4 lymphopenia (84%) were significant immunologic features. No immunologic marker reliably predicted clinical severity, which ranged from asymptomatic to death in early childhood. The majority of patients received immunoglobulin replacement and antibiotic prophylaxis, and 5 patients underwent hematopoietic stem cell transplantation. Five patients died from complications of APDS. APDS is a combined immunodeficiency with multiple clinical manifestations, many with incomplete penetrance and others with variable expressivity. The severity of complications in some patients supports consideration of hematopoietic stem cell transplantation for severe childhood disease. Clinical trials of selective PI3Kδ inhibitors offer new prospects for APDS treatment. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights

  8. Clinical characteristics and prognosis of ultra high-risk gestational trophoblastic neoplasia patients: A retrospective cohort study.

    PubMed

    Kong, Yujia; Yang, Junjun; Jiang, Fang; Zhao, Jun; Ren, Tong; Li, Jie; Wang, Xiaoyu; Feng, Fengzhi; Wan, Xirun; Xiang, Yang

    2017-07-01

    The gestational trophoblastic neoplasia (GTN) patients with the International Federation of Gynecology and Obstetrics (FIGO) score≥12 are defined as ultra high-risk GTN. This study aims to investigate the clinical characteristics, the treatment efficiency, and the prognosis of ultra high-risk GTN patients. Between January 2002 and December 2015, medical record data of 143 GTN patients with FIGO score≥12 at Peking Union Medical College Hospital (PUMCH) were reviewed. Ratios were compared using chi-square test, and prognostic risk factors were analyzed by univariate analysis and multivariate analysis. Among the 143 ultra high-risk GTN patients, 94 (65.7%) patients had achieved complete remission and 15.9% (15/94) patients relapsed after complete remission. The 5-year overall survival (OS) rate of the entire cohort approached 67.9%. The results of the multivariate analysis revealed that non-molar antecedent pregnancy [Relative risk (RR) 4.689, 95% CI 1.448-15.189, P=0.010], brain metastases (RR 2.280, 95% CI 1.248-4.163, P=0.007), previous failed multiagent chemotherapy (RR 5.345, 95% CI 2.222-12.857, P=0.000) and surgery (RR 0.336, 95% CI 0.177-0.641, P=0.001) all had influence on the prognosis of ultra high-risk GTN patients. GTN patients with FIGO score≥12 have a poor prognosis. More emphasis should be placed on non-molar antecedent pregnancy, brain metastases, and previous multiagent chemotherapy failure. Moreover, salvage surgery may improve the prognosis. Floxuridine-based multiagent chemotherapy is effective with manageable toxicity for ultra high-risk GTN patients. Copyright © 2017. Published by Elsevier Inc.

  9. Clinical presentation, treatment and outcome of paraphenylene-diamine induced acute kidney injury following hair dye poisoning: a cohort study.

    PubMed

    Shigidi, Mazin; Mohammed, Osama; Ibrahim, Mohammed; Taha, Elshafie

    2014-01-01

    In Africa and Asia hair dye is applied together with henna to decorate the hands and feet. Paraphenylene-diamine (PPD), a highly toxic constituent of hair dye can lead to acute kidney injury (AKI). A cohort study was conducted during the period from April 2012 to March 2013 in Khartoum Teaching Hospital, Sudan. It targeted adults presenting acutely with an evident history and clinical features of hair dye poisoning, together with AKI as per the RIFLE criteria. Analysis of data was done using SPSS. 30 adults were included, their mean age was 25.6 ± 4.2 years, 93.3% were females. Exposure to PPD was suicidal in 86.7%. The mean duration to onset of renal symptoms was 34.8 ± 7.6 hours, maximum median serum creatinine was 8.6 ± 2.3 mg/dl, 86.7% had loss of kidney function as per the RIFLE classification and required dialysis. Initial renal recovery was seen after a mean duration of 9.8 ± 2.2 days. One patient died, 3.3%; all others, 96.7%, recovered normal kidney function. The amount of ingested PPD correlated significantly to the severity of symptoms, number of dialysis sessions required and time for renal recovery with P values < 0.05. Hair dye poisoning was associated with prolonged hospital stay, requirement of dialysis and increased morbidity. The severity of symptoms directly correlates to the dose of PPD ingested, with the kidney damage being reversible in almost all survivors.

  10. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial.

    PubMed

    Watanabe, Yusuke; Hayashida, Kentaro; Takayama, Morimasa; Mitsudo, Kazuaki; Nanto, Shinsuke; Takanashi, Shuichiro; Komiya, Tatsuhiko; Kuratani, Toru; Tobaru, Tetsuya; Goto, Tsuyoshi; Lefèvre, Thierry; Sawa, Yoshiki; Morice, Marie-Claude

    2015-02-01

    The efficacy and safety of transcatheter aortic valve implantation (TAVI) in Asian populations were unknown. The purpose of this study was to compare directly the clinical outcomes of the first Japanese trial and a European single-center experience after TAVI. Between April 2010 and October 2011, 64 patients were included in the PREVAIL JAPAN multicenter trial which was set up to evaluate the safety and efficacy of the Edwards SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) in high-risk Japanese patients with severe aortic stenosis. Between March 2010 and January 2012, 237 consecutive patients treated with TAVI using the Edwards SAPIEN XT™ prosthesis at Institut Cardiovasculaire Paris Sud were prospectively included in the Massy cohort. We compared the clinical outcomes of these two cohorts. Patients were of similar age (83.4±6.6 years vs. 84.5±6.1 years, p=0.25), but logistic EuroSCORE was higher in the Massy cohort (20.2±11.7% vs. 15.6±8.0%, p<0.01). Body surface area was smaller in the PREVAIL JAPAN cohort (1.41±0.14m(2) vs. 1.72±0.18m(2); p<0.01) as was the annulus diameter (20.4±1.46mm vs. 22.0±1.84mm, p<0.01). The transfemoral approach was used in 57.8% in the Japanese cohort vs. 51.5% in the Massy cohort. Device success was similar (89.1% vs. 94.1%, p=0.21, respectively), as well as 30-day and 6-month survival rates (92.2% vs. 90.7% and 89.1% vs. 83.1%, p=0.71 and p=0.25, respectively). The incidence of major vascular complications was not significantly different between the two groups (9.4% vs. 5.9%, p=0.23, respectively). A higher post-procedural mean pressure gradient was observed in the PREVAIL JAPAN cohort (12.7±11.4mmHg vs. 10.1±3.6mmHg, p=0.01), but satisfactory improvement in 6-month functional status was obtained in both cohorts (76.5% vs. 77.2%, p=0.91). Clinical outcomes after TAVI in the patients included in the PREVAIL JAPAN trial were acceptable and as safe as that of a single-center European cohort. Copyright © 2014 Japanese

  11. Appendectomy and the clinical course of ulcerative colitis: a retrospective cohort study and a nested case-control study from Korea.

    PubMed

    Lee, Ho-Su; Park, Sang Hyoung; Yang, Suk-Kyun; Kim, Seon-Ok; Soh, Jae Seung; Lee, Seohyun; Bae, Jung Ho; Lee, Hyo Jeong; Yang, Dong-Hoon; Kim, Kyung Jo; Ye, Byong Duk; Byeon, Jeong-Sik; Myung, Seung-Jae; Kim, Jin-Ho

    2015-03-01

    Appendectomy protects against the development of ulcerative colitis (UC). However, the relationship between appendectomy and the clinical course of UC is complex, and could be impacted by a number of variables. The aim of this study was to compare the clinical course of UC between appendectomized patients and nonappendectomized patients in Korea. Data on 2648 UC patients were retrieved from the Inflammatory Bowel Disease registry at Asan Medical Center. This retrospective cohort study compared the clinical course of UC in 68 patients who received an appendectomy before their UC diagnosis and 2544 patients who did not receive this procedure. A nested case-control study was also conducted to compare the disease course before and after appendectomy in 36 patients who received this surgery after UC diagnosis. To control for potential confounders, 144 matched controls were retrieved from among 2544 nonappendectomized patients In the retrospective cohort study, an appendectomy before UC diagnosis demonstrated no influence on disease extent at diagnosis, rates of medication use, proximal disease extension, or colectomy. The 10- and 20-year probabilities of receiving a colectomy were 12.7% and 20.6%, respectively, in appendectomized patients, in comparison with 8.9% and 16.4%, respectively, in nonappendectomized patients (P = 0.81). According to the nested case-control study, an appendectomy after UC diagnosis did not change the subsequent disease course in terms of medication use, proximal disease extension, or hospital admission rate. The adjusted ratio of hospital admissions after appendectomy versus before appendectomy was 1.01 (95% confidence interval = 0.46-2.23; P = 0.97). Appendectomies performed before or after UC diagnosis do not affect its clinical course in the Korean population. © 2014 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.

  12. Selection factors in cohort studies

    SciTech Connect

    Nicholson, W.J.

    1985-05-01

    Cohort studies play an important role in the quantitation of cancer risk among occupationally exposed individuals. Properly conducted cohort studies can develop important data on the age, time, and exposure dependence of cancer risk. Such information allows identification of possible selection effects which may be present and allows generalization of risk estimates to other exposure circumstances.

  13. Cohort profile: Shahroud Eye Cohort Study.

    PubMed

    Fotouhi, Akbar; Hashemi, Hassan; Shariati, Mohammad; Emamian, Mohammad Hassan; Yazdani, Kamran; Jafarzadehpur, Ebrahim; Koohian, Hassan; Khademi, Mohammad Reza; Hodjatjalali, Kamran; Kheirkhah, Ahmad; Chaman, Reza; Malihi, Sarvenaz; Mirzaii, Mehdi; Khabazkhoob, Mehdi

    2013-10-01

    The Shahroud Eye Cohort Study was set up to determine the prevalence and incidence of visual impairment and major eye conditions in the 40-64-year-old population of Shahroud as a Middle Eastern population. The first phase of the study was conducted in 2009-10. Using random cluster sampling, 6311 Shahroud inhabitants were invited for ophthalmologic examinations; of these, 5190 participants completed phase 1 (participation rate of 82.2%). All participants were interviewed to collect data on participants' demographics, occupation status, socioeconomic status, history of smoking, and medical and ophthalmic history, as well as history of medication, and the quality and duration of their insurance. DNA and plasma samples, as well as four dots of whole blood were collected from participants. Extensive optometric and ophthalmologic examinations were performed for each participant, including lensometry of current glasses, testing near and far visual acuity; determining objective and subjective refraction; eye motility; cycloplegic refraction; colour vision test; slit-lamp biomicroscopy and intraocular pressure measurement; direct and indirect fundoscopy; perimetry test; ocular biometry; corneal topography; lens and fundus photography; and the Schirmer's (1008 participants) and tear breakup time tests (1013 participants). The study data are available for collaborative research at Noor Ophthalmology Research Center, Tehran, Iran.

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

    PubMed Central

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

    2011-01-01

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

  15. Preventive health care among HIV positive women in a Utah HIV/AIDS clinic: a retrospective cohort study

    PubMed Central

    2014-01-01

    Background Despite evidence that HIV positive women may suffer higher rates of heart disease, diabetes, human papillomavirus infection, and some types of cancer, the provision of preventive health services to HIV positive women is unknown. Preventive health services recommended for such women include breast, colorectal and cervical cancer screening, sexually transmitted infection (STI) testing, vaccinations, and patient counseling on a number of issues including sexual behaviors. Methods This retrospective cohort study utilized medical record reviews of 192 HIV positive women who were patients at the University of Utah Infectious Diseases Clinic in 2009. Medical records were reviewed for all encounters during 2009 using a standardized data collection form; data were collected on patient demographics and a variety of preventive health services. Chi squared tests were used to assess receipt of preventive health services by demographic factors, and multivariable logistic regression was used to determine predictors of receiving select services. Results The most commonly recorded preventive services included blood pressure screening, screening for Hepatitis A and B, Tetanus-Diphtheria-Pertussis vaccination, Pneumococcal pneumonia vaccination, substance abuse screening, and mental health screening. STI testing and safe sex counseling were documented in the medical records of only 37% and 33.9% of women, respectively. Documentation of cancer screening was also low, with cervical cancer screening documented for 56.8% of women, mammography for 65% (N = 26/40) of women, and colorectal cancer screening for 10% (N = 4/40) of women, where indicated. In multivariable models, women with private health insurance were less likely to have documented STI testing (OR 0.20; 95% CI 0.08 - 0.52), and, Hispanic women were less likely to have documented safe-sex counseling (OR 0.26; 95% CI 0.07 - 0.94). Conclusions HIV/AIDS providers should focus on the needs of all women for

  16. Clinical Diagnosis of Mental Disorders Immediately Before and After Cancer Diagnosis: A Nationwide Matched Cohort Study in Sweden.

    PubMed

    Lu, Donghao; Andersson, Therese M L; Fall, Katja; Hultman, Christina M; Czene, Kamila; Valdimarsdóttir, Unnur; Fang, Fang

    2016-09-01

    Psychiatric comorbidities are common among patients with cancer. However, whether or not there is increased risk of mental disorders during the diagnostic workup leading to a cancer diagnosis was unknown. To examine the relative risks of depression, anxiety, substance abuse, somatoform/conversion disorder, and stress reaction/adjustment disorder during the periods before and after cancer diagnosis compared with individuals without cancer. Nationwide matched cohort study from January 1, 2001, to December 31, 2010, in a Swedish population and health registers. We estimated the time-varying hazard ratios (HRs) of the first clinical diagnosis of the studied mental disorders from 2 years before cancer diagnosis, through the time of diagnosis, and until 10 years after diagnosis, adjusting for age, sex, calendar period, and educational level. To assess milder mental conditions and symptoms, we further assessed the use of related psychiatric medications for patients with cancer diagnosed during 2008-2009. The study included 304 118 patients with cancer and 3 041 174 cancer-free individuals who were randomly selected from the Swedish population and individually matched to the patients with cancer on year of birth and sex. The median age at diagnosis for the patients with cancer was 69 years, and 46.9% of the patients were female. The relative rate for all studied mental disorders started to increase from 10 months before cancer diagnosis (HR, 1.1; 95% CI, 1.1-1.2), peaked during the first week after diagnosis (HR, 6.7; 95% CI, 6.1-7.4), and decreased rapidly thereafter but remained elevated 10 years after diagnosis (HR, 1.1; 95% CI, 1.1-1.2). The rate elevation was clear for all main cancers except nonmelanoma skin cancer and was stronger for cancers of poorer prognosis. Compared with cancer-free individuals, increased use of psychiatric medications was noted from 1 month before cancer diagnosis and peaked around 3 months after diagnosis among patients with cancer

  17. Factors That Affect Quality of Life among People Living with HIV Attending an Urban Clinic in Uganda: A Cohort Study.

    PubMed

    Mutabazi-Mwesigire, Doris; Katamba, Achilles; Martin, Faith; Seeley, Janet; Wu, Albert W

    2015-01-01

    With the availability of antiretroviral therapy (ART) and primary general care for people living with HIV (PLHIV) in resource limited settings, PLHIV are living longer, and HIV has been transformed into a chronic illness. People are diagnosed and started on treatment when they are relatively well. Although ART results in clinical improvement, the ultimate goal of treatment is full physical functioning and general well-being, with a focus on quality of life rather than clinical outcomes. However, there has been little research on the relationship of specific factors to quality of life in PLHIV. The objective of this study was to investigate factors associated with quality of life among PLHIV in Uganda receiving basic care and those on ART. We enrolled 1274 patients attending an HIV outpatient clinic into a prospective cohort study. Of these, 640 received ART. All were followed up at 3 and 6 months. Health related quality of life was assessed with the MOS-HIV Health Survey and the Global Person Generated Index (GPGI). Multivariate linear regression and logistic regression with generalized estimating equations were used to examine the relationship of social behavioral and disease factors with Physical Health Summary (PHS) score, Mental Health Summary (MHS) score, and GPGI. Among PLHIV receiving basic care, PHS was associated with: sex (p=0.045) - females had lower PHS; age in years at enrollment (p=0.0001) - older patients had lower PHS; and depression (p<0.001) - depressed patients had lower PHS. MHS was only associated with opportunistic infection (p=0.01) - presence of an opportunistic infection was associated with lower MHS. For the GPG the associated variables were age (p=0.03) - older patients had lower GPGI; education (p=0.01) - higher education associated with higher GPGI; and depression - patients with depression had a lower GPGI (p<0.001). Among patients on ART, PHS was associated with: study visit (p=0.01), with increase in time there was better PHS, and

  18. Trends in Clinically Significant Pain Prevalence Among Hospitalized Cancer Patients at an Academic Hospital in Taiwan: A Retrospective Cohort Study.

    PubMed

    Wang, Wei-Yun; Ho, Shung-Tai; Wu, Shang-Liang; Chu, Chi-Ming; Sung, Chun-Sung; Wang, Kwua-Yun; Liang, Chun-Yu

    2016-01-01

    Clinically significant pain (CSP) is one of the most common complaints among cancer patients during repeated hospitalizations, and the prevalence ranges from 24% to 86%. This study aimed to characterize the trends in CSP among cancer patients and examine the differences in the prevalence of CSP across repeated hospitalizations. A hospital-based, retrospective cohort study was conducted at an academic hospital. Patient-reported pain intensity was assessed and recorded in a nursing information system. We examined the differences in the prevalence of worst pain intensity (WPI) and last evaluated pain intensity (LPI) of ≥ 4 or ≥ 7 points among cancer inpatients from the 1st to the 18th hospitalization. Linear mixed models were used to determine the significant difference in the WPI and LPI (≥ 4 or ≥ 7 points) at each hospitalization. We examined 88,133 pain scores from the 1st to the 18th hospitalization among cancer patients. The prevalence of the 4 CSP types showed a trend toward a reduction from the 1st to the 18th hospitalization. There was a robust reduction in the CSP prevalence from the 1st to the 5th hospitalization, except in the case of LPI ≥ 7 points. The prevalence of a WPI ≥ 4 points was significantly higher (0.240-fold increase) during the 1st hospitalization than during the 5th hospitalization. For the 2nd, 3rd, and 4th hospitalizations, there was a significantly higher prevalence of a WPI ≥ 4 points compared with the 5th hospitalization. We also observed significant reductions in the prevalence of a WPI ≥ 7 points during the 1st to the 4th hospitalizations, an LPI ≥ 4 points during the 1st to the 3rd hospitalizations, and an LPI ≥ 7 points during the 1st to the 2nd hospitalization. Although the prevalence of the 4 CSP types decreased gradually, it is impossible to state the causative factors on the basis of this observational and descriptive study. The next step will examine the factors that determine the CSP prevalence among cancer

  19. Couples' voluntary counselling and testing and nevirapine use in antenatal clinics in two African capitals: a prospective cohort study

    PubMed Central

    2010-01-01

    Background With the accessibility of prevention of mother to child transmission (PMTCT) services in sub-Saharan Africa, more women are being tested for HIV in antenatal care settings. Involving partners in the counselling and testing process could help prevent horizontal and vertical transmission of HIV. This study was conducted to assess the feasibility of couples' voluntary counseling and testing (CVCT) in antenatal care and to measure compliance with PMTCT. Methods A prospective cohort study was conducted over eight months at two public antenatal clinics in Kigali, Rwanda, and Lusaka, Zambia. A convenience sample of 3625 pregnant women was enrolled. Of these, 1054 women were lost to follow up. The intervention consisted of same-day individual voluntary counselling and testing (VCT) and weekend CVCT; HIV-positive participants received nevirapine tablets. In Kigali, nevirapine syrup was provided in the labour and delivery ward; in Lusaka, nevirapine syrup was supplied in pre-measured single-dose syringes. The main outcome measures were nurse midwife-recorded deliveries and reported nevirapine use. Results In eight months, 1940 women enrolled in Kigali (984 VCT, 956 CVCT) and 1685 women enrolled in Lusaka (1022 VCT, 663 CVCT). HIV prevalence was 14% in Kigali, and 27% in Lusaka. Loss to follow up was more common in Kigali than Lusaka (33% vs. 24%, p = 0.000). In Lusaka, HIV-positive and HIV-negative women had significantly different loss-to-follow-up rates (30% vs. 22%, p = 0.002). CVCT was associated with reduced loss to follow up: in Kigali, 31% of couples versus 36% of women testing alone (p = 0.011); and in Lusaka, 22% of couples versus 25% of women testing alone (p = 0.137). Among HIV-positive women with follow up, CVCT had no impact on nevirapine use (86-89% in Kigali; 78-79% in Lusaka). Conclusions Weekend CVCT, though new, was feasible in both capital cities. The beneficial impact of CVCT on loss to follow up was significant, while nevirapine compliance was

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

    PubMed

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

    2011-09-01

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

  1. Review of Cohort Studies for Mood Disorders

    PubMed Central

    Jeon, Hong Jin; Baek, Ji Hyun; Ahn, Yong-Min; Kim, Se Joo; Ha, Tae Hyun; Cha, Boseok; Moon, Eunsoo; Kang, Hee-Ju; Ryu, Vin; Cho, Chul-Hyun; Heo, Jung-Yoon; Kim, Kiwon

    2016-01-01

    This paper aimed to review currently available cohort studies of subjects with mood disorders such as major depressive disorder (MDD) and bipolar disorder (BD). Using the PubMed and KoreaMed databases, we reviewed eight major cohort studies. Most studies recruited participants with MDD and BD separately, so direct comparison of factors associated with diagnostic changes was difficult. Regular and frequent follow-up evaluations utilizing objective mood ratings and standardized evaluation methods in a naturalistic fashion are necessary to determine detailed clinical courses of mood disorders. Further, biological samples should also be collected to incorporate clinical findings in the development of new diagnostic and therapeutic approaches. An innovative cohort study that can serve as a platform for translational research for treatment and prevention of mood disorders is critical in determining clinical, psychosocial, neurobiological and genetic factors associated with long-term courses and consequences of mood disorders in Korean patients. PMID:27247592

  2. Online video in clinical skills education of oral medication administration for undergraduate student nurses: a mixed methods, prospective cohort study.

    PubMed

    Holland, Agi; Smith, Fiona; McCrossan, Gill; Adamson, Elizabeth; Watt, Susan; Penny, Kay

    2013-06-01

    Improvements in the safety of the prescribing, dispensing and administration of medicines are identified as a priority across international healthcare systems. It is therefore essential that higher education institutions play their part in helping to meet this patient safety objective. New developments in clinical skills education which are aligned to emerging educational theory are available, but evaluations and supportive evidence are limited. To evaluate the use of an online best practice exemplar as an adjunct to the clinical skills teaching of oral medication administration to undergraduate student nurses. Mixed-methods prospective cohort design. Two intakes of undergraduate nursing students (n=168, n=154) undertaking a first year clinical skills based module at a British university. The Control group received standard teaching using lectures and skills classes facilitated by experienced clinical skills lecturers. The Intervention group received the standard teaching and unlimited access to an online video clip of medication administration. Performance and satisfaction were measured using module assessment results and a satisfaction questionnaire. Qualitative data were gathered using focus groups (n=16, n=20). The Intervention group was significantly (p=0.021) more likely to pass the assessment and rate their satisfaction with the teaching significantly higher (p<0.05) on more than half of the items from the Student Satisfaction Survey. Two Categories were identified from focus group data; Classroom Learning and Transfer to Practice. Classroom Learning included four themes of Peers, Self, Teaching and Time and when Classroom Learning was positive, the Transfer to Practice of the clinical skill was enhanced. An online video of a best practice exemplar as an adjunct to taught clinical skills sessions improves student assessment results and satisfaction ratings. The video was also reported to positively influence all themes identified in Classroom Learning and

  3. Epidemiology and clinical characteristics of sarcoidosis: an update from a population-based cohort study from Olmsted County, Minnesota.

    PubMed

    Ungprasert, P; Crowson, C S; Matteson, E L

    2017-05-22

    Information about the epidemiology, clinical manifestations and comorbidities of sarcoidosis among Caucasians is relatively scarce. This review focuses primarily on the data from a recently published Caucasianpredominant population-based cohort from Olmsted County, Minnesota. Overall, the incidence rate was 10.0 per 100,000 population, which suggested that sarcoidosis is less common in Caucasians than in Blacks, but is more common in Caucasians than in Asians. Intrathoracic involvement was seen in the vast majority of patients, but less than half have respiratory symptoms. The most common extra-thoracic manifestations were skin rash followed by arthralgia, ophthalmologic involvement, hepatic involvement, splenomegaly, renal involvement, neurological involvement, extra-thoracic lymphadenopathy, exocrine gland involvement, upper respiratory tract involvement and cardiac involvement. Compared to sex and age-matched subjects, patients with sarcoidosis suffer from increased rates of cardiovascular disease, venous thromboembolism and hospitalized infection.

  4. The TARGET cohort study protocol: a prospective primary care cohort study to derive and validate a clinical prediction rule to improve the targeting of antibiotics in children with respiratory tract illnesses

    PubMed Central

    2013-01-01

    Background Children with respiratory tract infections are the single most frequent patient group to make use of primary care health care resources. The use of antibiotics remains highly prevalent in young children, but can lead to antimicrobial resistance as well as reinforcing the idea that parents should re-consult for similar symptoms. One of the main drivers of indiscriminate antimicrobial use is the lack of evidence for, and therefore uncertainty regarding, which children are at risk of poor outcome. This paper describes the protocol for the TARGET cohort study, which aims to derive and validate a clinical prediction rule to identify children presenting to primary care with respiratory tract infections who are at risk of hospitalisation. Methods/design The TARGET cohort study is a large, multicentre prospective observational study aiming to recruit 8,300 children aged ≥3 months and <16 years presenting to primary care with a cough and respiratory tract infection symptoms from 4 study centres (Bristol, London, Oxford and Southampton). Following informed consent, symptoms, signs and demographics will be measured. In around a quarter of children from the Bristol centre, a single sweep, dual bacterial-viral throat swab will be taken and parents asked to complete a symptom diary until the child is completely well or for 28 days, whichever is sooner. A review of medical notes including clinical history, re-consultation and hospitalisations will be undertaken. Multivariable logistic regression will be used to identify the independent clinical predictors of hospitalisation as well as the prognostic significance of upper respiratory tract microbes. The clinical prediction rule will be internally validated using various methods including bootstrapping. Discussion The clinical prediction rule for hospitalisation has the potential to help identify a small group of children for hospitalisation and a much larger group where hospitalisation is very unlikely and antibiotic

  5. Association study of dysbindin gene with clinical and outcome measures in a representative cohort of Italian schizophrenic patients.

    PubMed

    Tosato, Sarah; Ruggeri, Mirella; Bonetto, Chiara; Bertani, Mariaelena; Marrella, Giovanna; Lasalvia, Antonio; Cristofalo, Doriana; Aprili, Giuseppe; Tansella, Michele; Dazzan, Paola; Diforti, Marta; Murray, Robin M; Collier, David A

    2007-07-05

    There is evidence suggesting that Dysbindin (DTNBP1) is a susceptibility gene for schizophrenia in Caucasian, Chinese, and Japanese populations. We sought to determine if dysbindin was associated with schizophrenia and its symptoms in a representative group of schizophrenic patients from a Community-Based Mental Health Service (CMHS) in Verona, Italy. A prevalence cohort of schizophrenic patients (n = 141) was assessed at baseline and then 3 and 6 years later. Eighty patients and 106 healthy controls were genotyped for polymorphisms in dysbindin. We tested if diagnosis, clinical symptoms as measured by the Brief Psychiatric Rating Scale (BPRS), and functioning as measured by the Global Assessment of Functioning Scale (GAF), were associated with the presence of certain dysbindin polymorphisms. Finally, using the longitudinal clinical data, we tested if patients carrying dysbindin high-risk haplotypes had a more unfavorable longitudinal clinical outcome. A trend towards statistical association (P = 0.058) between schizophrenia and rs2619538 was found. Using GENECOUNTING software, we found that rs2619538-P1583 (P = 0.048), P1320-P1757 (P = 0.034), and rs2619538-P1583-P1578 (P = 0.040) haplotypes occurred more often in cases compared to controls before correction for multiple testing. The rs2619538-P1583 haplotype was more likely to be transmitted to subjects with more severe and persistent psychopathology. These preliminary results are compatible with the view that DTNBP1 is a susceptibility factor for schizophrenia, and is associated with worse psychopathology.

  6. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study

    PubMed Central

    2013-01-01

    Introduction Contemporary information on mechanical ventilation (MV) use in emerging countries is limited. Moreover, most epidemiological studies on ventilatory support were carried out before significant developments, such as lung protective ventilation or broader application of non-invasive ventilation (NIV). We aimed to evaluate the clinical characteristics, outcomes and risk factors for hospital mortality and failure of NIV in patients requiring ventilatory support in Brazilian intensive care units (ICU). Methods In a multicenter, prospective, cohort study, a total of 773 adult patients admitted to 45 ICUs over a two-month period requiring invasive ventilation or NIV for more than 24 hours were evaluated. Causes of ventilatory support, prior chronic health status and physiological data were assessed. Multivariate analysis was used to identifiy variables associated with hospital mortality and NIV failure. Results Invasive MV and NIV were used as initial ventilatory support in 622 (80%) and 151 (20%) patients. Failure with subsequent intubation occurred in 54% of NIV patients. The main reasons for ventilatory support were pneumonia (27%), neurologic disorders (19%) and non-pulmonary sepsis (12%). ICU and hospital mortality rates were 34% and 42%. Using the Berlin definition, acute respiratory distress syndrome (ARDS) was diagnosed in 31% of the patients with a hospital mortality of 52%. In the multivariate analysis, age (odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01 to 1.03), comorbidities (OR, 2.30; 95% CI, 1.28 to 3.17), associated organ failures (OR, 1.12; 95% CI, 1.05 to 1.20), moderate (OR, 1.92; 95% CI, 1.10 to 3.35) to severe ARDS (OR, 2.12; 95% CI, 1.01 to 4.41), cumulative fluid balance over the first 72 h of ICU (OR, 2.44; 95% CI, 1.39 to 4.28), higher lactate (OR, 1.78; 95% CI, 1.27 to 2.50), invasive MV (OR, 2.67; 95% CI, 1.32 to 5.39) and NIV failure (OR, 3.95; 95% CI, 1.74 to 8.99) were independently associated with hospital mortality

  7. Clinical outcomes of patients requiring ventilatory support in Brazilian intensive care units: a multicenter, prospective, cohort study.

    PubMed

    Azevedo, Luciano C P; Park, Marcelo; Salluh, Jorge I F; Rea-Neto, Alvaro; Souza-Dantas, Vicente C; Varaschin, Pedro; Oliveira, Mirella C; Tierno, Paulo Fernando G M M; dal-Pizzol, Felipe; Silva, Ulysses V A; Knibel, Marcos; Nassar, Antonio P; Alves, Rossine A; Ferreira, Juliana C; Teixeira, Cassiano; Rezende, Valeria; Martinez, Amadeu; Luciano, Paula M; Schettino, Guilherme; Soares, Marcio

    2013-04-04

    Contemporary information on mechanical ventilation (MV) use in emerging countries is limited. Moreover, most epidemiological studies on ventilatory support were carried out before significant developments, such as lung protective ventilation or broader application of non-invasive ventilation (NIV). We aimed to evaluate the clinical characteristics, outcomes and risk factors for hospital mortality and failure of NIV in patients requiring ventilatory support in Brazilian intensive care units (ICU). In a multicenter, prospective, cohort study, a total of 773 adult patients admitted to 45 ICUs over a two-month period requiring invasive ventilation or NIV for more than 24 hours were evaluated. Causes of ventilatory support, prior chronic health status and physiological data were assessed. Multivariate analysis was used to identifiy variables associated with hospital mortality and NIV failure. Invasive MV and NIV were used as initial ventilatory support in 622 (80%) and 151 (20%) patients. Failure with subsequent intubation occurred in 54% of NIV patients. The main reasons for ventilatory support were pneumonia (27%), neurologic disorders (19%) and non-pulmonary sepsis (12%). ICU and hospital mortality rates were 34% and 42%. Using the Berlin definition, acute respiratory distress syndrome (ARDS) was diagnosed in 31% of the patients with a hospital mortality of 52%. In the multivariate analysis, age (odds ratio (OR), 1.03; 95% confidence interval (CI), 1.01 to 1.03), comorbidities (OR, 2.30; 95% CI, 1.28 to 3.17), associated organ failures (OR, 1.12; 95% CI, 1.05 to 1.20), moderate (OR, 1.92; 95% CI, 1.10 to 3.35) to severe ARDS (OR, 2.12; 95% CI, 1.01 to 4.41), cumulative fluid balance over the first 72 h of ICU (OR, 2.44; 95% CI, 1.39 to 4.28), higher lactate (OR, 1.78; 95% CI, 1.27 to 2.50), invasive MV (OR, 2.67; 95% CI, 1.32 to 5.39) and NIV failure (OR, 3.95; 95% CI, 1.74 to 8.99) were independently associated with hospital mortality. The predictors of NIV failure

  8. Opportunities to diagnose chronic obstructive pulmonary disease in routine care in the UK: a retrospective study of a clinical cohort.

    PubMed

    Jones, Rupert C M; Price, David; Ryan, Dermot; Sims, Erika J; von Ziegenweidt, Julie; Mascarenhas, Laurence; Burden, Anne; Halpin, David M G; Winter, Robert; Hill, Sue; Kearney, Matt; Holton, Kevin; Moger, Anne; Freeman, Daryl; Chisholm, Alison; Bateman, Eric D

    2014-04-01

    Patterns of health-care use and comorbidities present in patients in the period before diagnosis of chronic obstructive pulmonary disease (COPD) are unknown. We investigated these factors to inform future case-finding strategies. We did a retrospective analysis of a clinical cohort in the UK with data from Jan 1, 1990 to Dec 31, 2009 (General Practice Research Database and Optimum Patient Care Research Database). We assessed patients aged 40 years or older who had an electronically coded diagnosis of COPD in their primary care records and had a minimum of 3 years of continuous practice data for COPD (2 years before diagnosis up to a maximum of 20 years, and 1 year after diagnosis) and at least two prescriptions for COPD since diagnosis. We identified missed opportunites to diagnose COPD from routinely collected patient data by reviewing patterns of health-care use and comorbidities present before diagnosis. We assessed patterns of health-care use in terms of lower respiratory consultations (infective and non-infective), lower respiratory consultations with a course of antibiotics or oral steroids, and chest radiography. If these events did not lead to a diagnosis of COPD, they were deemed to be missed opportunities. This study is registered with ClinicalTrials.gov, number NCT01655667. We assessed data for 38,859 patients. Opportunities for diagnosis were missed in 32,900 (85%) of 38,859 patients in the 5 years immediately preceding diagnosis of COPD; in 12,856 (58%) of 22,286 in the 6-10 years before diagnosis, in 3943 (42%) of 9351 in the 11-15 years before diagnosis; and in 95 (8%) of 1167 in the 16-20 years before diagnosis. Between 1990 and 2009, we noted decreases in the age at diagnosis (0·05 years of age per year, 95% CI 0·03-0·07) and yearly frequency of lower respiratory prescribing consultations (rate ratio 0·982 opportunities per year, 95% CI 0·979-0·985). Prevalence of all comorbidities present at COPD diagnosis increased except for asthma and

  9. Prostate cancer incidence, clinical stage and survival in relation to obesity: a prospective cohort study in Denmark.

    PubMed

    Møller, Henrik; Roswall, Nina; Van Hemelrijck, Mieke; Larsen, Signe Benzon; Cuzick, Jack; Holmberg, Lars; Overvad, Kim; Tjønneland, Anne

    2015-04-15

    There is no clear link between obesity and prostate cancer incidence but an association has been reported between obesity and fatal prostate cancer. We report on two prospective cohort analyses on (i) the incidence of prostate cancer in relation to obesity in a cohort of men with no previous cancer, and on (ii) the stage distribution and prostate cancer specific mortality in relation to obesity among men with prostate cancer. The "Diet, Cancer and Health" prospective cohort study was established in Denmark in 1993-1997 and accrued 26,944 men aged 50-64 years. Data were extracted on height, weight, body mass index (BMI), waist circumference and body fat percentage. Information on cancer incidence and deaths were obtained by record linkage with the Danish Cancer Register and the Danish Death Register. The incidence rate of prostate cancer was similar or slightly lower in obese men compared with nonobese men, but obese men tended to be diagnosed with more advanced prostate cancer. The proportion of Stage 3-4 cancers was 37% in the lowest BMI quartile and 48% in the highest (p = 0.006). Obese men with prostate cancer had higher prostate cancer specific mortality. The hazard ratio comparing the highest and the lowest quartiles of BMI was 1.48 (95% confidence interval: 1.06-2.05; p-value for trend: 0.002). The association was attenuated but not eliminated by statistical adjustment for stage, and the data are suggestive of a stage-independent causal pathway where prostate cancer in obese men has higher fatality, even in early-stage disease. © 2014 UICC.

  10. Impact of nutritional support that does and does not meet guideline standards on clinical outcome in surgical patients at nutritional risk: a prospective cohort study.

    PubMed

    Sun, Da-Li; Li, Wei-Ming; Li, Shu-Min; Cen, Yun-Yun; Lin, Yue-Ying; Xu, Qing-Wen; Li, Yi-Jun; Sun, Yan-Bo; Qi, Yu-Xing; Yang, Ting; Lu, Qi-Ping; Xu, Peng-Yuan

    2016-08-19

    To investigate the impact of nutritional support on clinical outcomes in patients at nutritional risk who receive nutritional support that meets guideline standards and those who do not. This prospective cohort study enrolled hospitalized patients from the Second Affiliated Hospital of Kunming Medical University from February 2010 to June 2012. The research protocols were approved by the university's ethics committee, and the patients signed informed consent forms. The clinical data were collected based on nutritional risk screening, administration of enteral and parenteral nutrition, surgical information, complications, and length of hospital stay. During the study period, 525 patients at nutritional risk were enrolled in the cohorts. Among patients who received nutritional support that met the guideline standards (Cohort 1), the incidence of infectious complications was lower than that in patients who did not meet guideline standards (Cohort 2) (17.1 % vs. 26.9 %, P = 0.01). Subgroup analysis showed that individuals who received a combination of parenteral nutrition (PN) and enteral nutrition (EN) for 7 or more days had a significantly lower incidence of infectious complications (P = 0.001) than those who received only PN for 7 or more days or those who received nutritional support for less than 7 days or at less than 10 kcal/kg/d. Binary logistic regression analysis showed that, after adjusting for confounding factors, nutritional support that met guideline standards for patients with nutritional risk was a protective factor for complications (OR: 0.870, P < 0.002). In patients at nutritional risk after abdominal surgery, nutritional support that meets recommended nutrient guidelines (especially regimens involving PN + EN ≥ 7 days) might decrease the incidence of infectious complications and is worth recommending; however, well-designed trials are needed to confirm our findings. Nutritional support that does not meet the guideline standards is considered

  11. The Welsh study of mothers and babies: protocol for a population-based cohort study to investigate the clinical significance of defined ultrasound findings of uncertain significance

    PubMed Central

    2014-01-01

    Background Improvement in ultrasound imaging has led to the identification of subtle non-structural markers during the 18 – 20 week fetal anomaly scan, such as echogenic bowel, mild cerebral ventriculomegaly, renal pelvicalyceal dilatation, and nuchal thickening. These markers are estimated to occur in between 0.6% and 4.3% of pregnancies. Their clinical significance, for pregnancy outcomes or childhood morbidity, is largely unknown. The aim of this study is to estimate the prevalence of seven markers in the general obstetric population and establish a cohort of children for longer terms follow-up to assess the clinical significance of these markers. Methods/Design All women receiving antenatal care within six of seven Welsh Health Boards who had an 18 to 20 week ultrasound scan in Welsh NHS Trusts between July 2008 and March 2011 were eligible for inclusion. Data were collected on seven markers (echogenic bowel, cerebral ventriculomegaly, renal pelvicalyceal dilatation, nuchal thickening, cardiac echogenic foci, choroid plexus cysts, and short femur) at the time of 18 – 20 week fetal anomaly scan. Ultrasound records were linked to routinely collected data on pregnancy outcomes (work completed during 2012 and 2013). Images were stored and reviewed by an expert panel. The prevalence of each marker (reported and validated) will be estimated. A projected sample size of 23,000 will allow the prevalence of each marker to be estimated with the following precision: a marker with 0.50% prevalence to within 0.10%; a marker with 1.00% prevalence to within 0.13%; and a marker with 4.50% prevalence to within 0.27%. The relative risk of major congenital abnormalities, stillbirths, pre-term birth and small for gestational age, given the presence of a validated marker, will be reported. Discussion This is a large, prospective study designed to estimate the prevalence of markers in a population-based cohort of pregnant women and to investigate associations with adverse

  12. Clinical impact of malnutrition on complication rate and length of stay in elective ENT patients: a prospective cohort study.

    PubMed

    Kisser, U; Kufeldt, J; Adderson-Kisser, C; Becker, S; Baumeister, P; Reiter, M; Harréus, U; Thomas, M N; Rittler, P

    2016-08-01

    Malnutrition is considered as an independent risk factor for morbidity, mortality and a prolonged hospital stay for in-hospital patients. While most available data on the impact of malnutrition on health-related and financial implications refer to gastroenterologic or abdominal surgery patients, little is known about the impact of malnutrition on Ear Nose Throat (ENT)/head and neck surgery patients. The objective of this study was to investigate the impact of malnutrition on morbidity and length of hospital stay in an elective ENT/head and neck surgery patient cohort. The study was performed as a single-center, prospective cohort study at a tertiary referral centre. Nutritional risk at admission was assessed using the NRS-2002 screening tool. Multivariate regression models were used to determine independent risk factors for complications and a prolonged hospitalization. Three hundred fifty one participants were included in the study. A malignant disease was found in 62 participants (17.7 %). 62 patients (17.7 %) were at a moderate to severe risk of malnutrition. A bad general health condition and complications during hospital stay could be identified as independent risk factors for a prolonged hospitalization. Patients with a malignant tumor showed a more than fourfold higher risk of developing at least one complication. Malnutrition, however, was not statistically associated with a higher complication rate or a prolonged hospital stay. Our data suggests that malnutrition does not seem to play such an important role as a risk factor for complications and a prolonged hospital stay in ENT patients as it does in other disciplines like abdominal surgery or gastroenterology.

  13. Comparison of an interstitial cystitis/bladder pain syndrome clinical cohort with symptomatic community women from the RAND Interstitial Cystitis Epidemiology study.

    PubMed

    Konkle, Katy S; Berry, Sandra H; Elliott, Marc N; Hilton, Lara; Suttorp, Marika J; Clauw, Daniel J; Clemens, J Quentin

    2012-02-01

    The RAND Interstitial Cystitis Epidemiology survey estimated that 2.7% to 6.5% of United States women have urinary symptoms consistent with a diagnosis of interstitial cystitis/bladder pain syndrome. We describe the demographic and clinical characteristics of the symptomatic community based RAND Interstitial Cystitis Epidemiology cohort, and compare them with those of a clinically based interstitial cystitis/bladder pain syndrome cohort. Subjects included 3,397 community women who met the criteria for the RAND Interstitial Cystitis Epidemiology high sensitivity case definition, and 277 women with an interstitial cystitis/bladder pain syndrome diagnosis recruited from specialist practices across the United States (clinical cohort). Questions focused on demographic information, symptom severity, quality of life indicators, concomitant diagnoses and treatment. Average symptom duration for both groups was approximately 14 years. Women in the clinical cohort reported worse baseline pain and maximum pain, although the absolute differences were small. Mean Interstitial Cystitis Symptom Index scores were approximately 11 for both groups, but mean Interstitial Cystitis Problem Index scores were 9.9 and 13.2 for the clinical cohort and the RAND Interstitial Cystitis Epidemiology cohort, respectively (p <0.001). The RAND Interstitial Cystitis Epidemiology subjects were more likely to be uninsured. The RAND Interstitial Cystitis Epidemiology community cohort was remarkably similar to an interstitial cystitis/bladder pain syndrome clinical cohort with respect to demographics, symptoms and quality of life measures. In contrast to other chronic pain conditions for which clinical cohorts typically report worse symptoms and functional status than population based samples, our data suggest that many measures of symptom severity and functional impact are similar, and sometimes worse, in the RAND Interstitial Cystitis Epidemiology cohort. These findings suggest that interstitial

  14. Association of teriparatide adherence and persistence with clinical and economic outcomes in Medicare Part D recipients: a retrospective cohort study

    PubMed Central

    2013-01-01

    Background Improper medication adherence is associated with increased morbidity, healthcare costs, and fracture risk among patients with osteoporosis. The objective of this study was to evaluate the healthcare utilization patterns of Medicare Part D beneficiaries newly initiating teriparatide, and to assess the association of medication adherence and persistence with bone fracture. Methods This retrospective cohort study assessed medical and pharmacy claims of 761 Medicare members initiating teriparatide in 2008 and 2009. Baseline characteristics, healthcare use, and healthcare costs 12 and 24 months after teriparatide initiation, were summarized. Adherence, measured by Proportion of Days Covered (PDC), was categorized as high (PDC ≥ 80%), moderate (50% ≥ PDC < 80%), and low (PDC < 50%). Non-persistence was measured as refill gaps in subsequent claims longer than 60 days plus the days of supply from the previous claim. Multivariate logistic regression evaluated the association of adherence and persistence with fracture rates at 12 months. Results Within 12 months of teriparatide initiation, 21% of the cohort was highly-adherent. Low-adherent or non-persistent patients visited the ER more frequently than did their highly-adherent or persistent counterparts (χ2 = 5.01, p < 0.05 and χ2 = 5.84, p < 0.05), and had significantly lower mean pharmacy costs ($4,361 versus $13,472 and $4,757 versus $13,187, p < 0.0001). Furthermore, non-persistent patients had significantly lower total healthcare costs. The healthcare costs of highly-adherent patients were largely pharmacy-related. Similar patterns were observed in the 222 patients who had fractures at 12 months, among whom 89% of fracture-related costs were pharmacy-related. The regression models demonstrated no significant association of adherence or persistence with 12-month fractures. Six months before initiating teriparatide, 50.7% of the cohort had experienced at least 1

  15. Early pregnancy prediction of preeclampsia in nulliparous women, combining clinical risk and biomarkers: the Screening for Pregnancy Endpoints (SCOPE) international cohort study.

    PubMed

    Kenny, Louise C; Black, Michael A; Poston, Lucilla; Taylor, Rennae; Myers, Jenny E; Baker, Philip N; McCowan, Lesley M; Simpson, Nigel A B; Dekker, Gus A; Roberts, Claire T; Rodems, Kelline; Noland, Brian; Raymundo, Michael; Walker, James J; North, Robyn A

    2014-09-01

    More than half of all cases of preeclampsia occur in healthy first-time pregnant women. Our aim was to develop a method to predict those at risk by combining clinical factors and measurements of biomarkers in women recruited to the Screening for Pregnancy Endpoints (SCOPE) study of low-risk nulliparous women. Forty-seven biomarkers identified on the basis of (1) association with preeclampsia, (2) a biological role in placentation, or (3) a role in cellular mechanisms involved in the pathogenesis of preeclampsia were measured in plasma sampled at 14 to 16 weeks' gestation from 5623 women. The cohort was randomly divided into training (n=3747) and validation (n=1876) cohorts. Preeclampsia developed in 278 (4.9%) women, of whom 28 (0.5%) developed early-onset preeclampsia. The final model for the prediction of preeclampsia included placental growth factor, mean arterial pressure, and body mass index at 14 to 16 weeks' gestation, the consumption of ≥3 pieces of fruit per day, and mean uterine artery resistance index. The area under the receiver operator curve (95% confidence interval) for this model in training and validation cohorts was 0.73 (0.70-0.77) and 0.68 (0.63-0.74), respectively. A predictive model of early-onset preeclampsia included angiogenin/placental growth factor as a ratio, mean arterial pressure, any pregnancy loss <10 weeks, and mean uterine artery resistance index (area under the receiver operator curve [95% confidence interval] in training and validation cohorts, 0.89 [0.78-1.0] and 0.78 [0.58-0.99], respectively). Neither model included pregnancy-associated plasma protein A, previously reported to predict preeclampsia in populations of mixed parity and risk. In nulliparous women, combining multiple biomarkers and clinical data provided modest prediction of preeclampsia. © 2014 American Heart Association, Inc.

  16. Scaling-Up Access to Antiretroviral Therapy for Children: A Cohort Study Evaluating Care and Treatment at Mobile and Hospital-Affiliated HIV Clinics in Rural Zambia

    PubMed Central

    van Dijk, Janneke H.; Moss, William J.; Hamangaba, Francis; Munsanje, Bornface; Sutcliffe, Catherine G.

    2014-01-01

    Background Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia. Methods Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility. Results Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ) and CD4+ T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4+ T-cell percentages. Conclusions HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas. PMID:25122213

  17. Interruptions of antiretroviral therapy in children and adolescents with HIV infection in clinical practice: a retrospective cohort study in the USA

    PubMed Central

    Rakhmanina, Natella; Lam, Kam S; Hern, Jaclyn; Young, Heather A; Walters, Alex; Castel, Amanda D

    2016-01-01

    Introduction Changes in combination antiretroviral therapy (cART) throughout childhood challenge the continuity of paediatric HIV treatment. This study aimed to evaluate the prevalence of treatment interruption (TI), including lamivudine (3TC) monotherapy, and the relationship of TI to virologic and immunologic parameters in HIV-infected paediatric patients. Methods Nested within a prospective observational study of a city-wide cohort of HIV-infected persons in the District of Columbia, this sub-study collected retrospective data on antiretroviral therapy, enrolment (endpoint) and historic (lifelong) CD4 counts and HIV RNA viral load (VL) of the paediatric cohort. TI was defined as interruption of cART ≥4 consecutive weeks. Data on TI, including 3TC monotherapy TI (MTI), were collected. Descriptive statistics and univariate testing were used to compare children with TI and MTI to children on continuous treatment (CT). Results Thirty-eight (28%) out of 136 enrolled children (median age=12.9 years) experienced TI, with 14 (37%) of those placed on 3TC MTI. Significantly lower endpoint median CD4 counts (598 cells/mm3 vs. 815 cells/mm3; p=0.003) and CD4% (27.5% vs. 33%; p=0.006) were observed in the TI cohort as compared to the CT cohort. The median endpoint VL in the overall TI cohort was ~4 times higher than among the CT cohort (1427 copies/mL vs. 5581 copies/mL; p<0.0001). After a median TI duration of one year, a majority (n=31; 82%) of patients with TI restarted cART, including 100% of those with total TI and 53% of those on MTI, respectively. Conclusions In our study, we observed high frequency of the TI in HIV in paediatric HIV clinical practice. All TIs, including 3TC MTI, were associated with significantly lower endpoint median CD4 counts and higher median VLs, as compared to CT in paediatric patients. The high frequency of TI and associated poor outcomes suggest a need for a better strategy in managing the course of the paediatric and adolescent cART. PMID

  18. Veterans Aging Cohort Study (VACS)

    PubMed Central

    Justice, Amy C.; Dombrowski, Elizabeth; Conigliaro, Joseph; Fultz, Shawn L.; Gibson, Deborah; Madenwald, Tamra; Goulet, Joseph; Simberkoff, Michael; Butt, Adeel A.; Rimland, David; Rodriguez-Barradas, Maria C.; Gibert, Cynthia L.; Oursler, Kris Ann K.; Brown, Sheldon; Leaf, David A.; Goetz, Matthew B.; Bryant, Kendall

    2010-01-01

    Background The Veterans Aging Cohort Study (VACS) is a study of human immunodeficiency virus (HIV) infected and uninfected patients seen in infectious disease and general medical clinics. VACS includes the earlier 3 and 5 site studies (VACS 3 and VACS 5) as well as the ongoing 8 site study. Objectives We sought to provide background and context for analyses based upon VACS data, including study design and rationale as well as its basic protocol and the baseline characteristics of the enrolled sample. Research Design We undertook a prospectively consented multisite observational study of veterans in care with and without HIV infection. Measures Data were derived from patient and provider self report, telephone interviews, blood and DNA samples, focus groups, and full access to the national VA “paperless” electronic medical record system. Results More than 7200 veterans have been enrolled in at least one of the studies. The 8 site study (VACS) has enrolled 2979 HIV-infected and 3019 HIV-uninfected age–race–site matched comparators and has achieved stratified enrollment targets for race/ethnicity and age and 99% of its total target enrollment as of October 30, 2005. Participants in VACS are similar to other veterans receiving care within the VA. VACS participants are older and more predominantly black than those reported by the Centers for Disease Control. Conclusions VACS has assembled a rich, in-depth, and representative sample of veterans in care with and without HIV infection to conduct longitudinal analyses of questions concerning the association between alcohol use and related comorbid and AIDS-defining conditions. PMID:16849964

  19. Clinically Diagnosed Insomnia and Risk of All-Cause and Diagnosis-Specific Disability Pension: A Nationwide Cohort Study

    PubMed Central

    Alexanderson, Kristina; Kecklund, Göran; Åkerstedt, Torbjörn

    2013-01-01

    Background. Insomnia and disability pension are major health problems, but few population-based studies have examined the association between insomnia and risk of disability pension. Methods. We conducted a prospective nationwide cohort study based on Swedish population-based registers including all 5,028,922 individuals living in Sweden on December 31, 2004/2005, aged 17–64 years, and not on disability or old age pension. Those having at least one admission/specialist visit with a diagnosis of disorders of initiating and maintaining sleep (insomnias) (ICD-10: G47.0) during 2000/2001–2005 were compared to those with no such inpatient/outpatient care. All-cause and diagnosis-specific incident disability pension were followed from 2006 to 2010. Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated by Cox regression. Results. In models adjusted for prior sickness absence, sociodemographic factors, and inpatient/specialized outpatient care, associations between insomnia and increased risks of all-cause disability pension (IRR 1.35, 95% CI 1.09–1.67) and disability pension due to mental diagnoses (IRR 1.86, 95% CI 1.38–2.50) were observed. After further adjustment for insomnia medications these associations disappeared. No associations between insomnia and risk of disability pension due to cancer, circulatory, or musculoskeletal diagnoses were observed. Conclusion. Insomnia seems to be positively associated with all-cause disability pension and disability pension due to mental diagnoses. PMID:24490078

  20. Clinical Risk Factors for Head Impact During Falls in Older Adults: A Prospective Cohort Study in Long-Term Care.

    PubMed

    Yang, Yijian; Mackey, Dawn C; Liu-Ambrose, Teresa; Leung, Pet-Ming; Feldman, Fabio; Robinovitch, Stephen N

    To examine risk factors associated with head impact during falls in older adults in long-term care (LTC). Two LTC facilities in British Columbia, Canada. 160 LTC residents. Prospective cohort study. Between 2007 and 2014, we video captured 520 falls experienced by participants. Each fall video was analyzed to determine whether impact occurred to the head. Using generalized estimating equation models, we examined how head impact was associated with other fall characteristics and health status prior to the fall. Head impact occurred in 33% of falls. Individuals with mild cognitive impairment were at higher risk for head impact (odds ratio = 2.8; 95% confidence interval, 1.5-5.0) than those with more severe cognitive impairment. Impaired vision was associated with 2.0-fold (1.3-3.0) higher odds of head impact. Women were 2.2 times (1.4-3.3) more likely than men to impact their head during a fall. Head impact is common during falls in LTC, with less cognitively impaired, female residents who suffered from visual impairment, being most likely to impact their head. Future research should focus on improving our ability to detect neural consequences of head impact and evaluating the effect of interventions for reducing the risk for fall-related head injuries in LTC.

  1. Cutaneous lupus erythematosus and systemic lupus erythematosus are associated with clinically significant cardiovascular risk: a Danish nationwide cohort study.

    PubMed

    Hesselvig, J Halskou; Ahlehoff, O; Dreyer, L; Gislason, G; Kofoed, K

    2017-01-01

    Systemic lupus erythematosus (SLE) is a well-known cardiovascular risk factor. Less is known about cutaneous lupus erythematosus (CLE) and the risk of developing cardiovascular disease (CVD). Therefore, we investigated the risk of mortality and adverse cardiovascular events in patients diagnosed with SLE and CLE. We conducted a cohort study of the entire Danish population aged ≥ 18 and ≤ 100 years, followed from 1997 to 2011 by individual-level linkage of nationwide registries. Multivariable adjusted Cox regression models were used to estimate the hazard ratios (HRs) for a composite cardiovascular endpoint and all-cause mortality, for patients with SLE and CLE. A total of 3282 patients with CLE and 3747 patients with SLE were identified and compared with 5,513,739 controls. The overall HR for the composite CVD endpoint was 1.31 (95% CI 1.16-1.49) for CLE and 2.05 (95% CI 1.15-3.44) for SLE. The corresponding HRs for all-cause mortality were 1.32 (95% CI 1.20-1.45) for CLE and 2.21 (95% CI 2.03-2.41) for SLE. CLE and SLE were associated with a significantly increased risk of CVD and all-cause mortality. Local and chronic inflammation may be the driver of low-grade systemic inflammation.

  2. Periconceptional folic acid supplementation among women attending antenatal clinic in Anhui, China: data from a population-based cohort study.

    PubMed

    Xing, Xiu-Ya; Tao, Fang-Biao; Hao, Jia-Hu; Huang, Kun; Huang, Zhao-Hui; Zhu, Xiao-Ming; Xiao, Li-Min; Cheng, Dai-Juan; Su, Pu-Yu; Zhu, Peng; Xu, Yuan-Yuan; Sun, Ying

    2012-06-01

    to examine the rate of periconceptional and optimal folic acid supplementation, and to characterise their patterns and determinants among antenatal women in central China. data from 4290 women in the Anhui Birth Defects and Child Development Cohort Study recruited between October 2008 and September 2009 were analysed. seven Maternal and Child Health Centres of two cities (Hefei and Maanshan) in Anhui province of central China. women initiating prenatal care were included and asked to complete a structured questionnaire regarding folic acid supplementation. sixty-eight per cent (2905/4290) of pregnant women reported taking folic acid supplementation periconceptionally (i.e. at some point before or during early pregnancy), and 32.8% (1405/4290) and 65.2% (2797/4290) had taken it before or during early pregnancy, respectively. However, only 16.1% (690/4290) used it optimally (i.e. regularly from four weeks before pregnancy throughout four weeks after pregnancy). Use of periconceptional folic acid was significantly associated with educational level, household income, registered residence, age, gestational age at recruitment, and planning of pregnancy. optimal folic acid supplementation was relatively low. further efforts are needed to inform the population and promote the use of folic acid supplementation. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. Development and validation of a clinical score for prognosis stratification in patients requiring antiretroviral therapy in sub-Saharan Africa: a prospective open cohort study

    PubMed Central

    Gerardo, Rivero; Dayana, Pérez

    2011-01-01

    Background Mortality rates among patients initiating antiretroviral therapy (ART) in sub-Saharan Africa continue high. Also HIV treatment services from the region are affronting the challenges of been attending more patients than never. In this scenario, there are no integrated scoring systems capable of an adequate risk identification/ prognostic stratification among patients requiring ART; in order of optimize actual programmes outcomes. Several independent risk factors at baseline are associated with a poor prognosis after ART initiation. These include: male sex, low body mass index, anemia, low CD4 count and stage-4 WHO disease. The aim of this research was evaluate prospectively a new scoring system composed by these factors. Methods An open cohort study was conducted in 1769 patients from May 2008 to December 2010 at two HIV clinics of Zimbabwe. A new clinical model (MASIB score) was applied at ART initiation and patients were followed for 4 months. After that, validation characteristics of the score were examined. Results Patients selected in this cohort exhibited similar baseline characteristics that the patients selected in previous cohorts from the region. Overall performance for mortality prediction of MASIB score was accurate, as reflected by the Brier score test result 0.084 (95%CI: 0.080–0.088). Calibration was adequate taking in consideration a p>0.05 in the Hosmer Lemeshow test and discrimination was also good (Area Under Curve: 0.915, 95%CI: 0,901– 0,928). Conclusion The new model developed exhibited adequate validation characteristics supporting the clinical use. Further evaluations of this model in others scenarios from the sub-Saharan region are needed. PMID:22187587

  4. Communication Barriers and the Clinical Recognition of Diabetic Peripheral Neuropathy in a Diverse Cohort of Adults: The DISTANCE Study

    PubMed Central

    Adams, Alyce S.; Parker, Melissa M.; Moffet, Howard H.; Jaffe, Marc; Schillinger, Dean; Callaghan, Brian; Piette, John; Adler, Nancy E.; Bauer, Amy; Karter, Andrew J.

    2016-01-01

    Objective The purpose of this study was to explore communication barriers as independent predictors and potential mediators of variation in clinical recognition of diabetic peripheral neuropathy (DPN). Methods In this cross-sectional analysis, we estimated the likelihood of having a DPN diagnosis among 4,436 patients with DPN symptoms. We controlled for symptom frequency, demographic and clinical characteristics, and visit frequency using a modified Poisson regression model. We then evaluated 4 communication barriers as independent predictors of clinical documentation and as possible mediators of racial/ethnic differences: difficulty speaking English, not talking to one’s doctor about pain, limited health literacy, and reports of suboptimal patient-provider communication. Results Difficulty speaking English and not talking with one’s doctor about pain were independently associated with not having a diagnosis, though limited health literacy and suboptimal patient-provider communication were not. Limited English proficiency partially attenuated, but did not fully explain, racial/ethnic differences in clinical documentation among Chinese, Latino and Filipino patients. Conclusions Providers should be encouraged to talk with their patients about DPN symptoms, and health systems should consider enhancing strategies to improve timely clinical recognition of DPN among patients who have difficult speaking English. More work is needed to understand persistent race/ethnic differences in diagnosis. PMID:27116591

  5. Asthma-like Features and Clinical Course of Chronic Obstructive Pulmonary Disease. An Analysis from the Hokkaido COPD Cohort Study.

    PubMed

    Suzuki, Masaru; Makita, Hironi; Konno, Satoshi; Shimizu, Kaoruko; Kimura, Hiroki; Kimura, Hirokazu; Nishimura, Masaharu

    2016-12-01

    Some patients with chronic obstructive pulmonary disease (COPD) have asthma-like features, such as significant bronchodilator reversibility, blood eosinophilia, and/or atopy, even if they are not clinically diagnosed as having asthma. However, the clinical significance of asthma-like features overlapping with COPD remains unclear. The aim of this study was to assess the effect of asthma-like features on the clinical course of patients with COPD who were adequately treated and followed-up over 10 years. A total of 268 patients with COPD who had been clinically considered as not having asthma by respiratory specialists were included in this study. The asthma-like features included in this study were bronchodilator reversibility (ΔFEV1, ≥12% and ≥200 ml), blood eosinophilia (≥300 cells/μl), and atopy (positive specific IgE for any inhaled antigen). The annual changes in post-bronchodilator FEV1 and COPD exacerbations were monitored during the first 5 years, and mortality was followed during the entire 10 years of the study. Fifty-seven subjects (21%) had bronchodilator reversibility, 52 (19%) had blood eosinophilia, and 67 (25%) had atopy. Subjects with blood eosinophilia had significantly slower annual post-bronchodilator FEV1 decline; bronchodilator reversibility and atopy did not affect the annual post-bronchodilator FEV1 decline, and none of the asthma-like features was associated with development of COPD exacerbation. Even if subjects had two or more asthma-like features, they displayed annual post-bronchodilator FEV1 declines and exacerbation rates similar to those of subjects with one or zero asthma-like features, as well as a lower 10-year mortality rate (P = 0.02). The presence of asthma-like features was associated with better clinical course in patients with COPD receiving appropriate treatment.

  6. PROMIS — Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer☆

    PubMed Central

    El-Shater Bosaily, A.; Parker, C.; Brown, L.C.; Gabe, R.; Hindley, R.G.; Kaplan, R.; Emberton, M.; Ahmed, H.U.

    2015-01-01

    Background Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway. Methods PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10–12 core TRUS-biopsy (standard) and 5 mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others. Results PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated. Conclusions PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer. PMID:25749312

  7. Pre-cART Elevation of CRP and CD4+ T-Cell Immune Activation Associated With HIV Clinical Progression in a Multinational Case-Cohort Study.

    PubMed

    Balagopal, Ashwin; Asmuth, David M; Yang, Wei-Teng; Campbell, Thomas B; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R; Lalloo, Umesh G; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B; Semba, Richard D; Thomas, David L; Bollinger, Robert C; Gupta, Amita

    2015-10-01

    Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore, some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. A case-cohort study (n = 470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings clinical trial (1571 HIV treatment-naive adults who initiated cART; CD4 T-cell count <300 cells/mm; 9 countries) was conducted. A subcohort of 30 participants per country was randomly selected; additional cases were added from the main cohort. Cases [n = 236 (random subcohort 36; main cohort 200)] had clinical progression (incident WHO stage 3/4 event or death) within 96 weeks after cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4 T-cell count was 167 cells per cubic millimeter. In multivariate analysis, highest quartile C-reactive protein concentration [adjusted hazard ratio (aHR), 2.53; 95% confidence interval (CI): 1.02 to 6.28] and CD4 T-cell activation (aHR, 5.18; 95% CI: 1.09 to 24.47) were associated with primary outcomes, compared with lowest quartiles. sCD14 had a trend toward association with clinical failure (aHR, 2.24; 95% CI: 0.96 to 5.21). Measuring C-reactive protein and CD4 T-cell activation may identify patients with CD4 T-cell counts <300 cells per cubic millimeter at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART.

  8. Retrospective cohort study on risk factors for development of gestational diabetes among mothers attending antenatal clinics in Nairobi County

    PubMed Central

    Adoyo, Maureen Atieno; Mbakaya, Charles; Nyambati, Venny; Kombe, Yeri

    2016-01-01

    Introduction World Health Organization estimates that deaths resulting from diabetes will rise above 50% by the year 2020; hence urgent action is needed to reverse the trend notably through nutrition and lifestyle intervention among populations at risks. Studies have established that nutritional environment and physiology of the mother affects neonate's health at infancy and later in life thus this study sought to investigate the risk factors for development of gestational diabetes focusing age, weight, family history and pre-existing medical condition which could be modified to improve population health. Methods A retrospective cohort study design was used. Subjects were sampled from selected maternity facilities in Nairobi and were subjected to oral glucose test to ascertain Gestational Diabetes mellitus (GDM) status. A questionnaire was administered to a sample of 238 respondents. Quantitative data was then analyzed as descriptive statistic, univariate and multivariate regression. Results Average age for mothers with GDM was high with a mean of 33.06 (95% C.I: 31.59-34.52) compared to a mean of 27.9 (95% C.I: 27.01-28.78) for non-GDM mothers. Weight before pregnancy was high with mean of 74.04 (95% C.I: 70.82-77.30) among mothers with GDM compared to mean of 60.27 (95% C.I:58.59-61.96) among non-GDM mothers. Mothers with diabetic history in the family had twice the risk of developing GDM (OR= 2.27; 95% C.I: 1.23-4.17) compared to those who did not observe diabetic history in the family. Conclusion Gestational diabetes cases are relatively high. Age advancement; high weight and diabetic history in family are determining factors for development of diabetes among pregnant women. PMID:27795753

  9. Validity of a self-reported diagnosis of depression among participants in a cohort study using the Structured Clinical Interview for DSM-IV (SCID-I)

    PubMed Central

    Sanchez-Villegas, Almudena; Schlatter, Javier; Ortuno, Felipe; Lahortiga, Francisca; Pla, Jorge; Benito, Silvia; Martinez-Gonzalez, Miguel A

    2008-01-01

    Background Depression assessment in population studies is usually based on depressive symptoms scales. However, the use of scales could lead to the choice of an arbitrary cut-off point depending on the sample characteristics and on the patient diagnosis. Thus, the use of a medical diagnosis of depression could be a more appropriate approach. Objective To validate a self-reported physician diagnosis of depression using the Structured Clinical Interview for DSM-IV (SCID-I) as Gold Standard and to assess the factors associated to a valid self-reported diagnosis. Methods The SUN Project is a cohort study based on university graduates followed-up through postal questionnaires. The response to the question included in the questionnaire: Have you ever been diagnosed of depression by a physician? was compared to that obtained through the SCID-I applied by a psychiatrist or a clinical psychologist. The percentages of confirmed depression and non-depression were assessed for the overall sample and according to several characteristics. Logistic regression models were fitted to ascertain the association between different factors and a correct classification regarding depression status. Results The percentage of confirmed depression was 74.2%; 95% confidence interval (95% CI) = 63.3–85.1. Out of 42 participants who did not report a depression diagnosis in the questionnaire, 34 were free of the disease (%confirmed non-depression = 81.1%; 95% CI = 69.1–92.9). The probability of being a true positive was higher among ex-smokers and non-smokers and among those overweight or obese but the differences were not statistically significant. Conclusion The validity of a self-reported diagnosis of depression in the SUN cohort is adequate. Thus, this question about depression diagnosis could be used in further investigations regarding this disease in this graduate cohort study. PMID:18558014

  10. Establishment of a predominantly African-American cohort for the study of Alzheimer's disease: the South Carolina Alzheimer's disease clinical core.

    PubMed

    Bachman, David L; Stuckey, Marilyn; Ebeling, Myla; Wagner, Mark T; Evans, W James; Hirth, Victor; Walker, Aljoeson; Memon, Mohammed; Joglekar, Rajiv; Faison, Warachal; Mintzer, Jacobo E

    2009-01-01

    The recruitment of culturally diverse subject populations into research studies, particularly African-Americans (AA), has been the focus of intense interest by many groups. In this paper, we present the methodology utilized to create a predominantly AA cohort for the longitudinal study of risk factors in Alzheimer's disease (AD). The underlying strategy was that of identifying geographically diverse clinical venues within South Carolina (SC) where large numbers of AA patients already come to seek medical care. This strategy was successful, although recruitment rates for AA subjects (43.4%) still fell below those for white subjects (70.3%; p = 0.0025). Subject characteristics of AA subjects that chose to enroll were not substantially different from those that declined to participate. The demographic characteristics of this cohort were largely similar to those of the SC Alzheimer Disease Registry, a population-based database. The problems of standardization of subject recruitment and assessment across diverse clinical venues are also addressed. The utilization of geographically diverse sites for research recruitment where minorities already receive medical care is one practical solution to the problem of minority participation in research. Multi-site recruitment to improve minority recruitment can be accomplished with acceptable standardization and inter-rater reliability.

  11. Effect of HIV-1 and increasing immunosuppression on malaria parasitaemia and clinical episodes in adults in rural Uganda: a cohort study.

    PubMed

    Whitworth, J; Morgan, D; Quigley, M; Smith, A; Mayanja, B; Eotu, H; Omoding, N; Okongo, M; Malamba, S; Ojwiya, A

    2000-09-23

    An association between HIV-1 and malaria is expected in theory, but has not been convincingly shown in practice. We studied the effects of HIV-1 infection and advancing immunosuppression on falciparum parasitaemia and clinical malaria. HIV-1-positive and HIV-1-negative adults selected from a population-based cohort in rural Uganda were invited to attend a clinic every 3 months (routine visits) and whenever they were sick (interim visits). At each visit, information was collected on recent fever, body temperature, and malaria parasites. Participants were assigned a clinical stage at each routine visit and had regular CD4-cell measurements. 484 participants made 7220 routine clinic visits between 1990 and 1998. Parasitaemia was more common at visits by HIV-1-positive individuals (328 of 2788 [11.8%] vs 231 of 3688 [6.3%], p<0.0001). At HIV-1-positive visits, lower CD4-cell counts were associated with higher parasite densities, compared with HIV-1-negative visits (p=0.0076). Clinical malaria was significantly more common at HIV-1-positive visits (55 of 2788 [2.0%] vs 26 of 3688 [0.7%], p=0.0003) and the odds of having clinical malaria increased with falling CD4-cell count (p=0.0002) and advancing clinical stage (p=0.0024). Participants made 3377 interim visits. The risk of clinical malaria was significantly higher at visits by HIV-1-positive individuals than HIV-1-negative individuals (4.0% vs 1.9%, p=0.009). The risk of clinical malaria tended to increase with falling CD4-cell counts (p=0.052). HIV-1 infection is associated with an increased frequency of clinical malaria and parasitaemia. This association tends to become more pronounced with advancing immunosuppression, and could have important public-health implications for sub-Saharan Africa.

  12. Female stress urinary incontinence: clinical efficacy and satisfaction after transobturator adjustable tape sling. An observational longitudinal cohort study.

    PubMed

    Patrelli, Tito Silvio; Gizzo, Salvatore; Noventa, Marco; Dall'Asta, Andrea; Musarò, Andrea; Faioli, Raffaele; Zanni, Giuliano Carlo; Piantelli, Giovanni; Lukanovic, Adolf; Bacchi Modena, Alberto; Berretta, Roberto

    2015-04-01

    We performed an observational longitudinal cohort study on patients affected by stress urinary incontinence (SUI) and surgically treated with a transobturator adjustable tape sling (TOA) in order to evaluate this surgical procedure in terms of efficacy, safety, quality of life (QoL) improvement, and patient satisfaction. For all patients, we recorded: general features, preoperative SUI risk factors, obstetrics history, preoperative urodynamic tests, intraoperative/postoperative complications, number of postoperative sling regulations, postmicturition residue, and hospital stay. All patients were asked to complete the validated short version of the Urogenital Distress Inventory (UDI-6) questionnaire 18 months after discharge to evaluate the efficacy of the TOA system. We added 2 adjunctive items to the UDI-6 in order to evaluate patient satisfaction and QoL. All 77 surgical procedures were performed under locoregional anesthesia without complications. Postoperative TOA regulations were performed in 46.8% of patients immediately after the procedure and in 14.3% during hospitalization. Before discharge, postmicturition residue was negative in 67 cases and less than 50 cc in 10 cases. Mean hospital stay was 2.18 days. From the questionnaire evaluation, we found that after the procedure, 90.9% of patients showed a complete regression of urinary symptoms, 1.3% obtained considerable relief from preoperative symptoms, and 6.6% reported poor or absent symptom improvements; 75.3% of patients were totally satisfied and 5.2% totally disappointed. The possibility of modulating postoperative sling tension and reusing the surgical materials in association with short hospitalization as well as high patient satisfaction render TOA a safe, effective, and low-cost technique for the treatment of female SUI.

  13. Prevalence and long-term clinical significance of intracranial atherosclerosis after ischaemic stroke or transient ischaemic attack: a cohort study

    PubMed Central

    Ovesen, Christian; Abild, Annemette; Christensen, Anders Fogh; Rosenbaum, Sverre; Hansen, Christine Krarup; Havsteen, Inger; Nielsen, Jens Kellberg; Christensen, Hanne

    2013-01-01

    Objectives We investigated the prevalence and long-term risk associated with intracranial atherosclerosis identified during routine evaluation. Design This study presents data from a prospective cohort of patients admitted to our stroke unit for thrombolysis evaluation. Setting and participants We included 652 with a final diagnosis of ischaemic stroke or transient ischaemic attack (TIA) from April 2009 to December 2011. All patients were acutely evaluated with cerebral CT and CT angiography (CTA). Acute radiological examinations were screened for intracranial arterial stenosis (IAS) or intracranial arterial calcifications (IAC). Intracranial stenosis was grouped into 30–50%, 50–70% and >70% lumen reduction. The extent of IAC was graded as number of vessels affected. Primary and secondary outcome measure Patients were followed until July 2013. Recurrence of an ischaemic event (stroke, ischaemic heart disease (IHD) and TIA) was documented through the national chart system. Poor outcome was defined as death or recurrence of ischaemic event. Results 101 (15.5%) patients showed IAS (70: 30–50%, 29: 50–70% and 16: >70%). Two-hundred and fifteen (33%) patients had no IAC, 339 (52%) in 1–2 vessels and 102 (16%) in >2 vessels. During follow-up, 53 strokes, 20 TIA and 14 IHD occurred, and 95 patients died. The risk of poor outcome was significantly different among different extents of IAS as well as IAC (log-rank test p<0.01 for both). In unadjusted analysis IAS and IAC predicted poor outcome and recurrent ischaemic event. When adjusted, IAS and IAC independently increased the risk of a recurrent ischaemic event (IAS: HR 1.67; CI 1.04 to 2.64 and IAC: HR 1.22; CI 1.02 to 1.47). Conclusions Intracranial atherosclerosis detected during acute evaluation predicts an increased risk of recurrent stroke. PMID:24148214

  14. Care Needs and Clinical Outcomes of Older People with Dementia: A Population-Based Propensity Score-Matched Cohort Study

    PubMed Central

    Hsiao, Fei-Yuan; Peng, Li-Ning; Wen, Yu-Wen; Liang, Chih-Kuang; Wang, Pei-Ning; Chen, Liang-Kung

    2015-01-01

    Objective To explore the healthcare resource utilization, psychotropic drug use and mortality of older people with dementia. Design A nationwide propensity score-matched cohort study. Setting National Health Insurance Research database. Participants A total of 32,649 elderly people with dementia and their propensity-score matched controls (n=32,649). Measurements Outpatient visits, inpatient care, psychotropic drug use, in-hospital mortality and all-cause mortality at 90 and 365 days. Results Compared to the non-dementia group, a higher proportion of patients with dementia used inpatient services (1 year after index date: 20.91% vs. 9.55%), and the dementia group had more outpatient visits (median [standard deviation]: 7.00 [8.87] vs. 3.00 [8.30]). Furthermore, dementia cases with acute admission had the highest psychotropic drug utilization both at baseline and at the post-index dates (difference-in-differences: all <0.001). Dementia was associated with an increased risk of all-cause mortality (90 days, Odds ratio (OR)=1.85 [95%CI 1.67-2.05], p<0.001; 365 days, OR=1.59 [1.50-1.69], p<0.001) and in-hospital mortality (90 days, OR=1.97 [1.71-2.27], p<0.001; 365 days, OR=1.82 [1.61-2.05], p<0.001) compared to matched controls. Conclusions When older people with dementia are admitted for acute illnesses, they may increase their use of psychotropic agents and their risk of death, particularly in-hospital mortality. PMID:25955163

  15. Trends in virological and clinical outcomes in individuals with HIV-1 infection and virological failure of drugs from three antiretroviral drug classes: a cohort study.

    PubMed

    Costagliola, Dominique; Lodwick, Rebecca; Ledergerber, Bruno; Torti, Carlo; van Sighem, Ard; Podzamczer, Daniel; Mocroft, Amanda; Dorrucci, Maria; Masquelier, Bernard; de Luca, Andrea; Jansen, Klaus; De Wit, Stephane; Obel, Niels; Fätkenheuer, Gerd; Touoloumi, Giota; Mussini, Cristina; Castagna, Antonella; Stephan, Cristoph; García, Federico; Zangerle, Robert; Duval, Xavier; Pérez-Hoyos, Santiago; Meyer, Laurence; Ghosn, Jade; Fabre-Colin, Céline; Kjaer, Jesper; Chene, Genevieve; Grarup, Jesper; Phillips, Andrew

    2012-02-01

    Limited treatment options have been available for people with HIV who have had virological failure of the three original classes of HIV antiretroviral drugs-so-called triple-class virological failure (TCVF). However, introduction of new drugs and drug classes might have improved outcomes. We aimed to assess trends in virological and clinical outcomes for individuals with TCVF in 2000-09. In our cohort study, we analysed data for adults starting antiretroviral therapy from 1998 in cohorts participating in the PLATO II project, which is part of COHERE, a collaboration of European cohorts. TCVF was defined as virological failure to at least two nucleoside reverse transcriptase inhibitors, one non-nucleoside reverse-transcriptase inhibitor, and one ritonavir-boosted protease inhibitor, with virological failure of a drug defined as one viral-load measurement of greater than 500 copies per mL after at least 4 months of continuous use. We used multivariable generalised estimating equation logistic models and Poisson regression models to study trends in virological suppression and incidence of AIDS or death after TCVF. We adjusted for sex, transmission group, age, AIDS status, CD4 cell count, plasma viral loads at TCVF, achievement of virological response (<50 copies per mL), and number of drug failures before TCVF. 28 of 33 cohorts in COHERE contributed data to the PLATO II project, of which four had no participants eligible for inclusion in this study. 2476 (3%) of 91 764 participants from the remaining 24 cohorts had TCVF and at least one viral load measurement in 2000-09. The proportion of patients with virological response after TCVF increased from 19·5% in 2000 to 57·9% in 2009 (adjusted p<0·0001). Incidence of AIDS decreased from 7·7 per 100 person-years in 2000-02 to 2·3 in 2008 and 1·2 in 2009 (adjusted p<0·0001). Mortality decreased from 4·0 per 100 person-years between 2000 and 2002 to 1·9 in 2007 and 1·4 in 2008 (unadjusted p=0·023), but the trend

  16. Relationship between clinical classification of chronic venous disease and patient-reported quality of life: results from an international cohort study.

    PubMed

    Kahn, Susan R; M'lan, Cyr E; Lamping, Donna L; Kurz, Xavier; Bérard, Anick; Abenhaim, Lucien A

    2004-04-01

    The CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical classification for chronic venous disease (CVD) is based on physician-evaluated clinical signs of CVD. The relationship between CEAP clinical classification and patient-perceived quality of life (QOL) has not been evaluated, but is important for the selection and interpretation of outcomes in clinical studies of patients with CVD. The purpose of this study was to evaluate whether CVD, as classified with CEAP, is related to patient-reported QOL, and to identify patient characteristics associated with CEAP class and QOL that need to be considered when interpreting outcomes in CVD. The Venous Insufficiency Epidemiologic and Economic Study (VEINES) population is an international cohort of 1531 patients with CVD recruited in Belgium, France, Italy, and Canada. At the baseline visit patients were categorized into one of seven CEAP clinical categories on the basis of a clinical examination, and completed standardized generic (Short-Form Health Survey, 36 items [SF-36]) and venous disease-specific (QOL [VEINES-QOL] and symptom severity [VEINES-Sym]) QOL questionnaires. Multivariate analyses were used to examine the relationship between CEAP class and QOL. The proportion of patients in the seven CEAP classes (class 0-6) was 3.8%, 13.3%, 24.1%, 12.8%, 36.4%, 7.3%, and 2.3%, respectively. In univariate analyses, SF-36 Physical Component Summary scores and VEINES-QOL and VEINES-Sym scores decreased significantly (ie, poorer QOL) with increasing CEAP class. Multivariate analyses controlling for age, sex, country, education, body mass index, years since CVD onset and comorbid conditions confirmed findings for VEINES-QOL and VEINES-Sym (P<.0001 and P<.0001, respectively). Physician-evaluated clinical category, based on the CEAP classification, predicts patient-reported QOL and symptom severity in CVD.

  17. Prospective cohort study of clinical characteristics and management patterns for patients with non-small-cell lung cancer in the Russian Federation: EPICLIN-Lung.

    PubMed

    Tjulandin, S; Imyanitov, E; Moiseyenko, V; Ponomarenko, D; Gurina, L; Koroleva, I; Karaseva, V

    2015-06-01

    Lung cancer is a major cause of mortality in Russia. This study aimed to document the characteristics, clinical management, EGFR mutation status and outcomes of patients with non-small-cell lung cancer (NSCLC) throughout the Russian Federation to inform future management decisions. This non-interventional, prospective cohort study (clinicaltrials.gov NCT01069835) was conducted at 33 sites across the Russian Federation. Patients with confirmed NSCLC were enrolled and followed for up to 12 months or until death. Investigators collected information on patient and disease characteristics, diagnosis and treatment patterns, clinical outcomes and adverse events (AEs). A logistic regression model was used to evaluate characteristics affecting tumor EGFR mutation status. Data were analyzed from 838 patients. Most (78.4%) were male and Caucasian (98%), mean age was 58.7 years and 26.5% were never-smokers. Squamous-cell carcinoma (54.3%) was the most prevalent histology, followed by adenocarcinoma (31%). Most patients presented with advanced disease (23.7% with stage IIIA, 14.1% with stage IIIB, 25.4% with stage IV) and 10.1% of patients had EGFR-mutation-positive tumors. EGFR mutation was significantly associated with female gender, never smoking, age and adenocarcinoma histology. First- or second-line chemotherapy had been performed in 370 and 96 patients, respectively, and median progression-free survival was 35 and 19.4 weeks, respectively. For 813 patients, 194 AEs were reported at visit 1. A median of two AEs was reported for patients who had at least one AE. Study limitations include potential site selection bias, short observation period, small sample size and inclusion of fewer than average stage III-IV patients. This study contributes to a better understanding of prognostic and predictive factors of NSCLC in the Russian Federation, which will enable optimal treatment selection in future clinical practice. Epidemiology of EGFR mutations in this NSCLC cohort was

  18. Clinical characteristics, sepsis interventions and outcomes in the obese patients with septic shock: an international multicenter cohort study

    PubMed Central

    2013-01-01

    Introduction Data are sparse as to whether obesity influences the risk of death in critically ill patients with septic shock. We sought to examine the possible impact of obesity, as assessed by body mass index (BMI), on hospital mortality in septic shock patients. Methods We performed a nested cohort study within a retrospective database of patients with septic shock conducted in 28 medical centers in Canada, United States and Saudi Arabia between 1996 and 2008. Patients were classified according to the World Health Organization criteria for BMI. Multivariate logistic regression analysis was performed to evaluate the association between obesity and hospital mortality. Results Of the 8,670 patients with septic shock, 2,882 (33.2%) had height and weight data recorded at ICU admission and constituted the study group. Obese patients were more likely to have skin and soft tissue infections and less likely to have pneumonia with predominantly Gram-positive microorganisms. Crystalloid and colloid resuscitation fluids in the first six hours were given at significantly lower volumes per kg in the obese and very obese patients compared to underweight and normal weight patients (for crystalloids: 55.0 ± 40.1 ml/kg for underweight, 43.2 ± 33.4 for normal BMI, 37.1 ± 30.8 for obese and 27.7 ± 22.0 for very obese). Antimicrobial doses per kg were also different among BMI groups. Crude analysis showed that obese and very obese patients had lower hospital mortality compared to normal weight patients (odds ratio (OR) 0.80, 95% confidence interval (CI) 0.66 to 0.97 for obese and OR 0.61, 95% CI 0.44 to 0.85 for very obese patients). After adjusting for baseline characteristics and sepsis interventions, the association became non-significant (OR 0.80, 95% CI 0.62 to 1.02 for obese and OR 0.69, 95% CI 0.45 to 1.04 for very obese). Conclusions The obesity paradox (lower mortality in the obese) documented in other populations is also observed in septic shock. This may be related in

  19. Toxicity and clinical outcomes in patients with HIV on zidovudine and tenofovir based regimens: a retrospective cohort study

    PubMed Central

    Thuppal, Sowmyanarayanan V.; Wanke, Christine A.; Noubary, Farzad; Cohen, Joshua T.; Mwamburi, Mkaya; Ooriapdickal, Abraham C.; Muliyil, Jayaprakash; Kang, Gagandeep; Varghese, George M.; Rupali, Priscilla; Karthik, Rajiv; Sathasivam, Rajkumar; Clarance, Peace; Pulimood, Susanne A.; Peter, Dincy; George, Leni

    2015-01-01

    Background Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. The less toxic tenofovir regimen is an alternative, but is seldom considered due to the higher costs. This study compared adverse drug reactions and other clinical outcomes resulting from the use of these two treatment regimens in India. Methods Baseline, clinical characteristics and follow-up outcomes were collected by chart reviews of HIV-positive adults and compared using univariate/multivariate analysis, with and without propensity score adjustments. Results Data were collected from 129 and 92 patients on zidovudine (with lamivudine and nevirapine) and tenofovir (with emtricitabine and efavirenz) regimens, respectively. Compared to patients receiving the zidovudine regimen, patients receiving the tenofovir regimen had fewer adverse drug reactions (47%, 61/129 vs 11%, 10/92; p<0.01), requiring fewer regimen changes (36%, 47/129 vs 3%, 3/92; p0.01). With the propensity score, the zidovudine regimen had 8 times more adverse drug reactions (p<0.01). Opportunistic infections were similar between regimens without propensity score, while the zidovudine regimen had 1.2 times (p=0.63) more opportunistic infections with propensity score. Patients on the tenofovir regimen gained more weight. Increase in CD4 levels and treatment adherence (>95%) was similar across regimens. Conclusions Patients on a tenofovir regimen have better clinical outcomes and improved general health than patients on the zidovudine regimen. PMID:25778734

  20. Using mobile phones to improve clinic attendance amongst an antiretroviral treatment cohort in rural Uganda: a cross-sectional and prospective study.

    PubMed

    Kunutsor, Setor; Walley, John; Katabira, Elly; Muchuro, Simon; Balidawa, Hudson; Namagala, Elizabeth; Ikoona, Eric

    2010-12-01

    We aimed to assess the patterns and dynamics of mobile phone usage amongst an antiretroviral treatment (ART) cohort in rural Uganda and ascertain its feasibility for improving clinic attendance. A cross-sectional study of clients on ART exploring their access to mobile phones and patterns of use was employed. Clinic attendances for antiretroviral drug refills were then monitored prospectively over 28 weeks in 176 patients identified in the cross-sectional survey who had access to mobile phones and had given consent to be contacted. Patients were contacted via voice calls or text messages to remind them about their missed clinic appointments. Of the 276 patients surveyed, 177 (64%) had access to mobile phones with all but one were willing to be contacted for missed visits reminders. Of the 560 total scheduled clinic appointments, 62 (11%) were missed visits. In 79% of episodes in which visits were missed, patients presented for treatment within a mean duration of 2.2 days (SD = 1.2 days) after mobile phone recall. Access to mobile phones was high in this setting. Privacy and confidentiality issues were not considered deterrents. Mobile phones have a potential for use in resource-constrained settings to substantially improve the clinical management of HIV/AIDS.

  1. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    PubMed

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  2. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART).

    PubMed

    Mata, Nelva; Alonso, Rodrigo; Badimón, Lina; Padró, Teresa; Fuentes, Francisco; Muñiz, Ovidio; Perez-Jiménez, Francisco; López-Miranda, José; Díaz, Jose L; Vidal, Jose I; Barba, A; Piedecausa, Mar; Sanchez, Juan F; Irigoyen, Luis; Guallar, Eliseo; Ordovas, José M; Mata, Pedro

    2011-06-10

    Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (LLT) in FH patients recruited in SAFEHEART. A cross-sectional analysis of cases recruited in the Spanish FH cohort at inclusion was performed. Demographic, lifestyle, medical and therapeutic data were collected by specific surveys. Blood samples for lipid profile and DNA were obtained. Genetic test for FH was performed through DNA-microarray. Data from 1852 subjects (47.5% males) over 19 years old were analyzed: 1262 (68.1%, mean age 45.6 years) had genetic diagnosis of FH and 590 (31.9%, mean age 41.3 years) were non-FH. Cardiovascular disease was present in 14% of FH and in 3.2% of non-FH subjects (P < 0.001), and was significantly higher in patients carrying a null mutation compared with those carrying a defective mutation (14.87% vs. 10.6%, respectively, P < 0.05). Prevalence of current smokers was 28.4% in FH subjects. Most FH cases were receiving LLT (84%). Although 51.5% were receiving treatment expected to reduce LDL-c levels at least 50%, only 13.6% were on maximum statin dose combined with ezetimibe. Mean LDL-c level in treated FH cases was 186.5 mg/dl (SD: 65.6) and only 3.4% of patients reached and LDL-c under 100 mg/dl. The best predictor for LDL-c goal attainment was the use of combined therapy with statin and ezetimibe. Although most of this high risk population is receiving LLT, prevalence of cardiovascular disease and LDL-c levels are still high and far from the optimum LDL-c therapeutic goal. However, LDL-c levels could be reduced by using more intensive LLT such as combined therapy with maximum statin dose and ezetimibe.

  3. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART)

    PubMed Central

    2011-01-01

    Aim Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (LLT) in FH patients recruited in SAFEHEART. Methods and Results A cross-sectional analysis of cases recruited in the Spanish FH cohort at inclusion was performed. Demographic, lifestyle, medical and therapeutic data were collected by specific surveys. Blood samples for lipid profile and DNA were obtained. Genetic test for FH was performed through DNA-microarray. Data from 1852 subjects (47.5% males) over 19 years old were analyzed: 1262 (68.1%, mean age 45.6 years) had genetic diagnosis of FH and 590 (31.9%, mean age 41.3 years) were non-FH. Cardiovascular disease was present in 14% of FH and in 3.2% of non-FH subjects (P < 0.001), and was significantly higher in patients carrying a null mutation compared with those carrying a defective mutation (14.87% vs. 10.6%, respectively, P < 0.05). Prevalence of current smokers was 28.4% in FH subjects. Most FH cases were receiving LLT (84%). Although 51.5% were receiving treatment expected to reduce LDL-c levels at least 50%, only 13.6% were on maximum statin dose combined with ezetimibe. Mean LDL-c level in treated FH cases was 186.5 mg/dl (SD: 65.6) and only 3.4% of patients reached and LDL-c under 100 mg/dl. The best predictor for LDL-c goal attainment was the use of combined therapy with statin and ezetimibe. Conclusion Although most of this high risk population is receiving LLT, prevalence of cardiovascular disease and LDL-c levels are still high and far from the optimum LDL-c therapeutic goal. However, LDL-c levels could be reduced by using more intensive LLT such as combined therapy with maximum statin dose and ezetimibe. PMID:21663647

  4. Longitudinal change of neuroimaging and clinical markers in autosomal dominant Alzheimer’s disease: a prospective cohort study

    PubMed Central

    Yau, Wai-Ying Wendy; Tudorascu, Dana L.; McDade, Eric M.; Ikonomovic, Snezana; James, Jeffrey A.; Minhas, Davneet; Mowrey, Wenzhu; Sheu, Lei K.; Snitz, Beth E.; Weissfeld, Lisa; Gianaros, Peter J.; Aizenstein, Howard J.; Price, Julie C.; Mathis, Chester A.; Lopez, Oscar L.; Klunk, William E.

    2015-01-01

    Background The biomarker model of Alzheimer’s disease (AD) hypothesizes a dynamic sequence of amyloidosis, neurodegeneration, and cognitive decline, as an individual progresses from preclinical AD to dementia. Despite supportive evidence from cross-sectional studies, verification with long-term within-individual data is needed. Methods Autosomal dominant AD (ADAD) mutation carriers, aged 21 years or older (no cognitive restrictions), were recruited from across the United States via referral by colleagues or ADAD families themselves. Sixteen individuals with mutations in PSEN1, PSEN2 or APP, aged 28 to 56, were assessed longitudinally every one to two years, between March 23, 2003 and August 1, 2014. Participants completed two to eight assessments (total=83), over a period of two to eleven years. We measured global amyloid-beta load with Pittsburgh Compound-B PET, posterior cortical metabolism with [18F]fluorodeoxyglucose PET, hippocampal volume (age-, and gender-corrected) with T1 MRI, verbal memory with 10-item delayed word recall, and general cognition with Mini Mental State Exam. We estimated overall biomarker trajectories across estimated years from symptom onset (EYO) using linear mixed models, and compared ADAD estimates to cross-sectional data from cognitively normal, older controls selected to be negative for amyloidosis, hypometabolism, and hippocampal atrophy. In seven individuals with the longest follow-up (seven/eight assessments spanning six to eleven years), we further examined the within-individual progression of amyloidosis, metabolism, hippocampal volume, and cognition, to identify progressive within-individual change in these markers (increase/decrease of greater than two Z-scores standardized to controls). Findings Significant differences in ADAD compared to controls (p<0·01) were detected in the following order: increased amyloidosis (−7.5 EYO), decreased metabolism (0 EYO), decreased hippocampal volume and verbal memory (+7.5 EYO

  5. Longitudinal cohort study to determine effectiveness of a novel simulated case and feedback system to improve clinical pathway adherence in breast, lung and GI cancers

    PubMed Central

    Kubal, Timothy; Letson, Doug G; Chiappori, Alberto A; Springett, Gregory M; Tamondong Lachica, Diana; Peabody, John W

    2016-01-01

    Objectives This study examined whether a measurement and feedback system led to improvements in adherence to clinical pathways. Design The M-QURE (Moffitt—Quality, Understanding, Research and Evidence) Initiative was introduced in 2012 to enhance and improve adherence to pathways at Moffitt Cancer Center (MCC) in three broad clinical areas: breast, lung and gastrointestinal (GI) cancers. M-QURE used simulated patient vignettes based on MCC's Clinical Pathways to benchmark clinician adherence and monitor change over three rounds of implementation. Setting MCC, located in Tampa, Florida, a National Cancer Institute Comprehensive Cancer Center. Participants Three non-overlapping cohorts at MCC (one each in breast, lung and GI) totalling 48 providers participated in this study, with each member of the multidisciplinary team (composed of medical oncologists, radiation oncologists, surgeons and advanced practice providers) invited to participate. Interventions Each participant was asked to complete a set of simulated patient vignettes over three rounds within their own cancer specialty. Participants were required to complete all assigned vignettes over each of the three rounds, or they would be excluded from this study. Primary outcome measure Increased domain and overall provider care adherence to clinical pathways, as scored by blinded physician abstractors. Results We found significant improvements in pathway adherence between the third and first rounds of data collection particularly for workup and treatment of cancer cases. By clinical grouping, breast improved by 13.6% (p<0.001), and lung improved by 12.1% (p<0.001) over baseline, whereas GI showed a decrease of 1.4% (p=0.68). Conclusions Clinical pathway adherence improved in a short timeframe for breast and lung cancers using group-level measurement and individual feedback. This suggests that a measurement and feedback programme may be a useful tool to improve clinical pathway adherence. PMID:27625063

  6. Cognitive and imaging markers in non-demented subjects attending a memory clinic: study design and baseline findings of the MEMENTO cohort.

    PubMed

    Dufouil, Carole; Dubois, Bruno; Vellas, Bruno; Pasquier, Florence; Blanc, Frédéric; Hugon, Jacques; Hanon, Olivier; Dartigues, Jean-François; Harston, Sandrine; Gabelle, Audrey; Ceccaldi, Mathieu; Beauchet, Olivier; Krolak-Salmon, Pierre; David, Renaud; Rouaud, Olivier; Godefroy, Olivier; Belin, Catherine; Rouch, Isabelle; Auguste, Nicolas; Wallon, David; Benetos, Athanase; Pariente, Jérémie; Paccalin, Marc; Moreaud, Olivier; Hommet, Caroline; Sellal, François; Boutoleau-Bretonniére, Claire; Jalenques, Isabelle; Gentric, Armelle; Vandel, Pierre; Azouani, Chabha; Fillon, Ludovic; Fischer, Clara; Savarieau, Helen; Operto, Gregory; Bertin, Hugo; Chupin, Marie; Bouteloup, Vincent; Habert, Marie-Odile; Mangin, Jean-François; Chêne, Geneviève

    2017-08-29

    The natural history and disease mechanisms of Alzheimer's disease and related disorders (ADRD) are still poorly understood. Very few resources are available to scrutinise patients as early as needed and to use integrative approaches combining standardised, repeated clinical investigations and cutting-edge biomarker measurements. In the nationwide French MEMENTO cohort study, participants were recruited in memory clinics and screened for either isolated subjective cognitive complaints (SCCs) or mild cognitive impairment (MCI; defined as test performance 1.5 SD below age, sex and education-level norms) while not demented (Clinical Dementia Rating [CDR] <1). Baseline data collection included neurological and physical examinations as well as extensive neuropsychological testing. To be included in the MEMENTO cohort, participants had to agree to undergo both brain magnetic resonance imaging (MRI) and blood sampling. Cerebral (18)F-fluorodeoxyglucose positon emission tomography and lumbar puncture were optional. Automated analyses of cerebral MRI included assessments of volumes of whole-brain, hippocampal and white matter lesions. The 2323 participants, recruited from April 2011 to June 2014, were aged 71 years, on average (SD 8.7), and 62% were women. CDR was 0 in 40% of participants, and 30% carried at least one apolipoprotein E ε4 allele. We observed that more than half (52%) of participants had amnestic mild cognitive impairment (17% single-domain aMCI), 32% had non-amnestic mild cognitive impairment (16.9% single-domain naMCI) and 16% had isolated SCCs. Multivariable analyses of neuroimaging markers associations with cognitive categories showed that participants with aMCI had worse levels of imaging biomarkers than the others, whereas participants with naMCI had markers at intermediate levels between SCC and aMCI. The burden of white matter lesions tended to be larger in participants with aMCI. Independently of CDR, all neuroimaging and neuropsychological markers

  7. Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

    PubMed Central

    2011-01-01

    Background Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes. Methods Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1) Neck pain disability index (100-point scale), 2) Oswestry back pain index (100-point scale), 3) 11-point numerical rating scale (NRS) for neck, headache, midback, and low back pain, 4) treatment satisfaction, and 5) Symptomatic Reactions (SR). Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score <3 NRS and <10%, respectively. A SR is defined as a new complaint not present at baseline or a worsening of the presenting complaint by >30% based on an 11-point numeric rating scale occurring <24 hours after any upper cervical procedure. Results A total of 1,090 patients completed the study having 4,920 (4.5 per patient) office visits requiring 2,653 (2.4 per patient) upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0%) patients had SRs meeting the accepted definition. Intense SR (NRS ≥8) occurred in 56 patients (5.1%). Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p <0.001) following care with a high level (mean = 9.1/10) of patient satisfaction. The 83 chiropractors administered >5 million career upper cervical adjustments without a reported incidence of serious adverse event. Conclusions Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs

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

    PubMed

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

    2015-10-01

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

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

    PubMed Central

    Lyons, Jason J; Greene, Tracy L; Haley, James M

    2015-01-01

    Objective To examine the diagnostic accuracy of a two-stage clinical decision support system for early recognition and stratification of patients with sepsis. Design Observational cohort study employing a two-stage sepsis clinical decision support to recognise and stratify patients with sepsis. The stage one component was comprised of a cloud-based clinical decision support with 24/7 surveillance to detect patients at risk of sepsis. The cloud-based clinical decision support delivered notifications to the patients’ designated nurse, who then electronically contacted a provider. The second stage component comprised a sepsis screening and stratification form integrated into the patient electronic health record, essentially an evidence-based decision aid, used by providers to assess patients at bedside. Setting Urban, 284 acute bed community hospital in the USA; 16,000 hospitalisations annually. Participants Data on 2620 adult patients were collected retrospectively in 2014 after the clinical decision support was implemented. Main outcome measure ‘Suspected infection’ was the established gold standard to assess clinical decision support clinimetric performance. Results A sepsis alert activated on 417 (16%) of 2620 adult patients hospitalised. Applying ‘suspected infection’ as standard, the patient population characteristics showed 72% sensitivity and 73% positive predictive value. A postalert screening conducted by providers at bedside of 417 patients achieved 81% sensitivity and 94% positive predictive value. Providers documented against 89% patients with an alert activated by clinical decision support and completed 75% of bedside screening and stratification of patients with sepsis within one hour from notification. Conclusion A clinical decision support binary alarm system with cross-checking functionality improves early recognition and facilitates stratification of patients with sepsis. PMID:26688744

  10. Toxicity and clinical outcomes in patients with HIV on zidovudine and tenofovir based regimens: a retrospective cohort study.

    PubMed

    Thuppal, Sowmyanarayanan V; Wanke, Christine A; Noubary, Farzad; Cohen, Joshua T; Mwamburi, Mkaya; Ooriapdickal, Abraham C; Muliyil, Jayaprakash; Kang, Gagandeep; Varghese, George M; Rupali, Priscilla; Karthik, Rajiv; Sathasivam, Rajkumar; Clarance, Peace; Pulimood, Susanne A; Peter, Dincy; George, Leni

    2015-06-01

    Adverse drug reactions are a major concern with zidovudine/stavudine treatment regimens. The less toxic tenofovir regimen is an alternative, but is seldom considered due to the higher costs. This study compared adverse drug reactions and other clinical outcomes resulting from the use of these two treatment regimens in India. Baseline, clinical characteristics and follow-up outcomes were collected by chart reviews of HIV-positive adults and compared using univariate/multivariate analysis, with and without propensity score adjustments. Data were collected from 129 and 92 patients on zidovudine (with lamivudine and nevirapine) and tenofovir (with emtricitabine and efavirenz) regimens, respectively. Compared to patients receiving the zidovudine regimen, patients receiving the tenofovir regimen had fewer adverse drug reactions (47%, 61/129 vs 11%, 10/92; p<0.01), requiring fewer regimen changes (36%, 47/129 vs 3%, 3/92; p0.01). With the propensity score, the zidovudine regimen had 8 times more adverse drug reactions (p<0.01). Opportunistic infections were similar between regimens without propensity score, while the zidovudine regimen had 1.2 times (p=0.63) more opportunistic infections with propensity score. Patients on the tenofovir regimen gained more weight. Increase in CD4 levels and treatment adherence (>95%) was similar across regimens. Patients on a tenofovir regimen have better clinical outcomes and improved general health than patients on the zidovudine regimen. © The Author 2015. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. CCL19 as a Chemokine Risk Factor for Posttreatment Lyme Disease Syndrome: a Prospective Clinical Cohort Study.

    PubMed

    Aucott, John N; Soloski, Mark J; Rebman, Alison W; Crowder, Lauren A; Lahey, Lauren J; Wagner, Catriona A; Robinson, William H; Bechtold, Kathleen T

    2016-09-01

    Approximately 10% to 20% of patients optimally treated for early Lyme disease develop persistent symptoms of unknown pathophysiology termed posttreatment Lyme disease syndrome (PTLDS). The objective of this study was to investigate associations between PTLDS and immune mediator levels during acute illness and at several time points following treatment. Seventy-six participants with physician-documented erythema migrans and 26 healthy controls with no history of Lyme disease were enrolled. Sixty-four cytokines, chemokines, and inflammatory markers were measured at each visit for a total of 6 visits over 1 year. An operationalized definition of PTLDS incorporating symptoms and functional impact was applied at 6 months and 1 year following treatment completion, and clinical outcome groups were defined as the return-to-health, symptoms-only, and PTLDS groups. Significance analysis of microarrays identified 7 of the 64 immune mediators to be differentially regulated by group. Generalized logit regressions controlling for potential confounders identified posttreatment levels of the T-cell chemokine CCL19 to be independently associated with clinical outcome group. Receiver operating characteristic analysis identified a CCL19 cutoff of >111.67 pg/ml at 1 month following treatment completion to be 82% sensitive and 83% specific for later PTLDS. We speculate that persistently elevated CCL19 levels among participants with PTLDS may reflect ongoing, immune-driven reactions at sites distal to secondary lymphoid tissue. Our findings suggest the relevance of CCL19 both during acute infection and as an immunologic risk factor for PTLDS during the posttreatment phase. Identification of a potential biomarker predictor for PTLDS provides the opportunity to better understand its pathophysiology and to develop early interventions in the context of appropriate and specific clinical information.

  12. CCL19 as a Chemokine Risk Factor for Posttreatment Lyme Disease Syndrome: a Prospective Clinical Cohort Study

    PubMed Central

    Soloski, Mark J.; Rebman, Alison W.; Crowder, Lauren A.; Wagner, Catriona A.; Robinson, William H.; Bechtold, Kathleen T.

    2016-01-01

    Approximately 10% to 20% of patients optimally treated for early Lyme disease develop persistent symptoms of unknown pathophysiology termed posttreatment Lyme disease syndrome (PTLDS). The objective of this study was to investigate associations between PTLDS and immune mediator levels during acute illness and at several time points following treatment. Seventy-six participants with physician-documented erythema migrans and 26 healthy controls with no history of Lyme disease were enrolled. Sixty-four cytokines, chemokines, and inflammatory markers were measured at each visit for a total of 6 visits over 1 year. An operationalized definition of PTLDS incorporating symptoms and functional impact was applied at 6 months and 1 year following treatment completion, and clinical outcome groups were defined as the return-to-health, symptoms-only, and PTLDS groups. Significance analysis of microarrays identified 7 of the 64 immune mediators to be differentially regulated by group. Generalized logit regressions controlling for potential confounders identified posttreatment levels of the T-cell chemokine CCL19 to be independently associated with clinical outcome group. Receiver operating characteristic analysis identified a CCL19 cutoff of >111.67 pg/ml at 1 month following treatment completion to be 82% sensitive and 83% specific for later PTLDS. We speculate that persistently elevated CCL19 levels among participants with PTLDS may reflect ongoing, immune-driven reactions at sites distal to secondary lymphoid tissue. Our findings suggest the relevance of CCL19 both during acute infection and as an immunologic risk factor for PTLDS during the posttreatment phase. Identification of a potential biomarker predictor for PTLDS provides the opportunity to better understand its pathophysiology and to develop early interventions in the context of appropriate and specific clinical information. PMID:27358211

  13. The Correlation of Endoscopic Findings and Clinical Features in Korean Patients with Scrub Typhus: A Cohort Study

    PubMed Central

    Lee, Jun; Kim, Dong-Min; Yun, Na Ra; Kim, Young Dae; Park, Chan Guk; Kim, Man Woo

    2016-01-01

    Scrub typhus is an infectious disease caused by Orientia tsutsugamushi-induced systemic vasculitis, but the involvement of the gastrointestinal tract and the endoscopic findings associated with scrub typhus are not well understood. We performed a prospective study and recommend performing esophagogastroduodenoscopy (EGD) for all possible scrub typhus patients, regardless of gastrointestinal symptoms. Gastrointestinal symptoms, endoscopic findings and clinical severity based on organ involvement and ICU admission were analyzed. Gastrointestinal symptoms occurred in up to 76.4% of scrub typhus patients. The major endoscopic findings were ulcers (43/127, 33.9%). Interestingly, 7.1% (9/127) of the patients presented with esophageal candidiasis. There was no correlation between the presence or absence of gastrointestinal symptoms and the endoscopic grade (P = 0.995). However, there was a positive correlation between the clinical severity and the endoscopic findings (P = 0.001). Sixty-three percent of the patients presented with erosion or ulcers on prospectively performed endoscopic evaluations, irrespective of gastrointestinal symptoms. Gastrointestinal symptoms did not reflect the need for endoscopy. Scrub typhus patients could have significant endoscopic abnormalities even in the absence of gastrointestinal symptoms. PMID:27195943

  14. Post-diagnostic oral bisphosphonate use and colorectal cancer mortality: a population-based cohort study within the UK Clinical Practice Research Datalink

    PubMed Central

    Hicks, B M; Murray, L J; Hughes, C; Cardwell, C R

    2015-01-01

    Background: We conducted the first study to investigate post-diagnostic oral bisphosphonates use and colorectal cancer-specific mortality. Methods: Colorectal cancer patients were identified from the National Cancer Data Repository (1998–2007) and linked to the UK Clinical Practice Research Datalink, providing prescription records, and Office of National Statistics mortality data. Time-dependent Cox regression models investigated colorectal cancer-specific mortality in post-diagnostic bisphosphonate users. Results: Overall, in 4791 colorectal cancer patients, there was no evidence of an association between bisphosphonate use and colorectal cancer-specific mortality (adjusted hazard ratio=1.11; 95% confidence interval 0.80, 1.54) or with drug frequency or type. Conclusions: In this novel population-based cohort study, post-diagnostic bisphosphonate use was not associated with longer rates of colorectal cancer survival. PMID:25989268

  15. Pre-cART Elevation of CRP and CD4+ T-cell Immune Activation Associated with HIV Clinical Progression in a Multinational Case-Cohort Study

    PubMed Central

    Balagopal, Ashwin; Asmuth, David M.; Yang, Wei-Teng; Campbell, Thomas B.; Gupte, Nikhil; Smeaton, Laura; Kanyama, Cecilia; Grinsztejn, Beatriz; Santos, Breno; Supparatpinyo, Khuanchai; Badal-Faesen, Sharlaa; Lama, Javier R.; Lalloo, Umesh G.; Zulu, Fatima; Pawar, Jyoti S; Riviere, Cynthia; Kumarasamy, Nagalingeswaran; Hakim, James; Li, Xiao-Dong; Pollard, Richard B.; Semba, Richard D.; Thomas, David L.; Bollinger, Robert C.; Gupta, Amita

    2015-01-01

    Background Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical progression in cART initiators. Methods A case-cohort study (n=470) within the multinational Prospective Evaluation of Antiretrovirals in Resource-Limited Settings (PEARLS) clinical trial (1571 HIV treatment-naïve adults who initiated cART; CD4+ T cell count <300 cells/mm3; nine countries) was conducted. A subcohort of 30 participants/country was randomly selected; additional cases were added from the main cohort. Cases (n=236 [random subcohort–36; main cohort–200]) had clinical progression (incident WHO Stage 3/4 event or death) within 96 weeks following cART initiation. Immune activation biomarkers were quantified pre-cART. Associations between biomarkers and clinical progression were examined using weighted multivariable Cox-proportional hazards models. Results Median age was 35 years, 45% were women, 49% black, 31% Asian, and 9% white. Median CD4+ T-cell count was 167 cells/mm3. In multivariate analysis, highest quartile CRP concentration (adjusted hazards ratio [aHR] 2.53, 95%CI 1.02-6.28) and CD4+ T-cell activation (aHR 5.18, 95CI 1.09-24.47) were associated with primary outcomes, compared to lowest quartiles. sCD14 had a trend towards association with clinical failure (aHR 2.24, 95%CI 0.96–5.21). Conclusions Measuring CRP and CD4+ T-cell activation may identify patients with CD4+ T cell counts < 300 cells/mm3 at risk for early clinical progression when initiating cART. Additional vigilance and symptom-based screening may be required in this subset of patients even after beginning cART. PMID:26017661

  16. Contemporary trends of the epidemiology, clinical characteristics, and resource utilization of necrotizing fasciitis in Texas: a population-based cohort study.

    PubMed

    Oud, Lavi; Watkins, Phillip

    2015-01-01

    Introduction. There are limited population-level reports on the contemporary trends of the epidemiology, clinical features, resource utilization, and outcomes of necrotizing fasciitis (NF). Methods. We conducted a cohort study of Texas inpatient population, identifying hospitalizations with a diagnosis of NF during the years 2001-2010. The incidence, clinical features, resource utilization, and outcomes of NF hospitalizations were examined. Results. There were 12,172 NF hospitalizations during study period, with ICU admission in 50.3%. The incidence of NF rose 2.7%/year (P = 0.0001). Key changes between 2001-2002 and 2009-2010 included rising incidence of NF (5.9 versus 7.6 per 100,000 [P < 0.0001]), chronic comorbidities (69.4% versus 76.7% [P < 0.0001]), and development of ≥1 organ failure (28.5% versus 51.7% [P < 0.0001]). Inflation-adjusted hospital charges rose 37% (P < 0.0001). Hospital mortality (9.3%) remained unchanged during study period. Discharges to long-term care facilities rose from 12.2 to 30% (P < 0.0001). Conclusions. The present cohort of NF is the largest reported to date. There has been increasing incidence, chronic illness, and severity of illness of NF over the past decade, with half of NF hospitalizations admitted to ICU. Hospital mortality remained unchanged, while need for long-term care rose nearly 2.5-fold among survivors, suggesting increasing residual morbidity. The sources of the observed findings require further study.

  17. Clinical presentation, etiology, and outcome of infective endocarditis in the 21st century: the International Collaboration on Endocarditis-Prospective Cohort Study.

    PubMed

    Murdoch, David R; Corey, G Ralph; Hoen, Bruno; Miró, José M; Fowler, Vance G; Bayer, Arnold S; Karchmer, Adolf W; Olaison, Lars; Pappas, Paul A; Moreillon, Philippe; Chambers, Stephen T; Chu, Vivian H; Falcó, Vicenç; Holland, David J; Jones, Philip; Klein, John L; Raymond, Nigel J; Read, Kerry M; Tripodi, Marie Francoise; Utili, Riccardo; Wang, Andrew; Woods, Christopher W; Cabell, Christopher H

    2009-03-09

    We sought to provide a contemporary picture of the presentation, etiology, and outcome of infective endocarditis (IE) in a large patient cohort from multiple locations worldwide. Prospective cohort study of 2781 adults with definite IE who were admitted to 58 hospitals in 25 countries from June 1, 2000, through September 1, 2005. The median age of the cohort was 57.9 (interquartile range, 43.2-71.8) years, and 72.1% had native valve IE. Most patients (77.0%) presented early in the disease (<30 days) with few of the classic clinical hallmarks of IE. Recent health care exposure was found in one-quarter of patients. Staphylococcus aureus was the most common pathogen (31.2%). The mitral (41.1%) and aortic (37.6%) valves were infected most commonly. The following complications were common: stroke (16.9%), embolization other than stroke (22.6%), heart failure (32.3%), and intracardiac abscess (14.4%). Surgical therapy was common (48.2%), and in-hospital mortality remained high (17.7%). Prosthetic valve involvement (odds ratio, 1.47; 95% confidence interval, 1.13-1.90), increasing age (1.30; 1.17-1.46 per 10-year interval), pulmonary edema (1.79; 1.39-2.30), S aureus infection (1.54; 1.14-2.08), coagulase-negative staphylococcal infection (1.50; 1.07-2.10), mitral valve vegetation (1.34; 1.06-1.68), and paravalvular complications (2.25; 1.64-3.09) were associated with an increased risk of in-hospital death, whereas viridans streptococcal infection (0.52; 0.33-0.81) and surgery (0.61; 0.44-0.83) were associated with a decreased risk. In the early 21st century, IE is more often an acute disease, characterized by a high rate of S aureus infection. Mortality remains relatively high.

  18. A prospective observational post-marketing study of natalizumab-treated multiple sclerosis patients: clinical, radiological and biological features and adverse events. The BIONAT cohort.

    PubMed

    Outteryck, O; Ongagna, J C; Brochet, B; Rumbach, L; Lebrun-Frenay, C; Debouverie, M; Zéphir, H; Ouallet, J C; Berger, E; Cohen, M; Pittion, S; Laplaud, D; Wiertlewski, S; Cabre, P; Pelletier, J; Rico, A; Defer, G; Derache, N; Camu, W; Thouvenot, E; Moreau, T; Fromont, A; Tourbah, A; Labauge, P; Castelnovo, G; Clavelou, P; Casez, O; Hautecoeur, P; Papeix, C; Lubetzki, C; Fontaine, B; Couturier, N; Bohossian, N; Clanet, M; Vermersch, P; de Sèze, J; Brassat, D

    2014-01-01

    BIONAT is a French multicentric phase IV study of natalizumab (NTZ)-treated relapsing-remitting multiple sclerosis (MS) patients. The purpose of this study was to collect clinical, radiological and biological data on 1204 patients starting NTZ, and to evaluate the clinical/radiological response to NTZ after 2 years of treatment. Patients starting NTZ at 18 French MS centres since June 2007 were included. Good response to NTZ was defined by the absence of clinical and radiological activity. Data analysed in this first report on the BIONAT study focus on patients who started NTZ at least 2 years ago (n = 793; BIONAT2Y ). NTZ was discontinued in 17.78% of BIONAT2Y. The proportion of patients without combined disease activity was 45.59% during the first two successive years of treatment. Systematic dosage of anti-NTZantibodies (Abs) detected only two supplementary patients with anti-NTZ Abs compared with strict application of recommendations. A significant decrease of IgG,M concentrations at 2 years of treatment was found. The efficacy of NTZ therapy on relapsing-remitting MS in a real life setting is confirmed in the BIONAT cohort. The next step will be the identification of biomarkers predicting response to NTZ therapy and adverse events. © 2013 The Author(s) European Journal of Neurology © 2013 EFNS.

  19. Platelet rich plasma use in allograft ACL reconstructions: two-year clinical results of a MOON cohort study.

    PubMed

    Magnussen, Robert A; Flanigan, David C; Pedroza, Angela D; Heinlein, Kate A; Kaeding, Christopher C

    2013-08-01

    Platelet rich plasma has been promoted as a biologic agent to enhance tissue healing. As a concentration of autologous growth factors, it has gained increased use in musculoskeletal applications. The purpose of this study was to evaluate the effect of intra-operative PRP on patient-reported outcomes 2 years after ACL reconstruction with tibialis anterior allograft. Fifty patients who underwent allograft ACL reconstruction with intra-operative application of PRP to the graft were matched with 50 allograft ACL -reconstructions without PRP use. The same surgeon performed all procedures with identical technique. Two year patient-reported outcomes including KOOS, IKDC, and Marx activity scores were obtained. Effusions in the immediate post-operative period, post-operative complications, and any subsequent procedures were also recorded. There was no difference between the groups with respect to additional surgeries or complications in the first 2 years after reconstruction. Decreased effusions at 10±4 days were noted in the PRP group, but this difference disappeared by 8±4 weeks. No differences in patient-reported outcomes were noted in the 58 patients with two-year outcome data. The study demonstrated that although PRP application in tibialis allograft ACL reconstructions appeared safe; clinical benefit was minor and short-term. No differences in patient-reported outcomes or number of additional surgeries at 2 years were noted. Level III - retrospective comparative study. Copyright © 2012 Elsevier B.V. All rights reserved.

  20. Cohort Profile Update: The China Jintan Child Cohort Study

    PubMed Central

    Liu, Jianghong; Cao, Siyuan; Chen, Zehang; Raine, Adrian; Hanlon, Alexandra; Ai, Yuexian; Zhou, Guoping; Yan, Chonghuai; Leung, Patrick W; McCauley, Linda; Pinto-Martin, Jennifer

    2015-01-01

    The China Jintan Child Cohort study began in 2004 with 1656 pre-school participants and a research focus on studying the impact of environmental exposures, such as lead, on children’s neurobehavioural outcomes. This population cohort now includes around 1000 of the original participants, who have been assessed three times over a period of 10 years. Since the original IJE cohort profile publication in 2010, participants have experienced a critical developmental transition from pre-school to school age and then adolescence. The study has also witnessed an increase in breadth and depth of data collection from the original aim of risk assessment. This cohort has added new directions to investigate the mechanisms and protective factors for the relationship between early health factors and child physical and mental health outcomes, with an emphasis on neurobehavioural consequences. The study now encompasses 11 domains, composed of repeated measures of the original variables and new domains of biomarkers, sleep, psychophysiology, neurocognition, personality, peer relationship, mindfulness and family dynamics. Depth of evaluation has increased from parent/teacher report to self/peer report and intergenerational family report. Consequently, the cohort has additional directions to include: (i) classmates of the original cohort participants for peer relationship assessment; and (ii) parental and grandparental measures to assess personality and dynamics within families. We welcome interest in our study and ask investigators to contact the corresponding author for additional information on data acquisition. PMID:26323725

  1. Cognitive compensatory processes of older, clinically fit patients with hematologic malignancies undergoing chemotherapy: A longitudinal cohort study.

    PubMed

    Libert, Yves; Borghgraef, Cindy; Beguin, Yves; Delvaux, Nicole; Devos, Martine; Doyen, Chantal; Dubruille, Stéphanie; Etienne, Anne-Marie; Liénard, Aurore; Merckaert, Isabelle; Reynaert, Christine; Slachmuylder, Jean-Louis; Straetmans, Nicole; Van Den Neste, Eric; Bron, Dominique; Razavi, Darius

    2017-03-18

    Despite the well-known negative impacts of cancer and anticancer therapies on cognitive performance, little is known about the cognitive compensatory processes of older patients with cancer. This study was designed to investigate the cognitive compensatory processes of older, clinically fit patients with hematologic malignancies undergoing chemotherapy. We assessed 89 consecutive patients (age ≥ 65 y) without severe cognitive impairment and 89 age-, sex-, and education level-matched healthy controls. Cognitive compensatory processes were investigated by (1) comparing cognitive performance of patients and healthy controls in novel (first exposure to cognitive tasks) and non-novel (second exposure to the same cognitive tasks) contexts, and (2) assessing psychological factors that may facilitate or inhibit cognitive performance, such as motivation, psychological distress, and perceived cognitive performance. We assessed cognitive performance with the Trail-Making, Digit Span and FCSR-IR tests, psychological distress with the Hospital Anxiety and Depression Scale, and perceived cognitive performance with the FACT-Cog questionnaire. In novel and non-novel contexts, average cognitive performances of healthy controls were higher than those of patients and were associated with motivation. Cognitive performance of patients was not associated with investigated psychological factors in the novel context but was associated with motivation and psychological distress in the non-novel context. Older, clinically fit patients with hematologic malignancies undergoing chemotherapy demonstrated lower cognitive compensatory processes compared to healthy controls. Reducing distress and increasing motivation may improve cognitive compensatory processes of patients in non-novel contexts. Copyright © 2017 John Wiley & Sons, Ltd.

  2. Prognostic impact of clinic and ambulatory blood pressure components in high-risk type 2 diabetic patients: the Rio de Janeiro Type 2 Diabetes Cohort Study.

    PubMed

    Salles, Gil F; Leite, Nathalie C; Pereira, Basílio B; Nascimento, Emilia M; Cardoso, Claudia R L

    2013-11-01

    The prognostic importance of tight clinic blood pressure (BP) control is controversial in diabetic patients. The objective was to investigate the prognostic impact of clinic and ambulatory BPs for cardiovascular morbidity and mortality in type 2 diabetes. In a prospective cohort study, 565 type 2 diabetic patients had clinical, laboratory and ambulatory BP monitoring (ABPM) data obtained at baseline and during follow-up. The primary endpoints were a composite of fatal and nonfatal cardiovascular events and all-cause mortality. Multivariable Cox survival and splines regression analyses assessed associations between each BP component [SBP, DBP and pulse pressure (PP)] and the endpoints. After a median follow-up of 5.75 years, 88 total cardiovascular events and 70 all-cause deaths occurred. After adjustments for cardiovascular risk factors, clinic SBP and DBPs were predictive of the composite endpoint but not of all-cause mortality, whereas all ambulatory BP components were predictors of both endpoints. Ambulatory systolic and PPs were the strongest predictors and achieved ambulatory BPs during follow-up improved risk prediction in relation to baseline values. When categorized at clinically relevant cut-off values, risk began only at clinic BPs at least 140/90 mmHg, whereas for ambulatory BPs it began at lower values (≥120/75 mmHg for the 24-h period). ABPM provides more valuable information regarding cardiovascular risk stratification than office BPs and should be performed, if possible, in every high-risk type 2 diabetic patient. Achieved 24-h ambulatory BPs less than 120/75 mmHg are associated with significant cardiovascular protection and, if confirmed by other studies, may be considered as BP treatment targets.

  3. Clinical course of isolated distal deep vein thrombosis in patients with active cancer: a multicenter cohort study.

    PubMed

    Dentali, F; Pegoraro, S; Barco, S; di Minno, M N D; Mastroiacovo, D; Pomero, F; Lodigiani, C; Bagna, F; Sartori, M; Barillari, G; Mumoli, N; Napolitano, M; Passamonti, S M; Benedetti, R; Ageno, W; Di Nisio, M

    2017-09-01

    Essentials Isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer. No study has specifically evaluated the long-term clinical course of cancer-associated IDDVT. Patients with cancer-associated IDDVT are at very high risk of symptomatic recurrence and death. We observed low rates of major bleeding during anticoagulation. Background Although isolated distal deep vein thrombosis (IDDVT) is frequently associated with cancer, no study has specifically evaluated the long-term clinical course of IDDVT in this setting. Aim To provide data on the rate of recurrent venous thromboembolism (VTE), major bleeding events and death in IDDVT patients with active cancer. Patients and Methods Consecutive patients with active cancer and an objective IDDVT diagnosis (January 2011 to September 2014) were included from our files. We collected information on baseline characteristics, IDDVT location and extension, VTE risk factors, and type and duration of anticoagulant treatment. Results A total of 308 patients (mean age 66.2 [standard deviation (SD), 13.2 years]; 57.1% female) with symptomatic IDDVT and a solid (n = 261) or hematologic (n = 47) cancer were included at 13 centers. Cancer was metastatic in 148 (48.1%) patients. All but three (99.0%) patients received anticoagulant therapy, which consisted of low-molecular-weight heparin in 288 (93.5%) patients. Vitamin K antagonists were used for the long-term treatment in 46 (14.9%) patients, whereas all others continued the initial parenteral agent for a mean treatment duration of 4.2 months (SD, 4.6 months). During a total follow-up of 355.8 patient-years (mean, 13.9 months), there were 47 recurrent objectively diagnosed VTEs for an incidence rate of 13.2 events per 100 patient-years. During anticoagulant treatment, the annual incidence of major bleeding was 2.0 per 100 patient-years. Conclusions Cancer patients with IDDVT have a high risk of VTE recurrence. Additional studies are warranted to investigate the

  4. Clinical Presentation and Determinants of Mortality of Invasive Pulmonary Aspergillosis in Kidney Transplant Recipients: A Multinational Cohort Study.

    PubMed

    López-Medrano, F; Fernández-Ruiz, M; Silva, J T; Carver, P L; van Delden, C; Merino, E; Pérez-Saez, M J; Montero, M; Coussement, J; de Abreu Mazzolin, M; Cervera, C; Santos, L; Sabé, N; Scemla, A; Cordero, E; Cruzado-Vega, L; Martín-Moreno, P L; Len, Ó; Rudas, E; de León, A P; Arriola, M; Lauzurica, R; David, M; González-Rico, C; Henríquez-Palop, F; Fortún, J; Nucci, M; Manuel, O; Paño-Pardo, J R; Montejo, M; Muñoz, P; Sánchez-Sobrino, B; Mazuecos, A; Pascual, J; Horcajada, J P; Lecompte, T; Moreno, A; Carratalà, J; Blanes, M; Hernández, D; Fariñas, M C; Andrés, A; Aguado, J M

    2016-11-01

    The prognostic factors and optimal therapy for invasive pulmonary aspergillosis (IPA) after kidney transplantation (KT) remain poorly studied. We included in this multinational retrospective study 112 recipients diagnosed with probable (75.0% of cases) or proven (25.0%) IPA between 2000 and 2013. The median interval from transplantation to diagnosis was 230 days. Cough, fever, and expectoration were the most common symptoms at presentation. Bilateral pulmonary involvement was observed in 63.6% of cases. Positivity rates for the galactomannan assay in serum and bronchoalveolar lavage samples were 61.3% and 57.1%, respectively. Aspergillus fumigatus was the most commonly identified species. Six- and 12-week survival rates were 68.8% and 60.7%, respectively, and 22.1% of survivors experienced graft loss. Occurrence of IPA within the first 6 months (hazard ratio [HR]: 2.29; p-value = 0.027) and bilateral involvement at diagnosis (HR: 3.00; p-value = 0.017) were independent predictors for 6-week all-cause mortality, whereas the initial use of a voriconazole-based regimen showed a protective effect (HR: 0.34; p-value = 0.007). The administration of antifungal combination therapy had no apparent impact on outcome. In conclusion, IPA entails a dismal prognosis among KT recipients. Maintaining a low clinical suspicion threshold is key to achieve a prompt diagnosis and to initiate voriconazole therapy. © Copyright 2016 The American Society of Transplantation and the American Society of Transplant Surgeons.

  5. Clinical importance of the drug interaction between statins and CYP3A4 inhibitors: a retrospective cohort study in The Health Improvement Network

    PubMed Central

    Rowan, Christopher G.; Brunelli, Steven M.; Munson, Jeffrey; Flory, James; Reese, Peter P.; Hennessy, Sean; Lewis, James; Mines, Daniel; Barrett, Jeffrey S.; Bilker, Warren; Strom, Brian L.

    2014-01-01

    Objective To compare the relative hazard of muscle toxicity, renal dysfunction, and hepatic dysfunction associated with the drug interaction between statins and concomitant medications that inhibit the CYP3A4 isoenzyme. Background Although statins provide important clinical benefits related to mitigating the risk of cardiovascular events, this class of medications also has the potential for severe adverse reactions. The risk for adverse events may be potentiated by concomitant use of medications that interfere with statin metabolism. Methods Data from The Health Improvement Network (THIN) from 1990 to 2008 were used to conduct a retrospective cohort study. Cohorts were created to evaluate each outcome (muscle toxicity, renal dysfunction, and hepatic dysfunction) independently. Each cohort included new statin initiators and compared the relative hazard of the outcome. The interaction ratio (I*R) was the primary contrast of interest. The I*R represents the relative effect of each statin type (statin 3A4 substrate vs. statin non-3A4 substrate) with a CYP3A4 inhibitor, independent of the effect of the statin type without a CYP3A4 inhibitor. We adjusted for confounding variables using the multinomial propensity score. Results The median follow-up time per cohort was 1.5 years. There were 7889 muscle toxicity events among 362 809 patients and 792 665 person-years. The adjusted muscle toxicity I*R was 1.22 (95% confidence interval [CI] = 0.90–1.66). There were 1449 renal dysfunction events among 272,099 patients and 574 584 person-years. The adjusted renal dysfunction I*R was 0.91 (95%CI = 0.58–1.44). There were 1434 hepatic dysfunction events among 367 612 patients and 815 945 person-years. The adjusted hepatic dysfunction I*R was 0.78 (95%CI = 0.45–1.31). Conclusions Overall, this study found no difference in the relative hazard of muscle toxicity, renal dysfunction, or hepatic dysfunction for patients prescribed a statin 3A4 substrate versus a statin non-3A4

  6. The impact of serial lactate monitoring on emergency department resuscitation interventions and clinical outcomes in severe sepsis and septic shock: an observational cohort study.

    PubMed

    Dettmer, Matthew; Holthaus, Christopher V; Fuller, Brian M

    2015-01-01

    Monitoring in the setting of critical illness must be linked to beneficial therapy to affect clinical outcome. Elevated serum lactate is associated with an increase in mortality in emergency department (ED) patients with severe sepsis and septic shock. The reduction of lactate levels toward normal during acute resuscitation is associated with improved clinical outcomes. The majority of data demonstrating the interventions used to achieve a reduction in lactate levels and the associated clinical outcomes have been obtained during protocolized randomized trials. We therefore conducted a retrospective observational cohort study of 243 adult patients with severe sepsis and septic shock to assess the interventions associated with nonprotocolized serial lactate monitoring and to assess clinical outcomes. A multivariable model was used to assess outcome differences between the serial lactate (SL) and no serial lactate (NL) cohorts. The SL group received more crystalloid resuscitation (3.6 L vs. 2.5 L; P < 0.01), central venous oxygen saturation monitoring (30% vs. 12%; P < 0.01), and central venous pressure monitoring (23.5% vs. 11.8%; P = 0.02). By day 28, a total of 31 patients in the SL group (23.5%) and 44 in the NL group (39.6%) had died. Multivariable logistic regression analysis demonstrated that the lack of serial lactate monitoring was independently associated with mortality (adjusted odds ratio, 2.09; 95% confidence interval [CI], 1.12 - 3.89; P = 0.02). The SL group also showed greater improvement in 24-h Sequential Organ Failure Assessment scores (1.16 vs. 0.19; P = 0.03), decreased intensive care unit length of stay in days (4.6 vs. 6.0; P = 0.04), and more ventilator-free (19.9 vs. 16; P = 0.05) and vasopressor-free (21.6 vs. 17.9; P = 0.02) days. In the setting of routine clinical care, serial lactate monitoring is associated with an increase in crystalloid administration, resuscitation interventions, and improved clinical outcomes in ED patients with

  7. [Are there associations of health status, disease activity and damage in SLE patients?---Results of a study of a cohort of a Swiss specialized outpatient clinic].

    PubMed

    Marx, C; Mörgeli, H P; Büchi, S; Stoll, T

    2007-05-30

    To study the relationship between self assessed health status of patients with Systemic Lupus Erythematosus (SLE), lupus activity, damage, patients' age and disease duration in a cohort of a Swiss specialized outpatient clinic. A cross sectional study of 38 patients fulfilling the classification criteria for SLE. The patients visited a rheumatology outpatient clinic in Switzerland between January 2002 and December 2004. The last assessment during this period was used for the study. The assessment included, besides demographic data, the measurement of disease activity using the BILAG index, the measurement of disease damage using the SLICC/ACR damage index (SDI), as well as the patient's self assessed health status using the patient's questionnaire Medical Outcome Survey Short Form 36 (SF-36). A total of 36 women and 2 men were included in the study (median age: 43 yrs, median disease duration: 11 yrs). Increased disease activity (total BILAG) was shown to be significantly correlated with reduced physical function. A greater damage (total SDI) correlated significantly with reduced role function due to emotional limitations. Neither age nor disease duration showed any significant correlation with health status in this study. The present study, which is based on internationally accepted assessment tools for SLE patients, shows a significant relationship between increased disease activity and reduced physical function. This result emphasizes the importance of optimizing treatment aiming at reducing disease activity.

  8. Contribution of Genetic Background and Clinical Risk Factors to Low-Trauma Fractures in Human Immunodeficiency Virus (HIV)-Positive Persons: The Swiss HIV Cohort Study.

    PubMed

    Junier, Thomas; Rotger, Margalida; Biver, Emmanuel; Ledergerber, Bruno; Barceló, Catalina; Bartha, Istvan; Kovari, Helen; Schmid, Patrick; Fux, Christoph; Bernasconi, Enos; Brun Del Re, Claudia; Weber, Rainer; Fellay, Jacques; Tarr, Philip E

    2016-04-01

    Background.  The impact of human genetic background on low-trauma fracture (LTF) risk has not been evaluated in the context of human immunodeficiency virus (HIV) and clinical LTF risk factors. Methods.  In the general population, 6 common single-nucleotide polymorphisms (SNPs) associate with LTF through genome-wide association study. Using genome-wide SNP arrays and imputation, we genotyped these SNPs in HIV-positive, white Swiss HIV Cohort Study participants. We included 103 individuals with a first, physician-validated LTF and 206 controls matched on gender, whose duration of observation and whose antiretroviral therapy start dates were similar using incidence density sampling. Analyses of nongenetic LTF risk factors were based on 158 cases and 788 controls. Results.  A genetic risk score built from the 6 LTF-associated SNPs did not associate with LTF risk, in both models including and not including parental hip fracture history. The contribution of clinical LTF risk factors was limited in our dataset. Conclusions.  Genetic LTF markers with a modest effect size in the general population do not improve fracture prediction in persons with HIV, in whom clinical LTF risk factors are prevalent in both cases and controls.

  9. Contribution of Genetic Background and Clinical Risk Factors to Low-Trauma Fractures in Human Immunodeficiency Virus (HIV)-Positive Persons: The Swiss HIV Cohort Study

    PubMed Central

    Junier, Thomas; Rotger, Margalida; Biver, Emmanuel; Ledergerber, Bruno; Barceló, Catalina; Bartha, Istvan; Kovari, Helen; Schmid, Patrick; Fux, Christoph; Bernasconi, Enos; Brun del Re, Claudia; Weber, Rainer; Fellay, Jacques; Tarr, Philip E.

    2016-01-01

    Background. The impact of human genetic background on low-trauma fracture (LTF) risk has not been evaluated in the context of human immunodeficiency virus (HIV) and clinical LTF risk factors. Methods. In the general population, 6 common single-nucleotide polymorphisms (SNPs) associate with LTF through genome-wide association study. Using genome-wide SNP arrays and imputation, we genotyped these SNPs in HIV-positive, white Swiss HIV Cohort Study participants. We included 103 individuals with a first, physician-validated LTF and 206 controls matched on gender, whose duration of observation and whose antiretroviral therapy start dates were similar using incidence density sampling. Analyses of nongenetic LTF risk factors were based on 158 cases and 788 controls. Results. A genetic risk score built from the 6 LTF-associated SNPs did not associate with LTF risk, in both models including and not including parental hip fracture history. The contribution of clinical LTF risk factors was limited in our dataset. Conclusions. Genetic LTF markers with a modest effect size in the general population do not improve fracture prediction in persons with HIV, in whom clinical LTF risk factors are prevalent in both cases and controls. PMID:27419173

  10. Body mass index is not a clinically meaningful predictor of patient reported outcomes of primary hip replacement surgery: prospective cohort study

    PubMed Central

    Judge, Andy; Batra, Rajbir N; Thomas, Geraint; Beard, David; Javaid, M Kassim; Murray, David; Dieppe, Paul A; Dreinhoefer, Karsten; Peter-Guenther, Klaus; Field, Richard; Cooper, Cyrus; Arden, Nigel K

    2014-01-01

    Objectives To describe whether body mass index (BMI) is a clinically meaningful predictor of patient reported outcomes following primary total hip replacement (THR) surgery Design Combined data from prospective cohort studies. We obtained information from four cohorts of patients receiving primary THR for osteoarthritis: Exeter Primary Outcomes Study (n=1431); EUROHIP (n=1327); Elective Orthopaedic Centre (n=2832); and St. Helier (n=787). The exposure of interest was pre-operative BMI. Confounding variables included: age, sex, SF-36 mental health, comorbidities, fixed flexion, analgesic use, college education, OA in other joints, expectation of less pain, radiographic K&L grade, ASA grade, years of hip pain. The primary outcome was the Oxford Hip Score (OHS). Regression models describe the association of BMI on outcome adjusting for all confounders. Results For a 5-unit increase in BMI, the attained 12-month OHS decreases by 0.78 points 95%CI (0.27 to 1.28), p-value 0.001. Compared to people of normal BMI (20 to 25), those in the obese class II (BMI 35 to 40) would have a 12-month OHS that is 2.34 points lower. Although statistically significant this effect is small and not clinically meaningful in contrast to the substantial change in OHS seen across all BMI groupings. In obese class II patients achieved a 22.2 point change in OHS following surgery. Conclusions Patients achieved substantial change in OHS after THR across all BMI categories, which greatly outweighs the small difference in attained post-operative score. The findings suggest BMI should not present a barrier to access THR in terms of PROMs. PMID:24418679

  11. Low frequency of genotypic resistance in HIV-1-infected patients failing an atazanavir-containing regimen: a clinical cohort study.

    PubMed

    Dolling, David I; Dunn, David T; Sutherland, Katherine A; Pillay, Deenan; Mbisa, Jean L; Parry, Chris M; Post, Frank A; Sabin, Caroline A; Cane, Patricia A

    2013-10-01

    To determine protease mutations that develop at viral failure for protease inhibitor (PI)-naive patients on a regimen containing the PI atazanavir. Resistance tests on patients failing atazanavir, conducted as part of routine clinical care in a multicentre observational study, were randomly matched by subtype to resistance tests from PI-naive controls to account for natural polymorphisms. Mutations from the consensus B sequence across the protease region were analysed for association and defined using the IAS-USA 2011 classification list. Four hundred and five of 2528 (16%) patients failed therapy containing atazanavir as a first PI over a median (IQR) follow-up of 1.76 (0.84-3.15) years and 322 resistance tests were available for analysis. Recognized major atazanavir mutations were found in six atazanavir-experienced patients (P < 0.001), including I50L and N88S. The minor mutations most strongly associated with atazanavir experience were M36I, M46I, F53L, A71V, V82T and I85V (P < 0.05). Multiple novel mutations, I15S, L19T, K43T, L63P/V, K70Q, V77I and L89I/T/V, were also associated with atazanavir experience. Viral failure on atazanavir-containing regimens was not common and major resistance mutations were rare, suggesting that adherence may be a major contributor to viral failure. Novel mutations were described that have not been previously documented.

  12. The Effect of Esmolol on Tissue Perfusion and Clinical Prognosis of Patients with Severe Sepsis: A Prospective Cohort Study

    PubMed Central

    Wang, Kaiyu; Xu, Jingqing; Gong, Shurong; Ye, Yong; Chen, Kaihua; Chen, Wei

    2016-01-01

    Purpose. This study was aimed at investigating the effect of esmolol on tissue perfusion and the clinical prognosis of patients with severe sepsis. Materials and Methods. One hundred fifty-one patients with severe sepsis were selected and divided into the esmolol group (n = 75) or the control group (n = 76), who received conventional antiseptic shock treatment. The esmolol group received a continuous infusion of esmolol via a central venous catheter, and their heart rate (HR) was maintained at 70–100 bpm over 72 hours. Results. The HR of all patients reached the target level within 72 hours of treatment for both groups. The effect of esmolol on PvaCO2 was only significant at 48 hours (P < 0.05). ScvO2 increased in the esmolol group and decreased in the control group (P < 0.01). Lac showed a linear downward trend over the treatment time, but the reduction was more significant in the control group at 48 hours (P < 0.05) between the two groups. Kaplan-Meier analysis showed a significantly shorter duration of mechanical ventilation in the esmolol group than in the control group (P < 0.05). Conclusions. Esmolol reduced the duration of mechanical ventilation in patients with severe sepsis, with no significant effect on circulatory function or tissue perfusion. PMID:27652257

  13. Clinical risk factors for pre-eclampsia determined in early pregnancy: systematic review and meta-analysis of large cohort studies.

    PubMed

    Bartsch, Emily; Medcalf, Karyn E; Park, Alison L; Ray, Joel G

    2016-04-19

    To develop a practical evidence based list of clinical risk factors that can be assessed by a clinician at ≤ 16 weeks' gestation to estimate a woman's risk of pre-eclampsia. Systematic review and meta-analysis of cohort studies. PubMed and Embase databases, 2000-15. Cohort studies with ≥ 1000 participants that evaluated the risk of pre-eclampsia in relation to a common and generally accepted clinical risk factor assessed at ≤ 16 weeks' gestation. Two independent reviewers extracted data from included studies. A pooled event rate and pooled relative risk for pre-eclampsia were calculated for each of 14 risk factors. There were 25,356,688 pregnancies among 92 studies. The pooled relative risk for each risk factor significantly exceeded 1.0, except for prior intrauterine growth restriction. Women with antiphospholipid antibody syndrome had the highest pooled rate of pre-eclampsia (17.3%, 95% confidence interval 6.8% to 31.4%). Those with prior pre-eclampsia had the greatest pooled relative risk (8.4, 7.1 to 9.9). Chronic hypertension ranked second, both in terms of its pooled rate (16.0%, 12.6% to 19.7%) and pooled relative risk (5.1, 4.0 to 6.5) of pre-eclampsia. Pregestational diabetes (pooled rate 11.0%, 8.4% to 13.8%; pooled relative risk 3.7, 3.1 to 4.3), prepregnancy body mass index (BMI) >30 (7.1%, 6.1% to 8.2%; 2.8, 2.6 to 3.1), and use of assisted reproductive technology (6.2%, 4.7% to 7.9%; 1.8, 1.6 to 2.1) were other prominent risk factors. There are several practical clinical risk factors that, either alone or in combination, might identify women in early pregnancy who are at "high risk" of pre-eclampsia. These data can inform the generation of a clinical prediction model for pre-eclampsia and the use of aspirin prophylaxis in pregnancy. 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.

  14. Risk factors and a clinical prediction model for low maternal thyroid function during early pregnancy: two population-based prospective cohort studies.

    PubMed

    Korevaar, Tim I M; Nieboer, Daan; Bisschop, Peter H L T; Goddijn, Mariette; Medici, Marco; Chaker, Layal; de Rijke, Yolanda B; Jaddoe, Vincent W V; Visser, Theo J; Steyerberg, Ewout W; Tiemeier, Henning; Vrijkotte, Tanja G; Peeters, Robin P

    2016-12-01

    Low maternal thyroid function during early pregnancy is associated with various adverse outcomes including impaired neurocognitive development of the offspring, premature delivery and abnormal birthweight. To aid doctors in the risk assessment of thyroid dysfunction during pregnancy, we set out to investigate clinical risk factors and derive a prediction model based on easily obtainable clinical variables. In total, 9767 women during early pregnancy (≤18 week) were selected from two population-based prospective cohorts: the Generation R Study (N = 5985) and the ABCD study (N = 3782). We aimed to investigate the association of easily obtainable clinical subject characteristics such as maternal age, BMI, smoking status, ethnicity, parity and gestational age at blood sampling with the risk of low free thyroxine (FT4) and elevated thyroid stimulating hormone (TSH), determined according to the 2·5th-97·5th reference range in TPOAb negative women. BMI, nonsmoking and ethnicity were risk factors for elevated TSH levels; however, the discriminative ability was poor (range c-statistic of 0·57-0·60). Sensitivity analysis showed that addition of TPOAbs to the model yielded a c-statistic of 0·73-0·75. Maternal age, BMI, smoking, parity and gestational age at blood sampling were risk factors for low FT4, which taken together provided adequate discrimination (range c-statistic of 0·72-0·76). Elevated TSH levels depend predominantly on TPOAb levels, and prediction of elevated TSH levels is not possible with clinical characteristics only. In contrast, the validated clinical prediction model for FT4 had high discriminative value to assess the likelihood of low FT4 levels. © 2016 John Wiley & Sons Ltd.

  15. Clinical and economic impact of urinary tract infections caused by ESBL-producing Escherichia coli requiring hospitalization: A matched cohort study.

    PubMed

    Esteve-Palau, E; Solande, G; Sánchez, F; Sorlí, L; Montero, M; Güerri, R; Villar, J; Grau, S; Horcajada, J P

    2015-12-01

    To analyze the clinical and economic impact of urinary tract infections (UTIs) caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli requiring hospitalization. Matched cohort study including adults with UTI caused by ESBL-producing E. coli admitted to a tertiary care hospital in Barcelona, Spain, between August 2010 and July 2013. Demographic, clinical and economic data were analyzed. One hundred and twenty episodes of UTI were studied: 60 due to ESBL-producing E. coli and 60 due to non-ESBL-producing E. coli. Bivariate analysis showed that prior antimicrobial treatment (p = 0.007) and ESBL production (p < 0.001) were related to clinical failure during the first 7 days. Multivariate analysis selected ESBL as the sole risk factor for clinical failure (p = 0.002). Regarding the economic impact of infections caused by ESBL-producing E. coli, an ESBL-producing infection cost more than a non-ESBL-producing E. coli infection (mean €4980 vs. €2612). Looking at hospital expenses separately, the total pharmacy costs and antibiotic costs of ESBL infections were considerably higher than for non-ESBL infections (p < 0.001), as was the need for outpatient parenteral antibiotic therapy (OPAT) and its related costs. Multivariate analysis performed for the higher costs of UTI episodes found statistically significant differences for males (p = 0.004), chronic renal failure (p = 0.025), ESBL production (p = 0.008) and OPAT (p = 0.009). UTIs caused by EBSL-producing E. coli requiring hospital admission are associated with worse clinical and economic outcomes. Copyright © 2015 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

  16. Improved outcome in acute myeloid leukemia patients enrolled in clinical trials: A national population-based cohort study of Danish intensive chemotherapy patients

    PubMed Central

    Østgård, Lene Sofie Granfeldt; Nørgaard, Mette; Sengeløv, Henrik; Medeiros, Bruno C.; Kjeldsen, Lars; Overgaard, Ulrik Malthe; Severinsen, Marianne Tang; Marcher, Claus Werenberg; Jensen, Morten Krogh; Nørgaard, Jan Maxwell

    2016-01-01

    Clinical trials are critical to improve AML treatment. It remains, however, unclear if clinical trial participation per se affects prognosis and to what extent the patients selected for trials differ from those of patients receiving intensive therapy off-trial. We conducted a population-based cohort study of newly diagnosed Danish AML patients treated with intensive chemotherapy between 2000–2013. We estimated accrual rates and compared characteristics, complete remission (CR) rates, and relative risks (RRs) of death at 90-day, 1-year, and 3-years in clinical trial patients to patients treated off-trial. Of 867 patients, 58.3% (n = 504) were included in a clinical trial. Accrual rates were similar across age groups (p = 0.55). Patients with poor performance status, comorbidity, therapy-related and secondary AML were less likely to be enrolled in trials. CR rates were 80.2% in trial-patients versus 68.6% in patients treated off- trial. Also, trial-patients had superior survival at 1-year; 72%, vs. 54% (adjusted RR of death 1.28(CI = 1.06–1.54)), and at 3 years; 45% vs. 29% (adjusted RR 1.14(CI = 1.03–1.26)) compared to patients treated off-trial. Despite high accrual rates, patients enrolled in clinical trials had a favorable prognostic profile and a better survival than patients treated off-trial. In conclusion, all trial results should be extrapolated with caution and population-based studies of “real world patients” have a prominent role in examining the prognosis of AML. PMID:27732947

  17. Symptoms and Needs of Head and Neck Cancer Patients at Diagnosis of Incurability - Prevalences, Clinical Implications, and Feasibility of a Prospective Longitudinal Multicenter Cohort Study.

    PubMed

    Alt-Epping, Bernd; Seidel, Wiebke; Vogt, Jeannette; Mehnert, Anja; Thomas, Michael; van Oorschot, Birgitt; Wolff, Hendrik; Schliephake, Henning; Canis, Martin; Dröge, Leif H; Nauck, Friedemann; Lordick, Florian

    2016-01-01

    Little is known about the physical symptoms and psychosocial burden of patients at the time of diagnosis of an incurable situation, although cancer treatment guidelines demand early assessment and integration of palliative care concepts, beginning from the diagnosis of incurability. Therefore, we initiated a prospective longitudinal multicenter cohort study assessing the symptoms and needs of patients suffering from incurable cancer (various entities), from the time of diagnosing incurability (i.e., before palliative anticancer treatment was initiated) and in 3-monthly intervals thereafter, by using validated self-reporting tools. Here, we focus on patients with head and neck cancer and present preliminary results on symptoms and need prevalences, on clinical implications, and on the feasibility of a methodologically complex assessment procedure in a particularly vulnerable study population. 22 patients completed the first visit. The Eastern Cooperative Oncology Group (ECOG) performance scores and most physical symptoms and psychosocial items varied between the extremes, from a virtually uncompromised condition to extremely perceived symptoms and needs. If intense face-to-face study support was provided, the study concept proved to be feasible, despite the complexity of assessment, problems in interdisciplinary and patient communication, comorbidities, and early death from complications. The striking variability in the perceived symptom and need intensities requires a highly individualized approach. For clinical purposes, a less complex screening procedure would be desirable, in order to enable a routine, early and comprehensive support, including palliative care services. © 2016 S. Karger GmbH, Freiburg.

  18. Prediction of citation counts for clinical articles at two years using data available within three weeks of publication: retrospective cohort study

    PubMed Central

    2008-01-01

    Objective To determine if citation counts at two years could be predicted for clinical articles that pass basic criteria for critical appraisal using data within three weeks of publication from external sources and an online article rating service. Design Retrospective cohort study. Setting Online rating service, Canada. Participants 1274 articles from 105 journals published from January to June 2005, randomly divided into a 60:40 split to provide derivation and validation datasets. Main outcome measures 20 article and journal features, including ratings of clinical relevance and newsworthiness, routinely collected by the McMaster online rating of evidence system, compared with citation counts at two years. Results The derivation analysis showed that the regression equation accounted for 60% of the variation (R2=0.60, 95% confidence interval 0.538 to 0.629). This model applied to the validation dataset gave a similar prediction (R2=0.56, 0.476 to 0.596, shrinkage 0.04; shrinkage measures how well the derived equation matches data from the validation dataset). Cited articles in the top half and top third were predicted with 83% and 61% sensitivity and 72% and 82% specificity. Higher citations were predicted by indexing in numerous databases; number of authors; abstraction in synoptic journals; clinical relevance scores; number of cited references; and original, multicentred, and therapy articles from journals with a greater proportion of articles abstracted. Conclusion Citation counts can be reliably predicted at two years using data within three weeks of publication. PMID:18292132

  19. Low frequency of genotypic resistance in HIV-1-infected patients failing an atazanavir-containing regimen: a clinical cohort study

    PubMed Central

    Dolling, David I.; Dunn, David T.; Sutherland, Katherine A.; Pillay, Deenan; Mbisa, Jean L.; Parry, Chris M.; Post, Frank A.; Sabin, Caroline A.; Cane, Patricia A.; Aitken, Celia; Asboe, David; Webster, Daniel; Cane, Patricia; Castro, Hannah; Dunn, David; Dolling, David; Chadwick, David; Churchill, Duncan; Clark, Duncan; Collins, Simon; Delpech, Valerie; Geretti, Anna Maria; Goldberg, David; Hale, Antony; Hué, Stéphane; Kaye, Steve; Kellam, Paul; Lazarus, Linda; Leigh-Brown, Andrew; Mackie, Nicola; Orkin, Chloe; Rice, Philip; Pillay, Deenan; Phillips, Andrew; Sabin, Caroline; Smit, Erasmus; Templeton, Kate; Tilston, Peter; Tong, William; Williams, Ian; Zhang, Hongyi; Zuckerman, Mark; Greatorex, Jane; Wildfire, Adrian; O'Shea, Siobhan; Mullen, Jane; Mbisa, Tamyo; Cox, Alison; Tandy, Richard; Hale, Tony; Fawcett, Tracy; Hopkins, Mark; Ashton, Lynn; Booth, Claire; Garcia-Diaz, Ana; Shepherd, Jill; Schmid, Matthias L.; Payne, Brendan; Hay, Phillip; Rice, Phillip; Paynter, Mary; Bibby, David; Kirk, Stuart; MacLean, Alasdair; Gunson, Rory; Coughlin, Kate; Fearnhill, Esther; Fradette, Lorraine; Porter, Kholoud; Ainsworth, Jonathan; Anderson, Jane; Babiker, Abdel; Fisher, Martin; Gazzard, Brian; Gilson, Richard; Gompels, Mark; Hill, Teresa; Johnson, Margaret; Kegg, Stephen; Leen, Clifford; Nelson, Mark; Palfreeman, Adrian; Post, Frank; Sachikonye, Memory; Schwenk, Achim; Walsh, John; Huntington, Susie; Jose, Sophie; Thornton, Alicia; Glabay, Adam; Orkin, C.; Garrett, N.; Lynch, J.; Hand, J.; de Souza, C.; Fisher, M.; Perry, N.; Tilbury, S.; Gazzard, B.; Nelson, M.; Waxman, M.; Asboe, D.; Mandalia, S.; Delpech, V.; Anderson, J.; Munshi, S.; Korat, H.; Welch, J.; Poulton, M.; MacDonald, C.; Gleisner, Z.; Campbell, L.; Gilson, R.; Brima, N.; Williams, I.; Schwenk, A.; Ainsworth, J.; Wood, C.; Miller, S.; Johnson, M.; Youle, M.; Lampe, F.; Smith, C.; Grabowska, H.; Chaloner, C.; Puradiredja, D.; Walsh, J.; Weber, J.; Ramzan, F.; Mackie, N.; Winston, A.; Leen, C.; Wilson, A.; Allan, S.; Palfreeman, A.; Moore, A.; Wakeman, K.

    2013-01-01

    Objectives To determine protease mutations that develop at viral failure for protease inhibitor (PI)-naive patients on a regimen containing the PI atazanavir. Methods Resistance tests on patients failing atazanavir, conducted as part of routine clinical care in a multicentre observational study, were randomly matched by subtype to resistance tests from PI-naive controls to account for natural polymorphisms. Mutations from the consensus B sequence across the protease region were analysed for association and defined using the IAS-USA 2011 classification list. Results Four hundred and five of 2528 (16%) patients failed therapy containing atazanavir as a first PI over a median (IQR) follow-up of 1.76 (0.84–3.15) years and 322 resistance tests were available for analysis. Recognized major atazanavir mutations were found in six atazanavir-experienced patients (P < 0.001), including I50L and N88S. The minor mutations most strongly associated with atazanavir experience were M36I, M46I, F53L, A71V, V82T and I85V (P < 0.05). Multiple novel mutations, I15S, L19T, K43T, L63P/V, K70Q, V77I and L89I/T/V, were also associated with atazanavir experience. Conclusions Viral failure on atazanavir-containing regimens was not common and major resistance mutations were rare, suggesting that adherence may be a major contributor to viral failure. Novel mutations were described that have not been previously documented. PMID:23711895

  20. Clinical features and outcomes of tuberculosis in transplant recipients as compared with the general population: a retrospective matched cohort study.

    PubMed

    Benito, N; García-Vázquez, E; Horcajada, J P; González, J; Oppenheimer, F; Cofán, F; Ricart, M J; Rimola, A; Navasa, M; Rovira, M; Roig, E; Pérez-Villa, F; Cervera, C; Moreno, A

    2015-07-01

    There are no previous studies comparing tuberculosis in transplant recipients (TRs) with other hosts. We compared the characteristics and outcomes of tuberculosis in TRs and patients from the general population. Twenty-two TRs who developed tuberculosis from 1996 through 2010 at a tertiary hospital were included. Each TR was matched by age, gender and year of diagnosis with four controls selected from among non-TR non-human immunodeficiency virus patients with tuberculosis. TRs (21 patients, 96%) had more factors predisposing to tuberculosis than non-TRs (33, 38%) (p <0.001). Pulmonary tuberculosis was more common in non-TRs (77 (88%) vs. 12 TRs (55%); p 0.001); disseminated tuberculosis was more frequent in TRs (five (23%) vs. four non-TRs (5%); p 0.005). Time from clinical suspicion of tuberculosis to definitive diagnosis was longer in TRs (median of 14 days) than in non-TRs (median of 0 days) (p <0.001), and invasive procedures were more often required (12 (55%) TRs and 15 (17%) non-TRs, respectively; p 0.001). Tuberculosis was diagnosed post-mortem in three TRs (14%) and in no non-TRs (p <0.001). Rates of toxicity associated with antituberculous therapy were 38% in TRs (six patients) and 10% (seven patients) in non-TRs (p 0.014). Tuberculosis-related mortality rates in TRs and non-TRs were 18% and 6%, respectively (p 0.057). The adjusted Cox regression analysis showed that the only predictor of tuberculosis-related mortality was a higher number of organs with tuberculosis involvement (adjusted hazard ratio 8.6; 95% CI 1.2-63). In conclusion, manifestations of tuberculosis in TRs differ from those in normal hosts. Post-transplant tuberculosis resists timely diagnosis, and is associated with a higher risk of death before a diagnosis can be made.

  1. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

    PubMed

    Andreasen, Rikke Asmussen; Kristensen, Lars Erik; Ellingsen, Torkell; Christensen, Robin; Baraliakos, Xenofon; Wied, Jimmi; Aalykke, Claus; Ulstrup, Thomas; Schiøttz-Christensen, Berit; Horn, Hans Christian; Emamifar, Amir; Duerlund, Bent; Fischer, Lars; Hansen, Inger Marie Jensen

    2017-07-10

    Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response. We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score. The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre

  2. Clinical and epidemiological differences between men and women with systemic sclerosis: a study in a Spanish systemic sclerosis cohort and literature review.

    PubMed

    Freire, Mayka; Rivera, Alberto; Sopeña, Bernardo; Tolosa Vilella, Carles; Guillén-Del Castillo, Alfredo; Colunga Argüelles, Dolores; Callejas Rubio, Jose Luis; Rubio Rivas, Manuel; Trapiella Martínez, Luis; Todolí Parra, Jose Antonio; Rodríguez Carballeira, Mónica; Iniesta Arandia, Nerea; García Hernández, Francisco José; Egurbide Arberas, María Victoria; Sáez Comet, Luis; Vargas Hitos, Jose Antonio; Ríos Blanco, Juan José; Marín Ballvé, Adela; Pla Salas, Xavier; Madroñero Vuelta, Ana Belén; Ruiz Muñoz, Manuel; Fonollosa Pla, Vicent; Simeón Aznar, Carmen Pilar

    2017-09-18

    The low overall prevalence of systemic sclerosis (SSc) and the low proportion of male patients have resulted in a scarcity of studies assessing sex differences in Ssc patients, and contradictory results have often been show among those studies that have been performed. A prospective study was conducted with the Spanish RESCLE register to analyse the influence of gender on survival of SSc patients. In total, 1506 SSc patients (1341 women, 165 men) were recruited from 21 centres. Older age at onset (OR 1.02), shorter time from onset to diagnosis (OR 0.96), smoking (OR 2.57), interstitial lung disease (ILD) (OR 1.58), less predisposition to sicca syndrome and to antinuclear antibody positivity (OR 0.29 and 0.43, respectively), and higher compliance with the ACR 1980 criteria (OR 1.79) were independently associated with the male sex. During follow-up, 30.4% of men versus 14.6% of women died (p<0.001). Survival at 10 years from the onset of symptoms was 75.3% for men and 92.9% for women (p<0.001), and the difference remained after selecting only SSc-related deaths (85.6% vs. 96.1%, p<0.001). The mortality predictive factors were diffuse SSc (OR 2.26), ILD (OR 1.82), digital ulcers (OR 1.38), tendon friction rubs (OR 1.74), male sex (OR 1.53), increased age at onset (OR 1.13) and isolated PH (considering only deaths from diagnosis), both in the overall (OR 3.63) and female cohorts (OR 3.97). The same risk factors were observed in the male cohort, except for isolated PH and ILD. The present study confirms the existence of epidemiological, clinical, laboratory and prognostic gender differences in systemic sclerosis patients.

  3. Clinical presentation and initial management of Black men and White men with prostate cancer in the United Kingdom: the PROCESS cohort study

    PubMed Central

    Evans, S; Metcalfe, C; Patel, B; Ibrahim, F; Anson, K; Chinegwundoh, F; Corbishley, C; Gillatt, D; Kirby, R; Muir, G; Nargund, V; Popert, R; Wilson, P; Persad, R; Ben-Shlomo, Y

    2009-01-01

    Background: In the United States, Black men have a higher risk of prostate cancer and worse survival than do White men, but it is unclear whether this is because of differences in diagnosis and management. We re-examined these differences in the United Kingdom, where health care is free and unlikely to vary by socioeconomic status. Methods: This study is a population-based retrospective cohort study of men diagnosed with prostate cancer with data on ethnicity, prognostic factors, and clinical care. A Delphi panel considered the appropriateness of investigations and treatments received. Results: At diagnosis, Black men had similar clinical stage and Gleason scores but higher age-adjusted prostate-specific antigen levels (geometric mean ratio 1.41, 95% confidence interval (95% CI): 1.15–1.73). Black men underwent more investigations and were more likely to undergo radical treatment, although this was largely explained by their younger age. Even after age adjustment, Black men were more likely to undergo a bone scan (odds ratio 1.37, 95% CI: 1.05–1.80). The Delphi analysis did not suggest differential management by ethnicity. Conclusions: This UK-based study comparing Black men with White men found no evidence of differences in disease characteristics at the time of prostate cancer diagnosis, nor of under-investigation or under-treatment in Black men. PMID:19935788

  4. The Neuropathology of Older Persons with and Without Dementia from Community versus Clinic Cohorts

    PubMed Central

    Schneider, Julie A.; Aggarwal, Neelum T.; Barnes, Lisa; Boyle, Patricia; Bennett, David A.

    2010-01-01

    Community-based cohorts of older persons may differ neuropathologically from clinic-based cohorts. This study investigated age-related pathologies in persons with and without dementia and included autopsied participants from two community-based cohorts, the Rush Religious Orders Study (n = 386) and the Memory and Aging Project (n = 195), and one clinic-based cohort, the Clinical Core of the Rush Alzheimer’s Disease Center (n = 392). Final clinical diagnoses included no cognitive impairment (n = 202), mild cognitive impairment (MCI) (n = 150), probable Alzheimer’s disease (AD) (n = 474), possible AD (n = 88), and other dementias (n = 59). Postmortem diagnoses included pathologic AD, cerebral infarcts, and Lewy body disease. Community-based persons with clinical AD had less severe AD pathology (p < 0.001) and had more cerebral infarcts (p < 0.001) compared to clinic-based persons. Additionally, community-based persons with MCI had more infarcts compared to clinic-based persons. Overall, there was a higher proportion of Lewy bodies and atypical pathologies in the clinic-based compared to the community-based cohorts (p < 0.001). Community-based persons with probable AD show less severe AD pathology and more often have infarcts and mixed pathologies; those with MCI more often have infarcts and mixed pathologies. Overall, clinic-based persons have more Lewy bodies and atypical pathologies. The spectrum of pathologies underlying cognitive impairment in clinic-based cohorts differs from community-based cohorts. PMID:19749406

  5. Clinical features of morphea patients with the pansclerotic subtype: a cross-sectional study from the Morphea in Adults and Children (MAC cohort)

    PubMed Central

    Kim, A; Marinkovich, N; Vasquez, R; Jacobe, HT

    2017-01-01

    Introduction Pansclerotic morphea is a poorly described form of morphea with little information on prevalence, demographics, and clinical features. Classification criteria for this subtype varies and the distinction from other forms of morphea such as extensive generalized morphea and pansclerotic morphea is not always clear. The purpose of this study was to clarify classification criteria for pansclerotic morphea by identifying its prevalence in the morphea in adults and children (MAC) cohort and describing its demographic and clinical features as compared with generalized morphea. Methods Patients who met predefined criteria for generalized and pansclerotic morphea were identified using a modified Laxer and Zulian classification system. Baseline demographic and clinical features of the patients were compiled and then analyzed for traits characteristic of pansclerotic morphea versus those of generalized morphea. 113 met criteria for inclusion – 13 pansclerotic and 100 generalized morphea type. Results Pansclerotic patients were more frequently male (46.2% vs. 6%, p<0.0001); had a shorter time to diagnosis (mean difference of 10.4 months [95% CI: 0.8-19.9 months], p=0.0332); higher rates of functional impairment (61.5% vs. 16%, p=0.0046); higher rates of deep involvement (61.5% vs. 17%, p=0.004); and higher average mRSS (mean difference of 10.8 points [95% CI: 5-16.6], p=0.0018), LoSDI (mean difference 28.3 [95% CI: 9-47.6], p=0.009), and PGA-D scores (mean difference 25.1 [95% CI: 0.3-50], p=0.048). Conclusions Our results suggest demographic and clinical features are sufficient to define the pansclerotic subtype as they represent a distinct clinical phenotype with a more rapidly progressive and severe course commonly accompanied by disability. Presence of features of the pansclerotic phenotype should alert practitioners to the possibility of significant morbidity and the need for early aggressive treatment. PMID:24293577

  6. Evidence That Onset of Clinical Psychosis Is an Outcome of Progressively More Persistent Subclinical Psychotic Experiences: An 8-Year Cohort Study

    PubMed Central

    Dominguez, M.D.G.; Wichers, Marieke; Lieb, Roselind; Wittchen, Hans-Ulrich; van Os, Jim

    2011-01-01

    This study examined the hypothesis that developmental expression of psychometric risk in the form of subclinical psychotic experiences in the general population is usually transitory but in some instances may become abnormally persistent and progress to a clinical psychotic state. A prospective cohort study was conducted in a general population sample of 845 adolescents, aged 14–17 years, in Munich, Germany (Early Developmental Stages of Psychopathology Study). Expression of psychosis was assessed 4 times (T0–T3) over a period of 8.4 years. Transition from subclinical psychosis at T0–T2 to clinical psychosis in terms of impairment at T3 was examined as a function of the level of prior persistence of subclinical psychosis (present never, once, twice, or thrice). The more the subclinical psychosis persisted over the period T0–T2, the greater the risk of transition to clinical psychosis at T3 in a dose-response fashion (subclinical psychosis expression once over T0–T2: odds ratio [OR] = 1.5 [95% confidence interval {CI} = 0.6–3.7], posttest probability [PP] = 5%; twice: OR = 5.0 [95% CI = 1.6–15.9], PP = 16%; at all 3 measurements: OR = 9.9 [95% CI = 2.5–39.8], PP = 27%). Of all clinical psychosis at T3, more than a third (38.3%) was preceded by subclinical psychotic experiences at least once and a fifth (19.6%) at least twice. Consequently, a significant proportion of psychotic disorder may be conceptualized as the rare poor outcome of a common developmental phenotype characterized by persistence of psychometrically detectable subclinical psychotic experiences. This may be summarized descriptively as a psychosis proneness-persistence-impairment model of psychotic disorder. PMID:19460881

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

    PubMed Central

    Mikocka-Walus, Antonina A; Turnbull, Deborah A; Moulding, Nicole T; Wilson, Ian G; Holtmann, Gerald J; Andrews, Jane M

    2008-01-01

    Background Whether there is a temporal relationship between psychological problems and clinical outcomes in patients with diseases of the digestive tract has not been widely researched. Thus, our aims were 1) To observe and compare prospectively clinical outcomes in relation to psychological co-morbidity in patients with inflammatory bowel disease (IBD), irritable bowel syndrome (IBS) and chronic hepatitis C (HCV) and, 2) To test the hypothesis that patients with psychological co-morbidities are less likely to have a satisfactory response to standard treatment at 12 months. Methods Overall, 139 patients were enrolled in this observational cohort prospective study. Over the ensuing year, physical and psychological measures were made at baseline and after 12 months (HADS, SCL90, SF-12 and disease activity measures). A logistic regression was conducted to observe any relationship between baseline characteristics and patients' clinical outcomes after 12 months. Results Overall, there was no relationship between psychological status and quality of life at baseline and relapse at 12 months (p > 0.05). However, patients with inactive disease at baseline were at lower risk of relapse after 12 months (OR = 0.046, CI: 0.012–0.178). No significant relationship was found between psychological problems such as depression/anxiety and a total number of relapses in the IBD group. However, interestingly, patients with an active disease at baseline tended to have a greater number of relapses (OR = 3.07, CI: 1.650–5.738) and CD participants were found at lower risk of relapse than UC participants (OR = 0.382, CI: 0.198–0.736). Conclusion In contrast to previous investigations, this study suggests that there is no temporal relationship between psychological problems at baseline and clinical outcomes over time. Longer and larger prospective studies are needed to better understand this result. PMID:18538012

  8. Clinical characteristics of inflammatory ocular disease in anti-neutrophil cytoplasmic antibody associated vasculitis: a retrospective cohort study.

    PubMed

    Ungprasert, Patompong; Crowson, Cynthia S; Cartin-Ceba, Rodrigo; Garrity, James A; Smith, Wendy M; Specks, Ulrich; Matteson, Eric L; Makol, Ashima

    2017-10-01

    To characterize the clinical correlates and outcome of inflammatory ocular disease (IOD) among patients with ANCA-associated vasculitides (AAV). Medical records of potential cases of AAV seen at Mayo Clinic from 2003 to 2013, inclusive, were reviewed to identify confirmed cases meeting the diagnosis of AAV using the Chapel Hill Consensus Conference 2012 descriptors. Records of confirmed cases of AAV were then further reviewed for IOD, and clinical characteristics, treatment and outcomes abstracted. A total of 1171 confirmed cases of AAV were identified of which 183 patients (mean age 49.0 years; 51% female; 95% Caucasian) had IOD. The most common manifestation of IOD was injection of the eye (57%) followed by eye pain (46%) and visual acuity loss (18%). Scleritis was the most common type of IOD (22%) followed by episcleritis (21%), orbital inflammation (18%), lacrimal duct stenosis (10%) and uveitis (9%). Oral glucocorticoids were used to treat IOD in the majority of patients (96%). CYC and rituximab were the most frequently used immunosuppressive agents (54 and 36%, respectively). Of those with orbital inflammation, 52% underwent therapeutic surgical intervention. Clinical remission of IOD was achieved in 91% of patients but relapses were seen in 23%. Significant visual acuity loss was observed in only six patients. IOD is a common manifestation of AAV and seen in about 16% of patients with AAV. Scleritis, episcleritis and orbital inflammation are the most common subtypes. Most patients respond well to glucocorticoids and immunosuppression, but relapse of IOD is common.

  9. Reversion of autoimmune lymphoproliferative syndrome with an antimalarial drug: preliminary results of a clinical cohort study and molecular observations.

    PubMed

    van der Werff Ten Bosch, Jutte; Schotte, Peter; Ferster, Alice; Azzi, Nadira; Boehler, Thomas; Laurey, Geneviève; Arola, Mikko; Demanet, Christian; Beyaert, Rudi; Thielemans, Kris; Otten, Jacques

    2002-04-01

    Autoimmune lymphoproliferative syndrome (ALPS) is a paediatric disease characterized by lymphoproliferation and autoimmunity. Most patients are known to carry heterozygous mutations of the TNFRSF6 gene leading to diminished Fas-mediated apoptosis and failure of activated lymphocytes to undergo apoptosis. A subgroup of patients without the TNFRSF6 gene mutation has similar defective apoptosis and clinical features. No effective treatment has been reported so far. Glucocorticoids, intravenous immunoglobulin and/or immunosuppressive drugs have usually led to only transient clinical improvement. Seven ALPS patients (two type Ia and five type III) were treated with the antimalarial drug Fansidar. No toxicity was observed. An objective response was seen in six of them and, in two, the treatment was stopped without reappearance of the symptoms. Moreover, a marked decrease in interleukin-10 levels was observed in two patients during the treatment. We found that the drug induced apoptosis in activated lymphocytes through activation of the mitochondrial apoptotic pathway.

  10. Influence of the bacterial phenotypes on the clinical manifestations in Klebsiella pneumoniae bacteremia patients: A retrospective cohort study.

    PubMed

    Togawa, Atsushi; Toh, Hiromi; Onozawa, Kyoko; Yoshimura, Michinobu; Tokushige, Chiemi; Shimono, Nobuyuki; Takata, Tohru; Tamura, Kazuo

    2015-07-01

    Ninety-four episodes of Klebsiella pneumoniae bloodstream infection were identified at a university hospital in Japan. After excluding extended-spectrum beta lactamase-producing strains, 83 blood isolates from these patients were assayed in terms of their bacterial phenotypes such as the mucoid and hypermucoviscosity phenotypes. Bacterial phenotypes were correlated with the patients' clinical manifestations. The hypermucoviscosity phenotype was significantly associated with septic shock at the onset of infections (odds ratio, 15.92; 95% confidence interval, 1.27-468.12), but was not associated with liver abscess formation. Mortality was determined by the presence of septic shock. RmpA gene was associated with the induction of the hypermucoviscosity phenotype. These results reveal unique roles of bacterial phenotypes on the patient's clinical condition in K. pneumoniae bacteremia.

  11. Socio-demographic, clinical, and health-related factors associated with breast reconstruction - A nationwide cohort study.

    PubMed

    Bodilsen, Anne; Christensen, Søren; Christiansen, Peer; Damsgaard, Tine E; Zachariae, Robert; Jensen, Anders B

    2015-10-01

    We collected registry- and questionnaire-based data on socio-economic and health status, tumor- and treatment-related variables, and explored associations with receipt of reconstruction and information about treatment options in a nationwide cohort of Danish women, treated for primary breast cancer. A total of 594 women were available for analysis, 240 (40%) of these received reconstruction. Multivariate analyses showed that receipt of reconstruction was associated with 1) younger age at time of primary surgery (<36 years: OR = 10.04, [3.80-26.50], p < 0.001 and 36-49 years: OR = 2.48, [1.73-3.56], p < 0.001, compared to 50-60 year olds), 2) having received radiotherapy (OR = 0.57, [0.40-0.81], p = 0.002), 3) high income (Second quartile: OR = 1.74, [1.05-2.90], p = 0.033 and fourth quartile: OR = 2.18, [1.31-3.62], p = 0.003, compared with the lowest income quartile), and 4) ethnicity other than Danish (OR = 6.32, [1.58-25.36], p = 0.009). Health-related factors at the time of primary surgery (physical functioning, body mass index, smoking, use of alcohol, and comorbidity) were not associated with reconstruction. Odds of having received information about the option of reconstruction decreased by 8% per year of age in the multivariate analysis (OR = 0.92, [0.87-0.97], p = 0.003). In conclusion, younger age and not having been treated with radiotherapy was independently associated with reconstruction. In addition, higher income was also found to be associated with reconstruction despite free and equal access to reconstruction and healthcare in Denmark. Healthrelated factors were not associated with the use of reconstruction following mastectomy. Our findings underscore the need for physicians to ensure optimal level of information and accessibility to reconstruction for all women regardless of age, treatment, and socio-economic status. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Clinical Features and Treatment Outcomes of Patients with Drug-Resistant and Drug-Sensitive Tuberculosis: A Historical Cohort Study in Porto Alegre, Brazil

    PubMed Central

    Micheletti, Vania Celina Dezoti; Kritski, Afrânio Lineu; Braga, José Ueleres

    2016-01-01

    Purpose To evaluate the clinical features and treatment outcomes of patients with pulmonary tuberculosis, stratified by level of drug resistance. Methods This was a historical cohort study based on data from the II National Anti-Tuberculosis Drug Resistance Survey (2006–2007) collected at eight participating health care facilities in Porto Alegre, southern Brazil. The cohort was followed for 3 years after the start of treatment. Results Of 299 cases of smear-positive pulmonary tuberculosis included in the study, 216 (72.2%) were diagnosed at five public primary health care units and 83 (27.8%) at three public hospitals. Among these cases, the prevalence of drug-resistant tuberculosis was 14.4%, and that of multidrug-resistant tuberculosis was 4.7%. Overall, 32.0% of drug-resistant and 2.0% of multidrug-resistant cases occurred in previously treated patients. The most common comorbidity in the sample was HIV infection (26.2%). There was no association between drug-resistant or multidrug-resistant tuberculosis and sociodemographic variables. Cure was achieved in 66.7% of patients, and the default rate was 21.2%. The 2-month sputum conversion rate was 34.2%, and the relapse rate was 16.9%. Patients with drug-resistant tuberculosis had lower rates of cure (45.2%) and 2-month sputum conversion (25%), as well as a higher relapse rate (30.7%). Conclusion These results highlight the urgent need for a more effective TB control program in this geographical setting, with a major emphasis on treatment of drug-resistant and multidrug-resistant tuberculosis. PMID:27505633

  13. Clinical Presentation, Etiology and Outcome of Infective Endocarditis in the 21st Century: The International Collaboration on Endocarditis-Prospective Cohort Study

    PubMed Central

    Murdoch, David R.; Corey, G. Ralph; Hoen, Bruno; Miró, José M.; Fowler, Vance G.; Bayer, Arnold S.; Karchmer, Adolf W.; Olaison, Lars; Pappas, Paul A.; Moreillon, Philippe; Chambers, Stephen T.; Chu, Vivian H.; Falcó, Vicenç; Holland, David J.; Jones, Philip; Klein, John L.; Raymond, Nigel J.; Read, Kerry M.; Tripodi, Marie Francoise; Utili, Riccardo; Wang, Andrew; Woods, Christopher W.; Cabell, Christopher H.

    2013-01-01

    Background The aim of this study was to provide a contemporary picture of the presentation, etiology and outcome of infective endocarditis (IE) in a large patient cohort from multiple locations worldwide. Methods Prospective cohort study of 2781 adults with definite IE admitted to 58 hospitals in 25 countries between June 2000 and September 2005. Results The median age of the cohort was 57.9 (IQR 43.2–71.8) years and 72% had native valve IE. Most (77%) patients presented early in the disease (<30 days) with few of the classic clinical hallmarks of IE. Recent health-care exposure was found in one quarter of patients. Staphylococcus aureus was the most common pathogen (31%). Mitral (41%) and aortic (38%) valves were infected most commonly. Complications were common: stroke (17%); embolization other than stroke (23%); heart failure (32%) and intracardiac abscess (14%). Surgical therapy was common (48%) and in-hospital mortality remained high (18%). Prosthetic valve involvement (OR 1.47, 95%CI 1.13–1.90), increasing age (OR 1.30, 95%CI 1.17–1.46 per 10-year interval), pulmonary edema (OR 1.79, 95%CI 1.39–2.30), S. aureus infection (OR 1.54, 95%CI 1.14–2.08), coagulase-negative staphylococcal infection (OR 1.50, 95%CI 1.07–2.10), mitral valve vegetation (OR 1.34, 95%CI 1.06–1.68), and paravalvular complications (OR 2.25, 95%CI 1.64–3.09) were associated with increased risk of in-hospital death, while viridans streptococcal infection (OR 0.52, 95%CI 0.33–0.81) and surgery (OR 0.61, 95%CI 0.44–0.83) were associated with decreased risk. Conclusions In the early 21st century, IE is more often an acute disease, characterized by a high rate of S. aureus infection. Mortality remains relatively high. PMID:19273776

  14. Clinically important body weight gain following total hip arthroplasty: A cohort study with five-year follow-up

    PubMed Central

    Singh, Jasvinder A.; Harmsen, William S; Schleck, Cathy D; Lewallen, David G

    2014-01-01

    Objective Literature examining the effects of total hip arthroplasty (THA) on subsequent body weight gain is inconclusive. Determining the extent to which clinically relevant weight gain occurs following THA has important public health implications. Design We used multivariable logistic regression to compare data from one of the largest US-based THA registries to a population-based control sample from the same geographic region. We also identified factors that increased risk of clinically important weight gain specifically among persons undergoing THA. The outcome measure of interest was weight gain of ≥ 5% of body weight up to 5 years following surgery. Results The multivariable adjusted (age, sex, BMI, education, comorbidity and pre-surgical weight change) odds ratio for important weight gain was 1.7 (95% CI, 1.06, 2.6) for a person with THA as compared the control sample. Additional arthroplasty procedures during the 5-year follow-up further increased odds for important weight gain (OR=2.0, 95% CI, 1.4, 2.7) relative to the control sample. A patient with THA had increased risk of important post-surgical weight gain of 12% (OR=1.12; 95%CI,1.08, 1.16) for every kilogram of pre-operative weight loss. Conclusions While findings should be interpreted with caution because of missing follow-up weight data, patients with THA appear to be at increased risk of clinically important weight gain following surgery as compared to peers. Patients less than 60 years and who have lost a substantial amount of weight prior to surgery appear to be at particularly high risk of important postsurgical weight gain. PMID:23047011

  15. d-dimer testing as an adjunct to ultrasonography in patients with clinically suspected deep vein thrombosis: prospective cohort study

    PubMed Central

    Bernardi, Enrico; Prandoni, Paolo; Lensing, Anthonie W A; Agnelli, Giancarlo; Guazzaloca, Giuliana; Scannapieco, Gianluigi; Piovella, Franco; Verlato, Fabio; Tomasi, Cristina; Moia, Marco; Scarano, Luigi; Girolami, Antonio

    1998-01-01

    Objective To investigate the efficacy of using a rapid plasma d-dimer test as an adjunct to compression ultrasound for diagnosing clinically suspected deep vein thrombosis. Design d-dimer concentrations were determined in all patients with a normal ultrasonogram at presentation. Repeat ultrasonography was performed 1 week later only in patients with abnormal d-dimer test results. Main outcome measure Patients with normal ultrasonograms were not treated with anticoagulants and were followed for 3 months for thromboembolic complications. Setting University research and affiliated centres. Subjects 946 patients with clinically suspected deep vein thrombosis. Results Ultrasonograms were abnormal at presentation in 260 (27.5%) patients. Of the remaining 686 patients tested for d-dimer, 88 (12.8%) had abnormal concentrations. During follow up venous thromboembolic complications occurred in one of the 598 patients who were not treated with anticoagulants and who had an initial normal ultrasonogram and d-dimer concentration, whereas thromboembolic complications occurred in two of the 83 untreated patients who had abnormal d-dimer concentrations but a normal repeat ultrasonogram. The cumulative incidence of venous thromboembolic complications during follow up was 0.4% (95% confidence interval 0% to 0.9%). The rapid plasma d-dimer test used as an adjunct to compression ultrasonography resulted in a reduction in the mean number of repeat ultrasound examinations and additional hospital visits from 0.7 to 0.1 per patient. Conclusions Testing for d-dimer as an adjunct to a normal baseline ultrasound examination decreased the number of subsequent ultrasound examinations considerably without any increased risk of venous thromboembolic complications in patients not receiving anticoagulants. The use of ultrasound and testing for d-dimer enabled treatment decisions to be made at the time of presentation in most patients. Key messagesPatients with clinically suspected deep vein

  16. Impact of a clinical program using weekly Short Message Service (SMS) on antiretroviral therapy adherence support in South Africa: a retrospective cohort study.

    PubMed

    Georgette, Nathan; Siedner, Mark J; Petty, Carter R; Zanoni, Brian C; Carpenter, Stephen; Haberer, Jessica E

    2017-02-20

    In randomized controlled trials, short message service (SMS) programs have improved adherence to HIV antiretroviral therapy (ART). In response, the World Health Organization recommended use of SMS programs to support ART. However, there is limited data on real-world implementations of SMS programs. We conducted a retrospective cohort study of an SMS program to improve ART adherence in a government-run HIV clinic in rural South Africa. We analyzed data from all adult patients who 1) enrolled at the clinic before the observation period (July 2013 through June 2014), 2) had ≥1 ART prescriptions in the observation period, and 3) had data on phone number availability (N = 2255). Our main outcome measure was prescription coverage, defined as the presence of a valid ART prescription for each day observed. We fit generalized linear mixed models adjusted for pre-program prescription coverage, demographics, and ART duration, dosing, and regimen. Exposure to the SMS program was independently associated with greater prescription coverage (AOR = 1.23, 95% CI 1.13-1.34, P < 0.001) compared with non-exposure, although the absolute increase in prescription coverage was small (4.7 days of ART prescription coverage per average patient per year). Among a subset of patients (n = 725) whose pre-program prescription coverage was <100%, the corresponding mean expected absolute increase in prescription coverage was 8.2 days per year. Our primary finding was that an SMS reminder program implemented in routine clinical care was associated with a small increase in prescription coverage of uncertain clinical significance.

  17. Early dialysis initiation does not improve clinical outcomes in elderly end-stage renal disease patients: A multicenter prospective cohort study.

    PubMed

    Park, Jae Yoon; Yoo, Kyung Don; Kim, Yong Chul; Kim, Dong Ki; Joo, Kwon Wook; Kang, Shin-Wook; Yang, Chul Woo; Kim, Nam-Ho; Kim, Yong-Lim; Lim, Chun-Soo; Kim, Yon Su; Lee, Jung Pyo

    2017-01-01

    The optimal timing for initiating dialysis in end-stage renal disease (ESRD) is controversial, especially in the elderly. 665 patients ≥65 years old who began dialysis from August 2008 to February 2015 were prospectively enrolled in the Clinical Research Center for End-Stage Renal Disease cohort study. Participants were divided into 2 groups based on the median estimated glomerular filtration rate at the initiation of dialysis. Propensity score matching (PSM) was used to compare the overall survival rate, cardiovascular events, Kidney Disease Quality of Life Short Form 36 (KDQOL-36) results, Karnofsky performance scale values, Beck's depression inventory values, and subjective global assessments. The mean patient age was 72.0 years, and 61.7% of the patients were male. Overall, the cumulative survival rates were lower in the early initiation group, although the difference was not significant after PSM. Additionally, the survival rates of the 2 groups did not differ after adjusting for age, sex, Charlson comorbidity index and hemoglobin, serum albumin, serum calcium and phosphorus levels. Although the early initiation group showed a lower physical component summary score on the KDQOL-36 3 months after dialysis, the difference in scores was not significant 12 months after dialysis. Furthermore, the difference was not significant after PSM. The Karnofsky performance scale, Beck's depression inventory, and subjective global assessments were not significantly different 3 and 12 months after dialysis initiation. The timing of dialysis initiation is not associated with clinical outcomes in elderly patients with ESRD.

  18. Observational Follow-up Study on a Cohort of Children with Severe Pneumonia after Discharge from a Day-care Clinic in Dhaka, Bangladesh

    PubMed Central

    Alam, Nur H.; Chisti, Mohammod J.; Salam, Mohammed A.; Ahmed, Tahmeed; Gyr, Niklaus

    2014-01-01

    ABSTRACT Compliance, morbidity, mortality, and hospitalization during fortnightly follow-up were evaluated by an observational study on a cohort of children with severe and very severe pneumonia after day-care treatment at an urban clinic. The primary outcome measures were proportions of success (compliance) and failure (non-compliance) of follow-up visits at the day-care clinic. In total, 251 children were followed up, with median (IQR) age of 5.0 (3.0-9.0) months, and their compliance dropped from 92% at the first to 85% at the sixth visit. Cough (28%), fever (20%), and rapid breathing (13%) were common morbidities. Successful follow-up visits were possible in 180 (95.2%) and 56 (90.3%) of the children with severe and very severe pneumonia respectively. Eleven (4.4%) needed hospitalization, and four (1.6%) died. Majority (≈90%) of the children could be successfully followed up; some failed to attend their scheduled follow-up visits due to hospitalization and death. The common morbidities indicate the importance of follow-up for detecting medical problems and early treatment, thus reducing risk of death. PMID:25076656

  19. A prospective cohort study on the clinical utility of second trimester mean arterial blood pressure in the prediction of late-onset preeclampsia among Nigerian women.

    PubMed

    Udenze, I C; Arikawe, A P; Makwe, C C; Olowoselu, O F

    2017-06-01

    Early detection of preeclampsia will help reduce the morbidities and mortalities associated with the disorder. Late-onset preeclampsia was the predominant presentation in this cohort. The search for biomarkers for predicting preeclampsia is still ongoing. Mean arterial blood pressure (MABP), which has the advantage of presenting a single cutoff value compared with the use of systolic and diastolic blood pressure measurements, merits evaluation. The study aims to evaluate the clinical utility of second trimester MABP in the prediction of preeclampsia. This was a prospective cohort study of 155 normotensive, nonproteinuric pregnant women without prior history of gestational hypertension. The women were booked patients attending the antenatal clinic at the Lagos University Teaching Hospital and were all in their second trimesters of pregnancy. The outcome measures were systolic blood pressure, diastolic blood pressure, and MABP. The end point of the study was the development of preeclampsia. The diagnosis of preeclampsia was made by the attending obstetrician. The data were analyzed using the IBM SPSS statistical software. Statistical significance was set at P < 0.05. One hundred and fifty-five pregnant women participated in the study. Eleven (7.1%) of the women developed preeclampsia after 34 weeks gestation and 144 (92.9%) had normal pregnancy. The mean gestational age at the time of assessment was 18.88 ± 3.15 weeks with a range of 14 weeks to 27 completed weeks. There was a statistically significant increase in the systolic blood pressure, diastolic blood pressure, and MABP values in the group of women who later developed preeclampsia, P = 0.005, 0.001, and <0.001, respectively. At a false-positive rate of 10%, MABP value of 88.33 mmHg predicted preeclampsia with a specificity of 90% and a sensitivity of 45.5%, P <0.05. The area under the receiver-operative characteristics curve (AUC) was 0.732 (95% confidence interval, 0.544-0.919, P = 0.011). The negative

  20. Associations of Adverse Clinical Course and Ingested Substances among Patients with Deliberate Drug Poisoning: A Cohort Study from an Intensive Care Unit in Japan

    PubMed Central

    Ichikura, Kanako; Takeuchi, Takashi

    2016-01-01

    Objectives Some patients with deliberate drug poisoning subsequently have an adverse clinical course. The present study aimed to examine whether the type of drugs ingested and psychiatric diagnoses were related to an adverse clinical course. Methods We conducted a cohort study of patients with deliberate drug poisoning admitted to the intensive care unit of a university hospital located in Tokyo, Japan, between September 2006 and June 2013. Intensive care unit (ICU) stay of ≥4 days was used as a primary outcome measure, while the incidence of aspiration pneumonitis was used as a secondary outcome measure. Ingested substances and psychiatric diagnoses were used as explanatory variables. Results Of the 676 patients with deliberate drug poisoning, 88% had a history of psychiatric treatment and 82% had ingested psychotropic drugs. Chlorpromazine-promethazine-phenobarbital combination drug (Vegetamin®) ranked fifth among the most frequently ingested substances in cases of deliberate drug poisoning and had the highest incidence of prolonged ICU stay (20%) and aspiration pneumonitis (29%). The top three major classes consisted of benzodiazepines (79%), new-generation antidepressants (25%), and barbiturates/non-barbiturates (23%). Barbiturate overdose was independently associated with increased odds of both prolonged ICU stay (8% vs. 17%; odds ratio [OR], 2.97; 95% confidence interval [CI], 1.60–5.55) and aspiration pneumonitis (8% vs. 24%; OR, 3.83; 95% CI, 2.18–6.79) relative to those associated with overdose of only other sedative-hypnotics (i.e., benzodiazepines). Conclusion These results suggest that judicious prescribing of barbiturates by psychiatrists could reduce the risk of an adverse clinical course when a patient attempts an overdose. PMID:27560966

  1. Associations of Adverse Clinical Course and Ingested Substances among Patients with Deliberate Drug Poisoning: A Cohort Study from an Intensive Care Unit in Japan.

    PubMed

    Ichikura, Kanako; Okumura, Yasuyuki; Takeuchi, Takashi

    2016-01-01

    Some patients with deliberate drug poisoning subsequently have an adverse clinical course. The present study aimed to examine whether the type of drugs ingested and psychiatric diagnoses were related to an adverse clinical course. We conducted a cohort study of patients with deliberate drug poisoning admitted to the intensive care unit of a university hospital located in Tokyo, Japan, between September 2006 and June 2013. Intensive care unit (ICU) stay of ≥4 days was used as a primary outcome measure, while the incidence of aspiration pneumonitis was used as a secondary outcome measure. Ingested substances and psychiatric diagnoses were used as explanatory variables. Of the 676 patients with deliberate drug poisoning, 88% had a history of psychiatric treatment and 82% had ingested psychotropic drugs. Chlorpromazine-promethazine-phenobarbital combination drug (Vegetamin®) ranked fifth among the most frequently ingested substances in cases of deliberate drug poisoning and had the highest incidence of prolonged ICU stay (20%) and aspiration pneumonitis (29%). The top three major classes consisted of benzodiazepines (79%), new-generation antidepressants (25%), and barbiturates/non-barbiturates (23%). Barbiturate overdose was independently associated with increased odds of both prolonged ICU stay (8% vs. 17%; odds ratio [OR], 2.97; 95% confidence interval [CI], 1.60-5.55) and aspiration pneumonitis (8% vs. 24%; OR, 3.83; 95% CI, 2.18-6.79) relative to those associated with overdose of only other sedative-hypnotics (i.e., benzodiazepines). These results suggest that judicious prescribing of barbiturates by psychiatrists could reduce the risk of an adverse clinical course when a patient attempts an overdose.

  2. Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study.

    PubMed

    Erdman, Laura K; D'Acremont, Valérie; Hayford, Kyla; Rajwans, Nimerta; Kilowoko, Mary; Kyungu, Esther; Hongoa, Philipina; Alamo, Leonor; Streiner, David L; Genton, Blaise; Kain, Kevin C

    2015-01-01

    Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO) has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance. We studied children with WHO-defined clinical pneumonia (n = 155) within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30), other infiltrates (n = 31), or normal chest x-ray (n = 94). Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis. Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5-98.8), 80.8% specificity (72.6-87.1), positive likelihood ratio 4.9 (3.4-7.1), negative likelihood ratio 0.083 (0

  3. Biomarkers of Host Response Predict Primary End-Point Radiological Pneumonia in Tanzanian Children with Clinical Pneumonia: A Prospective Cohort Study

    PubMed Central

    Erdman, Laura K.; D’Acremont, Valérie; Hayford, Kyla; Kilowoko, Mary; Kyungu, Esther; Hongoa, Philipina; Alamo, Leonor; Streiner, David L.; Genton, Blaise; Kain, Kevin C.

    2015-01-01

    Background Diagnosing pediatric pneumonia is challenging in low-resource settings. The World Health Organization (WHO) has defined primary end-point radiological pneumonia for use in epidemiological and vaccine studies. However, radiography requires expertise and is often inaccessible. We hypothesized that plasma biomarkers of inflammation and endothelial activation may be useful surrogates for end-point pneumonia, and may provide insight into its biological significance. Methods We studied children with WHO-defined clinical pneumonia (n = 155) within a prospective cohort of 1,005 consecutive febrile children presenting to Tanzanian outpatient clinics. Based on x-ray findings, participants were categorized as primary end-point pneumonia (n = 30), other infiltrates (n = 31), or normal chest x-ray (n = 94). Plasma levels of 7 host response biomarkers at presentation were measured by ELISA. Associations between biomarker levels and radiological findings were assessed by Kruskal-Wallis test and multivariable logistic regression. Biomarker ability to predict radiological findings was evaluated using receiver operating characteristic curve analysis and Classification and Regression Tree analysis. Results Compared to children with normal x-ray, children with end-point pneumonia had significantly higher C-reactive protein, procalcitonin and Chitinase 3-like-1, while those with other infiltrates had elevated procalcitonin and von Willebrand Factor and decreased soluble Tie-2 and endoglin. Clinical variables were not predictive of radiological findings. Classification and Regression Tree analysis generated multi-marker models with improved performance over single markers for discriminating between groups. A model based on C-reactive protein and Chitinase 3-like-1 discriminated between end-point pneumonia and non-end-point pneumonia with 93.3% sensitivity (95% confidence interval 76.5–98.8), 80.8% specificity (72.6–87.1), positive likelihood ratio 4.9 (3.4–7

  4. [Clinical research X. From the clinical judgement to the cohort design].

    PubMed

    Talavera, Juan O; Rivas-Ruiz, Rodolfo

    2012-01-01

    The second research design with higher quality of information, only after the clinical trial is the cohort, although it does not have the possibility of assigning the maneuver, it has the opportunity to follow subjects over time. Any research that tries to explain the phenomenon of causality runs the risk of bias, however, the characteristics of the cohort studies try to avoid them. Its main features are: 1. Be observational, where the researcher only measures the presence of the maneuver, characteristic that divides subjects into exposed and unexposed. 2. Be longitudinal, which provides the opportunity to track the subject through time documenting the temporal sequence of components ocurrence. 3. The directionality in measurements, generating what we know as prolective, retrolective and retro-prolective cohort studies; the former is the one with the highest quality as a result of the measurement of the variables in real time. 4. Be a comparative study.

  5. Role of a multidisciplinary clinic in the management of patients with pancreatic cysts: a single-center cohort study.

    PubMed

    Lennon, Anne Marie; Manos, Lindsey L; Hruban, Ralph H; Ali, Syed Z; Fishman, Elliot K; Kamel, Ihab R; Raman, Siva P; Zaheer, Atif; Hutfless, Susan; Salamone, Ashley; Kiswani, Vandhana; Ahuja, Nita; Makary, Martin A; Weiss, Matthew J; Hirose, Kenzo; Goggins, Michael; Wolfgang, Christopher L

    2014-10-01

    Incidental pancreatic cysts are common, a small number of which are premalignant or malignant. Multidisciplinary care has been shown to alter management and improve outcomes in many types of cancers, but its role has not been examined in patients with pancreatic cysts. We assessed the effect of a multidisciplinary pancreatic cyst clinic (MPCC) on the diagnosis and management of patients with pancreatic cysts. The referring institution and MPCC diagnosis and management plan were recorded. Patient were placed into one of five categories-no, low, intermediate, or high risk of malignancy within the cyst, and malignant cyst-on the basis of their diagnosis. Patients were assigned one of four management options: surveillance, surgical resection, further evaluation, or discharge with no further follow-up required. The MPCC was deemed to have altered patient care if the patient was assigned a different risk or management category after the MPCC review. Referring institution records were available for 262 patients (198 women; mean age 62.7 years), with data on risk category available in 138 patients and management category in 225. The most common diagnosis was branch duct intraductal papillary mucinous neoplasm. MPCC review altered the risk category in 11 (8.0%) of 138 patients. The management category was altered in 68 (30.2%) of 225 patients. Management was increased in 52 patients, including 22 patients who were recommended surgical resection. Management was decreased in 16 patients, including 10 who had their recommendation changed from surgery to surveillance. MPCC is helpful and alters the management over 30% of patients.

  6. Accuracy of the "traffic light" clinical decision rule for serious bacterial infections in young children with fever: a retrospective cohort study.

    PubMed

    De, Sukanya; Williams, Gabrielle J; Hayen, Andrew; Macaskill, Petra; McCaskill, Mary; Isaacs, David; Craig, Jonathan C

    2013-02-13

    To determine the accuracy of a clinical decision rule (the traffic light system developed by the National Institute for Health and Clinical Excellence (NICE)) for detecting three common serious bacterial infections (urinary tract infection, pneumonia, and bacteraemia) in young febrile children. Retrospective analysis of data from a two year prospective cohort study A paediatric emergency department. 15,781 cases of children under 5 years of age presenting with a febrile illness. Clinical features were used to categorise each febrile episodes as low, intermediate, or high probability of serious bacterial infection (green, amber, and red zones of the traffic light system); these results were checked (using standard radiological and microbiological tests) for each of the infections of interest and for any serious bacterial infection. After combination of the intermediate and high risk categories, the NICE traffic light system had a test sensitivity of 85.8% (95% confidence interval 83.6% to 87.7%) and specificity of 28.5% (27.8% to 29.3%) for the detection of any serious bacterial infection. Of the 1140 cases of serious bacterial infection, 157 (13.8%) were test negative (in the green zone), and, of these, 108 (68.8%) were urinary tract infections. Adding urine analysis (leucocyte esterase or nitrite positive), reported in 3653 (23.1%) episodes, to the traffic light system improved the test performance: sensitivity 92.1% (89.3% to 94.1%), specificity 22.3% (20.9% to 23.8%), and relative positive likelihood ratio 1.10 (1.06 to 1.14). The NICE traffic light system failed to identify a substantial proportion of serious bacterial infections, particularly urinary tract infections. The addition of urine analysis significantly improved test sensitivity, making the traffic light system a more useful triage tool for the detection of serious bacterial infections in young febrile children.

  7. Immunodeficiency and the risk of serious clinical endpoints in a well-studied cohort of treated HIV-infected patients

    PubMed Central

    Achhra, Amit C; Amin, Janaki; Law, Matthew G; Emery, Sean; Gerstoft, Jan; Gordin, Fred M; Vjecha, Michael J; Neaton, James D; Cooper, David A

    2010-01-01

    Objective To investigate the relative predictive value of CD4+ metrics for serious clinical endpoints. Design Observational Methods Patients (3012; 20317 person-years) from control arms of ESPRIT and SILCAAT trials were followed prospectively. We used Cox regression to identify CD4+ metrics (latest, baseline and nadir CD4+count, latest CD4+%, time spent with CD4+count below certain thresholds and CD4+ slopes) independently predictive of i)all-cause mortality; ii) non-AIDS deaths; iii) non-AIDS (cardiovascular, hepatic, renal and non-AIDS malignancy) and iv) AIDS events. Akaike Information Criteria (AIC) was calculated for each model. Significant metrics (p<0.05) were then additionally adjusted for latest CD4+ count. Results Non-AIDS deaths occurred at a higher rate than AIDS deaths (rate-ratio: 6.48, 95%CI: 5.1–8.1) and similarly, non-AIDS events (rate-ratio: 1.72, 95%CI: 1.65–1.79). Latest CD4+count was strongly predictive of lower risk of death (HR per log2 rise: 0.48, 95%CI: 0.43–0.54), with lowest AIC of all metrics. CD4+ slope over 7-visits, after additional adjustment for latest CD4+count, was the only metric to be independent predictor for all-cause (HR for slope<-10/mm3/month vs. 0±10: 3.04, 95%CI: 1.98–4.67) and non-AIDS deaths (HR for slope <-10/mm3/month vs. 0±10: 2.62, 95%CI: 1.62–4.22). Latest CD4+ count (per log2 rise) was the best predictor across all endpoints (i–iv) and predicted hepatic (HR: 0.46, 95%CI: 0.33–0.63) and renal events (HR: 0.39, 95%CI: 0.21–0.70), but not cardiovascular events (HR: 1.05, 95%CI: 0.77–1.43) or non-AIDS cancers (HR: 0.78, 95%CI: 0.59–1.03). Conclusion Latest CD4+count is the best predictor of serious endpoints. CD4+ slope independently predicts all-cause and non-AIDS deaths. PMID:20588170

  8. Immunodeficiency and the risk of serious clinical endpoints in a well studied cohort of treated HIV-infected patients.

    PubMed

    Achhra, Amit C; Amin, Janaki; Law, Matthew G; Emery, Sean; Gerstoft, Jan; Gordin, Fred M; Vjecha, Michael J; Neaton, James D; Cooper, David A

    2010-07-31

    To investigate the relative predictive value of CD4(+) metrics for serious clinical endpoints. Observational. Patients (3012; 20 317 person-years) from control arms of ESPRIT and SILCAAT were followed prospectively. We used Cox regression to identify CD4(+) metrics (latest, baseline and nadir CD4(+) cell count, latest CD4(+)%, time spent with CD4(+) count below certain thresholds and CD4(+) slopes) independently predictive of all-cause mortality, non-AIDS deaths, non-AIDS (cardiovascular, hepatic, renal and non-AIDS malignancy) and AIDS events. Akaike information criteria (AIC) were calculated for each model. Significant metrics (P < 0.05) were then additionally adjusted for latest CD4(+) cell count. Non-AIDS deaths occurred at a higher rate than AIDS deaths [rate ratio: 6.48, 95% confidence interval (CI) 5.1-8.1], and non-AIDS events likewise (rate ratio: 1.72, 95% CI 1.65-1.79). Latest CD4(+) cell count was strongly predictive of lower risk of death (hazard ratio per log2 rise: 0.48, 95% CI 0.43-0.54), with lowest AIC of all metrics. CD4(+) slope over seven visits, after additional adjustment for latest CD4(+) cell count, was the only metric to be an independent predictor for all-cause (hazard ratio for slope <-10 cells/microl per month vs. 0 +/- 10: 3.04, 95% CI 1.98-4.67) and non-AIDS deaths (hazard ratio for slope <-10 cells/microl per month vs. 0 +/- 10: 2.62, 95% CI 1.62-4.22). Latest CD4(+) cell count (per log(2) rise) was the best predictor across all four endpoints and predicted hepatic (hazard ratio 0.46, 95% CI 0.33-0.63) and renal events (hazard ratio 0.39, 95% CI 0.21-0.70), but not cardiovascular events (hazard ratio 1.05, 95% CI 0.77-1.43) or non-AIDS cancers (hazard ratio 0.78, 95% CI 0.59-1.03). Latest CD4(+) cell count is the best predictor of serious endpoints. CD4(+) slope independently predicts all-cause and non-AIDS deaths.

  9. Effects of clinical and environmental factors on bronchoalveolar antibody responses to Pneumocystis jirovecii: A prospective cohort study of HIV+ patients.

    PubMed

    Blount, Robert J; Daly, Kieran R; Fong, Serena; Chang, Emily; Grieco, Katherine; Greene, Meredith; Stone, Stephen; Balmes, John; Miller, Robert F; Walzer, Peter D; Huang, Laurence

    2017-01-01

    Humoral immunity plays an important role against Pneumocystis jirovecii infection, yet clinical and environmental factors that impact bronchoalveolar antibody responses to P. jirovecii remain uncertain. From October 2008-December 2011 we enrolled consecutive HIV-infected adults admitted to San Francisco General Hospital (SFGH) who underwent bronchoscopy for suspected Pneumocystis pneumonia (PCP). We used local air quality monitoring data to assign ozone, nitrogen dioxide, and fine particulate matter exposures within 14 days prior to hospital admission. We quantified serum and bronchoalveolar lavage fluid (BALF) antibody responses to P. jirovecii major surface glycoprotein (Msg) recombinant constructs using ELISA. We then fit linear regression models to determine whether PCP and ambient air pollutants were associated with bronchoalveolar antibody responses to Msg. Of 81 HIV-infected patients enrolled, 47 (58%) were diagnosed with current PCP and 9 (11%) had a prior history of PCP. The median CD4+ count was 51 cells/μl (IQR 15-129) and 44% were current smokers. Serum antibody responses to Msg were statistically significantly predictive of BALF antibody responses, with the exception of IgG responses to MsgC8 and MsgC9. Prior PCP was associated with increased BALF IgA responses to Msg and current PCP was associated with decreased IgA responses. For instance, among patients without current PCP, those with prior PCP had a median 73.2 U (IQR 19.2-169) IgA response to MsgC1 compared to a 5.00 U (3.52-12.6) response among those without prior PCP. Additionally, current PCP predicted a 22.5 U (95%CI -39.2, -5.82) lower IgA response to MsgC1. Ambient ozone within the two weeks prior to hospital admission was associated with decreased BALF IgA responses to Msg while nitrogen dioxide was associated with increased IgA responses. PCP and ambient air pollutants were associated with BALF IgA responses to P. jirovecii in HIV-infected patients evaluated for suspected PCP.

  10. Cohort profile: the Social Inequality in Cancer (SIC) cohort study.

    PubMed

    Nordahl, Helene; Hvidtfeldt, Ulla Arthur; Diderichsen, Finn; Rod, Naja Hulvej; Osler, Merete; Frederiksen, Birgitte Lidegaard; Prescott, Eva; Tjønneland, Anne; Lange, Theis; Keiding, Niels; Andersen, Per Kragh; Andersen, Ingelise

    2014-12-01

    The Social Inequality in Cancer (SIC) cohort study was established to determine pathways through which socioeconomic position affects morbidity and mortality, in particular common subtypes of cancer. Data from seven well-established cohort studies from Denmark were pooled. Combining these cohorts provided a unique opportunity to generate a large study population with long follow-up and sufficient statistical power to develop and apply new methods for quantification of the two basic mechanisms underlying social inequalities in cancer-mediation and interaction. The SIC cohort included 83 006 participants aged 20-98 years at baseline. A wide range of behavioural and biological risk factors such as smoking, physical inactivity, alcohol intake, hormone replacement therapy, body mass index, blood pressure and serum cholesterol were assessed by self-administered questionnaires, physical examinations and blood samples. All participants were followed up in nationwide demographic and healthcare registries. For those interested in collaboration, further details can be obtained by contacting the Steering Committee at the Department of Public Health, University of Copenhagen, at inan@sund.ku.dk.

  11. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART)

    USDA-ARS?s Scientific Manuscript database

    Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (L...

  12. Comparison of 10-year clinical wear of annealed and remelted highly cross-linked polyethylene: A propensity-matched cohort study.

    PubMed

    Hamai, Satoshi; Nakashima, Yasuharu; Mashima, Naohiko; Yamamoto, Takuaki; Kamada, Tomomi; Motomura, Goro; Imai, Hiroshi; Fukushi, Jun-Ichi; Miura, Hiromasa; Iwamoto, Yukihide

    2016-06-01

    No previous studies comparing the clinical wear rates of the two different kinds of cross-linked ultra-high-molecular-weight polyethylene (XLPE), annealed and remelted, are available. We compared the creep and steady wear rates of 36 matched pairs (72 hips in total) adjusting for baseline characteristics with propensity score matching techniques. Zirconia femoral heads with 26-mm diameter were used in all cases. The femoral-head cup penetration was measured digitally on radiographs. Significantly greater creep (p=0.006) was detected in the remelted (0.234mm) than annealed (0.159mm) XLPE. However, no significant difference (p=0.19) was found between the steady wear rates (0.003 and 0.008mm/year, respectively) of the annealed and remelted XLPE. Multiple regression analyses showed that remelted XLPE is significant independent variable (p<0.001) that is positively associated with creep. However, the patient age and body weight, cup size, the liner thickness, cup inclination, follow-up periods, and postoperative Merle d'Aubigné hip score had no significant effects (p>0.05) on the steady wear rates. No patients exhibited above the osteolysis threshold of 0.1mm/year, progressive radiolucencies, osteolysis, or polyethylene fracture. This propensity-matched cohort study document no significant difference in wear resistant performances of annealed and remelted XLPE over an average period of 10 years.

  13. Long-term effects of bilateral oophorectomy on brain aging: Unanswered questions from the Mayo Clinic Cohort Study of Oophorectomy and Aging

    PubMed Central

    Rocca, W A; Shuster, L T; Grossardt, B R; Maraganore, D M; Gostout, B S; Geda, Y E; Melton, L J

    2009-01-01

    Summary In the Mayo Clinic Cohort Study of Oophorectomy and Aging, women who had both ovaries removed before reaching natural menopause experienced a long-term increased risk of parkinsonism, cognitive impairment or dementia, and depressive and anxiety symptoms. Here, we discuss five possible mechanistic interpretations of the observed associations: 1) the associations may be non-causal because they result from the confounding effect of genetic variants or of other risk factors; 2) the associations may be mediated by an abrupt reduction in levels of circulating estrogen; 3) the associations may be mediated by an abrupt reduction in levels of circulating progesterone or testosterone; 4) the associations may be mediated by an increased release of gonadotropins by the pituitary gland; and 5) genetic variants may modify the hormonal effects of bilateral oophorectomy through simple or more complex interactions. Results from other studies are cited as evidence for or against each possible mechanism. These putative causal mechanisms are probably intertwined, and their clarification is a research priority. PMID:19102639

  14. Clinical and Renal Biopsy Findings Predicting Outcome in Renal Thrombotic Microangiopathy: A Large Cohort Study from a Single Institute in China

    PubMed Central

    Song, Di; Wang, Su-Xia; Song, Yan; Liu, Gang

    2014-01-01

    Objective. The current study aimed to investigate the spectrum of etiologies and associated disorders of renal biopsy-proven thrombotic microangiopathy (TMA) patients. Methods. The clinical, laboratory, and renal histopathological data of patients with renal TMA from 2000 to 2012 in our institute were collected and reviewed. Results. One hundred and nine TMA patients were enrolled in this study. The mean age was 34.0 ± 11.1 years. Seventy patients (64.2%) were male and thirty-nine patients (35.8%) were female. There were eight patients (7.3%) with hemolytic uremic syndrome (HUS). Sixty-one patients (56.0%) were secondary to malignant hypertension. Fourteen patients (12.8%) were pregnancy-associated TMA. Other associated disorders included 17 patients with connective tissue disorders, 2 patients with hematopoietic stem cell transplantation, 4 patients with Castleman's disease, 1 patient with cryoglobulinemia, and 2 patients with glomerulopathy. During followup, 8 patients died due to severe infection, 17 patients had doubling of serum creatinine, and 44 had end-stage renal disease. In multivariate analysis, male, elevated serum creatinine, and decreased hemoglobin were independently associated with poor renal outcomes. Conclusions. Renal TMA changes consisted of different disorders with various etiologies. aHUS, pregnancy-associated TMA, and malignant hypertension accounted for the majority of patients in our cohort. PMID:25184151

  15. What are the effects of varenicline compared with nicotine replacement therapy on long-term smoking cessation and clinically important outcomes? Protocol for a prospective cohort study.

    PubMed

    Davies, Neil M; Taylor, Gemma; Taylor, Amy E; Thomas, Kyla H; Windmeijer, Frank; Martin, Richard M; Munafò, Marcus R

    2015-11-05

    Smoking is a major avoidable cause of ill-health and premature death. Treatments that help patients successfully quit smoking have an important effect on health and life expectancy. Varenicline is a medication that can help smokers successfully quit smoking. However, there are concerns that it may cause adverse effects, such as increase in the occurrence of depression, self-harm and suicide and cardiovascular disease. In this study we aim to examine the effects of varenicline versus other smoking cessation pharmacotherapies on smoking cessation, health service use, all-cause and cause-specific mortality and physical and mental health conditions. In this project we will investigate the effects of varenicline compared to nicotine replacement therapies on: (1) long-term smoking cessation and whether these effects differ by area level deprivation; and (2) the following clinically-important outcomes: rate of general practice and hospital attendance; all-cause mortality and death due to diseases of the respiratory system and cardiovascular disease; and a primary care diagnosis of respiratory illness, myocardial infarction or depression and anxiety. The study is based on a cohort of patients prescribed these smoking cessation medications from the Clinical Practice Research Datalink (CPRD). We will use three methods to overcome confounding: multivariable adjusted Cox regression, propensity score matched Cox regression, and instrumental variable regression. The total expected sample size for analysis will be at least 180,000. Follow-up will end with the earliest of either an 'event' or censoring due to the end of registration or death. Ethics approval was not required for this study. This project has been approved by the CPRD's Independent Scientific Advisory Committee (ISAC). We will disseminate our findings via publications in international peer-reviewed journals and presentations at international conferences. Published by the BMJ Publishing Group Limited. For permission

  16. Biological complications and peri-implant clinical and radiographic changes at immediately placed dental implants. A prospective 5-year cohort study.

    PubMed

    Rodrigo, Daniel; Martin, Conchita; Sanz, Mariano

    2012-10-01

    To evaluate clinically and radiographically immediate implants 5 years after insertion and to compare them with delayed-placed implants in the same subjects. Twenty-two consecutive patients that needed at least two implants for replacing hopeless teeth, one immediately upon extraction and the other in a delayed fashion (at least 4 months post-extraction) were selected in this prospective cohort study. Post-extraction immediate implants (II) and delayed implants (DI) groups were defined. One and 5 years after implant loading, clinical and radiographical outcome variables were recorded and analysed both at site and at implant level. Intra-group and inter-group comparisons were performed. The intergroup comparison did not show significant differences for plaque index, bleeding on probing and suppuration. These parameters worsen in both groups along the study. This trend was stronger for the plaque index in the group II, which increased from 15.6% at 1 year to 25.9% at 5 years (P < 0.04). One year after loading, the sites with probing depth ≥5 mm were higher for the group II compared to DI (2.5% vs. 0%; P = 0.049). At the end of the study, no significant statistical differences were found. Radiographically, bone crestal changes did not yield significant differences. During the follow-up period, 25% of the implants (26.4% in group II and 23.5% in DI) showed biological complications: mucositis (20%) and/or periimplantitis (5.8%). No differences between groups were found. Within the same patients, the implants placed with the immediate protocol demonstrated a higher tendency to crestal bone loss and to peri-implantitis, although these differences were not statistically significant. © 2011 John Wiley & Sons A/S.

  17. Renal function improvement in liver transplant recipients after early everolimus conversion: A clinical practice cohort study in Spain.

    PubMed

    Bilbao, Itxarone; Salcedo, Magdalena; Gómez, Miguel Angel; Jimenez, Carlos; Castroagudín, Javier; Fabregat, Joan; Almohalla, Carolina; Herrero, Ignacio; Cuervas-Mons, Valentín; Otero, Alejandra; Rubín, Angel; Miras, Manuel; Rodrigo, Juan; Serrano, Trinidad; Crespo, Gonzalo; De la Mata, Manuel; Bustamante, Javier; Gonzalez-Dieguez, M Luisa; Moreno, Antonia; Narvaez, Isidoro; Guilera, Magda

    2015-08-01

    A national, multicenter, retrospective study was conducted to assess the results obtained for liver transplant recipients with conversion to everolimus in daily practice. The study included 477 recipients (481 transplantations). Indications for conversion to everolimus were renal dysfunction (32.6% of cases), hepatocellular carcinoma (HCC; 30.2%; prophylactic treatment for 68.9%), and de novo malignancy (29.7%). The median time from transplantation to conversion to everolimus was 68.7 months for de novo malignancy, 23.8 months for renal dysfunction, and 7.1 months for HCC and other indications. During the first year of treatment, mean everolimus trough levels were 5.4 (standard deviation [SD], 2.7) ng/mL and doses remained stable (1.5 mg/day) from the first month after conversion. An everolimus monotherapy regimen was followed by 28.5% of patients at 12 months. Patients with renal dysfunction showed a glomerular filtration rate (4-variable Modification of Diet in Renal Disease) increase of 10.9 mL (baseline mean, 45.8 [SD, 25.3] versus 57.6 [SD, 27.6] mL/minute/1.73 m(2) ) at 3 months after everolimus initiation (P < 0.001), and 6.8 mL at 12 months. Improvement in renal function was higher in patients with early conversion (<1 year). Adverse events were the primary reason for discontinuation in 11.2% of cases. The probability of survival at 3 years after conversion to everolimus was 83.0%, 71.1%, and 59.5% for the renal dysfunction, de novo malignancy, and HCC groups, respectively. Everolimus is a viable option for the treatment of renal dysfunction, and earlier conversion is associated with better recovery of renal function. Prospective studies are needed to confirm advantages in patients with malignancy. © 2015 American Association for the Study of Liver Diseases.

  18. Clinical outcomes in patients with a diagnosis of "indefinite for dysplasia" in Barrett's esophagus: a multicenter cohort study.

    PubMed

    Sinh, Preetika; Anaparthy, Rajeswari; Young, Patrick E; Gaddam, Srinivas; Thota, Prashanthi; Balasubramanian, Gokulakrishnan; Singh, Mandeep; Higbee, April D; Wani, Sachin; Gupta, Neil; Rastogi, Amit; Mathur, Sharad C; Bansal, Ajay; Horwhat, John D; Cash, Brooks D; Falk, Gary W; Lieberman, David A; Vargo, John J; Sampliner, Richard E; Sharma, Prateek

    2015-08-01

    Data are limited on the natural history of patients with Barrett's esophagus with a diagnosis of "indefinite for dysplasia" (IND). The aims of this study were to: (i) determine rates of progression to high grade dysplasia (HGD) or esophageal adenocarcinoma, and compare these with rates for low grade dysplasia (LGD); and (ii) determine the proportion of patients whose histological IND diagnosis changed on follow-up endoscopy. Demographic, endoscopic, and histologic information of patients with diagnoses of IND and LGD and at least 12 months of follow-up were extracted from the database of a multicenter Barrett's esophagus study. Rates and times for progression to HGD and esophageal adenocarcinoma and regression to nondysplastic epithelium were calculated. Proportions of diagnoses upgraded to HGD/esophageal adenocarcinoma or downgraded to nondysplastic epithelium at first follow-up endoscopy were evaluated. Amongst 2264 patients, 83 with a diagnosis of IND (mean age 60 years, 95 % men, 95 % white; mean follow-up 5.6 years) and 79 with diagnosis of LGD were identified. In the IND group, annual incidences of esophageal adenocarcinoma and HGD were 0.21 % and 0.64 %, respectively, representing a combined incidence of 0.8 %. Mean time to progression was 4.72 years. Within the IND group 55 % patients showed regression to nondysplastic epithelium at first follow-up endoscopy and the overall regression rate was 80 %. Corresponding rates in LGD patients were similar. Lesions diagnosed as IND and LGD show similar biological behavior and can be treated as a single category with respect to surveillance and follow-up. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Surgical Treatment of Facial Basal Cell Carcinoma: Patient-Based Assessment of Clinical Outcome in a Prospective Cohort Study.

    PubMed

    Ofaiche, Joséphine; Lopez, Raphael; Bérard, Emilie; André, Aymeric; Bulai-Livideanu, Cristina; Méresse, Thomas; Vairel, Benjamin B; Grolleau, Jean-Louis; Paul, Carle; Meyer, Nicolas

    2016-01-01

    There are limited data on the esthetic, functional, and morphological outcomes of surgical treatment of facial basal cell carcinoma (BCC). The aim of our study was to assess the determinants of the evaluation of both the patients and the investigator of the esthetic, functional, and morphological impact of the surgical treatment of facial BCC. A prospective observational study evaluated 111 patients treated surgically for facial BCCs (n = 135 BCCs), using the Patient and Observer Scar Assessment Scale (POSAS), a validated and reliable scale designed for the evaluation of all types of scars by professionals and patients. Scar assessment rated by the patients was very good. Skin aging was associated with a better surgical outcome as evaluated by POSAS (OR = 0.30, 95% CI: 0.09-0.98; p = 0.04). Conversely, histologically infiltrative or sclerosing BCC (OR = 2.33, 95% CI: 0.95-5.71; p = 0.06) was independently associated with poorer POSAS. In terms of the investigator's evaluation, aging signs (protective factor: OR = 0.17, 95% CI: 0.04-0.73; p = 0.01), location on the H-zone of the face (risk factor: OR = 2.95, 95% CI: 1.07-8.15; p = 0.03), and histologically infiltrative or sclerosing BCC (risk factor: OR = 2.89, 95% CI: 1.01-8.29; p = 0.04) were independently associated with POSAS. Esthetic, functional, and morphological outcomes of facial BCC surgery provide high patient satisfaction overall. Taking wider margins requires specific measures to improve the surgical outcome. © 2016 S. Karger AG, Basel.

  20. Associations between metabolic syndrome and clinical benign prostatic hyperplasia in a northern urban Han Chinese population: A prospective cohort study

    PubMed Central

    Zhao, Si-Cong; Xia, Ming; Tang, Jian-Chun; Yan, Yong

    2016-01-01

    Biologic rationales exist for the associations between metabolic syndrome (MetS) and benign prostatic hyperplasia (BPH). However, epidemiologic studies have yield inconsistent results. The aim of the present study was to prospectively evaluate the associations of MetS with the risk of BPH. The presence of MetS, the number of MetS components, and the individual MetS components were evaluated. After adjusting for potential confounders, MetS was associated with increased risk of BPH (HR: 1.29; 95% CI, 1.08–1.50; p < 0.001). Compared with subjects without any MetS components, the HRs were 0.88 (95% CI, 0.67–1.09; p = 0.86), 1.18 (95% CI, 0.89–1.47; p = 0.29) and 1.37 (95% CI, 1.08–1.66; p = 0.014) for subjects with 1, 2, or ≥3 MetS components, and there was a biologic gradient between the number of MetS components and the risk of BPH (p-trend < 0.001). Central obesity and low high-density lipoprotein cholesterol were the two main divers of the associations between these two conditions, with HRs of 1.93 (95% CI, 1.14–2.72; p = 0.001) for central obesity, and 1.56 (95% CI, 1.08–2.04; p = 0.012) for low HDL-C. Our findings support the notion that MetS may be an important target for BPH prevention and intervention. PMID:27653367

  1. Short communication: feasibility and acceptability of developing a multisite clinical cohort of transgender people with HIV infection.

    PubMed

    Poteat, Tonia C; Hanna, David B; Althoff, Keri N

    2015-09-01

    Transgender women bear a disproportionate burden of HIV, yet data among this population are not routinely collected in HIV clinical cohorts. Brief surveys and follow-up qualitative interviews were conducted with principal investigators or designated representatives of 17 HIV clinical cohorts to determine the acceptability and feasibility of pooling transgender-specific data from existing HIV clinical cohort studies. Twelve of 17 sites reported that they already collect gender identity data but not consistently. Others were receptive to collecting this information. Many also expressed interest in a study of clinical outcomes among HIV-infected transgender women using pooled data across cohorts. The collection of longitudinal data on transgender people living with HIV is acceptable and feasible for most North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD) cohorts. HIV clinical cohort studies should make efforts to include transgender individuals and develop the tools to collect quality data on this high-need population.

  2. Minimally invasive transcrestal guided sinus lift (TGSL): a clinical prospective proof-of-concept cohort study up to 52 months.

    PubMed

    Pozzi, Alessandro; Moy, Peter K

    2014-08-01

    This study describes a new procedure for sinus elevation using computer-guided planning and guided surgical approach through the use of computer-aided design (CAD)/computer-aided manufacturing (CAM)-generated surgical template in combination with expander-condensing osteotomes thus providing a minimally invasive surgical technique. Sixty-six consecutive patients were treated with 136 implants placed by transcrestal-guided sinus floor elevation technique and the patients were followed for at least 3 years in function. The drilling protocol is customized based on the bone density of each implant site to achieve an insertion torque ranging between 45 and 55 Ncm. Titanium temporary abutments were connected to the implants with prosthetic screws tightened to 35 Ncm and an acrylic resin provisional restoration was adapted and delivered immediately. Six months after initial loading, a definitive CAD/CAM-generated restoration was delivered. Outcome measurements assessed were implant and prosthesis survival rate, biological or biomechanical complications, marginal bone level changes, total alveolar ridge bone height before and after procedure, periodontal parameters measured as well as patient's perception of pain levels during recovery period. Mean follow-up was 43.96 (range from 36 to 52) months. Cumulative implant survival rate was 98.53% at 3 years. No biological or mechanical complications were encountered and no prosthetic failures occurred during the entire follow-up period. Mean marginal bone loss (MBL) during the first year of function was 0.33 ± 0.36 mm, while at the 3-year follow-up, the mean MBL was 0.51 ± 0.29 mm. The mean residual bone height of the alveolar crest prior to grafting was of 6.7 ± 1.6 mm (range 5.1-9.2 mm), while, the mean bone height gained was 6.4 ± 1.6 mm (range 3.2-8.1 mm). All patients reported low levels of pain and found to have normal periodontal parameters. This proof-of-concept study suggests that

  3. [Birth cohort studies in China: a review].

    PubMed

    Wang, L; Sun, L; He, X Y; Wang, Y X; Yu, W P

    2017-04-10

    With longer than 100-year experience of development, methods used on birth cohort study have been viewed as having important roles in exploring the probable effects of health and environment exposure both prior to and during the pregnancy in the life circle as infants, children, adolescents, adults, and the elderly. However in China, birth cohort studies started late but with rapid development. Recently, some well-known methods on birth cohort studies were established in mainland China, Hong Kong and Taiwan area. This paper presented an overall review on the progress about birth cohort studies and their prospects, in China.

  4. Understanding the health economic burden of patients with tuberous sclerosis complex (TSC) with epilepsy: a retrospective cohort study in the UK Clinical Practice Research Datalink (CPRD).

    PubMed

    Shepherd, Charles; Koepp, Matthias; Myland, Melissa; Patel, Keyur; Miglio, Cristiana; Siva, Vathani; Gray, Elizabeth; Neary, Maureen

    2017-10-05

    Epilepsy is highly prevalent in tuberous sclerosis complex (TSC), a multi-system genetic disorder. The clinical and economic burden of this condition is expected to be substantial due to treatment challenges, debilitating co-morbidities and the relationship between TSC-related manifestations. This study estimated healthcare resource utilisation (HCRU) and costs for patients with TSC with epilepsy (TSC+E) in the UK. Patients with TSC+E in the Clinical Practice Research Datalink (CPRD) linked to Hospital Episodes Statistics were identified from April 1997 to March 2012. Clinical data were extracted over the entire history, and costs were reported over the most recent 3-year period. HCRU was compared with a matched Comparator cohort, and the key cost drivers were identified by regression modelling. In total, 209 patients with TSC+E were identified, of which 40% recorded ≥2 other primary organ system manifestations and 42% had learning disability. Treatment with ≥2 concomitant antiepileptic drugs (AEDs) was prevalent (60%), potentially suggesting refractory epilepsy. Notwithstanding, many patients with TSC+E (12%) had no record of AED use in their entire history, which may indicate undertreatment for these patients.Brain surgery was recorded in 12% of patients. Routine electroencephalography and MRI were infrequently performed (30% of patients), yet general practitioner visits, hospitalisations and outpatient visits were more frequent in patients with TSC+E than the Comparator. This translated to threefold higher clinical costs (£14 335 vs £4448), which significantly increased with each additional primary manifestation (p<0.0001). Patients with TSC+E have increased HCRU compared with the general CPRD population, likely related to manifestations in several organ systems, substantial cognitive impairment and severe epilepsy, which is challenging to treat and may be intractable. Disease surveillance and testing appears to be inadequate with few treatments

  5. Effects of risk assessment and management programme for hypertension on clinical outcomes and cardiovascular disease risks after 12 months: a population-based matched cohort study.

    PubMed

    Yu, Esther Y T; Wan, Eric Y F; Wong, Carlos K H; Chan, Anca K C; Chan, Karina H Y; Ho, Sin-Yi; Kwok, Ruby L P; Lam, Cindy L K

    2017-03-01

    This study evaluated the effectiveness of a structured multidisciplinary risk assessment and management programme for patients with hypertension (RAMP-HT) who were managed in public primary care clinics but had suboptimal blood pressure (BP) control in improving BP, LDL-cholesterol (LDL-C) and predicted 10-year cardiovascular disease (CVD) risk after 12 months of intervention. A total of 10 262 hypertension patients with suboptimal BP despite treatment, aged less than 80 years and without existing CVD were enrolled in RAMP-HT between October 2011 and March 2012 from public general out-patient clinics in Hong Kong. Their clinical outcomes and predicted 10-year CVD risk were compared with a matched cohort of hypertension patients who were receiving usual care in general out-patient clinics without any RAMP-HT intervention by propensity score matching. Multivariable linear and logistic regressions were used to determine the independent effectiveness of RAMP-HT after adjusting for potential confounding variables. Compared with the usual care group after 12 months, significantly greater proportions of RAMP-HT participants achieved target BP (i.e. BP < 140/90 mmHg) (OR = 1.18, P < 0.01) and LDL-C levels (i.e. <3.4 mmol/l for patients with CVD risk ≤20% or <2.6 mmol/l for CVD risk >20%) (OR = 1.13, P < 0.01). RAMP-HT participants also had significantly greater reduction in predicted 10-year CVD risk by 0.44% (coefficient = -0.44, P < 0.01). The structured multidisciplinary RAMP-HT was more effective than usual care in achieving target BP, LDL-C and reducing predicted 10-year CVD risk in public primary care patients with suboptimal hypertension control after 12 months of intervention. A long-term follow-up should be conducted to confirm whether the improvement in clinical outcomes can be translated into actual reductions in CVD complications and mortalities and whether such approach is cost-effective.

  6. Clinical features of patients with morphea and the pansclerotic subtype: a cross-sectional study from the morphea in adults and children cohort.

    PubMed

    Kim, Andrew; Marinkovich, Nicholas; Vasquez, Rebecca; Jacobe, Heidi T

    2014-01-01

    Pansclerotic morphea is a poorly described form of morphea with little information on prevalence, demographics, and clinical features. Classification criteria for this subtype varies and the distinction from other forms of morphea, such as extensive generalized morphea and pansclerotic morphea, is not always clear. The purpose of our study was to clarify classification criteria for pansclerotic morphea by identifying its prevalence in the morphea in adults and children (MAC) cohort and describing its demographic and clinical features as compared with generalized morphea. Patients who met predefined criteria for generalized and pansclerotic morphea were identified using a modified Laxer and Zulian classification system. Baseline demographic and clinical features of the patients were compiled and then analyzed for traits characteristic of pansclerotic morphea versus those of generalized morphea. One hundred and thirteen patients met the criteria for inclusion: pansclerotic (n = 13) and generalized morphea type (n = 100). Patients with pansclerotic morphea were more frequently male (46.2% vs 6%; p < 0.0001); had a shorter time to diagnosis (mean difference of 10.4 mos; 95% CI: 0.8-19.9 mos; p = 0.0332); higher rates of functional impairment (61.5% vs 16%; p = 0.0046); higher rates of deep involvement (61.5% vs 17%; p = 0.004); and higher average Rodnan Skin Score (mean difference of 10.8 points; 95% CI: 5-16.6; p = 0.0017), Localized Scleroderma Skin Damage Index (mean difference 28.3; 95% CI: 9-47.6; p = 0.009), and Physician Global Assessment of Disease Damage scores (mean difference 25.1; 95% CI: 0.3-50; p = 0.048). Our results suggest demographic and clinical features are sufficient to define the pansclerotic subtype as they represent a distinct clinical phenotype with a more rapidly progressive and severe course commonly accompanied by disability. Presence of features of the pansclerotic phenotype should alert practitioners to the possibility of significant

  7. Comparison of hospital variation in acute myocardial infarction care and outcome between Sweden and United Kingdom: population based cohort study using nationwide clinical registries.

    PubMed

    Chung, Sheng-Chia; Sundström, Johan; Gale, Chris P; James, Stefan; Deanfield, John; Wallentin, Lars; Timmis, Adam; Jernberg, Tomas; Hemingway, Harry

    2015-08-07

    To assess the between hospital variation in use of guideline recommended treatments and clinical outcomes for acute myocardial infarction in Sweden and the United Kingdom. Population based longitudinal cohort study using nationwide clinical registries. Nationwide registry data comprising all hospitals providing acute myocardial infarction care in Sweden (SWEDEHEART/RIKS-HIA, n=87; 119,786 patients) and the UK (NICOR/MINAP, n=242; 391,077 patients), 2004-10. Between hospital variation in 30 day mortality of patients admitted with acute myocardial infarction. Case mix standardised 30 day mortality from acute myocardial infarction was lower in Swedish hospitals (8.4%) than in UK hospitals (9.7%), with less variation between hospitals (interquartile range 2.6% v 3.5%). In both countries, hospital level variation and 30 day mortality were inversely associated with provision of guideline recommended care. Compared with the highest quarter, hospitals in the lowest quarter for use of primary percutaneous coronary intervention had higher volume weighted 30 day mortality for ST elevation myocardial infarction (10.7% v 6.6% in Sweden; 12.7% v 5.8% in the UK). The adjusted odds ratio comparing the highest with the lowest quarters for hospitals' use of primary percutaneous coronary intervention was 0.70 (95% confidence interval 0.62 to 0.79) in Sweden and 0.68 (0.60 to 0.76) in the UK. Differences in risk between hospital quarters of treatment for non-ST elevation myocardial infarction and secondary prevention drugs for all discharged acute myocardial infarction patients were smaller than for reperfusion treatment in both countries. Between hospital variation in 30 day mortality for acute myocardial infarction was greater in the UK than in Sweden. This was associated with, and may be partly accounted for by, the higher practice variation in acute myocardial infarction guideline recommended treatment in the UK hospitals. High quality healthcare across all hospitals, especially

  8. Carbon fibre versus metal framework in full-arch immediate loading rehabilitations of the maxilla - a cohort clinical study.

    PubMed

    Pera, F; Pesce, P; Solimano, F; Tealdo, T; Pera, P; Menini, M

    2017-05-01

    Frameworks made of carbon fibre-reinforced composites (CFRC) seem to be a viable alternative to traditional metal frameworks in implant prosthodontics. CFRC provide stiffness, rigidity and optimal biocompatibility. The aim of the present prospective study was to compare carbon fibre frameworks versus metal frameworks used to rigidly splint implants in full-arch immediate loading rehabilitations. Forty-two patients (test group) were rehabilitated with full-arch immediate loading rehabilitations of the upper jaw (total: 170 implants) following the Columbus Bridge Protocol with four to six implants with distal tilted implants. All patients were treated with resin screw-retained full-arch prostheses endowed with carbon fibre frameworks. The mean follow-up was 22 months (range: 18-24). Differences in the absolute change of bone resorption over time between the two implant sides (mesial and distal) were assessed performing a Mann-Whitney U-test. The outcomes were statistically compared with those of patients rehabilitated following the same protocol but using metal frameworks (control group: 34 patients with 163 implants - data reported in Tealdo, Menini, Bevilacqua, Pera, Pesce, Signori, Pera, Int J Prosthodont, 27, 2014, 207). Ten implants failed in the control group (6·1%); none failed in the test group (P = 0·002). A statistically significant difference in the absolute change of bone resorption around the implants was found between the two groups (P = 0·004), with greater mean peri-implant bone resorption in the control group (1 mm) compared to the test group (0·8 mm). Carbon fibre frameworks may be considered as a viable alternative to the metal ones and showed less marginal bone loss around implants and a greater implant survival rate during the observation period. © 2017 John Wiley & Sons Ltd.

  9. Bedside clinical signs associated with impending death in patients with advanced cancer: preliminary findings of a prospective, longitudinal cohort study.

    PubMed

    Hui, David; Dos Santos, Renata; Chisholm, Gary; Bansal, Swati; Souza Crovador, Camila; Bruera, Eduardo

    2015-03-15

    Five highly specific physical signs associated with death within 3 days among cancer patients were recently reported that may aid in the diagnosis of impending death. In this study, the frequency and onset of another 52 bedside physical signs and their diagnostic performance for impending death were examined. Three hundred fifty-seven consecutive patients with advanced cancer who had been admitted to acute palliative care units at 2 tertiary care cancer centers were enrolled. Fifty-two physical signs were systematically documented every 12 hours from admission to death or discharge. The frequency and median time of onset of each sign from death backwards were examined, and the likelihood ratios (LRs) associated with death within 3 days were calculated. Two hundred three of the 357 patients (57%) died at the end of the admission. Eight physical signs that were highly diagnostic of impending death were identified. These signs occurred in 5% to 78% of the patients within the last 3 days of life, had a late onset, and had a high specificity (>95%) and a high positive LR for death within 3 days. They included nonreactive pupils (positive LR, 16.7; 95% confidence interval [CI], 14.9-18.6), a decreased response to verbal stimuli (positive LR, 8.3; 95% CI, 7.7-9), a decreased response to visual stimuli (positive LR, 6.7; 95% CI, 6.3-7.1), an inability to close eyelids (positive LR, 13.6; 95% CI, 11.7-15.5), drooping of the nasolabial fold (positive LR, 8.3; 95% CI, 7.7-8.9), hyperextension of the neck (positive LR, 7.3; 95% CI, 6.7-8), grunting of vocal cords (positive LR, 11.8; 95% CI, 10.3-13.4), and upper gastrointestinal bleeding (positive LR, 10.3; 95% CI, 9.5-11.1). Eight highly specific physical signs associated with death within 3 days among cancer patients were identified. These signs may inform the diagnosis of impending death. © 2015 American Cancer Society.

  10. Clinical investigation on axial versus tilted implants for immediate fixed rehabilitation of edentulous arches: preliminary results of a single cohort study.

    PubMed

    Agnini, Alessandro; Agnini, Andrea Mastrorosa; Romeo, Davide; Chiesi, Manuele; Pariente, Leon; Stappert, Christian F J

    2014-08-01

    The purpose of this clinical investigation was to evaluate full-arch fixed-dental restorations supported by immediate loaded axial and tilted implants in a single-cohort study. Survival rate of axial and tilted implants was compared. From 2006 to 2010, 30 patients were recruited and treated with dental implants. Provisional fixed-dental prostheses were screw-retained over axial or axial and tilted implants within 24 hours after surgery. Follow-ups at 6, 12, and 24 months and annually up to 5 years were scheduled, and radiographic evaluation of peri-implant bone level changes was conducted. Thirty patients (20 females and 10 males) were followed up for an average of 44 months (range 18-67 months). Six patients received both upper and lower implant rehabilitations, resulting in 36 restorations. A total of two hundred two implants were placed (maxilla = 118; mandible = 84) and 46% of the fixtures were evaluated at the 4-year recall. Four axial implants were lost in three patients, leading to 98.02% implant (97.56% axial implants and 100% tilted implants) and 100% prosthetic cumulative survival rate, respectively. No significant difference in marginal bone loss was found between tilted and axial implants in both jaws at 1-year evaluation. Midterm results confirmed that immediate loading of axial and tilted implants provides a viable treatment modality for the rehabilitation of edentulous arches. © 2012 Wiley Periodicals, Inc.

  11. Is it possible to diagnose the therapeutic adherence of patients with COPD in clinical practice? A cohort study

    PubMed Central

    2011-01-01

    Background Therapeutic adherence of patients with chronic obstructive pulmonary disease (COPD) is poor. It is therefore necessary to determine the magnitude of non-adherence to develop strategies to correct this behaviour. The purpose of this study was to analyse the diagnostic validity of indirect adherence methods. Methods Sample: 195 COPD patients undergoing scheduled inhaled treatment attending 5 Primary Care Centres of Malaga, Spain. Variables: Sociodemographic profile, illness data, spirometry, quality of life (St. George Respiratory Questionnaire: SGRQ), and inhaled medication counting (count of dose/pill or electronic monitoring) were collected. The patient's knowledge of COPD (Batalla test:BT),their attitude towards treatment (Morisky-Green test: MGT) and their self-reported therapeutic adherence (Haynes-Sackett test: HST) were used as methods of evaluating adherence. The follow-up consisted four visits over one year (the recruitment visit: V0; and after 1 month:V1; 6 months:V2; and 1 year:V3). Results The mean age was 69.59 (95% CI, 68.29-70.89) years old and 93.8% were male. Other findings included: 85.4% had a low educational level, 23.6% were smokers, 71.5% mild-moderate COPD stage with a FEV1 = 56.86 (SD = 18.85); exacerbations per year = 1.41(95% CI, 1-1.8). The total SGRQ score was 44.96 (95% CI, 42.46-47.46), showing a mild self-perceived impairment in health. The prevalence of adherence (dose/pill count) was 68.1% (95% CI, 60.9-75.3) at V1, 80% (95% CI, 73-87) at V2 and 84% (95% CI, 77.9) at V3. The MGT showed a specificity of 67.34% at V1, 76.19% at V2 and 69.62% at V3. The sensitivity was 53.33% at V1, 66.66% at V2 and 33.33% at V3.The BT showed a specificity of 55.1% at V1, 70.23% at V2 and 67.09% at V3. The sensitivity was 68.88% at V1, 71.43% at V2 and 46.66% at V3. Considering both tests together, the specificity was 86.73% at V1, 94.04% at V2 and 92.49% at V3 and the sensitivity was 37.77% at V1, 47.62% at V2 and 13.3% at V3. Conclusions

  12. Association Between Overweight and Obesity and Risk of Clinically Diagnosed Knee, Hip, and Hand Osteoarthritis: A Population-Based Cohort Study.

    PubMed

    Reyes, Carlen; Leyland, Kirsten M; Peat, George; Cooper, Cyrus; Arden, Nigel K; Prieto-Alhambra, Daniel

    2016-08-01

    Studies of previous cohorts have demonstrated an association between a status of overweight/obesity and the presence of knee and hand osteoarthritis (OA). However, no data on the effect of these factors on the OA burden are available. The aim of the present study was to analyze the effect of being overweight or obese on the incidence of routinely diagnosed knee, hip, and hand OA. The study was conducted in a population-based cohort using primary care records from the Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària database (>5.5 million subjects, covering >80% of the population of Catalonia, Spain). Participants were subjects ages ≥40 years who were without a diagnosis of OA on January 1, 2006 and had available body mass index (BMI) data. All subjects were followed up from January 1, 2006 to December 31, 2010 or to the time of loss to follow-up or death. Measures included the World Health Organization categories of BMI (exposure), and incident clinical diagnoses of knee, hip, or hand OA according to International Classification of Diseases, Tenth Revision codes. In total, 1,764,061 subjects were observed for a median follow-up period of 4.45 years (interquartile range 4.19-4.98 years). Incidence rates (per 1,000 person-years at risk) of knee, hip, and hand OA were 3.7 (99% confidence interval [99% CI] 3.6-3.8), 1.7 (99% CI 1.7-1.8), and 2.6 (99% CI 2.5-2.7), respectively, among subjects in the normal weight category, and 19.5 (99% CI 19.1-19.9), 3.8 (99% CI 3.7-4.0), and 4.0 (99% CI 3.9-4.2), respectively, in those with a classification of grade II obesity. Compared to subjects with normal weight, being overweight or obese increased the risk of OA at all 3 joint sites, especially at the knee. A status of overweight, grade I obesity, and grade II obesity increased the risk of knee OA by a factor of 2-fold, 3.1-fold, and 4.7-fold, respectively. Being overweight or obese increases the risk of hand, hip, and knee OA, with the

  13. Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

    PubMed

    Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

    2016-05-01

    Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

  14. Clinical, ultrasound and molecular biomarkers for early prediction of large for gestational age infants in nulliparous women: An international prospective cohort study.

    PubMed

    Vieira, Matias C; McCowan, Lesley M E; Gillett, Alexandra; Poston, Lucilla; Fyfe, Elaine; Dekker, Gustaaf A; Baker, Philip N; Walker, James J; Kenny, Louise C; Pasupathy, Dharmintra

    2017-01-01

    To develop a prediction model for term infants born large for gestational age (LGA) by customised birthweight centiles. International prospective cohort of nulliparous women with singleton pregnancy recruited to the Screening for Pregnancy Endpoints (SCOPE) study. LGA was defined as birthweight above the 90th customised centile, including adjustment for parity, ethnicity, maternal height and weight, fetal gender and gestational age. Clinical risk factors, ultrasound parameters and biomarkers at 14-16 or 19-21 weeks were combined into a prediction model for LGA infants at term using stepwise logistic regression in a training dataset. Prediction performance was assessed in a validation dataset using area under the Receiver Operating Characteristics curve (AUC) and detection rate at fixed false positive rates. The prevalence of LGA at term was 8.8% (n = 491/5628). Clinical and ultrasound factors selected in the prediction model for LGA infants were maternal birthweight, gestational weight gain between 14-16 and 19-21 weeks, and fetal abdominal circumference, head circumference and uterine artery Doppler resistance index at 19-21 weeks (AUC 0.67; 95%CI 0.63-0.71). Sensitivity of this model was 24% and 49% for a fixed false positive rate of 10% and 25%, respectively. The addition of biomarkers resulted in selection of random glucose, LDL-cholesterol, vascular endothelial growth factor receptor-1 (VEGFR1) and neutrophil gelatinase-associated lipocalin (NGAL), but with minimal improvement in model performance (AUC 0.69; 95%CI 0.65-0.73). Sensitivity of the full model was 26% and 50% for a fixed false positive rate of 10% and 25%, respectively. Prediction of LGA infants at term has limited diagnostic performance before 22 weeks but may have a role in contingency screening in later pregnancy.

  15. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study

    PubMed Central

    Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

    2017-01-01

    Objective To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. Design A cohort study. Setting New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Main outcome measures Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. Results From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval—of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons—including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. Conclusions If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. PMID:28179418

  16. Association of age at onset of migraine with family history of migraine in children attending a pediatric headache clinic: a retrospective cohort study.

    PubMed

    Eidlitz-Markus, Tal; Haimi-Cohen, Yishay; Zeharia, Avraham

    2015-07-01

    Migraine is known to run in families and has long been considered a strongly heritable disorder. This study sought to evaluate the relationship between age at onset of pediatric migraine and family history of migraine. Review of the medical files of the headache clinic of a tertiary pediatric medical center yielded 344 children with migraine for whom details on migraine in family members were available. Mean age of the cohort was 11.69 ± 3.49 years, and mean frequency of headache per month, 13.68 ± 11.26. Mean age at migraine onset in patients with a negative parental history was10.48 ± 3.39 years; in patients with one parent with migraine, 8.84 ± 3.72 years; and in patients with both parents with migraine, 7.32 ± 3.22 years (p < 0.001).The duration of migraine attacks (in hours) was significantly longer in patients with any family member with migraine than in those with no family history (p = 0.026). Among children attending a tertiary pediatric headache clinic, migraine appears at a younger age in those with parental history of migraine than in those with a negative family history. The findings suggest that having a genetic background of migraine makes a child more susceptible to migraine earlier in life than a child without a family history. © International Headache Society 2014.

  17. Clinical, ultrasound and molecular biomarkers for early prediction of large for gestational age infants in nulliparous women: An international prospective cohort study

    PubMed Central

    McCowan, Lesley M. E.; Gillett, Alexandra; Poston, Lucilla; Fyfe, Elaine; Dekker, Gustaaf A.; Baker, Philip N.; Walker, James J.; Kenny, Louise C.; Pasupathy, Dharmintra

    2017-01-01

    Objective To develop a prediction model for term infants born large for gestational age (LGA) by customised birthweight centiles. Methods International prospective cohort of nulliparous women with singleton pregnancy recruited to the Screening for Pregnancy Endpoints (SCOPE) study. LGA was defined as birthweight above the 90th customised centile, including adjustment for parity, ethnicity, maternal height and weight, fetal gender and gestational age. Clinical risk factors, ultrasound parameters and biomarkers at 14–16 or 19–21 weeks were combined into a prediction model for LGA infants at term using stepwise logistic regression in a training dataset. Prediction performance was assessed in a validation dataset using area under the Receiver Operating Characteristics curve (AUC) and detection rate at fixed false positive rates. Results The prevalence of LGA at term was 8.8% (n = 491/5628). Clinical and ultrasound factors selected in the prediction model for LGA infants were maternal birthweight, gestational weight gain between 14–16 and 19–21 weeks, and fetal abdominal circumference, head circumference and uterine artery Doppler resistance index at 19–21 weeks (AUC 0.67; 95%CI 0.63–0.71). Sensitivity of this model was 24% and 49% for a fixed false positive rate of 10% and 25%, respectively. The addition of biomarkers resulted in selection of random glucose, LDL-cholesterol, vascular endothelial growth factor receptor-1 (VEGFR1) and neutrophil gelatinase-associated lipocalin (NGAL), but with minimal improvement in model performance (AUC 0.69; 95%CI 0.65–0.73). Sensitivity of the full model was 26% and 50% for a fixed false positive rate of 10% and 25%, respectively. Conclusion Prediction of LGA infants at term has limited diagnostic performance before 22 weeks but may have a role in contingency screening in later pregnancy. PMID:28570613

  18. Quality of life and associated socio-clinical factors after encephalitis in children and adults in England: a population-based, prospective cohort study.

    PubMed

    Ramanuj, Parashar Pravin; Granerød, Julia; Davies, Nicholas W S; Conti, Stefano; Brown, David W G; Crowcroft, Natasha S

    2014-01-01

    We sought to measure HRQoL in all-cause encephalitis survivors and assess the impact of various socio-clinical factors on outcome. We used a prospective cohort study design, using the short-form 36 (SF-36) to measure the HRQoL in patients 15 years and older, and the short-form 10 (SF-10) for patients less than 15 years old. We posted questionnaires to individuals six months after discharge from hospital. All scores were normalised to the age- and sex-matched general population. We used multivariate statistical analysis to assess the relative association of clinical and socio-demographic variables on HRQoL in adults. Of 109 individuals followed-up, we received 61 SF-36 and twenty SF-10 questionnaires (response rate 74%). Patients scored consistently worse than the general population in all domains of the SF-36 and SF-10, although there was variation in individual scores. Infectious encephalitis was associated with the worst HRQoL in those aged 15 years and over, scoring on average 5.64 points less than immune-mediated encephalitis (95% CI -8.77- -2.89). In those aged less than 15 years the worst quality of life followed encephalitis of unknown cause. Immuno compromise, unemployment, and the 35-44 age group all had an independent negative association with HRQoL. A poor Glasgow Outcome Score was most strongly associated with a poor HRQoL. Less than half of those who had made a 'good' recovery on the score reported a HRQoL equivalent to the general population. Encephalitis has adverse effects on the majority of survivors' wellbeing and quality of life. Many of these adverse consequences could be minimised by prompt identification and treatment, and with better rehabilitation and support for survivors.

  19. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study.

    PubMed

    Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

    2017-02-08

    To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. A cohort study. New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval-of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons-including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. 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/.

  20. Early dialysis initiation does not improve clinical outcomes in elderly end-stage renal disease patients: A multicenter prospective cohort study

    PubMed Central

    Park, Jae Yoon; Yoo, Kyung Don; Kim, Yong Chul; Kim, Dong Ki; Joo, Kwon Wook; Kang, Shin-Wook; Yang, Chul Woo; Kim, Nam-Ho; Kim, Yong-Lim; Lim, Chun-Soo; Kim, Yon Su; Lee, Jung Pyo

    2017-01-01

    Background The optimal timing for initiating dialysis in end-stage renal disease (ESRD) is controversial, especially in the elderly. Methods 665 patients ≥65 years old who began dialysis from August 2008 to February 2015 were prospectively enrolled in the Clinical Research Center for End-Stage Renal Disease cohort study. Participants were divided into 2 groups based on the median estimated glomerular filtration rate at the initiation of dialysis. Propensity score matching (PSM) was used to compare the overall survival rate, cardiovascular events, Kidney Disease Quality of Life Short Form 36 (KDQOL-36) results, Karnofsky performance scale values, Beck’s depression inventory values, and subjective global assessments. Results The mean patient age was 72.0 years, and 61.7% of the patients were male. Overall, the cumulative survival rates were lower in the early initiation group, although the difference was not significant after PSM. Additionally, the survival rates of the 2 groups did not differ after adjusting for age, sex, Charlson comorbidity index and hemoglobin, serum albumin, serum calcium and phosphorus levels. Although the early initiation group showed a lower physical component summary score on the KDQOL-36 3 months after dialysis, the difference in scores was not significant 12 months after dialysis. Furthermore, the difference was not significant after PSM. The Karnofsky performance scale, Beck’s depression inventory, and subjective global assessments were not significantly different 3 and 12 months after dialysis initiation. Conclusions The timing of dialysis initiation is not associated with clinical outcomes in elderly patients with ESRD. PMID:28414758

  1. Quality of Life and Associated Socio-Clinical Factors after Encephalitis in Children and Adults in England: A Population-Based, Prospective Cohort Study

    PubMed Central

    Ramanuj, Parashar Pravin; Granerød, Julia; Davies, Nicholas W. S.; Conti, Stefano; Brown, David W. G.; Crowcroft, Natasha S.

    2014-01-01

    Objective We sought to measure HRQoL in all-cause encephalitis survivors and assess the impact of various socio-clinical factors on outcome. Methods We used a prospective cohort study design, using the short-form 36 (SF-36) to measure the HRQoL in patients 15 years and older, and the short-form 10 (SF-10) for patients less than 15 years old. We posted questionnaires to individuals six months after discharge from hospital. All scores were normalised to the age- and sex-matched general population. We used multivariate statistical analysis to assess the relative association of clinical and socio-demographic variables on HRQoL in adults. Results Of 109 individuals followed-up, we received 61 SF-36 and twenty SF-10 questionnaires (response rate 74%). Patients scored consistently worse than the general population in all domains of the SF-36 and SF-10, although there was variation in individual scores. Infectious encephalitis was associated with the worst HRQoL in those aged 15 years and over, scoring on average 5.64 points less than immune-mediated encephalitis (95% CI −8.77– −2.89). In those aged less than 15 years the worst quality of life followed encephalitis of unknown cause. Immuno compromise, unemployment, and the 35–44 age group all had an independent negative association with HRQoL. A poor Glasgow Outcome Score was most strongly associated with a poor HRQoL. Less than half of those who had made a ‘good’ recovery on the score reported a HRQoL equivalent to the general population. Conclusions Encephalitis has adverse effects on the majority of survivors’ wellbeing and quality of life. Many of these adverse consequences could be minimised by prompt identification and treatment, and with better rehabilitation and support for survivors. PMID:25072738

  2. Patterns of the Demographics, Clinical Characteristics, and Resource Utilization Among Maternal Decedents in Texas, 2001 - 2010: A Population-Based Cohort Study.

    PubMed

    Oud, Lavi

    2015-12-01

    Contemporary reporting of maternal mortality is focused on single, mutually exclusive causes of death among a minority of maternal decedents (pregnancy-related deaths), reflecting initial events leading to death. Although obstetric patients are susceptible to the lethal effects of downstream, more proximate contributors to death and to conditions not caused or precipitated by pregnancy, the burden of both categories and related patients' attributes is invisible to clinicians and healthcare policy makers with the current reporting system. Thus, the population-level demographics, clinical characteristics, and resource utilization associated with pregnancy-associated deaths in the United States have not been adequately characterized. We used the Texas Inpatient Public Use Data File to perform a population-based cohort study of the patterns of demographics, chronic comorbidity, occurrence of early maternal demise, potential contributors to maternal death, and resource utilization among maternal decedents in the state during 2001 - 2010. There were 557 maternal decedents during study period. Chronic comorbidity was reported in 45.2%. Most women (74.1%) were admitted to an ICU. Hemorrhage (27.8%), sepsis (23.5%), and cardiovascular conditions (22.6%) were the most commonly reported potential contributing conditions to maternal death, varying across categories of pregnancy-associated hospitalizations. More than one condition was reported in 39% of decedents. One in three women died during their first day of hospitalization, with no significant change over the past decade. The mean hospital length of stay was 7.9 days and total hospital charges were $250,000 or higher in 65 (11.7%) women. The findings of the high burden of chronic illness, patterns of occurrence of a broad array of potential contributing conditions to pregnancy-associated death, and the resource-intensive needs of a large contemporary population-based cohort of maternal decedents may better inform

  3. Weight loss required by the severely obese to achieve clinically important differences in health-related quality of life: two-year prospective cohort study.

    PubMed

    Warkentin, Lindsey M; Majumdar, Sumit R; Johnson, Jeffrey A; Agborsangaya, Calypse B; Rueda-Clausen, Christian F; Sharma, Arya M; Klarenbach, Scott W; Karmali, Shahzeer; Birch, Daniel W; Padwal, Raj S

    2014-10-15

    Guidelines and experts describe 5% to 10% reductions in body weight as 'clinically important'; however, it is not clear if 5% to 10% weight reductions correspond to clinically important improvements in health-related quality of life (HRQL). Our objective was to calculate the amount of weight loss required to attain established minimal clinically important differences (MCIDs) in HRQL, measured using three validated instruments. Data from the Alberta Population-based Prospective Evaluation of Quality of Life Outcomes and Economic Impact of Bariatric Surgery (APPLES) study, a population-based, prospective Canadian cohort including 150 wait-listed, 200 medically managed and 150 surgically treated patients were examined. Two-year changes in weight and HRQL measures (Short-Form (SF)-12 physical (PCS; MCID = 5) and mental (MCS; MCID = 5) component summary score, EQ-5D Index (MCID = 0.03) and Visual Analog Scale (VAS; MCID = 10), Impact of Weight on Quality of Life (IWQOL)-Lite total score (MCID = 12)) were calculated. Separate multivariable linear regression models were constructed within medically and surgically treated patients to determine if weight changes achieved HRQL MCIDs. Pooled analysis in all 500 patients was performed to estimate the weight reductions required to achieve the pre-defined MCID for each HRQL instrument. Mean age was 43.7 (SD 9.6) years, 88% were women, 92% were white, and mean initial body mass index was 47.9 (SD 8.1) kg/m2. In surgically treated patients (two-year weight loss = 16%), HRQL MCIDs were reached for all instruments except the SF-12 MCS. In medically managed patients (two-year weight loss = 3%), MCIDs were attained in the EQ-index but not the other instruments. In all patients, percent weight reductions to achieve MCIDs were: 23% (95% confidence interval (CI): 17.5, 32.5) for PCS, 25% (17.5, 40.2) for MCS, 9% (6.2, 15.0) for EQ-Index, 23% (17.3, 36.1) for EQ-VAS, and 17% (14.1, 20.4) for IWQOL-Lite total score. Weight reductions to

  4. Serum 25-hydroxyvitamin D concentration and risk for major clinical disease events in a community-based population of older adults: a cohort study.

    PubMed

    de Boer, Ian H; Levin, Gregory; Robinson-Cohen, Cassianne; Biggs, Mary L; Hoofnagle, Andy N; Siscovick, David S; Kestenbaum, Bryan

    2012-05-01

    Circulating concentrations of 25-hydroxyvitamin D [25-(OH)D] are used to define vitamin D deficiency. Current clinical 25-(OH)D targets based on associations with intermediate markers of bone metabolism may not reflect optimal levels for other chronic diseases and do not account for known seasonal variation in 25-(OH)D concentration. To evaluate the relationship of 25-(OH)D concentration with the incidence of major clinical disease events that are pathophysiologically relevant to vitamin D. Cohort study. The Cardiovascular Health Study conducted in 4 U.S. communities. Data from 1992 to 2006 were included in this analysis. 1621 white older adults. Serum 25-(OH)D concentration (using a high-performance liquid chromatography-tandem mass spectrometry assay that conforms to National Institute of Standards and Technology reference standards) and associations with time to a composite outcome of incident hip fracture, myocardial infarction, cancer, or death. Over a median 11-year follow-up, the composite outcome occurred in 1018 participants (63%). Defining events included 137 hip fractures, 186 myocardial infarctions, 335 incidences of cancer, and 360 deaths. The association of low 25-(OH)D concentration with risk for the composite outcome varied by season (P = 0.057). A concentration lower than a season-specific Z score of -0.54 best discriminated risk for the composite outcome and was associated with a 24% higher risk in adjusted analyses (95% CI, 9% to 42%). Corresponding season-specific 25-(OH)D concentrations were 43, 50, 61, and 55 nmol/L (17, 20, 24, and 22 ng/mL) in winter, spring, summer, and autumn, respectively. The observational study was restricted to white participants. Threshold concentrations of 25-(OH)D associated with increased risk for relevant clinical disease events center near 50 nmol/L (20 ng/mL). Season-specific targets for 25-(OH)D concentration may be more appropriate than static targets when evaluating health risk. National Institutes of Health.

  5. Is it best to expect the worst? Influence of patients' side-effect expectations on endocrine treatment outcome in a 2-year prospective clinical cohort study.

    PubMed

    Nestoriuc, Y; von Blanckenburg, P; Schuricht, F; Barsky, A J; Hadji, P; Albert, U-S; Rief, W

    2016-10-01

    This study aims to determine the role of patient expectations as potentially modifiable factor of side-effects, quality of life, and adherence to endocrine treatment of breast cancer. A 2-year prospective clinical cohort study was conducted in routine primary care with postoperative patients with hormone-receptor-positive breast cancer, scheduled to start adjuvant endocrine treatment. Structured patient-reported assessments of side-effects, side-effect expectations, quality of life, and adherence took place during the first week post-surgery and after 3 and 24 months of endocrine treatment. Of 111 enrolled patients, at 3 and 24 months, 107 and 88 patients, respectively, were assessed. After 2 years of endocrine treatment, patients reported high rates of side-effects (arthralgia: 71.3%, weight gain: 53.4%, hot flashes: 46.5%), including symptoms not directly attributable to the medication (breathing problems: 28.1%, dizziness: 25.6%). Pre-treatment expectations significantly predicted patient-reported long-term side-effects and quality of life in multivariate models controlling for relevant medical and psychological variables. Relative risk of side-effects after 2 years of endocrine treatment was higher in patients with high negative expectations at baseline than in those with low negative expectations (RR = 1.833, CI 95%, 1.032-3.256). A significant interaction confirmed this expectation effect to be particularly evident in patients with high side-effects at 3 months. Furthermore, baseline expectations were associated with adherence at 24 months (r = -0.25, P = 0.006). Expectations are a genuine factor of clinical outcome from endocrine treatment for breast cancer. Negative expectations increase the risk of treatment-specific side-effects, nocebo side-effects, and non-adherence. Yet, controlled studies are needed to analyze potential causal relationships. Optimizing individual expectations might be a promising strategy to improve side-effect burden, quality of life

  6. Prevalence of Comorbidities in Rheumatoid Arthritis and Evaluation of Their Monitoring in Clinical Practice: The Spanish Cohort of the COMORA Study.

    PubMed

    Balsa, Alejandro; Lojo-Oliveira, Leticia; Alperi-López, Mercedes; García-Manrique, María; Ordóñez-Cañizares, Carmen; Pérez, Lorena; Ruiz-Esquide, Virginia; Corrales, Alfonso; Narváez, Javier; Rey-Rey, José; Rodríguez-Lozano, Carlos; Ojeda, Soledad; Muñoz-Fernández, Santiago; Nolla, Joan M; García-Torrón, José; Gamero, Fernando; García-Vicuña, Rosario; Hernández-Cruz, Blanca; Campos, José; Rosas, José; García-Llorente, José Francisco; Gómez-Centeno, Antonio; Cáliz, Rafael; Sanmartí, Raimon; Bermúdez, Alberto; Abasolo-Alcázar, Lydia; Fernández-Nebro, Antonio; Rodríguez-Rodríguez, Luis; Marras, Carlos; González-Gay, Miguel Ángel; Hmamouchi, Ihsane; Martín-Mola, Emilio

    2017-07-12

    To describe the prevalence of comorbidities in patients with RA in Spain and discuss their management and implications using data from the Spanish cohort of the multinational study on COMOrbidities in Rheumatoid Arthritis (COMORA). This is a national sub-analysis of the COMORA study. We studied the demographics and disease characteristics of 200 adults patients diagnosed with RA (1987 ACR), and routine practices for screening and preventing the following selected comorbidities: cardiovascular, infections, cancer, gastrointestinal, pulmonary, osteoporosis and depression. Patients had a mean age of 58 years and a mean RA duration of 10 years. Mean DAS28 score was 3.3 and approximately 25% of patients were in remission (DAS28 <2.6). Forty-four (22%) patients had ≥1 comorbidity, the most frequent being depression (27%) and obesity (26%). A history of myocardial infarction or stroke was observed in 5% and 1% of patients, respectively, and any solid tumor in 6%. Having a Framingham Risk Score >20% (51%), hypercholesterolemia (46%) or hypertension (41%) and smoking (25%) were the most common CV risk factors. For prostate, colon and skin cancers, only 9%, 10% and 18% of patients, respectively, were optimally monitored. Infections were also inadequately managed, with 7% and 17% of patients vaccinated against influenza and pneumococcal, respectively, as was osteoporosis, with 47% of patients supplemented with vitamin D and 56% with a bone densitometry performed. In Spain, the prevalence of comorbidities and CV risk factors in RA patients with established and advanced disease is relatively high, and their management in clinical daily practice remains suboptimal. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  7. Does COPD have a clinically relevant impact on hearing loss? A retrospective matched cohort study with selection of patients diagnosed with COPD

    PubMed Central

    Kamenski, Gustav; Bendova, Jana; Fink, Waltraud; Sönnichsen, Andreas; Spiegel, Wolfgang; Zehetmayer, Sonja

    2015-01-01

    Objectives Chronic obstructive pulmonary disease (COPD) as a multisystemic disease has a measurable and biologically explainable impact on the auditory function detectable in the laboratory. This study tries to clarify if COPD is also a significant and clinically relevant risk factor for hearing impairment detectable in the general practice setting. Design Retrospective matched cohort study with selection of patients diagnosed with COPD. Setting 12 general practices in Lower Austria. Participants Consecutive patients >35 years with a diagnosis of COPD who consulted 1 of 12 single-handed GPs in 2009 and 2010 were asked to participate. Those who agreed were individually 1:1 matched with controls according to age, sex, hypertension, diabetes, coronary heart disease and chronic heart failure. Main outcome measures Sensorineural hearing impairment as assessed by pure tone audiometry, answers of three questions concerning a self-perceived hearing problem, application of the whispered voice test and the score of the Hearing Inventory for the Elderly, Screening Version (HHIE-S). Results 194 patients (97 pairs of 194 cases and controls) with a mean age of 65.5 (SD 10.2) were tested. Univariate conditional logistic regression resulted in significant differences in the mean bone conduction hearing loss and in the total score of HHIE-S, in the multiple conditional regression model, only smoking (p<0.0001) remained significant. Conclusions The results of this study do not support the hypothesis that there is an association between COPD and hearing impairment which, if found, would have allowed better management of patients with COPD. PMID:26586319

  8. [Development over 3 years of asthma recently diagnosed in a cohort of children (ASMA study). Factors related to improvement in clinical status].

    PubMed

    Liard, R; Soussan, D; Zureik, M; Touron, D; Lepage, T; Martinat, Y; Rogeaux, Y; Neukirch, F

    2002-04-13

    The objective of the ASMA study was to describe the evolution of light to moderate asthma, newly or recently (12 Pounds months) diagnosed in private pneumology centers, and to search for the predictive factors. In 1995, 251 private pneumologists, throughout Metropolitan France, recruited 396 asthmatic children, 6 to 12 years old (64% boys). The 334 patients eligible for the study were examined every 4 months during 3 years (a mean of 6 controls were conducted out of the expected 9). The data were collected on standardized questionnaires completed by the physicians and notebooks filled-in by the patients the week before each control. This questionnaire comprised two asthma 'control' criteria: "control" of the clinical state, defined as asthma attacks < 1 per week AND nocturnal awakening < 1 per week AND absence of asthma symptoms between attacks on every control visit; "control" of the need for b2 mimetics on request, defined as the non-use throughout the week preceding the control visit. The global clinical state of the cohort rapidly improved once care was initiated: the proportion of children exhibiting at least one attack of asthma per week rapidly dropped to 43% on inclusion and to 13% on the first control visit (4 months), 10% on the second control visit, and then fluctuated at around 8% up until the last control visit. A similar evolution was noted regarding nocturnal asthma attacks. The proportion of patients with prescriptions for inhaled corticosteroids and long-lasting b2-mimetics increased over the three years of follow-up. Analysis of the factors related to the individual 'control' of the clinical state showed a negative effect in family histories of asthma (father) and the presence of smokers in the home, but above all a positive effect of compliance to treatment and particularly its understanding (OR = 2.5; p = 0.03) and respect of the doses (OR = 2.7; p < 0.01). The positive effect of compliance was confirmed by analysis of the factors related to the

  9. A comprehensive strength testing protocol offers no clinical value in predicting risk of hamstring injury: a prospective cohort study of 413 professional football players.

    PubMed

    van Dyk, Nicol; Bahr, Roald; Burnett, Angus F; Whiteley, Rod; Bakken, Arnhild; Mosler, Andrea; Farooq, Abdulaziz; Witvrouw, Erik

    2017-07-29

    Hamstring injuries remain prevalent across a number of professional sports. In football, the incidence has even increased by 4% per year at the Champions League level over the last decade. The role of muscle strength or strength ratios and their association with risk of hamstring injury remain restricted by small sample sizes and inconclusive results. The purpose of this study is to identify risk factors for hamstring injury in professional football players in an adequately powered, prospective cohort study. Using both established (isokinetic) and novel (eccentric hamstring test device) measures of muscle strength, we aimed to investigate the relationship between these strength characteristics over the entire range of motion with risk of hamstring injury. All teams (n=18) eligible to compete in the premier football league in Qatar underwent a comprehensive strength assessment during their annual periodic health evaluation at Aspetar Orthopaedic and Sports Medicine Hospital in Doha, Qatar. Variables included isokinetic strength, Nordic hamstring exercise strength and dynamic hamstring: quadriceps ratios. Of the 413 players included (68.2% of all league players), 66 suffered a hamstring injury over the two seasons. Only isokinetic quadriceps concentric at 300°/s (adjusted for bodyweight) was associated with risk of hamstring injury when considered categorically. Age, body mass and playing position were also associated with risk of hamstring injury. None of the other 23 strength variables examined were found to be associated with hamstring injury. The clinical value of isolated strength testing is limited, and its use in musculoskeletal screening to predict future hamstring injury is unfounded. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. Clinical Value of Basal Serum Progesterone Prior to Initiate Ovarian Hyper-Stimulation with GnRH Antagonists: A Retrospective Cohort Study.

    PubMed

    Faulisi, Sonia; Reschini, Marco; Borroni, Raffaella; Paffoni, Alessio; Busnelli, Andrea; Somigliana, Edgardo

    2017-01-01

    The routine assessment of day 3 serum progesterone prior to initiation of ovarian hyper-stimulation with the use of GnRH antagonists is under debate. In this study, we evaluated the clinical utility of this policy. Retrospective cohort study of women undergoing in vitro fertilization (IVF) with the use of GnRH antagonists aimed at determining the frequency of cases with progesterone levels exceeding the recommended threshold of 1,660 pg/ml and at evaluating whether this assessment may be predictive of pregnancy. Serum progesterone exceeded the recommended threshold in one case (0.3%, 95% CI 0.01-1.5). The median (interquartile range) basal progesterone in women who did (n = 95) and did not (n = 217) become pregnant were 351 (234-476) and 380 (237-531) pg/ml, respectively (p = 0.28). The 90th percentile of the basal progesterone distribution in women who became pregnant was 660 pg/ml. Cases with serum progesterone exceeding this threshold in successful and unsuccessful cycles were 10 (10%) and 30 (14%), respectively (p = 0.47). The capacity of basal progesterone to predict pregnancy was evaluated using receiver operating characteristic curve (area under the curve = 0.54, 95% CI 0.47-0.61, p = 0.28). No graphically evident threshold emerged. Routine day 3 serum progesterone assessment in IVF cycles with the use of GnRH antagonists is not justified. Further evidence is warranted prior to claiming its systematic use. © 2016 S. Karger AG, Basel.

  11. Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case–control study in a clinical cohort

    PubMed Central

    Nerum, H; Halvorsen, L; Straume, B; Sørlie, T; Øian, P

    2013-01-01

    Objective To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). Design Case–control study in a clinical cohort. Setting University Hospital of North Norway. Sample In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. Methods Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. Main outcome measures Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. Results As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4–29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4–33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. Conclusions There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies. PMID:23157417

  12. Primary care consultation rates among people with and without severe mental illness: a UK cohort study using the Clinical Practice Research Datalink

    PubMed Central

    Kontopantelis, Evangelos; Olier, Ivan; Planner, Claire; Reeves, David; Ashcroft, Darren M; Gask, Linda; Doran, Tim; Reilly, Siobhan

    2015-01-01

    Objectives Little is known about service utilisation by patients with severe mental illness (SMI) in UK primary care. We examined their consultation rate patterns and whether they were impacted by the introduction of the Quality and Outcomes Framework (QOF), in 2004. Design Retrospective cohort study using individual patient data collected from 2000 to 2012. Setting 627 general practices contributing to the Clinical Practice Research Datalink, a large UK primary care database. Participants SMI cases (346 551) matched to 5 individuals without SMI (1 732 755) on age, gender and general practice. Outcome measures Consultation rates were calculated for both groups, across 3 types: face-to-face (primary outcome), telephone and other (not only consultations but including administrative tasks). Poisson regression analyses were used to identify predictors of consultation rates and calculate adjusted consultation rates. Interrupted time-series analysis was used to quantify the effect of the QOF. Results Over the study period, face-to-face consultations in primary care remained relatively stable in the matched control group (between 4.5 and 4.9 per annum) but increased for people with SMI (8.8–10.9). Women and older patients consulted more frequently in the SMI and the matched control groups, across all 3 consultation types. Following the introduction of the QOF, there was an increase in the annual trend of face-to-face consultation for people with SMI (average increase of 0.19 consultations per patient per year, 95% CI 0.02 to 0.36), which was not observed for the control group (estimates across groups statistically different, p=0.022). Conclusions The introduction of the QOF was associated with increases in the frequency of monitoring and in the average number of reported comorbidities for patients with SMI. This suggests that the QOF scheme successfully incentivised practices to improve their monitoring of the mental and physical health of this group of patients

  13. Different labour outcomes in primiparous women that have been subjected to childhood sexual abuse or rape in adulthood: a case-control study in a clinical cohort.

    PubMed

    Nerum, H; Halvorsen, L; Straume, B; Sørlie, T; Øian, P

    2013-03-01

    To compare the duration and outcome of the first labour in women who have been subjected to childhood sexual abuse (CSA) and women who have been raped in adulthood (RA). Case-control study in a clinical cohort. University Hospital of North Norway. In all, 373 primiparas: 185 subjected to CSA, 47 to RA and 141 controls without a history of abuse. Data on birth outcomes were retrieved from the patient files. Information on sexual abuse was reported in consultation with specialised midwives in the mental health team. Birth outcomes were analysed by multinominal regression analysis. Vaginal births, delivery by caesarean section, operative vaginal delivery and duration of labour. As compared with controls, the RA group showed a significantly higher risk for caesarean section (adjusted OR 9.9, 95% CI 3.4-29.4) and operative vaginal delivery (adjusted OR 12.2, 95% CI 4.4-33.7). There were no significant differences between the CSA and the control group. The RA group displayed significantly longer duration of labour in all phases as compared with the control and CSA groups. There were major differences in the duration of labour and birth outcomes in the two abuse groups. Despite a higher proportion of obstetric risk factors at onset of labour in the CSA group, women subjected to CSA had shorter labours and less risk for caesarean section and operative vaginal deliveries than women subjected to RA. The best care for birthing women subjected to sexual abuse needs to be explored in further studies. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  14. Detection of interleukin-2 is not useful for distinguishing between latent and active tuberculosis in clinical practice: a prospective cohort study.

    PubMed

    Santin, M; Morandeira-Rego, F; Alcaide, F; Rabuñal, R; Anibarro, L; Agüero-Balbín, R; Casas-Garcia, X; Pérez-Escolano, E; Navarro, M D; Sánchez, F; Coira-Nieto, A; Trigo-Daporta, M; Martinez-Meñaca, A; Gonzalez-Cuevas, A; López-Prieto, M D; Domínguez-Castellano, A; Jové, N

    2016-12-01

    Previous reports have identified interleukin-2 (IL-2), quantified in the supernatants of QuantiFERON(®)-TB Gold In-tube (QFT) after 72 h of incubation, as a potential biomarker for distinguishing between latent and active tuberculosis (TB). However, its validity has not been tested in an appropriate clinical cohort. A multicentre study of 161 consecutive adult patients undergoing evaluation for active TB at eight TB Units in Spain. Interferon-γ (IFN-γ) and IL-2 were assessed in the supernatant of QFT after 16-24 h and 72 h of incubation. The accuracy of IL-2 for indicating latent TB infection (LTBI) was assessed by receiving operating characteristic curves. . Twenty-eight participants were not infected, 43 had LTBI, 69 had TB, and 21 were not classifiable. Median (interquartile range) IL-2 concentrations after 72 h of incubation were 0.0 pg/mL (0.0-0.0) in uninfected individuals, 261.0 pg/mL (81.0-853.0) in LTBI individuals, 166.5 pg/mL (33.5-551.5) in patients with extrapulmonary TB, 95.0 pg/mL (26.0-283.0) in patients with smear-negative pulmonary TB, and 38.5 pg/mL (7.5-178.0) in patients with smear-positive pulmonary TB (p <0.0001). The area under the curve of the receiving operating characteristic curve (95% CI) of IL-2 after 72 h of incubation for the diagnosis of LTBI was 0.63 (0.53-0.74) when all TB cases were considered as a single group, ranging from 0.59 (0.47-0.71) to 0.72 (0.58-0.85) when only extrapulmonary and smear-positive pulmonary TB cases respectively were considered. Quantification of IL-2 in the supernatant of QFT after a prolonged incubation is not useful to distinguish between LTBI and active disease in clinical practice. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  15. Association between secure patient-clinician email and clinical services utilisation in a US integrated health system: a retrospective cohort study.

    PubMed

    Meng, Di; Palen, Ted E; Tsai, Joanne; McLeod, Melanie; Garrido, Terhilda; Qian, Heather

    2015-11-09

    To assess associations between secure patient-clinician email use and clinical services utilisation over time. Retrospective cohort study between July 2010 and December 2013. Controlling for a utilisation surge around first secure email use, we analysed difference of differences between propensity score-matched groups of secure patient-clinician email users and non-users for utilisation 1-12 months before and 7-18 months after first email (users) or a randomly assigned index date (non-users). US integrated healthcare delivery system. 9345 adults with first secure email use between July 2011 and July 2012 and continuous enrolment for ≥30 months and 9345 adults without secure email use between July 2010 and July 2012 matched to users on demographics, health status, and baseline utilisation. Rates of office visits, patient-initiated phone calls, scheduled telephone visits, after-hours clinic visits, emergency department visits, and hospitalisations. After controlling for multiple factors, no statistically significant differences in utilisation between secure email users and non-users occurred. Utilisation transiently increased by 88-237% around first email use. Annual rates of patient-initiated phone calls decreased among secure email users, 0.2 fewer calls per person (95% CI -0.3 to -0.1), from a mean of 4.1 calls per person 1-12 months before first use to a mean of 3.8 calls per person 7-18 months after first use. Rates of patient-initiated phone calls also decreased among non-users, 0.1 fewer calls per person (95% CI -0.2 to 0.0), from a mean of 4.2 calls per person 1-12 months before the index date to mean of 4.1 calls per person 7-18 months after the index date. Compared with non-users, patient use of secure email with clinicians was not associated with statistically significant differences in clinical services utilisation 7-18 months after first use. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted

  16. Association between secure patient–clinician email and clinical services utilisation in a US integrated health system: a retrospective cohort study

    PubMed Central

    Meng, Di; Palen, Ted E; Tsai, Joanne; McLeod, Melanie; Garrido, Terhilda; Qian, Heather

    2015-01-01

    Objective To assess associations between secure patient–clinician email use and clinical services utilisation over time. Design Retrospective cohort study between July 2010 and December 2013. Controlling for a utilisation surge around first secure email use, we analysed difference of differences between propensity score-matched groups of secure patient–clinician email users and non-users for utilisation 1–12 months before and 7–18 months after first email (users) or a randomly assigned index date (non-users). Setting US integrated healthcare delivery system. Participants 9345 adults with first secure email use between July 2011 and July 2012 and continuous enrolment for ≥30 months and 9345 adults without secure email use between July 2010 and July 2012 matched to users on demographics, health status, and baseline utilisation. Primary Outcome Measures Rates of office visits, patient-initiated phone calls, scheduled telephone visits, after-hours clinic visits, emergency department visits, and hospitalisations. Results After controlling for multiple factors, no statistically significant differences in utilisation between secure email users and non-users occurred. Utilisation transiently increased by 88–237% around first email use. Annual rates of patient-initiated phone calls decreased among secure email users, 0.2 fewer calls per person (95% CI −0.3 to −0.1), from a mean of 4.1 calls per person 1–12 months before first use to a mean of 3.8 calls per person 7–18 months after first use. Rates of patient-initiated phone calls also decreased among non-users, 0.1 fewer calls per person (95% CI −0.2 to 0.0), from a mean of 4.2 calls per person 1–12 months before the index date to mean of 4.1 calls per person 7–18 months after the index date. Conclusions Compared with non-users, patient use of secure email with clinicians was not associated with statistically significant differences in clinical services utilisation 7–18

  17. Observational follow-up study following two cohorts of children with severe pneumonia after discharge from day care clinic/hospital in Dhaka, Bangladesh

    PubMed Central

    Alam, Nur H; Chisti, Mohammod Jobayer; Salam, Mohammed Abdus; Ahmed, Tahmeed; Gyr, Niklaus

    2012-01-01

    Objectives To compare the features of relapse, morbidity, mortality and re-hospitalisation following successful discharge after severe pneumonia in children between a day care group and a hospital group and to explore the predictors of failures during 3 months of follow-up. Design An observational study following two cohorts of children with severe pneumonia for 3 months after discharge from hospital/clinic. Setting Day care was provided at the Radda Clinic and hospital care at a hospital in Dhaka, Bangladesh. Participants Children aged 2–59 months with severe pneumonia attending the clinic/hospital who survived to discharge. Intervention No intervention was done except providing some medications for minor illnesses, if indicated. Primary outcome measures The primary outcome measures were the proportion of successes and failures of day care at follow-up visits as determined by estimating the OR with 95% CI in comparison to hospital care. Results The authors enrolled 360 children with a mean (SD) age of 8 (7) months, 81% were infants and 61% were men. The follow-up compliance dropped from 95% at first to 85% at sixth visit. The common morbidities during the follow-up period included cough (28%), fever (17%), diarrhoea (9%) and rapid breathing (7%). During the follow-up period, significantly more day care children (n=22 (OR 12.2 (95% CI 8.2–17.8))) required re-hospitalisation after completion of initial day care compared with initial hospital care group (n=11 (OR 6.1 (95% CI 3.4–10.6))). The predictors for failure were associated with tachycardia, tachypnoea and hypoxaemia on admission and prolonged duration of stay. Conclusions There are considerable morbidities in children discharged following treatment of severe pneumonia like cough, fever, rapid breathing and diarrhoea during 3-month period. The findings indicate the importance of follow-up for early detection of medical problems and their management to reduce the risk of death. Establishment of an

  18. Medical school predictors of later perceived mastery of clinical work among Norwegian doctors: a cohort study with 10-year and 20-year follow-up.

    PubMed

    Belfrage, Anna; Grotmol, Kjersti Støen; Lien, Lars; Moum, Torbjørn; Wiese, Ragna Veslemøy; Tyssen, Reidar

    2017-09-24

    Doctors' self-perceived mastery of clinical work might have an impact on their career and patient care, in addition to their own health and well-being. The aim of this study is to identify predictors at medical school of perceived mastery later in doctors' careers. A cohort of medical students (n=631) was surveyed in the final year of medical school in 1993/1994 (T1), and 10 (T2) and 20 (T3) years later. Nationwide healthcare institutions. Medical students from all universities in Norway. Perceived mastery of clinical work was measured at T2 and T3. The studied predictors measured at T1 included personality traits, medical school stress, perceived medical recording skills, identification with the role of doctor, hazardous drinking and drinking to cope, in addition to age and gender. Effects were studied using multiple linear regression models. Response rates: T1, 522/631 (83%); T2, 390/522 (75%); and T3, 303/522 (58%). Mean scores at T2 and T3 were 22.3 (SD=4.2) and 24.5 (3.0) (t=8.2, p<0.001), with no gender difference. Adjusted associations at T2 were: role identification (β=0.16; p=0.006; 95% CI 0.05 to 0.28), perceived medical recording skills (β=0.13; p=0.02; 95% CI 0.02 to 0.24) and drinking to cope (β=-2.45; p=0.001; 95% CI -3.88 to -1.03). Adjusted association at T3 was perceived medical recording skills (β=0.11; p=0.015; 95% CI 0.02 to 0.21). Perceived medical recording skills and role identification were associated with higher perceived mastery. Medical schools should provide experiences, teaching and assessment to enhance students' physician role identification and confidence in their own skills. Drinking to cope was associated with lower perceived mastery, which indicates the importance of acquiring healthier coping strategies in medical school. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Prevalence of CKD and Its Relationship to eGFR-Related Genetic Loci and Clinical Risk Factors in the SardiNIA Study Cohort

    PubMed Central

    Bragg-Gresham, Jennifer; Masala, Marco; Piras, Doloretta; Atzeni, Alice; Pilia, Maria G.; Ferreli, Liana; Balaci, Lenuta; Curreli, Nicolò; Delitala, Alessandro; Loi, Francesco; Abecasis, Gonçalo R.; Schlessinger, David; Cucca, Francesco

    2014-01-01

    The prevalence of CKD and of renal failure vary worldwide, yet parallel increases in leading risk factors explain only part of the differential prevalence. We measured CKD prevalence and eGFR, and their relationship with traditional and additional risk factors, in a Sardinian founder population cohort. The eGFR was calculated using equations from the CKD Epidemiology Collaboration and Modification of Diet in Renal Disease studies. With use of the Kidney Disease Improving Global Outcomes guidelines, a cross-sectional analysis of 4842 individuals showed that CKD prevalence was 15.1%, including 3.6% of patients in the high-risk and 0.46% in the very-high-risk categories. Longitudinal analyses performed on 4074 of these individuals who completed three visits with an average follow-up of 7 years revealed that, consistent with other populations, average eGFR slope was −0.79 ml/min per 1.73 m2 per year, but 11.4% of the participants had an eGFR decline >2.3 ml/min per 1.73 m2 per year (fast decline). A genetic score was generated from 13 reported eGFR- and CKD-related loci, and univariable and multivariable analyses were applied to assess the relationship between clinical, ultrasonographic, and genetic variables with three outcomes: CKD, change in eGFR, and fast eGFR decline. Genetic risk score, older age, and female sex independently correlated with each outcome. Diabetes was associated with CKD prevalence, whereas hypertension and hyperuricemia correlated more strongly with fast eGFR decline. Diabetes, hypertension, hyperuricemia, and high baseline eGFR were associated with a decline of eGFR. Along with differential health practices, population variations in this spectrum of risk factors probably contributes to the variable CKD prevalence worldwide. PMID:24511125

  20. Breastfeeding Progression in Preterm Infants Is Influenced by Factors in Infants, Mothers and Clinical Practice: The Results of a National Cohort Study with High Breastfeeding Initiation Rates

    PubMed Central

    Maastrup, Ragnhild; Hansen, Bo Moelholm; Kronborg, Hanne; Bojesen, Susanne Norby; Hallum, Karin; Frandsen, Annemi; Kyhnaeb, Anne; Svarer, Inge; Hallström, Inger

    2014-01-01

    Background and Aim Many preterm infants are not capable of exclusive breastfeeding from birth. To guide mothers in breastfeeding, it is important to know when preterm infants can initiate breastfeeding and progress. The aim was to analyse postmenstrual age (PMA) at breastfeeding milestones in different preterm gestational age (GA) groups, to describe rates of breastfeeding duration at pre-defined times, as well as analyse factors associated with PMA at the establishment of exclusive breastfeeding. Methods The study was part of a prospective survey of a national Danish cohort of preterm infants based on questionnaires and structured telephone interviews, including 1,221 mothers and their 1,488 preterm infants with GA of 24–36 weeks. Results Of the preterm infants, 99% initiated breastfeeding and 68% were discharged exclusively breastfed. Breastfeeding milestones were generally reached at different PMAs for different GA groups, but preterm infants were able to initiate breastfeeding at early times, with some delay in infants less than GA 32 weeks. Very preterm infants had lowest mean PMA (35.5 weeks) at first complete breastfeed, and moderate preterm infants had lowest mean PMA at the establishment of exclusive breastfeeding (36.4 weeks). Admitting mothers to the NICU together with the infant and minimising the use of a pacifier during breastfeeding transition were associated with 1.6 (95% CI 0.4–2.8) and 1.2 days (95% CI 0.1–2.3) earlier establishment of exclusive breastfeeding respectively. Infants that were small for gestational age were associated with 5.6 days (95% CI 4.1–7.0) later establishment of exclusive breastfeeding. Conclusion Breastfeeding competence is not developed at a fixed PMA, but is influenced by multiple factors in infants, mothers and clinical practice. Admitting mothers together with their infants to the NICU and minimising the use of pacifiers may contribute to earlier establishment of exclusive breastfeeding. PMID:25251690

  1. Baseline Serum Osteopontin Levels Predict the Clinical Effectiveness of Tocilizumab but Not Infliximab in Biologic-Naïve Patients with Rheumatoid Arthritis: A Single-Center Prospective Study at 1 Year (the Keio First-Bio Cohort Study).

    PubMed

    Izumi, Keisuke; Kaneko, Yuko; Hashizume, Misato; Yoshimoto, Keiko; Takeuchi, Tsutomu

    2015-01-01

    To explore the baseline predictors of clinical effectiveness after tocilizumab or infliximab treatment in biologic-naïve rheumatoid arthritis patients. Consecutive biologic-naïve patients with rheumatoid arthritis initiating infliximab (n = 57) or tocilizumab (n = 70) treatment were included in our prospective cohort study. Our cohort started in February 2010, and the patients observed for at least 1 year as of April 2013 were analysed. We assessed baseline variables including patients' characteristics (age, sex, disease duration, prednisolone dose, methotrexate dose, other disease-modifying antirheumatic drug use, Clinical Disease Activity Index [CDAI]) and serum biomarker levels (C-reactive protein, immunoglobulin M-rheumatoid factor, anti-cyclic citrullinated protein/peptide antibodies, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-8, IL-10, IL-17, tumor necrosis factor-α, soluble intercellular adhesion molecule-1, bone alkaline phosphatase, osteonectin, osteopontin) to extract factors associated with clinical remission (CDAI ≤ 2.8) at 1 year using univariate analyses, and the extracted factors were entered into a multivariate logistic regression model. Similar analyses were also performed for Simplified Disease Activity Index (SDAI) remission (≤ 3.3) and Disease Activity Score with 28 joint counts, erythrocyte sedimentation rate (DAS28-ESR) remission (< 2.6). There were no significant differences in the baseline characteristics except for methotrexate use between the groups. In the multivariate analyses, the low baseline osteopontin levels (OR 0.9145, 95% CI 0.8399-0.9857) were identified as predictors of CDAI remission in the tocilizumab group, whereas no predictors of CDAI remission were found in the infliximab group. Similar results were obtained when using SDAI and DAS28-ESR remission criteria. Baseline low serum osteopontin levels predict clinical remission 1 year after tocilizumab treatment and not infliximab treatment in biologic

  2. The Swiss Systemic lupus erythematosus Cohort Study (SSCS) - cross-sectional analysis of clinical characteristics and treatments across different medical disciplines in Switzerland.

    PubMed

    Ribi, Camillo; Trendelenburg, Marten; Gayet-Ageron, Angèle; Cohen, Clemens; Dayer, Eric; Eisenberger, Ute; Hauser, Thomas; Hunziker, Thomas; Leimgruber, Annette; Lindner, Gregor; Koenig, Katrin; Otto, Petra; Spertini, François; Stoll, Thomas; Von Kempis, Johannes; Chizzolini, Carlo

    2014-01-01

    To describe disease characteristics and treatment modalities in a multidisciplinary cohort of systemic lupus erythematosus (SLE) patients in Switzerland. Cross-sectional analysis of 255 patients included in the Swiss SLE Cohort and coming from centres specialised in Clinical Immunology, Internal Medicine, Nephrology and Rheumatology. Clinical data were collected with a standardised form. Disease activity was assessed using the Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI), an integer physician's global assessment score (PGA) ranging from 0 (inactive) to 3 (very active disease) and the erythrocyte sedimentation rate (ESR). The relationship between SLE treatment and activity was assessed by propensity score methods using a mixed-effect logistic regression with a random effect on the contributing centre. Of the 255 patients, 82% were women and 82% were of European ancestry. The mean age at enrolment was 44.8 years and the median SLE duration was 5.2 years. Patients from Rheumatology had a significantly later disease onset. Renal disease was reported in 44% of patients. PGA showed active disease in 49% of patients, median SLEDAI was 4 and median ESR was 14 millimetre/first hour. Prescription rates of anti-malarial drugs ranged from 3% by nephrologists to 76% by rheumatologists. Patients regularly using anti-malarial drugs had significantly lower SELENA-SLEDAI scores and ESR values. In our cohort, patients in Rheumatology had a significantly later SLE onset than those in Nephrology. Anti-malarial drugs were mostly prescribed by rheumatologists and internists and less frequently by nephrologists, and appeared to be associated with less active SLE.

  3. Clinical Outcomes of Tenofovir Versus Zidovudine-based Regimens Among People Living with HIV/AIDS: a Two Years Retrospective Cohort Study

    PubMed Central

    Ayele, Teshale; Jarso, Habtemu; Mamo, Girma

    2017-01-01

    Background: Tenofovir (TDF) based regimen is one of the first line agents that has been utilized routinely since 2013 in Ethiopia. Unfortunately, there is limited information regarding the Clinical outcomes and associated risk factors in this setting, where patients generally present late, have high rates of TB and other infectious conditions. Methods: A two year retrospective cohort study was conducted from February 10/2015 to March 10/2015 at Jimma University Specialized Hospital. A total of 280 records were reviewed by including data from September 3, 2012 to July 31, 2014. Records were selected using a simple random sampling technique. Data was collected on socio-demographic, clinical and drug related variables. Data was analyzed using STATA 13.1. Kaplan-Meier and Cox regression were used to compare survival experience and identify independent predictors. Propensity score matching analysis was conducted to elucidate the average treatment effects of each regimen over opportunistic infections. Results: Of 280 patients, 183(65.36%) were females and 93(33.32%) of females belong to Tenofovir group. Through 24 months analysis, TDF based regimen had a protective effect against death and opportunistic infections (OIs), (AHR=0.79, 95% CI [0.24, 2.62]) and (AHR=0.78, 95%CI [0.43, 1.4] respectively. The average treatment effect of TDF/3TC/EFV was (-71/1000, p=0.026), while it was (+114/1000, p=0.049) for AZT/3TC/EFV. However, TDF/3TC/NVP was associated with statistically insignificant morbidity reduction (-74/1000, p=0.377). Those with body mass-index (BMI) <18.5kg/m2 (AHR=3.21, 95%CI [0.93, 11.97]) had higher hazard of death. Absence of baseline prophylaxis (AHR=8.22, 95% CI [1.7, 39.77]), Cotrimoxazole prophylaxis alone (AHR=6.15, 95% CI [1.47, 26.67]) and BMI<18.5kg/m2 (AHR=2.06, 95% CI [1.14, 3.73]) had higher hazards of OIs. Conclusion: The survival benefit of TDF based regimen was similar to AZT based regimen and therefore can be used as an alternative for HIV

  4. Incidence and predictors of attrition from antiretroviral care among adults in a rural HIV clinic in Coastal Kenya: a retrospective cohort study.

    PubMed

    Hassan, Amin S; Mwaringa, Shalton M; Ndirangu, Kennedy K; Sanders, Eduard J; de Wit, Tobias F Rinke; Berkley, James A

    2015-05-10

    Scale up of antiretroviral therapy (ART) has led to substantial declines in HIV related morbidity and mortality. However, attrition from ART care remains a major public health concern and has been identified as one of the key reportable indicators in assessing the success of ART programs. This study describes the incidence and predictors of attrition among adults initiating ART in a rural HIV clinic in Coastal Kenya. A retrospective cohort study design was used. Adults (≥ 15 years) initiated ART between January 2008 and December 2010 were followed up for two years. Attrition was defined as individuals who were either reported dead or lost to follow up (LFU, ≥ 180 days late since the last clinic visit). Kaplan Meier survival probabilities and Weibull baseline hazard regression analyses were used to model the incidence and predictors of time to attrition. Of the 928 eligible participants, 308 (33.2% [95% CI, 30.2 - 36.3]) underwent attrition at an incident rate of 23.1 (95% CI, 20.6 - 25.8)/100 pyo. Attrition at 6 and 12 months was 18.4% (95% CI, 16.0 - 21.1) and 23.2% (95% CI, 19.9 - 25.3) respectively. Gender (male vs. female, adjusted hazard ratio [95% CI], p-value: 1.5 [1.1 - 2.0], p = 0.014), age (15 - 24 vs. ≥ 45 years, 2.2 [1.3 - 3.7], p = 0.034) and baseline CD4 T-cell count (100 - 350 cells/uL vs. < 100 cells/uL, 0.5 [0.3 - 0.7], p = 0.002) were independent predictors of time to attrition. A third of individuals initiating ART were either reported dead or LFU during two years of care, with more than a half of these occurring within six months of treatment initiation. Practical and sustainable biomedical interventions and psychosocial support systems are warranted to improve ART retention in this setting.

  5. Reconsultation, self-reported health status and costs following treatment at a musculoskeletal Clinical Assessment and Treatment Service (CATS): a 12-month prospective cohort study

    PubMed Central

    Roddy, Edward; Jordan, Kelvin P; Oppong, Raymond; Chen, Ying; Jowett, Sue; Dawes, Peter; Hider, Samantha L; Packham, Jon; Stevenson, Kay; Zwierska, Irena; Hay, Elaine M

    2016-01-01

    Objectives To determine (1) reconsultation frequency, (2) change in self-reported health status, (3) baseline factors associated with reconsultation and change in health status and (4) associated healthcare costs and quality-adjusted life-years (QALYs), following assessment at a musculoskeletal Clinical and Assessment Treatment Service (CATS). Design Prospective cohort study. Setting Single musculoskeletal CATS at the primary–secondary care interface. Participants 2166 CATS attenders followed-up by postal questionnaires at 6 and 12 months and review of medical records. Outcome measures Primary outcome was consultation in primary care with the same musculoskeletal problem within 12 months. Secondary outcome measures were consultation at the CATS with the same musculoskeletal problem within 12 months, physical function and pain (Short Form-36), anxiety and depression (Hospital Anxiety and Depression Scale), time off work, healthcare costs and QALYs. Results Over 12 months, 507 (38%) reconsulted for the same problem in primary care and 345 (26%) at the CATS. Primary care reconsultation in the first 3 months was associated with baseline pain interference (relative risk ratio 5.33; 95% CI 3.23 to 8.80) and spinal pain (1.75; 1.09 to 2.82), and after 3–6 months with baseline assessment by a hospital specialist (2.06; 1.13 to 3.75). Small mean improvements were seen in physical function (1.88; 95% CI 1.44 to 2.32) and body pain (3.86; 3.38 to 4.34) at 6 months. Poor physical function at 6 months was associated with obesity, chronic pain and poor baseline physical function. Mean (SD) 6-month cost and QALYs per patient were £422.40 (660.11) and 0.257 (0.144), respectively. Conclusions While most patients are appropriate for a ‘one-stop shop’ model, those with troublesome, disabling pain and spinal pain commonly reconsult and have ongoing problems. Services should be configured to identify and address such clinical complexity. PMID:27733409

  6. Riyadh Mother and Baby Multicenter Cohort Study: The Cohort Profile

    PubMed Central

    Esmaeil, Samia; Alzeidan, Rasmieh; Elawad, Mamoun; Tabassum, Rabeena; Hansoti, Shehnaz; Magzoup, Mohie Edein; Al-Kadri, Hanan; Elsherif, Elham; Al-Mandil, Hazim; Al-Shaikh, Ghadeer; Zakaria, Nasria

    2016-01-01

    Objectives To assess the effects of non-communicable diseases, such as diabetes, hypertension and obesity, on the mother and the infant. Methods A multicentre cohort study was conducted in three hospitals in the city of Riyadh in Saudi Arabia. All Saudi women and their babies who delivered in participating hospitals were eligible for recruitment. Data on socio-demographic characteristics in addition to the maternal and neonatal outcomes of pregnancy were collected. The cohort demographic profile was recorded and the prevalence of maternal conditions including gestational diabetes, pre-gestational diabetes, hypertensive disorders in pregnancy and obesity were estimated. Findings The total number of women who delivered in participating hospitals during the study period was 16,012 of which 14,568 women participated in the study. The mean age of the participants was 29 ± 5.9 years and over 40% were university graduates. Most of the participants were housewives, 70% were high or middle income and 22% were exposed to secondhand smoke. Of the total cohort, 24% were married to a first cousin. More than 68% of the participants were either overweight or obese. The preterm delivery rate was 9%, while 1.5% of the deliveries were postdate. The stillbirth rate was 13/1000 live birth. The prevalence of gestational diabetes was 24% and that of pre-gestational diabetes was 4.3%. The preeclampsia prevalence was 1.1%. The labour induction rate was 15.5% and the cesarean section rate was 25%. Conclusion Pregnant women in Saudi Arabia have a unique demographic profile. The prevalence of obesity and diabetes in pregnancy are among the highest in the world. PMID:26937965

  7. Impact of nutrition support on clinical outcome and cost-effectiveness analysis in patients at nutritional risk: A prospective cohort study with propensity score matching.

    PubMed

    Zhang, Hui; Wang, Yang; Jiang, Zhu-Ming; Kondrup, Jens;