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Sample records for clinical cohort studies

  1. Is the clinical course of HIV-1 changing? Cohort study.

    PubMed Central

    Sinicco, A.; Fora, R.; Raiteri, R.; Sciandra, M.; Bechis, G.; Calvo, M. M.; Gioannini, P.

    1997-01-01

    OBJECTIVE: To assess whether the clinical course of HIV infection has changed from 1985 to 1995. DESIGN: Cohort Study. SETTING: Infectious disease clinic. SUBJECTS: 285 patients recruited from September 1985 to January 1995 with < or = 12 months between the dates of their last seronegative and first seropositive test result and with first follow up visit in the six months after seroconversion and at least 12 months' follow up. Patients were grouped according to the date of seroconversion. MAIN OUTCOME MEASURES: Time to CD4 cell count of < 500, 400, and 200 x 10(6) cells/l, and clinical outcome defining AIDS; variation in cell count per day between consecutive visits, and ratio between this variation and time from estimated date of seroconversion at each visit. RESULTS: The groups were similar in age, number with acute primary HIV infection, CD4 cell count at intake, and cell count at the beginning of antiretroviral treatment; they differed in sex ratio, risk factors for HIV, probability of CD4 cell decline to < 500, 400, and 200 x 10(6) cells/l. and risk of developing AIDS. Acute infection, seroconversion after December 1989, and serum beta 2 microglobulin > 296 nmol/l were independent predictors of poor clinical course. The speed of CD4 cell decline, expressed as cell variation divided by the number of days between consecutive visits, increased with more recent seroconversion (P = 0.02). Ratio between the speed of CD4 cell decline and time from estimated date of seroconversion at each visit was also higher in the patients who seroconverted after December 1989. CONCLUSIONS: The faster disease progression and the higher speed of CD4 cell decline at early stages in the patients with recently acquired HIV infection suggest changes in the clinical course of HIV infection. PMID:9154026

  2. 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

  3. 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…

  4. Clinical orofacial characteristics associated with risk of first-onset TMD: the OPPERA prospective cohort study

    PubMed Central

    Ohrbach, Richard; Bair, Eric; Fillingim, Roger B.; Gonzalez, Yoly; Gordon, Sharon M.; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Diatchenko, Luda; Dubner, Ron; Greenspan, Joel D.; Knott, Charles; Maixner, William; Smith, Shad; Slade, Gary

    2013-01-01

    Case-control studies have documented clinical manifestations of chronic temporomandibular disorders (TMD), whereas clinical predictors of TMD development are largely unknown. We evaluated 41 clinical orofacial characteristics thought to predict first-onset TMD in a prospective cohort study of U.S. adults aged 18-44 years. During the median 2.8-year follow-up period, 2,737 people completed quarterly screening questionnaires. Those reporting symptoms were examined and 260 people were identified with first-onset TMD. Univariate and multivariate Cox regression models quantified associations between baseline clinical orofacial measures and TMD incidence. Significant predictors from baseline self-report instruments included oral parafunctions, prior facial pain and its life-impact, TMJ noises and jaw locking, and non-specific orofacial symptoms. Significant predictors from the baseline clinical examination were pain on jaw opening and pain from palpation of masticatory, neck, and body muscles. Examiner assessments of TMJ noise and tooth wear facets did not predict incidence. In multivariate analysis, non-specific orofacial symptoms, pain from jaw opening and oral parafunctions predicted TMD incidence. The results indicate that only a few orofacial examination findings influenced TMD incidence, and only to a modest degree. More pronounced influences were found for self-reported symptoms, particularly those that appeared to reflect alterations to systems beyond the masticatory tissues. PMID:24275222

  5. 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

  6. The clinical outcomes of chronic hepatitis C in South Korea: A prospective, multicenter cohort study.

    PubMed

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-08-01

    This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region.From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival.During the median follow-up of 39.0 months (range 18.0-81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 10/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002).The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  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. RISK OF HEMOPTYSIS IN CYSTIC FIBROSIS CLINICAL TRIALS: A RETROSPECTIVE COHORT STUDY

    PubMed Central

    Mayer-Hamblett, N.; Kloster, M.; Bilton, D.; Flume, P. A.

    2015-01-01

    Background Cystic fibrosis (CF) is characterized by airways infection and inflammation resulting in respiratory complications including hemoptysis. The objectives of this study were to characterize risk of hemoptysis attributable to the underlying disease and in the presence of standard of care therapy. Methods This retrospective cohort study estimated hemoptysis rates overall and by relevant risk factors utilizing adverse event data from longitudinal prospective CF clinical trials. Results Of the 1008 participants, 73% were ≤18 years old; of 929 with available spirometry, 27% had an FEV1 < 70% predicted. During the average 8.2 months of follow-up, 8% experienced ≥1 hemoptysis events (95% CI: 6%, 10%). Of the 125 events, 76% were mild in severity and only 9% were serious. Hemoptysis rates were greater among adults than children, those with FEV1 < 70% predicted, and participants infected with P. aeruginosa but not with S. aureus. Conclusions Hemoptysis is a common adverse event among CF clinical trial participants, and particularly in adults with more severe lung disease. These results can be used to predict event occurrence in future clinical trials. PMID:25725985

  9. 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

  10. Clinical, Electroencephalographic, and Neuroradiological Outcome Predictors in Acute Nonhypoxic Encephalopathy: A Nine-Year Cohort Study.

    PubMed

    Sutter, Raoul; Kaplan, Peter W

    2016-01-01

    Marked impairment of consciousness, brain lesion on neuroimaging, and nonreactive electroencephalographic (EEG) background activity are established outcome predictors in patients with hypoxic encephalopathy. In this observational cohort study, we aimed to assess the predictive value of clinical, neuroimaging and EEG characteristics for outcome in different types of acute nonhypoxic encephalopathic patients. All adult intensive care unit patients from a tertiary academic medical care center with clinical and EEG evidence of acute nonhypoxic encephalopathy were included from 2004 to 2012. Clinical data, neuroimaging studies, EEG characteristics, and outcome were assessed. In-hospital death was the main outcome. Median age of 262 patients was 65 years (range 18-98 years). Mortality was 12.6%. In Poisson regression analyses, older age (P=.02), intracranial hemorrhage (P=.008), coma (P=.012), and nonreactive EEG background activity (P<.0001) were independently associated with death with nonreactive EEG being the strongest predictor (relative risk 3.74; 95% confidence interval 2.02-6.91). Subgroup analysis revealed no significant effect modification for the predictive value of nonreactive EEG by the presence or absence of coma and different types of acute brain lesions. In conclusion, this study identifies and quantifies the independent predictive value of older age, intracranial hemorrhage, coma, and nonreactive EEG for death, in patients with different types of acute nonhypoxic encephalopathy. These results add further credence to the limited body of evidence that EEG provides important prognostic information in different types of acute encephalopathy not related to hypoxic brain injury. Further studies are warranted to analyze the robustness of this predictor in larger subpopulations with specific etiologies of acute nonhypoxic encephalopathies. PMID:25828484

  11. 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

  12. Effect of polypharmacy, potentially inappropriate medications and anticholinergic burden on clinical outcomes: a retrospective cohort study

    PubMed Central

    Lu, Wan-Hsuan; Wen, Yu-Wen; Chen, Liang-Kung; Hsiao, Fei-Yuan

    2015-01-01

    Background: Polypharmacy, potentially inappropriate medications and anticholinergic burden (as assessed by the anticholinergic risk scale) are commonly used as quality indicators of pharmacotherapy in older adults. However, their role in clinical practice is undefined. We sought to investigate longitudinal changes in these indicators and their effects on clinical outcomes. Methods: We used Taiwan’s Longitudinal Health Insurance Database to retrieve quarterly information about drug use for people aged 65 years and older over a 10-year period. We analyzed the association between indicators and all-cause admission to hospital, fracture-specific admission to hospital and death using generalized estimating equations. Results: The study cohort comprised 59 042 older adults (65–74 yr: 39 358 [66.7%], 75–84 yr: 16 903 [28.6%], and ≥ 85 yr: 2781 [4.7%]). The mean changes in polypharmacy over the course of the study were greatest among patients aged 65–74 years (absolute difference +2.14, 95% confidence interval [CI] 2.10–2.19), then among those aged 75–84 yr (+1.79, 95% CI 1.70–1.88), and finally those aged 85 years and older (+0.71, 95% CI 0.36–1.05). The number of potentially inappropriate medications increased among patients aged 65–74 years (+0.16 [0.15–0.18]) and 75–84 years (+0.09 [0.06–0.08]), but decreased in those aged 85 years and older (−0.15 [−0.26 to −0.04]). Polypharmacy, potentially inappropriate medications and anticholinergic risk scale were each associated with an increased risk of admission to hospital, but not with death. In addition, both polypharmacy (5–9 drugs: odds ratio [OR] 1.18, 95% CI 1.12–1.24; ≥ 10 drugs: OR 1.54, 95% CI 1.42–1.66) and anticholinergic burden (score 1–2: 1.39, 95% CI 1.31–1.48; ≥ 3: 1.53, 95% CI 1.41–1.66) showed dose–response relations with fracture-specific admission to hospital. Interpretation: The total number of drugs taken (polypharmacy), number of potentially inappropriate

  13. Translation of clinical prediction rules for febrile children to primary care practice: an observational cohort study

    PubMed Central

    van Ierland, Yvette; Elshout, Gijs; Berger, Marjolein Y; Vergouwe, Yvonne; de Wilde, Marcel; van der Lei, Johan; Mol, Henriëtte A; Oostenbrink, Rianne

    2015-01-01

    Background Clinical prediction rules (CPRs) to identify children with serious infections lack validation in low-prevalence populations, which hampers their implementation in primary care practice. Aim To evaluate the diagnostic value of published CPRs for febrile children in primary care. Design and setting Observational cohort study among febrile children (<16 years) who consulted five GP cooperatives (GPCs) in the Netherlands. Method Alarm signs of serious infection and clinical management were extracted from routine clinical practice data and manually recoded with a structured electronic data-entry program. Eight CPRs were selected from literature. CPR-variables were matched with alarm signs and CPRs were applied to the GPC-population. ‘Referral to emergency department (ED)’ was used as a proxy outcome measure for ‘serious infection’. CPR performance was assessed by calibration analyses, sensitivity, specificity, and area under the ROC-curve (ROC-area). Results A total of 9794 GPC-contacts were eligible, 54% male, median age 2.3 years (interquartile range 1.0–4.6 years) and 8.1% referred to ED. Frequencies of CPR-variables varied from 0.5% (cyanosis, drowsy) to 25% (temperature ≥40°C). Alarm signs frequently included in CPRs were ‘ill appearance’, ‘inconsolable’, and ‘abnormal circulatory or respiratory signs’. The height of the CPR’s predicted risks generally corresponded with being (or not being) referred to the ED in practice. However, calibration-slopes indicated that three CPRs underestimated the risk of serious infection in the GPC-population. Sensitivities ranged from 42% to 54%, specificities from 68% to 89%. ROC-areas ranged from 0.52 to 0.81, with best performance of CPRs for children aged <3 months. Conclusion Published CPRs performed moderately well in the primary out-of-hours care population. Advice is given on how to improve translation of CPRs to primary care practice. PMID:25824182

  14. Clinical Outcomes of Minimally Invasive Versus Open TLIF: A Propensity-Matched Cohort Study.

    PubMed

    Djurasovic, Mladen; Rouben, David P; Glassman, Steven D; Casnellie, Michael T; Carreon, Leah Y

    2016-01-01

    In this study, we compare intermediate-term outcomes in minimally invasive surgical transforaminal lumbar interbody fusion (MIS TLIF) to open TLIF. Sixty-four patients who underwent 1- to 2-level MIS TLIF with baseline, 1-, and 2-year outcome measures were identified. These were propensity-matched to a cohort of open TLIF patients based on age, body mass index, sex, smoking status, workers' compensation status, and preoperative outcome measures. At 1 year, both groups had similar improvements in pain and Short-Form 36 (SF-36) Physical Composite Summary (PCS), but the MIS TLIF group had a statistically significantly greater improvement in Oswestry Disability Index (ODI) compared with the open TLIF group. At 2 years, the MIS TLIF group had a statistically significantly greater improvement in pain and ODI compared with the open TLIF group, but no statistically significant difference in SF-36 PCS. Both MIS TLIF and open TLIF lead to significant improvements in clinical outcomes. At 1 year after surgery, MIS TLIF patients had greater improvements in ODI, and at 2 years after surgery, they had greater improvements in pain and ODI. This study showed that the perioperative advantages of MIS TLIF, such as less muscle dissection and faster recovery, continue to be beneficial 1 to 2 years after surgery. PMID:26991587

  15. Clinical Outcomes and Microbiological Characteristics of Severe Pneumonia in Cancer Patients: A Prospective Cohort Study

    PubMed Central

    Rabello, Ligia S. C. F.; Silva, Jose R. L.; Azevedo, Luciano C. P.; Souza, Ivens; Torres, Viviane B. L.; Rosolem, Maíra M.; Lisboa, Thiago; Soares, Marcio; Salluh, Jorge I. F.

    2015-01-01

    Introduction Pneumonia is the most frequent type of infection in cancer patients and a frequent cause of ICU admission. The primary aims of this study were to describe the clinical and microbiological characteristics and outcomes in critically ill cancer patients with severe pneumonia. Methods Prospective cohort study in 325 adult cancer patients admitted to three ICUs with severe pneumonia not acquired in the hospital setting. Demographic, clinical and microbiological data were collected. Results There were 229 (71%) patients with solid tumors and 96 (29%) patients with hematological malignancies. 75% of all patients were in septic shock and 81% needed invasive mechanical ventilation. ICU and hospital mortality rates were 45.8% and 64.9%. Microbiological confirmation was present in 169 (52%) with a predominance of Gram negative bacteria [99 (58.6%)]. The most frequent pathogens were methicillin-sensitive S. aureus [42 (24.9%)], P. aeruginosa [41(24.3%)] and S. pneumonia [21 (12.4%)]. A relatively low incidence of MR [23 (13.6%)] was observed. Adequate antibiotics were prescribed for most patients [136 (80.5%)]. In multivariate analysis, septic shock at ICU admission [OR 5.52 (1.92–15.84)], the use of invasive MV [OR 12.74 (3.60–45.07)] and poor Performance Status [OR 3.00 (1.07–8.42)] were associated with increased hospital mortality. Conclusions Severe pneumonia is associated with high mortality rates in cancer patients. A relatively low rate of MR pathogens is observed and severity of illness and organ dysfunction seems to be the best predictors of outcome in this population. PMID:25803690

  16. 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

  17. Pre-clinical and clinical walking kinematics in female breeding pigs with lameness: A nested case-control cohort study.

    PubMed

    Stavrakakis, S; Guy, J H; Syranidis, I; Johnson, G R; Edwards, S A

    2015-07-01

    Gait profiles were investigated in a cohort of female pigs experiencing a lameness period prevalence of 29% over 17 months. Gait alterations before and during visually diagnosed lameness were evaluated to identify the best quantitative clinical lameness indicators and early predictors for lameness. Pre-breeding gilts (n= 84) were recruited to the study over a period of 6 months, underwent motion capture every 5 weeks and, depending on their age at entry to the study, were followed for up to three successive gestations. Animals were subject to motion capture in each parity at 8 weeks of gestation and on the day of weaning (28 days postpartum). During kinematic motion capture, the pigs walked on the same concrete walkway and an array of infra-red cameras was used to collect three dimensional coordinate data of reflective skin markers attached to the head, trunk and limb anatomical landmarks. Of 24 pigs diagnosed with lameness, 19 had preclinical gait records, whilst 18 had a motion capture while lame. Depending on availability, data from one or two preclinical motion capture 1-11 months prior to lameness and on the day of lameness were analysed. Lameness was best detected and evaluated using relative spatiotemporal gait parameters, especially vertical head displacement and asymmetric stride phase timing. Irregularity in the step-to-stride length ratio was elevated (deviation  ≥ 0.03) in young pigs which presented lameness in later life (odds ratio 7.2-10.8). PMID:25986130

  18. 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

  19. 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

  20. 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

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

    PubMed

    DeLuca, Stephanie C; 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Clinical experience with BIAsp 30: Results from the Bangladesh cohort of the global A1chieve study.

    PubMed

    Latif, Z A; Pathan, M F; Mannan, M A; Siddiqui, M N I; Ashrafuzzaman, S M; Rahman, M M; Sobhan, M J

    2013-12-01

    The aim of A1chieve was to remedy the deficit of data on the efficacy and safety of insulin analogues in routine clinical care in less well-resourced developed countries. To present results from the Bangladesh cohort of the A1chieve study receiving BIAsp 30 ± oral anti diabetic drugs. A1chieve was a 6-month, observational study of 66,726 people with type 2 diabetes, started on insulin detemir, insulin aspart or biphasic insulin aspart (BIAsp 30) in 28 countries across four continents. A total of 1,093 subjects were recruited from 49 sites in Bangladesh and 580 subjects initiated on BIAsp 30 were studied. In the entire cohort, treatment with BIAsp 30 for 24 weeks significantly reduced mean HbA(1c) (2.8%, p < 0.001), fasting plasma glucose (4.0 mmol/L, p < 0.001) and post prandial plasma glucose (6.6 mmol/L, p < 0.001) levels from baseline. The rate of overall hypoglycaemic events in the entire cohort also reduced significantly at 24 weeks (1.86 to 0.02 events/person year, p < 0.0001). BIAsp 30 can be considered as a safe and effective option for initiating as well as intensifying insulin therapy for type 2 diabetes. PMID:26118154

  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. 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

  9. 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

  10. Psoriasis and the Risk of Major Cardiovascular Events: Cohort Study Using the Clinical Practice Research Datalink.

    PubMed

    Parisi, Rosa; Rutter, Martin K; Lunt, Mark; Young, Helen S; Symmons, Deborah P M; Griffiths, Christopher E M; Ashcroft, Darren M

    2015-09-01

    The association between psoriasis and risk of major cardiovascular (CV) events (myocardial infarction, acute coronary syndrome, unstable angina, and stroke) is unclear. A cohort study with 48,523 patients with psoriasis and 208,187 controls was conducted. During a median follow-up of 5.2 years, 1,257 patients with psoriasis (2.59%) had a major CV event, compared with 4,784 controls (2.30%). In the multivariable analysis, inflammatory arthritis hazard ratio (HR) 1.36 (1.18-1.58), diabetes HR 1.18 (1.06-1.31), chronic kidney disease HR 1.18 (1.07-1.31), hypertension HR 1.37 (1.29-1.45), transient ischemic attack HR 2.74 (2.41-3.12), atrial fibrillation HR 1.54 (1.36-1.73), valvular heart disease HR 1.23 (1.05-1.44), thromboembolism 1.32 (1.17-1.49), congestive heart failure HR 1.57 (1.39-1.78), depression HR 1.16 (1.01-1.34), current smoker HR 2.18 (2.03-2.33), age (year) HR 1.07 (1.07-1.07), and male gender HR 1.83 (1.69-1.98) were statistically significant for the risk of major CV events. The age- and gender-adjusted HRs of a major CV event for psoriasis were 1.10 (1.04-1.17) and for severe psoriasis 1.40 (1.07-1.84), whereas the fully adjusted HRs were attenuated to 1.02 (0.95-1.08) and 1.28 (0.96-1.69). In conclusion, neither psoriasis nor severe psoriasis were associated with the short-to-medium term (over 3-5 years) risk of major CV events after adjusting for known cardiovascular disease risk factors. PMID:25742120

  11. 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. PMID:25414068

  12. Clinical predictors for severe sepsis in patients with necrotizing fasciitis: an observational cohort study in northern Thailand

    PubMed Central

    Khamnuan, Patcharin; Chongruksut, Wilaiwan; Jearwattanakanok, Kijja; Patumanond, Jayanton; Tantraworasin, Apichat

    2015-01-01

    Background Necrotizing fasciitis (NF) is a life-threatening infection of skin and fascia. Its progress is extremely fast, with extensive necrosis. Delay in treatment, with subsequent huge soft tissue loss and associated severe sepsis, remains a major cause of death in the management of NF. Objective The aim of this study was to explore clinical characteristics that may be used to predict severe sepsis in patients with NF, in the context of routine clinical practice in northern Thailand. Methods A retrospective observational cohort study was conducted. The patient cohort in this study consisted of all patients who were diagnosed with NF by surgical or pathological confirmation. The follow-up period started with the admission date and ended with the discharge date. The clinical variables were collected from patients registered at three provincial hospitals in northern Thailand from 2009 to 2012. The clinical predictors for severe sepsis were analyzed using multivariable risk regression. Results A total of 1,452 patients were diagnosed with NF, either with severe sepsis (n=237 [16.3%]) or without severe sepsis (n=1,215 [83.7%]). From the multivariable analysis, female sex (relative risk [RR] =1.51; 95% confidence interval [CI] =1.04–2.20), diabetes mellitus (RR =1.40; 95% CI =1.25–1.58), chronic heart disease (RR =1.31; 95% CI =1.15–1.49), hemorrhagic bleb (RR =1.47; 95% CI =1.32–1.63), skin necrosis (RR =1.45; 95% CI =1.34–1.57), and serum protein <6 g/dL (RR =2.67; 95% CI =1.60–4.47) were all predictive factors for severe sepsis. Conclusion The clinical predictors for severe sepsis in patients with suspicion of NF included female sex, diabetes mellitus, chronic heart disease, hemorrhagic bleb, skin necrosis, and serum protein <6 d/dL. The risk ratio was much higher in patients with total protein less than 6 g/dL, which is associated with malnutrition. Therefore, provision of sufficient nutritional support and close monitoring for these clinical

  13. A Clinical Algorithm to Identify HIV Patients at High Risk for Incident Active Tuberculosis: A Prospective 5-Year Cohort Study

    PubMed Central

    Lee, Susan Shin-Jung; Lin, Hsi-Hsun; Tsai, Hung-Chin; Su, Ih-Jen; Yang, Chin-Hui; Sun, Hsin-Yun; Hung, Chien-Chin; Sy, Cheng-Len; Wu, Kuan-Sheng; Chen, Jui-Kuang; Chen, Yao-Shen; Fang, Chi-Tai

    2015-01-01

    Background Predicting the risk of tuberculosis (TB) in people living with HIV (PLHIV) using a single test is currently not possible. We aimed to develop and validate a clinical algorithm, using baseline CD4 cell counts, HIV viral load (pVL), and interferon-gamma release assay (IGRA), to identify PLHIV who are at high risk for incident active TB in low-to-moderate TB burden settings where highly active antiretroviral therapy (HAART) is routinely provided. Materials and Methods A prospective, 5-year, cohort study of adult PLHIV was conducted from 2006 to 2012 in two hospitals in Taiwan. HAART was initiated based on contemporary guidelines (CD4 count < = 350/μL). Cox regression was used to identify the predictors of active TB and to construct the algorithm. The validation cohorts included 1455 HIV-infected individuals from previous published studies. Area under the receiver operating characteristic (ROC) curve was calculated. Results Seventeen of 772 participants developed active TB during a median follow-up period of 5.21 years. Baseline CD4 < 350/μL or pVL ≥ 100,000/mL was a predictor of active TB (adjusted HR 4.87, 95% CI 1.49–15.90, P = 0.009). A positive baseline IGRA predicted TB in patients with baseline CD4 ≥ 350/μL and pVL < 100,000/mL (adjusted HR 6.09, 95% CI 1.52–24.40, P = 0.01). Compared with an IGRA-alone strategy, the algorithm improved the sensitivity from 37.5% to 76.5%, the negative predictive value from 98.5% to 99.2%. Compared with an untargeted strategy, the algorithm spared 468 (60.6%) from unnecessary TB preventive treatment. Area under the ROC curve was 0.692 (95% CI: 0.587–0.798) for the study cohort and 0.792 (95% CI: 0.776–0.808) and 0.766 in the 2 validation cohorts. Conclusions A validated algorithm incorporating the baseline CD4 cell count, HIV viral load, and IGRA status can be used to guide targeted TB preventive treatment in PLHIV in low-to-moderate TB burden settings where HAART is routinely provided to all PLHIV. The

  14. 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

  15. 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). PMID:24550246

  16. Incidence Rates of Clinically Significant Tinnitus: 10-Year Trend From a Cohort Study in England

    PubMed Central

    Wallenhorst, Christopher; McFerran, Don; Hall, Deborah A.

    2015-01-01

    Objective: To investigate the incidence of tinnitus that burdens the health service in England. Design: This was an observational study of 4.7 million residents of England under 85 years of age who were at risk for developing clinically significant tinnitus (sigT). SigT was defined by a discharge from hospital with a primary diagnosis of tinnitus, or a primary care recording of tinnitus with subsequent related medical follow-up within 28 days. The database used was the Clinical Practice Research Datalink and individual records were linked to additional data from the Hospital Episode Statistics. The observational period was from January 1, 2002 to December 31, 2011. Age-, gender-, and calendar year-specific incidence rates for and cumulative incidences of sigT were estimated and a projection of new cases of sigT between 2012 and 2021 was performed. Results: There were 14,303 incident cases of sigT identified among 26.5 million person-years of observation. The incidence rate was 5.4 new cases of sigT per 10,000 person-years (95% confidence interval: 5.3 to 5.5). The incidence rate did not depend on gender but increased with age, peaking at 11.4 per 10,000 in the age group 60 to 69 years. The annual incidence rate of sigT increased from 4.5 per 10,000 person-years in 2002 to 6.6 per 10,000 person-years in 2011. The 10-year cumulative incidence of sigT was 58.4 cases (95% confidence interval: 57.4 to 59.4) per 10,000 residents. Nearly 324,000 new cases of sigT are expected to occur in England between 2012 and 2021. Conclusions: Tinnitus presents a burden to the health care system that has been rising in recent years. Population-based studies provide crucial underpinning evidence; highlighting the need for further research to address issues around effective diagnosis and clinical management of this heterogeneous condition. PMID:25470370

  17. 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

  18. 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

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

    PubMed

    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

  20. Clinical Characteristics and Prognostic Significance of TERT Promoter Mutations in Cancer: A Cohort Study and a Meta-Analysis

    PubMed Central

    Yuan, Ping; Cao, Jin-lin; Abuduwufuer, Abudumailamu; Wang, Lu-Ming; Yuan, Xiao-Shuai; Lv, Wang; Hu, Jian

    2016-01-01

    Background The prevalence of telomerase reverse transcriptase (TERT) promoter mutations (pTERTm) in non-small-cell lung cancer (NSCLC) have been investigated, but the results were inconsistent. In addition, several studies have analysed the role of pTERTm in the etiology of various types of cancers, however, the results also remain inconsistent. Methods The genomic DNA sequence of 103 NSCLC samples were analysed to investigate the frequency of pTERTm in these patients and to establish whether these mutations are associated with their clinical data. Furthermore, a meta-analysis based on previously published articles and our cohort study was performed to investigate the association of pTERTm with patient gender, age at diagnosis, metastasis status, tumour stage and cancer prognosis (5-year overall survival rate). Results In the cohort study, 4 patients had C228T and 2 had C250T, with a total mutation frequency up to 5.8%. Significant difference of clinical data between pTERTm carriers and noncarriers was only found in age at diagnosis. In the meta-analysis, We found that pTERTm carriers in cancer patients are older than noncarriers (Mean difference (MD) = 5.24; 95% confidence interval [CI], 2.00 to 8.48), male patients were more likely to harbour pTERTm (odds Ratios (OR) = 1.38; 95% CI, 1.22 to 1.58), and that pTERTm had a significant association with distant metastasis (OR = 3.78; 95% CI, 2.45 to 5.82), a higher tumour grade in patients with glioma (WHO grade III, IV vs. I, II: OR, 2.41; 95% CI, 1.88 to 3.08) and a higher tumour stage in other types of cancer (III, IV vs. I, II: OR, 2.48; 95% CI, 1.48 to 4.15). pTERTm was also significantly associated with a greater risk of death (hazard ratio = 1.71; 95% CI, 1.41 to 2.08). Conclusions pTERTm are a moderately prevalent genetic event in NSCLC. The current meta-analysis indicates that pTERTm is associated with patient age, gender and distant metastasis. It may serves as an adverse prognostic factor in individuals with

  1. The effect of early, comprehensive genomic testing on clinical care in neonatal diabetes: an international cohort study

    PubMed Central

    De Franco, Elisa; Flanagan, Sarah E; Houghton, Jayne AL; Allen, Hana Lango; Mackay, Deborah JG; Temple, I Karen; Ellard, Sian; Hattersley, Andrew T

    2015-01-01

    Summary Background Traditional genetic testing focusses on analysis of one or a few genes according to clinical features; this approach is changing as improved sequencing methods enable simultaneous analysis of several genes. Neonatal diabetes is the presenting feature of many discrete clinical phenotypes defined by different genetic causes. Genetic subtype defines treatment, with improved glycaemic control on sulfonylurea treatment for most patients with potassium channel mutations. We investigated the effect of early, comprehensive testing of all known genetic causes of neonatal diabetes. Methods In this large, international, cohort study, we studied patients with neonatal diabetes diagnosed with diabetes before 6 months of age who were referred from 79 countries. We identified mutations by comprehensive genetic testing including Sanger sequencing, 6q24 methylation analysis, and targeted next-generation sequencing of all known neonatal diabetes genes. Findings Between January, 2000, and August, 2013, genetic testing was done in 1020 patients (571 boys, 449 girls). Mutations in the potassium channel genes were the most common cause (n=390) of neonatal diabetes, but were identified less frequently in consanguineous families (12% in consanguineous families vs 46% in non-consanguineous families; p<0·0001). Median duration of diabetes at the time of genetic testing decreased from more than 4 years before 2005 to less than 3 months after 2012. Earlier referral for genetic testing affected the clinical phenotype. In patients with genetically diagnosed Wolcott-Rallison syndrome, 23 (88%) of 26 patients tested within 3 months from diagnosis had isolated diabetes, compared with three (17%) of 18 patients referred later (>4 years; p<0·0001), in whom skeletal and liver involvement was common. Similarly, for patients with genetically diagnosed transient neonatal diabetes, the diabetes had remitted in only ten (10%) of 101 patients tested early (<3 months) compared with 60

  2. Clinical characteristics associated with adverse events in patients with exacerbation of chronic obstructive pulmonary disease: a prospective cohort study

    PubMed Central

    Stiell, Ian G.; Clement, Catherine M.; Aaron, Shawn D.; Rowe, Brian H.; Perry, Jeffrey J.; Brison, Robert J.; Calder, Lisa A.; Lang, Eddy; Borgundvaag, Bjug; Forster, Alan J.; Wells, George A.

    2014-01-01

    Background: To assist physicians with difficult decisions about hospital admission for patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) presenting in the emergency department, we sought to identify clinical characteristics associated with serious adverse events. Methods: We conducted this prospective cohort study in 6 large Canadian academic emergency departments. Patients were assessed for standardized clinical variables and then followed for serious adverse events, defined as death, intubation, admission to a monitored unit or new visit to the emergency department requiring admission. Results: We enrolled 945 patients, of whom 354 (37.5%) were admitted to hospital. Of 74 (7.8%) patients with a subsequent serious adverse event, 36 (49%) had not been admitted after the initial emergency visit. Multivariable modelling identified 5 variables that were independently associated with adverse events: prior intubation, initial heart rate ≥ 110/minute, being too ill to do a walk test, hemoglobin < 100 g/L and urea ≥ 12 mmol/L. A preliminary risk scale incorporating these and 5 other clinical variables produced risk categories ranging from 2.2% for a score of 0 to 91.4% for a score of 10. Using a risk score of 2 or higher as a threshold for admission would capture all patients with a predicted risk of adverse events of 7.2% or higher, while only slightly increasing admission rates, from 37.5% to 43.2%. Interpretation: In Canada, many patients with COPD suffer a serious adverse event or death after being discharged home from the emergency department. We identified high-risk characteristics and developed a preliminary risk scale that, once validated, could be used to stratify the likelihood of poor outcomes and to enable rational and safe admission decisions. PMID:24549125

  3. Risk factors for hip-related clinical signs in a prospective cohort study of four large dog breeds in Norway.

    PubMed

    Krontveit, Randi I; Trangerud, Cathrine; Sævik, Bente K; Skogmo, Hege K; Nødtvedt, Ane

    2012-02-01

    We conducted a prospective cohort study including privately owned dogs from the breeds Newfondland (NF), Labrador Retriever (LR), Leonberger (LEO), and Irish Wolfhound (IW) followed from birth until age 9 yrs. We wanted to investigate whether radiological hip dysplasia status given at approximately age 12-18 mos and other factors during growth influenced development of clinical signs due to hip-joint disease necessitating veterinary consultation. Whether or not such signs occurred due to hip dysplasia or due to secondary or primary DJD could not be distinguished, and we therefore used the term "owner-reported veterinary-diagnosed hip-related clinical signs" ("the event"). The included dogs were followed from birth to the event or until a maximum of 9 yrs of age. Our objectives were to describe breed differences in time to incidence and to evaluate potential risk factors for the time to event. We used Kaplan-Meier curves to describe time to incidence, and potential risk factors were assessed by use of a Cox proportional-hazards model. We enrolled 494 dogs from 103 litters, and 46 dogs were reported as having had the event during the observation period. We observed a significant time-varying effect (TVE): LR and LEO developed clinical signs later in life than NF. If the radiological hip status was either mild, moderate, or severe the hazard of experiencing the event was significantly increased. Access to off-leash exercise at age 12 mos decreased the hazard of the event, and the hazard varied by litter. The findings supported the hypothesis that radiological hip status at screening and exercise conditions during growth influenced the time to incidence of the event and that there were breed differences in time to the event. PMID:21982689

  4. Next Generation Sequencing in the Clinic: a Patterns of Care Study in a Retrospective Cohort of Subjects Referred to a Genetic Medicine Clinic for Suspected Lynch Syndrome.

    PubMed

    Gallego, Carlos J; Perez, Matthew L; Burt, Amber; Amendola, Laura M; Shirts, Brian H; Pritchard, Colin C; Hisama, Fuki M; Bennett, Robin L; Veenstra, David L; Jarvik, Gail P

    2016-06-01

    Next generation sequencing (NGS) gene panels are increasingly used in medical genetics clinics for the evaluation of common inherited cancer syndromes, but the clinical efficacy of these tests, and the factors driving clinical providers to order them are unclear. We conducted a patterns-of-care study to compare patients evaluated with NGS gene panels with a reference group. We abstracted demographic, socioeconomic, and clinical information in a retrospective cohort of patients referred to a large medical genetics clinic for evaluation of inherited colorectal cancer and polyposis syndromes. Patients tested with NGS gene panels were more likely to be insured compared to the reference group (85.3 % vs. 69.2 %, p = 0.0068),less likely to have prior tumor tissue testing (29.4 % vs. 54.3 %, p = 0.0004), and less likely to have an abnormal tumor tissue test result (46.7 % vs. 74.5 %, p = 0.01). No significant differences were found between groups in age, gender, race, employment status, personal history of colorectal cancer, or proportion of patients fulfilling Lynch syndrome clinical criteria. Patients with NGS testing were less likely to have a pathogenic/likely pathogenic variant detected (13.7 % vs. 31.9 %, p = 0.002). Patients referred for NGS testing to evaluate inherited colorectal cancer/polyposis risk appear to undergo tumor tissue testing less frequently than non-NGS testing patients. Further studies are needed to assess the most effective and cost-effective approach to genomic diagnosis in this patient population. PMID:26637299

  5. 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

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

    PubMed Central

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

    2016-01-01

    Objective This study sought to determine the influence of postoperative complications on the clinical outcomes of patients who underwent thoracic and gastrointestinal cancer surgery. Methods 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. Results 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). Conclusions 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. PMID:27096675

  7. 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

  8. The clinical application of "jetting suture" technique in annular repair under microendoscopic discectomy: A prospective single-cohort observational study.

    PubMed

    Qi, Lei; Li, Mu; Si, Haipeng; Wang, Liang; Jiang, Yunpeng; Zhang, Shuai; Li, Le

    2016-08-01

    To introduce a new designed suture technique in annular repair under the microendoscopic discectomy (MED) surgery and to evaluate the clinical application of the technique in annular repair under MED with at least 2-year follow-up period.A new method of annular repair was designed and named "jetting suture" technique. Thirty consecutive patients with lumbar disc herniation were enrolled in the prospective single-cohort observational study. Patients were followed up at intervals of preoperative, postoperative 1 week, 3 months, 6 months, 1 year, and last follow-up. The clinical outcomes were evaluated by using Japanese Orthopaedic Association (JOA) score, Oswestry Disability Index, and modified Mcnab criteria.The procedure was successfully performed in all cases. No case required conversion to an open procedure. The mean age of patients was 36.6 years. Average blood loss was 45.8 ± 10.2 mL. The preoperative symptoms were alleviated significantly after surgery. All the standardized measures improved significantly at the last follow-up, including JOA score (10.1 to 26.6; P < 0.05) and Oswestry Disability Index (75.3 to 9.6; P < 0.05). Improvement rate of JOA score was 86.4%. Approximately 83.4% of patients reported good or excellent outcomes based on modified Mcnab criteria. No postoperative complication and recurrence of disc herniation was reported.The designed "jetting suture" technique in annular repair under MED can be performed safely and effectively. It could be a viable alternative to annular repair under lumbar discectomy. PMID:27495101

  9. 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

  10. 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. PMID:24802976

  11. Sex differences in disease presentation, treatment and clinical outcomes of patients with hepatocellular carcinoma: a single-centre cohort study

    PubMed Central

    Ladenheim, Maya R; Kim, Nathan G; Nguyen, Pauline; Le, An; Stefanick, Marcia L; Garcia, Gabriel; Nguyen, Mindie H

    2016-01-01

    Background Although sex differences in hepatocellular carcinoma (HCC) risk are well known, it is unclear whether sex differences also exist in clinical presentation and survival outcomes once HCC develops. Methods We performed a retrospective cohort study of 1886 HCC patients seen in a US medical centre in 1998–2015. Data were obtained by chart review with survival data also by National Death Index search. Results The cohort consisted of 1449 male and 437 female patients. At diagnosis, men were significantly younger than women (59.9±10.7 vs 64.0±11.6, p<0.0001). Men had significantly higher rates of tobacco (57.7% vs 31.0%, p<0.001) and alcohol use (63.2% vs 35.1%, p<0.001). Women were more likely to be diagnosed by routine screening versus symptomatically or incidentally (65.5% vs 58.2%, p=0.03) and less likely to present with tumours >5 cm (30.2% vs 39.8%, p=0.001). Surgical and non-surgical treatment utilisation was similar for both sexes. Men and women had no significant difference in median survival from the time of diagnosis (median 30.7 (range=24.5–41.3) vs 33.1 (range=27.4–37.3) months, p=0.84). On multivariate analysis, significant predictors for improved survival included younger age, surgical or non-surgical treatment (vs supportive care), diagnosis by screening, tumour within Milan criteria and lower Model for End-Stage Liver Disease score, but not female sex (adjusted HR=1.01, CI 0.82 to 1.24, p=0.94). Conclusions Although men have much higher risk for HCC development, there were no significant sex differences in disease presentation or survival except for older age and lower tumour burden at diagnosis in women. Female sex was not an independent predictor for survival. PMID:27493763

  12. The characteristics and clinical outcome of drug-induced liver injury in a Chinese hospital: A retrospective cohort study.

    PubMed

    Chen, Sheng-Sen; Yu, Kang-Kang; Huang, Chong; Li, Ning; Zheng, Jian-Ming; Bao, Su-Xia; Chen, Ming-Quan; Zhang, Wen-Hong

    2016-08-01

    The aim of this cohort study was to determine the characteristics and clinical outcome of 287 patients with drug-induced liver injury (DILI) in a Chinese hospital.Between January 2008 and January 2013, individuals who were diagnosed with DILI were selected. The complete medical records of each case were reviewed, and factors for the outcome of patients with DILI were extracted and analyzed using univariate and multivariate analysis.Two hundred eighty-seven cases identified as DILI were included in the study. A total of 105 different drugs were considered to be related to the hepatotoxicity. The main causative group of drugs was Chinese herb (n = 111). Liver failure developed in 9 (3.1%) patients, and 2 died (0.7%). Overall, complete recovery occurred in 92 (32.1%) patients. Univariate analysis and binary logistic regression analysis identified the digestive symptoms, jaundice, total bilirubin (TBIL), and direct bilirubin (DBIL) as independent factors for the non-recovery of DILI. Then the prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, was built by using binary logistic regression analysis again. Receiver operating characteristic curve validated the strong power (area under the curve (AUC) = 0.907) of prediction model for predicting the DILI non-recovery.DILI is an important cause of liver test abnormalities, and Chinese herb represented the most common drug group. The factors such as digestive symptoms, jaundice, TBIL, and DBIL have effect on DILI outcomes. The prediction model, including digestive symptoms, jaundice, TBIL, and DBIL, established in this study is really an excellent predictive tool for non-recovery of DILI patients. PMID:27559976

  13. 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

  14. 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. PMID:25740759

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

    PubMed Central

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

    2014-01-01

    Introduction 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). Methods 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. Results 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. Conclusion 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. PMID:25810799

  16. Short-term Clinical Outcomes after Transscleral Fixation Using the Intrascleral Pocket Technique: A Retrospective Cohort Study Analysis

    PubMed Central

    Cho, Yong-Wun; Yoo, Woong-Sun; Chung, Inyoung; Seo, Seong-Wook; Yoo, Ji-Myong

    2016-01-01

    Purpose To compare the two transscleral fixation (TSF) techniques of intrascleral pocket and conventional scleral flap with conjunctival division techniques in terms of short-term clinical effects. Methods This retrospective cohort study included all consecutive patients with aphakia in Gyeongsang National University Hospital in Jinju, Korea, who underwent TSF between January 2012 and December 2014. The medical records of all patients were retrospectively reviewed, and the endothelial cell count (ECC), refraction, best-corrected visual acuity (BCVA), intraocular pressure, slit lamp, and fundus examination results before and 1 day and 6 months after surgery were recorded. The postoperative complications and visual outcomes were also recorded. Results The intrascleral pocket and conventional-flap groups did not differ significantly in terms of demographics, presurgical BCVA, or ECC. However, the intrascleral pocket group had a significantly lower BCVA at 1 day and 6 months after surgery compared to the conventional-flap group. The two groups did not differ in terms of ECC 6 months after surgery. The intrascleral pocket group had no postoperative complications, but five patients in the conventional-flap group complained of irritation. In both groups, the intraocular lens was well positioned without tilting or subluxation, and astigmatism was significantly reduced at 1 day and 6 months after surgery. Conclusions The intrascleral pocket technique of TSF does not involve conjunctival dissection and is a successful method of sulcus fixation. It stably corrects the intraocular lens and is easy to perform, which helps to reduce operation time. It also reliably yields rapid visual acuity recovery without complications. PMID:27051258

  17. Clinical and haematological risk factors for cerebral macrovasculopathy in a sickle cell disease newborn cohort: a prospective study.

    PubMed

    Sommet, Julie; Alberti, Corinne; Couque, Nathalie; Verlhac, Suzanne; Haouari, Zinedine; Mohamed, Damir; François, Martine; Missud, Florence; Holvoet, Laurent; Elmaleh, Monique; Ithier, Ghislaine; Denjean, André; Elion, Jacques; Baruchel, André; Benkerrou, Malika

    2016-03-01

    Children with sickle cell disease (SCD) have a significant vascular morbidity, especially cerebral macrovasculopathy (CV), detectable by transcranial Doppler. This study aimed to identify risk factors for CV using longitudinal biological and clinical data in a SCD newborn cohort followed at the Robert Debre Reference centre (n = 375 SS/Sβ(0) ). Median follow-up was 6·8 years (2677 patient-years). Among the 59 children presenting with CV, seven had a stroke. Overall, the incidence of CV was 2·20/100 patient-years [95% confidence interval (95% CI): 1·64-2·76] and the incidence of stroke was 0·26/100 patient-years (95% CI: 0·07-0·46). The cumulative risk of CV by age 14 years was 26·0% (95% CI: 20·0-33·3%). Risk factors for CV were assessed by a Cox model encompassing linear multivariate modelling of longitudinal quantitative variables. Years per upper-airway obstruction [Hazard ratio (HR) = 1·47; 95% CI: 1·05-2·06] or bronchial obstruction (HR = 1·76; 95% CI: 1·49-2·08) and reticulocyte count (HR = 1·82 per 50 × 10(9) /l increase; 95% CI: 1·10-3·01) were independent risk factors whereas fetal haemoglobin level (HR = 0·68 per 5% increase; 95% CI: 0·48-0·96) was protective. Alpha-thalassaemia was not protective in multivariate analysis (ancillary analysis n = 209). Specific treatment for upper or lower-airway obstruction and indirect targeting of fetal haemoglobin and reticulocyte count by hydroxycarbamide could potentially reduce the risk of CV. PMID:26728571

  18. 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

  19. Review of Cohort Studies for Mood Disorders.

    PubMed

    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; Lee, Heon-Jeong

    2016-05-01

    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

  20. 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

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

    PubMed Central

    Mutabazi-Mwesigire, Doris

    2015-01-01

    Introduction 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. Methods 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. Results 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

  2. 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

  3. Clinical course of light-chain smouldering multiple myeloma (idiopathic Bence Jones proteinuria): a retrospective cohort study

    PubMed Central

    Kyle, Robert A; Larson, Dirk R; Therneau, Terry M; Dispenzieri, Angela; Melton, L Joseph; Benson, Joanne T; Kumar, Shaji; Rajkumar, S Vincent

    2014-01-01

    Summary Background Bence Jones proteinuria is a disorder that is defined by the excretion of monoclonal light-chain protein. About 15–20% of patients with multiple myeloma secrete monoclonal light chains only, without expression of the normal immunoglobulin heavy chain, which constitutes light-chain multiple myeloma. The definition, prevalence, and progression of these premalignant phases of light-chain multiple myeloma have not been fully characterised. We aimed to identify a subset of patients with idiopathic Bence Jones proteinuria who had a high risk of progression to light-chain multiple myeloma analogous to that seen in patients with smouldering multiple myeloma. Methods In this retrospective cohort study, we studied all patients seen at the Mayo Clinic (Rochester, MN, USA) within 30 days of diagnosis of idiopathic Bence Jones proteinuria between Jan 1, 1960, and June 30, 2004. Inclusion criteria were monoclonal light chain in the urine (≥0·2 g/24 h), absence of intact monoclonal immunoglobulin (M protein) in the serum, and no evidence of multiple myeloma, light-chain amyloidosis, or other related plasma-cell proliferative disorders. The primary endpoint was progression to symptomatic multiple myeloma or light-chain amyloidosis. We examined the cumulative probability of progression and the association of potential risk factors on progression rates to identify patients with a high risk of progression to multiple myeloma or light-chain amyloidosis. Findings We identified 101 patients with idiopathic Bence Jones proteinuria. During 901 total person-years of follow-up, 27 (27%) patients developed multiple myeloma and seven (7%) developed light-chain amyloidosis. The major risk factors for progression were amount of urinary excretion of M protein per 24 h, proportion of bone marrow plasma cells, presence of a markedly abnormal free-light-chain ratio (<0·01 or >100), and reduction of all three uninvolved immunoglobulins. Based on the risk of progression

  4. 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

  5. Evaluation of clinical course and neurocognition in children with self-limited infantile epilepsy in a Turkish cohort study.

    PubMed

    Bozaykut, Abdulkadir; Aksoy, Halil Ural; Sezer, Rabia Gönül; Polat, Muzaffer

    2015-03-01

    The outcome of children with self-limited infantile epilepsy was reported to be normal psychosocial and cognitive development as a characteristic criterion. We aimed to investigate the clinical course and neurocognitive outcome in children with self-limited infantile epilepsy in a Turkish cohort. The clinical course, electroencephalographic (EEG) characteristics, neuroimaging, treatment, and outcome of children with self-limited infantile epilepsy were retrospectively analyzed. All infants were reevaluated with the Denver Developmental Screening Test in addition to neurologic examination. Of 44 patients, self-limited familial infantile epilepsy was diagnosed in 8 infants (18.2%) and self-limited nonfamilial infantile epilepsy in 28 (63.6%). Interictal EEGs and neurologic examinations were normal in all cases. Fine motor and gross motor skills, language, adaptive personal/social skills were near-normal in all patients with self-limited familial infantile epilepsy. Delay in language parameters was observed in 2 infants with self-limited nonfamilial infantile epilepsy. Language skills should be thoroughly evaluated with detailed neurocognitive screening tests in patients with self-limited infantile epilepsy. PMID:24958006

  6. Antibiotic use and clinical outcomes in the acute setting under management by an infectious diseases acute physician versus other clinical teams: a cohort study

    PubMed Central

    Jones, Nicola; Mistry, Vikash; Crook, Derrick; Peto, Tim; Walker, A Sarah

    2016-01-01

    Objectives To assess the magnitude of difference in antibiotic use between clinical teams in the acute setting and assess evidence for any adverse consequences to patient safety or healthcare delivery. Design Prospective cohort study (1 week) and analysis of linked electronic health records (3 years). Setting UK tertiary care centre. Participants All patients admitted sequentially to the acute medical service under an infectious diseases acute physician (IDP) and other medical teams during 1 week in 2013 (n=297), and 3 years 2012–2014 (n=47 585). Primary outcome measure Antibiotic use in days of therapy (DOT): raw group metrics and regression analysis adjusted for case mix. Secondary outcome measures 30-day all-cause mortality, treatment failure and length of stay. Results Antibiotic use was 173 vs 282 DOT/100 admissions in the IDP versus non-IDP group. Using case mix-adjusted zero-inflated Poisson regression, IDP patients were significantly less likely to receive an antibiotic (adjusted OR=0.25 (95% CI 0.07 to 0.84), p=0.03) and received shorter courses (adjusted rate ratio (RR)=0.71 (95% CI 0.54 to 0.93), p=0.01). Clinically stable IDP patients of uncertain diagnosis were more likely to have antibiotics held (87% vs 55%; p=0.02). There was no significant difference in treatment failure or mortality (adjusted p>0.5; also in the 3-year data set), but IDP patients were more likely to be admitted overnight (adjusted OR=3.53 (95% CI 1.24 to 10.03), p=0.03) and have longer length of stay (adjusted RR=1.19 (95% CI 1.05 to 1.36), p=0.007). Conclusions The IDP-led group used 30% less antibiotic therapy with no adverse clinical outcome, suggesting antibiotic use can be reduced safely in the acute setting. This may be achieved in part by holding antibiotics and admitting the patient for observation rather than prescribing, which has implications for costs and hospital occupancy. More information is needed to indicate whether any such longer admission will

  7. 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

  8. 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. PMID:26993656

  9. 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

  10. 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

  11. 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

  12. The Incidence, Clinical Outcomes, and Risk Factors of Thrombocytopenia in Intra-Abdominal Infection Patients: A Retrospective Cohort Study

    PubMed Central

    Wu, Qin; Ren, Jianan; Wang, Gefei; Li, Guanwei; Gu, Guosheng; Wu, Xiuwen; Li, Yuan; Chen, Jun; Zhao, Yunzhao; Li, Jieshou

    2016-01-01

    Background Studies on the incidence and risk factors of thrombocytopenia among intra-abdominal infection patients remain absent, hindering efficacy assessments regarding thrombocytopenia prevention strategies. Methods We retrospectively studied 267 consecutively enrolled patients with intra-abdominal infections. Occurrence of thrombocytopenia was scanned for all patients. All-cause 28-day mortality was recorded. Variables from univariate analyses that were associated with occurrence of hospital-acquired thrombocytopenia were included in a multivariable logistic regression analysis to determine thrombocytopenia predictors. Results Median APACHE II score and SOFA score of the whole cohort was 12 and 3 respectively. The overall ICU mortality was 7.87% and the 28-day mortality was 8.98%. The incidence of thrombocytopenia among intra-abdominal infection patients was 21.73%. Regardless of preexisting or hospital-acquired one, thrombocytopenia is associated with an increased ICU mortality and 28-day mortality as well as length of ICU or hospital stay. A higher SOFA and ISTH score at admission were significant hospital-acquired thrombocytopenia risk factors. Conclusions This is the first study to identify a high incidence of thrombocytopenia in patients with intra-abdominal infections. Our findings suggest that the inflammatory milieu of intra-abdominal infections may uniquely predispose those patients to thrombocytopenia. More effective thrombocytopenia prevention strategies are necessary in intra-abdominal infection patients. PMID:26808492

  13. Treated versus non-treated subjects with depression from a 30-year cohort study: prevalence and clinical covariates.

    PubMed

    Hengartner, Michael P; Angst, Felix; Ajdacic-Gross, Vladeta; Rössler, Wulf; Angst, Jules

    2016-03-01

    The aim of this study was to determine prevalence rates of several components of depression (unipolar and bipolar major, minor, recurrent brief depression, and dysthymia) and to identify covariates of treatment. We analysed a representative population-based, long-term prospective cohort study from age 20 to 50. Across the seven semi-structured interviews, generalized estimating equations examined the associations between diagnoses and treatment status during the course. The results show that the mean annual treatment rate across 30 years in persons with MDE was 39.2%. The weighted treatment prevalence for any depressive disorder was 23.4% (15.7% for MDE, 4.3% for minor depressive disorders and 3.4% for non-diagnosed subjects). Persons were more likely to seek treatment as they grew older. Women with MDE had triple the treatment prevalence of men (23.8 vs. 7.4%). Variables of distress/suffering under depression (OR 1.36-1.52) and the number of diagnostic depressive symptoms (OR 1.47) were statistically significant predictors of treatment, as were episode duration (OR 2.21) and various variables assessing impairment due to depression (OR 4.65-8.02). In conclusion, only a minority of persons with depressive disorders seek professional treatment in the year of disorder onset. Women and subjects suffering from high levels of depressive symptoms, frequent episodes, long episode duration and consecutive high distress and impairment were more likely to seek treatment. PMID:26499773

  14. Clinically diagnosed insomnia and risk of all-cause and diagnosis-specific disability pension: a nationwide cohort study.

    PubMed

    Jansson, Catarina; Alexanderson, Kristina; Kecklund, Göran; Akerstedt, 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

  15. 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

  16. LONGITUDINAL COHORT METHODS STUDIES

    EPA Science Inventory

    Accurate exposure classification tools are required to link exposure with health effects in epidemiological studies. Exposure classification for occupational studies is relatively easy compared to predicting residential childhood exposures. Recent NHEXAS (Maryland) study articl...

  17. 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

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

    PubMed

    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

    2016-05-01

    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). 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. 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. 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 racial/ethnic differences in diagnosis. PMID:27116591

  19. Sexual and testing behaviour associated with Chlamydia trachomatis infection: a cohort study in an STI clinic in Sweden

    PubMed Central

    Veličko, Inga; Ploner, Alexander; Sparén, Pär; Marions, Lena; Herrmann, Björn; Kühlmann-Berenzon, Sharon

    2016-01-01

    Background Genital chlamydia infection (chlamydia) is the most commonly reported sexually transmitted infection (STI) in Sweden. To guide prevention needs, we aimed to investigate factors associated with chlamydia. Methods A cohort of visitors aged 20–40 years at an urban STI clinic in Sweden was recruited. Behavioural data were collected using a self-administered questionnaire. Self-sampled specimens were tested for chlamydia by a DNA amplification assay. Statistically significant (p<0.05) and epidemiologically relevant covariates were entered in a multivariate Poisson model adjusted for potential confounders (age and gender). Backward stepwise elimination produced a final model. Multiple imputation was used to account for missing values. Results Out of 2814 respondents, 1436 were men with a chlamydia positivity rate of 12.6% vs 8.9% in women. Lifetime testing for chlamydia and HIV was high (82% and 60%, respectively). Factors significantly associated with chlamydia were: 20–24 years old (adjusted risk ratio (ARR)=2.10, 95% CI 1.21 to 3.65); testing reason: contact with a chlamydia case (ARR=6.55, 95% CI 4.77 to 8.98) and having symptoms (ARR=2.19, 95% CI 1.48 to 3.24); 6–10 sexual partners (ARR=1.53, 95% CI 1.06 to 2.21); last sexual activity ‘vaginal sex and oral sex and anal sex and petting’ (ARR=1.84, 95% CI 1.09 to 3.10); alcohol use before sex (ARR=1.98, 95% CI 1.10 to 3.57); men with symptoms (ARR=2.09, 95% CI 1.38 to 3.18); tested for chlamydia (ARR=0.72, 95% CI 0.55 to 0.94). Conclusions Risk factors associated with chlamydia were consistent with previous reports in similar settings and suggest no major changes over time. Increased risk for chlamydia infection associated with high-risk behaviour (eg, alcohol use, increased number of sexual partners) supports the need for behavioural interventions in this population such as promotion of safer sex behaviour (condom use) and testing. PMID:27566631

  20. A web-based simulation of a longitudinal clinic used in a 4-week ambulatory rotation: a cohort study

    PubMed Central

    Wong, Rene WG; Lochnan, Heather A

    2009-01-01

    Background Residency training takes place primarily on inpatient wards. In the absence of a resident continuity clinic, internal medicine residents rely on block rotations to learn about continuity of care. Alternate methods to introduce continuity of care are needed. Methods A web-based tool, Continuity of Care Online Simulations (COCOS), was designed for use in a one-month, postgraduate clinical rotation in endocrinology. It is an interactive tool that simulates the continuing care of any patient with a chronic endocrine disease. Twenty-three residents in internal medicine participated in a study to investigate the effects of using COCOS during a clinical rotation in endocrinology on pre-post knowledge test scores and self-assessment of confidence. Results Compared to residents who did the rotation alone, residents who used COCOS during the rotation had significantly higher improvements in test scores (% increase in pre-post test scores +21.6 [standard deviation, SD, 8.0] vs. +5.9 [SD 6.8]; p < .001). Test score improvements were most pronounced for less commonly seen conditions. There were no significant differences in changes in confidence. Residents rated COCOS very highly, recommending its use as a standard part of the rotation and throughout residency. Conclusion A stand-alone web-based tool can be incorporated into an existing clinical rotation to help residents learn about continuity of care. It has the most potential to teach residents about topics that are less commonly seen during a clinical rotation. The adaptable, web-based format allows the creation of cases for most chronic medical conditions. PMID:19187554

  1. Methodology Series Module 1: Cohort Studies

    PubMed Central

    Setia, Maninder Singh

    2016-01-01

    Cohort design is a type of nonexperimental or observational study design. In a cohort study, the participants do not have the outcome of interest to begin with. They are selected based on the exposure status of the individual. They are then followed over time to evaluate for the occurrence of the outcome of interest. Some examples of cohort studies are (1) Framingham Cohort study, (2) Swiss HIV Cohort study, and (3) The Danish Cohort study of psoriasis and depression. These studies may be prospective, retrospective, or a combination of both of these types. Since at the time of entry into the cohort study, the individuals do not have outcome, the temporality between exposure and outcome is well defined in a cohort design. If the exposure is rare, then a cohort design is an efficient method to study the relation between exposure and outcomes. A retrospective cohort study can be completed fast and is relatively inexpensive compared with a prospective cohort study. Follow-up of the study participants is very important in a cohort study, and losses are an important source of bias in these types of studies. These studies are used to estimate the cumulative incidence and incidence rate. One of the main strengths of a cohort study is the longitudinal nature of the data. Some of the variables in the data will be time-varying and some may be time independent. Thus, advanced modeling techniques (such as fixed and random effects models) are useful in analysis of these studies. PMID:26955090

  2. Vomiting and Hyponatremia Are Risk Factors for Worse Clinical Outcomes Among Patients Hospitalized Due to Nonsurgical Abdominal Pain: A Retrospective Cohort Study.

    PubMed

    Goren, Idan; Israel, Ariel; Carmel-Neiderman, Narin N; Kliers, Iris; Gringauz, Irina; Dagan, Amir; Lavi, Bruno; Segal, Omer; Segal, Gad

    2016-04-01

    After initial evaluation in the Emergency Department (ED), many patients complaining of abdominal pain are classified as suffering from nonsurgical abdominal pain (NSAP). Clinical characteristics and risk factors for worse prognosis were not published elsewhere.Characterizing the clinical profile of patients hospitalized due to NSAP and identifying predictor variables for worse clinical outcomes.We made a retrospective cohort analysis of patients hospitalized due to NSAP compared to matched control patients (for age, gender, and Charlson comorbidity index) hospitalized due to other, nonsurgical reasons in a ratio of 1 to 10. We further performed in-group analysis of patients admitted due to NSAP in order to appreciate variables (clinical and laboratory parameters) potentially associated with worse clinical outcomes.Overall 23,584 patients were included, of which 2144 were admitted due to NSAP and 21,440 were matched controls. Patients admitted due to NSAP had overall better clinical outcomes: they had lower rates of in-hospital and 30-days mortality (2.8% vs 5.5% and 7.9% vs 10.4% respectively, P < 0.001 for both comparisons). They also had a significantly shorter length of hospital stay (3.9 vs 6.2 days, P < 0.001). Rates of re-hospitalization within 30-days were not significantly different between study groups. Among patients hospitalized due to NSAP, we found that vomiting or hyponatremia at presentation or during hospital stay were associated with worse clinical outcomes.Compared to patients hospitalized due to other, nonsurgical reasons, the overall prognosis of patients admitted due to NSAP is favorable. The combination of NSAP with vomiting and hyponatremia is associated with worse clinical outcomes. PMID:27057886

  3. 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

  4. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study

    PubMed Central

    Teixidor, Pilar; Vidal, Xavier; Montané, Eva

    2016-01-01

    Background During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas’ patients. Methods National, multicenter and prospective observational study. Inclusion criteria: authorized conditions of use of 5-ALA. Exclusion criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities. Results Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance. Conclusion In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as

  5. 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. PMID:25893115

  6. The Performance of a Modified Glasgow Blatchford Score in Predicting Clinical Interventions in Patients with Acute Nonvariceal Upper Gastrointestinal Bleeding: A Vietnamese Prospective Multicenter Cohort Study

    PubMed Central

    Quach, Duc Trong; Dao, Ngoi Huu; Dinh, Minh Cao; Nguyen, Chung Huu; Ho, Linh Xuan; Nguyen, Nha-Doan Thi; Le, Quang Dinh; Vo, Cong Minh Hong; Le, Sang Kim; Hiyama, Toru

    2016-01-01

    Background/Aims To compare the performance of a modified Glasgow Blatchford score (mGBS) to the Glasgow Blatchford score (GBS) and the pre-endoscopic Rockall score (RS) in predicting clinical interventions in Vietnamese patients with acute nonvariceal upper gastrointestinal bleeding (AN-VUGIB). Methods A prospective multicenter cohort study was conducted in five tertiary hospitals from May 2013 to February 2014. The mGBS, GBS, and pre-endoscopic RS scores were prospectively calculated for all patients. The accuracy of mGBS was compared with that of GBS and pre-endoscopic RS using area under the receiver operating characteristic curve (AUC). Clinical interventions were defined as blood transfusions, endoscopic or radiological intervention, or surgery. Results There were 395 patients including 128 (32.4%) needing endoscopic treatment, 117 (29.6%) requiring blood transfusion and two (0.5%) needing surgery. In predicting the need for clinical intervention, the mGBS (AUC, 0.707) performed as well as the GBS (AUC, 0.708; p=0.87) and outperformed the pre-endoscopic RS (AUC, 0.594; p<0.001). However, none of these scores effectively excluded the need for endoscopic intervention at a threshold of 0. Conclusions mGBS performed as well as GBS and better than pre-endoscopic RS for predicting clinical interventions in Vietnamese patients with ANVUGIB. PMID:26601829

  7. 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. PMID:27358211

  8. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States.

    PubMed

    Getman, Damon; Jiang, Alice; O'Donnell, Meghan; Cohen, Seth

    2016-09-01

    The prevalence rates of Mycoplasma genitalium infections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested for M. genitalium and for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Sequencing was used to assess macrolide antibiotic resistance among M. genitalium-positive subjects. M. genitalium prevalence rates were 16.1% for females and 17.2% for males. Significant risk factors for M. genitalium infections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. Female M. genitalium infections were significantly more prevalent than C. trachomatis and N. gonorrhoeae infections, while the M. genitalium infection rate in males was significantly higher than the N. gonorrhoeae and T. vaginalis infection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence of M. genitalium single infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States. PMID:27307460

  9. Mycoplasma genitalium Prevalence, Coinfection, and Macrolide Antibiotic Resistance Frequency in a Multicenter Clinical Study Cohort in the United States

    PubMed Central

    Jiang, Alice; O'Donnell, Meghan; Cohen, Seth

    2016-01-01

    The prevalence rates of Mycoplasma genitalium infections and coinfections with other sexually transmitted organisms and the frequency of a macrolide antibiotic resistance phenotype were determined in urogenital specimens collected from female and male subjects enrolled in a multicenter clinical study in the United States. Specimens from 946 subjects seeking care from seven geographically diverse clinical sites were tested for M. genitalium and for Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Sequencing was used to assess macrolide antibiotic resistance among M. genitalium-positive subjects. M. genitalium prevalence rates were 16.1% for females and 17.2% for males. Significant risk factors for M. genitalium infections were black race, younger age, non-Hispanic ethnicity, and female symptomatic status. Female M. genitalium infections were significantly more prevalent than C. trachomatis and N. gonorrhoeae infections, while the M. genitalium infection rate in males was significantly higher than the N. gonorrhoeae and T. vaginalis infection rates. The macrolide-resistant phenotype was found in 50.8% of females and 42% of males. These results show a high prevalence of M. genitalium single infections, a lower prevalence of coinfections with other sexually transmitted organisms, and high rates of macrolide antibiotic resistance in a diverse sample of subjects seeking care across a wide geographic area of the United States. PMID:27307460

  10. 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

  11. 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

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

    PubMed Central

    Bartsch, Emily; Medcalf, Karyn E; Park, Alison L

    2016-01-01

    Objective 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. Design Systematic review and meta-analysis of cohort studies. Data sources PubMed and Embase databases, 2000-15. Eligibility criteria for selecting studies 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. Data extraction 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. Results 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. Conclusions 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. PMID:27094586

  13. The Prevalence, Clinical, and Molecular Characteristics of Congenital Hypothyroidism Caused by DUOX2 Mutations: A Population-Based Cohort Study in Guangzhou.

    PubMed

    Tan, M; Huang, Y; Jiang, X; Li, P; Tang, C; Jia, X; Chen, Q; Chen, W; Sheng, H; Feng, Y; Wu, D; Liu, L

    2016-09-01

    Thyroid dyshormonogenesis (DH) has recently been reported to be more frequently associated with mutations in the dual oxidase 2 (DUOX2) gene. The present study was aimed to investigate the prevalence, clinical, and molecular characteristics of congenital hypothyroidism (CH) caused by DUOX2 mutations in Guangzhou. A population-based cohort of 156 patients with CH was recruited based on neonatal screening among 433 578 newborns born in Guangzhou from 2011 to 2012. Genetic analysis of DUOX2 was performed in 96 patients with suspected thyroid dyshormonogenesis (SDH) by PCR-amplified direct sequencing. Apart from 2 cases without ultrasonographic data, 118 (76.6%) of the 156 patients were classified as SDH and 36 (23.4%) as thyroid dysgenesis (TD) according to thyroid ultrasound at diagnosis. Genetic analysis revealed 23 different variants in 60 unrelated individuals (60/96, 62.5%), including 13 novel variants that were absent from HGMD, dbSNP databases, and the 50 normal controls. The novel missense variants were predicted to be pathogenic by SIFT and PolyPhen-2. The p.K530X was the most common mutation. Ninety-three percent of mutant alleles occurred in exons 5, 6, 9, 14, 17, 20, 25, 27, and 28. There were no significant differences in phenotypes between biallelic and monoallelic variants cases or between with-DUOX2 and non-DUOX2 variants cases. Most patients with DUOX2 defects (78.2%) were transient CH. In conclusion, the prevalence of DUOX2 pathogenic variants was high (62.5%) in this cohort. Thirteen novel probably pathologic variants were reported. The p.K530X was the most common mutation in the Chinese population. There was no correlation between DUOX2 genotypes and clinical phenotypes. PMID:27557340

  14. Diagnoses and clinical features associated with high risk for unplanned readmission in vascular surgery. A cohort study

    PubMed Central

    Yiasemidou, Marina; Mavor, Andrew I.D.; Kent, Patrick J.

    2015-01-01

    Background Readmission rate is an established health quality indicator. Preventable readmissions bear an unnecessary, high cost on the healthcare system. An analysis performed by the National Centre for Health Outcomes Development (NCHOD) has demonstrated an increasing trend in emergency readmissions in the UK. Vascular surgery has been reported to have high readmission rates second only to congestive heart failure. This study aims to identify diagnoses and other clinical risk factors for high unplanned readmission rates. This may be the first step to sparing both the health care system and patients of unnecessary readmissions. Results The overall 30 day readmission rate for Leeds Vascular Institute was 8.8%. The two diagnoses with the highest readmission rates were lower limb ischaemia and diabetic foot sepsis. The readmission rate for medical reasons was overwhelmingly higher than for surgical reasons (6.5% and 2.3% respectively). The most common medical diagnoses were renal disease and COPD. The majority of the patients readmitted under the care of vascular surgery required further surgical treatment. Conclusion Vascular units should focus on holistic and multidisciplinary treatment of lower limb ischaemia and diabetic foot sepsis, in order to prevent readmissions. Furthermore, the early involvement and input of physicians in the treatment of vascular patients with renal disease and COPD may be appropriate. PMID:26005566

  15. Effect of metallo-β-lactamase production and multidrug resistance on clinical outcomes in patients with Pseudomonas aeruginosa bloodstream infection: a retrospective cohort study

    PubMed Central

    2013-01-01

    Background Blood stream infections (BSI) with Pseudomonas aeruginosa lead to poor clinical outcomes. The worldwide emergence and spread of metallo-β-lactamase (MBL) producing, often multidrug-resistant organisms may further aggravate this problem. Our study aimed to investigate the effect of MBL-producing P. aeruginosa (MBL-PA) and various other resistance phenotypes on clinical outcomes. Methods A retrospective cohort study was conducted in three German hospitals. Medical files from 2006 until 2012 were studied, and a number of 113 patients with P. aeruginosa BSI were included. The presence of VIM, IMP and NDM genes was detected using molecular techniques. Genetic relatedness was assessed through multilocus sequence typing (MLST). The effect of resistance patterns or MBL production on clinical outcomes was investigated by using multivariate Cox regression models. Results In-hospital mortality was significantly higher in patients with MBL-PA and multidrug-resistant P. aeruginosa. However, neither BSI with MBL-PA nor BSI with various resistance phenotypes of P. aeruginosa were independently associated with mortality or length of hospital stay. In multivariate models, the SAPS II score (HR 1.046), appropriate definitive treatment (HR range 0.25-0.26), and cardiovascular disease (HR range 0.44-0.46) were independent predictors of mortality. Concomitant infections were associated with an excess length of stay (HR < 1). Conclusions Medication with appropriate antimicrobial agents at any time during the course of infection remains the key for improving clinical outcomes in patients with P. aeruginosa BSI and should be combined with a strict implementation of routine infection control measures. PMID:24176052

  16. 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. PMID:26126154

  17. 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. PMID:25882369

  18. 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

  19. 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

  20. 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

  1. 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. PMID:26139600

  2. 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

  3. 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

  4. Immunological and Clinical Responses following the Use of Antiretroviral Therapy among Elderly HIV-Infected Individuals Attending Care and Treatment Clinic in Northwestern Tanzania: A Retrospective Cohort Study

    PubMed Central

    Mpondo, Bonaventura C. T.; Gunda, Daniel W.; Kilonzo, Semvua B.; Mgina, Erick

    2016-01-01

    Background. Limited information exists on adults ≥50 years receiving HIV care in sub-Saharan Africa despite their increasing number. We aimed at studying immunologic and clinical responses to ART in this population. Methods. Data of patients who initiated HAART between 30th of June 2004 and 1st of May 2008 at Sekou Toure Care and Treatment Clinic were retrospectively analyzed. Date of ART initiation was used as a baseline and 48 months as a follow-up date. Immune recovery was defined as a CD4 count of ≥350 cells/mm3 at 48 months and late presentation as presentation with WHO stage 3 or 4 at clinic enrollment. Proportions of patients reaching this endpoint were compared between the two groups. Results. A total of 728 patients were included in our study; of these 73 (10.0%) were aged 50 years and above. Late presentation was more common in elderly patients than young patients (65.7% versus 56.1%, P = 0.12). Proportion of patients with CD4 count ≥350 (immune recovery) was higher in younger patients than in elderly patients, although this was not statistically significant (54.5% versus 44.9%, P = 0.2). Median absolute increase in CD4 at 48 months was higher in younger patients than in elderly patients (+241.5 cells/mm3 versus +146 cells/mm3, P = 0.007). Conclusion. Elderly HIV patients have higher rates of late presentation, with lower immune recovery. Strategies to increase HIV testing in this group are required for early diagnosis and treatment to improve outcomes. PMID:27042375

  5. Birth Weight Ratio as an Alternative to Birth Weight Percentile to Express Infant Weight in Research and Clinical Practice: A Nationwide Cohort Study

    PubMed Central

    Kazemier, Brenda M.; Schuit, Ewoud; Mol, Ben Willem J.; Pajkrt, Eva; Ganzevoort, Wessel

    2014-01-01

    Objective. To compare birth weight ratio and birth weight percentile to express infant weight when assessing pregnancy outcome. Study Design. We performed a national cohort study. Birth weight ratio was calculated as the observed birth weight divided by the median birth weight for gestational age. The discriminative ability of birth weight ratio and birth weight percentile to identify infants at risk of perinatal death (fetal death and neonatal death) or adverse pregnancy outcome (perinatal death + severe neonatal morbidity) was compared using the area under the curve. Outcomes were expressed stratified by gestational age at delivery separate for birth weight ratio and birth weight percentile. Results. We studied 1,299,244 pregnant women, with an overall perinatal death rate of 0.62%. Birth weight ratio and birth weight percentile have equivalent overall discriminative performance for perinatal death and adverse perinatal outcome. In late preterm infants (33+0–36+6 weeks), birth weight ratio has better discriminative ability than birth weight percentile for perinatal death (0.68 versus 0.63, P  0.01) or adverse pregnancy outcome (0.67 versus 0.60, P < 0.001). Conclusion. Birth weight ratio is a potentially valuable instrument to identify infants at risk of perinatal death and adverse pregnancy outcome and provides several advantages for use in research and clinical practice. Moreover, it allows comparison of groups with different average birth weights. PMID:25197283

  6. 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. PMID:26751705

  7. Similar Clinical and Surgical Outcomes Achieved with Early Compared to Late Anti-TNF Induction in Mild-to-Moderate Ulcerative Colitis: A Retrospective Cohort Study

    PubMed Central

    Fedorak, Darryl K.; Dieleman, Levinus A.; Halloran, Brendan P.

    2016-01-01

    Background. Biologic agents targeting tumor necrosis factor alpha are effective in the management of ulcerative colitis (UC), but their use is often postponed until after failure of other treatment modalities. Objectives. We aim to determine if earlier treatment with infliximab or adalimumab alters clinical and surgical outcomes in UC patients. Methods. A retrospective cohort study was conducted evaluating UC outpatients treated with infliximab or adalimumab from 2003 to 2014. Patients were stratified by time to first anti-TNF exposure; early initiation was defined as starting treatment within three years of diagnosis. Primary outcomes were colectomy, UC-related hospitalization, and clinical secondary loss of response. Kaplan-Meier analysis was used to assess time to the primary outcomes. Results. 115 patients were included (78 infliximab, 37 adalimumab). Median follow-up was 175.6 weeks (IQR 72.4–228.4 weeks). Fifty-seven (49.6%) patients received early anti-TNF therapy; median time to treatment in this group was 38.1 (23.3–91.0) weeks compared to 414.0 (254.0–561.3) weeks in the late initiator cohort (p < 0.0001). Patients treated with early anti-TNF therapy had more severe endoscopic disease at induction (mean Mayo endoscopy subscore 2.46 (SD ± 0.66) versus 1.86 (±0.67), p < 0.001) and trended towards increased risk of colectomy (17.5% versus 8.6%, p = 0.16) and UC-related hospitalization (43.9% versus 27.6%, p = 0.07). In multivariate regression analysis, early anti-TNF induction was not associated with colectomy (HR 2.02 [95% CI: 0.57–7.20]), hospitalization (HR 1.66 [0.84–3.30]), or secondary loss of response (HR 0.86 [0.52–1.42]). Conclusions. Anti-TNF therapy is initiated earlier in patients with severe UC but earlier treatment does not prevent hospitalization, colectomy, or secondary loss of response. PMID:27478817

  8. 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 Central

    Davies, Neil M; Taylor, Gemma; Taylor, Amy E; Thomas, Kyla H; Windmeijer, Frank; Martin, Richard M; Munafò, Marcus R

    2015-01-01

    Introduction 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. Methods 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 and dissemination 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. PMID

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

  10. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone—the STONE score: retrospective and prospective observational cohort studies

    PubMed Central

    Bomann, Scott; Daniels, Brock; Luty, Seth; Molinaro, Annette; Singh, Dinesh; Gross, Cary P

    2014-01-01

    Objective To derive and validate an objective clinical prediction rule for the presence of uncomplicated ureteral stones in patients eligible for computed tomography (CT). We hypothesized that patients with a high probability of ureteral stones would have a low probability of acutely important alternative findings. Design Retrospective observational derivation cohort; prospective observational validation cohort. Setting Urban tertiary care emergency department and suburban freestanding community emergency department. Participants Adults undergoing non-contrast CT for suspected uncomplicated kidney stone. The derivation cohort comprised a random selection of patients undergoing CT between April 2005 and November 2010 (1040 patients); the validation cohort included consecutive prospectively enrolled patients from May 2011 to January 2013 (491 patients). Main outcome measures In the derivation phase a priori factors potentially related to symptomatic ureteral stone were derived from the medical record blinded to the dictated CT report, which was separately categorized by diagnosis. Multivariate logistic regression was used to determine the top five factors associated with ureteral stone and these were assigned integer points to create a scoring system that was stratified into low, moderate, and high probability of ureteral stone. In the prospective phase this score was observationally derived blinded to CT results and compared with the prevalence of ureteral stone and important alternative causes of symptoms. Results The derivation sample included 1040 records, with five factors found to be most predictive of ureteral stone: male sex, short duration of pain, non-black race, presence of nausea or vomiting, and microscopic hematuria, yielding a score of 0-13 (the STONE score). Prospective validation was performed on 491 participants. In the derivation and validation cohorts ureteral stone was present in, respectively, 8.3% and 9.2% of the low probability (score 0

  11. 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

  12. 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. PMID:25990257

  13. Patterns of the Demographics, Clinical Characteristics, and Resource Utilization Among Maternal Decedents in Texas, 2001 - 2010: A Population-Based Cohort Study

    PubMed Central

    Oud, Lavi

    2015-01-01

    Background 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. Methods 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. Results 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. Conclusions 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

  14. Strong Association between Serological Status and Probability of Progression to Clinical Visceral Leishmaniasis in Prospective Cohort Studies in India and Nepal

    PubMed Central

    Hasker, Epco; Malaviya, Paritosh; Gidwani, Kamlesh; Picado, Albert; Ostyn, Bart; Kansal, Sangeeta; Singh, Rudra Pratap; Singh, Om Prakash; Chourasia, Ankita; Singh, Abhishek Kumar; Shankar, Ravi; Wilson, Mary E.; Khanal, Basudha; Rijal, Suman; Boelaert, Marleen; Sundar, Shyam

    2014-01-01

    Introduction Asymptomatic persons infected with the parasites causing visceral leishmaniasis (VL) usually outnumber clinically apparent cases by a ratio of 4–10 to 1. We assessed the risk of progression from infection to disease as a function of DAT and rK39 serological titers. Methods We used available data on four cohorts from villages in India and Nepal that are highly endemic for Leishmania donovani. In each cohort two serosurveys had been conducted. Based on results of initial surveys, subjects were classified as seronegative, moderately seropositive or strongly seropositive using both DAT and rK39. Based on the combination of first and second survey results we identified seroconvertors for both markers. Seroconvertors were subdivided in high and low titer convertors. Subjects were followed up for at least one year following the second survey. Incident VL cases were recorded and verified. Results We assessed a total of 32,529 enrolled subjects, for a total follow-up time of 72,169 person years. Altogether 235 incident VL cases were documented. The probability of progression to disease was strongly associated with initial serostatus and with seroconversion; this was particularly the case for those with high titers and most prominently among seroconvertors. For high titer DAT convertors the hazard ratio reached as high as 97.4 when compared to non-convertors. The strengths of the associations varied between cohorts and between markers but similar trends were observed between the four cohorts and the two markers. Discussion There is a strongly increased risk of progressing to disease among DAT and/or rK39 seropositives with high titers. The options for prophylactic treatment for this group merit further investigation, as it could be of clinical benefit if it prevents progression to disease. Prophylactic treatment might also have a public health benefit if it can be corroborated that these asymptomatically infected individuals are infectious for sand flies. PMID

  15. [Clinical significance of proteinuria and renal function: findings from a population-based cohort, the Takahata study].

    PubMed

    Konta, Tsuneo

    2013-07-01

    Proteinuria/albuminuria and renal insufficiency are major components of chronic kidney disease (CKD), and are strongly associated with end-stage renal disease, cardiovascular events and premature death. To clarify the prevalence of these renal disorders and the association between renal disorders and mortality in the Japanese population, we conducted a community-based longitudinal study. This study included 3,445 registered Japanese subjects, with a 7-year follow-up. Proteinuria/albuminuria was evaluated using dipstick strips and the urinary protein/albumin creatinine ratio (PCR/ACR). Glomerular filtration rate (GFR) was estimated using the equation for Japanese subjects. The prevalence of dipstick proteinuria, proteinuria (PCR > or = 0.15 g/gCr), albuminuria(ACR > or =30 mg/gCr) and renal insufficiency(estimated GFR< 60 ml/min/1.73m2) were 5%, 8%, 15% and 7%, respectively. The overlap between urinary abnormality and renal insufficiency was small. The prevalence of proteinuria/albuminuria increased along with the increase of blood pressure, 24-hour urinary sodium excretion, HbAlc and the number of components of metabolic syndrome. Kaplan Meier analysis showed that all-cause mortality was significantly increased along with the increase in urinary albumin excretion and the subjects with albuminuria showed a significantly higher mortality rate than those without albuminuria. Cox proportional hazard analysis after adjusting for possible confounders showed that albuminuria was an independent risk for all-cause and cardiovascular mortality. In conclusion, proteinuria/albuminuria and renal insufficiency are prevalent and were independently associated with mortality in the Japanese general population. The detection of renal disorders at the earliest opportunity is important to prevent premature death. PMID:24205706

  16. Ventricular enlargement and its clinical correlates in the imaging cohort from the ADCS MCI donepezil/vitamin E study.

    PubMed

    Apostolova, Liana G; Babakchanian, Sona; Hwang, Kristy S; Green, Amity E; Zlatev, Dimitar; Chou, Yi-Yu; DeCarli, Charlie; Jack, Clifford R; Petersen, Ronald C; Aisen, Paul S; Cummings, Jeffrey L; Toga, Arthur W; Thompson, Paul M

    2013-01-01

    We analyzed the baseline and 3-year T1-weighted magnetic resonance imaging data of 110 amnestic mild cognitive impairment (MCI) participants with minimal hippocampal atrophy at baseline from the Alzheimer's Disease Cooperative Study group MCI Donepezil/Vitamin E trial. Forty-six subjects converted to Alzheimer disease (AD) (MCIc), whereas 64 remained stable (MCInc). We used the radial distance technique to examine the differences in lateral ventricle shape and size between MCIc and MCInc and the associations between ventricular enlargement and cognitive decline. MCIc group had significantly larger frontal and right body/occipital horns relative to MCInc at baseline and significantly larger bilateral frontal, body/occipital, and left temporal horns at follow-up. Global cognitive decline measured with AD Assessment scale cognitive subscale and Mini-Mental State Examination and decline in activities of daily living (ADL) were associated with posterior lateral ventricle enlargement. Decline in AD Assessment scale cognitive subscale and ADL were associated with left temporal and decline in Mini-Mental State Examination with right temporal horn enlargement. After correction for baseline hippocampal volume, decline in ADL showed a significant association with right frontal horn enlargement. Executive decline was associated with right frontal and left temporal horn enlargement. PMID:23694947

  17. Association between hemoglobin levels and clinical outcomes in adult patients after in-hospital cardiac arrest: a retrospective cohort study.

    PubMed

    Wang, Chih-Hung; Huang, Chien-Hua; Chang, Wei-Tien; Tsai, Min-Shan; Yu, Ping-Hsun; Wang, An-Yi; Chen, Nai-Chuan; Chen, Wen-Jone

    2016-08-01

    In addition to cardiac output, oxygen delivery is determined by the amount of oxygen carried by hemoglobin, which is estimated by the product of hemoglobin level and peripheral hemoglobin oxygen saturation (SpO2). Optimal hemoglobin concentration for post-cardiac arrest syndrome (PCAS) has not yet been investigated thoroughly. We conducted a retrospective observational study in a single medical center. We included adult patients between 2006 and 2012 who experienced in-hospital cardiac arrest, and achieved sustained return of spontaneous circulation (ROSC). We used multivariable logistic regression analysis to identify factors associated with favorable neurological status at hospital discharge, defined as a score of 1 or 2 on the Cerebral Performance Category scale. Minimum hemoglobin concentration and SpO2 during the initial 24 h after ROSC were used for analysis. Anemia was defined by the World Health Organization criteria as a hemoglobin concentration <12 g/dL in women and <13 g/dL in men. Of the 426 patients included in our analysis, 387 patients (90.8 %) met the criteria for anemia. The mean minimum hemoglobin concentration among all the patients was 9.2 g/dL. The product of hemoglobin × SpO2 was correlated with a favorable neurological outcome (odds ratio 1.003, 95 % confidence interval 1.002-1.004). According to recommended SpO2 by resuscitation guidelines (94-98 %), we calculated the corresponding range of minimum required hemoglobin concentration to be 8.6-9.0 g/dL for a favorable neurological outcome. Anemia common among PCAS patients. Neurological outcome in PCAS might be correlated with hemoglobin concentration following resuscitation. PMID:26758060

  18. 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

  19. 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

  20. No clinically relevant effect on cognitive outcomes after low-dose radiation to the infant brain: A population-based cohort study in Sweden

    PubMed Central

    Holmberg, Erik; Åberg, Maria A. I.; Lundell, Marie; Björk-Eriksson, Thomas; Karlsson, Per; Blomgren, Klas

    2014-01-01

    While the detrimental effects of cranial radiotherapy on the developing brain are well known, the effects on cognitive performance of low doses of ionizing radiation is less studied. We performed a population-based cohort study to determine whether low doses of ionizing radiation to the brain in infancy affects cognitive function later in life. Further we hypothesized that the dose to the hippocampus predicts cognitive late side effects better than the anterior or the posterior brain doses. Material and methods During 1950–1960 3860 boys were treated with radiation in Sweden for cutaneous hemangiomas before the age of 18 months. Of these, 3030 were analyzed for military test scores at the age of 18 years and 2559 for the highest obtained educational level. Results Logical, spatial and technical test scores were not affected by increasing irradiation doses. The verbal test scores displayed a significant trend for decreasing scores with increasing doses to the hippocampus (p = 0.005). However, the absolute mean difference between the zero dose and the highest dose category (median 680 mGy) was very small, only 0.64 stanine points, and the significance was dependent on the highest dose category, containing few subjects. The educational level was not affected by brain irradiation. Overall, the hippocampal dose was a better predictor of late cognitive side effects than the doses to the anterior or the posterior brain. In conclusion, there was no decrease in logical, spatial and technical verbal or global test scores after ionizing radiation doses up to 250 mGy, but a subtle decrease in verbal test scores if the highest dose category was included (median 680 mGy). However, the clinical relevance of this decline in the highest dose group is questionable, since we could not find any effect on the highest obtained educational level. PMID:24697746

  1. 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

  2. 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

  3. Clinical Manifestation of Calreticulin Gene Mutations in Essential Thrombocythemia without Janus Kinase 2 and MPL Mutations: A Chinese Cohort Clinical Study

    PubMed Central

    Sun, Chao; Zhou, Xin; Zou, Zhi-Jian; Guo, Hong-Feng; Li, Jian-Yong; Qiao, Chun

    2016-01-01

    Background: Recently, calreticulin (CALR) gene mutations have been identified in patients with essential thrombocythemia (ET). A high-frequency of ET cases without Janus kinase 2 (JAK2) mutations contain CALR mutations and exhibit clinical characteristics different from those with mutant JAK2. Thus, we investigated the frequency and clinical features of Chinese patients of Han ethnicity with CALR mutations in ET. Methods: We recruited 310 Chinese patients of Han ethnicity with ET to analyze states of CALR, JAK2V617F, and MPLW515 mutations by polymerase chain reaction and direct sequencing. We analyzed the relationship between the mutations and clinical features. Results: CALR, JAK2V617F, and MPLW515 mutations were detected in 30% (n = 92), 48% (n = 149), and 1% (n = 4) of patients with ET, respectively. The mutation types of CALR involved deletion and insertion of base pairs. Most of them were Type 1 (52-bp deletion) and Type 2 (5-bp insertion, TTGTC) mutations, leading to del367fs46 and ins385fs47, respectively. The three mutations were exclusive. Clinically, patients with mutated CALR had a lower hemoglobin level, lower white blood cell (WBC) count, and higher platelet count compared to those with mutated JAK2 (P < 0.05). Furthermore, a significant difference was found in WBCs between wild-type patients (triple negative for JAK2, MPL, and CALR mutations) and patients with JAK2 mutations. Patients with CALR mutations predominantly clustered into low or intermediate groups according to the International Prognostic Score of thrombosis for ET (P < 0.05). Conclusions: CALR mutations were frequent in Chinese patients with ET, especially in those without JAK2 or MPL mutations. Compared with JAK2 mutant ET, CALR mutant ET showed a different clinical manifestation and an unfavorable prognosis. Thus, CALR is a potentially valuable diagnostic marker and therapeutic target in ET. PMID:27453224

  4. REGRESSION MODELS FOR COHORT MORTALITY STUDIES

    EPA Science Inventory

    Cohort studies evaluate suspect health hazards from occupational or environmental exposures by recording tile facts and causes of deaths in the exposed group as they occur over an extended time period. his article reviews several methods for analyzing cohort: mortality data and s...

  5. Socio-economic, clinical and biological risk factors for mother - to – child transmission of HIV-1 in Muhima health centre (Rwanda): a prospective cohort study

    PubMed Central

    2013-01-01

    Background Three decades since the first HIV-1 infected patients in Rwanda were identified in 1983; the Acquired Immunodeficiency Syndrome epidemic has had a devastating history and is still a major public health challenge in the country. This study was aimed at assessing socioeconomic, clinical and biological risk factors for mother – to – child transmission of HIV- in Muhima health centre (Kigali/Rwanda). Methods The prospective cohort study was conducted at Muhima Health centre (Kigali/Rwanda). During the study period (May 2007 – April 2010), of 8,669 pregnant women who attended antenatal visits and screened for HIV-1, 736 tested HIV-1 positive and among them 700 were eligible study participants. Hemoglobin, CD4 count and viral load tests were performed for participant mothers and HIV-1 testing using DNA PCR technique for infants. Follow up data for eligible mother-infant pairs were obtained from women themselves and log books in Muhima health centre and maternity, using a structured questionnaire. Predictors of mother-to-child transmission of HIV-1 were assessed by multivariable logistic regression analysis. Results Among the 679 exposed and followed-up infants, HIV-1 status was significantly associated with disclosure of HIV status to partner both at 6 weeks of age (non-disclosure of HIV status, adjusted odds ratio [AOR] 4.68, CI 1.39 to 15.77, p < 0.05; compared to disclosure) and at 6 months of age (non-disclosure of HIV status, AOR, 3.41, CI 1.09 to 10.65, p < 0.05, compared to disclosure). A significant association between mother’s viral load (HIV-1 RNA) and infant HIV-1 status was found both at 6 weeks of age (> = 1000 copies/ml, AOR 7.30, CI 2.65 to 20.08, p < 0.01, compared to <1000 copies/ml) and at 6 months of age (> = 1000 copies/ml, AOR 4.60, CI 1.84 to 11.49, p < 0.01, compared to <1000 copies/ml). Conclusion In this study, the most relevant factors independently associated with increased risk of mother – to

  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 Prior Healthcare-Associated Exposure on Clinical and Molecular Characterization of Methicillin-Susceptible Staphylococcus aureus Bacteremia: Results From a Retrospective Cohort Study

    PubMed Central

    Chen, Pao-Yu; Chuang, Yu-Chung; Wang, Jann-Tay; Chang, Shan-Chwen

    2015-01-01

    Abstract By virtue of medical advances and an aging society, people have increased opportunities for healthcare exposure. Little is known about the impact of healthcare exposure on the clinical features and molecular typing of methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia. We classified the onset of MSSA bacteremia into 3 mutually exclusive categories according to the Centers for Disease Control definition, and conducted a retrospective cohort study to investigate the differences among patients with community-associated (CA), healthcare-associated community onset (HACO), and hospital onset (HO) MSSA bacteremia at a medical center from January 1, 2002 through December 31, 2011. Antibiotic susceptibilities and multilocus sequence typing of MSSA isolates were also determined. A total of 290 patients with MSSA bacteremia, including of 165 (56.9%), 91 (31.4%), and 34 (11.7%) of HACO, HO, and CA, respectively, were studied. ST188 (29.3%) was the most common sequence type regardless of classification. Patients with HACO bacteremia were significantly older, had more solid tumors, higher Charlson scores, and more catheter-related bloodstream infections than those with CA bacteremia. The proportions of osteoarticular infections among patients with both HACO and CA bacteremia were higher than that of patients with HO bacteremia. By univariate analysis, patients with HO bacteremia had significantly higher in-hospital mortality compared to those with CA or HACO bacteremia (31.9% vs 18.8% and 20.4%). Multivariate analysis showed that Charlson score (odds ratio [OR], 1.29; 95% confidence interval [CI], 1.10–1.52), septic shock (OR, 5.28; 95% CI, 2.37–11.78), liver cirrhosis (OR, 3.57; 95% CI, 1.14–11.24), receipt of β-lactams other than oxacillin and cefazolin as definitive therapy (OR, 9.27; 95% CI, 4.25–20.23), and higher oxacillin minimum inhibitory concentration (MIC) (≥0.5 mg/L) (OR, 2.35; 95% CI, 1.05–5.25) of the causative pathogen were

  8. Implant Optimisation for Primary Hip Replacement in Patients over 60 Years with Osteoarthritis: A Cohort Study of Clinical Outcomes and Implant Costs Using Data from England and Wales

    PubMed Central

    Jameson, Simon S.; Mason, James; Baker, Paul N.; Gregg, Paul J.; Deehan, David J.; Reed, Mike R.

    2015-01-01

    Background Hip replacement is one of the most commonly performed surgical procedures worldwide; hundreds of implant configurations provide options for femoral head size, joint surface material and fixation method with dramatically varying costs. Robust comparative evidence to inform the choice of implant is needed. This retrospective cohort study uses linked national databases from England and Wales to determine the optimal type of replacement for patients over 60 years undergoing hip replacement for osteoarthritis. Methods and Findings Implants included were the commonest brand from each of the four types of replacement (cemented, cementless, hybrid and resurfacing); the reference prosthesis was the cemented hip procedure. Patient reported outcome scores (PROMs), costs and risk of repeat (revision) surgery were examined. Multivariable analyses included analysis of covariance to assess improvement in PROMs (Oxford hip score, OHS, and EQ5D index) (9159 linked episodes) and competing risks modelling of implant survival (79,775 procedures). Cost of implants and ancillary equipment were obtained from National Health Service procurement data. Results EQ5D score improvements (at 6 months) were similar for all hip replacement types. In females, revision risk was significantly higher in cementless hip prostheses (hazard ratio, HR = 2.22, p<0.001), when compared to the reference hip. Although improvement in OHS was statistically higher (22.1 versus 20.5, p<0.001) for cementless implants, this small difference is unlikely to be clinically important. In males, revision risk was significantly higher in cementless (HR = 1.95, p = 0.003) and resurfacing implants, HR = 3.46, p<0.001), with no differences in OHS. Material costs were lowest with the reference implant (cemented, range £1103 to £1524) and highest with cementless implants (£1928 to £4285). Limitations include the design of the study, which is intrinsically vulnerable to omitted variables, a paucity of long

  9. Cohort profile: golestan hepatitis B cohort study- a prospective long term study in northern iran ​.

    PubMed

    Poustchi, Hossein; Katoonizadeh, Aezam; Ostovaneh, Mohammad Reza; Moossavi, Shirin; Sharafkhah, Maryam; Esmaili, Saeed; Pourshams, Akram; Mohamadkhani, Ashraf; Besharat, Sima; Merat, Shahin; Mohamadnejad, Mehdi; George, Jacob; Malekzadeh, Reza

    2014-10-01

    Hepatitis B virus (HBV) infection is the most common cause of end stage liver disease in Iran and in Golestan province. Large-scale population-based prospective cohort studies with long term follow-up are the method of choice to accurately understand the natural course of HBV infection. To date, several studies of HBV epidemiology, natural history, progression to cirrhosis and association with HCC have been reported from other countries. However, few of these are prospective and fewer still are population-based. Moreover, the underlying molecular mechanisms and immunogenetic determinants of the outcome of HBV infection especially in low and middle income countries remains largely unknown. Therefore, the hepatitis B cohort study (HBCS), nested as part of the Golestan Cohort Study (GCS), Golestan, Iran was established in 2008 with the objective to prospectively investigate the natural course of chronic hepatitis B with reference to its epidemiology, viral/host genetic interactions, clinical features and outcome in the Middle East where genotype D HBV accounts for >90% of infections. In 2008, a baseline measurement of HBV surface antigen (HBsAg) was performed on stored serum samples of all GCS participants. A sub-cohort of 3,505 individuals were found to be HBsAg positive and were enrolled in the Golestan HBCS. In 2011, all first degree relatives of HBsAg positive subjects including their children and spouses were invited for HBV serology screening and those who were positive for HBsAg were also included in the Golestan HBCS. PMID:25349681

  10. The Role of Preference on Outcomes of People Receiving Evidence-Informed Community Wound Care in Their Home or in a Nurse-Clinic Setting: A Cohort Study (n = 230)

    PubMed Central

    Harrison, Margaret B.; VanDenKerkhof, Elizabeth G.; Hopman, Wilma M.; Carley, Meg E.

    2014-01-01

    This study followed a cohort of community-dwelling individuals receiving wound-care in a large urban-rural region. During a randomized control trial (RCT) evaluating outcomes of receiving care in a nurse-clinic or at home, many approached were willing to participate if they could choose their location of care. This provided a unique opportunity to enroll them as a “choice” cohort, following them in the same manner as the trial participants but allowing them to select their setting of care. The objective was to investigate the role of preference and location of care on care outcomes, including satisfaction with care, healing, health-related quality of life (HRQL), pain, and resource use. This is a secondary analysis of a prospective cohort of 126 individuals enrolled in an RCT to receive care at home or in a nurse-clinic (Allocated group), and an additional 104 who received care at home or in a nurse-clinic based on their preference (Choice group). Mobile individuals with a leg ulcer of venous or mixed venous etiology, referred for community leg ulcer care, were eligible. Specially-trained nurses provided care to both groups using an evidence-informed protocol. Baseline data included socio-demographic, circumstance-of-living and a detailed wound assessment. Mean age of the cohort was 68 years. Satisfaction, healing, recurrence, pain, HRQL, and resource utilization did not differ between groups. If available, individuals should have an option of care venue given almost half of those approached indicated a clear preference for clinic or home. With outcomes being similar, health care planners and decision-makers, as well as individuals and their families, can feel confident that the setting of care will not impact the outcomes. However, larger studies in other contexts are needed to explore the interaction between choice and setting. PMID:27429284

  11. A Study of Group Dynamics in Educational Leadership Cohort and Non-Cohort Groups

    ERIC Educational Resources Information Center

    Greenlee, Bobbie J.; Karanxha, Zorka

    2010-01-01

    The purpose of this study was to examine group dynamics of educational leadership students in cohorts and make comparisons with the group dynamics characteristics of non-cohort students. Cohorts have emerged as dynamic and adaptive entities with attendant group dynamic processes that shape collective learning and action. Cohort (n=42) and…

  12. The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study

    PubMed Central

    Langton, David J; Sidaginamale, Raghavendra P; Joyce, Thomas J; Natu, Shonali; Blain, Peter; Jefferson, Robert Drysdale; Rushton, Stephen; Nargol, Antoni V F

    2013-01-01

    Objective To determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD). Design Cohort study. Setting Single centre orthopaedic unit. Participants Following the identification of complications potentially related to metal wear debris, a blood metal ion screening programme was instigated at our unit in 2007 for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip resurfacings. Patients were followed annually unless symptoms presented earlier. Symptomatic patients were investigated with ultrasound scan and joint aspiration. The clinical course of all 278 patients with ‘no pain’ or ‘slight/occasional’ pain and a Harris Hip Score greater than or equal to 95 at the time of venesection were documented. A retrospective analysis was subsequently conducted using mixed effect modelling to investigate the temporal pattern of blood Co levels in the patients and survival analysis to investigate the potential role of case demographics and blood Co levels as risk factors for subsequent failure secondary to ARMD. Results Blood Co concentration was a positive and significant risk factor (z=8.44, p=2×10–16) for joint failure, as was the device, where the Birmingham Hip Resurfacing posed a significantly reduced risk for revision by 89% (z=−3.445, p=0.00005 (95% CI on risk 62 to 97)). Analysis using Cox-proportional hazards models indicated that men had a 66% lower risk of joint failure than women (z=−2.29419, p=0.0218, (95% CI on risk reduction 23 to 89)). Conclusions The results suggest that elevated blood metal ion concentrations are associated with early failure of MoM devices secondary to adverse reactions to metal debris. Co concentrations greater than 20 µg/l are frequently associated with metal staining of tissues and the development of osteolysis. Development of soft tissue damage appears to be more complex

  13. Chronic fatigue syndrome (CFS) or myalgic encephalomyelitis (ME) is different in children compared to in adults: a study of UK and Dutch clinical cohorts

    PubMed Central

    Collin, Simon M; Nuevo, Roberto; van de Putte, Elise M; Nijhof, Sanne L; Crawley, Esther

    2015-01-01

    Objective To investigate differences between young children, adolescents and adults with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Study design Comparison of clinical cohorts from 8 paediatric and 27 adult CFS/ME services in the UK and a paediatric randomised controlled trial from the Netherlands. Outcome measures include: fatigue (the UK—Chalder Fatigue Scale); Disability (the UK—SF-36 physical function subscale; the Netherlands—CHQ-CF87); school attendance, pain, anxiety and depression (the UK—Hospital Anxiety & Depression Scale, Spence Children's Anxiety Scale; the Netherlands—Spielberger State-Trait Anxiety Inventory for Children, Children's Depression Inventory); symptoms; time-to-assessment; and body mass index. We used multinomial regression to compare younger (aged <12 years) and older (aged 12–18 years) children with adults, and logistic regression to compare UK and Dutch adolescents. Results Younger children had a more equal gender balance compared to adolescents and adults. Adults had more disability and fatigue, and had been ill for longer. Younger children were less likely to have cognitive symptoms (OR 0.18 (95% CI 0.13 to 0.25)) and more likely to present with a sore throat (OR 1.42 (1.07 to 1.90). Adolescents were more likely to have headaches (81.1%, OR 1.56 (1.36% to 1.80%)) and less likely to have tender lymph nodes, palpitations, dizziness, general malaise and pain, compared to adults. Adolescents were more likely to have comorbid depression (OR 1.51 (1.33 to 1.72)) and less likely to have anxiety (OR 0.46 (0.41 to 0.53)) compared to adults. Conclusions Paediatricians need to recognise that children with CFS/ME present differently from adults. Whether these differences reflect an underlying aetiopathology requires further investigation. Trial registration numbers FITNET trial registration numbers are ISRCTN59878666 and NCT00893438. This paper includes secondary (post-results) analysis of data from this trial

  14. Cohort Profile: The International Collaboration of Incident HIV and Hepatitis C in Injecting Cohorts (InC3) Study

    PubMed Central

    Grebely, Jason; Morris, Meghan D; Rice, Thomas M; Bruneau, Julie; Cox, Andrea L; Kim, Arthur Y; McGovern, Barbara H; Shoukry, Naglaa H; Lauer, Georg; Maher, Lisa; Lloyd, Andrew R; Hellard, Margaret; Prins, Maria; Dore, Gregory J; Page, Kimberly

    2013-01-01

    The International Collaboration of Incident HIV and Hepatitis C in Injecting Cohorts (InC3) Study is an international multi-cohort project of pooled biological and behavioural data from nine prospective cohorts of people who inject drugs (PWID). InC3 brings together researchers from Australia, Canada, USA and the Netherlands with expertise in epidemiology, biostatistics, clinical and behavioural sciences, virology and immunology to investigate research questions relevant to hepatitis C virus (HCV) and HIV outcomes. InC3 was established to: (i) create a merged multi-cohort study of pooled data from well-characterized cohorts of PWID with prospective data on HIV and HCV infections, with a particular focus on HCV; (ii) facilitate new studies not possible within individual cohorts; and (iii) bring together researchers across disciplines to answer a broad range of research questions. Study cohorts identify acute HCV cases through follow-up of high-risk HCV antibody–negative PWID or through clinical referral networks. To date, data from 1986 to 2010 have been received from all contributing cohorts, with 821 HCV-infected and 1216 HCV-uninfected participants (overall, n = 2037). Data collected include demographics, host genetics, HCV ribonucleic acid testing, alanine aminotransferase testing, HIV/hepatitis B virus testing, HCV therapy, loss to follow-up and mortality. Potential collaborators should contact the InC3 PI Dr Kimberley Page (kPage@psg.ucsf.edu) for further information. PMID:23203695

  15. Returning findings within longitudinal cohort studies: the 1958 birth cohort as an exemplar.

    PubMed

    Wallace, Susan E; Walker, Neil M; Elliott, Jane

    2014-01-01

    Population-based, prospective longitudinal cohort studies are considering the issues surrounding returning findings to individuals as a result of genomic and other medical research studies. While guidance is being developed for clinical settings, the process is less clear for those conducting longitudinal research. This paper discusses work conducted on behalf of The UK Cohort and Longitudinal Study Enhancement Resource programme (CLOSER) to examine consent requirements, process considerations and specific examples of potential findings in the context of the 1958 British Birth cohort. Beyond deciding which findings to return, there are questions of whether re-consent is needed and the possible impact on the study, how the feedback process will be managed, and what resources are needed to support that process. Recommendations are made for actions a cohort study should consider taking when making vital decisions regarding returning findings. Any decisions need to be context-specific, arrived at transparently, communicated clearly, and in the best interests of both the participants and the study. PMID:25126104

  16. Evaluation of the effect of methylphenidate by computed tomography, electroencephalography, neuropsychological tests, and clinical symptoms in children with attention-deficit/hyperactivity disorder: A prospective cohort study

    PubMed Central

    Yildiz Oc, Ozlem; Agaoglu, Belma; Sen Berk, Fatma; Komsuoglu, Sezer; Karakaya, Isik; Coskun, Aysen

    2007-01-01

    Background: Stimulant drugs are the most commonly used treatments for attention-deficit/hyperactivity disorder (ADHD), although the mechanism of action of these drugs is still not entirely understood. Objective: The aim of this study was to investigate the effects of the psychostimulant drug methylphenidate (MPH) on regional cerebral blood flow (rCBF), electrical activity of the brain, and clinical symptoms in children with ADHD using single-photon emission computed tomography (SPECT), electroencephalography (EEG), and neuropsychological tests. Methods: In this prospective cohort study, pediatric outpatients received MPH for 3 months at a mean dose of 1 mg/kg · d (range, 0.5–1.5 mg/kg · d). They were then administered the Wechsler Intelligence Scale for Children-Revised, the Bender Visual-Motor Gestalt Test (BGT), EEG, and SPECT of the brain. The parents and/or teacher of each child were asked to complete the Conners' Parent Rating Scale (CPRS), the Conners' Teacher Rating Scale (CTRS), and the Turgay Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-based Child and Adolescent Behavior Disorders Screening and Rating Scale (T-DSM-IV-S). All of the evaluations were performed at baseline and after 3 months of MPH treatment. Each child underwent a Stroop test as an activation method 15 minutes before the SPECT procedure. Results: Sixty patients were assessed for inclusion. Twenty-one children (18 boys [85.7%], 3 girls [14.3%]; mean [SD] age, 9.7 [1.7] years; range, 8–13 years) with a diagnosis of ADHD were included in and completed the study. Mean (SD) BGT scores before MPH treatment compared with after MPH treatment were significantly decreased (9.8 [4.2] vs 6.3 [3.4]; Z = -3.27; P = 0.001). After treatment with MPH, the visual SPECT results suggested that low rCBF was normalized in the right frontotemporal areas in 10 children with ADHD. After treatment, 12 patients (57.1%) had no change in EEG activity, 5 (23.8%) had improvement, and 4 (19

  17. Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study.

    PubMed

    Habermann, Frank; Fritzsche, Juliane; Fuhlbrück, Frederike; Wacker, Evelin; Allignol, Arthur; Weber-Schoendorfer, Corinna; Meister, Reinhard; Schaefer, Christof

    2013-08-01

    Women of childbearing age are often affected with psychotic disorders, requiring the use of antipsychotic medication during pregnancy. In the present study, we prospectively followed the pregnancies of 561 women exposed to second-generation antipsychotic agents (SGAs; study cohort) and compared these to 284 pregnant women exposed to first-generation antipsychotic agents (FGAs; comparison cohort I) and to 1122 pregnant women using drugs known as not harmful to the unborn (comparison cohort II). Subjects were enrolled through the Institute's consultation service. Major malformation rates of SGA exposed were higher compared to comparison cohort II (adjusted odds ratio, 2.17; 95% confidence interval, 1.20-3.91), possibly reflecting a detection bias concerning atrial and ventricular septal defects. Postnatal disorders occurred significantly more often in infants prenatally exposed to SGAs (15.6%) and FGAs (21.6%) compared to 4.2% of comparison cohort II. Cumulative incidences of elective terminations of pregnancy were significantly higher in both the study cohort (17%) and comparison cohort I (21%) compared to comparison cohort II (3%), whereas the rates of spontaneous abortions did not differ. The numbers of stillbirths and neonatal deaths were within the reference range. Preterm birth and low birth weight were more common in infants exposed to FGAs. To conclude, our findings did not reveal a major teratogenic risk for SGAs, making the better studied drugs of this group a treatment option during pregnancy. Because neonates exposed to SGAs or FGAs in the last gestational week are at higher risk of postnatal disorders, delivery should be planned in clinics with neonatal intensive care units. PMID:23764684

  18. 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 Central

    Izumi, Keisuke; Kaneko, Yuko; Hashizume, Misato; Yoshimoto, Keiko; Takeuchi, Tsutomu

    2015-01-01

    Objective To explore the baseline predictors of clinical effectiveness after tocilizumab or infliximab treatment in biologic-naïve rheumatoid arthritis patients. Methods 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). Results 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. Conclusion Baseline low serum osteopontin levels predict clinical remission 1 year after tocilizumab treatment and not

  19. Phosphodiesterase Type 5 Inhibitors and Risk of Malignant Melanoma: Matched Cohort Study Using Primary Care Data from the UK Clinical Practice Research Datalink

    PubMed Central

    Langan, Sinéad M.; Douglas, Ian J.; Smeeth, Liam; Bhaskaran, Krishnan

    2016-01-01

    Background Laboratory evidence suggests that reduced phosphodiesterase type 5 (PDE5) expression increases the invasiveness of melanoma cells; hence, pharmacological inhibition of PDE5 could affect melanoma risk. Two major epidemiological studies have investigated this and come to differing conclusions. We therefore aimed to investigate whether PDE5 inhibitor use is associated with an increased risk of malignant melanoma, and whether any increase in risk is likely to represent a causal relationship. Methods and Findings We conducted a matched cohort study using primary care data from the UK Clinical Practice Research Datalink. All men initiating a PDE5 inhibitor and with no prior cancer diagnosis were identified and matched on age, diabetes status, and general practice to up to four unexposed controls. Ever use of a PDE5 inhibitor and time-updated cumulative number of PDE5 inhibitor prescriptions were investigated as exposures, and the primary outcome was malignant melanoma. Basal cell carcinoma, solar keratosis, and colorectal cancer were investigated as negative control outcomes to exclude bias. Hazard ratios (HRs) were estimated from Cox models stratified by matched set and adjusted for potential confounders. 145,104 men with ≥1 PDE5 inhibitor prescription, and 560,933 unexposed matched controls were included. In total, 1,315 incident malignant melanoma diagnoses were observed during 3.44 million person-years of follow-up (mean 4.9 y per person). After adjusting for potential confounders, there was weak evidence of a small positive association between PDE5 inhibitor use and melanoma risk (HR = 1.14, 95% CI 1.01–1.29, p = 0.04). A similar increase in risk was seen for the two negative control outcomes related to sun exposure (HR = 1.15, 95% CI 1.11–1.19, p < 0.001, for basal cell carcinoma; HR = 1.21, 95% CI 1.17–1.25, p < 0.001, for solar keratosis), but there was no increased risk for colorectal cancer (HR = 0.91, 95% CI 0.85–0.98, p = 0.01). There was

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

    PubMed

    Bach, Matthias; Geisel, Tabea; Martin, Julia; Schulze, Bettina; Schaefer, Roland; Virgin, Garth; Stein, Juergen

    2015-01-01

    Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65-101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1-3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years. PMID:26236500

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

    PubMed Central

    Bach, Matthias; Geisel, Tabea; Martin, Julia; Schulze, Bettina; Schaefer, Roland; Virgin, Garth; Stein, Juergen

    2015-01-01

    Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65–101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1–3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years. PMID:26236500

  2. Effect of human papillomavirus (HPV) vaccination on clinical indicators of sexual behaviour among adolescent girls: the Ontario Grade 8 HPV Vaccine Cohort Study

    PubMed Central

    Smith, Leah M.; Kaufman, Jay S.; Strumpf, Erin C.; Lévesque, Linda E.

    2015-01-01

    Background: Suboptimal human papillomavirus (HPV) vaccine coverage in some jurisdictions is partly attributed to fears that vaccination may increase risky sexual behaviour. We assessed the effect of HPV vaccination on clinical indicators of sexual behaviour among adolescent girls in Ontario. Methods: Using Ontario’s administrative health databases, we identified a population-based cohort of girls in grade 8 in the 2 years before (2005/06 and 2006/07) and after (2007/08 and 2008/09) implementation of Ontario’s grade 8 HPV vaccination program. For each girl, we then obtained data on vaccine receipt in grades 8 and 9 and data on indicators of sexual behaviour (pregnancy and non–HPV-related sexually transmitted infections) in grades 10–12. Using a quasi-experimental method known as regression discontinuity, we estimated, for each outcome, the risk difference (RD) and relative risk (RR) attributable to vaccination and to program eligibility. Results: The cohort comprised 260 493 girls, of whom 131 781 were ineligible for the program and 128 712 were eligible. We identified 15 441 (5.9%) cases of pregnancy and sexually transmitted infection and found no evidence that vaccination increased the risk of this composite outcome: RD per 1000 girls −0.61 (95% confidence interval [CI] −10.71 to 9.49) and RR 0.96 (95% CI 0.81 to 1.14). Similarly, we found no discernible effect of program eligibility: RD per 1000 girls −0.25 (95% CI −4.35 to 3.85) and RR 0.99 (95% CI 0.93 to 1.06). The findings were similar when outcomes were assessed separately. Interpretation: We present strong evidence that HPV vaccination does not have any significant effect on clinical indicators of sexual behaviour among adolescent girls. These results suggest that concerns over increased promiscuity following HPV vaccination are unwarranted and should not deter from vaccinating at a young age. PMID:25487660

  3. Clinical outcomes, survivorship and adverse events with mobile-bearings versus fixed-bearings in hip arthroplasty-a prospective comparative cohort study of 143 ADM versus 130 trident cups at 2 to 6-year follow-up.

    PubMed

    Epinette, Jean-Alain

    2015-02-01

    The principle of dual mobility cups, often called "tripolar", has been developed to overcome the problem of instability following primary hip arthroplasty. We prospectively compared two cohorts which differed only by the type of bearings, i.e." mobile bearing hip" (MBH) in a 143-study cohort of ADM cups versus "fixed bearing hip" (FBH) of 130 Trident PSL cups, at a follow-up at 2-6years. The survival rates at 4.13-years, with instability as endpoint was significantly (P=0.0176) in favor of mobile bearings at 100% with no dislocation reported, versus 94.8% with fixed bearings. These mobile bearings, matching both "modern" dual mobility cups and annealed highly crossed polyethylene, would appear to offer at longer follow-up a valuable solution to clinical outcomes in acetabular arthroplasty. PMID:25449593

  4. Brain-Science Based Cohort Studies

    ERIC Educational Resources Information Center

    Koizumi, Hideaki

    2011-01-01

    This article describes a number of human cohort studies based on the concept of brain-science and education. These studies assess the potential effects of new technologies on babies, children and adolescents, and test hypotheses drawn from animal and genetic case studies to see if they apply to people. A flood of information, virtual media,…

  5. Using large clinical data sets to infer pathogenicity for rare copy number variants in autism cohorts

    PubMed Central

    Moreno-De-Luca, D; Sanders, S J; Willsey, A J; Mulle, J G; Lowe, J K; Geschwind, D H; State, M W; Martin, C L; Ledbetter, D H

    2013-01-01

    Copy number variants (CNVs) have a major role in the etiology of autism spectrum disorders (ASD), and several of these have reached statistical significance in case–control analyses. Nevertheless, current ASD cohorts are not large enough to detect very rare CNVs that may be causative or contributory (that is, risk alleles). Here, we use a tiered approach, in which clinically significant CNVs are first identified in large clinical cohorts of neurodevelopmental disorders (including but not specific to ASD), after which these CNVs are then systematically identified within well-characterized ASD cohorts. We focused our initial analysis on 48 recurrent CNVs (segmental duplication-mediated ‘hotspots') from 24 loci in 31 516 published clinical cases with neurodevelopmental disorders and 13 696 published controls, which yielded a total of 19 deletion CNVs and 11 duplication CNVs that reached statistical significance. We then investigated the overlap of these 30 CNVs in a combined sample of 3955 well-characterized ASD cases from three published studies. We identified 73 deleterious recurrent CNVs, including 36 deletions from 11 loci and 37 duplications from seven loci, for a frequency of 1 in 54; had we considered the ASD cohorts alone, only 58 CNVs from eight loci (24 deletions from three loci and 34 duplications from five loci) would have reached statistical significance. In conclusion, until there are sufficiently large ASD research cohorts with enough power to detect very rare causative or contributory CNVs, data from larger clinical cohorts can be used to infer the likely clinical significance of CNVs in ASD. PMID:23044707

  6. What Difference Does Patient and Public Involvement Make and What Are Its Pathways to Impact? Qualitative Study of Patients and Researchers from a Cohort of Randomised Clinical Trials

    PubMed Central

    Dudley, Louise; Gamble, Carrol; Preston, Jennifer; Buck, Deborah; Hanley, Bec; Williamson, Paula; Young, Bridget

    2015-01-01

    Background Patient and public involvement (PPI) is advocated in clinical trials yet evidence on how to optimise its impact is limited. We explored researchers' and PPI contributors' accounts of the impact of PPI within trials and factors likely to influence its impact. Methods Semi-structured qualitative interviews with researchers and PPI contributors accessed through a cohort of randomised clinical trials. Analysis of transcripts of audio-recorded interviews was informed by the principles of the constant comparative method, elements of content analysis and informant triangulation. Results We interviewed 21 chief investigators, 10 trial managers and 17 PPI contributors from 28 trials. The accounts of informants within the same trials were largely in agreement. Over half the informants indicted PPI had made a difference within a trial, through contributions that influenced either an aspect of a trial, or how researchers thought about a trial. According to informants, the opportunity for PPI to make a difference was influenced by two main factors: whether chief investigators had goals and plans for PPI and the quality of the relationship between the research team and the PPI contributors. Early involvement of PPI contributors and including them in responsive (e.g. advisory groups) and managerial (e.g. trial management groups) roles were more likely to achieve impact compared to late involvement and oversight roles (e.g. trial steering committees). Conclusion Those seeking to enhance PPI in trials should develop goals for PPI at an early stage that fits the needs of the trial, plan PPI implementation in accordance with these goals, invest in developing good relationships between PPI contributors and researchers, and favour responsive and managerial roles for contributors in preference to oversight-only roles. These features could be used by research funders in judging PPI in trial grant applications and to inform policies to optimise PPI within trials. PMID:26053063

  7. Cohort studies in health sciences librarianship

    PubMed Central

    Eldredge, Jonathan

    2002-01-01

    Question: What are the key characteristics of the cohort study design and its varied applications, and how can this research design be utilized in health sciences librarianship? Data Sources: The health, social, behavioral, biological, library, earth, and management sciences literatures were used as sources. Study Selection: All fields except for health sciences librarianship were scanned topically for either well-known or diverse applications of the cohort design. The health sciences library literature available to the author principally for the years 1990 to 2000, supplemented by papers or posters presented at annual meetings of the Medical Library Association. Data Extraction: A narrative review for the health, social, behavioral, biological, earth, and management sciences literatures and a systematic review for health sciences librarianship literature for the years 1990 to 2000, with three exceptions, were conducted. The author conducted principally a manual search of the health sciences librarianship literature for the years 1990 to 2000 as part of this systematic review. Main Results: The cohort design has been applied to answer a wide array of theoretical or practical research questions in the health, social, behavioral, biological, and management sciences. Health sciences librarianship also offers several major applications of the cohort design. Conclusion: The cohort design has great potential for answering research questions in the field of health sciences librarianship, particularly evidence-based librarianship (EBL), although that potential has not been fully explored. PMID:12398244

  8. PRImary care Streptococcal Management (PRISM) study: identifying clinical variables associated with Lancefield group A β-haemolytic streptococci and Lancefield non-Group A streptococcal throat infections from two cohorts of patients presenting with an acute sore throat

    PubMed Central

    Little, Paul; Moore, Michael; Hobbs, F D R; Mant, David; McNulty, Cliodna; Williamson, Ian; Cheng, Edith; Stuart, Beth; Kelly, Joanne; Barnett, Jane; Mullee, Mark

    2013-01-01

    Objective To assess the association between features of acute sore throat and the growth of streptococci from culturing a throat swab. Design Diagnostic cohort. Setting UK general practices. Participants Patients aged 5 or over presenting with an acute sore throat. Patients were recruited for a second cohort (cohort 2, n=517) consecutively after the first (cohort 1, n=606) from similar practices. Main outcome Predictors of the presence of Lancefield A/C/G streptococci. Results The clinical score developed from cohort 1 had poor discrimination in cohort 2 (bootstrapped estimate of area under the receiver operator characteristic (ROC) curve (0.65), due to the poor validity of the individual items in the second data set. Variables significant in multivariate analysis in both cohorts were rapid attendance (prior duration 3 days or less; multivariate adjusted OR 1.92 cohort, 1.67 cohort 2); fever in the last 24 h (1.69, 2.40); and doctor assessment of severity (severely inflamed pharynx/tonsils (2.28, 2.29)). The absence of coryza or cough and purulent tonsils were significant in univariate analysis in both cohorts and in multivariate analysis in one cohort. A five-item score based on Fever, Purulence, Attend rapidly (3 days or less), severely Inflamed tonsils and No cough or coryza (FeverPAIN) had moderate predictive value (bootstrapped area under the ROC curve 0.73 cohort 1, 0.71 cohort 2) and identified a substantial number of participants at low risk of streptococcal infection (38% in cohort 1, 36% in cohort 2 scored ≤1, associated with a streptococcal percentage of 13% and 18%, respectively). A Centor score of ≤1 identified 23% and 26% of participants with streptococcal percentages of 10% and 28%, respectively. Conclusions Items widely used to help identify streptococcal sore throat may not be the most consistent. A modified clinical scoring system (FeverPAIN) which requires further validation may be clinically helpful in identifying individuals who are

  9. Cohort Survival and Withdrawal Study District Report.

    ERIC Educational Resources Information Center

    Shainline, Michael

    At the completion of the 1986-87 school year, the Albuquerque (New Mexico) Public Schools (APS) conducted a cohort survival and withdrawal study to follow-up 5,976 students who had begun the ninth grade within the district in 1983-84. Current records were matched with those from the 1983-84 school year to determine whether members of the…

  10. Studies on the extended Techa river cohort: cancer risk estimation

    SciTech Connect

    Kossenko, M M.; Preston, D L.; Krestinina, L Y.; Degteva, M O.; Startsev, N V.; Thomas, T; Vyushkova, O V.; Anspaugh, L R.; Napier, Bruce A. ); Kozheurov, V P.; Ron, E; Akleyev, A V.

    2001-12-01

    Initial population-based studies of riverside residents were begun in the late 1950s and in 1967 a systematic effort was undertaken to develop a well-defined fixed cohort of Techa river residents, to carry out ongoing mortality and (limited) clinical follow-up of this cohort, and to provide individualized dose estimates for cohort members. Over the past decade, extensive efforts have been made to refine the cohort definition and improve both the follow-up and dosimetry data. Analyses of the Techa river cohort can provide useful quantitative estimates of the effects of low dose rate, chronic external and internal exposures on cancer mortality and incidence and non-cancer mortality rates. These risk estimates complement quantitative risk estimates for acute exposures based on the atomic bomb survivors and chronic exposure risk estimates from worker studies, including Mayak workers and other groups with occupational radiation exposures. As the dosimetry and follow-up are refined it may also be possible to gain useful insights into risks associated with 90Sr exposures.

  11. Postmarket safety of drugs approved by Health Canada on the basis of clinical and surrogate outcomes: a cohort study

    PubMed Central

    Ahmed, Tareq

    2015-01-01

    Background Health Canada approves drugs on the basis of evidence from clinical trials using clinical or surrogate outcomes. This study compares the postmarket safety of these 2 groups of drugs. Methods Information about whether clinical or surrogate outcomes were used and the date of market approval were obtained from Health Canada’s Summary Basis of Decision documents issued from Jan. 1, 2005, to Dec. 31, 2014. Safety warnings and the dates they were issued were identified through advisories on the MedEffect Canada website. Kaplan–Meier survival curves were calculated to determine the likelihood that drugs in the clinical and surrogate outcome groups would receive a serious safety warning. The time from market authorization to first serious safety warning was compared for the 2 groups of drugs. Results A total of 124 drugs were approved by Health Canada using clinical outcomes and 114 using surrogate outcomes. Kaplan–Meier curves did not differ between the 2 groups (p < 0.9). The median time from market authorization to first serious safety warning was 722 days in the clinical outcome group and 818 days in the surrogate outcome group (difference 96 days, 95% confidence interval –295 to 425). Interpretation We found no statistically significant difference in postmarket safety between drugs approved using clinical outcomes and those approved using surrogate outcomes. Because drugs in the surrogate outcome group are approved before their benefit:harm ratio is fully established, these drugs should be used with caution until their clinical benefits are better understood. PMID:26442227

  12. Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort.

    PubMed

    Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin, Gerald; Cantor, Ryan S; Petri, Michelle; Ramsey-Goldman, Rosalind; Reveille, John D; Kimberly, Robert P; Alarcón, Graciela S; Vilá, Luis M; Brown, Elizabeth E

    2015-07-01

    The aim of this study was to determine the association of anti-Sm antibodies with clinical manifestations, comorbidities, and disease damage in a large multi-ethnic SLE cohort. SLE patients (per American College of Rheumatology criteria), age ≥16 years, disease duration ≤10 years at enrollment, and defined ethnicity (African American, Hispanic or Caucasian), from a longitudinal US cohort were studied. Socioeconomic-demographic features, cumulative clinical manifestations, comorbidities, and disease damage (as per the Systemic Lupus International Collaborating Clinics Damage Index [SDI]) were determined. The association of anti-Sm antibodies with clinical features was examined using multivariable logistic regression analyses adjusting for age, gender, ethnicity, disease duration, level of education, health insurance, and smoking. A total of 2322 SLE patients were studied. The mean (standard deviation, SD) age at diagnosis was 34.4 (12.8) years and the mean (SD) disease duration was 9.0 (7.9) years; 2127 (91.6%) were women. Anti-Sm antibodies were present in 579 (24.9%) patients. In the multivariable analysis, anti-Sm antibodies were significantly associated with serositis, renal involvement, psychosis, vasculitis, Raynaud's phenomenon, hemolytic anemia, leukopenia, lymphopenia, and arterial hypertension. No significant association was found for damage accrual. In this cohort of SLE patients, anti-Sm antibodies were associated with several clinical features including serious manifestations such as renal, neurologic, and hematologic disorders as well as vasculitis. PMID:25896533

  13. Investigation into the causes of indwelling urethral catheter implementation and its effects on clinical outcomes and health care resources among dementia patients with pneumonia: A retrospective cohort study.

    PubMed

    Maeda, Toshiki; Babazono, Akira; Nishi, Takumi; Yasui, Midori; Harano, Yumi

    2016-08-01

    There is a possibility that unnecessary treatments and low-quality medical care, such as inappropriate indwelling urethral catheter use, are being provided to older Japanese individuals.The aim of this study was to investigate contextual effects relating to indwelling urethral catheters in older people with dementia and to clarify the effects of indwelling urethral catheter use on patients' mortality, length of stay (LOS), and health care spending. This retrospective cohort study involved 4501 male and female Japanese participants. Those who were aged 75 or older with dementia and had a primary diagnosis of acute lower respiratory disease with antibiotics administered during hospitalization were eligible for inclusion. Patient mortality, LOS, and total charge during hospitalization were the main study outcomes. This study showed that indwelling urethral catheter use was significantly associated with higher mortality, longer LOS, and higher total charge for hospitalization. The pattern of indwelling urethral catheter use was clustered by care facility level. Physician density was significantly associated with indwelling urethral catheter use; the relationship was not linear but U-shaped, such that the approximate median had the lowest rate of urethral catheter use and this increased gradually toward both lower and higher physician densities. Our study found considerable variation in indwelling urethral catheter use between care facilities in older people with dementia. Additionally, indwelling urethral catheter use was related to poor outcomes. Based on these findings, we consider there to be an urgent need for constructing a framework to measure, report on, and promote the improvement of care quality for older individuals in Japan. PMID:27583898

  14. Do Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis Have the Same Clinical Outcomes? A Ten-year Cohort Study in Taiwan.

    PubMed

    Tang, Chao-Hsiun; Chen, Tso-Hsiao; Fang, Te-Chao; Huang, Siao-Yuan; Huang, Kuan-Chih; Wu, Yu-Ting; Wang, Chia-Chen; Sue, Yuh-Mou

    2016-01-01

    This paper reports a comprehensive comparison for mortality and technique failure rates between automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) in Taiwan. A propensity-score matched cohort study was conducted by retrieving APD and CAPD patients identified from the Taiwan National Health Insurance Research Database between 2001 and 2010. The main outcomes were the 5-year mortality and technique failure rates. Further analyses were then carried out based upon the first (2001-2004), second (2005-2007), and third (2008-2010) sub-periods. Similar baseline characteristics were identified for APD (n = 2,287) and CAPD (n = 2,287) patients. The proportion on APD therapy increased rapidly in the second sub-period. As compared to CAPD patients of this sub-period, APD patients had a significantly higher risk of mortality (HR, 1.37; 95% CI 1.09-1.72; p < 0.01) and technique failure (HR, 1.43; 95% CI, 1.10-1.86; p < 0.01), particularly in the first year after peritoneal dialysis commencement. However, APD patients had similar mortality and technique failure rates to those of CAPD patients throughout the full sample period and the first and third sub-periods. These findings do not suggest the presence of a clear advantage of CAPD over APD. Differences observed between these two modalities might be attributed to specials circumstances of sub-periods. PMID:27388055

  15. Do Automated Peritoneal Dialysis and Continuous Ambulatory Peritoneal Dialysis Have the Same Clinical Outcomes? A Ten-year Cohort Study in Taiwan

    PubMed Central

    Tang, Chao-Hsiun; Chen, Tso-Hsiao; Fang, Te-Chao; Huang, Siao-Yuan; Huang, Kuan-Chih; Wu, Yu-Ting; Wang, Chia-Chen; Sue, Yuh-Mou

    2016-01-01

    This paper reports a comprehensive comparison for mortality and technique failure rates between automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD) in Taiwan. A propensity-score matched cohort study was conducted by retrieving APD and CAPD patients identified from the Taiwan National Health Insurance Research Database between 2001 and 2010. The main outcomes were the 5-year mortality and technique failure rates. Further analyses were then carried out based upon the first (2001–2004), second (2005–2007), and third (2008–2010) sub-periods. Similar baseline characteristics were identified for APD (n = 2,287) and CAPD (n = 2,287) patients. The proportion on APD therapy increased rapidly in the second sub-period. As compared to CAPD patients of this sub-period, APD patients had a significantly higher risk of mortality (HR, 1.37; 95% CI 1.09–1.72; p < 0.01) and technique failure (HR, 1.43; 95% CI, 1.10–1.86; p < 0.01), particularly in the first year after peritoneal dialysis commencement. However, APD patients had similar mortality and technique failure rates to those of CAPD patients throughout the full sample period and the first and third sub-periods. These findings do not suggest the presence of a clear advantage of CAPD over APD. Differences observed between these two modalities might be attributed to specials circumstances of sub-periods. PMID:27388055

  16. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  17. Cohort Profile: Sympathetic activity and Ambulatory Blood Pressure in Africans (SABPA) prospective cohort study.

    PubMed

    Malan, Leoné; Hamer, Mark; Frasure-Smith, Nancy; Steyn, Hendrik S; Malan, Nicolaas T

    2015-12-01

    Adapting to an over-demanding stressful urban environment may exhaust the psychophysiological resources to cope with these demands, and lead to sympathetic nervous system dysfunction. The evidence that an urban-dwelling lifestyle may be detrimental to the cardiometabolic health of Africans motivated the design of the Sympathetic activity and Ambulatory Blood Pressure in African Prospective cohort study. We aimed to determine neural mechanistic pathways involved in emotional distress and vascular remodelling. The baseline sample included 409 teachers representing a bi-ethnic sex cohort from South Africa. The study was conducted in 2008-09 and repeated after 3-year follow-up in 2011-12, with an 87.8% successful follow-up rate. Seasonal changes were avoided and extensive clinical assessments were performed in a well-controlled setting. Data collection included sociodemographics, lifestyle habits, psychosocial battery and genetic analysis, mental stress responses mimicking daily life stress (blood pressure and haemostatic, cardiometabolic, endothelial and stress hormones). Target organ damage was assessed in the brain, heart, kidney, blood vessels and retina. A unique highly phenotyped cohort is presented that can address the role of a hyperactive sympathetic nervous system and neural response pathways contributing to the burden of cardiometabolic diseases in Africans. PMID:25344943

  18. Profile of Participants and Genotype Distributions of 108 Polymorphisms in a Cross-Sectional Study of Associations of Genotypes With Lifestyle and Clinical Factors: A Project in the Japan Multi-Institutional Collaborative Cohort (J-MICC) Study

    PubMed Central

    Wakai, Kenji; Hamajima, Nobuyuki; Okada, Rieko; Naito, Mariko; Morita, Emi; Hishida, Asahi; Kawai, Sayo; Nishio, Kazuko; Yin, Guang; Asai, Yatami; Matsuo, Keitaro; Hosono, Satoyo; Ito, Hidemi; Watanabe, Miki; Kawase, Takakazu; Suzuki, Takeshi; Tajima, Kazuo; Tanaka, Keitaro; Higaki, Yasuki; Hara, Megumi; Imaizumi, Takeshi; Taguchi, Naoto; Nakamura, Kazuyo; Nanri, Hinako; Sakamoto, Tatsuhiko; Horita, Mikako; Shinchi, Koichi; Kita, Yoshikuni; Turin, Tanvir Chowdhury; Rumana, Nahid; Matsui, Kenji; Miura, Katsuyuki; Ueshima, Hirotsugu; Takashima, Naoyuki; Nakamura, Yasuyuki; Suzuki, Sadao; Ando, Ryosuke; Hosono, Akihiro; Imaeda, Nahomi; Shibata, Kiyoshi; Goto, Chiho; Hattori, Nami; Fukatsu, Mitsuru; Yamada, Tamaki; Tokudome, Shinkan; Takezaki, Toshiro; Niimura, Hideshi; Hirasada, Kazuyo; Nakamura, Akihiko; Tatebo, Masaya; Ogawa, Shin; Tsunematsu, Noriko; Chiba, Shirabe; Mikami, Haruo; Kono, Suminori; Ohnaka, Keizo; Takayanagi, Ryoichi; Watanabe, Yoshiyuki; Ozaki, Etsuko; Shigeta, Masako; Kuriyama, Nagato; Yoshikawa, Aya; Matsui, Daisuke; Watanabe, Isao; Inoue, Kaoru; Ozasa, Kotaro; Mitani, Satoko; Arisawa, Kokichi; Uemura, Hirokazu; Hiyoshi, Mineyoshi; Takami, Hidenobu; Yamaguchi, Miwa; Nakamoto, Mariko; Takeda, Hideo; Kubo, Michiaki; Tanaka, Hideo

    2011-01-01

    Background Most diseases are thought to arise from interactions between environmental factors and the host genotype. To detect gene–environment interactions in the development of lifestyle-related diseases, and especially cancer, the Japan Multi-institutional Collaborative Cohort (J-MICC) Study was launched in 2005. Methods We initiated a cross-sectional study to examine associations of genotypes with lifestyle and clinical factors, as assessed by questionnaires and medical examinations. The 4519 subjects were selected from among participants in the J-MICC Study in 10 areas throughout Japan. In total, 108 polymorphisms were chosen and genotyped using the Invader assay. Results The study group comprised 2124 men and 2395 women with a mean age of 55.8 ± 8.9 years (range, 35–69 years) at baseline. Among the 108 polymorphisms examined, 4 were not polymorphic in our study population. Among the remaining 104 polymorphisms, most variations were common (minor allele frequency ≥0.05 for 96 polymorphisms). The allele frequencies in this population were comparable with those in the HapMap-JPT data set for 45 Japanese from Tokyo. Only 5 of 88 polymorphisms showed allele-frequency differences greater than 0.1. Of the 108 polymorphisms, 32 showed a highly significant difference in minor allele frequency among the study areas (P < 0.001). Conclusions This comprehensive data collection on lifestyle and clinical factors will be useful for elucidating gene–environment interactions. In addition, it is likely to be an informative reference tool, as free access to genotype data for a large Japanese population is not readily available. PMID:21467728

  19. Infection with the human immunodeficiency virus: clinical manifestations and their relationship to immune deficiency. A report from the Multicenter AIDS Cohort Study.

    PubMed

    Kaslow, R A; Phair, J P; Friedman, H B; Lyter, D; Solomon, R E; Dudley, J; Polk, B F; Blackwelder, W

    1987-10-01

    In 1984 a large prospective study of gay and bisexual men was begun to elucidate the natural history of the human immunodeficiency virus (HIV) infection. At two successive semiannual examinations, clinical or hematologic abnormalities were found up to 13 times more often among HIV-seropositive men (n = 1611) than HIV-seronegative men (n = 2646). More than 30% of the seropositive participants had persistent generalized lymphadenopathy, independent of T-helper lymphocyte (CD4) counts and most other signs and symptoms. Other clinical manifestations such as thrush, anemia, thrombocytopenia, neutropenia, fever, and fatigue occurred with only slightly reduced CD4 counts (400 to 700/mm3) and appeared to increase exponentially with progressively lower counts. A simple systematically derived clinical index using these manifestations identified more than 70% of the seropositive men with significant T-helper cell depletion. This kind of clinical index may be useful for assessing groups of HIV-infected persons, especially those whose T-lymphocyte numbers and function cannot be readily measured. PMID:2957944

  20. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    PubMed

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome. PMID:25924999

  1. Radiofrequency thermocoagulation for V2/V3 idiopathic trigeminal neuralgia: effect of treatment temperatures on long-term clinical outcomes: A Cohort Study.

    PubMed

    Yao, Peng; Deng, Yi-Yong; Hong, Tao; Wang, Zhi-Bin; Ma, Jia-Ming; Zhu, Yong-Qiang; Li, Hong-Xi; Ding, Yuan-Yuan; Pan, Shi-Nong

    2016-06-01

    Radiofrequency thermocoagulation (RFT) is widely used to treat trigeminal neuralgia (TN); however, the optimal temperature at which RFT is most efficacious remains under much debate. Thus, the aim of the present study was to determine the lowest temperature at which morbidity could be minimized and patient outcomes maximized.A multivariate analysis was used to study 1354 patients who underwent computed tomography (CT)-guided RFT for V2/V3 idiopathic trigeminal neuralgia (ITN) during from June 2006 to May 2015. RFT was carried out at 62, 65, and 68°C, while keeping all other RF parameters the same. This was a prospective cohort study, in which we assessed intra- and postoperative complications, pain relief, and long-term health-related quality of life (HRQoL).The intraoperative and in-hospital complications of patients were mainly facial hematoma, mouth and external auditory meatus penetration, nausea, vomiting, dizziness, and headache, which were all treated symptomatically. In long-term follow-up, patients with pain relief (defined as no pain and no required drug intervention) at 62, 65, and 68°C accounted for 94.2%, 98.3%, and 98.8% (at discharge); 83.8%, 90.1%, and 91.4% (at 1 year); 66.7%, 80.5%, and 88.2% (at 3 years); 59.0%, 64.3%, and 77.2% (at 5 years); 48.7%, 57.8%, and 72.3% (at 7 years); 40.6%, 53.7%, and 60.3% (at 9 years), respectively. The number of patients with facial numbness, masticatory atonia, or corneal hypoesthesia was increased with the elevation of temperature, but these complications were all mild. No blindness, deafness, intracranial hemorrhage, or death as a result of the surgical intervention occurred in any patients. SF-36 scores showed highest HRQoL in the group treated at 68°C, followed by the 65 and 62°C groups, respectively.Our results demonstrate that 68°C is a good choice for RFT of V2/V3 ITN. The alternative option is 65 or 62°C for RFT to minimize the occurrence of complications including facial numbness, yet which often

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

    PubMed Central

    2013-01-01

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

  3. A cohort mortality study of petrochemical workers

    SciTech Connect

    Austin, S.G.; Schnatter, A.R.

    1983-04-01

    A historical prospective cohort mortality study was conducted for a cohort of 6,588 white male employees of a Texas petrochemical plant because of a suspected increased incidence of malignant brain tumors. Mortality experience from 1941 to 1977 was determined and compared with that of the general U.S. white male population adjusting for age and time period. Overall and cause-specific standardized mortality ratios were calculated for various subgroups of the population defined by length of employment, latency and payroll status. Significant deficits in total cohort mortality were found for all causes of death, all circulatory diseases, all respiratory diseases and all digestive diseases. Although not statistically significant, fewer deaths were observed (O) than expected (E) for all malignant neoplasms. No statistically significant excess of malignant brain tumors was found in the overall plant population (O/E = 12/7.42 = 1.62). A borderline significant excess of brain cancer deaths was found among hourly employees with more than six months' employment based on 10 observed and five expected deaths. This excess was observed to occur among elderly employees (over 55 years) and in later follow-up years (post-1970). Risk did not appear to be related to length of employment. Because of the nature of the problem that prompted this study, the small number of cases involved and the lack of a suspect agent in the plant that could have produced this excess, insufficient evidence was found to conclude that these tumors were occupationally related.

  4. Clinical Malaria Diagnosis in Pregnancy in Relation to Early Perinatal Mother-to-Child-Transmission of HIV: A Prospective Cohort Study

    PubMed Central

    Ezeamama, AE; Duggan, C; Manji, KP; Spiegelman, D; Hertzmark, E; Bosch, RJ; Kupka, R; Okuma, JO; Kisenge, R; Aboud, S; Fawzi, WW

    2015-01-01

    Objectives We prospectively investigated fever symptoms and maternal diagnosis of malaria in pregnancy (MIP) in relation to child HIV infection among 2,368 pregnant HIV-positive women and their infants, followed-up from pregnancy until birth and 6 weeks post-delivery in Tanzania. Methods Doctors clinically diagnosed and treated MIP and fever symptoms during prenatal healthcare. Child HIV status was determined via DNA-PCR. Multivariable logistic regression models estimated relative risks (RR) and 95% confidence intervals (CI) for HIV mother-to-child-transmission (MTCT) by 6th week of life. Results Mean gestational age at enrollment was 22.2 weeks. During follow-up, 16.6% had ≥1 MIP diagnosis, 15.9% reported fever symptoms and 8.7% had both fever and MIP diagnosis. Eleven percent of HIV-exposed infants were HIV-positive by 6 weeks. The RR of HIV MTCT was statistically similar for infants whose mothers were ever vs. never clinical MIP diagnosed (RR=1.24, 95%CI:0.94–1.64), were diagnosed with 1 vs. 0 clinical MIP episode (RR=1.07;95%CI:0.77–1.48) and had ever vs. never reported fever symptoms (RR=1.04, 95%CI:0.78,1.38) in pregnancy. However, HIV MTCT risk increased by 29% (95%CI:4–58%) per MIP episode. Infants of women with ≥2 vs. 0 MIP diagnoses were 2.1 times more likely to be HIV infected by 6weeks old (95%CI:1.31–3.45). Conclusions Clinical MIP diagnosis, but not fevers, in HIV-positive pregnant women was associated with elevated risk of early HIV MTCT suggesting that malaria prevention and treatment in pregnant HIV-positive women may enhance the effectiveness of HIV prevention in MTCT programs in this setting. Future studies using laboratory confirmed malaria is needed to confirm this association. PMID:24215465

  5. Cohort profile: the lidA Cohort Study-a German Cohort Study on Work, Age, Health and Work Participation.

    PubMed

    Hasselhorn, Hans Martin; Peter, Richard; Rauch, Angela; Schröder, Helmut; Swart, Enno; Bender, Stefan; du Prel, Jean-Baptist; Ebener, Melanie; March, Stefanie; Trappmann, Mark; Steinwede, Jacob; Müller, Bernd Hans

    2014-12-01

    The lidA Cohort Study (German Cohort Study on Work, Age, Health and Work Participation) was set up to investigate and follow the effects of work and work context on the physical and psychological health of the ageing workforce in Germany and subsequently on work participation. Cohort participants are initially employed people subject to social security contributions and born in either 1959 (n = 2909) or 1965 (n = 3676). They were personally interviewed in their homes in 2011 and will be visited every 3 years. Data collection comprises socio-demographic data, work and private exposures, work ability, work and work participation attitudes, health, health-related behaviour, personality and attitudinal indicators. Employment biographies are assessed using register data. Subjective health reports and physical strength measures are complemented by health insurance claims data, where permission was given. A conceptual framework has been developed for the lidA Cohort Study within which three confirmatory sub-models assess the interdependencies of work and health considering age, gender and socioeconomic status. The first set of the data will be available to the scientific community by 2015. Access will be given by the Research Data Centre of the German Federal Employment Agency at the Institute for Employment Research (http://fdz.iab.de/en.aspx). PMID:24618186

  6. Characteristics of bipolar disorder patients treated with immediate- and extended-release quetiapine in a real clinical setting: a longitudinal, cohort study of 1761 patients

    PubMed Central

    Thuresson, Marcus; Ferntoft, Lena; Bodegard, Johan

    2015-01-01

    Objectives: The objective of this work was to study characteristics and clinical treatment patterns of bipolar disorder (BD) patients admitted to hospital and treated with quetiapine (immediate-release [IR] or extended-release [XR] formulations). Methods: BD patients admitted to hospital and prescribed quetiapine IR were followed by linking two Swedish nationwide registries; the hospitalization and drug dispense registries [ClinicalTrials.gov identifier: NCT01455961]. The study period was from 1 January 2008, to end of 31 December 2011. Data was primarily analysed using descriptive methods. Results: Quetiapine IR was used in 1761 patients of whom 1303 subsequently switched to XR (switch XR) and 458 remained on IR (continuous IR). At baseline, Switch XR patients were younger (−3.3 years), more frequently employed (+7.1%), had higher prevalence of single depressive episodes (+6.7%) and anxiety disorders (+5.8%), lower mean daily IR dose (−19.3%) and fewer medications for somatic disorders (−7.5%) than continuous IR patients. During follow up, the number of concomitant psychiatric medications was lower in switch XR patients (−6%) and higher in continuous IR patients (+6%). Mean daily quetiapine dose was 21% higher in switch XR versus continuous IR patients. Prescriptions of lower quetiapine dosages calculated below 50 mg per day in the XR switch and IR continuous groups were seen in 8% versus 10% of the patients, respectively. Conclusions: Differential use of quetiapine XR and IR in bipolar disorder patients with different and important characteristics was demonstrated. Patients who were switched to quetiapine XR had a higher psychiatric disease burden, were younger and had a higher degree of employment. These differences demonstrate the heterogeneity among bipolar disorder patients and indicate the need in clinical practice for individualized treatment to reduce the risk for both patient and society related losses. PMID:25653826

  7. Barriers to and Facilitators of Compliance with Clinic-Based Cervical Cancer Screening: Population-Based Cohort Study of Women Aged 23-60 Years

    PubMed Central

    Östensson, Ellinor; Alder, Susanna; Elfström, K. Miriam; Sundström, Karin; Zethraeus, Niklas; Arbyn, Marc; Andersson, Sonia

    2015-01-01

    Objective This study aims to identify possible barriers to and facilitators of cervical cancer screening by (a) estimating time and travel costs and other direct non-medical costs incurred in attending clinic-based cervical cancer screening, (b) investigating screening compliance and reasons for noncompliance, (c) determining women’s knowledge of human papillomavirus (HPV), its relationship to cervical cancer, and HPV and cervical cancer prevention, and (d) investigating correlates of HPV knowledge and screening compliance. Materials and Methods 1510 women attending the clinic-based cervical cancer screening program in Stockholm, Sweden were included. Data on sociodemographic characteristics, time and travel costs and other direct non-medical costs incurred in attending (e.g., indirect cost of time needed for the screening visit, transportation costs, child care costs, etc.), mode(s) of travel, time, distance, companion’s attendance, HPV knowledge, and screening compliance were obtained via self-administered questionnaire. Results Few respondents had low socioeconomic status. Mean total time and travel costs and direct non-medical cost per attendance, including companion (if any) were €55.6. Over half (53%) of the respondents took time off work to attend screening (mean time 147 minutes). A large portion (44%) of the respondents were noncompliant (i.e., did not attend screening within 1 year of the initial invitation), 51% of whom stated difficulties in taking time off work. 64% of all respondents knew that HPV vaccination was available; only 34% knew it was important to continue to attend screening following vaccination. Age, education, and income were the most important correlates of HPV knowledge and compliance; and additional factors associated with compliance were time off work, accompanying companion and HPV knowledge. Conclusion Time and travel costs and other direct non-medical costs for clinic-based screening can be considerable, may affect the cost

  8. Impact of therapeutic drug monitoring of antiretroviral drugs in routine clinical management of patients infected with human immunodeficiency virus and related health care costs: a real-life study in a large cohort of patients

    PubMed Central

    Perrone, Valentina; Cattaneo, Dario; Radice, Sonia; Sangiorgi, Diego; Federici, Augusto B; Gismondo, Maria Rita; Medaglia, Massimo; Micheli, Valeria; Vimercati, Stefania; Pallone, Enza; Esposti, Luca Degli; Clementi, Emilio

    2014-01-01

    Background Highly active antiretroviral therapy (HAART) has reduced morbidity and mortality in patients infected with human immunodeficiency virus (HIV). Studies have documented high interindividual variability in the pharmacokinetics of antiretroviral drugs, which may impair the success of HAART if not managed properly. Therapeutic drug monitoring (TDM) is a useful diagnostic tool that helps clinicians to optimize drug doses so that drug concentrations associated with the highest therapeutic efficacy are obtained with a reduced risk of concentration-dependent adverse effects. The aim of this study was to assess whether use of TDM improves clinical outcomes and cost of illness. Methods A retrospective cohort study was conducted at L Sacco University Hospital in Milan, Italy, in HIV-infected patients aged ≥18 years with at least one prescription of antiretroviral drugs for which TDM was applied. The inclusion period was from January 2010 to December 2011, with a follow-up period of up to 12 months. Laboratory and administrative databases were analyzed and matched with each other. Results The cohort consisted of 5,347 patients (3,861 males and 1,486 females) of mean age 43.9±12.5 years. We found that TDM had been used in 143 of these patients, among whom adherence with therapy was significantly higher than among those in whom TDM had not been used (94% versus 78%). In TDM-controlled patients, the mean length of HIV-related hospitalization stay and mean cost of hospitalization were significantly reduced with respect to those observed in the group in which TDM had not been used (7.21 days versus 29.47 days and €293 versus €688, respectively). Conclusion Inclusion of TDM as part of routine clinical optimization of drug dosing in HIV-infected patients is associated with higher adherence to therapy, reduced length of hospitalization stay, and reduced cost of illness. PMID:25053888

  9. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the Qatar cohort of the A1chieve study

    PubMed Central

    Daghash, Mohamed Hasan; Raja, Jabbar Mubarak; Milad, Mohamed

    2013-01-01

    Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Qatar. Results: A total of 91 patients were enrolled in the study. Two insulin analogue regimens were used in the study. Study patients had started on or were switched to biphasic insulin aspart (n = 88), insulin detemir (n = 2), and other insulin combinations (n = 1). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 10.9%) and insulin users (mean HbA1c: 9.1%) groups. After 24 weeks of treatment, all the study groups showed improvement in HbA1c (insulin naïve: −1.8%, insulin users: −1.3%). Major hypoglycaemia did not occur in the study patients. SADRs were reported in 1.4% of insulin users. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia. PMID:24404484

  10. Clinical outcome and bone healing of implants placed with high insertion torque: 12-month results from a multicenter controlled cohort study.

    PubMed

    Grandi, T; Guazzi, P; Samarani, R; Grandi, G

    2013-04-01

    This study evaluated the clinical outcome and the crestal bone resorption of implants placed with high insertion torque (up to 80 N cm). 102 patients were treated with 156 tapered implants. 42 implants (control group) presented insertion torque between 30 and 45 N cm (mean=37.4 SD 8.2). 114 implants (experimental group) were placed with insertion torque between 50 and 80 N cm (mean=74.8 SD 7.9). All implants were early loaded after 2 months. Peri-implant marginal bone levels were assessed immediately after surgery, and at 6- and 12-month follow up examinations. At the 12-month follow up all implants were clinically stable. After 12 months, patients in the experimental group lost an average of 0.41 mm (CI 95% 0.522; 0.263) of crestal bone compared with 0.45 mm (CI 95% 0.561; 0.286) for those in the control group. There were no significant differences between the two groups. No direct or inverse relationship was observed between the insertion torque values and crestal bone resorption. The results show that the use of high insertion torque (up to 80 N cm) did not prevent osseointegration and did not increase bone resorption around tapered implants early loaded up to 1 year after implant placement. PMID:23159169

  11. The epidemiological and clinical presentation of syphilis in a venereal disease centre in Paris, France. A cohort study of 284 consecutive cases over the period 2000-2007.

    PubMed

    FARHI, David; ZIZI, Nada; GRANGE, Philippe; BENHADDOU, Nadjet; GERHARDT, Philippe; AVRIL, Marie-Françoise; DUPIN, Nicolas

    2009-01-01

    Since 2000, the incidence of syphilis has risen in developed countries. An updated knowledge of syphilis features is the key for early diagnosis and treatment. Our objective was to appraise the clinical and epidemiological presentation of syphilis in Paris, France. A retrospective monocentric descriptive study of 284 consecutive syphilis cases was conducted in a venereal disease centre (Paris, France), over the period 2000-2007. Epidemiological, clinical and microbiological data were systematically collected, using standardized medical forms. Overall, 95% of the cases occurred in men (271/284), 83% in men having sex with men (MSM) (231/278), 58% in patients having more than 10 partners/year (138/240) and 19% in patients who never use a condom (49/253). At least one STD has been previously diagnosed in 79% (220/279) of the cases. In 50.5% of the cases (142/281), HIV serology was positive. Most patients had primary (82/279, 29%) or secondary (125/279, 45%) syphilis. The most frequent physical signs in primary and secondary syphilis were, respectively, a genital chancre (63/82, 77%) and a diffuse exanthema (108/125, 86%). Syphilis occurs chiefly in MSM, often in HIV-positive patients. Many patients never use condoms. These data will help provide the basis for the development of national information and screening campaigns. PMID:19703802

  12. Cohort Profile: Recruitment cohorts in the neuropsychological substudy of the Multicenter AIDS Cohort Study.

    PubMed

    Becker, James T; Kingsley, Lawrence A; Molsberry, Samantha; Reynolds, Sandra; Aronow, Aaron; Levine, Andrew J; Martin, Eileen; Miller, Eric N; Munro, Cynthia A; Ragin, Ann; Sacktor, Ned; Selnes, Ola A

    2015-10-01

    The Multicenter AIDS Cohort Study (MACS) is one of the largest and longest running studies of the natural and treated history of HIV disease. The Neuropsychological (NP) substudy was begun in 1988 following reports of significant adverse neurological consequences of HIV disease, including dementia. The goal was to characterize the neuropsychological deficits among individuals with HIV disease, and track the natural history of the neurological complications over time. There were three distinct MACS recruitment stages that focused on different groups of HIV-infected men, or men at risk for infection. Initially, a subcohort was evaluated semi-annually with NP tests but, beginning in 2005, the entire group of MACS participants have had NP examinations biannually, unless closer follow-up was warranted. The participants complete a battery of NP tests, and are classified as either normal, mildly or severely impaired using the Antinori criteria for HIV-Associated Neurocognitive Disorder (HAND). Additional behavioural data, including mood state and psychoactive substance use, are recorded as part of the main MACS data collection. The MACS public data set (PDS) has been available since 1994 and includes baseline and 6-monthly follow-up data. Beginning in October 1995, the PDS has been released annually with new releases superseding previous versions. PMID:24771276

  13. Using Semantic Web Technologies for Cohort Identification from Electronic Health Records for Clinical Research

    PubMed Central

    Pathak, Jyotishman; Kiefer, Richard C.; Chute, Christopher G.

    2012-01-01

    The ability to conduct genome-wide association studies (GWAS) has enabled new exploration of how genetic variations contribute to health and disease etiology. One of the key requirements to perform GWAS is the identification of subject cohorts with accurate classification of disease phenotypes. In this work, we study how emerging Semantic Web technologies can be applied in conjunction with clinical data stored in electronic health records (EHRs) to accurately identify subjects with specific diseases for inclusion in cohort studies. In particular, we demonstrate the role of using Resource Description Framework (RDF) for representing EHR data and enabling federated querying and inferencing via standardized Web protocols for identifying subjects with Diabetes Mellitus. Our study highlights the potential of using Web-scale data federation approaches to execute complex queries. PMID:22779040

  14. Using semantic web technologies for cohort identification from electronic health records for clinical research.

    PubMed

    Pathak, Jyotishman; Kiefer, Richard C; Chute, Christopher G

    2012-01-01

    The ability to conduct genome-wide association studies (GWAS) has enabled new exploration of how genetic variations contribute to health and disease etiology. One of the key requirements to perform GWAS is the identification of subject cohorts with accurate classification of disease phenotypes. In this work, we study how emerging Semantic Web technologies can be applied in conjunction with clinical data stored in electronic health records (EHRs) to accurately identify subjects with specific diseases for inclusion in cohort studies. In particular, we demonstrate the role of using Resource Description Framework (RDF) for representing EHR data and enabling federated querying and inferencing via standardized Web protocols for identifying subjects with Diabetes Mellitus. Our study highlights the potential of using Web-scale data federation approaches to execute complex queries. PMID:22779040

  15. Polymorphism in the IL4R gene and clinical features are associated with glioma prognosis: Analyses of case-cohort studies.

    PubMed

    Jin, Tian Bo; Du, Shuli; Zhu, Xi Kai; Li, Gang; Ouyang, Yongri; He, Na; Zhang, Zhiying; Zhang, Yuan; Kang, Longli; Yuan, Dongya

    2016-08-01

    Inflammatory gene polymorphisms may be associated with glioma risk. The purpose of this study was to analyze effects of certain inflammatory gene and some clinical factors on patient survival.The clinical information of 269 glioma patients conceived operation from September 2010 to May 2014 to decide the 1-, 3-year survival rates according to follow-up results and analyze age, gender, the WHO classification, extent of surgical resection, radiotherapy and chemotherapy factors effects on prognosis. Survival distributions were estimated by using the Kaplan-Meier method and difference in the survival was tested using the log-rank test. To estimate the association between the IL4, IL13, IL10, IL4R SNPs, and PFS and OS in glioma, the HR and 95% CI were calculated by univariate Cox proportional hazards model. Multivariate Cox model were performed to compute adjusted HR and 95% CI. All data was analyzed with SPSS17.0 package. Extent of surgical resection, chemotherapy, and age are an important factor in glioma overall survival and progression-free survival overall. Extent of surgery and chemotherapy are important factors in astrocytoma overall survival. Univariate analysis showed that IL4R rs1801275 was significantly associated with overall survival of glioma and astrocytoma patients (P < 0.05). Multivariate Cox regression analysis showed that IL4R rs1801275 GG genotype could increase the death risk of glioma and astrocytoma patients (Glioma: hazard ratio [HR]: 4.897, 95% confidence limits [95% CI]: 1.962-12.222, P = 0.001; Astrocytoma: HR: 15.944, 95% CI: 4.019-63.253, P < 0.05).Our research results showed that extent of surgical resection, age, and chemotherapy affect the prognosis of glioma. The IL4R gene may affect the survival of glioma patients. PMID:27495027

  16. Cohort study of atypical pressure ulcers development.

    PubMed

    Jaul, Efraim

    2014-12-01

    Atypical pressure ulcers (APU) are distinguished from common pressure ulcers (PU) with both unusual location and different aetiology. The occurrence and attempts to characterise APU remain unrecognised. The purpose of this cohort study was to analyse the occurrence of atypical location and the circumstances of the causation, and draw attention to the prevention and treatment by a multidisciplinary team. The cohort study spanned three and a half years totalling 174 patients. The unit incorporates two weekly combined staff meetings. One concentrates on wound assessment with treatment decisions made by the physician and nurse, and the other, a multidisciplinary team reviewing all patients and coordinating treatment. The main finding of this study identified APU occurrence rate of 21% within acquired PU over a three and a half year period. Severe spasticity constituted the largest group in this study and the most difficult to cure wounds, located in medial aspects of knees, elbows and palms. Medical devices caused the second largest occurrence of atypical wounds, located in the nape of the neck, penis and nostrils. Bony deformities were the third recognisable atypical wound group located in shoulder blades and upper spine. These three categories are definable and time observable. APU are important to be recognisable, and can be healed as well as being prevented. The prominent role of the multidisciplinary team is primary in identification, prevention and treatment. PMID:23374746

  17. Cohort Profile: The Manitoba Follow-up Study (MFUS).

    PubMed

    Tate, Robert B; Cuddy, T Edward; Mathewson, Francis A L

    2015-10-01

    The Manitoba Follow-up Study (MFUS) is Canada's longest running study of cardiovascular disease and ageing. The MFUS cohort consists of 3983 men recruited from the Royal Canadian Air Force at the end of World War II. At entry to the study, 1 July 1948, their mean age was 31 years, with 90% between ages 20 and 39 years. All study members were free of clinical evidence of ischaemic heart disease. The protocol of MFUS was to obtain routine medical examinations from these men at regular intervals over time. The research goal of the study was to examine the role that any abnormalities detected on routine electrocardiograms from apparently healthy men might play in the prediction of subsequent diagnoses of cardiovascular disease. Over the course of 65 years, about 35% of the cohort has documented evidence of ischaemic heart disease. The research focus was expanded in 1996 to explore the roles of physical, mental and social functioning in support of healthy and successful ageing. On 1 July 2013, 429 original cohort members were alive with a mean age of 92 years. Collaborative research with others outside the in-house team is welcomed. PMID:25064641

  18. Inferior cerebellar hypoplasia resembling a Dandy-Walker-like malformation in purebred Eurasier dogs with familial non-progressive ataxia: a retrospective and prospective clinical cohort study.

    PubMed

    Bernardino, Filipa; Rentmeister, Kai; Schmidt, Martin J; Bruehschwein, Andreas; Matiasek, Kaspar; Matiasek, Lara A; Lauda, Alexander; Schoon, Heinz A; Fischer, Andrea

    2015-01-01

    Cerebellar malformations can be inherited or caused by insults during cerebellar development. To date, only sporadic cases of cerebellar malformations have been reported in dogs, and the genetic background has remained obscure. Therefore, this study`s objective was to describe the clinical characteristics, imaging features and pedigree data of a familial cerebellar hypoplasia in purebred Eurasier dogs. A uniform cerebellar malformation characterized by consistent absence of the caudal portions of the cerebellar vermis and, to a lesser degree, the caudal portions of the cerebellar hemispheres in association with large retrocerebellar fluid accumulations was recognized in 14 closely related Eurasier dogs. Hydrocephalus was an additional feature in some dogs. All dogs displayed non-progressive ataxia, which had already been noted when the dogs were 5-6 weeks old. The severity of the ataxia varied between dogs, from mild truncal sway, subtle dysmetric gait, dysequilibrium and pelvic limb ataxia to severe cerebellar ataxia in puppies and episodic falling or rolling. Follow-up examinations in adult dogs showed improvement of the cerebellar ataxia and a still absent menace response. Epileptic seizures occurred in some dogs. The association of partial vermis agenesis with an enlarged fourth ventricle and an enlarged caudal (posterior) fossa resembled a Dandy-Walker-like malformation in some dogs. Pedigree analyses were consistent with autosomal recessive inheritance. PMID:25668516

  19. Biopsychosocial influence on shoulder pain: risk subgroups translated across preclinical and clinical prospective cohorts.

    PubMed

    George, Steven Z; Wallace, Margaret R; Wu, Samuel S; Moser, Michael W; Wright, Thomas W; Farmer, Kevin W; Borsa, Paul A; Parr, Jeffrey J; Greenfield, Warren H; Dai, Yunfeng; Li, Hua; Fillingim, Roger B

    2015-01-01

    Tailored treatment based on individual risk factors is an area with promise to improve options for pain relief. Musculoskeletal pain has a biopsychosocial nature, and multiple factors should be considered when determining risk for chronic pain. This study investigated whether subgroups comprised genetic and psychological factors predicted outcomes in preclinical and clinical models of shoulder pain. Classification and regression tree analysis was performed for an exercise-induced shoulder injury cohort (n = 190) to identify high-risk subgroups, and a surgical pain cohort (n = 150) was used for risk validation. Questionnaires for fear of pain and pain catastrophizing were administered before injury and preoperatively. DNA collected from saliva was genotyped for a priori selected genes involved with pain modulation (COMT and AVPR1A) and inflammation (IL1B and TNF/LTA). Recovery was operationalized as a brief pain inventory rating of 0/10 for current pain intensity and <2/10 for worst pain intensity. Follow-up for the preclinical cohort was in daily increments, whereas follow-up for the clinical cohort was at 3, 6, and 12 months postoperatively. Risk subgroups comprised the COMT high pain sensitivity variant and either pain catastrophizing or fear of pain were predictive of heightened shoulder pain responses in the preclinical model. Further analysis in the clinical model identified the COMT high pain sensitivity variant and pain catastrophizing subgroup as the better predictor. Future studies will determine whether these findings can be replicated in other anatomical regions and whether personalized medicine strategies can be developed for this risk subgroup. PMID:25599310

  20. Identifying Prognostic SNPs in Clinical Cohorts: Complementing Univariate Analyses by Resampling and Multivariable Modeling

    PubMed Central

    Hieke, Stefanie; Benner, Axel; Schlenk, Richard F.; Schumacher, Martin; Bullinger, Lars; Binder, Harald

    2016-01-01

    Clinical cohorts with time-to-event endpoints are increasingly characterized by measurements of a number of single nucleotide polymorphisms that is by a magnitude larger than the number of measurements typically considered at the gene level. At the same time, the size of clinical cohorts often is still limited, calling for novel analysis strategies for identifying potentially prognostic SNPs that can help to better characterize disease processes. We propose such a strategy, drawing on univariate testing ideas from epidemiological case-controls studies on the one hand, and multivariable regression techniques as developed for gene expression data on the other hand. In particular, we focus on stable selection of a small set of SNPs and corresponding genes for subsequent validation. For univariate analysis, a permutation-based approach is proposed to test at the gene level. We use regularized multivariable regression models for considering all SNPs simultaneously and selecting a small set of potentially important prognostic SNPs. Stability is judged according to resampling inclusion frequencies for both the univariate and the multivariable approach. The overall strategy is illustrated with data from a cohort of acute myeloid leukemia patients and explored in a simulation study. The multivariable approach is seen to automatically focus on a smaller set of SNPs compared to the univariate approach, roughly in line with blocks of correlated SNPs. This more targeted extraction of SNPs results in more stable selection at the SNP as well as at the gene level. Thus, the multivariable regression approach with resampling provides a perspective in the proposed analysis strategy for SNP data in clinical cohorts highlighting what can be added by regularized regression techniques compared to univariate analyses. PMID:27159447

  1. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study.

    PubMed

    Friedel, Walter E; Matthes, Harald; Bock, Paul R; Zänker, Kurt S

    2009-01-01

    In Europe, patients with colorectal carcinoma (CRC) frequently receive mistletoe extracts to improve quality of life and survival. This study was designed to evaluate supportive treatment with mistletoe extract Iscador (ISC) in nonmetastatic CRC patients under routine clinical conditions and to create well-founded hypotheses for future prospective clinical studies. The design of a multicenter, controlled, retrospective, observational cohort study with parallel groups met the Good Epidemiological Practice rules. Anonymous unselected standardized data from eligible patients with surgically treated stage I-III CRC and adjuvant therapy (AT) or conventional aftercare were included. End points were adjuvant therapy-related adverse reactions (AT-ADRs), symptoms, and disease-free survival (DFS). The results were adjusted for confounder effects. Eight hundred four (429 ISC vs 375 control) CRC patients from 26 centers were observed for a median of 58 versus 51 months; the median ISC therapy lasted 52 months. ISC patients showed fewer AT-ADRs (19% vs 48%, p < .001) and fewer persisting symptoms (p < .001). The DFS hazard ratio of 0.60 (p = .013) suggests a survival benefit in ISC patients versus controls. ISC was well tolerated without life-threatening ADRs, drug interactions, or tumor enhancement. These results suggest a beneficial effect of supportive care ISC therapy within AT protocols and long-term ISC treatment in stage I-III CRC patients, particularly improvement in AT-ADRs and symptoms and possible extension of DFS. PMID:19883529

  2. Cerebral palsy in two national cohort studies.

    PubMed

    Emond, A; Golding, J; Peckham, C

    1989-06-01

    The prevalence of cerebral palsy in the 1958 British Perinatal Mortality Survey and the 1970 British Births Survey remained constant at 2.5/1000 births (40 and 41 cases, respectively). The prevalence at 10 years was higher in the 1970 cohort in which all children with cerebral palsy survived, whereas 22% of the cases in the 1958 cohort died during the first 10 years of life. A case-control study matched three controls for social class, maternal age, parity and marital state, and a further three controls for the infant's sex, gestation, and birth weight. Comparison of cases and controls showed no consistent differences in social and environmental factors, history of pregnancy, labour, or delivery. Important differences were found in the incidence of respiratory and neurological symptoms in the neonatal period. These prospective data derived form two whole populations of births support the hypothesis that most cases of cerebral palsy are not associated with adverse obstetric factors, and confirm that neonatal neurological symptoms are associated with subsequent cerebral palsy. PMID:2774617

  3. Challenges in translating endpoints from trials to observational cohort studies in oncology

    PubMed Central

    Ording, Anne Gulbech; Cronin-Fenton, Deirdre; Ehrenstein, Vera; Lash, Timothy L; Acquavella, John; Rørth, Mikael; Sørensen, Henrik Toft

    2016-01-01

    Clinical trials are considered the gold standard for examining drug efficacy and for approval of new drugs. Medical databases and population surveillance registries are valuable resources for post-approval observational research, which are increasingly used in studies of benefits and risk of new cancer drugs. Here, we address the challenges in translating endpoints from oncology trials to observational studies. Registry-based cohort studies can investigate real-world safety issues – including previously unrecognized concerns – by examining rare endpoints or multiple endpoints at once. In contrast to clinical trials, observational cohort studies typically do not exclude real-world patients from clinical practice, such as old and frail patients with comorbidity. The observational cohort study complements the clinical trial by examining the effectiveness of interventions applied in clinical practice and by providing evidence on long-term clinical outcomes, which are often not feasible to study in a clinical trial. Various endpoints can be included in clinical trials, such as hard endpoints, soft endpoints, surrogate endpoints, and patient-reported endpoints. Each endpoint has it strengths and limitations for use in research studies. Endpoints used in oncology trials are often not applicable in observational cohort studies which are limited by the setting of standard clinical practice and by non-standardized endpoint determination. Observational studies can be more helpful moving research forward if they restrict focus to appropriate and valid endpoints. PMID:27354827

  4. Contrasting clinical outcomes in two cohorts of cats naturally infected with feline immunodeficiency virus (FIV)

    PubMed Central

    Bęczkowski, Paweł M.; Litster, Annette; Lin, Tsang Long; Mellor, Dominic J.; Willett, Brian J.; Hosie, Margaret J.

    2015-01-01

    Despite over 25 years of feline immunodeficiency virus (FIV) research, relatively little is known about the longitudinal course of FIV infection following natural infection. In contrast to published reports of experimental infections using lethal strains of the virus, clinical signs of naturally acquired FIV infection can be mild or inapparent, rather than life-threatening. In this prospective, longitudinal controlled study, based in Chicago, IL (n = 17) and Memphis, TN (n = 27), we investigated two cohorts of privately owned, naturally infected cats kept under different housing conditions. Cats in the Chicago cohort (Group 1) were kept in households of ≤2 cats, while the Memphis cohort (Group 2) comprised part of a large multi-cat household of over 60 cats kept indoors only, with unrestricted access to one another. The majority of cats from Group 1 did not display clinical signs consistent with immunodeficiency during the 22-month observation period. In contrast, the outcome of infection in Group 2 was dramatically different; 17/27 (63%) of cats lost a median of 51.3% of their bodyweight (P < 0.0005) and died during the study period, with lymphoma being the most common cause of mortality. Although the decrease in CD4+ T cell count between enrolment and terminal disease was significant (P = 0.0017), the CD4:CD8 ratio at the time of enrolment did not reliably distinguish FIV-positive cats classified as ‘healthy’ and ‘not healthy’ at either cohort. FIV load at enrolment was significantly lower in Group 1 than in Group 2 (P < 0.0001), but there were no significant differences at enrolment between healthy and not healthy cats at either group. In conclusion, the results of this study suggest that management and housing conditions impact on disease progression and survival times of FIV-positive cats. PMID:25595267

  5. Clinical and endoscopic characteristics do not reliably differentiate PPI-responsive esophageal eosinophilia and eosinophilic esophagitis in patients undergoing upper endoscopy: A Prospective Cohort Study

    PubMed Central

    Dellon, Evan S.; Speck, Olga; Woodward, Kimberly; Gebhart, Jessica H.; Madanick, Ryan D.; Levinson, Sidney; Fritchie, Karen J.; Woosley, John T.; Shaheen, Nicholas J.

    2015-01-01

    Objectives Proton pump inhibitor-responsive esophageal eosinophilia (PPI-REE) is a newly recognized entity that must be differentiated from eosinophilic esophagitis (EoE). Little is known about this condition. We aimed to determine the prevalence of PPI-REE and EoE in patients undergoing upper endoscopy, and determine features that distinguish the two groups. Methods This prospective study conducted at University of North Carolina from 2009–2011 enrolled consecutive adult patients undergoing outpatient upper endoscopy. Subjects had esophageal biopsies to quantify the maximum eosinophil count per high-powered field (eos/hpf; hpf = 0.24mm2). If biopsies revealed ≥15 eos/hpf, subjects were treated with twice daily PPI for 8 weeks and endoscopy was repeated. If ≥15 eos/hpf persisted despite PPI therapy, EoE was diagnosed. If there were <15 eos/hpf, PPI-REE was diagnosed. The proportion of patients in each group was calculated, and patients with EoE and PPI-REE were compared. Results Of the 223 subjects enrolled, 173 had dysphagia and 50 did not. Of those with dysphagia, 66 (38%) had ≥15 eos/hpf. After the PPI trial, 40 (23%) were confirmed to have EoE, and 24 (14%) had PPI-REE. Of those without dysphagia, 2 (4%) had ≥15 eos/hpf and after the PPI trial, 1 (2%) had EoE. Compared with EoE, PPI-REE patients were more likely to be older and male, and less likely to have typical endoscopic findings of EoE. However, none of the individual factors was independently predictive of PPI-REE status on multivariable analysis. Similarly, while some endoscopic findings were differentially distributed between PPI-REE and EoE, none were significantly associated with disease status on multivariable analysis. Conclusions Esophageal eosinophilia is common among patients undergoing EGD for dysphagia. While EoE was seen in nearly a quarter of patients with dysphagia, PPI-REE was almost as common, and accounted for over one-third of those with ≥15 eos/hpf. No clinical or

  6. Cohort profile: the Spanish WORKing life Social Security (WORKss) cohort study

    PubMed Central

    López Gómez, María Andrée; Durán, Xavier; Zaballa, Elena; Sanchez-Niubo, Albert; Delclos, George L; Benavides, Fernando G

    2016-01-01

    Purpose The global economy is changing the labour market and social protection systems in Europe. The effect of both changes on health needs to be monitored in view of an ageing population and the resulting increase in prevalence of chronic health conditions. The Spanish WORKing life Social Security (WORKss) cohort study provides unique longitudinal data to study the impact of labour trajectories and employment conditions on health, in terms of sickness absence, permanent disability and death. Participants The WORKss cohort originated from the Continuous Working Life Sample (CWLS) generated by the General Directorate for the Organization of the Social Security in Spain. The CWLS contains a 4% representative sample of all individuals in contact with the Social Security system. The WORKss cohort exclusively includes individuals with a labour trajectory from 1981 or later. In 2004, the cohort was initiated with 1 022 779 Social Security members: 840 770 (82.2%) contributors and 182 009 (17.8%) beneficiaries aged 16 and older. Findings to date The WORKss cohort includes demographic characteristics, chronological data about employment history, retirement, permanent disability and death. These data make possible the measurement of incidence of permanent disability, the number of potential years of working life lost, and the number of contracts and inactive periods with the Social Security system. The WORKss cohort was linked to temporary sickness absence registries to study medical diagnoses that lead to permanent disability and consequently to an earlier exit from the labour market in unhealthy conditions. Future plans Thanks to its administrative source, the WORKss cohort study will continue follow-up in the coming years, keeping the representativeness of the Spanish population affiliated to the Social Security system. The linkage between the WORKss cohort and temporary sickness absence registries is envisioned to continue. Future plans include the linkage of

  7. Statins and congenital malformations: cohort study

    PubMed Central

    Hernandez-Diaz, Sonia; Fischer, Michael A; Seely, Ellen W; Ecker, Jeffrey L; Franklin, Jessica M; Desai, Rishi J; Allen-Coleman, Cora; Mogun, Helen; Avorn, Jerry; Huybrechts, Krista F

    2015-01-01

    Objective To examine the teratogenic potential of statins. Design Cohort study. Setting United States. Participants A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007. Methods We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs. Results 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses. Conclusions Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe. PMID:25784688

  8. A Clinical Scoring Algorithm for Determination of the Risk of Tuberculosis in HIV-Infected Adults: A Cohort Study Performed at Ethiopian Health Centers

    PubMed Central

    Balcha, T. T.; Skogmar, S.; Sturegård, E.; Schön, T.; Winqvist, N.; Reepalu, A.; Jemal, Z. H.; Tibesso, G.; Björk, J.; Björkman, P.

    2014-01-01

    Background  The World Health Organization (WHO) tuberculosis (TB) symptom screening instrument (WHO-TB) can identify human immunodeficiency virus (HIV)-infected individuals at low risk of tuberculosis (TB); however, many patients report WHO-TB symptoms and require further TB investigations. We hypothesized that further clinical scoring could classify subjects with a positive WHO-TB screening result (WHO-TB+) for the likelihood of TB. Methods  HIV-infected adults eligible to initiate antiretroviral therapy (ART) were recruited and prospectively followed at 5 Ethiopian health centers. Irrespective of symptoms, all participants underwent sputum bacteriological testing for TB. Symptoms, physical findings, hemoglobin, and CD4 cell count results were compared between subjects with and those without bacteriologically confirmed TB. Variables associated with TB in WHO-TB+ individuals were used to construct a scoring algorithm with multiple logistic regression analysis. Results  Among 812 participants, 137 (16.9%) had TB. One hundred fifty-nine persons (20%) had a negative WHO-TB screen, 10 of whom had TB (negative predictive value [NPV], 94% [95% confidence interval {CI}, 90%–97.5%]). For WHO-TB+ subjects, the following variables were independently associated with TB, and were assigned 1 point each in the clinical scoring algorithm: cough, Karnofsky score ≤80, mid-upper arm circumference <20 cm, lymphadenopathy, and hemoglobin <10 g/dL. Among subjects with 0–1 points, 20 of 255 had TB (NPV, 92% [95% CI, 89%–95%]), vs 19 of 34 participants with ≥4 points (positive predictive value, 56% [95% CI, 39%–73%]). The use of WHO-TB alone identified 159 of 784 (20%) with a low risk of TB, vs 414 of 784 (53%) using WHO-TB followed by clinical scoring (P< .001). The difference in proportions of confirmed TB in these subsets was nonsignificant (6.3% vs 7.2%; P= .69). Conclusions  Clinical scoring can further classify HIV-infected adults with positive WHO-TB screen to

  9. [The benefit of large-scale cohort studies for health research: the example of the German National Cohort].

    PubMed

    Ahrens, Wolfgang; Jöckel, K-H

    2015-08-01

    The prospective nature of large-scale epidemiological multi-purpose cohort studies with long observation periods facilitates the search for complex causes of diseases, the analysis of the natural history of diseases and the identification of novel pre-clinical markers of disease. The German National Cohort (GNC) is a population-based, highly standardised and in-depth phenotyped cohort. It shall create the basis for new strategies for risk assessment and identification, early diagnosis and prevention of multifactorial diseases. The GNC is the largest population-based cohort study in Germany to date. In the year 2014 the examination of 200,000 women and men aged 20-69 years started in 18 study centers. The study facilitates the investigation of the etiology of chronic diseases in relation to lifestyle, genetic, socioeconomic, psychosocial and environmental factors. By this the GNC creates the basis for the development of methods for early diagnosis and prevention of these diseases. Cardiovascular and respiratory diseases, cancer, diabetes, neurodegenerative/-psychiatric diseases, musculoskeletal and infectious diseases are in focus of this study. Due to its mere size, the study could be characterized as a Big Data project. We deduce that this is not the case. PMID:26077870

  10. Increased Acquired Cholesteatoma Risk in Patients with Osteoporosis: A Retrospective Cohort Study

    PubMed Central

    Wang, Tang-Chuan; Lin, Che-Chen; Lin, Chia-Der; Chung, Hsiung-Kwang; Wang, Ching-Yuang; Tsai, Ming-Hsui; Kao, Chia-Hung

    2015-01-01

    Objective Clinically, we found the increased incidence of acquired colesteatoma in the patients with osteoporosis. In this study, we used a retrospective cohort to examine this association and to investigate the possible mechanism. Methods We conducted a population-based retrospective cohort study by using the National Health Insurance Research Database (NHIRD). We identified an osteoporosis cohort comprising 37 124 patients newly diagnosed with osteoporosis aged 20 years or older. Patients in the comparison cohort had no history of osteoporosis and were frequency matched with the patients in the osteoporosis cohort according to sex, age, and index year. Results The acquired cholesteatoma incidence rates for the osteoporosis and comparison cohorts were 1.12 and 0.83 per 1000 person-years, respectively. After we adjusted for confounding factors, the osteoporosis cohort exhibited a 1.32-fold increased acquired cholesteatoma risk relative to the comparison cohort (hazard ratio [HR] = 1.32, 95% confidence interval [CI] = 1.11–1.57). In addition, patients with no history of otitis media (HR = 1.33, 95% CI = 1.11–1.59), cancer (HR = 1.34, 95% CI = 1.12–1.60), or COPD (HR = 1.26, 95% CI = 1.05–1.52) in the osteoporosis cohort exhibited an increased risk of subsequent acquired cholesteatoma relative to those in the comparison cohort. Conclusions Our cohort study indicated that patients with osteoporosis had a 1.31-fold increased acquired cholesteatoma risk relative to the comparison cohort. This risk was further increased in patients with comorbid otitis media. Hence, we recommend that otolaryngologists evaluate the condition of the middle ear of patients with osteoporosis. PMID:26171780

  11. Study design of DIACORE (DIAbetes COhoRtE) – a cohort study of patients with diabetes mellitus type 2

    PubMed Central

    2013-01-01

    Background Diabetes mellitus type 2 (DM2) is highly associated with increased risk for chronic kidney disease (CKD), end stage renal disease (ESRD) and cardiovascular morbidity. Epidemiological and genetic studies generate hypotheses for innovative strategies in DM2 management by unravelling novel mechanisms of diabetes complications, which is essential for future intervention trials. We have thus initiated the DIAbetes COhoRtE study (DIACORE). Methods DIACORE is a prospective cohort study aiming to recruit 6000 patients of self-reported Caucasian ethnicity with prevalent DM2 for at least 10 years of follow-up. Study visits are performed in University-based recruiting clinics in Germany using standard operating procedures. All prevalent DM2 patients in outpatient clinics surrounding the recruiting centers are invited to participate. At baseline and at each 2-year follow-up examination, patients are subjected to a core phenotyping protocol. This includes a standardized online questionnaire and physical examination to determine incident micro- and macrovascular DM2 complications, malignancy and hospitalization, with a primary focus on renal events. Confirmatory outcome information is requested from patient records. Blood samples are obtained for a centrally analyzed standard laboratory panel and for biobanking of aliquots of serum, plasma, urine, mRNA and DNA for future scientific use. A subset of the cohort is subjected to extended phenotyping, e.g. sleep apnea screening, skin autofluorescence measurement, non-mydriatic retinal photography and non-invasive determination of arterial stiffness. Discussion DIACORE will enable the prospective evaluation of factors involved in DM2 complication pathogenesis using high-throughput technologies in biosamples and genetic epidemiological studies. PMID:23409726

  12. Oral presentation bias: a retrospective cohort study.

    PubMed

    Decullier, Evelyne; Chapuis, François

    2007-03-01

    The aim of this paper was to assess oral presentation bias at a national level. This was a retrospective cohort study with initial characteristics of the approved protocols extracted from the committee's archives, and follow-up characteristics obtained from a questionnaire mailed to the principal investigators. A representative sample of French research ethics committees (25/48), the only committees legally endorsed for ethical authorisation in biomedical research, were studied. All completed research protocols, which had been approved in 1994 by these committees, were included. Initial characteristics (design, study size, investigator) of completed studies and follow-up information (direction of results, rates of publication and rates of oral presentation) were collected. Complete information on results and their dissemination was available for 248 completed non-confidential protocols. Half of these (49%) were declared as orally presented. The observed ranking for strategies to disseminate results was the following: orally presented and published, published only, neither orally presented nor published and orally presented only. Confirmatory results were more often orally presented, with an adjusted OR of 6.4 (95% CI 2.69 to 15.22). Other associated variables are the following: national/international scope of the study, protocol writer's university status, adverse events and interim analysis. There is a trend to submit or accept confirmatory results for oral presentations: meetings are a biased representation of research, and oral presentation bias could even be higher than publication bias. PMID:17325393

  13. Diagnostic Intervals and Its Association with Breast, Prostate, Lung and Colorectal Cancer Survival in England: Historical Cohort Study Using the Clinical Practice Research Datalink

    PubMed Central

    Redaniel, Maria Theresa; Martin, Richard M.; Ridd, Matthew J.; Wade, Julia; Jeffreys, Mona

    2015-01-01

    Rapid diagnostic pathways for cancer have been implemented, but evidence whether shorter diagnostic intervals (time from primary care presentation to diagnosis) improves survival is lacking. Using the Clinical Practice Research Datalink, we identified patients diagnosed with female breast (8,639), colorectal (5,912), lung (5,737) and prostate (1,763) cancers between 1998 and 2009, and aged >15 years. Presenting symptoms were classified as alert or non-alert, according to National Institute for Health and Care Excellence guidance. We used relative survival and excess risk modeling to determine associations between diagnostic intervals and five-year survival. The survival of patients with colorectal, lung and prostate cancer was greater in those with alert, compared with non-alert, symptoms, but findings were opposite for breast cancer. Longer diagnostic intervals were associated with lower mortality for colorectal and lung cancer patients with non-alert symptoms, (colorectal cancer: Excess Hazards Ratio, EHR >6 months vs <1 month: 0.85; 95% CI: 0.72-1.00; Lung cancer: EHR 3-6 months vs <1 month: 0.87; 95% CI: 0.80-0.95; EHR >6 months vs <1 month: 0.81; 95% CI: 0.74-0.89). Prostate cancer mortality was lower in patients with longer diagnostic intervals, regardless of type of presenting symptom. The association between diagnostic intervals and cancer survival is complex, and should take into account cancer site, tumour biology and clinical practice. Nevertheless, unnecessary delay causes patient anxiety and general practitioners should continue to refer patients with alert symptoms via the cancer pathways, and actively follow-up patients with non-alert symptoms in the community. PMID:25933397

  14. From plans to actions in patient and public involvement: qualitative study of documented plans and the accounts of researchers and patients sampled from a cohort of clinical trials

    PubMed Central

    Buck, Deborah; Gamble, Carrol; Dudley, Louise; Preston, Jennifer; Hanley, Bec; Williamson, Paula R; Young, Bridget

    2014-01-01

    Patient and public involvement (PPI) in research is increasingly required, although evidence to inform its implementation is limited. Objective Inform the evidence base by describing how plans for PPI were implemented within clinical trials and identifying the challenges and lessons learnt by research teams. Methods We compared PPI plans extracted from clinical trial grant applications (funded by the National Institute for Health Research Health Technology Assessment Programme between 2006 and 2010) with researchers’ and PPI contributors’ interview accounts of PPI implementation. Analysis of PPI plans and transcribed qualitative interviews drew on the Framework technique. Results Of 28 trials, 25 documented plans for PPI in funding applications and half described implementing PPI before applying for funding. Plans varied from minimal to extensive, although almost all anticipated multiple modes of PPI. Interview accounts indicated that PPI plans had been fully implemented in 20/25 trials and even expanded in some. Nevertheless, some researchers described PPI within their trials as tokenistic. Researchers and contributors noted that late or minimal PPI engagement diminished its value. Both groups perceived uncertainty about roles in relation to PPI, and noted contributors’ lack of confidence and difficulties attending meetings. PPI contributors experienced problems in interacting with researchers and understanding technical language. Researchers reported difficulties finding ‘the right’ PPI contributors, and advised caution when involving investigators’ current patients. Conclusions Engaging PPI contributors early and ensuring ongoing clarity about their activities, roles and goals, is crucial to PPI's success. Funders, reviewers and regulators should recognise the value of preapplication PPI and allocate further resources to it. They should also consider whether PPI plans in grant applications match a trial's distinct needs. Monitoring and reporting PPI

  15. Are there long-term benefits of experiential, interprofessional education for non-specialists on clinical behaviours and outcomes in diabetes care? A cohort study

    PubMed Central

    Ching, Daniel; Forte, Denise; Aitchison, Elizabeth; Earle, Kenneth

    2016-01-01

    Objectives Our aim was to assess the impact of an educational initiative for non-specialist, healthcare professionals in the community on the process and quality measures of diabetes care delivered, and changes in their learning experiences and clinical management behaviour in the short and long term. Setting Single locality of 26 primary care practices associated with one secondary centre. Participants General practitioners and practice nurses managing 4167 patients with diabetes. Intervention A rolling 10-week, experiential, interprofessional education programme delivered to 57 practitioners and observations in practice. Primary and secondary outcome measures Primary outcomes were changes in the proportion of patients receiving foot care, urine albumin:creatinine ratio assessments and achieving National Quality Outcome Framework targets for blood pressure (<145/80 mm Hg), glycated haemoglobin (HbA1c; >86 mmol/mol (10%) and <57.4 mmol/mol (7.4%)) and total cholesterol (<5 mmol/L) thresholds. Secondary outcomes were evidence of sustained learning and changes in the number of patients referred to secondary care. Results Evaluation of care processes and quality outcomes took place 15 months after the programme was initiated. The proportion of patients with a HbA1c of <57.4 mmol/mol (7.4%) and >85 mmol/mol (10%) was significantly higher (44% vs 53% p=0.0001) and lower (12.5% vs 10%; p=0.002) respectively. There was an increase in the proportion (95% CI) of patients receiving foot care reviews (+26.0% (24.0% to 28.1%)), microalbuminuria screening (+29.8% (27.7% to 31.9%)) and who achieved targets for blood pressure (+9.6% (7.5% to 11.6%)) and total cholesterol (+14.4% (12.3% to 16.5%); p<0.001). 241 fewer patients were referred to secondary care. Increases in the healthcare professional's confidence and collaborative clinical behaviour were evident 3 years after completing the programme. Conclusions An experiential, interprofessional intervention can

  16. The impact of cannabis use on age of onset and clinical characteristics in first-episode psychotic patients. Data from the Psychosis Incident Cohort Outcome Study (PICOS).

    PubMed

    Tosato, Sarah; Lasalvia, Antonio; Bonetto, Chiara; Mazzoncini, Rodolfo; Cristofalo, Doriana; De Santi, Katia; Bertani, Mariaelena; Bissoli, Sarah; Lazzarotto, Lorenza; Marrella, Giovanna; Lamonaca, Dario; Riolo, Rosanna; Gardellin, Francesco; Urbani, Anna; Tansella, Michele; Ruggeri, Mirella

    2013-04-01

    Cannabis use is frequent among first-episode psychosis (FEP) patients and has been associated with several clinical features. This study aimed in an FEP sample to determine whether cannabis use is associated with (1) a higher level of positive symptoms, a lower level of depression and a better premorbid adjustment, (2) an earlier age of onset, and a better premorbid IQ. The study was conducted within the framework of the Psychosis Incident Cohort Outcome Study (PICOS), a multisite collaborative research on FEP patients who attended the psychiatric services in Veneto Region, Italy. Standardized instruments were used to collect sociodemographic, clinical, and drug use data. A total of 555 FEP patients met the inclusion criteria, 517 of whom received an ICD-10 diagnosis of psychosis; 397 (55% males; mean age: 32 yrs ± 9.5) were assessed. Out of these, 311 patients agreed to be interviewed on drug and alcohol misuse; 20.3% was positive for drug misuse: cannabis (19.0%), cocaine (3.9%), and hallucinogens (3.9%). Cannabis use was not associated with a higher level of positive symptoms, but correlated with less severe depressive symptoms. No relationship was observed between premorbid adjustment or IQ and cannabis use. FEP patients who used cannabis had an earlier age of onset than abstinent patients, even after adjusting for gender and diagnosis. Our results suggest a possible causal role of cannabis in triggering psychosis in certain vulnerable subjects. Particular attention must be paid to this behaviour, because reducing cannabis use can delay or prevent some cases of psychosis. PMID:23290558

  17. Clinical predictors of antipsychotic use in children and adolescents with autism spectrum disorders: a historical open cohort study using electronic health records.

    PubMed

    Downs, Johnny; Hotopf, Matthew; Ford, Tamsin; Simonoff, Emily; Jackson, Richard G; Shetty, Hitesh; Stewart, Robert; Hayes, Richard D

    2016-06-01

    Children with autism spectrum disorders (ASD) are more likely to receive antipsychotics than any other psychopharmacological medication, yet the psychiatric disorders and symptoms associated with treatment are unclear. We aimed to determine the predictors of antipsychotic use in children with ASD receiving psychiatric care. The sample consisted of 3482 children aged 3-17 with an ICD-10 diagnosis of ASD referred to mental health services between 2008 and 2013. Antipsychotic use outcome, comorbid diagnoses, and other clinical covariates, including challenging behaviours were extracted from anonymised patient records. Of the 3482 children (79 % male) with ASD, 348 (10 %) received antipsychotic medication. The fully adjusted model indicated that comorbid diagnoses including hyperkinetic (OR 1.44, 95 %CI 1.01-2.06), psychotic (5.71, 3.3-10.6), depressive (2.36, 1.37-4.09), obsessive-compulsive (2.31, 1.16-4.61) and tic disorders (2.76, 1.09-6.95) were associated with antipsychotic use. In addition, clinician-rated levels of aggression, self-injurious behaviours, reduced adaptive function, and overall parental concern for their child's presenting symptoms were significant risk factors for later antipsychotic use. In ASD, a number of comorbid psychiatric disorders are independent predictors for antipsychotic treatment, even after adjustment for familial, socio-demographic and individual factors. As current trial evidence excludes children with comorbidity, more pragmatic randomised controlled trials with long-term drug monitoring are needed. PMID:26472118

  18. Global teaching and training initiatives for emerging cohort studies.

    PubMed

    Paulus, Jessica K; Santoyo-Vistrain, Rocío; Havelick, David; Cohen, Amy; Kalyesubula, Robert; Ajayi, Ikeoluwapo O; Mattsson, Jens G; Adami, Hans-Olov; Dalal, Shona

    2012-09-01

    A striking disparity exists across the globe, with essentially no large-scale longitudinal studies ongoing in regions that will be significantly affected by the oncoming non-communicable disease epidemic. The successful implementation of cohort studies in most low-resource research environments presents unique challenges that may be aided by coordinated training programs. Leaders of emerging cohort studies attending the First World Cohort Integration Workshop were surveyed about training priorities, unmet needs and potential cross-cohort solutions to these barriers through an electronic pre-workshop questionnaire and focus groups. Cohort studies representing India, Mexico, Nigeria, South Africa, Sweden, Tanzania and Uganda described similar training needs, including on-the-job training, data analysis software instruction, and database and bio-bank management. A lack of funding and protected time for training activities were commonly identified constraints. Proposed solutions include a collaborative cross-cohort teaching platform with web-based content and interactive teaching methods for a range of research personnel. An international network for research mentorship and idea exchange, and modifying the graduate thesis structure were also identified as key initiatives. Cross-cohort integrated educational initiatives will efficiently meet shared needs, catalyze the development of emerging cohorts, speed closure of the global disparity in cohort research, and may fortify scientific capacity development in low-resource settings. PMID:23856451

  19. Posttraumatic Stress Disorder and Cancer Risk: A Nationwide Cohort Study

    PubMed Central

    Gradus, Jaimie L.; Farkas, Dóra Körmendiné; Svensson, Elisabeth; Ehrenstein, Vera; Lash, Timothy L.; Milstein, Arnold; Adler, Nancy; Sørensen, Henrik Toft

    2015-01-01

    Background The association between stress and cancer incidence has been studied for more than seven decades. Despite plausible biological mechanisms and evidence from laboratory studies, findings from clinical research are conflicting. The objective of this study was to examine the association between PTSD and various cancer outcomes. Methods This nation-wide cohort study included all Danish-born residents of Denmark from 1995 – 2011. The exposure was PTSD diagnoses (n = 4,131). The main outcomes were cancer diagnoses including: 1) all malignant neoplasms; 2) hematologic malignancies; 3) immune-related cancers; 4) smoking- and alcohol-related cancers; 5) cancers at all other sites. Standardized incidence ratios (SIR) were calculated. Results Null associations were found between PTSD and nearly all cancer diagnoses examined, both overall (SIR for all cancers = 1.0, 95% confidence interval (CI) = 0.88, 1.2) and in analyses stratified by gender, age, substance abuse history and time since PTSD diagnosis. Conclusions This study is the most comprehensive examination to date of PTSD as a predictor of many cancer types. Our data show no evidence of an association between PTSD and cancer in this nationwide cohort. PMID:25957083

  20. Posttraumatic stress disorder and cancer risk: a nationwide cohort study.

    PubMed

    Gradus, Jaimie L; Farkas, Dóra Körmendiné; Svensson, Elisabeth; Ehrenstein, Vera; Lash, Timothy L; Milstein, Arnold; Adler, Nancy; Sørensen, Henrik Toft

    2015-07-01

    The association between stress and cancer incidence has been studied for more than seven decades. Despite plausible biological mechanisms and evidence from laboratory studies, findings from clinical research are conflicting. The objective of this study was to examine the association between PTSD and various cancer outcomes. This nation-wide cohort study included all Danish-born residents of Denmark from 1995 to 2011. The exposure was PTSD diagnoses (n = 4131). The main outcomes were cancer diagnoses including: (1) all malignant neoplasms; (2) hematologic malignancies; (3) immune-related cancers; (4) smoking- and alcohol-related cancers; (5) cancers at all other sites. Standardized incidence ratios (SIR) were calculated. Null associations were found between PTSD and nearly all cancer diagnoses examined, both overall [SIR for all cancers = 1.0, 95 % confidence interval (CI) = 0.88, 1.2] and in analyses stratified by gender, age, substance abuse history and time since PTSD diagnosis. This study is the most comprehensive examination to date of PTSD as a predictor of many cancer types. Our data show no evidence of an association between PTSD and cancer in this nationwide cohort. PMID:25957083

  1. Cohort profile: the Young Lives study.

    PubMed

    Barnett, Inka; Ariana, Proochista; Petrou, Stavros; Penny, Mary E; Duc, Le Thuc; Galab, S; Woldehanna, Tassew; Escobal, Javier A; Plugge, Emma; Boyden, Jo

    2013-06-01

    Young Lives is an international longitudinal study investigating the changing nature of childhood poverty in four low-income countries [Ethiopia, India (Andhra Pradesh), Peru and Vietnam] over a 15-year period. In each country, the cohort is comprised of ≈ 2000 children aged between 6 and 18 months and up to 1000 children aged between 7 and 8 years, recruited in 2002 and sampled from 20 sentinel sites. The first survey data collection from primary caregivers and older children took place in 2002, the second in 2006-07 and the third in 2009-10. Data on the community contexts were collected to complement the household surveys. To elaborate and extend the quantitative data, longitudinal qualitative research with a subgroup of the children was carried out in 2007, 2008 and 2010-11. Topic areas covered included nutrition, health and well-being, cognitive and physical development, health behaviours and education, as well as the social, demographic and economic status of the household. Survey data from the study are archived in the International Section of the UK Public Data Archive. PMID:22617687

  2. The mummy's curse: historical cohort study

    PubMed Central

    Nelson, Mark R

    2002-01-01

    Objective To examine survival of individuals exposed to the “mummy's curse” reputedly associated with the opening of the tomb of Tutankhamen in Luxor, Egypt, between February 1923 and November 1926. Design Retrospective cohort study. Participants 44 Westerners identified by Howard Carter as present in Egypt at the specified dates, 25 of whom were potentially exposed to the curse. Main outcome measures Length of survival after date of potential exposure. Results In the 25 people exposed to the curse the mean age at death was 70 years (SD 12) compared with 75 (13) in those not exposed (P=0.87 for difference). Survival after the date of exposure was 20.8 (15.2) v 28.9 (13.6) years respectively (P=0.95 for difference). Female sex was a predictor for survival (P=0.02). Conclusions There was no significant association between exposure to the mummy's curse and survival and thus no evidence to support the existence of a mummy's curse. What is already known on this topicThe methods of evidence based medicine have not been used to investigate the reality of the “mummy's curse”The arguments against the curse have been as anecdotal as the contemporary newspapers that reported itWhat this study addsThere was no association between potential exposure to the mummy's curse during the excavation of Tutankamen's tomb and death within 10 yearsNo evidence was found for the existence of a mummy's curse PMID:12493675

  3. Snoring during Pregnancy and Delivery Outcomes: A Cohort Study

    PubMed Central

    O'Brien, Louise M.; Bullough, Alexandra S.; Owusu, Jocelynn T.; Tremblay, Kimberley A.; Brincat, Cynthia A.; Chames, Mark C.; Kalbfleisch, John D.; Chervin, Ronald D.

    2013-01-01

    Study Objective: This cohort study examined the impact of maternal snoring on key delivery outcomes such as mode of delivery, infant birth centile, and small-for-gestational age. Design: Cohort study. Setting: A large tertiary medical center. Patients or Participants: Pregnant women in their third trimester were recruited between March 2007 and December 2010. Measurements and Results: Women were screened for habitual snoring, as a known marker for sleep disordered breathing. Outcome data were obtained from medical records following delivery and birth centiles were calculated. Of 1,673 women, a total of 35% reported habitual snoring (26% with pregnancy-onset snoring and 9% with chronic snoring). After adjusting for confounders, chronic snoring was associated with small-forgestational age (OR 1.65, 95%CI 1.02-2.66, P = 0.041) and elective cesarean delivery (OR 2.25, 95%CI 1.22-4.18, P = 0.008). Pregnancy-onset snoring was associated with emergency cesarean delivery (OR 1.68, 95%CI 1.22-2.30, P = 0.001). Conclusion: Maternal snoring during pregnancy is a risk factor for adverse delivery outcomes including cesarean delivery and small-for-gestational age. Screening pregnant women for symptoms of SDB may provide an early opportunity to identify women at risk of poor delivery outcomes. Clinical Trials Registration: Identifier: NCT01030003. Citation: O'Brien LM; Bullough AS; Owusu JT; Tremblay KA; Brincat CA; Chames MC; Kalbfleisch JD; Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. SLEEP 2013;36(11):1625-1632. PMID:24179294

  4. Investing in Prospective Cohorts for Etiologic Study of Occupational Exposures

    PubMed Central

    Blair, A.; Hines, C.J.; Thomas, K.W.; Alavanja, M.C.R.; Beane Freeman, L.E.; Hoppin, J.A.; Kamel, F.; Lynch, C.F.; Lubin, J.H.; Silverman, D.T.; Whelan, E.; Zahm, S. H.; Sandler, D. P.

    2015-01-01

    Prospective cohorts have played a major role in understanding the contribution of diet, physical activity, medical conditions, and genes to the development of many diseases, but have not been widely used for occupational exposures. Studies in agriculture are an exception. We draw upon our experience using this design to study agricultural workers to identify conditions that might foster use of prospective cohorts to study other occupational settings. Prospective cohort studies are perceived by many as the strongest epidemiologic design. It allows updating of information on exposure and other factors, collection of biologic samples before disease diagnosis for biomarker studies, assessment of effect modification by genes, lifestyle, and other occupational exposures, and evaluation of a wide range of health outcomes. Increased use of prospective cohorts would be beneficial in identifying hazardous exposures in the workplace. Occupational epidemiologists should seek opportunities to initiate prospective cohorts to investigate high priority, occupational exposures. PMID:25603935

  5. Antiepileptics and blood dyscrasias: a cohort study.

    PubMed

    Blackburn, S C; Oliart, A D; García Rodríguez, L A; Pérez Gutthann, S

    1998-01-01

    We conducted a cohort study to investigate the frequency of serious blood dyscrasias in patients age 10-74 years, taking antiepileptic drugs between January 1, 1990, and October 31, 1994. Main outcome measures were validated diagnoses of neutropenia, agranulocytosis, hemolytic anemia, thrombocytopenia, bicytopenia, pancytopenia, or aplastic anemia. A total of 29,357 recipients of antiepileptic therapy received 684,706 prescriptions. Among them there were 21 cases of serious blood dyscrasia of which only 18 could be considered to have a temporal relationship to drug use. Seventeen cases occurred in current users of carbamazepine, phenobarbital, phenytoin or valproate, and 7 in patients taking two or more drugs. Twenty of the 21 patients recovered. The overall rate of blood dyscrasias was 3-4/100,000 prescriptions. The rate in those age less than 60 years was 2.0 (range 0.9-3.6)/100,000 prescriptions compared with 4.0 (range 1.6-8.2) for those age 60 or older. The overall rate of neutropenia was 1.2 (0.5-2.3)/100,000 prescriptions, compared with 0.9 (0.3-1.9) for thrombocytopenia and 0.4 (0.1-1.3) for hemolytic anemia. Rates did not differ among the four drugs. Serious blood dyscrasias are rare in patients taking antiepileptic agents. PMID:9855327

  6. Does contemporary vancomycin dosing achieve therapeutic targets in a heterogeneous clinical cohort of critically ill patients? Data from the multinational DALI study

    PubMed Central

    2014-01-01

    Introduction The objective of this study was to describe the pharmacokinetics of vancomycin in ICU patients and to examine whether contemporary antibiotic dosing results in concentrations that have been associated with favourable response. Methods The Defining Antibiotic Levels in Intensive Care (DALI) study was a prospective, multicentre pharmacokinetic point-prevalence study. Antibiotic dosing was as per the treating clinician either by intermittent bolus or continuous infusion. Target trough concentration was defined as ≥15 mg/L and target pharmacodynamic index was defined as an area under the concentration-time curve over a 24-hour period divided by the minimum inhibitory concentration of the suspected bacteria (AUC0–24/MIC ratio) >400 (assuming MIC ≤1 mg/L). Results Data of 42 patients from 26 ICUs were eligible for analysis. A total of 24 patients received vancomycin by continuous infusion (57%). Daily dosage of vancomycin was 27 mg/kg (interquartile range (IQR) 18 to 32), and not different between patients receiving intermittent or continuous infusion. Trough concentrations were highly variable (median 27, IQR 8 to 23 mg/L). Target trough concentrations were achieved in 57% of patients, but more frequently in patients receiving continuous infusion (71% versus 39%; P = 0.038). Also the target AUC0–24/MIC ratio was reached more frequently in patients receiving continuous infusion (88% versus 50%; P = 0.008). Multivariable logistic regression analysis with adjustment by the propensity score could not confirm continuous infusion as an independent predictor of an AUC0–24/MIC >400 (odds ratio (OR) 1.65, 95% confidence interval (CI) 0.2 to 12.0) or a Cmin ≥15 mg/L (OR 1.8, 95% CI 0.4 to 8.5). Conclusions This study demonstrated large interindividual variability in vancomycin pharmacokinetic and pharmacodynamic target attainment in ICU patients. These data suggests that a re-evaluation of current vancomycin dosing recommendations in

  7. Effect of telehealth on hospital utilisation and mortality in routine clinical practice: a matched control cohort study in an early adopter site

    PubMed Central

    Steventon, Adam; Ariti, Cono; Fisher, Elizabeth; Bardsley, Martin

    2016-01-01

    Objectives To assess the effects of a home-based telehealth intervention on the use of secondary healthcare and mortality. Design Observational study of a mainstream telehealth service, using person-level administrative data. Time to event analysis (Cox regression) was performed comparing telehealth patients with controls who were matched using a machine-learning algorithm. Setting A predominantly rural region of England (North Yorkshire). Participants 716 telehealth patients were recruited from community, general practice and specialist acute care, between June 2010 and March 2013. Patients had chronic obstructive pulmonary disease, congestive heart failure or diabetes, and a history of associated inpatient admission. Patients were matched 1:1 to control patients, also selected from North Yorkshire, with respect to demographics, diagnoses of health conditions, previous hospital use and predictive risk score. Interventions Telehealth involved the remote exchange of medical data between patients and healthcare professionals as part of the ongoing management of the patient's health condition. Monitoring centre staff alerted healthcare professionals if the telemonitored data exceeded preset thresholds. Control patients received usual care, without telehealth. Primary and secondary outcome measures Time to the first emergency (unplanned) hospital admission or death. Secondary metrics included time to death and time to first admission, outpatient attendance and emergency department visit. Results Matched controls and telehealth patients were similar at baseline. Following enrolment, telehealth patients were more likely than matched controls to experience emergency admission or death (adjusted HR 1.34, 95% CI 1.16 to 1.56, p<0.001). They were also more likely to have outpatient attendances (adjusted HR=1.25, 1.11 to 1.40, p<0.001), but mortality rates were similar between groups. Sensitivity analyses showed that we were unlikely to have missed reductions in the

  8. Cohort profile: the Finnish Medication and Alzheimer's disease (MEDALZ) study

    PubMed Central

    Tolppanen, Anna-Maija; Taipale, Heidi; Koponen, Marjaana; Lavikainen, Piia; Tanskanen, Antti; Tiihonen, Jari; Hartikainen, Sirpa

    2016-01-01

    Purpose The aim of the Medicine use and Alzheimer's disease (MEDALZ) study is to investigate the changes in medication and healthcare service use among persons with Alzheimer's disease (AD) and to evaluate the safety and effectiveness of medications in this group. This is important, because the number of persons with AD is rapidly growing and even though they are a particularly vulnerable patient group, the number of representative, large-scale studies with adequate follow-up time is limited. Participants MEDALZ contains all residents of Finland who received a clinically verified diagnosis of AD between 2005 and 2011 and were community-dwelling at the time of diagnosis (N=70 719). The diagnosis is based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCS-ADRDA) and Diagnostic and Statistical Manual Fourth Edition (DSM-IV) criteria for Alzheimer's disease. The cohort contains socioeconomic data (education, occupational status and taxable income, 1972–2012) and causes of death (2005–2012), data from the prescription register (1995–2012), the special reimbursement register (1972–2012) and the hospital discharge register (1972–2012). Future updates are planned. The average age was 80.1 years (range 34.5–104.6 years). The majority of cohort (65.2%) was women. Currently, the average length of follow-up after AD diagnosis is 3.1 years and altogether 26 045 (36.8%) persons have died during the follow-up. Findings Altogether 53% of the cohort had used psychotropic drugs within 1 year after AD diagnoses. The initiation rate of for example, benzodiazepines and related drugs and antidepressants began to increase already before AD diagnosis. Future plans We are currently assessing if these, and other commonly used medications are related to adverse events such as death, hip fractures, head injuries and pneumonia. PMID:27412109

  9. What Drives Teacher Engagement: A Study of Different Age Cohorts

    ERIC Educational Resources Information Center

    Guglielmi, Dina; Bruni, Ilaria; Simbula, Silvia; Fraccaroli, Franco; Depolo, Marco

    2016-01-01

    Despite the growing body of research on work engagement, little is known about what drives work engagement among different age cohorts. This study aims to investigate whether engagement varies across age cohorts and examines the job resources that foster teacher engagement. A questionnaire was distributed to 537 teachers who were employed in…

  10. Cohort Profile: Wisconsin longitudinal study (WLS)

    PubMed Central

    Herd, Pamela; Carr, Deborah; Roan, Carol

    2014-01-01

    The Wisconsin Longitudinal Study (WLS) is a longitudinal study of men and women who graduated from Wisconsin high schools in 1957 and one of their randomly selected siblings. Wisconsin is located in the upper midwest of the United States and had a population of approximately 14 000 000 in 1957, making it the 14th most populous state at that time. Data spanning almost 60 years allow researchers to link family background, adolescent characteristics, educational experiences, employment experiences, income, wealth, family formation and social and religious engagement to midlife and late-life physical health, mental health, psychological well-being, cognition, end of life planning and mortality. The WLS is one of the few longitudinal data sets that include an administrative measure of cognition from childhood. Further, recently collected saliva samples allow researchers to explore the inter-relationships among genes, behaviours and environment, including genetic determinants of behaviours (e.g. educational attainment); the interactions between genes and environment; and how these interactions predict behaviours. Most panel members were born in 1939, and the sample is broadly representative of White, non-Hispanic American men and women who have completed at least a high school education. Siblings cover several adjoining cohorts: they were born primarily between 1930 and 1948. At each interview, about two-thirds of the sample lived in Wisconsin, and about one-third lived elsewhere in the United States or abroad. The data, along with documentation, are publicly accessible and can be accessed at http://www.ssc.wisc.edu/wlsresearch/. Requests for protected data or assistance should be sent to wls@ssc.wisc.edu. PMID:24585852

  11. Fat distribution and longitudinal anthropometric changes in HIV-infected men with and without clinical evidence of lipodystrophy and HIV-uninfected controls: A substudy of the Multicenter AIDS Cohort Study

    PubMed Central

    Brown, Todd T; Xu, Xiaoqiang; John, Majnu; Singh, Jaya; Kingsley, Lawrence A; Palella, Frank J; Witt, Mallory D; Margolick, Joseph B; Dobs, Adrian S

    2009-01-01

    Background Fat abnormalities are common among HIV-infected persons, but few studies have compared regional body fat distribution, including visceral fat, in HIV-infected and HIV-uninfected persons and their subsequent trajectories in body composition over time. Methods Between 1999 and 2002, 33 men with clinical evidence of lipodystrophy (LIPO+), 23 HIV-infected men without clinical evidence of lipodytrophy (LIPO-), and 33 HIV-uninfected men were recruited from the four sites of the Multicenter AIDS Cohort Study (MACS). Participants underwent dual-energy x-ray absorptiometry, quantitative computerized tomography of the abdomen and thigh, and circumference measurements of the waist, hip and thigh. Circumference measurements at each semi-annual MACS visit between recruitment and 2008 were used to compare average annual anthropometric changes in the 3 groups. Results Body mass index (BMI) was lower in LIPO+ men than in the LIPO- men and the HIV- uninfected controls (BMI: 23.6 ± 0.4 vs 26.8 ± 1.5 vs 28.7 ± 0.9 kg/m2, respectively, p < 0.001). The average amount of visceral adipose tissue (VAT) was similar in all three groups (p = 0.26), but after adjustment for BMI, VAT was higher in the LIPO+ group (169 ± 10 cm2) compared to the LIPO- men (129 ± 12 cm2, p = 0.03) and the HIV-uninfected group (133 ± 11 cm2, p = 0.07). Subcutaneous adipose tissue (thigh, abdomen) and total extremity fat were less in the HIV-infected men (LIPO+ and LIPO-) than in the HIV-uninfected men. Over an average of 6 years of follow-up, waist circumference increased at a faster rate in LIPO+ group, compared to the LIPO- men (0.51 cm/year vs 0.08 cm/year, p = 0.02) and HIV-uninfected control men (0.21 cm/year, p = 0.06). The annual changes in hip and thigh circumferences were similar in all three groups Conclusion Subcutaneous lipoatrophy was observed in HIV-infected patients, even those without clinical evidence of lipodystrophy, compared to age-matched HIV-uninfected men. Despite markedly

  12. Treatment Patterns and Clinical Outcomes in Patients With Metastatic Colorectal Cancer Initially Treated with FOLFOX–Bevacizumab or FOLFIRI–Bevacizumab: Results From ARIES, a Bevacizumab Observational Cohort Study

    PubMed Central

    Bekaii-Saab, Tanios S.; Cohn, Allen L.; Hurwitz, Herbert I.; Kozloff, Mark; Tezcan, Haluk; Roach, Nancy; Mun, Yong; Fish, Susan; Flick, E. Dawn; Dalal, Darshan; Grothey, Axel

    2012-01-01

    Background. The Avastin® Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community-based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan–Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX–bevacizumab (n = 968) or FOLFIRI–bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX–bevacizumab and FOLFIRI–bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI–bevacizumab resulted in a similar PFS (HR, 1.03; 95% confidence interval [CI], 0.88–1.21) and OS (HR, 0.95; 95% CI, 0.78–1.16) outcome as with FOLFOX–bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-line mCRC patients, the FOLFOX–bevacizumab and FOLFIRI–bevacizumab regimens were associated with similar

  13. Chronic lymphocytic leukemia: a clinical review including Korean cohorts

    PubMed Central

    Jeon, Young-Woo; Cho, Seok-Goo

    2016-01-01

    Only 5th decade ago, chronic lymphocytic leukemia (CLL) was only recognized as disease group of presenting features like peripheral lymphocytosis, organomegaly including of splenomegaly. As understanding of disease biology and molecular diagnostic tools are getting improved gradually, characterization of variation in CLL’s clinical courses was facilitated, resulting in better risk stratification and targeted treatments. Consequently multiple new targeted agents have been used in treatment of CLL, it makes improved clinical outcome. Rituximab containing chemoimmunotherapy (combination of rituximab, fludarabine, and cyclophosphamide) have shown better overall response rate and progression-free survival on fit patients’ group in front-line setting, result in standard first-line therapeutic option for CLL. Furthermore, after introducing that the B-cell receptor is crucial for the evolution and progression of CLL, emerging treatments targeting highly activated surface antigens and oncogenic signaling pathways have been associated with several successes in recent decades. These include new anti-CD 20 monoclonal antibody (obinutuzumab), the bruton tyrosine kinase inhibitor (ibrutinib), the phosphatidylinositol 3-kinase inhibitor (idelalisib), and B-cell CLL/lymphoma 2 inhibitor (ABT-199 and ABT-263). So, we discuss not only general pathophysiology of CLL, but also rapidly advancing treatment strategies that are being studied or approved for treatment of CLL. PMID:27044858

  14. Chronic lymphocytic leukemia: a clinical review including Korean cohorts.

    PubMed

    Jeon, Young-Woo; Cho, Seok-Goo

    2016-05-01

    Only 5th decade ago, chronic lymphocytic leukemia (CLL) was only recognized as disease group of presenting features like peripheral lymphocytosis, organomegaly including of splenomegaly. As understanding of disease biology and molecular diagnostic tools are getting improved gradually, characterization of variation in CLL's clinical courses was facilitated, resulting in better risk stratification and targeted treatments. Consequently multiple new targeted agents have been used in treatment of CLL, it makes improved clinical outcome. Rituximab containing chemoimmunotherapy (combination of rituximab, fludarabine, and cyclophosphamide) have shown better overall response rate and progression-free survival on fit patients' group in front-line setting, result in standard first-line therapeutic option for CLL. Furthermore, after introducing that the B-cell receptor is crucial for the evolution and progression of CLL, emerging treatments targeting highly activated surface antigens and oncogenic signaling pathways have been associated with several successes in recent decades. These include new anti-CD 20 monoclonal antibody (obinutuzumab), the bruton tyrosine kinase inhibitor (ibrutinib), the phosphatidylinositol 3-kinase inhibitor (idelalisib), and B-cell CLL/lymphoma 2 inhibitor (ABT-199 and ABT-263). So, we discuss not only general pathophysiology of CLL, but also rapidly advancing treatment strategies that are being studied or approved for treatment of CLL. PMID:27044858

  15. [Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trial].

    PubMed

    Guo Xiaolei

    2015-07-01

    Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rationally lessen industrial burdensome. PMID:26665950

  16. Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews

    PubMed Central

    Saini, Pooja; Loke, Yoon K; Gamble, Carrol; Altman, Douglas G; Williamson, Paula R

    2014-01-01

    Objective To determine the extent and nature of selective non-reporting of harm outcomes in clinical studies that were eligible for inclusion in a cohort of systematic reviews. Design Cohort study of systematic reviews from two databases. Setting Outcome reporting bias in trials for harm outcomes (ORBIT II) in systematic reviews from the Cochrane Library and a separate cohort of systematic reviews of adverse events. Participants 92 systematic reviews of randomised controlled trials and non-randomised studies published in the Cochrane Library between issue 9, 2012 and issue 2, 2013 (Cochrane cohort) and 230 systematic reviews published between 1 January 2007 and 31 December 2011 in other publications, synthesising data on harm outcomes (adverse event cohort). Methods A 13 point classification system for missing outcome data on harm was developed and applied to the studies. Results 86% (79/92) of reviews in the Cochrane cohort did not include full data from the main harm outcome of interest of each review for all of the eligible studies included within that review; 76% (173/230) for the adverse event cohort. Overall, the single primary harm outcome was inadequately reported in 76% (705/931) of the studies included in the 92 reviews from the Cochrane cohort and not reported in 47% (4159/8837) of the 230 reviews in the adverse event cohort. In a sample of primary studies not reporting on the single primary harm outcome in the review, scrutiny of the study publication revealed that outcome reporting bias was suspected in nearly two thirds (63%, 248/393). Conclusions The number of reviews suspected of outcome reporting bias as a result of missing or partially reported harm related outcomes from at least one eligible study is high. The declaration of important harms and the quality of the reporting of harm outcomes must be improved in both primary studies and systematic reviews. PMID:25416499

  17. Descriptive Epidemiology of the Multicenter ACL Revision Study (MARS) Cohort

    PubMed Central

    2013-01-01

    Background Revision anterior cruciate ligament (ACL) reconstruction has worse outcomes than primary reconstructions. Predictors for these worse outcomes are not known. The Multicenter ACL Revision Study (MARS) Group was developed to perform a multisurgeon, multicenter prospective longitudinal study to obtain sufficient subjects to allow multivariable analysis to determine predictors of clinical outcome. Purpose To describe the formation of MARS and provide descriptive analysis of patient demographics and clinical features for the initial 460 enrolled patients to date in this prospective cohort. Study Design Cross-sectional study; Level of evidence, 2. Methods After training and institutional review board approval, surgeons began enrolling patients undergoing revision ACL reconstruction, recording patient demographics, previous ACL reconstruction methods, intra-articular injuries, and current revision techniques. Enrolled subjects completed a questionnaire consisting of validated patient-based outcome measures. Results As of April 1, 2009, 87 surgeons have enrolled a total of 460 patients (57% men; median age, 26 years). For 89%, the reconstruction was the first revision. Mode of failure as deemed by the revising surgeon was traumatic (32%), technical (24%), biologic (7%), combination (37%), infection (<1%), and no response (<1%). Previous graft present at the time of injury was 70% autograft, 27% allograft, 2% combination, and 1% unknown. Sixty-two percent were more than 2 years removed from their last reconstruction. Graft choice for revision ACL reconstruction was 45% autograft, 54% allograft, and more than 1% both allograft and autograft. Meniscus and/or chondral damage was found in 90% of patients. Conclusion The MARS Group has been able to quickly accumulate the largest revision ACL reconstruction cohort reported to date. Traumatic reinjury is deemed by surgeons to be the most common single mode of failure, but a combination of factors represents the most

  18. Criminality and suicide: a longitudinal Swedish cohort study

    PubMed Central

    Stenbacka, M; Romelsjö, A; Jokinen, J

    2014-01-01

    Objectives This study aimed to investigate whether violent and non-violent offending were related to elevated risk of suicide. We also investigated whether the risk was higher among those with repeated offences and how experiences of substance misuse and suicide attempt modified the relationship. Design A nationwide prospective cohort study. Setting A register study of 48 834 conscripted men in 1969/1970 in Sweden followed up during a 35-year period in official registers. Participants A birth cohort of 48 834 men who were mandatory conscripted for military service in 1969/70 at the age of 18–20 years. Possible confounders were retrieved from psychological assessments at conscription and the cohort was linked to mortality and hospitalisation and crime records from 1970 onwards. Estimates of suicide risks were calculated as HR with 95% CIs using Cox proportional regression analyses with adjustment for potential confounding by family, psychological and behavioural factors including substance use and psychiatric disorders. Results Of the total cohort, 2671 (5.5%) persons died during the follow-up period. Of these, 615 (23%) persons died due to suicide. Non-violent criminality was evident for 29% and violent criminality for 4.7% of all the participants. In the crude model, the violent offenders had nearly five times higher risk (HR=4.69, 3.56 to 6.19) to die from suicide and non-violent criminals had about two times higher risk (HR=2.08, 1.72 to 2.52). In the fully adjusted model, the HRs were still significant for suicide in the non-violent group. Conclusions Experiences of violent or non-violent criminality were associated with increased risk of suicide. Comorbidity with alcohol and substance use and psychiatric disorders modified the risk, but the suicide risk remained significantly elevated for non-violent criminals. It is crucial to identify offenders and especially repeated offenders who also suffer from alcohol or substance misuse and psychiatric illness in

  19. Estimation of Error Components in Cohort Studies: A Cross-Cohort Analysis of Dutch Mathematics Achievement

    ERIC Educational Resources Information Center

    Keuning, Jos; Hemker, Bas

    2014-01-01

    The data collection of a cohort study requires making many decisions. Each decision may introduce error in the statistical analyses conducted later on. In the present study, a procedure was developed for estimation of the error made due to the composition of the sample, the item selection procedure, and the test equating process. The math results…

  20. A cohort study of bacteremic pneumonia

    PubMed Central

    Guillamet, Cristina Vazquez; Vazquez, Rodrigo; Noe, Jonas; Micek, Scott T.; Kollef, Marin H.

    2016-01-01

    Abstract Bacteremic pneumonia is usually associated with greater mortality. However, risk factors associated with hospital mortality in bacteremic pneumonia are inadequately described. The study was a retrospective cohort study, conducted in Barnes-Jewish Hospital (2008–2015). For purposes of this investigation, antibiotic susceptibility was determined according to ceftriaxone susceptibility, as ceftriaxone represents the antimicrobial agent most frequently recommended for hospitalized patients with community-acquired pneumonia as opposed to nosocomial pneumonia. Two multivariable analyses were planned: the first model included resistance to ceftriaxone as a variable, whereas the second model included the various antibiotic-resistant species (methicillin-resistant Staphylococcus aureus, Pseudomonas aeruginosa, and Enterobacteriaceae). In all, 1031 consecutive patients with bacteremic pneumonia (mortality 37.1%) were included. The most common pathogens associated with infection were S aureus (34.1%; methicillin resistance 54.0%), Enterobacteriaceae (28.0%), P aeruginosa (10.6%), anaerobic bacteria (7.3%), and Streptococcus pneumoniae (5.6%). Compared with ceftriaxone-susceptible pathogens (46.8%), ceftriaxone-resistant pathogens (53.2%) were significantly more likely to receive inappropriate initial antibiotic treatment (IIAT) (27.9% vs 7.1%; P < 0.001) and to die during hospitalization (41.5% vs 32.0%; P = 0.001). The first logistic regression analysis identified IIAT with the greatest odds ratio (OR) for mortality (OR 2.2, 95% confidence interval [CI] 1.5–3.2, P < 0.001). Other independent predictors of mortality included age, mechanical ventilation, immune suppression, prior hospitalization, prior antibiotic administration, septic shock, comorbid conditions, and severity of illness. In the second multivariable analysis that included the antibiotic-resistant species, IIAT was still associated with excess mortality, and P aeruginosa infection was

  1. Clinical Characteristics and Outcomes Associated with the Natural History of Early Repolarization in a Young, Biracial Cohort Followed to Middle Age: The Coronary Artery Risk Development in Young Adults (CARDIA) Study

    PubMed Central

    Ilkhanoff, Leonard; Soliman, Elsayed Z.; Prineas, Ronald J.; Walsh, Joseph A.; Ning, Hongyan; Liu, Kiang; Carr, J. Jeffrey; Jacobs, David R.; Lloyd-Jones, Donald M.

    2014-01-01

    Background Early repolarization (ER), a common electrocardiographic phenotype, has been associated with increased mortality risk in middle-aged adults. Data are sparse on long-term follow-up and outcomes associated with ER in younger adults. Methods and Results We prospectively examined 5,039 participants (mean age 25 years at baseline, 40% black) from the CARDIA cohort over 23 years. Twelve-lead electrocardiograms were recorded and analyzed at Years 0, 7 and 20 and coded as definite or probable ER using a standardized algorithm. Cox regression was used, and models were adjusted for important baseline and clinical covariates. Kaplan-Meier curves were created for presence of ER and total mortality and cardiovascular (CV) mortality. Participants with ER were more likely to be black, male, smoke, have higher systolic blood pressure, lower heart rate, and BMI, and also higher exercise duration, and longer PR, QRS and QT intervals. ER was associated with total mortality (HR1.77, 1.38–2.28, p<0.01), and CV mortality (HR 1.59, 1.01–2.50, p=0.04) in unadjusted analyses, but adjustment for age, sex, and race attenuated associations almost completely. Sex-race stratified analyses showed no significant associations between ER and outcome for any of the subgroups except blacks. Conclusions The presence of ER at any time point over 23 years of follow-up was not associated with adverse outcomes. Black race and male sex confound the unadjusted association of ER and outcomes, with no race-sex interactions noted. Further studies are necessary to understand the factors associated with heightened risk of death in those who maintain ER into and beyond middle age. PMID:24759868

  2. Rare Causes of Primary Adrenal Insufficiency: Genetic and Clinical Characterization of a Large Nationwide Cohort

    PubMed Central

    Buonocore, Federica; Saka, Nurcin; Ozbek, Mehmet Nuri; Aycan, Zehra; Bereket, Abdullah; Bas, Firdevs; Darcan, Sukran; Bideci, Aysun; Guven, Ayla; Demir, Korcan; Akinci, Aysehan; Buyukinan, Muammer; Aydin, Banu Kucukemre; Turan, Serap; Agladioglu, Sebahat Yilmaz; Atay, Zeynep; Abali, Zehra Yavas; Tarim, Omer; Catli, Gonul; Yuksel, Bilgin; Akcay, Teoman; Yildiz, Metin; Ozen, Samim; Doger, Esra; Demirbilek, Huseyin; Ucar, Ahmet; Isik, Emregul; Ozhan, Bayram; Bolu, Semih; Ozgen, Ilker Tolga; Suntharalingham, Jenifer P.; Achermann, John C.

    2016-01-01

    Context: Primary adrenal insufficiency (PAI) is a life-threatening condition that is often due to monogenic causes in children. Although congenital adrenal hyperplasia occurs commonly, several other important molecular causes have been reported, often with overlapping clinical and biochemical features. The relative prevalence of these conditions is not known, but making a specific diagnosis can have important implications for management. Objective: The objective of the study was to investigate the clinical and molecular genetic characteristics of a nationwide cohort of children with PAI of unknown etiology. Design: A structured questionnaire was used to evaluate clinical, biochemical, and imaging data. Genetic analysis was performed using Haloplex capture and next-generation sequencing. Patients with congenital adrenal hyperplasia, adrenoleukodystrophy, autoimmune adrenal insufficiency, or obvious syndromic PAI were excluded. Setting: The study was conducted in 19 tertiary pediatric endocrinology clinics. Patients: Ninety-five children (48 females, aged 0–18 y, eight familial) with PAI of unknown etiology participated in the study. Results: A genetic diagnosis was obtained in 77 patients (81%). The range of etiologies was as follows: MC2R (n = 25), NR0B1 (n = 12), STAR (n = 11), CYP11A1 (n = 9), MRAP (n = 9), NNT (n = 7), ABCD1 (n = 2), NR5A1 (n = 1), and AAAS (n = 1). Recurrent mutations occurred in several genes, such as c.560delT in MC2R, p.R451W in CYP11A1, and c.IVS3ds+1delG in MRAP. Several important clinical and molecular insights emerged. Conclusion: This is the largest nationwide study of the molecular genetics of childhood PAI undertaken. Achieving a molecular diagnosis in more than 80% of children has important translational impact for counseling families, presymptomatic diagnosis, personalized treatment (eg, mineralocorticoid replacement), predicting comorbidities (eg, neurological, puberty/fertility), and targeting clinical genetic testing in the

  3. Public perceptions of cohort studies and biobanks in Germany.

    PubMed

    Starkbaum, Johannes; Gottweis, Herbert; Gottweis, Ursula; Kleiser, Christina; Linseisen, Jakob; Meisinger, Christa; Kamtsiuris, Panagiotis; Moebus, Susanne; Jöckel, Karl-Heinz; Börm, Sonja; Wichmann, H-Erich

    2014-04-01

    Cohort studies and biobank projects have led to public discussions in several European countries in the past. In Germany, many medium-sized studies are currently running successfully in terms of respondent rates. However, EU-wide research on general public perceptions of biobanks and cohort studies have shown that Germany is among those countries where people express the highest reluctance for providing body material and other data for research purposes. Because of early efforts of the just-initiated German National Cohort Study, we are able to begin to investigate in greater detail how various groups of people across Germany reflect and discuss the ongoing implementation of cohort studies and biobanking in Germany. Our research is based on 15 focus group discussions in four German regions, as well as on Eurobarometer poll data on biobanking. PMID:24749879

  4. Longitudinal cohort survey of women's smoking behaviour and attitudes in pregnancy: study methods and baseline data

    PubMed Central

    Orton, Sophie; Bowker, Katharine; Cooper, Sue; Naughton, Felix; Ussher, Michael; Pickett, Kate E; Leonardi-Bee, Jo; Sutton, Stephen; Dhalwani, Nafeesa N; Coleman, Tim

    2014-01-01

    Objectives To report the methods used to assemble a contemporary pregnancy cohort for investigating influences on smoking behaviour before, during and after pregnancy and to report characteristics of women recruited. Design Longitudinal cohort survey. Setting Two maternity hospitals, Nottingham, England. Participants 3265 women who attended antenatal ultrasound scan clinics were offered cohort enrolment; those who were 8–26 weeks pregnant and were currently smoking or had recently stopped smoking were eligible. Cohort enrollment took place between August 2011 and August 2012. Primary and secondary outcome measures Prevalence of smoking at cohort entry and at two follow-up time points (34–36 weeks gestation and 3 months postnatally); response rate, participants’ sociodemographic characteristics. Results 1101 (33.7%, 95% CI 32.1% to 35.4%) women were eligible for inclusion in the cohort, and of these 850 (77.2%, 95% CI 74.6% to 79.6%) were recruited. Within the cohort, 57.4% (N=488, 95% CI 54.1% to 60.7%) reported to be current smokers. Current smokers were significantly younger than ex-smokers (p<0.05), more likely to have no formal qualifications and to not be in current paid employment compared to recent ex-smokers (p<0.001). Conclusions This contemporary cohort, which seeks very detailed information on smoking in pregnancy and its determinants, includes women with comparable sociodemographic characteristics to those in other UK cross-sectional studies and cohorts. This suggests that future analyses using this cohort and aimed at understanding smoking behaviour in pregnancy may produce findings that are broadly generalisable. PMID:24833689

  5. Aragon workers’ health study – design and cohort description

    PubMed Central

    2012-01-01

    Background Spain, a Mediterranean country with relatively low rates of coronary heart disease, has a high prevalence of traditional cardiovascular risk factors and is experiencing a severe epidemic of overweight/obesity. We designed the Aragon Workers’ Health Study (AWHS) to characterize the factors associated with metabolic abnormalities and subclinical atherosclerosis in a middle aged population in Spain free of clinical cardiovascular disease. The objective of this paper is to describe the study design, aims and baseline characteristics of participants in the AWHS. Methods/Design Longitudinal cohort study based on the annual health exams of 5,400 workers of a car assembly plant in Figueruelas (Zaragoza, Spain). Study participants were recruited during a standardized clinical exam in 2009–2010 (participation rate 95.6%). Study participants will undergo annual clinical exams and laboratory assays, and baseline and triennial collection of biological materials for biobanking and cardiovascular imaging exams (carotid, femoral and abdominal ultrasonography, coronary calcium score, and ankle-arm blood pressure index). Participants will be followed-up for 10 years. Results The average (SD) age, body mass index, and waist circumference were 49.3 (8.7) years, 27.7 (3.6) kg/m2 and 97.2 (9.9) cm, respectively, among males (N = 5,048), and 40.8 (11.6) years, 24.4 (3.8) kg/m2, and 81.9 (9.9) cm, among females (N = 351). The prevalence of overweight, obesity, current smoking, hypertension, hypercholesterolemia, and diabetes were 55.0, 23.1, 37.1, 40.3, 75.0, and 7.4%, respectively, among males, and 23.7, 8.3, 45.0, 12.1, 59.5, and 0.6%, respectively, among females. In the initial 587 study participants who completed all imaging exams (94.5% male), the prevalence of carotid plaque, femoral plaque, coronary calcium score >1 to 100, and coronary calcium score >100 was 30.3, 56.9, 27.0, and 8.8%, respectively. 67.7% of study participants had at least one plaque in

  6. Clinical and Epidemiological Factors Associated with Mortality in Parkinson's Disease in a Brazilian Cohort

    PubMed Central

    Fernandes, Gustavo Costa; Socal, Mariana Peixoto; Schuh, Artur Francisco Schumacher; Rieder, Carlos R. M.

    2015-01-01

    Background. Prognosis of PD is variable. Most studies show higher mortality rates in PD patients compared to the general population. Clinical and epidemiologic factors predicting mortality are poorly understood. Methods. Clinical and epidemiologic features including patient history and physical, functional, and cognitive scores were collected from a hospital-based cohort of PD patients using standardized protocols and clinical scales. Data on comorbidities and mortality were collected on follow-up. Results. During a mean follow-up of 4.71 years (range 1–10), 43 (20.9%) of the 206 patients died. Those who died had higher mean age at disease onset than those still alive at the last follow-up (67.7 years versus 56.3 years; p < 0.01). In the univariate analysis, age at baseline was associated with decreased survival. In the adjusted Cox proportional hazards model, age at disease onset and race/ethnicity were predictors of mortality. Conclusions. Late age at disease onset and advanced chronological age are associated with decreased survival. Comorbidities and PD characteristics were not associated with decreased survival in our sample. Race/ethnicity was found in our study to be associated with increased hazard of mortality. Our findings indicate the importance of studying survival among different populations of PD patients. PMID:26819798

  7. Clinical and Epidemiological Factors Associated with Mortality in Parkinson's Disease in a Brazilian Cohort.

    PubMed

    Fernandes, Gustavo Costa; Socal, Mariana Peixoto; Schuh, Artur Francisco Schumacher; Rieder, Carlos R M

    2015-01-01

    Background. Prognosis of PD is variable. Most studies show higher mortality rates in PD patients compared to the general population. Clinical and epidemiologic factors predicting mortality are poorly understood. Methods. Clinical and epidemiologic features including patient history and physical, functional, and cognitive scores were collected from a hospital-based cohort of PD patients using standardized protocols and clinical scales. Data on comorbidities and mortality were collected on follow-up. Results. During a mean follow-up of 4.71 years (range 1-10), 43 (20.9%) of the 206 patients died. Those who died had higher mean age at disease onset than those still alive at the last follow-up (67.7 years versus 56.3 years; p < 0.01). In the univariate analysis, age at baseline was associated with decreased survival. In the adjusted Cox proportional hazards model, age at disease onset and race/ethnicity were predictors of mortality. Conclusions. Late age at disease onset and advanced chronological age are associated with decreased survival. Comorbidities and PD characteristics were not associated with decreased survival in our sample. Race/ethnicity was found in our study to be associated with increased hazard of mortality. Our findings indicate the importance of studying survival among different populations of PD patients. PMID:26819798

  8. Clinical determinants of Lyme borreliosis, babesiosis, bartonellosis, anaplasmosis, and ehrlichiosis in an Australian cohort

    PubMed Central

    Mayne, Peter J

    2015-01-01

    Background Borrelia burgdorferi is the causative agent of Lyme borreliosis. This spirochete, along with Babesia, Bartonella, Anaplasma, Ehrlichia, and the Rickettsia spp. are recognized tick-borne pathogens. In this study, the clinical manifestation of these zoonoses in Australia is described. Methods The clinical presentation of 500 patients over the course of 5 years was examined. Evidence of multisystem disease and cranial nerve neuropathy was sought. Supportive laboratory evidence of infection was examined. Results Patients from every state of Australia presented with a wide range of symptoms of disease covering multiple systems and a large range of time intervals from onset. Among these patients, 296 (59%) were considered to have a clinical diagnosis of Lyme borreliosis and 273 (54% of the 500) tested positive for the disease, the latter not being a subset of the former. In total, 450 (90%) had either clinical evidence for or laboratory proof of borrelial infection, and the great majority of cases featured neurological symptoms involving the cranial nerves, thus mimicking features of the disease found in Europe and Asia, as distinct from North America (where extracutaneous disease is principally an oligoarticular arthritis). Only 83 patients (17%; number [n]=492) reported never leaving Australia. Of the 500 patients, 317 (63%) had clinical or laboratory-supported evidence of coinfection with Babesia or Bartonella spp. Infection with A. phagocytophilum was detected in three individuals, and Ehrlichia chaffeensis was detected in one individual who had never traveled outside Australia. In the cohort, 30 (11%; n=279) had positive rickettsial serology. Conclusion The study suggests that there is a considerable presence of borreliosis in Australia, and a highly significant burden of coinfections accompanying borreliosis transmission. The concept sometimes advanced of a “Lyme-like illness” on the continent needs to be re-examined as the clinical interplay between

  9. A clinical and radiological profile of neuromyelitis optica and spectrum disorders in an Indian cohort

    PubMed Central

    Barhate, Kavita Sohan; Ganeshan, Malti; Singhal, Bhim Sen

    2014-01-01

    Background: There is insufficient data on the clinical and radiological features of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) from India. Objective: The objective of the following study is to examine the clinico-radiological features of NMO and NMOSD in an Indian cohort. Materials and Methods: This retrospective study included 44 consecutive patients who (1) satisfied the 2006 Wingerchuk criteria for NMO (16 seropositive and 7 seronegative); or (2) had isolated or recurrent optic neuritis (ON) with seropositivity (n = 4); or (3) had isolated or recurrent myelitis with seropositivity (n = 17). Results: The female:male ratio was 7.8:1 with median age of onset 26.5 (range 8-72). Annualized relapse rate (ARR) was comparable across all groups (F [3, 40] = 0.938 and P = 0.431). Various presentations other than ON and myelitis were noted. All 40 patients with myelitis had spinal cord lesions involving ≥3 vertebral segments during the course of the disease. Cervicomedullary involvement was seen in 32.5% (13/40) patients. Brain magnetic resonance imaging was available for 40 patients; eight of these (20%) had brain lesions in locations described in multiple sclerosis (MS), 27.5% (11/40) had lesions at sites unusual for MS and 52.5% (21/40) had normal brain imaging. Conclusion: NMO and NMOSD patients in this cohort have comparable ARR regardless of clinical presentation, supporting the emerging trend of treating all patients with immunotherapeutic agents at an early stage. Varied presentations seen in NMO and NMOSD highlight the need for a high index of suspicion for NMO in demyelinating episodes not classical for MS. PMID:24753665

  10. Cliques and Cohesion in a Clinical Psychology Graduate Cohort: A Longitudinal Social Network Analysis

    ERIC Educational Resources Information Center

    Kunze, Kimberley Annette

    2013-01-01

    To date, no published research has utilized social network analysis (SNA) to analyze graduate cohorts in clinical psychology. The purpose of this research is to determine how issues of likability among students correlate with other measures, such as disclosure, health, spiritual maturity, help in projects, familiarity, and ease of providing…

  11. Chest wall syndrome among primary care patients: a cohort study

    PubMed Central

    Verdon, François; Burnand, Bernard; Herzig, Lilli; Junod, Michel; Pécoud, Alain; Favrat, Bernard

    2007-01-01

    Background The epidemiology of chest pain differs strongly between outpatient and emergency settings. In general practice, the most frequent cause is the chest wall pain. However, there is a lack of information about the characteristics of this syndrome. The aims of the study are to describe the clinical aspects of chest wall syndrome (CWS). Methods Prospective, observational, cohort study of patients attending 58 private practices over a five-week period from March to May 2001 with undifferentiated chest pain. During a one-year follow-up, questionnaires including detailed history and physical exam, were filled out at initial consultation, 3 and 12 months. The outcomes were: clinical characteristics associated with the CWS diagnosis and clinical evolution of the syndrome. Results Among 24 620 consultations, we observed 672 cases of chest pain and 300 (44.6%) patients had a diagnosis of chest wall syndrome. It affected all ages with a sex ratio of 1:1. History and sensibility to palpation were the keys for diagnosis. Pain was generally moderate, well localised, continuous or intermittent over a number of hours to days or weeks, and amplified by position or movement. The pain however, may be acute. Eighty-eight patients were affected at several painful sites, and 210 patients at a single site, most frequently in the midline or a left-sided site. Pain was a cause of anxiety and cardiac concern, especially when acute. CWS coexisted with coronary disease in 19 and neoplasm in 6. Outcome at one year was favourable even though CWS recurred in half of patients. Conclusion CWS is common and benign, but leads to anxiety and recurred frequently. Because the majority of chest wall pain is left-sided, the possibility of coexistence with coronary disease needs careful consideration. PMID:17850647

  12. Viral Co-infection and Leprosy Outcomes: A Cohort Study

    PubMed Central

    Machado, Paulo R. L.; Machado, Lídia M.; Shibuya, Mayume; Rego, Jamile; Johnson, Warren D.; Glesby, Marshall J.

    2015-01-01

    Background The role of the host immunity in determining leprosy clinical forms and complications is well recognized, implying that changes in the immune status may interfere with several aspects of the disease. Therefore, we hypothesized that the presence of viral co-infections and associated immunological changes will have a clinical impact on leprosy outcomes. The aim of our study was to determine the clinical impact of human immunodeficiency virus (HIV), human T cell lymphotrophic virus type 1 (HTLV-1), hepatitis B virus (HBV) and hepatitis C virus (HCV) co-infection on the development of reactions, neuritis, neuropathy and relapses. Methodology/Principal Findings Cohort study in 245 leprosy subjects from Bahia, Brazil. Patients were followed from the time of diagnosis until at least the end of multidrug therapy. Viral co-infection was detected in 36 out of the 245 patients (14.7%). Specific co-infection rates were 10.6% for HBV, 2.9% for HIV, 2.5% for HTLV-1 and 0.8% for HCV. All four groups of co-infected patients had higher rates of neuritis and nerve function impairment compared to non co-infected leprosy subjects. The relapse rate was also higher in the co-infected group (8.3%) versus patients without co-infection (1.9%); relative risk 4.37, 95% confidence interval 1.02–18.74. Conclusions/Significance Leprosy patients should be screened for HBV, HCV, HIV and HTLV-1 co-infections. Besides contributing to better health care, this measure will facilitate the early detection of severe complications through targeting of higher risk patients. PMID:26267882

  13. Psychosis and Hallucinations in FTD with C9ORF72 mutation: A detailed clinical cohort

    PubMed Central

    Kertesz, Andrew; Ang, Lee Cyn; Jesso, Sarah; MacKinley, Julia; Baker, Matt; Brown, Patricia; Shoesmith, Christen; Rademakers, Rosa; Finger, Elizabeth C.

    2014-01-01

    OBJECTIVE To describe in detail the presenting symptoms and clinical course of a cohort of patients with Frontotemporal dementia and the recently described C9ORF72 repeat expansion. BACKGROUND Recent discovery of the C9ORF72 repeat expansion linked to familial frontotemporal dementia and ALS has permitted retrospective evaluation of potential defining clinical characteristics that may distinguish C9ORF72 mutation carriers from other patients with FTD. Prior reports have identified a subset of patients with an increased incidence of psychosis, specifically delusions, though the detailed nature of these symptoms is not yet well described. METHODS We conducted a retrospective chart review of to report the detailed case histories of 7 patients with C9ORF72 mutations from a cohort of 61 patients with FTD. Results Detailed histories available from these patients reveal an increased incidence of psychosis, including visual and auditory hallucinations and delusions compared to sporadic FTD patients in our cohort. CONCLUSIONS This cohort confirms and adds symptom-related details to prior reports of increased incidence of psychotic phenomenon in FTD and ALS patients with C9ORF72 mutations, to enhance future clinical identification and diagnosis of patients presenting with these symptoms. PMID:24077574

  14. Southern community cohort study: establishing a cohort to investigate health disparities.

    PubMed Central

    Signorello, Lisa B.; Hargreaves, Margaret K.; Steinwandel, Mark D.; Zheng, Wei; Cai, Qiuyin; Schlundt, David G.; Buchowski, Maciej S.; Arnold, Carolyne W.; McLaughlin, Joseph K.; Blot, William J.

    2005-01-01

    OBJECTIVES: To demonstrate the methods of recruitment of a low-income, predominantly African-American study population for the Southern Community Cohort Study (SCCS), a prospective epidemiologic investigation of racial disparities in cancer risk. METHODS: Partnerships with community health centers (CHCs) were formed to reach underserved populations throughout the south. Recruitment of participants (aged 40-79) in CHCs began in March 2002. Participants complete a comprehensive baseline interview and provide a blood or buccal cell sample. Recruitment will expand to the general population of the south to achieve a broad cross-section of socioeconomic status, The final cohort size is expected to be approximately 100,000. RESULTS: A high level of cooperation and recruitment was achieved in the CHCs. From March 2002 to October 2004, 32,632 participants (80% black, 41% male, 62% with total household income < $15,000, 34% with < 12 years schooling) enrolled. Participants reported a high prevalence of medical conditions (21% diabetic, 44% obese) and adverse health behaviors (45% current smokers). CONCLUSIONS: Working in CHCs is successful for recruiting a population that has been difficult to reach in previous studies. The SCCS is a unique cohort that will provide a rich resource for evaluating disparities in cancer and other chronic disease risk as it is followed over time. PMID:16080667

  15. Embedding clinical interventions into observational studies.

    PubMed

    Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

    2016-01-01

    Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

  16. Adhesive capsulitis and dynamic splinting: a controlled, cohort study

    PubMed Central

    Gaspar, Paul D; Willis, F Buck

    2009-01-01

    Background Adhesive Capsulitis (AC) affects patient of all ages, and stretching protocols are commonly prescribed for this condition. Dynamic splinting has been shown effective in contracture reduction from pathologies including Trismus to plantar fasciitis. The purpose of this study was to examine the efficacy of dynamic splinting on patients with AC. Methods This controlled, cohort study, was conducted at four physical therapy, sports medicine clinics in Texas and California. Sixty-two patients diagnosed with Stage II Adhesive Capsulitis were grouped by intervention. The intervention categories were as follows: Group I (Control); Group II (Physical Therapy exclusively with standardized protocols); Group III; (Shoulder Dynasplint system exclusively); Group IV (Combined treatment with Shoulder Dynasplint and standardized Physical Therapy). The duration of this study was 90 days for all groups, and the main outcome measures were change in active, external rotation. Results Significant difference was found for all treatment groups (p < 0.001) following a one-way ANOVA. The greatest change with the smallest standard deviation was for the combined treatment group IV, (mean change of 29°). Conclusion The difference for the combined treatment group was attributed to patients' receiving the best PT combined with structured "home therapy" that contributed an additional 90 hours of end-range stretching. This adjunct should be included in the standard of care for adhesive Capsulitis. Trial Registration Trial Number: NCT00873158 PMID:19735563

  17. In-hospital versus out-of-hospital pediatric cardiac arrest: A multicenter cohort study

    PubMed Central

    Moler, Frank W.; Meert, Kathleen; Donaldson, Amy E.; Nadkarni, Vinay; Brilli, Richard J.; Dalton, H.J.; Clark, Robert S. B.; Shaffner, D. H.; Schleien, Charles L.; Statler, Kimberly; Tieves, Kelly S.; Hackbarth, Richard; Pretzlaff, Robert; van der Jagt, Elise W.; Levy, Fiona; Hernan, Lynn; Silverstein, Faye S.; Dean, J Michael

    2009-01-01

    Objectives To describe a large multicenter cohort of pediatric cardiac arrest (CA) with return of circulation (ROC) from either the in-hospital (IH) or out-of-hospital (OH) setting in order to determine if significant differences related to pre-event, arrest event, early post-arrest event characteristics and outcomes exist that would be critical in planning a clinical trial of therapeutic hypothermia (TH). Design Retrospective cohort study Setting Fifteen Pediatric Emergency Care Applied Research Network (PECARN) sites. Patients Patients from 24 hours (h) to 18 years with either IH or OH CA who had a history of at least 1 minute of chest compressions and ROC for at least 20 minutes were eligible. Interventions None Measurements and Main Results A total of 491 patients met study entry criteria with 353 IH cases and 138 OH cases. Major differences between the IH and OH cohorts were observed for patient pre-arrest characteristics; arrest event initial rhythm described; and arrest medication use. Several post-arrest interventions were utilized differently, however, the use of TH was similar (<5%) in both cohorts. During the 0–12 h interval following ROC, OH cases had lower minimum temperature and pH, and higher maximum serum glucose recorded. Mortality was greater in the OH cohort (62% vs. 51%, p=0.04) with the cause attributed to a neurological indication much more frequent in the OH than IH cohort (69% vs. 20%; p < 0.01). Conclusions For pediatric CA with ROC, several major differences exist between IH and OH cohorts. The finding that the etiology of death was attributed to neurological indications much more frequently in OH arrests has important implications for future research. Investigators planning to evaluate the efficacy of new interventions such as TH should be aware that the IH and OH populations differ greatly and require independent clinical trials. PMID:19455024

  18. "Cancer 2015": A Prospective, Population-Based Cancer Cohort-Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic.

    PubMed

    Parisot, John P; Thorne, Heather; Fellowes, Andrew; Doig, Ken; Lucas, Mark; McNeil, John J; Doble, Brett; Dobrovic, Alexander; John, Thomas; James, Paul A; Lipton, Lara; Ashley, David; Hayes, Theresa; McMurrick, Paul; Richardson, Gary; Lorgelly, Paula; Fox, Stephen B; Thomas, David M

    2015-01-01

    "Cancer 2015" is a longitudinal and prospective cohort. It is a phased study whose aim was to pilot recruiting 1000 patients during phase 1 to establish the feasibility of providing a population-based genomics cohort. Newly diagnosed adult patients with solid cancers, with residual tumour material for molecular genomics testing, were recruited into the cohort for the collection of a dataset containing clinical, molecular pathology, health resource use and outcomes data. 1685 patients have been recruited over almost 3 years from five hospitals. Thirty-two percent are aged between 61-70 years old, with a median age of 63 years. Diagnostic tumour samples were obtained for 90% of these patients for multiple parallel sequencing. Patients identified with somatic mutations of potentially "actionable" variants represented almost 10% of those tumours sequenced, while 42% of the cohort had no mutations identified. These genomic data were annotated with information such as cancer site, stage, morphology, treatment and patient outcomes and health resource use and cost. This cohort has delivered its main objective of establishing an upscalable genomics cohort within a clinical setting and in phase 2 aims to develop a protocol for how genomics testing can be used in real-time clinical decision-making, providing evidence on the value of precision medicine to clinical practice. PMID:26529019

  19. Using Large Clinical Corpora for Query Expansion in Text-based Cohort Identification

    PubMed Central

    Zhu, Dongqing; Wu, Stephen; Carterette, Ben; Liu, Hongfang

    2014-01-01

    In light of the heightened problems of polysemy, synonymy, and hyponymy in clinical text, we hypothesize that patient cohort identification can be improved by using a large, in-domain clinical corpus for query expansion. We evaluate the utility of four auxiliary collections for the Text REtrieval Conference task of IR-based cohort retrieval, considering the effects of collection size, the inherent difficulty of a query, and the interaction between the collections. Each collection was applied to aid in cohort retrieval from the Pittsburgh NLP Repository by using a mixture of relevance models. Measured by mean average precision, performance using any auxiliary resource (MAP=0.386 and above) is shown to improve over the baseline query likelihood model (MAP=0.373). Considering subsets of the Mayo Clinic collection, we found that after including 2.5 billion term instances, retrieval is not improved by adding more instances. However, adding the Mayo Clinic collection did improve performance significantly over any existing setup, with a system using all four auxiliary collections obtaining the best results (MAP=0.4223). Because optimal results in the mixture of relevance models would require selective sampling of the collections, the common sense approach of “use all available data” is inappropriate. However, we found that it was still beneficial to add the Mayo corpus to any mixture of relevance models. On the task of IR-based cohort identification, query expansion with the Mayo Clinic corpus resulted in consistent and significant improvements. As such, any IR query expansion with access to a large clinical corpus could benefit from the additional resource. Additionally, we have shown that more data is not necessarily better, implying that there is value in collection curation. PMID:24680983

  20. Endogenous hormones and breast cancer: a prospective cohort study.

    PubMed

    Toniolo, P G; Pasternack, B S; Shore, R E; Sonnenschein, E; Koenig, K L; Rosenberg, C; Strax, P; Strax, S

    1991-05-01

    A cohort study is under way in New York City to evaluate how levels of endogenous reproductive hormones influence the risk of breast cancer. The study, in which approximately 15,000 women are being recruited, utilizes a prospective design in which volunteers are asked to provide repeated specimens of serum during the period 1985-1992. A case-control study nested within the cohort is planned by which specimens from all cases arising in the population and from a randomly selected sample of time-matched controls will be analyzed and compared. As of December 31, 1989, 13,609 volunteers had donated blood specimens, about 50% of whom had already donated more than once. Of the 187 incident breast cancer cases who are expected to arise in the cohort before the end of 1992, 77 have been detected thus far. PMID:1873553

  1. Clinical Attack Rate of Chikungunya in a Cohort of Nicaraguan Children.

    PubMed

    Balmaseda, Angel; Gordon, Aubree; Gresh, Lionel; Ojeda, Sergio; Saborio, Saira; Tellez, Yolanda; Sanchez, Nery; Kuan, Guillermina; Harris, Eva

    2016-02-01

    Chikungunya virus (CHIKV) was recently introduced into the Americas. In Nicaragua, the first endogenous transmission of CHIKV was recognized in September 2014. We used an ongoing dengue cohort study of children aged 2-14 years in Managua, Nicaragua, to document the attack rate of symptomatic chikungunya in a presumably naive population. From September 2014 through March 2015, the overall clinical attack rate of laboratory-confirmed CHIKV infection was 2.9% (95% confidence interval [CI]: 2.3%, 3.4%). The attack rate was greater in children ≥ 8 years of age (4.1%; 95% CI: 3.2%, 5.1%) than in those < 8 years of age (1.5%; 95% CI: 0.9%, 2.1%). The mean age of CHIKV cases presenting with typical chikungunya symptoms was 9.8 years, compared with 7.8 years for cases presenting with undifferentiated fever (P = 0.04). Our data suggest that the clinical attack rate in children may underestimate the true burden of disease as some children, especially young children, may experience more atypical symptoms (e.g., undifferentiated fever). PMID:26643531

  2. A Reverse Dipping Pattern Predicts Cardiovascular Mortality In a Clinical Cohort

    PubMed Central

    Kim, Bae Keun; Kim, Yu-Mi; Lee, Youngu; Lim, Young-Hyo

    2013-01-01

    An abnormal dipping pattern in ambulatory blood pressure monitoring (ABPM) is a cardiovascular (CV) risk factor. However, its impact on CV mortality has not been investigated sufficiently in clinical practice to be considered a standard parameter. We assessed the association between abnormal dipping patterns and increased CV mortality in a tertiary hospital in Korea. Our retrospective cohort study included 401 patients who underwent ABPM between 1994 and 1996 in Hanyang University Hospital, Seoul, Korea. The patients were classified as risers (<0% drop in systolic BP; n=107), and others included dippers and non-dippers (≥0% drop, n=294). The follow-up period was 120 months. The frequency of CV mortality was 14.0% in risers and 5.8% in others. A Cox regression analysis found a significant association between dipping pattern and CV mortality, after adjusting for age, gender, body mass index, hypertension, diabetes mellitus, smoking and hypercholesterolemia. Risers were at greater risk of CV death than others (RR, 3.02, P=0.022), but there was no difference in event rates between dippers and non-dippers. The reverse dipping pattern may be more frequent in clinical settings than in the population at large, and it is strongly associated with increased risk of CV mortality in Korea. PMID:24133351

  3. Increased Risk of Acute Kidney Injury following Pneumococcal Pneumonia: A Nationwide Cohort Study

    PubMed Central

    Lin, Te-Yu; Chen, Yu-Guang; Lin, Cheng-Li; Kao, Chia-Hung

    2016-01-01

    Purpose Pneumococcal disease leads to renal complications ranging from persistent proteinuria to end-stage renal disease. Studies on the association between pneumococcal pneumonia (PP) and acute kidney injury (AKI) are scant. This study assessed the relationship between PP and risk of AKI. Methods This nationwide population-based cohort study examined data from the Taiwan National Health Insurance Research Database for the period 2000–2011. We identified inpatients with newly diagnosed PP according to the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. In addition, we selected a comparison cohort from inpatient claims without the diagnosis of PP that was randomly frequency-matched with the PP cohort according to age, sex, index year and comorbidities. We analyzed the risks of AKI by using Cox proportional hazards regression models, adjusted for sex, age, and comorbidities. Results A total of 10,069 patients with PP and 10,069 controls were enrolled in this study. After adjustments for age, sex, and comorbidities, patients with PP had a 1.11-fold risk of developing AKI compared with the comparison cohort. Conclusion This study indicates that AKI risks are higher in patients with PP compared with the comparison cohort. Careful follow-up observation and aggressive treatment are necessary for patients with PP to reduce the risk of AKI. PMID:27362355

  4. Methodology of the Pelotas birth cohort study from 1982 to 2004-5, Southern Brazil

    PubMed Central

    Barros, Fernando C; Victora, Cesar G; Horta, Bernardo L; Gigante, Denise P

    2009-01-01

    OBJECTIVE: To describe the methods employed in the longitudinal and follow-up studies of children born in Pelotas (Southern Brazil) in 1982. METHODS: The cohort began with a perinatal health survey that included all 6,011 children born in maternity wards in Pelotas in 1982. The 5,914 children born alive in the city were included in the follow-up studies. By 2004-5, we had conducted eight follow-ups, which consisted of the administration of questionnaires to mothers and/or cohort members, depending on age, in addition to anthropometric and clinical examination. Cohort subjects are described in terms of demographic, socioeconomic, and health-related variables collected during early follow-up studies, which are used as exposure variables. RESULTS: The majority of subjects in the cohort were followed for 23 years and on multiple occasions. The most successful follow-ups were those preceded by a city census. Using this method, we were able to locate 87.2% of subjects in 1984 (mean age 19 months), 84.1% in 1986 (mean age 43 months), and 77.4% in 2004-5, and 77.4% in 2004-5 (mean age 23 years). CONCLUSIONS: Birth cohort studies can be carried out successfully in developing countries, and the methods employed in this life-cycle study have allowed us to investigate the influence of early exposures in determining disease outcomes in adult life. PMID:19142340

  5. Study Design and Outcomes of Korean Obstructive Lung Disease (KOLD) Cohort Study

    PubMed Central

    Park, Tai Sun; Lee, Jae Seung; Seo, Joon Beom; Hong, Yoonki; Yoo, Jung-Wan; Kang, Byung Ju; Lee, Sei Won; Oh, Yeon-Mok

    2014-01-01

    Background The Korean Obstructive Lung Disease (KOLD) Cohort Study is a prospective longitudinal study of patients with chronic obstructive pulmonary disease (COPD), asthma, or other unclassified obstructive lung diseases. It was designed to develop new classification models and biomarkers that predict clinically relevant outcomes for patients with obstructive lung diseases. Methods Patients over 18 years old who have chronic respiratory symptoms and airflow limitations or bronchial hyper-responsiveness were enrolled at 17 centers in South Korea. After a baseline visit, the subjects were followed up every 3 months for various assessments. Results From June 2005 to October 2013, a total of 477 subjects (433 [91%] males; 381 [80%] diagnosed with COPD) were enrolled. Analyses of the KOLD Cohort Study identified distinct phenotypes in patients with COPD, and predictors of therapeutic responses and exacerbations as well as the factors related to pulmonary hypertension in COPD. In addition, several genotypes were associated with radiological phenotypes and therapeutic responses among Korean COPD patients. Conclusion The KOLD Cohort Study is one of the leading long-term prospective longitudinal studies investigating heterogeneity of the COPD and is expected to provide new insights for pathogenesis and the long-term progression of COPD. PMID:24851130

  6. A study of the clinical and radiological features in a cohort of 93 patients with a COL2A1 mutation causing spondyloepiphyseal dysplasia congenita or a related phenotype.

    PubMed

    Terhal, Paulien A; Nievelstein, Rutger Jan A J; Verver, Eva J J; Topsakal, Vedat; van Dommelen, Paula; Hoornaert, Kristien; Le Merrer, Martine; Zankl, Andreas; Simon, Marleen E H; Smithson, Sarah F; Marcelis, Carlo; Kerr, Bronwyn; Clayton-Smith, Jill; Kinning, Esther; Mansour, Sahar; Elmslie, Frances; Goodwin, Linda; van der Hout, Annemarie H; Veenstra-Knol, Hermine E; Herkert, Johanna C; Lund, Allan M; Hennekam, Raoul C M; Mégarbané, André; Lees, Melissa M; Wilson, Louise C; Male, Alison; Hurst, Jane; Alanay, Yasemin; Annerén, Göran; Betz, Regina C; Bongers, Ernie M H F; Cormier-Daire, Valerie; Dieux, Anne; David, Albert; Elting, Mariet W; van den Ende, Jenneke; Green, Andrew; van Hagen, Johanna M; Hertel, Niels Thomas; Holder-Espinasse, Muriel; den Hollander, Nicolette; Homfray, Tessa; Hove, Hanne D; Price, Susan; Raas-Rothschild, Annick; Rohrbach, Marianne; Schroeter, Barbara; Suri, Mohnish; Thompson, Elizabeth M; Tobias, Edward S; Toutain, Annick; Vreeburg, Maaike; Wakeling, Emma; Knoers, Nine V; Coucke, Paul; Mortier, Geert R

    2015-03-01

    Type 2 collagen disorders encompass a diverse group of skeletal dysplasias that are commonly associated with orthopedic, ocular, and hearing problems. However, the frequency of many clinical features has never been determined. We retrospectively investigated the clinical, radiological, and genotypic data in a group of 93 patients with molecularly confirmed SEDC or a related disorder. The majority of the patients (80/93) had short stature, with radiological features of SEDC (n = 64), others having SEMD (n = 5), Kniest dysplasia (n = 7), spondyloperipheral dysplasia (n = 2), or Torrance-like dysplasia (n = 2). The remaining 13 patients had normal stature with mild SED, Stickler-like syndrome or multiple epiphyseal dysplasia. Over 50% of the patients had undergone orthopedic surgery, usually for scoliosis, femoral osteotomy or hip replacement. Odontoid hypoplasia was present in 56% (95% CI 38-74) and a correlation between odontoid hypoplasia and short stature was observed. Atlanto-axial instability, was observed in 5 of the 18 patients (28%, 95% CI 10-54) in whom flexion-extension films of the cervical spine were available; however, it was rarely accompanied by myelopathy. Myopia was found in 45% (95% CI 35-56), and retinal detachment had occurred in 12% (95% CI 6-21; median age 14 years; youngest age 3.5 years). Thirty-two patients complained of hearing loss (37%, 95% CI 27-48) of whom 17 required hearing aids. The ophthalmological features and possibly also hearing loss are often relatively frequent and severe in patients with splicing mutations. Based on clinical findings, age at onset and genotype-phenotype correlations in this cohort, we propose guidelines for the management and follow-up in this group of disorders. PMID:25604898

  7. Investing in Prospective Cohorts for Etiologic Study of Occupational Exposures

    EPA Science Inventory

    Prospective cohorts have played a major role in understanding the role of diet, physical activity, medical conditions, and genes in the development of many diseases, but have not been widely used in the study of occupational exposures. Studies in agriculture are an exception. W...

  8. Central auditory processing disorders: some cohorts studies.

    PubMed

    Demanez, L; Boniver, V; Dony-Closon, B; Lhonneux-Ledoux, F; Demanez, J P

    2003-01-01

    This paper presents an overview of the use of a French-speaking battery for the assessment of a central auditory processing disorder (CAPD) in a variety of clinical populations: prematurely born children; 8 years old children who had otitis media with effusion in early infancy; children with learning problems and dyslexia; French-speaking children attending Dutch and English schools; adults with King-Kopetzky syndrome and elderly hearing aids users. Population characteristics of each of these groups are presented and discussed. PMID:14714946

  9. Epilepsy in adults with mitochondrial disease: A cohort study

    PubMed Central

    Devine, Helen E.; Gorman, Grainne S.; Schaefer, Andrew M.; Horvath, Rita; Ng, Yi; Nesbitt, Victoria; Lax, Nichola Z.; McFarland, Robert; Cunningham, Mark O.; Taylor, Robert W.; Turnbull, Douglass M.

    2015-01-01

    Objective The aim of this work was to determine the prevalence and progression of epilepsy in adult patients with mitochondrial disease. Methods We prospectively recruited a cohort of 182 consecutive adult patients attending a specialized mitochondrial disease clinic in Newcastle upon Tyne between January 1, 2005 and January 1, 2008. We then followed this cohort over a 7‐year period, recording primary outcome measures of occurrence of first seizure, status epilepticus, stroke‐like episode, and death. Results Overall prevalence of epilepsy in the cohort was 23.1%. Mean age of epilepsy onset was 29.4 years. Prevalence varied widely between genotypes, with several genotypes having no cases of epilepsy, a prevalence of 34.9% in the most common genotype (m.3243A>G mutation), and 92.3% in the m.8344A>G mutation. Among the cohort as a whole, focal seizures, with or without progression to bilateral convulsive seizures, was the most common seizure type. Conversely, all of the patients with the m.8344A>G mutation and epilepsy experienced myoclonic seizures. Patients with the m.3243A>G mutation remain at high risk of developing stroke‐like episodes (1.16% per year). However, although the standardized mortality ratio for the entire cohort was high (2.86), this ratio did not differ significantly between patients with epilepsy (2.96) and those without (2.83). Interpretation Epilepsy is a common manifestation of mitochondrial disease. It develops early in the disease and, in the case of the m.3243A>G mutation, often presents in the context of a stroke‐like episode or status epilepticus. However, epilepsy does not itself appear to contribute to the increased mortality in mitochondrial disease. Ann Neurol 2015;78:949–957 PMID:26381753

  10. Etiology of atopy in infancy: the KOALA Birth Cohort Study.

    PubMed

    Kummeling, Ischa; Thijs, Carel; Penders, John; Snijders, Bianca E P; Stelma, Foekje; Reimerink, Johan; Koopmans, Marion; Dagnelie, Pieter C; Huber, Machteld; Jansen, Margje C J F; de Bie, Rob; van den Brandt, Piet A

    2005-12-01

    The aim of the KOALA Birth Cohort Study in the Netherlands is to identify factors that influence the clinical expression of atopic disease with a main focus on lifestyle (e.g., anthroposophy, vaccinations, antibiotics, dietary habits, breastfeeding and breast milk composition, intestinal microflora composition, infections during the first year of life, and gene-environment interaction). The recruitment of pregnant women started in October 2000. First, participants with 'conventional lifestyles' (n = 2343) were retrieved from an ongoing prospective cohort study (n = 7020) on pregnancy-related pelvic girdle pain. In addition, pregnant women (n = 491) with 'alternative lifestyles' with regard to child rearing practices, dietary habits (organic, vegetarian), vaccination schemes and/or use of antibiotics, were recruited through organic food shops, anthroposophic doctors and midwives, Steiner schools, and dedicated magazines. All participants were enrolled between 14 and 18 wk of gestation and completed an intake questionnaire on family history of atopy and infant care intentions. Documentation of other relevant variables started in the pregnant mother and covered the first and third trimester as well as early childhood by repeated questionnaires at 14-18, 30, and 34 wk of gestation and 3, 7, 12, and 24 months post-partum. A subgroup of participants, including both conventional and alternative lifestyles, was asked to consent to maternal blood sampling, breast milk and a faecal sample of the infant at 1 month post-partum, capillary blood at age 1 yr, venous blood and observation of manifestation of atopic dermatitis during home visits at the age of 2 yr (using the UK working party criteria and the severity scoring of atopic dermatitis index), and buccal swabs for DNA isolation from child-parent trios. From the start, ethical approval and informed consent procedures included gene-environment interaction studies. Follow-up at 3 and 7 months post-partum was completed with

  11. The Chronic Renal Insufficiency Cohort (CRIC) Study: Design and Methods.

    PubMed

    Feldman, Harold I; Appel, Lawrence J; Chertow, Glenn M; Cifelli, Denise; Cizman, Borut; Daugirdas, John; Fink, Jeffrey C; Franklin-Becker, Eunice D; Go, Alan S; Hamm, L Lee; He, Jiang; Hostetter, Tom; Hsu, Chi-Yuan; Jamerson, Kenneth; Joffe, Marshall; Kusek, John W; Landis, J Richard; Lash, James P; Miller, Edgar R; Mohler, Emile R; Muntner, Paul; Ojo, Akinlolu O; Rahman, Mahboob; Townsend, Raymond R; Wright, Jackson T

    2003-07-01

    Insights into end-stage renal disease have emerged from many investigations but less is known about the epidemiology of chronic renal insufficiency (CRI) and its relationship to cardiovascular disease (CVD). The Chronic Renal Insufficiency Cohort (CRIC) Study was established to examine risk factors for progression of CRI and CVD among CRI patients and develop models to identify high-risk subgroups, informing future treatment trials, and increasing application of preventive therapies. CRIC will enroll approximately 3000 individuals at seven sites and follow participants for up to 5 yr. CRIC will include a racially and ethnically diverse group of adults aged 21 to 74 yr with a broad spectrum of renal disease severity, half of whom have diagnosed diabetes mellitus. CRIC will exclude subjects with polycystic kidney disease and those on active immunosuppression for glomerulonephritis. Subjects will undergo extensive clinical evaluation at baseline and at annual clinic visits and via telephone at 6 mo intervals. Data on quality of life, dietary assessment, physical activity, health behaviors, depression, cognitive function, health care resource utilization, as well as blood and urine specimens will be collected annually. (125)I-iothalamate clearances and CVD evaluations including a 12-lead surface electrocardiogram, an echocardiogram, and coronary electron beam or spiral CT will be performed serially. Analyses planned in CRIC will provide important information on potential risk factors for progressive CRI and CVD. Insights from CRIC should lead to the formulation of hypotheses regarding therapy that will serve as the basis for targeted interventional trials focused on reducing the burden of CRI and CVD. PMID:12819321

  12. Existing data sources for clinical epidemiology: Scandinavian Cohort for osteonecrosis of the jaw – work in progress and challenges

    PubMed Central

    Schiodt, Morten; Larsson Wexell, Cecilia; Herlofson, Bente Brokstad; Giltvedt, Karen Marie; Norholt, Sven Erik; Ehrenstein, Vera

    2015-01-01

    Osteonecrosis of the jaw (ONJ) is a severe side effect associated with antiresorptive treatment. Monitoring of ONJ using routine databases in Scandinavian countries is a challenge owing to lack of valid algorithms and to heterogeneous referral practices. The aim of this paper is to describe the process of establishing a Scandinavian ONJ Cohort enrolling all ONJ cases related to antiresorptive treatment arising in Denmark, Norway, and Sweden between 2011 and 2019. The initial purpose of the cohort is to support an ongoing pharmacovigilance study of denosumab and zoledronic acid in Denmark, Norway, and Sweden. The three countries, with their 199 clinics, departments, and units of oral and maxillofacial surgery, both hospital-based and freestanding, differ somewhat in referral practices of the ONJ patients. By directly contacting all providers of care to ONJ patients in the three countries, we established a network for reporting incident cases to each country’s research database directly or through a member of the Scandinavian ONJ task force as a liaison. The task force includes a Scandinavian coordinator and three national coordinators collaborating directly with the clinics. A uniform ONJ registration form has been developed, and the relevant medical community has been informed either directly or through presentations at professional meetings. A website with study information is published in each country, and data entry is ongoing. This large-scale systematic uniform registration of ONJ cases in Denmark, Norway, and Sweden, with an underlying total population of more than 20 million people, merged into the Scandinavian ONJ Cohort, will contribute to better knowledge and understanding of this challenging group of patients, and ultimately, help improve patient care. The Scandinavian ONJ Cohort as a whole and its component national ONJ research databases may offer the potential for large-scale multinational intervention and safety studies in the future. PMID:25657594

  13. Exposure Assessment in Cohort Studies of Childhood Asthma

    PubMed Central

    Arrandale, Victoria H.; Brauer, Michael; Brook, Jeffrey R.; Brunekreef, Bert; Gold, Diane R.; London, Stephanie J.; Miller, J. David; Özkaynak, Halûk; Ries, Nola M.; Sears, Malcolm R.; Silverman, Frances S.; Takaro, Tim K.

    2011-01-01

    Background The environment is suspected to play an important role in the development of childhood asthma. Cohort studies are a powerful observational design for studying exposure–response relationships, but their power depends in part upon the accuracy of the exposure assessment. Objective The purpose of this paper is to summarize and discuss issues that make accurate exposure assessment a challenge and to suggest strategies for improving exposure assessment in longitudinal cohort studies of childhood asthma and allergies. Data synthesis Exposures of interest need to be prioritized, because a single study cannot measure all potentially relevant exposures. Hypotheses need to be based on proposed mechanisms, critical time windows for effects, prior knowledge of physical, physiologic, and immunologic development, as well as genetic pathways potentially influenced by the exposures. Modifiable exposures are most important from the public health perspective. Given the interest in evaluating gene–environment interactions, large cohort sizes are required, and planning for data pooling across independent studies is critical. Collection of additional samples, possibly through subject participation, will permit secondary analyses. Models combining air quality, environmental, and dose data provide exposure estimates across large cohorts but can still be improved. Conclusions Exposure is best characterized through a combination of information sources. Improving exposure assessment is critical for reducing measurement error and increasing power, which increase confidence in characterization of children at risk, leading to improved health outcomes. PMID:21081299

  14. Association Between Tuberculosis and Parkinson Disease: A Nationwide, Population-Based Cohort Study.

    PubMed

    Shen, Chih-Hao; Chou, Chung-Hsing; Liu, Feng-Cheng; Lin, Te-Yu; Huang, Wen-Yen; Wang, Yu-Chiao; Kao, Chia-Hung

    2016-02-01

    Few studies have investigated the association between tuberculosis (TB) and Parkinson disease (PD). This nationwide, population-based, retrospective cohort study investigated the risk of PD in patients with TB.We selected patients newly diagnosed with TB (International Classification of Diseases, Ninth Revision, Clinical Modification: 011) from 2000 to 2009 in the Taiwan National Health Insurance Database as the TB cohort. The comparison cohort (the non-TB cohort) was frequency matched to the TB cohort at a ratio of 4:1 by sex, age, and the index date. We analyzed the risks of PD by using Cox proportional hazard regression models.A total of 121,951 patients with TB and 487,800 non-TB controls were enrolled in this study. The TB cohort had a 1.38-fold risk of PD compared with the non-TB cohort after adjustment for age, sex, and comorbidities (aHR, 95% CI: 1.30-1.46). The adjusted risk of PD in the TB and non-TB cohorts increased in subgroups regardless of age, sex, and comorbidities. Combined effect of TB and comorbidities on the risk of PD were significant in patients with TB who had diabetes (aHR: 2.26, 95% CI: 2.02-2.52), hypertension (aHR: 2.23, 95% CI: 2.04-2.44), head injury (aHR: 2.32, 95% CI: 1.95-2.77), chronic kidney disease (aHR: 2.02, 95% CI: 1.49-2.72), chronic obstructive pulmonary disease (aHR: 1.84, 95% CI: 1.66-2.05), depression (aHR: 4.66, 95% CI: 3.59-6.05), dementia (aHR: 3.70, 95% CI: 2.99-4.59), and stroke (aHR: 2.56, 95% CI: 2.28-2.87). The risk of PD was higher in a follow-up within 1 year (aHR: 1.78, 95% CI: 1.58-2.00) and decreased with the follow-up period in the TB cohort.Patients with TB have an independently 1.38-fold risk of PD. The risk of PD decreased with the follow-up period in the TB cohort. Physicians should be aware of the risk of PD in patients with TB when treating such patients. PMID:26937925

  15. DRINKING WATER ARSENIC IN UTAH: A COHORT MORTALITY STUDY

    EPA Science Inventory

    The association of drinking water arsenic and mortality outcome was investigated in a cohort of residents from Millard County, Utah. Median drinking water arsenic concentrations for selected study towns ranged from 14 to 166 ppb and were from public and private samples collected ...

  16. The Southern Community Cohort Study: Investigating Health Disparities

    PubMed Central

    Signorello, Lisa B.; Hargreaves, Margaret K.; Blot, William J.

    2010-01-01

    Summary Over 73,700 adults age 40–79, nearly 70% African American, were recruited at community health centers across 12 southeastern states; individual characteristics were recorded and biologic specimens collected at baseline for later follow-up. The Southern Community Cohort Study is a unique national resource for assessing determinants of racial/ethnic differentials in diseases. PMID:20173283

  17. Teratogen risk counselling by internet: a prospective cohort study.

    PubMed

    Han, J-Y; Yang, J H; Chung, J H; Choi, J S; Ahn, H K; Ryu, H M; Kim, M Y; Cho, S I; Nava-Ocampo, A A

    2005-07-01

    Although the internet may play a role in providing proper teratogen-risk counselling for pregnant women, the experience with this type of service has not been reported. We aimed to compare the pregnancy outcome of women counselled by the internet to women that received typically in-clinic teratogen risk counselling in the clinic. In a prospective cohort design, 1,011 patients were counselled in the clinic and 235 patients were counselled via the internet. Teratogen risk counselling was provided according with the information obtained from medical literature and specialised software. Information about pregnancy outcome (delivery, spontaneous abortion, or termination of pregnancy and major malformations) was obtained from 903 (89.3%) patients from the clinic group and 141 (60%) from the internet group. The amount of alcohol, cigarettes smoked, and millirads of X-ray were greater ( p < 0.05) in patients counselled by internet than in clinic. The rate of deliveries, ongoing pregnancies, pregnancy terminations, and spontaneous abortions were similar between clinic and internet (chi2 = 1.32; p = 0.7). Of 498 babies born to mothers counselled in the clinic, major malformations were identified in 3.6%. Of 67 babies born to mothers counselled by internet, major malformations were present in 1.5% ( p = 0.6). Teratogen-risk counselling by internet and clinic seems to have a similar efficacy in pregnancy outcome. PMID:16183573

  18. ADHD in international adoptees: a national cohort study.

    PubMed

    Lindblad, Frank; Weitoft, Gunilla Ringbäck; Hjern, Anders

    2010-01-01

    Several investigators have reported an increased frequency of attention/hyperactivity symptoms in international adoptees, though population-based studies are lacking. In this national cohort study, we aimed to determine the prevalence of ADHD medication in international adoptees in Sweden, in comparison to the general population. A further purpose was to study gender, age at adoption and region of origin as predictors of ADHD medication in international adoptees. The study population consisted of all Swedish residents born in 1985-2000 with Swedish-born parents, divided into 16,134 adoptees, and a comparison population of 1,326,090. ADHD medications were identified in the Swedish Prescribed Drug Register during 2006. Logistic regression was used to calculate the odds ratios. The rates of ADHD medication were higher in international adoptees than in the comparison population for both boys (5.3 vs. 1.5% for 10-15-year olds) and girls (2.1 vs. 0.3% for 10-15-year olds). International adoptees from all regions of birth more often consumed ADHD medication compared with the majority population, but the age and sex adjusted odds ratios were particularly high for adoptees from Eastern Europe, Middle East/Africa and Latin America. Adjusting for maternal education and single parenthood increased the odds ratios even further. The risk also increased with higher age at adoption. Adoptees from Eastern Europe have a very high risk for ADHD medication. A structured identification and support programme should be tailored for this group. Adoptees from other regions have a more moderately increased risk, which should be communicated to adoptive parents and to professionals who care for adoptees in their clinical practice. PMID:19543791

  19. DEDUCE Clinical Text: An Ontology-based Module to Support Self-Service Clinical Notes Exploration and Cohort Development.

    PubMed

    Roth, Christopher; Rusincovitch, Shelley A; Horvath, Monica M; Brinson, Stephanie; Evans, Steve; Shang, Howard C; Ferranti, Jeffrey M

    2013-01-01

    Large amounts of information, as well as opportunities for informing research, education, and operations, are contained within clinical text such as radiology reports and pathology reports. However, this content is less accessible and harder to leverage than structured, discrete data. We report on an extension to the Duke Enterprise Data Unified Content Explorer (DEDUCE), a self-service query tool developed to provide clinicians and researchers with access to data within the Duke Medicine Enterprise Data Warehouse (EDW). The DEDUCE Clinical Text module supports ontology-based text searching, enhanced filtering capabilities based on document attributes, and integration of clinical text with structured data and cohort development. The module is implemented with open-source tools extensible to other institutions, including a Java-based search engine (Apache Solr) with complementary full-text indexing library (Lucene) employed with a negation engine (NegEx) modified by clinical users to include to local domain-specific negation phrases. PMID:24303270

  20. Interactive visual analysis of heterogeneous cohort-study data.

    PubMed

    Angelelli, Paolo; Oeltze, Steffen; Haász, Judit; Turkay, Cagatay; Hodneland, Erlend; Lundervold, Arvid; Lundervold, Astri J; Preim, Bernhard; Hauser, Helwig

    2014-01-01

    Medical cohort studies enable the study of medical hypotheses with many samples. Often, these studies acquire a large amount of heterogeneous data from many subjects. Usually, researchers study a specific data subset to confirm or reject specific hypotheses. A new approach enables the interactive visual exploration and analysis of such data, helping to generate and validate hypotheses. A data-cube-based model handles partially overlapping data subsets during the interactive visualization. This model enables seamless integration of the heterogeneous data and the linking of spatial and nonspatial views of the data. Researchers implemented this model in a prototype application and used it to analyze data acquired in a cohort study on cognitive aging. Case studies employed the prototype to study aspects of brain connectivity, demonstrating the model's potential and flexibility. PMID:25248201

  1. Cohort Profile: The French Childhood Cancer Survivor Study For Leukaemia (LEA Cohort)

    PubMed Central

    Berbis, Julie; Michel, Gérard; Baruchel, André; Bertrand, Yves; Chastagner, Pascal; Demeocq, François; Kanold, Justyna; Leverger, Guy; Plantaz, Dominique; Poirée, Marilyne; Stephan, Jean-Louis; Auquier, Pascal; Contet, Audrey; Dalle, Jean-Hugues; Ducassou, Stéphane; Gandemer, Virginie; Lutz, Patrick; Sirvent, Nicolas; Tabone, Marie-Dominique; Thouvenin-Doulet, Sandrine

    2015-01-01

    The main aim of the Leucémies de l’Enfant et l’Adolescent (LEA) project (Childhood and Adolescent Leukaemia) is to study the determinants (medical, socioeconomic, behavioural and environmental) of medium- and long-term outcomes of patients treated for childhood acute leukaemia (AL). The LEA study began in 2004 and is based on a French multicentric prospective cohort. Included are children treated for AL since January 1980 (incident and prevalent cases), surviving at month 24 for myeloblastic AL and lymphoblastic AL grafted in first complete remission or at month 48 for lymphoblastic AL not grafted in first complete remission. Information is collected during specific medical visits and notably includes the following data: socioeconomic data, AL history, physical late effects (such as fertility, cardiac function and metabolic syndrome) and quality of life. Data are collected every 2 years until the patient is 20 years old and has had a 10-year follow-up duration from diagnosis or last relapse. Thereafter, assessments are planned every 4 years. In active centres in 2013, eligible patients number more than 3000. The cohort has already included 2385 survivors, with rate of exhaustiveness of almost 80%. Data access can be requested from principal coordinators and must be approved by the steering committee. PMID:24639445

  2. CT maxillary sinus evaluation-A retrospective cohort study

    PubMed Central

    Vaz, Paula; Faria-Almeida, Ricardo; Braga, Ana-Cristina; Felino, António

    2015-01-01

    Background Proximity of the dental roots to the sinus floor makes dental disease a probable cause of maxillary sinusitis. The aim of this study was to find out if maxillary sinus pathologic changes were more prevalent in patients with dental disease and to evaluate the performance of computed tomography (CT) in analyzing and detecting apical periodontitis and other odontogenic causes on the maxillary sinusitis etiology in a Portuguese Caucasian population. Material and Methods Retrospective cohort study. The total sample of 504 patients and their CT was included in this study. The patients were from a private dental clinic, specializing in oral surgery, where the first complaint was not directly related to sinus disease, but with dental pathology. For each patient, the etiological factors of maxillary sinusitis and the imaging CT findings were analyzed. All the axial, coronal and sagittal CT slices were evaluated and general data were registered. The latter was selected based on the maxillary sinus CT published literature. Results 32.40% of patients presented normal sinus (without any etiological factor associated), 29.00% showed presence of etiological and imaging findings in the maxillary sinus, 20.60% had only imaging changes in the maxillary sinus and 18.00% of patients presented only etiological factors and no change in the maxillary sinus. Conclusions Radiological imaging is an important tool for establishing the diagnosis of maxillary sinus pathology. These results indicate that the CT scan should be an excellent tool for complement the odontogenic sinusitis diagnosis. Key words: Maxillary sinusitis/etiology, odontogenic, computed tomography, maxillary sinus. PMID:25858084

  3. Evolution of prodromal clinical markers of Parkinson disease in a glucocerebrosidase mutation positive cohort

    PubMed Central

    Beavan, Michelle; McNeill, Alisdair; Proukakis, Christos; Hughes, Derralynn A; Mehta, Atul; Schapira, Anthony H V

    2015-01-01

    Importance Numerically, the most important genetic risk factor for the development of Parkinson disease (PD) is the presence of a glucocerebrosidase gene (GBA) mutation. Objective The purpose of this study was the longitudinal clinical evaluation of a GBA mutation positive cohort and the evolution of the prodromal features of PD. Design Individuals were participants in a study of the aetiology and prodrome of PD and have been re-evaluated in this 2 year follow-up report. Setting Clinic-based. Participants Type 1 GD patients and heterozygous GBA mutation positive carriers were recruited in 2010 from the Lysosomal Storage Disorder Unit at the Royal Free Hospital, London. Thirty previously diagnosed Type 1 GD patients, twenty-eight heterozygous GBA mutation carriers and twenty-six genetically unrelated controls were included. For both GD and carrier subjects, exclusion criteria included a diagnosis of PD or dementia and for controls, any existing neurological disease. Main Outcome(s) and Measure(s) Assessment was performed for clinical markers including hyposmia, rapid eye movement sleep behaviour disorder (RBD), depression, autonomic dysfunction, cognitive function and parkinsonian motor signs (UPDRS part III). Results Over 2 years, depression scores were significantly worse in heterozygotes (P = ·01), RBD scores were significantly worse in GD patients (P < ·001) and heterozygotes (P < ·001), and UPDRS III scores were significantly worse in GD patients (P < ·001) and heterozygotes (P < ·001). In controls, there was a small but significant deterioration in the UPDRS II score (P = ·006). At 2 years, olfactory and cognitive assessment scores were lower in GD patients and heterozygotes compared to controls, but did not differ significantly from baseline. When the results from GD patients and heterozygotes were combined, there was a significant deterioration from baseline in RBD, BDI, UPDRS II and III scores (in all, P < ·01), and at 2 years, significant

  4. A cohort study on Actinobacillus pleuropneumoniae colonisation in suckling piglets.

    PubMed

    Tobias, T J; Klinkenberg, D; Bouma, A; van den Broek, J; Daemen, A J J M; Wagenaar, J A; Stegeman, J A

    2014-06-01

    Actinobacillus pleuropneumoniae causes respiratory disease in pigs and despite the use of preventive measures such as vaccination and antimicrobials clinical outbreaks still occur. At weaning often many piglets are not colonised. If differences in prevalence between litters are large and if factors were known that could explain these differences, this may provide an opportunity to raise groups of A. pleuropneumoniae free piglets. To this end, a cohort study was performed on two endemically infected farrow-to-finish farms. Seventy-six of 133 sows were selected using stratified random selection by parity. Farmers complied with a strict hygiene and animal management protocol to prevent transmission between litters. Tonsil brush and serum samples taken three weeks before parturition were tested for antigen with an apxIVA qPCR and antibodies with Apx and Omp ELISAs, respectively. Three days before weaning tonsil brush samples from all piglets (n=871) were collected and tested for antigen. Whereas all sows tested positive both in serology tests as well as qPCR, 0.41 of the litters tested fully negative and 0.73 of all piglets tested negative. The proportion of positively tested piglets in positive litters ranged from 0.08-1.0 (median=0.36). A grouped logistic regression model with a beta binomial distribution of the probability for piglets to become infected was fitted to the data and associations with explanatory variables were explored. To test the possibility that alternatively the clustering was caused by onwards transmission among the piglets, a transmission model was fitted to the data incorporating sow-piglet and piglet-piglet transmission, but this model did not fit better. The results of this study showed that the number of colonised suckling piglets was highly clustered and mainly attributable to the variability of infectiousness of the dam, but no dam related risk factor for colonisation status of litter or piglets within litters could be identified. PMID

  5. A Prospective Cohort Study of Mineral Metabolism After Kidney Transplantation

    PubMed Central

    Wolf, Myles; Weir, Matthew R.; Kopyt, Nelson; Mannon, Roslyn B.; Von Visger, Jon; Deng, Hongjie; Yue, Susan; Vincenti, Flavio

    2016-01-01

    Background Kidney transplantation corrects or improves many complications of chronic kidney disease, but its impact on disordered mineral metabolism is incompletely understood. Methods We performed a multicenter, prospective, observational cohort study of 246 kidney transplant recipients in the United States to investigate the evolution of mineral metabolism from pretransplant through the first year after transplantation. Participants were enrolled into 2 strata defined by their pretransplant levels of parathyroid hormone (PTH), low PTH (>65 to ≤300 pg/mL; n = 112), and high PTH (>300 pg/mL; n = 134) and underwent repeated, longitudinal testing for mineral metabolites. Results The prevalence of posttransplant, persistent hyperparathyroidism (PTH >65 pg/mL) was 89.5%, 86.8%, 83.1%, and 86.2%, at months 3, 6, 9, and 12, respectively, among participants who remained untreated with cinacalcet, vitamin D sterols, or parathyroidectomy. The results did not differ across the low and high PTH strata, and rates of persistent hyperparathyroidism remained higher than 40% when defined using a higher PTH threshold greater than 130 pg/mL. Rates of hypercalcemia peaked at 48% at week 8 in the high PTH stratum and then steadily decreased through month 12. Rates of hypophosphatemia (<2.5 mg/dL) peaked at week 2 and then progressively decreased through month 12. Levels of intact fibroblast growth factor 23 decreased rapidly during the first 3 months after transplantation in both PTH strata and remained less than 40 pg/mL thereafter. Conclusions Persistent hyperparathyroidism is common after kidney transplantation. Further studies should determine if persistent hyperparathyroidism or its treatment influences long-term posttransplantation clinical outcomes. PMID:26177089

  6. Effects of angiotensin-converting enzyme inhibitors and beta blockers on clinical outcomes in patients with and without coronary artery obstructions at angiography (from a Register-Based Cohort Study on Acute Coronary Syndromes).

    PubMed

    Manfrini, Olivia; Morrell, Christine; Das, Rajiv; Barth, Julian H; Hall, Alistair S; Gale, Christopher P; Cenko, Edina; Bugiardini, Raffaele

    2014-05-15

    We sought to determine the effectiveness of angiotensin-converting enzyme (ACE) inhibition and β-blocker treatment as a function of the degree of coronary artery disease (CAD) obstruction at angiography. The Evaluation of Methods and Management of Acute Coronary Events registry enrolled patients who had been hospitalized for an acute coronary syndrome. There were 1,602 patients who had cardiac catheterization that were used for this analysis. The main outcome measures were evidence-based therapies prescribed at discharge and 6-month incidence of all-cause mortality. The cohort consisted of 1,252 patients with obstructive CAD (>50% luminal diameter obstructed) and 350 patients with nonobstructive CAD. Multivariate logistic regression analysis adjusted for further medications and other clinical factors was performed. Patients with nonobstructive CAD had significantly (p <0.001) higher rates of β-blocker (77.8% vs 63.3%) and lower rates of ACE-inhibitor (57.7% vs 66.4%) prescriptions. In patients with nonobstructive CAD, ACE-inhibitor therapy was clearly associated with a lower 6-month mortality (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.03 to 0.78, p = 0.004). No significant association between β-blocker use and death was found. In patients with obstructive CAD, both β blockers (OR 0.47, 95% CI 0.32 to 0.67, p <0.001) and ACE inhibitors (OR 0.47, 95% CI 0.26 to 0.87, p = 0.01) were significantly associated with a reduced risk of 6-month mortality. In conclusion, ACE-inhibitor therapy seems to be an effective first-line treatment for preventing the occurrence of mortality in patients with nonobstructive CAD. PMID:24698468

  7. Findings from longitudinal cohort studies: Gothenburg and Jerusalem.

    PubMed

    Stessman, J; Hammerman-Rozenberg, R; Svanborg, A

    1996-08-01

    The longitudinal study of age-homogeneous cohorts is a powerful tool to elucidate age-related changes and to attempt to distinguish normal aging from the effects of disease. Many influences, such as the effect of changing lifestyle, medical practices and environmental factors with time must be considered when designing and interpreting such studies. Cross-cultural differences manifest in comparing different studies must also be accounted for, but alternately provide a tool to distinguish between endogenous and exogenous factors influencing human aging. The first stage of the longitudinal study of 70 year olds in Gothenburg, Sweden, a cross-sectional survey performed in 1971, is compared to a similar cross-sectional survey performed in Jerusalem in 1991 as part of a projected longitudinal study. The similarities between the two cohorts with regard to living conditions, functional independence and disease prevalence are striking. There are also significant contrasts that reflect the 20 years that elapsed between the execution of the two studies, as well as the cultural and social differences. In particular, the ethnic diversity of the Jerusalem population, hailing from 40 separate countries, is emphasized. The comparison of these two studies highlights many of the principles critical to the role of longitudinal cohort studies in gerontology. PMID:8816868

  8. A cross sectional study of two independent cohorts identifies serum biomarkers for facioscapulohumeral muscular dystrophy (FSHD).

    PubMed

    Petek, Lisa M; Rickard, Amanda M; Budech, Christopher; Poliachik, Sandra L; Shaw, Dennis; Ferguson, Mark R; Tawil, Rabi; Friedman, Seth D; Miller, Daniel G

    2016-07-01

    Measuring the severity and progression of facioscapulohumeral muscular dystrophy (FSHD) is particularly challenging because muscle weakness progresses over long periods of time and can be sporadic. Biomarkers are essential for measuring disease burden and testing treatment strategies. We utilized the sensitive, specific, high-throughput SomaLogic proteomics platform of 1129 proteins to identify proteins with levels that correlate with FSHD severity in a cross-sectional study of two independent cohorts. We discovered biomarkers that correlate with clinical severity and disease burden measured by magnetic resonance imaging. Sixty-eight proteins in the Rochester cohort (n = 48) and 51 proteins in the Seattle cohort (n = 30) had significantly different levels in FSHD-affected individuals when compared with controls (p-value ≤ .005). A subset of these varied by at least 1.5 fold and four biomarkers were significantly elevated in both cohorts. Levels of creatine kinase MM and MB isoforms, carbonic anhydrase III, and troponin I type 2 reliably predicted the disease state and correlated with disease severity. Other novel biomarkers were also discovered that may reveal mechanisms of disease pathology. Assessing the levels of these biomarkers during clinical trials may add significance to other measures of quantifying disease progression or regression. PMID:27185459

  9. Critical Pertussis Illness in Children, A Multicenter Prospective Cohort Study

    PubMed Central

    Berger, John T.; Carcillo, Joseph A.; Shanley, Thomas P.; Wessel, David L.; Clark, Amy; Holubkov, Richard; Meert, Kathleen L.; Newth, Christopher J.L.; Berg, Robert A.; Heidemann, Sabrina; Harrison, Rick; Pollack, Murray; Dalton, Heidi; Harvill, Eric; Karanikas, Alexia; Liu, Teresa; Burr, Jeri S.; Doctor, Allan; Dean, J. Michael; Jenkins, Tammara L.; Nicholson, Carol E.

    2013-01-01

    Objective Pertussis persists in the United States despite high immunization rates. The present report characterizes the presentation and acute course of critical pertussis by quantifying demographic data, laboratory findings, clinical complications, and critical care therapies required among children requiring admission to the pediatric intensive care unit (PICU). Design Prospective cohort study. Setting Eight PICUs comprising the Eunice Kennedy Shriver National Institute for Child Health and Human Development Collaborative Pediatric Critical Care Research Network and 17 additional PICUs across the United States. Patients Eligible patients had laboratory confirmation of pertussis infection, were < 18 years of age, and died in the PICU or were admitted to the PICU for at least 24 hours between June 2008 and August 2011. Interventions None. Measurements and Main Results 127 patients were identified. Median age was 49 days, and 105 (83%) patients were < 3 months of age. Fifty-five (43%) required mechanical ventilation. Twelve (9.4%) died during initial hospitalization. Pulmonary hypertension was found in 16 patients (12.5%), and was present in 75% of patients who died, compared with 6% of survivors (p< 0.001). Median white blood cell count (WBC) was significantly higher in those requiring mechanical ventilation (p<0.001), those with pulmonary hypertension (p<0.001) and non-survivors (p<0.001). Age, sex and immunization status did not differ between survivors and non-survivors. Fourteen patients received leukoreduction therapy (exchange transfusion (12), leukopheresis (1) or both (1)). Survival benefit was not apparent. Conclusions Pulmonary hypertension may be associated with mortality in pertussis critical illness. Elevated WBC is associated with the need for mechanical ventilation, pulmonary hypertension, and mortality risk. Research is indicated to elucidate how pulmonary hypertension, immune responsiveness, and elevated WBC contribute to morbidity and mortality

  10. Allergy to complex platinum salts: A historical prospective cohort study.

    PubMed Central

    Niezborala, M; Garnier, R

    1996-01-01

    OBJECTIVE: To assess the incidence of allergy to complex platinum salts in a platinum refinery. METHODS: A historical prospective cohort study was carried out on 77 workers (67 men) who started work between 1 January 1979 and 31 December 1991 and who were not atopic on skin prick tests to three common allergens at the time of recruitment. Skin prick tests with complex platinum salts were carried out and diagnosis of allergy to complex platinum salts made by the company's doctor. Skin tests and medical examinations were carried out routinely every six months. Follow up was until 30 September 1992 or until leaving refinery work. RESULTS: 18 workers developed a positive result on skin tests and 23 developed symptoms, including all 18 subjects with positive skin tests; the probability of surviving (95% confidence interval (95% CI)) for 72 months after joining the company, with negative skin test results was 0.67 (0.51-0.79) or with no symptoms was 0.63 (0.49-0.75). The incidence of positive skin tests and symptoms was highest during the first two years of work. Symptoms occurred more frequently in September and October than during the other months of the year. The exclusion of atopic subjects did not seem to have resulted in a lower incidence of sensitisation. Smoking was a significant predictive factor for both positive skin tests (estimated relative risk 5.53) and symptoms (4.70). CONCLUSION: The findings confirm that smoking is and that atopy may not be a high risk factor for the development of allergy to complex platinum salts. The high incidence of sensitisation and the available data on the clinical course of sensitised workers show that sensitised workers must be promptly and completely removed from exposure. PMID:8664963

  11. Pulse oximetry in a cohort study of sickle cell disease.

    PubMed

    Homi, J; Levee, L; Higgs, D; Thomas, P; Serjeant, G

    1997-03-01

    Oxygen saturation was determined by pulse oximetry in a representative sample of Jamaican patients with steady-state sickle cell disease in a cohort study from birth. There were 220 with homozygous sickle cell (SS) disease and 142 with sickle cell-haemoglobin C (SC) disease aged 9-18 years, and 122 with a normal haemoglobin (AA) genotype aged 15-18 years. Pulse oximetry (SpO2) values were lower in SS disease (mean [95% confidence interval], 92.5 [92.0-93.0]) than in SC disease (96.7[96.5-96.9]) or AA controls (97.1 [96.8-97.3]). Inhalation of 100% oxygen in SS patients with O2 saturations below 90% consistently increased saturation to 99-100%. In SS disease, SpO2 correlated positively with haemoglobin and fetal haemoglobin and negatively with reticulocyte counts but not with MCHC, MCV or bilirubin level. Mean SpO2 in SS subjects with a normal alpha globin gene complement (mean [SD], 91.7 [3.9]%) was lower than in heterozygotes (93.4 [4.0]%) or homozygotes (96.1 [3.0]%) for alpha+ thalassaemia, the effects of alpha-thalassaemia not being explained by differences in haemoglobin or MCHC. In SS disease, SpO2 levels were not associated with age (within this age range), sex, number of sick clinic visits or number of hospital admissions. Higher SpO2 levels were associated with greater height and weight, more frequent painful crises and less frequent acute chest syndrome, but these associations were not significant after adjustment for haemoglobin level. Desaturation is common in steady-state SS disease and knowledge of the individual's steady-state value may be important in the interpreting low values during acute complications. PMID:9146942

  12. Does palliative home oxygen improve dyspnoea? A consecutive cohort study.

    PubMed

    Currow, D C; Agar, M; Smith, J; Abernethy, A P

    2009-06-01

    Palliative oxygen for refractory dyspnoea is frequently prescribed, even when the criteria for long-term home oxygen (based on survival, rather than the symptomatic relief of breathlessness) are not met. Little is known about how palliative home oxygen affects symptomatic breathlessness. A 4-year consecutive cohort from a regional community palliative care service in Western Australia was used to compare baseline breathlessness before oxygen therapy with dyspnoea sub-scales on the symptom assessment scores (SAS; 0-10) 1 and 2 weeks after the introduction of oxygen. Demographic and clinical characteristics of people who responded were included in a multi-variable logistic regression model. Of the study population (n = 5862), 21.1% (n = 1239) were prescribed oxygen of whom 413 had before and after data that could be included in this analysis. The mean breathlessness before home oxygen was 5.3 (SD 2.5; median 5; range 0-10). There were no significant differences overall at 1 or 2 weeks (P = 0.28) nor for any diagnostic sub-groups. One hundred and fifty people (of 413) had more than a 20% improvement in mean dyspnoea scores. In multi-factor analysis, neither the underlying diagnosis causing breathlessness nor the demographic factors predicted responders at 1 week. Oxygen prescribed on the basis of breathlessness alone across a large population predominantly with cancer does not improve breathlessness for the majority of people. Prospective randomised trials in people with cancer and non-cancer are needed to determine whether oxygen can reduce the progression of breathlessness compared to a control arm. PMID:19304806

  13. Comorbid Depression and Heart Failure: A Community Cohort Study

    PubMed Central

    Mair, Frances S.; Roger, Véronique L.; Weston, Susan A.; Jiang, Ruoxiang; Chamberlain, Alanna M.

    2016-01-01

    Objective To examine the association between depression and clinical outcomes in heart failure (HF) in a community cohort. Patients and Methods HF patients in Minnesota, United States completed depression screening using the 9-item Patient Health Questionnaire (PHQ-9) between 1st Oct 2007 and 1st Dec 2011; patients with PHQ-9≥5 were labelled “depressed”. We calculated the risk of death and first hospitalization within 2 years using Cox regression. Results were adjusted for 10 commonly used prognostic factors (age, sex, systolic blood pressure, estimated glomerular filtration rate, serum sodium, ejection fraction, blood urea nitrogen, brain natriuretic peptide, presence of diabetes and ischaemic aetiology). Area under the curve (AUC), integrated discrimination improvement (IDI) and net reclassification improvement (NRI) compared depression as a predictor against the aforementioned factors. Results 425 patients (mean age 74, 57.6% males) were included in the study; 179 (42.1%) had PHQ-9≥5. The adjusted hazard ratio of death was 2.02 (95% CI 1.34–3.04) and of hospitalization was 1.42 (95% CI 1.13–1.80) for those with compared to those without depression. Adding depression to the models did not appreciably change the AUC but led to statistically significant improvements in both the IDI (p = 0.001 and p = 0.005 for death and hospitalization, respectively) and NRI (for death and hospitalization, 35% (p = 0.002) and 27% (p = 0.007) were reclassified correctly, respectively). Conclusion Depression is frequent among community patients with HF and associated with increased risk of hospitalizations and death. Risk prediction for death and hospitalizations in HF patients can be improved by considering depression. PMID:27362359

  14. Calcium intake and risk of hip fracture in men and women a meta-analysis of prospective cohort studies and randomized controlled trials

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The role of total calcium intake for the prevention of hip fracture risk has not been well established. The objective of this analysis was to assess the relation of calcium intake to risk of hip fracture based on meta-analyses of cohort studies and clinical trials. In cohort studies in women (7 stu...

  15. Systematic review of birth cohort studies in Africa

    PubMed Central

    Campbell, Alasdair; Rudan, Igor

    2011-01-01

    Aim In sub-Saharan Africa, unacceptably high rates of mortality amongst women and children continue to persist. The emergence of research employing new genomic technologies is advancing knowledge on cause of disease. This review aims to identify birth cohort studies conducted in sub-Saharan Africa and to consider their suitability as a platform to support genetic epidemiological studies. Methods A systematic literature review was conducted to identify birth cohort studies in sub-Saharan Africa across the following databases: MEDLINE, EMBASE, AFRO and OpenSIGLE. A total of 8110 papers were retrieved. Application of inclusion/exclusion criteria retained only 189 papers, of which 71 met minimum quality criteria and were retained for full text analysis. Results The search revealed 28 birth cohorts: 14 of which collected biological data, 10 collected blood samples and only one study collected DNA for storage. These studies face many methodological challenges: notably, high rates of attrition and lack of funding for several rounds of study follow up. Population-based ‘biobanks’ have emerged as a major approach to harness genomic technologies in health research and yet the sub-Saharan African region still awaits large scale birth cohort biobanks collecting DNA and associated health and lifestyle data. Conclusion Investment in this field, together with related endeavours to foster and develop research capacity for these studies, may lead to an improved understanding of the determinants of intrauterine growth and development, birth outcomes such as prematurity and low birth weight, the links between maternal and infant health, survival of infectious diseases in the first years of life, and response to vaccines and antibiotic treatment. PMID:23198102

  16. Clinical Characteristics of a Cohort of 244 Patients with Congenital Adrenal Hyperplasia

    PubMed Central

    Finkielstain, Gabriela P.; Kim, Mimi S.; Sinaii, Ninet; Nishitani, Miki; Van Ryzin, Carol; Hill, Suvimol C.; Reynolds, James C.; Hanna, Reem M.

    2012-01-01

    Context: Patients with congenital adrenal hyperplasia (CAH) often suffer from long-term complications secondary to chronic glucocorticoid therapy and suboptimal treatment regimens. Objective: The aim of the study was to describe clinical characteristics of a large cohort of pediatric and adult CAH patients. Design and Setting: We conducted a cross-sectional study of 244 CAH patients [183 classic, 61 nonclassic (NC)] included in a Natural History Study at the National Institutes of Health. Main Outcome Measure(s): Outcome variables of interest were height sd score, obesity, hypertensive blood pressure (BP), insulin resistance, metabolic syndrome, bone mineral density, hirsutism (females), and testicular adrenal rest (TART). Results: The majority had elevated or suppressed androgens, with varied treatment regimens. Mean adult height sd score was −1.0 ± 1.1 for classic vs. −0.4 ± 0.9 for NC patients (P = 0.015). Obesity was present in approximately one third of patients, across phenotypes. Elevated BP was more common in classic than NC patients (P ≤ 0.01); pediatric hypertensive BP was associated with suppressed plasma renin activity (P = 0.001). Insulin resistance was common in classic children (27%) and adults (38% classic, 20% NC); 18% of adults had metabolic syndrome. The majority (61%) had low vitamin D; 37% of adults had low bone mineral density. Hirsutism was common (32% classic; 59% NC women). TART was found in classic males (33% boys; 44% men). Conclusions: Poor hormonal control and adverse outcomes are common in CAH, necessitating new treatments. Routine monitoring of classic children should include measuring BP and plasma renin activity. Osteoporosis prophylaxis and TART screening should begin during childhood. A longitudinal study is under way. PMID:22990093

  17. DISTRESS AND PTSD IN PATIENTS WITH CANCER: COHORT STUDY CASE

    PubMed Central

    Pranjic, Nurka; Bajraktarevic, Amila; Ramic, Enisa

    2016-01-01

    Introduction: embarrassed emotional experience may affect the ability to oncology patient effectively cope with cancer, symptoms and treatment. Distress extends a long period, from common, normal feelings of vulnerability, sadness and fears to problems of PTSD, depression, anxiety, panic, social isolation and the perception of spiritual crisis. The aim of the research is to determine the level of distress and PTSD in cancer patients. Patients and Methods: In a prospective, cohort study cases from 2011- 2014 were included patients with cancer who are treated under the supervision of his chosen family medicine doctor. Including a factor for the participation of patients in the study is that from the moment of diagnosis of malignant disease passed <12 months. The total sample was 174 of the planned 200 (response rate=87%). The subjects were divided into three groups. A key factor in the creation of the group was the time elapsed from the moment of acknowledgment and confirmation of the diagnosis: T1 <14 days, n=56 patients; T2>14 days-<6 months, n=79 patients; T3>6 months n=39 patients. To achieve the set goals of the research was used instruments of 3 questionnaires: Questionnaire on the clinical characteristics of patients with malignant disease, demographic and individual characteristics; questionnaire distress oncology patient–hospital scales of depression and anxiety, HADS scale (Hospital Anxiety and Depression Scale - HADS) and a rapid test for self-assessment of the symptoms of PTSD. Results: Age of patients was 54.63 ± 11:46 years, and the age of the respondents when they were diagnosed with cancer 54.34 ± 11.26 years. The prevalence of distress was a high 76% 82x higher than expected), and PTSD 55%. Predictors of burnout syndrome in cancer patients are all important determinants of malignant disease: the time elapsed since the diagnosis of the disease which determines the clinical status of malignant disease (β=0.280; P=0.001; 95% CI, 0742

  18. Predicting Reading and Spelling Disorders: A 4-Year Prospective Cohort Study

    PubMed Central

    Bigozzi, Lucia; Tarchi, Christian; Caudek, Corrado; Pinto, Giuliana

    2016-01-01

    In this 4-year prospective cohort study, children with a reading and spelling disorder, children with a spelling impairment, and children without a reading and/or spelling disorder (control group) in a transparent orthography were identified in third grade, and their emergent literacy performances in kindergarten compared retrospectively. Six hundred and forty-two Italian children participated. This cohort was followed from the last year of kindergarten to third grade. In kindergarten, the children were assessed in phonological awareness, conceptual knowledge of writing systems and textual competence. In third grade, 18 children with a reading and spelling impairment and 13 children with a spelling impairment were identified. Overall, conceptual knowledge of the writing system was the only statistically significant predictor of the clinical samples. No differences were found between the two clinical samples. PMID:27014145

  19. The German Thorotrast Cohort Study: a review and how to get access to the data.

    PubMed

    Grosche, B; Birschwilks, M; Wesch, H; Kaul, A; van Kaick, G

    2016-08-01

    It is well known that exposures like those from (226)Ra, (224)Ra and Thorotrast(®) injections increase the risk of neoplasia in bone marrow and liver. The thorium-based radioactive contrast agent Thorotrast(®) was introduced in 1929 and applied worldwide until the 1950s, especially in angiography and arteriography. Due to the extremely long half-life of several hundred years and the life-long retention of the thorium dioxide particles in the human body, patients suffer lifetime internal exposure. The health effects from the incorporated thorium were investigated in a few cohort studies with a German study being the largest among them. This retrospective cohort study was set up in 1968 with a follow-up until 2004. The study comprises 2326 Thorotrast patients and 1890 patients of a matched control group. For those being alive at the start of the study in 1968 follow-up was done by clinical examinations on a biannual basis. For the others, causes of death were collected in various ways. Additionally, clinical, radiological and biophysical studies of patients were conducted and large efforts were made to best estimate the radiation doses associated with incorporation of the Thorotrast. The aim of this paper is to describe the cohort, important results and some open questions. The data from the German Thorotrast Study are available to other interested researchers. Information can be found at http://storedb.org . PMID:27154786

  20. Incidence of and risk factors for cognitive impairment in an early Parkinson disease clinical trial cohort

    PubMed Central

    Uc, E Y.; McDermott, M P.; Marder, K S.; Anderson, S W.; Litvan, I; Como, P G.; Auinger, P; Chou, K L.; Growdon, J C.

    2009-01-01

    Objective: To investigate the incidence of and risk factors for cognitive impairment in a large, well-defined clinical trial cohort of patients with early Parkinson disease (PD). Methods: The Mini-Mental State Examination (MMSE) was administered periodically over a median follow-up period of 6.5 years to participants in the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism trial and its extension studies. Cognitive impairment was defined as scoring 2 standard deviations below age- and education-adjusted MMSE norms. Results: Cumulative incidence of cognitive impairment in the 740 participants with clinically confirmed PD (baseline age 61.0 ± 9.6 years, Hoehn-Yahr stage 1–2.5) was 2.4% (95% confidence interval: 1.2%–3.5%) at 2 years and 5.8% (3.7%–7.7%) at 5 years. Subjects who developed cognitive impairment (n = 46) showed significant progressive decline on neuropsychological tests measuring verbal learning and memory, visuospatial working memory, visuomotor speed, and attention, while the performance of the nonimpaired subjects (n = 694) stayed stable. Cognitive impairment was associated with older age, hallucinations, male gender, increased symmetry of parkinsonism, increased severity of motor impairment (except for tremor), speech and swallowing impairments, dexterity loss, and presence of gastroenterologic/urologic disorders at baseline. Conclusions: The relatively low incidence of cognitive impairment in the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism study may reflect recruitment bias inherent to clinical trial volunteers (e.g., younger age) or limitations of the Mini-Mental State Examination–based criterion. Besides confirming known risk factors for cognitive impairment, we identified potentially novel predictors such as bulbar dysfunction and gastroenterologic/urologic disorders (suggestive of autonomic dysfunction) early in the course of the disease. GLOSSARY CI = confidence interval; COWA = Controlled Word Association

  1. An Update of the Mayo Clinic Cohort of Patients With Adult Primary Central Nervous System Vasculitis

    PubMed Central

    Salvarani, Carlo; Brown, Robert D.; Christianson, Teresa; Miller, Dylan V.; Giannini, Caterina; Huston, John; Hunder, Gene G.

    2015-01-01

    Abstract Primary central nervous system vasculitis (PCNSV) is an uncommon condition in which lesions are limited to vessels of the brain and spinal cord. Because the clinical manifestations are not specific, the diagnosis is often difficult, and permanent disability and death are frequent outcomes. This study is based on a cohort of 163 consecutive patients with PCNSV who were examined at the Mayo Clinic over a 29-year period from 1983 to 2011. The aim of the study was to define the characteristics of these patients, which represents the largest series in adults reported to date. A total of 105 patients were diagnosed by angiographic findings and 58 by biopsy results. The patients diagnosed by biopsy more frequently had at presentation cognitive dysfunction, greater cerebrospinal fluid total protein concentrations, less frequent cerebral infarcts, and more frequent leptomeningeal gadolinium-enhanced lesions on magnetic resonance imaging (MRI), along with less mortality and disability at last follow-up. The patients diagnosed by angiograms more frequently had at presentation hemiparesis or a persistent neurologic deficit or stroke, more frequent infarcts on MRI and an increased mortality. These differences were mainly related to the different size of the vessels involved in the 2 groups. Although most patients responded to therapy with glucocorticoids alone or in conjunction with cyclophosphamide and tended to improve during the follow-up period, an overall increased mortality rate was observed. Relapses occurred in one-quarter of the patients and were less frequent in patients treated with prednisone and cyclophosphamide compared with those treated with prednisone alone. The mortality rate and degree of disability at last follow-up were greater in those with increasing age, cerebral infarctions on MRI, angiographic large vessel involvement, and diagnosis made by angiography alone, but were lower in those with gadolinium-enhanced lesions on MRI and in those with

  2. Reproducibility of Vertebral Fracture Assessment Readings From Dual-energy X-ray Absorptiometry in Both a Population-based and Clinical Cohort: Cohen's and Uniform Kappa.

    PubMed

    Aubry-Rozier, Bérengère; Chapurlat, Roland; Duboeuf, François; Iglesias, Katia; Krieg, Marc-Antoine; Lamy, Olivier; Burnand, Bernard; Hans, Didier

    2015-01-01

    Vertebral fracture assessments (VFAs) using dual-energy X-ray absorptiometry increase vertebral fracture detection in clinical practice and are highly reproducible. Measures of reproducibility are dependent on the frequency and distribution of the event. The aim of this study was to compare 2 reproducibility measures, reliability and agreement, in VFA readings in both a population-based and a clinical cohort. We measured agreement and reliability by uniform kappa and Cohen's kappa for vertebral reading and fracture identification: 360 VFAs from a population-based cohort and 85 from a clinical cohort. In the population-based cohort, 12% of vertebrae were unreadable. Vertebral fracture prevalence ranged from 3% to 4%. Inter-reader and intrareader reliability with Cohen's kappa was fair to good (0.35-0.71 and 0.36-0.74, respectively), with good inter-reader and intrareader agreement by uniform kappa (0.74-0.98 and 0.76-0.99, respectively). In the clinical cohort, 15% of vertebrae were unreadable, and vertebral fracture prevalence ranged from 7.6% to 8.1%. Inter-reader reliability was moderate to good (0.43-0.71), and the agreement was good (0.68-0.91). In clinical situations, the levels of reproducibility measured by the 2 kappa statistics are concordant, so that either could be used to measure agreement and reliability. However, if events are rare, as in a population-based cohort, we recommend evaluating reproducibility using the uniform kappa, as Cohen's kappa may be less accurate. PMID:25439454

  3. Herpes simplex virus 2 meningitis: a retrospective cohort study.

    PubMed

    Miller, Stephanie; Mateen, Farrah J; Aksamit, Allen J

    2013-04-01

    Herpes simplex virus 2 is a leading cause of viral meningitis and the most commonly recognized infectious cause of benign, recurrent meningitis. We report a retrospective, observational cohort study of patients with herpes simplex virus type 2 (HSV-2) meningitis, confirmed by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF). The terms "herpes simplex," "meningitis," or "encephalitis" were searched in the medical records system of the Mayo Clinic in Rochester, Minnesota (1995-2008). Patients were included if they had a clinical diagnosis of meningitis and HSV-2 detected by PCR in the CSF. There were 28 patients with 33 episodes identified (83 % female; mean age at presentation of meningitis 36 years, range 17-53; mean time to HSV2 detection from symptom onset 3 days, range 0-6; history of genital herpes 23 %). No patient took oral antiviral treatment at the time of presentation. Episodes were most likely to include headache (100 %), photophobia (47 %), self-reported fever (45 %), meningismus (44 %), and nausea and/or vomiting (29 %). CSF at the time of meningitis was notable for elevated protein (mean 156 g/dL, range 60-258) and white cell count (mean 504 cells/μL, range 86-1,860) with normal glucose (mean 54 mg/dL, range 32-80). Mollaret cells were never detected. Neuroimaging was most often normal (83 %) when performed, although some cases showed nonspecific (14 %) or meningeal changes (3 %). There was no consistent relationship to genital herpes. The duration of treatment with intravenous acyclovir ranged from 3 to 14 days for the first meningitic episode (daily dose range from 500 to 1,000 mg and total dose range from 500 mg q8h for 3 days to 800 mg q8h for 14 days). For subsequent episodes, the duration of treatment of intravenous acyclovir ranged from less than 1 to 14 days (total dose range from 1,390 mg for 1 day to 900 mg q8h for 10 days). The dose of valacyclovir ranged from 500 mg once daily to 500 mg four times daily. The median duration

  4. Latent Topic Discovery of Clinical Concepts from Hospital Discharge Summaries of a Heterogeneous Patient Cohort

    PubMed Central

    Lehman, Li-wei; Long, William; Saeed, Mohammed; Mark, Roger

    2016-01-01

    Patients in critical care often exhibit complex disease patterns. A fundamental challenge in clinical research is to identify clinical features that may be characteristic of adverse patient outcomes. In this work, we propose a data-driven approach for phenotype discovery of patients in critical care. We used Hierarchical Dirichlet Process (HDP) as a non-parametric topic modeling technique to automatically discover the latent “topic” structure of diseases, symptoms, and findings documented in hospital discharge summaries. We show that the latent topic structure can be used to reveal phenotypic patterns of diseases and symptoms shared across subgroups of a patient cohort, and may contain prognostic value in stratifying patients’ post hospital discharge mortality risks. Using discharge summaries of a large patient cohort from the MIMIC II database, we evaluate the clinical utility of the discovered topic structure in identifying patients who are at high risk of mortality within one year post hospital discharge. We demonstrate that the learned topic structure has statistically significant associations with mortality post hospital discharge, and may provide valuable insights in defining new feature sets for predicting patient outcomes. PMID:25570320

  5. Latent topic discovery of clinical concepts from hospital discharge summaries of a heterogeneous patient cohort.

    PubMed

    Lehman, Li-Wei; Long, William; Saeed, Mohammed; Mark, Roger

    2014-01-01

    Patients in critical care often exhibit complex disease patterns. A fundamental challenge in clinical research is to identify clinical features that may be characteristic of adverse patient outcomes. In this work, we propose a data-driven approach for phenotype discovery of patients in critical care. We used Hierarchical Dirichlet Process (HDP) as a non-parametric topic modeling technique to automatically discover the latent "topic" structure of diseases, symptoms, and findings documented in hospital discharge summaries. We show that the latent topic structure can be used to reveal phenotypic patterns of diseases and symptoms shared across subgroups of a patient cohort, and may contain prognostic value in stratifying patients' post hospital discharge mortality risks. Using discharge summaries of a large patient cohort from the MIMIC II database, we evaluate the clinical utility of the discovered topic structure in identifying patients who are at high risk of mortality within one year post hospital discharge. We demonstrate that the learned topic structure has statistically significant associations with mortality post hospital discharge, and may provide valuable insights in defining new feature sets for predicting patient outcomes. PMID:25570320

  6. Mysid Population Responses to Resource Limitation Differ from those Predicted by Cohort Studies

    EPA Science Inventory

    Effects of anthropogenic stressors on animal populations are often evaluated by assembling vital rate responses from isolated cohort studies into a single demographic model. However, models constructed from cohort studies are difficult to translate into ecological predictions be...

  7. Data linkage in an established longitudinal cohort: the Western Australian Pregnancy Cohort (Raine) Study.

    PubMed

    Mountain, Jenny A; Nyaradi, Anett; Oddy, Wendy H; Glauert, Rebecca A; de Klerk, Nick H; Straker, Leon M; Stanley, Fiona J

    2016-01-01

    The Western Australian Data Linkage System is one of a few comprehensive, population-based data linkage systems worldwide, creating links between information from different sources relating to the same individual, family, place or event, while maintaining privacy. The Raine Study is an established cohort study with more than 2000 currently active participants. Individual consent was obtained from participants for information in publicly held databases to be linked to their study data. A waiver of consent was granted where it was impracticable to obtain consent. Approvals to link the datasets were obtained from relevant ethics committees and data custodians. The Raine Study dataset was subsequently linked to academic testing data collected by the Western Australian Department of Education. Examination of diet and academic performance showed that children who were predominantly breastfed for at least 6 months scored higher academically at age 10 than children who were breastfed for less than 6 months. A further study found that better diet quality at ages 1, 2 and 3 years was associated with higher academic scores at ages 10 and 12 years. Examination of nutritional intake at 14 years of age found that a better dietary pattern was associated with higher academic performance. The detailed longitudinal data collected in the Raine Study allowed for adjustment for multiple covariates and confounders. Data linkage reduces the burden on cohort participants by providing additional information without the need to contact participants. It can give information on participants who have been lost to follow-up; provide or complement missing data; give the opportunity for validation studies comparing recall of participants with administrative records; increase the population sample of studies by adding control participants from the general population; and allow for the adjustment of multiple covariates and confounders. The Raine Study dataset is extensive and detailed, and can be

  8. Identifying clinical/translational research cohorts: ascertainment via querying an integrated multi-source database

    PubMed Central

    Hurdle, John F; Haroldsen, Stephen C; Hammer, Andrew; Spigle, Cindy; Fraser, Alison M; Mineau, Geraldine P; Courdy, Samir J

    2013-01-01

    Background Ascertainment of potential subjects has been a longstanding problem in clinical research. Various methods have been proposed, including using data in electronic health records. However, these methods typically suffer from scaling effects—some methods work well for large cohorts; others work for small cohorts only. Objective We propose a method that provides a simple identification of pre-research cohorts and relies on data available in most states in the USA: merged public health data sources. Materials and methods The Utah Population Database Limited query tool allows users to build complex queries that may span several types of health records, such as cancer registries, inpatient hospital discharges, and death certificates; in addition, these can be combined with family history information. The architectural approach incorporates several coding systems for medical information. It provides a front-end graphical user interface and enables researchers to build and run queries and view aggregate results. Multiple strategies have been incorporated to maintain confidentiality. Results This tool was rapidly adopted; since its release, 241 users representing a wide range of disciplines from 17 institutions have signed the user agreement and used the query tool. Three examples are discussed: pregnancy complications co-occurring with cardiovascular disease; spondyloarthritis; and breast cancer. Discussion and conclusions This query tool was designed to provide results as pre-research so that institutional review board approval would not be required. This architecture uses well-described technologies that should be within the reach of most institutions. PMID:23059733

  9. Cohort Profile: The Hawai’i Family Study of Cognition

    PubMed Central

    Onoye, Jane MM; Hishinuma, Earl S; McArdle, John J; Zonderman, Alan B; Takeshita, Junji

    2014-01-01

    Intergenerational longitudinal studies over the lifespan provide valuable information for understanding the contexts and dynamic relations among cognition, family and health in adults and the elderly. The Hawai‘i Family Study of Cognition (HFSC), initiated in the early 1970s, included a cohort of over 6500 individuals representing over 1800 families of parents and their offspring. The HFSC gathered data on cognitive, personality, biological and other psychosocial variables, and provided novel information on the nature of cognitive abilities, especially on family issues. Some families were reassessed with short-term retesting in the 1970s. A select sample of offspring and their siblings and spouses were re-measured in the 1980s. Decades later, a 40-year follow-up of the original HFSC cohort was facilitated by the availability of contemporary tracking and tracing methods and internet-based testing. A subgroup of the original HFSC participants was re-contacted and retested on contemporary cognitive as well as socio-demographic and health measures. In this paper, we describe the original HFSC cohort and the design and methodology of the re-contact and retest studies of the HFSC, plans for expanding the re-contact and retesting, as well as directions for future research and collaborations. The Principal Investigator may be contacted for more information regarding the application, review and approval process for data access requests from qualified individuals outside the project. PMID:24639439

  10. Changes in Saturday outpatient volume and billings after introducing the Saturday incentive programme to clinics in South Korea: a longitudinal cohort study using claims data from 2012 to 2014

    PubMed Central

    Ha, Hyun Ji; Han, Kyu-Tae; Kim, Sun Jung; Sohn, Tae Yong; Jeon, Byungyool; Park, Eun-Cheol

    2016-01-01

    Objective In October 2013, the South Korean government introduced an incentive programme to increase the availability of Saturday treatment at clinics, hoping to increase the role of primary care providers as gatekeepers to medical care. To the best of our knowledge, no one has yet investigated this programme's effect on overall outpatient care. Our study aims to analyse the change in Saturday outpatient volume and billings in clinics that adopted the Saturday incentive programme. Setting Our study used 3 types of data from the period October 2012 to March 2014: National Health Insurance Service (NHIS) claims data, hospital evaluation data and medical institution data. Participants These data consisted of 66 825 881 outpatient cases from 2837 clinics. Interventions Introducing the Saturday incentive programme. Outcome measure We performed a multilevel analysis that adjusted for clinic-level and outpatient-level variables to examine the difference in the percentage of Saturday outpatient volume and billings after introducing the Saturday incentive programme. Results The percentages of Saturday outpatient volume and billings were higher after introducing the programme (outpatient volume: β=2.065, p<0.001; outpatient billings: β=3.518, p<0.001). In addition, outpatient volume and billings on Friday and Saturday increased after introducing the programme, while those on weekdays, excluding Friday, decreased. Conclusions Our findings suggest that the Saturday incentive programme has affected clinic outpatient care and is a worthwhile health policy in terms of promoting primary care. Thus, it may improve healthcare accessibility and quality of care, and prevent inappropriate usage such as emergency room visits by providing patients with weekend clinic hours. PMID:27288380

  11. Clinical Characteristics and Outcome of Primary Sjogren’s Syndrome: A Large Asian Indian Cohort

    PubMed Central

    Sandhya, Pulukool; Jeyaseelan, Lakshmanan; Scofield, Robert Hal; Danda, Debashish

    2015-01-01

    Objective : To characterise the clinical features, immunological profile and outcome in a cohort of Asian Indian patients with primary Sjögren's syndrome (SS). Methods : Electronic medical records from a tertiary care teaching hospital in south India were screened for SS between 2004 and 2011. Patients fulfilling American European Consensus group (AECG) 2002 or American College of Rheumatology (ACR) 2012 classification criteria were included. Agglomerative hierarchical cluster analysis to identify patterns of associations between clinical and immunological features was done. Multivariate logistic regression to identify predictors of major systemic involvement was performed. Data on treatment and outcome were retrieved from electronic records. Results : Of 423 patients suspected to have SS, 332 fulfilled inclusion criteria. Only 8.3% of patients complained of sicca symptoms on their own at initial presentation. Younger age of onset, higher female to male ratio, paucity of cryoglobulinemia, Raynaud’s phenomenon and hyperglobulinemia were unique to this cohort. Cluster analysis revealed two subsets: The first cluster comprised of patients having a major systemic illness with high antibody titers and the second comprised of seronegative patients with mild disease. Over a third of SS cases had severe systemic manifestations necessitating treatment with immunosuppressants. In multivariate logistic regression analysis, anti-Ro and anti-La antibody positivity was associated with higher odds for systemic disease features (OR=2.67, P=0.03 and OR=3.25, P=0.003, respectively) whereas chronic pain was associated with lower odds (OR=0.4, p=0.032). Clinical improvement including symptomatic benefit in sicca and musculoskeletal features was noted with immunomodulators in the majority. Conclusion : Our cohort of patients with SS has characteristic clinical features; some of them are in contrast with previous observations reported in European patients. This cohort consisted of

  12. A cohort study on the mortality of firefighters.

    PubMed Central

    Hansen, E S

    1990-01-01

    This study was set up to investigate the effect of exposure to combustion effluents on the chronic health of firefighters. A cohort of firefighters was followed up through 10 years with regard to cause specific mortality. Comparisons were made with another cohort of civil servants and salaried employees in physically demanding jobs. After a latency of five years, an excess mortality from cancer was seen for persons aged 30 to 74 (standardised mortality ratio (SMR) 173, 95% confidence interval (95% CI) 104-270). A significant increase in lung cancer was seen in the group aged 60 to 74 (SMR 317, 95% CI 117-691), whereas non-pulmonary cancer was significantly increased in the group aged 30 to 49 (SMR 575, 95% CI 187-1341). It is concluded that inhalation of carcinogenic and toxic compounds during firefighting may constitute an occupational cancer risk. An extended use of respiratory protective equipment is advocated. PMID:2271386

  13. A Cohort Study on Meniscal Lesions among Airport Baggage Handlers.

    PubMed

    Mikkelsen, Sigurd; Brauer, Charlotte; Pedersen, Ellen Bøtker; Alkjær, Tine; Koblauch, Henrik; Simonsen, Erik Bruun; Helweg-Larsen, Karin; Thygesen, Lau Caspar

    2016-01-01

    Meniscal lesions are common and may contribute to the development of knee arthrosis. A few case-control and cross-sectional studies have identified knee-straining work as risk factors for meniscal lesions, but exposure-response relations and the role of specific exposures are uncertain, and previous results may be sensitive to reporting and selection bias. We examined the relation between meniscal lesions and cumulative exposure to heavy lifting in a prospective register-based study with complete follow-up and independent information on exposure and outcome. We established a cohort of unskilled men employed at Copenhagen Airport or in other companies in the metropolitan Copenhagen area from 1990 to 2012 (the Copenhagen Airport Cohort). The cohort at risk included 3,307 airport baggage handlers with heavy lifting and kneeling or squatting work tasks and 63,934 referents with a similar socioeconomic background and less knee-straining work. Baggage handlers lifted suitcases with an average weight of approximately 15 kg, in total approximately five tonnes during a 9-hour workday. The cohort was followed in the National Patient Register and Civil Registration System. The outcome was a first time hospital diagnosis or surgery of a meniscal lesion. Baggage handlers had a higher incidence of meniscal lesions than the referents. Within baggage handlers spline regression showed that the incidence rate ratio was 1.91 (95% confidence interval: 1.29-2.84) after five years as a baggage handler and then decreased slowly to reach unity after approximately 30 years, adjusted for effects of potential confounders. This relation between baggage handling and meniscal lesions was present for work on the apron which involves lifting in a kneeling or squatting position, but not in the baggage hall, which only involves lifting in standing positions. The results support that long-term heavy lifting in a kneeling or squatting position is a risk factor for the development of symptomatic

  14. Alcohol and breast cancer: results from The Netherlands Cohort Study.

    PubMed

    van den Brandt, P A; Goldbohm, R A; van 't Veer, P

    1995-05-15

    Although the results of cohort studies on the association between alcohol and breast cancer are rather consistent, the current evidence is based solely on North American cohorts. Therefore, this association was evaluated in the Netherlands Cohort Study on diet and cancer, conducted since 1986 among 62,573 women aged 55-69 years. After 3.3 years of follow-up (1986-1989), 422 incident breast cancer cases for which there were complete alcohol consumption data were available for analysis. In multivariate case-cohort analyses, the rate ratio for breast cancer in drinkers versus nondrinkers was 1.31 (95 percent confidence interval 1.00-1.71). When separate alcohol intake categories were compared with nondrinking, the rate ratios were 1.30, 1.29, 1.28, and 1.72 for women who consumed < 5, 5-14, 15-29, and > or = 30 g of alcohol per day, respectively (trend p = 0.047). Whereas beer consumption was not associated with breast cancer risk, increased risks were found at higher levels of both wine and liquor consumption. The alcohol-breast cancer association was found to be stronger among women with a history of benign breast disease, women with a history of breast cancer among sister(s), and women with an early menopause, and it varied considerably according to age at first birth. These results support a positive association between alcohol and breast cancer among postmenopausal women. The increased risk was particularly found among women who consumed 30 g or more of alcohol daily. PMID:7741120

  15. A Cohort Study on Meniscal Lesions among Airport Baggage Handlers

    PubMed Central

    Mikkelsen, Sigurd; Brauer, Charlotte; Pedersen, Ellen Bøtker; Alkjær, Tine; Koblauch, Henrik; Simonsen, Erik Bruun; Helweg-Larsen, Karin; Thygesen, Lau Caspar

    2016-01-01

    Meniscal lesions are common and may contribute to the development of knee arthrosis. A few case-control and cross-sectional studies have identified knee-straining work as risk factors for meniscal lesions, but exposure-response relations and the role of specific exposures are uncertain, and previous results may be sensitive to reporting and selection bias. We examined the relation between meniscal lesions and cumulative exposure to heavy lifting in a prospective register-based study with complete follow-up and independent information on exposure and outcome. We established a cohort of unskilled men employed at Copenhagen Airport or in other companies in the metropolitan Copenhagen area from 1990 to 2012 (the Copenhagen Airport Cohort). The cohort at risk included 3,307 airport baggage handlers with heavy lifting and kneeling or squatting work tasks and 63,934 referents with a similar socioeconomic background and less knee-straining work. Baggage handlers lifted suitcases with an average weight of approximately 15 kg, in total approximately five tonnes during a 9-hour workday. The cohort was followed in the National Patient Register and Civil Registration System. The outcome was a first time hospital diagnosis or surgery of a meniscal lesion. Baggage handlers had a higher incidence of meniscal lesions than the referents. Within baggage handlers spline regression showed that the incidence rate ratio was 1.91 (95% confidence interval: 1.29–2.84) after five years as a baggage handler and then decreased slowly to reach unity after approximately 30 years, adjusted for effects of potential confounders. This relation between baggage handling and meniscal lesions was present for work on the apron which involves lifting in a kneeling or squatting position, but not in the baggage hall, which only involves lifting in standing positions. The results support that long-term heavy lifting in a kneeling or squatting position is a risk factor for the development of symptomatic

  16. Influenza and Pneumococcal Vaccination Uptake in Patients with Rheumatoid Arthritis Treated with Immunosuppressive Therapy in the UK: A Retrospective Cohort Study Using Data from the Clinical Practice Research Datalink

    PubMed Central

    Winthrop, Kevin L.; Pye, Stephen R.; Brown, Benjamin; Dixon, William G.

    2016-01-01

    Introduction Guidelines for the management of rheumatoid arthritis (RA) recommend using influenza and pneumococcal vaccinations to mitigate infection risk. The level of adherence to these guidelines is not well known in the UK. The aims of this study were to describe the uptake of influenza and pneumococcal vaccinations in patients with RA in the UK, to compare the characteristics of those vaccinated to those not vaccinated and to compare vaccination rates across regions of the UK. Methods A retrospective cohort study of adults diagnosed with incident RA and treated with non-biologic immunosuppressive therapy, using data from a large primary care database. For the influenza vaccination, patients were considered unvaccinated on 1st September each year and upon vaccination their status changed to vaccinated. For pneumococcal vaccination, patients were considered vaccinated after their first vaccination until the end of follow-up. Patients were stratified by age 65 at the start of follow-up, given differences in vaccination guidelines for the general population. Results Overall (N = 15,724), 80% patients received at least one influenza vaccination, and 50% patients received a pneumococcal vaccination, during follow-up (mean 5.3 years). Of those aged below 65 years (N = 9,969), 73% patients had received at least one influenza vaccination, and 43% patients received at least one pneumococcal vaccination. Of those aged over 65 years (N = 5,755), 91% patients received at least one influenza vaccination, and 61% patients had received at least one pneumococcal vaccination. Those vaccinated were older, had more comorbidity and visited the GP more often. Regional differences in vaccination rates were seen with the highest rates in Northern Ireland, and the lowest rates in London. Conclusions One in five patients received no influenza vaccinations and one in two patients received no pneumonia vaccine over five years of follow-up. There remains significant scope to improve

  17. Systematically missing confounders in individual participant data meta-analysis of observational cohort studies.

    PubMed

    Jackson, Dan; White, Ian; Kostis, J B; Wilson, A C; Folsom, A R; Wu, K; Chambless, L; Benderly, M; Goldbourt, U; Willeit, J; Kiechl, S; Yarnell, J W G; Sweetnam, P M; Elwood, P C; Cushman, M; Psaty, B M; Tracy, R P; Tybjaerg-Hansen, A; Haverkate, F; de Maat, M P M; Thompson, S G; Fowkes, F G R; Lee, A J; Smith, F B; Salomaa, V; Harald, K; Rasi, V; Vahtera, E; Jousilahti, P; D'Agostino, R; Kannel, W B; Wilson, P W F; Tofler, G; Levy, D; Marchioli, R; Valagussa, F; Rosengren, A; Wilhelmsen, L; Lappas, G; Eriksson, H; Cremer, P; Nagel, D; Curb, J D; Rodriguez, B; Yano, K; Salonen, J T; Nyyssönen, K; Tuomainen, T-P; Hedblad, B; Engström, G; Berglund, G; Loewel, H; Koenig, W; Hense, H W; Meade, T W; Cooper, J A; De Stavola, B; Knottenbelt, C; Miller, G J; Cooper, J A; Bauer, K A; Rosenberg, R D; Sato, S; Kitamura, A; Naito, Y; Iso, H; Salomaa, V; Harald, K; Rasi, V; Vahtera, E; Jousilahti, P; Palosuo, T; Ducimetiere, P; Amouyel, P; Arveiler, D; Evans, A E; Ferrieres, J; Juhan-Vague, I; Bingham, A; Schulte, H; Assmann, G; Cantin, B; Lamarche, B; Despres, J-P; Dagenais, G R; Tunstall-Pedoe, H; Lowe, G D O; Woodward, M; Ben-Shlomo, Y; Davey Smith, G; Palmieri, V; Yeh, J L; Meade, T W; Rudnicka, A; Brennan, P; Knottenbelt, C; Cooper, J A; Ridker, P; Rodeghiero, F; Tosetto, A; Shepherd, J; Lowe, G D O; Ford, I; Robertson, M; Brunner, E; Shipley, M; Feskens, E J M; Di Angelantonio, E; Kaptoge, S; Lewington, S; Lowe, G D O; Sarwar, N; Thompson, S G; Walker, M; Watson, S; White, I R; Wood, A M; Danesh, J

    2009-04-15

    One difficulty in performing meta-analyses of observational cohort studies is that the availability of confounders may vary between cohorts, so that some cohorts provide fully adjusted analyses while others only provide partially adjusted analyses. Commonly, analyses of the association between an exposure and disease either are restricted to cohorts with full confounder information, or use all cohorts but do not fully adjust for confounding. We propose using a bivariate random-effects meta-analysis model to use information from all available cohorts while still adjusting for all the potential confounders. Our method uses both the fully adjusted and the partially adjusted estimated effects in the cohorts with full confounder information, together with an estimate of their within-cohort correlation. The method is applied to estimate the association between fibrinogen level and coronary heart disease incidence using data from 154,012 participants in 31 cohorts PMID:19222087

  18. Changing relationships between smoking and psychiatric disorders across twentieth century birth cohorts: clinical and research implications.

    PubMed

    Talati, A; Keyes, K M; Hasin, D S

    2016-04-01

    As the risks of tobacco use become recognized and smoking becomes stigmatized, new smokers may be increasingly driven to smoke by biological or genetic vulnerabilities rather than social desirability. Given that genetic risk for deviant proneness is shared across other psychiatric and addictive disorders, we predicted that as rates of smoking decreased through the latter half of the twentieth century, associations between smoking and psychopathology would increase. Participants (N=25 412) from a large US study-the National Epidemiologic Survey on Alcohol and Related Conditions, NESARC-were interviewed using the Alcohol Use Disorder and Associated Disabilities Interview Schedule - DSM-IV Version (AUDADIS-IV) and classified into one of five birth cohort decades (1940s to 1980s) and three smoking history (nonsmokers, never-dependent smokers and ever-dependent smokers) groups. We found that the prevalence of smoking decreased across the five birth cohorts, but associations of smoking with drug and AUDs, attention-deficit hyperactivity disorder, bipolar disorder and antisocial personality disorder, each increased monotonically in more recently born cohorts, even after adjusting for concurrent demographic and socioeconomic changes. For drug and AUDs, increases were observed among smokers both with and without a history of nicotine dependence; for other outcomes, increases were entirely driven by nicotine-dependent smokers. Findings suggest that smokers in more recent cohorts have disproportionately high psychiatric vulnerability, and may benefit from greater mental health screenings. Differentiating between casual and dependent smokers may further help prioritize those at greatest risk. Researchers should also be aware of potential variation in psychiatric comorbidity based on cohort of birth when defining groups of smokers, to minimize confounding. PMID:26809837

  19. Drinking water arsenic in Utah: A cohort mortality study.

    PubMed Central

    Lewis, D R; Southwick, J W; Ouellet-Hellstrom, R; Rench, J; Calderon, R L

    1999-01-01

    The association of drinking water arsenic and mortality outcome was investigated in a cohort of residents from Millard County, Utah. Median drinking water arsenic concentrations for selected study towns ranged from 14 to 166 ppb and were from public and private samples collected and analyzed under the auspices of the State of Utah Department of Environmental Quality, Division of Drinking Water. Cohort members were assembled using historical documents of the Church of Jesus Christ of Latter-day Saints. Standard mortality ratios (SMRs) were calculated. Using residence history and median drinking water arsenic concentration, a matrix for cumulative arsenic exposure was created. Without regard to specific exposure levels, statistically significant findings include increased mortality from hypertensive heart disease [SMR = 2.20; 95% confidence interval (CI), 1.36-3.36], nephritis and nephrosis (SMR = 1.72; CI, 1.13-2.50), and prostate cancer (SMR = 1.45; CI, 1.07-1. 91) among cohort males. Among cohort females, statistically significant increased mortality was found for hypertensive heart disease (SMR = 1.73; CI, 1.11-2.58) and for the category of all other heart disease, which includes pulmonary heart disease, pericarditis, and other diseases of the pericardium (SMR = 1.43; CI, 1.11-1.80). SMR analysis by low, medium, and high arsenic exposure groups hinted at a dose relationship for prostate cancer. Although the SMRs by exposure category were elevated for hypertensive heart disease for both males and females, the increases were not sequential from low to high groups. Because the relationship between health effects and exposure to drinking water arsenic is not well established in U.S. populations, further evaluation of effects in low-exposure populations is warranted. PMID:10210691

  20. Drinking water arsenic in Utah: A cohort mortality study.

    PubMed

    Lewis, D R; Southwick, J W; Ouellet-Hellstrom, R; Rench, J; Calderon, R L

    1999-05-01

    The association of drinking water arsenic and mortality outcome was investigated in a cohort of residents from Millard County, Utah. Median drinking water arsenic concentrations for selected study towns ranged from 14 to 166 ppb and were from public and private samples collected and analyzed under the auspices of the State of Utah Department of Environmental Quality, Division of Drinking Water. Cohort members were assembled using historical documents of the Church of Jesus Christ of Latter-day Saints. Standard mortality ratios (SMRs) were calculated. Using residence history and median drinking water arsenic concentration, a matrix for cumulative arsenic exposure was created. Without regard to specific exposure levels, statistically significant findings include increased mortality from hypertensive heart disease [SMR = 2.20; 95% confidence interval (CI), 1.36-3.36], nephritis and nephrosis (SMR = 1.72; CI, 1.13-2.50), and prostate cancer (SMR = 1.45; CI, 1.07-1. 91) among cohort males. Among cohort females, statistically significant increased mortality was found for hypertensive heart disease (SMR = 1.73; CI, 1.11-2.58) and for the category of all other heart disease, which includes pulmonary heart disease, pericarditis, and other diseases of the pericardium (SMR = 1.43; CI, 1.11-1.80). SMR analysis by low, medium, and high arsenic exposure groups hinted at a dose relationship for prostate cancer. Although the SMRs by exposure category were elevated for hypertensive heart disease for both males and females, the increases were not sequential from low to high groups. Because the relationship between health effects and exposure to drinking water arsenic is not well established in U.S. populations, further evaluation of effects in low-exposure populations is warranted. PMID:10210691

  1. Clinical and genetic features of cervical dystonia in a large multicenter cohort

    PubMed Central

    Vemula, Satya R.; Xiao, Jianfeng; Thompson, Misty M.; Perlmutter, Joel S.; Wright, Laura J.; Jinnah, H.A.; Rosen, Ami R.; Hedera, Peter; Comella, Cynthia L.; Weissbach, Anne; Junker, Johanna; Jankovic, Joseph; Barbano, Richard L.; Reich, Stephen G.; Rodriguez, Ramon L.; Berman, Brian D.; Chouinard, Sylvain; Severt, Lawrence; Agarwal, Pinky; Stover, Natividad P.

    2016-01-01

    Objective: To characterize the clinical and genetic features of cervical dystonia (CD). Methods: Participants enrolled in the Dystonia Coalition biorepository (NCT01373424) with initial manifestation as CD were included in this study (n = 1,000). Data intake included demographics, family history, and the Global Dystonia Rating Scale. Participants were screened for sequence variants (SVs) in GNAL, THAP1, and Exon 5 of TOR1A. Results: The majority of participants were Caucasian (95%) and female (75%). The mean age at onset and disease duration were 45.5 ± 13.6 and 14.6 ± 11.8 years, respectively. At the time of assessment, 68.5% had involvement limited to the neck, shoulder(s), and proximal arm(s), whereas 47.4% had dystonia limited to the neck. The remaining 31.5% of the individuals exhibited more extensive anatomical spread. A head tremor was noted in 62% of the patients. Head tremor and laryngeal dystonia were more common in females. Psychiatric comorbidities, mainly depression and anxiety, were reported by 32% of the participants and were more common in females. Family histories of dystonia, parkinsonian disorder, and tremor were present in 14%, 11%, and 29% of the patients, respectively. Pathogenic or likely pathogenic SVs in THAP1, TOR1A, and GNAL were identified in 8 participants (0.8%). Two individuals harbored novel missense SVs in Exon 5 of TOR1A. Synonymous and noncoding SVs in THAP1 and GNAL were identified in 4% of the cohort. Conclusions: Head tremor, laryngeal dystonia, and psychiatric comorbidities are more common in female participants with CD. Coding and noncoding variants in GNAL, THAP1, and TOR1A make small contributions to the pathogenesis of CD. PMID:27123488

  2. Tenofovir-associated renal dysfunction in clinical practice: An observational cohort from western India

    PubMed Central

    Patel, Ketan K.; Patel, Atul K.; Ranjan, Rajiv R.; Patel, Apurva R.; Patel, Jagdish K.

    2010-01-01

    Background: Tenofovir (TDF) is preferred nucleoside reverse transcriptase inhibitors (NRTI) for the treatment of human immunodeficiency virus infection because of its potency and safety. Renal toxicity with TDF use is low and comparable with other NRTI in clinical trials, but there are many case studies and small case series of renal dysfunction with TDF. Materials and Methods: This is an observational longitudinal cohort of patients started on a TDF-based regimen from January 2007 to April 2010. Patients were evaluated at baseline and with every follow-up visit for serum creatinine and calculated creatinine clearance (Cockroft-Gault formula). In addition to this, the patients were also subjected to test for serum potassium, phosphorous and urine examinations as and when indicated. Renal dysfunction was defined as rise in serum creatinine to more than the upper level of normal (>1.2 mg%). Results: Of 1,271 patients started on a TDF-containing antiretroviral treatment (ART) 83 (6.53%) developed renal dysfunction, of which 79 had impaired serum creatinine and five had Fanconi’s syndrome. Renal dysfunction was more common with boosted a protease inhibitor (PI) (9.44%)-based regimen as compared to a non- nucleoside reverse transcriptase inhibitors (NNRTI) (5.01%)-based regimen (P = 0.003). The mean decline in creatinine clearance from baseline was 22.27 ml/min. The median time to develop renal dysfunction was 154 (15–935) days. Serum creatinine returned to normal in all the patients after stopping TDF. Five patients presented with features suggestive of Fanconi’s syndrome without alteration in serum creatinine. Conclusion: TDF-based treatment is associated with mild but reversible renal dysfunction. Patients receiving PI/r are at a higher risk of renal dysfunction compared to those receiving NNRTI-based ART. Clinicians should be adviced to have intensive renal monitoring, including creatinine clearance, urine examination, K+ and phosphate levels at baseline and

  3. Cohort and Age Effects of Mass Drug Administration on Prevalence of Trachoma: A Longitudinal Study in Rural Tanzania

    PubMed Central

    Shekhawat, Nakul; Mkocha, Harran; Munoz, Beatriz; Gaydos, Charlotte; Dize, Laura; Quinn, Thomas C.; West, Sheila K.

    2014-01-01

    Purpose. Mass drug administration (MDA) is part of the SAFE strategy for trachoma elimination. This study examined the effect of three annual MDAs on prevalence of trachoma among 13 longitudinal cohorts of Tanzanian children. Methods. Children younger than 10 years were assigned to cohorts based on age at baseline and followed annually for 3 years, with newborns assigned to new cohorts over time. Annual MDA consisted of topical tetracycline for children younger than 6 months and oral azithromycin for those 6 months and older. Follicular trachoma (TF) and Chlamydia trachomatis infection status were assessed annually before the next MDA. Prevalence and risk factors for TF and infection at each age were compared across cohorts. Results. At each survey, most age groups and cohorts had MDA coverage of more than 80% and showed decreased TF prevalence after every MDA. One cohort had consistently lower coverage, higher-than-expected TF and infection at ages 6 and 7, and elevated risk of TF at age 7 relative to the preceding cohort in spite of receiving one additional MDA (odds ratio 2.3, 95% confidence interval 1.0–5.2). Cohorts aged 1 or older at baseline generally showed reductions in TF and infection after each MDA, whereas younger cohorts showed decreased infection but increased TF over time. Successive cohorts of never-treated children younger than 1 year showed sequential TF and infection reductions with each MDA (P < 0.001). Conclusions. Multiple MDAs significantly reduce trachoma prevalence and appear to increasingly protect children born into these communities. The youngest children show declining/stable rates of infection but increasing rates of trachoma, which may reflect longer duration of clinical signs. PMID:24448262

  4. Clinical Significance of Asthma Clusters by Longitudinal Analysis in Korean Asthma Cohort

    PubMed Central

    Kim, Sujeong; Yoon, Sun-young; Kwon, Hyouk-Soo; Chang, Yoon-Seok; Cho, You Sook; Jang, An-Soo; Park, Jung Won; Nahm, Dong-Ho; Yoon, Ho-Joo; Cho, Sang-Heon; Cho, Young-Joo; Choi, ByoungWhui; Moon, Hee-Bom; Kim, Tae-Bum

    2013-01-01

    Background We have previously identified four distinct groups of asthma patients in Korean cohorts using cluster analysis: (A) smoking asthma, (B) severe obstructive asthma, (C) early-onset atopic asthma, and (D) late-onset mild asthma. Methods and Results A longitudinal analysis of each cluster in a Korean adult asthma cohort was performed to investigate the clinical significance of asthma clusters over 12 months. Cluster A showed relatively high asthma control test (ACT) scores but relatively low FEV1 scores, despite a high percentage of systemic corticosteroid use. Cluster B had the lowest mean FEV1, ACT, and the quality of life questionnaire for adult Korean asthmatics (QLQAKA) scores throughout the year, even though the percentage of systemic corticosteroid use was the highest among the four clusters. Cluster C was ranked second in terms of FEV1, with the second lowest percentage of systemic corticosteroid use, and showed a marked improvement in subjective symptoms over time. Cluster D consistently showed the highest FEV1, the lowest systemic corticosteroid use, and had high ACT and QLQAKA scores. Conclusion Our asthma clusters had clinical significance with consistency among clusters over 12 months. These distinctive phenotypes may be useful in classifying asthma in real practice. PMID:24391784

  5. Familial risk of cerebral palsy: population based cohort study

    PubMed Central

    Wilcox, Allen J; Lie, Rolv T; Moster, Dag

    2014-01-01

    Objective To investigate risks of recurrence of cerebral palsy in family members with various degrees of relatedness to elucidate patterns of hereditability. Design Population based cohort study. Setting Data from the Medical Birth Registry of Norway, linked to the Norwegian social insurance scheme to identify cases of cerebral palsy and to databases of Statistics Norway to identify relatives. Participants 2 036 741 Norwegians born during 1967-2002, 3649 of whom had a diagnosis of cerebral palsy; 22 558 pairs of twins, 1 851 144 pairs of first degree relatives, 1 699 856 pairs of second degree relatives, and 5 165 968 pairs of third degree relatives were identified. Main outcome measure Cerebral palsy. Results If one twin had cerebral palsy, the relative risk of recurrence of cerebral palsy was 15.6 (95% confidence interval 9.8 to 25) in the other twin. In families with an affected singleton child, risk was increased 9.2 (6.4 to 13)-fold in a subsequent full sibling and 3.0 (1.1 to 8.6)-fold in a half sibling. Affected parents were also at increased risk of having an affected child (6.5 (1.6 to 26)-fold). No evidence was found of differential transmission through mothers or fathers, although the study had limited power to detect such differences. For people with an affected first cousin, only weak evidence existed for an increased risk (1.5 (0.9 to 2.7)-fold). Risks in siblings or cousins were independent of sex of the index case. After exclusion of preterm births (an important risk factor for cerebral palsy), familial risks remained and were often stronger. Conclusions People born into families in which someone already has cerebral palsy are themselves at elevated risk, depending on their degree of relatedness. Elevated risk may extend even to third degree relatives (first cousins). The patterns of risk suggest multifactorial inheritance, in which multiple genes interact with each other and with environmental factors. These data offer additional

  6. Using a population-based observational cohort study to address difficult comparative effectiveness research questions: the CEASAR study

    PubMed Central

    Barocas, Daniel A; Chen, Vivien; Cooperberg, Matthew; Goodman, Michael; Graff, John J; Greenfield, Sheldon; Hamilton, Ann; Hoffman, Karen; Kaplan, Sherrie; Koyama, Tatsuki; Morgans, Alicia; Paddock, Lisa E; Phillips, Sharon; Resnick, Matthew J; Stroup, Antoinette; Wu, Xiao-Cheng; Penson, David F

    2016-01-01

    Background While randomized controlled trials represent the highest level of evidence we can generate in comparative effectiveness research, there are clinical scenarios where this type of study design is not feasible. The Comparative Effectiveness Analyses of Surgery and Radiation in localized prostate cancer (CEASAR) study is an observational study designed to compare the effectiveness and harms of different treatments for localized prostate cancer, a clinical scenario in which randomized controlled trials have been difficult to execute and, when completed, have been difficult to generalize to the population at large. Methods CEASAR employs a population-based, prospective cohort study design, using tumor registries as cohort inception tools. The primary outcome is quality of life after treatment, measured by validated instruments. Risk adjustment is facilitated by capture of traditional and nontraditional confounders before treatment and by propensity score analysis. Results We have accrued a diverse, representative cohort of 3691 men in the USA with clinically localized prostate cancer. Half of the men invited to participate enrolled, and 86% of patients who enrolled have completed the 6-month survey. Conclusion Challenging comparative effectiveness research questions can be addressed using well-designed observational studies. The CEASAR study provides an opportunity to determine what treatments work best, for which patients, and in whose hands. PMID:24236685

  7. Reproductive Factors and Kidney Cancer Risk in 2 US Cohort Studies, 1993–2010

    PubMed Central

    Karami, Sara; Daugherty, Sarah E.; Schonfeld, Sara J.; Park, Yikyung; Hollenbeck, Albert R.; Grubb, Robert L.; Hofmann, Jonathan N.; Chow, Wong-Ho; Purdue, Mark P.

    2013-01-01

    Clinical and experimental findings suggest that female hormonal and reproductive factors could influence kidney cancer development. To evaluate this association, we conducted analyses in 2 large prospective cohorts (the National Institutes of Health–AARP Diet and Health Study (NIH-AARP), 1995–2006, and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), 1993–2010). Cohort-specific and aggregated hazard ratios and 95% confidence intervals relating reproductive factors and kidney cancer risk were computed by Cox regression. The analysis included 792 incident kidney cancer cases among 283,952 postmenopausal women. Women who had undergone a hysterectomy were at a significantly elevated kidney cancer risk in both NIH-AARP (hazard ratio = 1.28, 95% confidence interval: 1.09, 1.50) and PLCO (hazard ratio = 1.41, 95% confidence interval: 1.06, 1.88). Similar results were observed for both cohorts after analyses were restricted to women who had undergone a hysterectomy with or without an oophorectomy. For the NIH-AARP cohort, an inverse association was observed with increasing age at menarche (P for trend = 0.02) and increasing years of oral contraceptive use (P for trend = 0.02). No clear evidence of an association with parity or other reproductive factors was found. Our results suggest that hysterectomy is associated with increased risk of kidney cancer. The observed associations with age at menarche and oral contraceptive use warrant further investigation. PMID:23624999

  8. Registry of the clinical characteristics of spondyloarthritis in a cohort of Egyptian population.

    PubMed

    Tayel, M Y; Soliman, E; El Baz, W F; El Labaan, A; Hamaad, Y; Ahmed, M H

    2012-09-01

    The aim of this study was to characterize the socioeconomic features, as well as disease activity and functional status, treatment use, and quality of life in a cohort of Egyptian population. All are measured by standard instruments. This is a descriptive multicenter; cross-sectional study included consecutive patients with spondyloarthritis (SpAs) diagnosed according to the European spondyloarthritis study group criteria. Four Egyptian centers participated (one from the Upper Egypt, one from the Delta, and two from the West Coast), all adopted the same criteria for patient assessment, and data were collected in the same data base over a 12-month duration. A total of 75 patients were included in the study. The series consisted of 34 ankylosing spondylitis (AS) patients (64%), 23 patients with psoriatic arthritis (45.3%), 15 patients with Juvenile onset AS (18.7%), 2 patients with reactive arthritis (2.7%), and one with inflammatory bowel disease-related arthritis (1.3%). There was predominance of male patients (84%). All were Caucasians; 13% from the Upper Egypt, and 87% from the Delta and West coast Egypt. Their mean age was 37.44 ± 12.8 years; mean disease duration was 11.85 ± 9.27 years. Pure axial disease was reported by 24% of the patients, and pure peripheral involvement was observed in 4%, while the mixed pattern (axial, peripheral, and entheseal) was observed in 34%. Dactylitis was detected in 9.3%, tarsitis in 8%, and enthesitis in 29.3%. The most common extra-articular manifestation was anterior uveitis, reported by 5.3% of patients. Human leukocytic antigen B27 (HLA-B27) was positive in 58.7% of the tested patients (n = 29). Mean Bath Ankylosing Spondylitis Disease activity Index (BASDAI) score was 4.16 ± 2.12, of which 22 patients had a score more than 4; mean Bath Ankylosing Spondylitis Functional Index 5.12 ± 2.40, mean BASMI 4.17 ± 2.95, mean BAS-GI 5.92 ± 2.00, and mean Health assessment questionnaire 1.10 ± 0.65. In addition, patients with

  9. Targeted methylation testing of a patient cohort broadens the epigenetic and clinical description of imprinting disorders.

    PubMed

    Poole, Rebecca L; Docherty, Louise E; Al Sayegh, Abeer; Caliebe, Almuth; Turner, Claire; Baple, Emma; Wakeling, Emma; Harrison, Lucy; Lehmann, Anna; Temple, I Karen; Mackay, Deborah J G

    2013-09-01

    Imprinting disorders are associated with mutations and epimutations affecting imprinted genes, that is those whose expression is restricted by parent of origin. Their diagnosis is challenging for two reasons: firstly, their clinical features, particularly prenatal and postnatal growth disturbance, are heterogeneous and partially overlapping; secondly, their underlying molecular defects include mutation, epimutation, copy number variation, and chromosomal errors, and can be further complicated by somatic mosaicism and multi-locus methylation defects. It is currently unclear to what extent the observed phenotypic heterogeneity reflects the underlying molecular pathophysiology; in particular, the molecular and clinical diversity of multilocus methylation defects remains uncertain. To address these issues we performed comprehensive methylation analysis of imprinted genes in a research cohort of 285 patients with clinical features of imprinting disorders, with or without a positive molecular diagnosis. 20 of 91 patients (22%) with diagnosed epimutations had methylation defects of additional imprinted loci, and the frequency of developmental delay and congenital anomalies was higher among these patients than those with isolated epimutations, indicating that hypomethylation of multiple imprinted loci is associated with increased diversity of clinical presentation. Among 194 patients with clinical features of an imprinting disorder but no molecular diagnosis, we found 15 (8%) with methylation anomalies, including missed and unexpected molecular diagnoses. These observations broaden the phenotypic and epigenetic definitions of imprinting disorders, and show the importance of comprehensive molecular testing for patient diagnosis and management. PMID:23913548

  10. Construction and Characterization of a Population-Based Cohort to Study the Association of Anesthesia Exposure with Neurodevelopmental Outcomes

    PubMed Central

    Hu, Danqing; Flick, Randall P.; Gleich, Stephen J.; Scanlon, Maura M.; Zaccariello, Michael J.; Colligan, Robert C.; Katusic, Slavica K.; Schroeder, Darrell R.; Hanson, Andrew C.; Buenvenida, Shonie L.; Wilder, Robert T.; Sprung, Juraj; Warner, David O.

    2016-01-01

    Exposure to general anesthesia at an early age has been associated with adverse neurodevelopmental outcomes in both animal and human studies, but some of these studies employed anesthetic agents that are no longer in clinical use. In this manuscript, we describe the methods used to construct a new population-based study cohort to study the association between early anesthetic exposure and subsequent neurodevelopmental outcomes. A birth cohort of all children born in Olmsted County, MN from January 1, 1996 to December 31, 2000 was identified. For each, school enrollment status in the Independent School District (ISD) 535 at age 5 or 6 and all episodes of anesthetic exposure before age 3 were identified. A study cohort was created by matching children enrolled in ISD 535 based on the propensity of receiving general anesthesia. Three analyses were performed to characterize the study cohort by comparing the birth and parental information, comorbidities, and socioeconomic status. The first analysis compared the characteristics of birth cohort children who were and were not enrolled in ISD 535. The second analysis evaluated the success of the propensity matching schemes in creating groups of children that were similar in measured characteristics except for anesthesia exposure. The third analysis compared the characteristics of children with anesthesia exposures who were and were not included in the final cohort based on propensity matching. Results of these analyses demonstrate only slight differences among the comparison groups, and therefore these are unlikely to compromise our future analysis of anesthetic exposure and neurodevelopmental outcomes. PMID:27167371

  11. Single-specificity anti-Ku antibodies in an international cohort of 2140 systemic sclerosis subjects: clinical associations

    PubMed Central

    Hoa, S.; Hudson, M.; Troyanov, Y.; Proudman, S.; Walker, J.; Stevens, W.; Nikpour, M.; Assassi, S.; Mayes, M.D.; Wang, M.; Baron, M.; Fritzler, M.J.

    2016-01-01

    Abstract Autoantibodies directed against the Ku autoantigen are present in systemic sclerosis (SSc) and have been associated with myositis overlap and interstitial lung disease (ILD). However, there is a paucity of data on the clinical correlates of anti-Ku antibodies in the absence of other SSc-specific antibodies. The aim of this study was to assess the clinical correlates of single-specificity anti-Ku in SSc. An international (Canada, Australia, USA, Mexico) cohort of 2140 SSc subjects was formed, demographic and clinical variables were harmonized, and sera were tested for anti-Ku using a line immunoassay. Associations between single-specificity anti-Ku antibodies (i.e., in isolation of other SSc-specific antibodies) and outcomes of interest, including myositis, ILD, and survival, were investigated. Twenty-four (1.1%) subjects had antibodies against Ku, and 13 (0.6%) had single-specificity anti-Ku antibodies. Subjects with single-specificity anti-Ku antibodies were more likely to have ILD (58% vs 34%), and to have increased creatine kinase levels (>3× normal) at baseline (11% vs 1%) and during follow-up (10% vs 2%). No difference in survival was noted in subjects with and without single-specificity anti-Ku antibodies. This is the largest cohort to date focusing on the prevalence and disease characteristics of single-specificity anti-Ku antibodies in subjects with SSc. These results need to be interpreted with caution in light of the small sample. International collaboration is key to understanding the clinical correlates of uncommon serological profiles in SSc. PMID:27583908

  12. Single-specificity anti-Ku antibodies in an international cohort of 2140 systemic sclerosis subjects: clinical associations.

    PubMed

    Hoa, S; Hudson, M; Troyanov, Y; Proudman, S; Walker, J; Stevens, W; Nikpour, M; Assassi, S; Mayes, M D; Wang, M; Baron, M; Fritzler, M J

    2016-08-01

    Autoantibodies directed against the Ku autoantigen are present in systemic sclerosis (SSc) and have been associated with myositis overlap and interstitial lung disease (ILD). However, there is a paucity of data on the clinical correlates of anti-Ku antibodies in the absence of other SSc-specific antibodies. The aim of this study was to assess the clinical correlates of single-specificity anti-Ku in SSc.An international (Canada, Australia, USA, Mexico) cohort of 2140 SSc subjects was formed, demographic and clinical variables were harmonized, and sera were tested for anti-Ku using a line immunoassay. Associations between single-specificity anti-Ku antibodies (i.e., in isolation of other SSc-specific antibodies) and outcomes of interest, including myositis, ILD, and survival, were investigated.Twenty-four (1.1%) subjects had antibodies against Ku, and 13 (0.6%) had single-specificity anti-Ku antibodies. Subjects with single-specificity anti-Ku antibodies were more likely to have ILD (58% vs 34%), and to have increased creatine kinase levels (>3× normal) at baseline (11% vs 1%) and during follow-up (10% vs 2%). No difference in survival was noted in subjects with and without single-specificity anti-Ku antibodies.This is the largest cohort to date focusing on the prevalence and disease characteristics of single-specificity anti-Ku antibodies in subjects with SSc. These results need to be interpreted with caution in light of the small sample. International collaboration is key to understanding the clinical correlates of uncommon serological profiles in SSc. PMID:27583908

  13. Antioxidant vitamin intake and mortality: the Leisure World Cohort Study.

    PubMed

    Paganini-Hill, Annlia; Kawas, Claudia H; Corrada, María M

    2015-01-15

    To assess the relationship between antioxidant vitamin intake and all-cause mortality in older adults, we examined these associations using data from the Leisure World Cohort Study, a prospective study of residents of the Leisure World retirement community in Laguna Hills, California. In the early 1980s, participants (who were aged 44-101 years) completed a postal survey, which included details on use of vitamin supplements and dietary intake of foods containing vitamins A and C. Age-adjusted and multivariate-adjusted (for factors related to mortality in this cohort—smoking, alcohol intake, caffeine consumption, exercise, body mass index, and histories of hypertension, angina, heart attack, stroke, diabetes, rheumatoid arthritis, and cancer) hazard ratios for death were calculated using Cox regression for 8,640 women and 4,983 men (median age at entry, 74 years). During follow-up (1981-2013), 13,104 participants died (median age at death, 88 years). Neither dietary nor supplemental intake of vitamin A or vitamin C nor supplemental intake of vitamin E was significantly associated with mortality after multivariate adjustment. A compendium that summarizes previous findings of cohort studies evaluating vitamin intake and mortality is provided. Attenuation in the observed associations between mortality and antioxidant vitamin use after adjustment for confounders in our study and in previous studies suggests that such consumption identifies persons with other mortality-associated lifestyle and health risk factors. PMID:25550360

  14. Strong Opinions Are No Substitute for Balanced Arguments: Comments on Cicchetti, Kaufman, and Sparrow's Critical Appraisal of PCB Cohort Studies

    ERIC Educational Resources Information Center

    Winneke, Gerhard; Walkowiak, Jens; Kramer, Ursula

    2004-01-01

    This paper comments on a critical review of cohort studies on PCB-related neurodevelopmental deficit in young children by D.V. Cicchetti, A.S. Kaufman, and S.S. Sparrow (CKS). Major points of criticism of CKS, namely alleged violation of statistical principles, presumed lack of clinical significance of findings, and alleged insufficient control of…

  15. Nested Cohort

    Cancer.gov

    NestedCohort is an R software package for fitting Kaplan-Meier and Cox Models to estimate standardized survival and attributable risks for studies where covariates of interest are observed on only a sample of the cohort.

  16. Determinants of workplace injury among Thai Cohort Study participants

    PubMed Central

    Berecki-Gisolf, Janneke; Tawatsupa, Benjawan; McClure, Roderick; Seubsman, Sam-ang; Sleigh, Adrian

    2013-01-01

    Objectives To explore individual determinants of workplace injury among Thai workers. Design Cross-sectional analysis of a large national cohort. Setting Thailand. Participants Thai Cohort Study participants who responded to the 2009 follow-up survey were included if they reported doing paid work or being self-employed (n=51 751). Outcome measures Self-reported injury incidence over the past 12 months was calculated. Multivariate logistic regression models were used to test associations between individual determinants and self-reported workplace injury. Results Workplace injuries were reported by 1317 study participants (2.5%); the incidence was 34 (95% CI 32 to 36)/1000 worker-years for men, and 18 (17–20) for women. Among men working ≥41 h and earning <10 000 Baht, the injury rate was four times higher compared with men working <11 h and earning ≥20 001 Baht; differences in injury rates were less pronounced in women. Multivariate modelling showed that working ≥49 h/week (23%) and working for ≤10 000 Bath/month (37%) were associated with workplace injury. The increase in injury risk with increased working hours did not exceed the risk expected from increased exposure. Conclusions Reductions in occupational injury rates could be achieved by limiting working hours to 48/week. Particularly for Thai low wage earners and those with longer workdays, there is a need for effective injury preventive programmes. PMID:23869104

  17. The Asia pacific cohort studies collaboration: a decade of achievements.

    PubMed

    Woodward, Mark; Huxley, Rachel; Ueshima, Hirotsugu; Fang, Xianghua; Kim, Hyeon Chang; Lam, Tai-Hing

    2012-12-01

    The Asia Pacific Cohort Studies Collaboration (APCSC) was established in the late 1990s when there was a distinct shortfall in evidence of the importance of risk factors for cardiovascular disease in Asia. With few exceptions, most notably from Japan, most of the published reports on cardiovascular disease in the last century were from Western countries, and there was uncertainty how far etiological associations found in the West could be assumed to prevail in the East. Against this background, APCSC was set up as a pooling project, combining individual participant data (about 600,000 subjects) from all available leading cohort studies (36 from Asia and 8 from Australasia) in the region, to fill the knowledge gaps. In the past 10 years, APCSC has published 50 peer-reviewed publications of original epidemiological research, primarily concerned with coronary heart disease, stroke, and cancer. This work has established that Western risk factors generally act similarly in Asia and in Australasia, just as they do in other parts of the world. Consequently, strategies to reduce the prevalence of elevated blood pressure, obesity, and smoking are at least as important in Asia as elsewhere- and possibly more important when the vast size of Asia is considered. This article reviews the achievements of APCSC in the past decade, with an emphasis on coronary heart disease. PMID:25689943

  18. The High Prevalence of Diabetes in a Large Cohort of Patients Drawn From Safety Net Clinics

    PubMed Central

    McBurnie, MaryAnn; Paul, Ludmilla; Potter, Jennifer E.; McCann, Sheila; Mayer, Kenneth; Melgar, Gerardo; D’Amato, Sele; DeVoe, Jennifer E.

    2016-01-01

    Introduction Underserved populations have been overlooked or underrepresented in research based on data from diabetes registries. We estimated diabetes prevalence using a cohort developed from the electronic health records of 3 networks of safety net clinics that provide care to underserved populations. Methods ADVANCE (Accelerating Data Value Across a National Community Health Center Network) is a partnership of the OCHIN Community Health Information Network (OCHIN), the Health Choice Network (HCN), and the Fenway Health Institute (FHI), representing 97 federally qualified health centers (FQHCs) and 744 clinic sites in 22 US states. Among 952,316 adults with a body mass index (BMI) measurement and at least 2 outpatient visits in 2012 to 2014, we calculated diabetes prevalence using outpatient diagnoses, diagnostic laboratory results, or dispenses of anti-hyperglycemic agents no more than 730 days apart. We calculated prevalence by age, sex, race, Hispanic ethnicity, and BMI class. Results The crude prevalence of diabetes was 14.4%. Men had a higher prevalence than women (16.5% vs 13.2%); diabetes prevalence increased across age categories. White patients had the lowest prevalence (11.4%) and Hawaiian/Pacific Islanders, the highest prevalence (21.9%), with prevalence ranging from 15.2% to 16.5% for other race/ethnicities. The association between BMI class and diabetes prevalence was similar across all racial/ethnic groups. Conclusion The ADVANCE diabetes cohort offers an opportunity to conduct epidemiologic and comparative effectiveness research on underserved and underrepresented individuals, who have a higher prevalence of diabetes than the general US population. PMID:27309415

  19. Preexisting Neutralizing Antibody Responses Distinguish Clinically Inapparent and Apparent Dengue Virus Infections in a Sri Lankan Pediatric Cohort

    PubMed Central

    Corbett, Kizzmekia S.; Katzelnick, Leah; Tissera, Hasitha; Amerasinghe, Ananda; de Silva, Aruna Dharshan; de Silva, Aravinda M.

    2015-01-01

    Dengue viruses (DENVs) are mosquito-borne flaviviruses that infect humans. The clinical presentation of DENV infection ranges from inapparent infection to dengue hemorrhagic fever and dengue shock syndrome. We analyzed samples from a pediatric dengue cohort study in Sri Lanka to explore whether antibody responses differentiated clinically apparent infections from clinically inapparent infections. In DENV-naive individuals exposed to primary DENV infections, we observed no difference in the quantity or quality of acquired antibodies between inapparent and apparent infections. Children who experienced primary infections had broad, serotype–cross-neutralizing antibody responses that narrowed in breadth to a single serotype over a 12-month period after infection. In DENV immune children who were experiencing a repeat infection, we observed a strong association between preexisting neutralizing antibodies and clinical outcome. Notably, children with preexisting monospecific neutralizing antibody responses were more likely to develop fever than children with cross-neutralizing responses. Preexisting DENV neutralizing antibodies are correlated with protection from dengue disease. PMID:25336728

  20. Clinical experience with insulin detemir, biphasic insulin aspart and insulin aspart in people with type 2 diabetes: Results from the West India cohort of the A1chieve study

    PubMed Central

    Jain, Sunil M.; Jindal, Sushil; Malve, Harshad; Shetty, Raman; Bhoraskar, Anil

    2013-01-01

    Background: The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents. Materials and Methods: Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from West India. Results: A total of 4192 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 2846), insulin detemir (n = 596), insulin aspart (n = 517), basal insulin plus insulin aspart (n = 140) and other insulin combinations (n = 83). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 8.8%) and insulin user (mean HbA1c: 9.1%) groups. After 24 weeks of treatment, both the groups showed improvement in HbA1c (insulin naïve: −1.6%, insulin users: −1.7%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients. Conclusion: Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia. PMID:24404488

  1. Socioeconomic Status, Race, and Mortality: A Prospective Cohort Study

    PubMed Central

    Cohen, Sarah S.; Williams, David R.; Munro, Heather M.; Hargreaves, Margaret K.; Blot, William J.

    2014-01-01

    Objectives. We evaluated the independent and joint effects of race, individual socioeconomic status (SES), and neighborhood SES on mortality risk. Methods. We conducted a prospective analysis involving 52 965 non-Hispanic Black and 23 592 non-Hispanic White adults taking part in the Southern Community Cohort Study. Cox proportional hazards modeling was used to determine associations of race and SES with all-cause and cause-specific mortality. Results. In our cohort, wherein Blacks and Whites had similar individual SES, Blacks were less likely than Whites to die during the follow-up period (hazard ratio [HR] = 0.78; 95% confidence interval [CI] = 0.73, 0.84). Low household income was a strong predictor of all-cause mortality among both Blacks and Whites (HR = 1.76; 95% CI = 1.45, 2.12). Being in the lowest (vs highest) category with respect to both individual and neighborhood SES was associated with a nearly 3-fold increase in all-cause mortality risk (HR = 2.76; 95% CI = 1.99, 3.84). There was no significant mortality-related interaction between individual SES and neighborhood SES among either Blacks or Whites. Conclusions. SES is a strong predictor of premature mortality, and the independent associations of individual SES and neighborhood SES with mortality risk are similar for Blacks and Whites. PMID:25322291

  2. HHV8 and Kaposi's sarcoma: a time cohort study.

    PubMed Central

    Kennedy, M M; Lucas, S B; Jones, R R; Howells, D D; Picton, S J; Hanks, E E; McGee, J O; O'Leary, J J

    1997-01-01

    AIMS: The recent finding that human herpes virus 8 (HHV8) is found in the majority of Kaposi's sarcoma (KS) cases supports the epidemiological observation that the tumour may be caused by an infectious agent. This study aimed to address when and how HHV8 evolved. METHODS: A cohort of African endemic KS (49 samples from 45 patients) and European KS (18 samples from 13 patients), spanning 27 years, was assessed for the presence of HHV8 by both standard solution phase polymerase chain reaction (PCR) and the newly described technique of TaqMan PCR. RESULTS: HHV8 was present in approximately 49% (24 of 49 tissue samples) of the African cases and in more than 90% (16 of 18 tissue samples) of the European cohort, in keeping with recent seroepidemiological data. CONCLUSIONS: HHV8 is strongly linked to the development of KS; however, in some patients, other factors may operate. The utility and flexibility of TaqMan PCR in detecting low copy viral target in human tissues was demonstrated. Images PMID:9231158

  3. Physical performance limitations in the Childhood Cancer Survivor Study cohort.

    PubMed

    Ness, Kirsten K; Hudson, Melissa M; Ginsberg, Jill P; Nagarajan, Rajaram; Kaste, Sue C; Marina, Neyssa; Whitton, John; Robison, Leslie L; Gurney, James G

    2009-05-10

    Physical performance limitations are one of the potential long-term consequences following diagnosis and treatment for childhood cancer. The purpose of this review is to describe the risk factors for and the participation restrictions that result from physical performance limitations among childhood cancer survivors who participated in the Childhood Cancer Survivor Study (CCSS). Articles previously published from the CCSS cohort related to physical performance limitations were reviewed and the results summarized. Our review showed that physical performance limitations are prevalent among childhood cancer survivors and may increase as they age. Host-based risk factors for physical disability include an original diagnosis of bone tumor, brain tumor, or Hodgkin's disease; female sex; and an income less than $20,000 per year. Treatment-based risk factors include radiation and treatment with a combination of alkylating agents and anthracyclines. Musculoskeletal, neurologic, cardiac, pulmonary, sensory, and endocrine organ system dysfunction also increase the risk of developing a physical performance limitation. In summary, monitoring of physical performance limitations in an aging cohort of childhood cancer survivors is important and will help determine the impact of physical performance limitations on morbidity, mortality, and caregiver burden. In addition, in developing restorative and preventive interventions for childhood cancer survivors, we must take into account the special needs of survivors with physical disability to optimize their health and enhance participation in daily living activities. PMID:19332713

  4. Birth order and mortality: a population-based cohort study.

    PubMed

    Barclay, Kieron; Kolk, Martin

    2015-04-01

    This study uses Swedish population register data to investigate the relationship between birth order and mortality at ages 30 to 69 for Swedish cohorts born between 1938 and 1960, using a within-family comparison. The main analyses are conducted with discrete-time survival analysis using a within-family comparison, and the estimates are adjusted for age, mother's age at the time of birth, and cohort. Focusing on sibships ranging in size from two to six, we find that mortality risk in adulthood increases with later birth order. The results show that the relative effect of birth order is greater among women than among men. This pattern is consistent for all the major causes of death but is particularly pronounced for mortality attributable to cancers of the respiratory system and to external causes. Further analyses in which we adjust for adult socioeconomic status and adult educational attainment suggest that social pathways only mediate the relationship between birth order and mortality risk in adulthood to a limited degree. PMID:25777302

  5. Outcome of a cohort of 300 patients with systemic lupus erythematosus attending a dedicated clinic for over two decades

    PubMed Central

    Moss, K; Ioannou, Y; Sultan, S; Haq, I; Isenberg, D

    2002-01-01

    Objective: To examine the mortality rate and causes of death in a cohort of 300 patients with systemic lupus erythematosus (SLE). Methods: A retrospective analysis was performed on all patients attending the SLE clinic between 1978 and 2000. Information was obtained on those patients lost to follow up. Cause of death was analysed and categorised as early (<5 years after diagnosis of SLE) and late (>5 years after diagnosis of SLE). Standardised mortality rates were obtained. Results: The patients were followed up for a median of 8.3 years. Seventy three (24%) patients were no longer followed up at the end of the study period, of whom 41 (14%) had died. Of the 32 patients lost to follow up, 14 were being actively followed up within the UK, 16 were followed up outside the UK, and two patients were untraceable. The most common cause of death was malignancy, which accounted for eight (20%) deaths, followed by infection and vascular disease, which accounted for seven (17%) deaths each. Conclusions: Malignancy was the most common cause of death. Cause of death varied depending on disease duration. Forty per cent of early deaths were due to SLE related renal disease, whereas 23% of late deaths were due to vascular causes. Death due to infection occurred throughout the follow up period. There was a fourfold increased risk of death in our cohort of patients with SLE compared with the general population. PMID:11959764

  6. Intracytoplasmic morphologically selected sperm injection and congenital birth defects: a retrospective cohort study.

    PubMed

    Hershko-Klement, A; Sukenik-Halevy, R; Biron Shental, T; Miller, N; Berkovitz, A

    2016-09-01

    Our objective was to study the birth defect rates in intracytoplasmic morphologically selected sperm injection (IMSI) pregnancies. A cohort of couples presenting male factor infertility between January 2006 and January 2014 was retrospectively analyzed. Discharge letters and a telephone interview were performed for assessing pregnancy outcome. All clinical data were reviewed by a board certified medical geneticist. Main outcomes were fetal/birth defect and chromosomal abnormality rates. Two thousand two hundred and fifty-eight pregnancies were available for analysis, of them, 1669 (73.9%) resulting from ICSI and 2258 (26.1%) achieved by IMSI. Pregnancy outcome distribution did not show a significant difference. For the fresh embryo transfer cohort, fetal/birth defect rate was 4.5%, chromosomal aberration rate was 1.0%, and structural malformation rate was 3.5%. IMSI vs. ICSI pregnancies were less likely to involve a fetal/birth defect: 3.5% vs. 4.8%, respectively, but did not reach a statistical significance OR 0.71 (95% CI 0.39-1.22). Split by multiplicity, this trend existed only for singleton pregnancies; 1.4% structural malformations rate vs. 3.8%, respectively, OR 0.35 (95% CI 0.11-0.9). The frozen cohort demonstrated a significantly lower birth defect rate (OR 0.25, 95% CI 0.09-0.58). We conclude that IMSI procedure does not involve an increased malformation rate and may offer a reduced anomaly incidence. Further studies are required. PMID:27317040

  7. High Risk of Depressive Disorders in Patients With Gout: A Nationwide Population-Based Cohort Study.

    PubMed

    Changchien, Te-Chang; Yen, Yung-Chieh; Lin, Cheng-Li; Lin, Ming-Chia; Liang, Ji-An; Kao, Chia-Hung

    2015-12-01

    Metabolic abnormalities are common in patients with depressive disorders. However, the relationship between gout and depression is unclear. We explored the causal relationship among gout, antigout medication, and the associated risk of incidental depressive disorders.In this nationwide cohort study, we sampled data from the National Health Insurance Research Database to recruit 34,050 patients with gout as the gout cohort and 68,100 controls (without gout) as the nongout cohort. Our primary endpoint was the diagnosis of depressive disorders during follow-up. The overall study population was followed up until depression diagnosis, withdrawal from the NHI program, or the end of the study. The differences in demographic and clinical characteristics between both cohorts were determined using the Chi-square test for categorical variables and the t-test for continuous variables. Cox proportional hazard regression models were used to examine the effect of gout on the risk of depression, represented using the hazard ratio with the 95% confidence interval.Patients with gout exhibited a higher risk of depressive disorders than controls did. The risk of depressive disorders increased with age and was higher in female patients and those with hypertension, stroke, and coronary artery disease. Nonsteroidal antiinflammatory drug and prednisolone use was associated with a reduced risk of depression. Patients with gout who had received antigout medication exhibited a reduced risk of depressive disorders compared with nongout patients.Our findings support that gout increases the risk of depressive disorders, and that antigout medication use reduces the risk. PMID:26717394

  8. Effectiveness of DNA-recombinant anti-hepatitis B vaccines in blood donors: a cohort study

    PubMed Central

    Kupek, Emil; de Souza, Denise ER; Petry, Andrea

    2007-01-01

    Background Although various studies have demonstrated efficacy of DNA-recombinant anti-hepatitis B vaccines, their effectiveness in health care settings has not been researched adequately. This gap is particularly visible for blood donors, a group of significant importance in the reduction of transfusion-transmitted hepatitis B. Methods This is a double cohort study of 1411 repeat blood donors during the period 1998–2002, involving a vaccinated and an unvaccinated cohort, with matching of the two in terms of sex, age and residence. Average follow-up was 3.17 person-years. The outcome measure was infection with hepatitis B virus (HBV), defined by testing positive on serologic markers HBsAg or anti-HBC. All blood donors were from the blood bank in Joaçaba, federal state of Santa Catarina, Brazil. Results The cohorts did not differ significantly regarding sex, age and marital status but the vaccinated cohort had higher mean number of blood donations and higher proportion of those residing in the county capital Joaçaba. Hepatitis B incidences per 1000 person-years were zero among vaccinated and 2,33 among non-vaccinated, resulting in 100% vaccine effectiveness with 95% confidence interval from 30,1% to 100%. The number of vaccinated persons necessary to avoid one HBV infection in blood donors was estimated at 429 with 95% confidence interval from 217 to 21422. Conclusion The results showed very high effectiveness of DNA-recombinant anti-HBV vaccines in blood donors. Its considerable variation in this study is likely due to the limited follow-up and the influence of confounding factors normally balanced out in efficacy clinical trials. PMID:17986330

  9. Childhood adversities and adult-onset asthma: a cohort study

    PubMed Central

    Korkeila, Jyrki; Lietzen, Raija; Sillanmäki, Lauri H; Rautava, Päivi; Korkeila, Katariina; Kivimäki, Mika; Koskenvuo, Markku; Vahtera, Jussi

    2012-01-01

    Objectives Childhood adversities may be important determinants of later illnesses and poor health behaviour. However, large-scale prospective studies on the associations between childhood adversities and the onset of asthma in adulthood are lacking. Design Prospective cohort study with 7-year follow-up. Setting Nationally representative study. Data were collected from the Health and Social Support (HeSSup) survey and national registers. Participants The participants represent the Finnish population from the following age groups: 20–24, 30–34, 40–44, and 50–54 years at baseline in 1998 (24 057 survey participants formed the final cohort of this study). The occurrence of childhood adversities was assessed at baseline with a six-item survey scale. The analyses were adjusted for sociodemographic characteristics, behavioural health risks and common mental disorders. Primary and secondary outcomes The survey data were linked to data from national health registers on incident asthma during a 7-year follow-up to define new-onset asthma cases with verified diagnoses. Results A total of 12 126 (59%) participants reported that they encountered a childhood adversity. Of them 3677 (18% of all) endured three to six adversities. During a follow-up of 7 years, 593 (2.9%) participants were diagnosed with incident asthma. Those who reported three or more childhood adversities had a 1.6-fold (95% CI 1.31 to 2.01) greater risk of asthma compared to those without childhood adversities. This hazard attenuated but remained statistically significant after adjustment for conventional risk factors (HR 1.33; 95% CI 1.06 to 1.67). Conclusions Adults who report having encountered adversities in childhood may have an increased risk of developing asthma. PMID:23069774

  10. A cohort study of mortality among Ontario pipe trades workers

    PubMed Central

    Finkelstein, M; Verma, D

    2004-01-01

    Aims: To study mortality in a cohort of members of the United Association of Journeymen and Apprentices of the Plumbing and Pipe Fitting Industry of the United States and Canada and to compare results with two previous proportional mortality studies. Methods: A cohort of 25 285 workers who entered the trade after 1949 was assembled from records of the international head office. Mortality was ascertained by linkage to the Canadian Mortality Registry at Statistics Canada. Standardised mortality ratios were computed using Ontario general population mortality rates as the reference. Results: There were significant increases in lung cancer mortality rates (SMR 1.27; 95% CI 1.13 to 1.42). Increased lung cancer risk was observed among plumbers, pipefitters, and sprinkler fitters. Increased risk was observed among workers joining the Union as late as the 1970s. A random effects meta-analysis of this study and the two PMR studies found significant increases in oesophageal (RR 1.24; 95% CI 1.00 to 1.53), lung (RR 1.31; 95% CI 1.19 to 1.44), and haematological/lymphatic (RR 1.21; 95% CI 1.08 to 1.35) malignancies. Conclusions: The mortality pattern is consistent with the effects of occupational exposure to asbestos. Increased risk due to other respiratory carcinogens such as welding fume cannot be excluded. There are substantial amounts of asbestos in place in industrial and commercial environments. The education and training of workers to protect themselves against inhalation hazards will be necessary well into the future. PMID:15317913

  11. Patient characteristics associated with venous thromboembolic events: a cohort study using pooled electronic health record data

    PubMed Central

    Foster, Wendy; Gilder, Jason; Love, Thomas E; Jain, Anil K

    2012-01-01

    Objective To demonstrate the potential of de-identified clinical data from multiple healthcare systems using different electronic health records (EHR) to be efficiently used for very large retrospective cohort studies. Materials and methods Data of 959 030 patients, pooled from multiple different healthcare systems with distinct EHR, were obtained. Data were standardized and normalized using common ontologies, searchable through a HIPAA-compliant, patient de-identified web application (Explore; Explorys Inc). Patients were 26 years or older seen in multiple healthcare systems from 1999 to 2011 with data from EHR. Results Comparing obese, tall subjects with normal body mass index, short subjects, the venous thromboembolic events (VTE) OR was 1.83 (95% CI 1.76 to 1.91) for women and 1.21 (1.10 to 1.32) for men. Weight had more effect then height on VTE. Compared with Caucasian, Hispanic/Latino subjects had a much lower risk of VTE (female OR 0.47, 0.41 to 0.55; male OR 0.24, 0.20 to 0.28) and African-Americans a substantially higher risk (female OR 1.83, 1.76 to 1.91; male OR 1.58, 1.50 to 1.66). This 13-year retrospective study of almost one million patients was performed over approximately 125 h in 11 weeks, part time by the five authors. Discussion As research informatics tools develop and more clinical data become available in EHR, it is important to study and understand unique opportunities for clinical research informatics to transform the scale and resources needed to perform certain types of clinical research. Conclusions With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources. PMID:22759621

  12. Qingdao Port Cardiovascular Health Study: a prospective cohort study

    PubMed Central

    Spatz, Erica S; Jiang, Xianyan; Lu, Jiapeng; Masoudi, Frederick A; Spertus, John A; Wang, Yongfei; Li, Xi; Downing, Nicholas S; Nasir, Khurram; Du, Xue; Li, Jing; Krumholz, Harlan M; Liu, Xiancheng; Jiang, Lixin

    2015-01-01

    Purpose In China, efforts are underway to respond to rapidly increasing rates of heart disease and stroke. Yet the epidemiology of cardiovascular disease in China may be different from that of other populations. Thus, there is a critical need for population-based studies that provide insight into the risk factors, incidence and outcomes of cardiovascular disease in China. The Qingdao Port Cardiovascular Health Study is designed to investigate the burden of cardiovascular disease and the sociodemographic, biological, environmental and clinical risk factors associated with disease onset and outcomes. Participants For this study, from 2000 through 2013, 32 404 employees aged 18 years or older were recruited from the Qingdao Port Group in China, contributing 221 923 annual health assessments. The mean age at recruitment was 43.4 (SD=12.9); 79% were male. In this ongoing study, annual health assessments, governed by extensive quality control mechanisms, include a questionnaire (capturing demographic and employment information, medical history, medication use, health behaviours and health outcomes), physical examination, ECG, and blood and urine analysis. Additional non-annual assessments include an X-ray, echocardiogram and carotid ultrasound; bio-samples will be collected for future genetic and proteomic analyses. Cardiovascular outcomes are accessed via self-report and are actively being verified with medical insurance claims; efforts are underway to adjudicate outcomes with hospital medical records. Findings to date Early findings reveal a significant increase in cardiovascular risk factors from 2000 to 2010 (hypertension: 26.4–39.4%; diabetes: 3.3–8.9%; hyperlipidaemia: 5.0–33.6%; body mass index >28 m/kg2: 14.1–18.6%). Future Plans We aim to generate novel insights about the epidemiology and outcomes of cardiovascular disease in China, with specific emphasis on the potentially unique risk factor profiles of this Chinese population. Knowledge

  13. Risk Factors for Alloimmunisation after red blood Cell Transfusions (R-FACT): a case cohort study

    PubMed Central

    Zwaginga, Jaap Jan; van der Bom, J G

    2012-01-01

    Introduction Individuals exposed to red blood cell alloantigens through transfusion, pregnancy or transplantation may produce antibodies against the alloantigens. Alloantibodies can pose serious clinical problems such as delayed haemolytic reactions and logistic problems, for example, to obtain timely and properly matched transfusion blood for patients in which new alloantibodies are detected. Objective The authors hypothesise that the particular clinical conditions (eg, used medication, concomitant infection, cellular immunity) during which transfusions are given may contribute to the risk of immunisation. The aim of this research was to examine the association between clinical, environmental and genetic characteristics of the recipient of erythrocyte transfusions and the risk against erythrocyte alloimmunisation during that transfusion episode. Methods and analysis Study design Incident case–cohort study. Setting Secondary care, nationwide study (within the Netherlands) including seven hospitals, from January 2005 to December 2011. Study population Consecutive red cell transfused patients at the study centres. Inclusion The study cohort comprises of consecutive red blood cell transfused patients at the study centre. Exclusion Patients with transfusions before the study period and/or pre-existing alloantibodies.Cases defined as first time alloantibody formers; Controls defined as transfused individuals matched (on number of transfusions) to cases and have not formed an alloantibody. Statistical analysis Logistic regression models will be used to assess the association between the risk to develop antibodies and potential risk factors, adjusted for other risk factors. Ethics and dissemination Approval at each local ethics regulatory committee will be obtained. Data will be coded for privacy reasons. Patients will be sent a letter and an information brochure explaining the purpose of the study. A consent form in presence of the study coordinator will be signed

  14. Statins and morbidity and mortality in COPD in the COMIC study: a prospective COPD cohort study

    PubMed Central

    Citgez, Emanuel; van der Palen, Job; Koehorst-ter Huurne, Kirsten; Movig, Kris; van der Valk, Paul; Brusse-Keizer, Marjolein

    2016-01-01

    Background Both chronic inflammation and cardiovascular comorbidity play an important role in the morbidity and mortality of patients with chronic obstructive pulmonary disease (COPD). Statins could be a potential adjunct therapy. The additional effects of statins in COPD are, however, still under discussion. The aim of this study is to further investigate the association of statin use with clinical outcomes in a well-described COPD cohort. Methods 795 patients of the Cohort of Mortality and Inflammation in COPD (COMIC) study were divided into statin users or not. Statin use was defined as having a statin for at least 90 consecutive days after inclusion. Outcome parameters were 3-year survival, based on all-cause mortality, time until first hospitalisation for an acute exacerbation of COPD (AECOPD) and time until first community-acquired pneumonia (CAP). A sensitivity analysis was performed without patients who started a statin 3 months or more after inclusion to exclude immortal time bias. Results Statin use resulted in a better overall survival (corrected HR 0.70 (95% CI 0.51 to 0.96) in multivariate analysis), but in the sensitivity analysis this association disappeared. Statin use was not associated with time until first hospitalisation for an AECOPD (cHR 0.95, 95% CI 0.74 to 1.22) or time until first CAP (cHR 1.1, 95% CI 0.83 to 1.47). Conclusions In the COMIC study, statin use is not associated with a reduced risk of all-cause mortality, time until first hospitalisation for an AECOPD or time until first CAP in patients with COPD. PMID:27403321

  15. Can Psychopathology at Age 7 Be Predicted from Clinical Observation at One Year? Evidence from the ALSPAC Cohort

    ERIC Educational Resources Information Center

    Allely, C. S.; Doolin, O.; Gillberg, C.; Gillberg, I. C.; Puckering, C.; Smillie, M.; McConnachie, A.; Heron, J.; Golding, J.; Wilson, P.

    2012-01-01

    One of the challenges of developmental psychopathology is to determine whether identifiable pathways to developmental disorders exist in the first months or years of life. Early identification of such disorders poses a similar challenge for clinical services. Using data from a large contemporary birth cohort, we examined whether psychopathology at…

  16. Danish cohort of monozygotic inflammatory bowel disease twins: Clinical characteristics and inflammatory activity

    PubMed Central

    Moller, Frederik Trier; Knudsen, Lina; Harbord, Marcus; Satsangi, Jack; Gordon, Hannah; Christiansen, Lene; Christensen, Kaare; Jess, Tine; Andersen, Vibeke

    2016-01-01

    AIM: To describe the establishment of a Danish inflammatory bowel diseases (IBD) twin cohort with focus on concordance of treatment and inflammatory markers. METHODS: We identified MZ twins, likely to be discordant or concordant for IBD, by merging information from the Danish Twin Register and the National Patient Register. The twins were asked to provide biological samples, questionnaires, and data access to patient files and public registries. Biological samples were collected via a mobile laboratory, which allowed for immediate centrifugation, fractionation, and storage of samples. The mean time from collection of samples to storage in the -80 °C mobile freezer was less than one hour. The diagnoses where validated using the Copenhagen diagnostic criteria. RESULTS: We identified 159 MZ IBD twin pairs, in a total of 62 (39%) pairs both twins agreed to participate. Of the supposed 62 IBD pairs, the IBD diagnosis could be confirmed in 54 pairs. The cohort included 10 concordant pairs, whereof some were discordant for either treatment or surgery. The 10 concordant pairs, where both pairs suffered from IBD, included eight CD/CD pairs, one UC/UC pair and one UC/IBDU pair. The discordant pairs comprised 31 UC, 5 IBDU (IBD unclassified), and 8 CD discordant pairs. In the co-twins not affected by IBD, calprotectin was above 100 μg/g in 2 participants, and above 50 μg/g in a further 5 participants. CONCLUSION: The presented IBD twin cohorts are an excellent resource for bioinformatics studies with proper adjustment for disease-associated exposures including medication and inflammatory activity in the co-twins. PMID:27275097

  17. The frequency of rehospitalization and associated factors in Colombian psychiatric patients: a cohort study

    PubMed Central

    2014-01-01

    Background The rehospitalization of patients with mental disorders is common, with rehospitalization rates of up to 80% observed in these patients. This phenomenon negatively impacts families, patients, and the health care system. Several factors have been associated with an increased likelihood of rehospitalization. This study was aimed at determining the frequency and the factors associated with rehospitalization in a psychiatric clinic. Methods We performed a prospective cohort study with 361 patients who were hospitalized at the Clinic of Our Lady of Peace in Bogota, Colombia from August-December 2009. We calculated the incidence rates of rehospitalization and the risk factors using Cox regression. Results Overall, 60% of the patients in this cohort were rehospitalized during the year that followed the index event. The variables associated with rehospitalization were separated, divorced, or single status; higher socio-economic strata; a longer duration of index hospitalization; and a diagnosis of substance abuse, schizophrenia, bipolar disorder, or depression. Conclusions The rehospitalization rate in our study was as high as reported in other studies. The associated factors with it in this group, may contribute to the design of programs that will reduce the frequency of rehospitalization among patients with mental disorders, in countries like Colombia. Additionally, these results may be useful in interventions, such as coping skills training, psycho-education, and community care strategies, which have been demonstrated to reduce the frequency of rehospitalization. PMID:24888262

  18. The relative risk in a cohort study with Poisson cases.

    PubMed

    Mulder, P G

    1988-01-01

    This paper deals with making statistical inference about the relative risk (or risk ratio) in a cohort (or prospective) study with dichotomous exposure when the number of cases is a Poisson distributed variable. The exact procedure for testing the null hypothesis for the relative risk and the exact computation of its confidence interval for a single 2 X 2 table is presented. Maximum likelihood methods and the homogeneity test are presented for the common risk ratio when data is stratified in several 2 X 2 tables. These methods are based upon a sufficient statistic and therefore are considered proper statistical alternatives to the more descriptive epidemiological measures such as (in)directly standardized mortality (morbidity) ratios. All computations can be done on a programmable pocket calculator. With the HP-41 CV more than 70 strata can be distinguished. PMID:3180748

  19. Historical cohort study of mortality among chemical researchers

    SciTech Connect

    Maher, K.V.; Defonso, L.R.

    1986-03-01

    This historical cohort study examined mortality among 1,510 white male researchers employed from 1950-1959 who handled chemicals. During 1950-1979, 95 deaths were observed, significantly less than the 173.2 predicted by general population rates (SMR = 55). This was due to deficits in overall cancer deaths (SMR = 66), particularly respiratory cancer (SMR = 28), and reduced mortality from circulatory diseases and accidents. Those who had worked directly with chemicals for more than 5 yr and those who had the most hazardous exposures experienced similar low mortality for all causes, all cancers, and respiratory cancer. Although deaths due to digestive cancer were elevated among those with 1-5 yr of work experience, there was no excess among those working more than 5 yr as would be expected from occupational exposure.

  20. MILLARD COUNTY, UTAH DRINKING WATER ARSENIC COHORT STUDY

    EPA Science Inventory

    Cohort members: Assembly of the cohort is based on historic membership records of members of the Church of Jesus Christ of Latter-Day Saints (LDS) in an area of Millard County, Utah which is located in the central western part of the state. Personal information including name, bi...

  1. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

  2. The French Chronic Kidney Disease-Renal Epidemiology and Information Network (CKD-REIN) cohort study

    PubMed Central

    Stengel, Bénédicte; Combe, Christian; Jacquelinet, Christian; Briançon, Serge; Fouque, Denis; Laville, Maurice; Frimat, Luc; Pascal, Christophe; Herpe, Yves-Edouard; Deleuze, Jean-François; Schanstra, Joost; Pisoni, Ron L.; Robinson, Bruce M.; Massy, Ziad A.

    2014-01-01

    Background While much has been learned about the epidemiology and treatment of end-stage renal disease (ESRD) in the last 30 years, chronic kidney disease (CKD) before the end-stage has been less investigated. Not enough is known about factors associated with CKD progression and complications, as well as its transition to ESRD. We designed the CKD-renal epidemiology and information network (REIN) cohort to provide a research platform to address these key questions and to assess clinical practices and costs in patients with moderate or advanced CKD. Methods A total of 46 clinic sites and 4 renal care networks participate in the cohort. A stratified selection of clinic sites yields a sample that represents a diversity of settings, e.g. geographic region, and public versus for-profit and non-for-profit private clinics. In each site, 60–90 patients with CKD are enrolled at a routine clinic visit during a 12-month enrolment phase: 3600 total, including 1800 with Stage 3 and 1800 with Stage 4 CKD. Follow-up will continue for 5 years, including after initiation of renal replacement therapy. Data will be collected from medical records at inclusion and at yearly intervals, as well as from self-administered patient questionnaires and provider-level questionnaires. Patients will also be interviewed at baseline, and at 1, 3 and 5 years. Healthcare costs will also be determined. Blood and urine samples will be collected and stored for future studies on all patients at enrolment and at study end, and at 1 and 3 years in a subsample of 1200. Conclusions The CKD-REIN cohort will serve to improve our understanding of the biological, clinical and healthcare system determinants associated with CKD progression and adverse outcomes as well as of international variations in collaboration with the CKD Outcome and Practice Pattern Study (CKDopps). It will foster CKD epidemiology and outcomes research and provide evidence to improve the health and quality of life of patients with CKD and

  3. Influence of advancing age on clinical presentation, treatment efficacy and safety, and long-term outcome of pre-excitation syndromes: a retrospective cohort study of 961 patients included over a 25-year period

    PubMed Central

    Brembilla-Perrot, Béatrice; Olivier, Arnaud; Sellal, Jean-Marc; Manenti, Vladimir; Brembilla, Alice; Villemin, Thibaut; Admant, Philippe; Beurrier, Daniel; Bozec, Erwan; Girerd, Nicolas

    2016-01-01

    Objectives There are very little data on pre-excitation syndrome (PS) in the elderly. We investigated the influence of advancing age on clinical presentation, treatment and long-term outcome of PS. Setting Single-centre retrospective study of patient files. Participants In all, 961 patients (72 patients ≥60 years (mean 68.5±6), 889 patients <60 years (mean 30.5±14)) referred for overt pre-excitation and indication for electrophysiological study (EPS) were followed for 5.3±5 years. Usual care included 24 h Holter monitoring, echocardiography and EPS. Patients underwent accessory pathway (AP) ablation if necessary. Primary and secondary outcome measures Occurrence of atrial fibrillation (AF) or procedure-induced adverse event. Results Electrophysiological data and recourse to AP ablation (43% vs 48.5%, p=0.375) did not significantly differ between the groups. Older patients more often had symptomatic forms (81% vs 63%, p=0.003), history of spontaneous AF (8% vs 3%, p=0.01) or adverse presentation (poorly tolerated arrhythmias: 18% vs 7%, p=0.0009). In multivariable analysis, patients ≥60 years had a significantly higher risk of history of AF (OR=4.2, 2.1 to 8.3, p=0.001) and poorly tolerated arrhythmias (OR=3.8, 1.8 to 8.1, p=0.001). Age ≥60 years was associated with an increased major AP ablation complication risk (10% vs 1.9%, p=0.006). During follow-up, occurrence of AF (13.9% vs 3.6%, p<0.001) and incidence of poorly tolerated tachycardia (4.2% vs 0.6%, p=0.001) were more frequent in patients ≥60 years, although frequency of ablation failure or recurrence was similar (20% vs 15.5%, p=0.52). In multivariable analysis, patients ≥60 years had a significantly higher risk of AF (OR=2.9, 1.2 to 6.8, p≤0.01). Conclusions In this retrospective monocentre study, patients ≥60 years referred for PS work up appeared at higher risk of AF and adverse presentation, both prior and after the work up. These results suggest that, in elderly

  4. Cohort Study Design: An Underutilized Approach for Advancement of Evidence-Based and Patient-Centered Practice in Athletic Training

    PubMed Central

    Wilkerson, Gary B.; Denegar, Craig R.

    2014-01-01

    Objective: Providing patient-centered care requires consideration of numerous factors when making decisions that will influence a patient's health status. Background: Clinical decisions should be informed by relevant research evidence, but the literature often lacks pertinent information for problems encountered in routine clinical practice. Although a randomized clinical trial provides the best research design to ensure the internal validity of study findings, ethical considerations and the competitive culture of sport often preclude random assignment of patients or participants to a control condition. Clinical Advantages: A cohort study design and Bayesian approach to data analysis can provide valuable evidence to support clinical decisions. Dichotomous classification of both an outcome and 1 or more predictive factors permits quantification of the likelihood of occurrence of a specified outcome. Conclusions: Multifactorial prediction models can reduce uncertainty in clinical decision making and facilitate the individualization of treatment, thereby supporting delivery of clinical services that are both evidence based and patient centered. PMID:24933432

  5. Disease Relapses among Patients with Giant Cell Arteritis: A Prospective, Longitudinal Cohort Study

    PubMed Central

    Kermani, Tanaz A.; Warrington, Kenneth J.; Cuthbertson, David; Carette, Simon; Hoffman, Gary S.; Khalidi, Nader A.; Koening, Curry L.; Langford, Carol A.; Maksimowicz-McKinnon, Kathleen; McAlear, Carol A.; Monach, Paul A.; Seo, Philip; Merkel, Peter A.; Ytterberg, Steven R.

    2015-01-01

    Objective To evaluate the frequency, timing, and clinical features of relapses in giant cell arteritis (GCA). Methods Patients with GCA enrolled in a prospective, multicenter, longitudinal study were included in the analysis. Relapse was defined as either new disease activity after a period of remission or worsening disease activity. Results The study included 128 subjects: 102 women (80%) and 26 men (20%). Mean ± SD age at diagnosis of GCA was 69.9 ± 8.6 years. Mean followup for the cohort was 21.4 ± 13.9 months. Median (interquartile range) duration of disease at study enrollment was 4.6 months (1.2, 16.8). During followup, 59 relapses were observed in 44 patients (34%). Ten patients (8%) experienced 2 or more relapses. The most common symptoms at relapse were headache (42%) and polymyalgia rheumatica (51%), but ischemic (some transient) manifestations (visual symptoms, tongue or jaw claudication, and/or limb claudication) occurred in 29% of relapses (12% cohort). Forty-three relapses (73%) occurred while patients were taking glucocorticoid therapy at a median (range) prednisone dose of 7.5 (0–35) mg. In 21% of relapses, both erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were normal. Among 69 patients enrolled in the cohort with newly diagnosed disease, 24% experienced a first relapse within 12 months after diagnosis. Conclusion Among patients with GCA, relapses are common, often occurring during treatment. ESR and CRP are frequently normal at times of clinical relapse, highlighting the need for better biomarkers to assess disease activity in GCA. There remains a need for effective therapeutic alternatives to glucocorticoids in GCA. PMID:25877501

  6. DEVELOPMENT OF A PRELIMINARY CLINICAL PREDICTION RULE TO IDENTIFY PATIENTS WITH NECK PAIN THAT MAY BENEFIT FROM A STANDARDIZED PROGRAM OF STRETCHING AND MUSCLE PERFORMANCE EXERCISE: A PROSPECTIVE COHORT STUDY

    PubMed Central

    Kolber, Morey J.; George, Steven Z.; Young, Ian; Patel, Chetan K.; Cleland, Joshua A.

    2013-01-01

    Background and Purpose: Neck pain is a significant problem and many treatment options exist. While some studies suggest exercise is beneficial for individuals with non‐specific neck pain clinicians have few tools to assist in the decision making process. Therefore, the purpose of this study was to derive a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise‐based treatment program. Exercise‐based interventions have demonstrated positive outcomes in patients with NP, however it is unclear which patients are more likely to respond to this treatment approach. Methods: Consecutive patients with a primary report of nonspecific NP with or without arm pain were recruited. All patients participated in a standardized exercise program and then were classified as having a successful or non‐successful outcome at 6 weeks. Potential predictor variables were entered into a stepwise regression analysis. Variables retained in the regression model were used to develop a multivariate CPR that can be used to classify patients with NP that may benefit from exercise‐based treatment. A 6‐month follow up of the patients was used to evaluate the long‐term effects. Results: Ninety‐one patients were enrolled in the study of which 50 had a successful outcome. A CPR with 5 variables was identified (Neck Disability Index score < 18/50, presence of shoulder protraction during static postural assessment, patient does not bicycle for exercise, cervical side bending < 32°, and Fear Avoidance Belief Questionnaire–Physical Activity Score < 15). If 4 of the 5 variables were present, the probability of a successful outcome shifted from 56% to 78% (+LR 2.97). At 6 months no significant difference existed in self‐reported outcomes between those considered positive on the rule for a successful outcome and those negative on the rule for a successful outcome. Conclusions: The proposed CPR may identify patients with NP

  7. Intensification of insulin therapy in patients with type 2 diabetes: a retrospective, non- interventional cohort study of patients treated with insulin glargine or biphasic human insulin in daily clinical practice

    PubMed Central

    2013-01-01

    Background The aim of this study is to compare the efficacy of intensification of insulin treatment with insulin glargine and biphasic human insulin in patients with type 2 diabetes on concomitant therapy with oral antidiabetic drugs (OAD) in daily clinical practice. Methods A retrospective multicentre parallel two-arm study included 301 patients with type 2 diabetes already on treatment with biphasic human insulin twice daily (bd) in combination with OAD. Data were collected retrospectively from 142 patients who had been switched from biphasic human insulin to insulin glargine in a period of 6–12 months prior to their inclusion (active group) and compared to data collected retrospectively from 159 patients who continued treatment with biphasic human insulin bd for the same time period (control group). Our primary objective was to examine the efficacy of the two treatments, assessed as change in HbA1c. Secondary objectives were to examine for changes in fasting blood glucose (FBG), body weight, treatment with OAD or fast-acting insulin and safety, by assessing the frequency and severity of hypoglycaemic episodes. Results At the end of the study there was a significant reduction in HbA1c in both arms. The least squares (LS) mean [(95% confidence intervals (CI)] reduction in HbA1c was -1.13 (-0.96 to -1.30)% in the active and -0.59 (-0.41to -0.77)% in the control group [LS mean treatment difference 0.53 (0.31-0.76)%, p < 0.001]. Similarly, fasting blood glucose declined significantly in both arms. The LS mean decline in FBG was -47.02 (-37.89 to -56.14) mg/dl in the active and -19.73 (-11.57 to -27.89) mg/dl in the control group [LS mean treatment difference 27.85 (15.74-39.95) mg/dl, p < 0.001]. No significant difference in hypoglycaemic episodes and in body weight was found. In the active group, more patients received rapid-acting pre-meal insulin and used insulin secretagogues drugs. Conclusions Glargine alone or in combination with fast acting insulin

  8. Dogslife: A cohort study of Labrador Retrievers in the UK

    PubMed Central

    Pugh, C.A.; Bronsvoort, B.M.de C.; Handel, I.G.; Summers, K.M.; Clements, D.N.

    2015-01-01

    Studies of animals that visit primary and secondary veterinary centres dominate companion animal epidemiology. Dogslife is a research initiative that collects data directly from owners about the health and lifestyle of Kennel Club (KC) registered Labrador Retrievers (LR) in the UK. The ultimate aim is to seek associations between canine lifestyle and health. A selection of data from Dogslife regarding the height, weight and lifestyle of 4307 LR up to four years of age is reported here. The majority of the dogs were household pets, living with at least one other pet, in families or households with more than one adult. The dogs typically ate diets of dried food and daily meal frequency decreased as the dogs aged. Working dogs spent more time exercising than pets, and dogs in Wales and Scotland were exercised more than their counterparts in England. Dogs in households with children spent less time exercising than dogs in other types of households. There was considerable variation in height and weight measurements indicative of a highly heterogeneous population. The average male height at the shoulders was 2–3 cm taller than the UK breed standard. Dog weights continued to increase between one and four years of age. Those with chocolate coloured coats were heavier than their yellow and black counterparts. Greater dog weight was also associated with dogs whose owners reported restricting their dog’s exercise due to where they lived. These findings highlight the utility of wide public engagement in the collation of phenotypic measures, providing a unique insight into the physical development and lifestyle of a cohort of LRs. In combination with concurrently collected data on the health of the cohort, phenotypic data from the Dogslife Project will contribute to understanding the relationship between dog lifestyle and health. PMID:26189582

  9. Are Clinical Studies for You?

    MedlinePlus

    ... Page > Participate in Clinical Studies If you are thinking about participating in a Clinical Study at NIH, ... medical care and activities of daily living. In thinking about the risks of research, it is helpful ...

  10. Opium use and mortality in Golestan Cohort Study: prospective cohort study of 50 000 adults in Iran

    PubMed Central

    Khademi, Hooman; Pourshams, Akram; Jafari, Elham; Salahi, Rasool; Semnani, Shahryar; Abaie, Behrooz; Islami, Farhad; Nasseri-Moghaddam, Siavosh; Etemadi, Arash; Byrnes, Graham; Abnet, Christian C; Dawsey, Sanford M; Day, Nicholas E; Pharoah, Paul D; Boffetta, Paolo; Kamangar, Farin

    2012-01-01

    Objectives To investigate the association between opium use and subsequent risk of death. Design Prospective cohort study. Setting The Golestan Cohort Study in north-eastern Iran collected detailed validated data on opium use and other exposures at baseline. Participants were enrolled between January 2004 and June 2008 and were followed to May 2011, with a follow-up success rate of over 99%. Participants 50 045 participants aged 40-75 at baseline. Main outcomes Mortality, all cause and major subcategories. Results 17% (n=8487) of the participants reported opium use, with a mean duration of 12.7 years. During the follow-up period 2145 deaths were reported. The adjusted hazard ratio for all cause mortality associated with ever use of opium was 1.86 (95% confidence interval 1.68 to 2.06). Opium consumption was significantly associated with increased risks of deaths from several causes including circulatory diseases (hazard ratio 1.81) and cancer (1.61). The strongest associations were seen with deaths from asthma, tuberculosis, and chronic obstructive pulmonary disease (11.0, 6.22, and 5.44, respectively). After exclusion of people who self prescribed opium after the onset of major chronic illnesses, the associations remained strong with a dose-response relation. Conclusion Opium users have an increased risk of death from multiple causes compared with non-users. Increased risks were also seen in people who used low amounts of opium for a long period and those who had no major illness before use. PMID:22511302

  11. Identification of homogeneous and heterogeneous variables in pooled cohort studies.

    PubMed

    Cheng, Xin; Lu, Wenbin; Liu, Mengling

    2015-06-01

    Pooled analyses integrate data from multiple studies and achieve a larger sample size for enhanced statistical power. When heterogeneity exists in variables' effects on the outcome across studies, the simple pooling strategy fails to present a fair and complete picture of the effects of heterogeneous variables. Thus, it is important to investigate the homogeneous and heterogeneous structure of variables in pooled studies. In this article, we consider the pooled cohort studies with time-to-event outcomes and propose a penalized Cox partial likelihood approach with adaptively weighted composite penalties on variables' homogeneous and heterogeneous effects. We show that our method can characterize the variables as having heterogeneous, homogeneous, or null effects, and estimate non-zero effects. The results are readily extended to high-dimensional applications where the number of parameters is larger than the sample size. The proposed selection and estimation procedure can be implemented using the iterative shooting algorithm. We conduct extensive numerical studies to evaluate the performance of our proposed method and demonstrate it using a pooled analysis of gene expression in patients with ovarian cancer. PMID:25732747

  12. The Netherlands Cohort Study – Meat Investigation Cohort; a population-based cohort over-represented with vegetarians, pescetarians and low meat consumers

    PubMed Central

    2013-01-01

    Background Vegetarian diets have been associated with lower risk of chronic disease, but little is known about the health effects of low meat diets and the reliability of self-reported vegetarian status. We aimed to establish an analytical cohort over-represented with vegetarians, pescetarians and 1 day/week meat consumers, and to describe their lifestyle and dietary characteristics. In addition, we were able to compare self-reported vegetarians with vegetarians whose status has been confirmed by their response on the extensive food frequency questionnaire (FFQ). Study methods Embedded within the Netherlands Cohort Study (n = 120,852; including 1150 self-reported vegetarians), the NLCS-Meat Investigation Cohort (NLCS-MIC) was defined by combining all FFQ-confirmed-vegetarians (n = 702), pescetarians (n = 394), and 1 day/week meat consumers (n = 1,396) from the total cohort with a random sample of 2–5 days/week- and 6–7 days/week meat consumers (n = 2,965 and 5,648, respectively). Results Vegetarians, pescetarians, and 1 day/week meat consumers had more favorable dietary intakes (e.g. higher fiber/vegetables) and lifestyle characteristics (e.g. lower smoking rates) compared to regular meat consumers in both sexes. Vegetarians adhered to their diet longer than pescetarians and 1 day/week meat consumers. 75% of vegetarians with a prevalent cancer at baseline had changed to this diet after diagnosis. 50% of self-reported vegetarians reported meat or fish consumption on the FFQ. Although the misclassification that occurred in terms of diet and lifestyle when merely relying on self-reporting was relatively small, the impact on associations with disease risk remains to be studied. Conclusion We established an analytical cohort over-represented with persons at the lower end of the meat consumption spectrum which should facilitate prospective studies of major cancers and causes of death using ≥20.3 years of follow-up. PMID:24289207

  13. "Feeling better" or "feeling well" in usual care of hip and knee osteoarthritis pain: determination of cutoff points for patient acceptable symptom state (PASS) and minimal clinically important improvement (MCII) at rest and on movement in a national multicenter cohort study of 2414 patients with painful osteoarthritis.

    PubMed

    Perrot, Serge; Bertin, Philippe

    2013-02-01

    Patient-reported outcome measures are being developed for more relevant assessments of pain management. The patient acceptable symptom state (PASS) ("feeling well") and the minimal clinically important improvement (MCII) ("feeling better") have been determined in clinical trials, but not in daily pain management. We carried out a national multicenter cohort study of patients over the age of 50years with painful knee osteoarthritis (KOA) or hip osteoarthritis (HOA) who had visited their general practitioner and required treatment for more than 7days. Overall, 2414 patients (50.2% men, mean age 67.3years, body mass index 27.9kg/m(2), 33.5% with HOA) were enrolled by 1116 general practitioners. After 7days of treatment, PASS was estimated on a numerical rating scale as 4 at rest and 5 on movement, for both HOA and KOA, above the PASS threshold in clinical trials. In KOA, PASS was more frequently reached in men and younger people with less pain at rest and on movement, and in patients specifically seeking an improvement during sport activities. In HOA, PASS was most frequently reached in patients with low levels of pain at risk and in nonobese patients. MCII was -1 numerical rating scale point after 7days of usual treatment. This improvement is smaller than that recorded in randomized controlled trials, and was the same for both sites, both at rest and on movement. In conclusion, patient-reported outcome values in daily practice differ from those in clinical trials, and their determinant factors may depend on the site of osteoarthritis. Assessments of the treatment of painful osteoarthritis should be adapted to the characteristics and daily life of the patient, to personalize patient management. PMID:23265687

  14. Generalized and Specific Cognitive Performance in Clinical High-Risk Cohorts: A Review Highlighting Potential Vulnerability Markers for Psychosis

    PubMed Central

    Brewer, Warrick J.; Wood, Stephen J.; Phillips, Lisa J.; Francey, Shona M.; Pantelis, Christos; Yung, Alison R.; Cornblatt, Barbara; McGorry, Patrick D.

    2006-01-01

    Cognitive deficits are a core feature of established psychotic illnesses. However, the association between cognition and emerging psychosis is less understood. While there is some evidence that cognitive deficits are present prior to the onset of psychosis, findings are not consistent. In this article we provide an overview of the more general cognitive findings available from genetic high-risk studies, retrospective studies, and birth cohort studies. We then focus the review on neuropsychological performance in clinically “at-risk” groups. Overall, general cognitive ability as assessed by established batteries appears to remain relatively intact in these ultra-high risk cohorts and is a poor predictor close to illness onset relative to other vulnerability factors. Further decline may occur with illness progression, more consistent with state relative to trait factors. In addition, most established cognitive tasks involve several relatively discrete cognitive subprocesses, where findings from general batteries of subtests may mask specific deficits. In this context, our review suggests that relatively specific olfactory identification and spatial working memory deficits exist prior to illness onset and may be more potent trait markers for psychosis than cognitively dense tasks such as verbal memory. Suggestions for further research address the importance of standardization of inclusion criteria and the maintenance of basic neuropsychological assessment to allow better comparison of findings across centers. Further, in order to better understand the aetiopathology of cognitive dysfunction in psychosis, more experimental, hypothesis-driven measures of discrete cognitive processes are required. Delineation of the relationship between specific cognitive ability and symptoms from data-driven approaches may improve our understanding of the role of cognition during psychosis onset. PMID:16782759

  15. Cohort profile: the Amsterdam Growth and Health Longitudinal Study.

    PubMed

    Wijnstok, Nienke J; Hoekstra, Trynke; van Mechelen, Willem; Kemper, Han C G; Twisk, Jos W R

    2013-04-01

    The Amsterdam Growth and Health Longitudinal Study (AGHLS) is a unique, multidisciplinary cohort study that was initially set up to examine growth and health among teenagers. Throughout the years, the AGHLS has aimed to answer research questions dealing with the relationships between the (natural) development of anthropometry, lifestyle and health from adolescence into adulthood. The AGHLS specifically focuses on anthropometrics, physical activity and fitness, cardiovascular disease risk, lifestyle, musculoskeletal health, psychological health and well-being. Besides this, many methodological issues related to the analysis of longitudinal data were also explored within the framework of the AGHLS. In 1976, students from two secondary schools from the greater Amsterdam area were included in the study. Between 1976 and 2006, 10 rounds of measurement were performed covering an age range between 13 and 43 years. The huge database collected so far has been primarily used to answer relevant research questions regarding the longitudinal relationship between lifestyle and health. Further information about the study can be obtained from the principal investigator Jos Twisk (jwr.twisk@vumc.nl), and up-to-date information on AGHLS can be found by visiting the website www.aggo.nl. PMID:22434862

  16. Dietary Antioxidants and Melanoma: Evidence from Cohort and Intervention Studies.

    PubMed

    Miura, Kyoko; Green, Adèle C

    2015-01-01

    Melanoma is the most serious form of skin cancer affecting mostly people of Caucasian origin and is associated with high exposure to solar ultraviolet (UV) radiation. Antioxidants in the diet are thought to prevent UV-induced DNA damage and oxidative stress and laboratory-based studies have shown that high antioxidant intakes inhibit melanoma development. Corresponding epidemiological evidence is inconsistent, however. We therefore reviewed results from prospective observational studies and randomized controlled trials (RCTs) to clarify whether consumption of antioxidant vitamin C, E (tocopherol), and A (retinol), carotenoids and selenium, as food, supplements, or both, or high fruit and vegetable intake, reduce the incidence of cutaneous melanoma. A total of 9 studies (2 cohort, 1 nested case-control, 6 RCTs) were included. Neither antioxidant nutrients, individually or combined, nor fruit and vegetable intake showed any strong and significant associations with melanoma, though the number of relevant studies was limited and several had methodological shortcomings. In particular, melanoma was not a primary disease outcome in any of the RCTs and therefore, none adequately accounted for potential confounding by sun exposure. In conclusion, available evidence is currently inadequate to assess possible beneficial effects of antioxidant intake on melanoma risk. PMID:26147450

  17. STATUS REPORT, BEGIN TO DEVELOP COMPLETE OPERATIONS MANUALS FOR THE COHORT: PREPARE TO IMPLEMENT A COHORT STUDY OF CHILDREN'S ENVIRONMENTAL HEALTH

    EPA Science Inventory

    As a precursor to the National Children's Study (NCS), the North Carolina Cohort Study (NC Cohort Study) will provide the opportunity to field test procedures to better inform the implementation of the NCS. In order to test some of the study hypotheses, it will be important to ob...

  18. Clinical response and hospital costs associated with the empirical use of vancomycin and linezolid for hospital-acquired pneumonia in a Chinese tertiary care hospital: a retrospective cohort study

    PubMed Central

    Song, Yuanlin; Yang, Yicheng; Chen, Wendong; Liu, Wei; Wang, Kai; Li, Xuehai; Wang, Ke; Papadimitropoulos, Manny; Montgomery, William

    2014-01-01

    Aims To evaluate clinical outcomes and allocation of hospital costs associated with empirical use of vancomycin or linezolid for hospital-acquired pneumonia (HAP) in the People’s Republic of China. Methods Hospital episodes including HAP treated by vancomycin or linezolid between 2008 and 2012 in a Chinese tertiary care hospital were retrospectively identified from hospital administrative databases. Propensity score methods created best-matched pairs for the antibiotics. The matched pairs were used for adjusted comparisons on clinical response and allocation of hospital costs. Multiple regression analyses adjusting residual imbalance after matching were performed to confirm adjusted comparisons. Results Sixty matched pairs were created. Adjusted comparisons between vancomycin and linezolid showed similar clinical response rates (clinical cure: 30.0% versus 31.7%, respectively; P=0.847; treatment failure: 55.0% versus 45.0%, respectively; P=0.289) but a significantly lower in-hospital mortality rate for vancomycin (3.3% versus 18.3%, respectively; P=0.013). After further adjusting for the imbalanced variables between matched treatment groups, the risks of treatment failure associated with the two antibiotics were comparable (odds ratio: 1.139; P=0.308) and there was a nonsignificant trend of lower risk of in-hospital mortality associated with vancomycin (odds ratio: 0.186; P=0.055). The total hospital costs associated with vancomycin had a nonsignificant trend of being lower, likely because of its significantly lower acquisition costs (median: RMB 2,880 versus RMB 8,194; P<0.001; 1 RMB =0.16 USD). Conclusion In tertiary care hospitals in the People’s Republic of China, empirical treatment of patients with HAP with vancomycin had a comparable treatment failure rate but likely had a lower in-hospital mortality rate when compared with linezolid. Vancomycin also costs significantly less for drug acquisition than linezolid when treating HAP empirically. PMID:25378939

  19. Glycemic Control and the Risk of Tuberculosis: A Cohort Study

    PubMed Central

    Lai, Ting-Chun; Chiang, Chen-Yuan; Chan, Chang-Chuan; Lin, Hsien-Ho

    2016-01-01

    Background Diabetes is a well-known risk factor for tuberculosis (TB) and is increasingly prevalent in low- and middle-income countries, where the burden of TB is high. Glycemic control has the potential to modify the risk of TB. However, there are few studies on the association between glycemic control and TB risk, and the results are inconsistent. Methods and Findings We assembled a cohort using 123,546 individuals who participated in a community-based health screening service in northern Taiwan from 5 March 2005 to 27 July 2008. Glycemic control was measured using fasting plasma glucose (FPG) at the time of screening. The cohort was followed up to 31 December 2012 for the occurrence of TB by cross-matching the screening database to the national health insurance database. Multiple imputation was used to handle missing information. During a median follow-up of 4.6 y, 327 cases of TB occurred. In the multivariable Cox regression model, diabetic patients with poor glycemic control (FPG > 130 mg/dl) had a significantly higher hazard of TB (adjusted hazard ratio [aHR] 2.21, 95% CI 1.63–2.99, p < 0.001) compared to those without diabetes. The hazard of TB in diabetic patients with good glycemic control (FPG ≤ 130 mg/dl) did not differ significantly from that in nondiabetic individuals (aHR 0.69, 95% CI 0.35–1.36, p = 0.281). In the linear dose-response analysis, the hazard of TB increased with FPG (aHR 1.06 per 10-mg/dl increase in FPG, 95% CI 1.03–1.08, p < 0.001). Assuming the observed association between glycemic control and TB was causal, an estimated 7.5% (95% CI 4.1%–11.5%) of incident TB in the study population could be attributed to poor glycemic control. Limitations of the study include one-time measurement of fasting glucose at baseline and voluntary participation in the health screening service. Conclusions Good glycemic control could potentially modify the risk of TB among diabetic patients and may contribute to the control of TB in settings where

  20. Cohort Profile: The Study of Respiratory Pathogens in Andean Children

    PubMed Central

    Grijalva, Carlos G; Griffin, Marie R; Edwards, Kathryn M; Williams, John V; Gil, Ana I; Verastegui, Héctor; Hartinger, Stella M; Vidal, Jorge E; Klugman, Keith P; Lanata, Claudio F

    2014-01-01

    We investigated respiratory pathogens in a prospective cohort study of young children living in the Peruvian Andes. In the study we assessed viral respiratory infections among young children, and explored interactions of viruses with common respiratory bacteria, especially Streptococcus pneumoniae. Through weekly household visits, data were collected on the signs and symptoms of acute respiratory illness (ARI), nasal samples were collected to test for viruses during episodes of ARI, and nasopharyngeal samples were collected on a monthly basis to monitor bacterial colonisation. We also collected data on vaccination coverage, patterns of social mixing, geographic information, and environmental and socio-demographic variables. Understanding the interaction of respiratory viruses with bacteria and its impact on the burden and severity of ARIs in rural areas of developing countries is critical to designing strategies for preventing such infections. Investigators interested in more details about this study or in accessing these resources should contact Dr. Carlos G. Grijalva at Vanderbilt University (carlos.grijalva@vanderbilt.edu). PMID:23771719

  1. Cohort Profile: The Nicotine Dependence in Teens (NDIT) Study.

    PubMed

    O'Loughlin, Jennifer; Dugas, Erika N; Brunet, Jennifer; DiFranza, Joseph; Engert, James C; Gervais, Andre; Gray-Donald, Katherine; Karp, Igor; Low, Nancy C; Sabiston, Catherine; Sylvestre, Marie-Pierre; Tyndale, Rachel F; Auger, Nathalie; Auger, Nathalie; Mathieu, Belanger; Tracie, Barnett; Chaiton, Michael; Chenoweth, Meghan J; Constantin, Evelyn; Contreras, Gisèle; Kakinami, Lisa; Labbe, Aurelie; Maximova, Katerina; McMillan, Elizabeth; O'Loughlin, Erin K; Pabayo, Roman; Roy-Gagnon, Marie-Hélène; Tremblay, Michèle; Wellman, Robert J; Hulst, Andraeavan; Paradis, Gilles

    2015-10-01

    The Nicotine Dependence in Teens (NDIT) study is a prospective cohort investigation of 1294 students recruited in 1999-2000 from all grade 7 classes in a convenience sample of 10 high schools in Montreal, Canada. Its primary objectives were to study the natural course and determinants of cigarette smoking and nicotine dependence in novice smokers. The main source of data was self-report questionnaires administered in class at school every 3 months from grade 7 to grade 11 (1999-2005), for a total of 20 survey cycles during high school education. Questionnaires were also completed after graduation from high school in 2007-08 and 2011-12 (survey cycles 21 and 22, respectively) when participants were aged 20 and 24 years on average, respectively. In addition to its primary objectives, NDIT has embedded studies on obesity, blood pressure, physical activity, team sports, sedentary behaviour, diet, genetics, alcohol use, use of illicit drugs, second-hand smoke, gambling, sleep and mental health. Results to date are described in 58 publications, 20 manuscripts in preparation, 13 MSc and PhD theses and 111 conference presentations. Access to NDIT data is open to university-appointed or affiliated investigators and to masters, doctoral and postdoctoral students, through their primary supervisor (www.nditstudy.ca). PMID:25022274

  2. Risk factors for seabather's eruption: a prospective cohort study.

    PubMed Central

    Kumar, S; Hlady, W G; Malecki, J M

    1997-01-01

    OBJECTIVE: A prospective cohort study was performed to identify risk factors for seabather's eruption. METHODS: Study participants were recruited at four beaches in Palm Beach County, Florida, during three weekends of May and June 1993. Participants were interviewed by telephone after 48 hours regarding medical history, beach activities, development of rashes, and use of possible preventive measures. RESULTS: Seabather's eruption, defined by the occurrence of a rash within two days of exposure to seawater, was reported by 114 (16%) of 735 respondents. The strongest predictor of seabather's eruption was a past history of the condition. Children less than 16 years of age were also at increased risk, as were surfers. Showering with one's bathing suit off was a useful protective measure. CONCLUSION: The study's findings suggest that when the seasonal risk of seabather's eruption is present, children, people with a history of seabather's eruption, and surfers are at greatest risk. During the sea lice season, seabathers can minimize their risk by showering with their bathing suits off after seabathing. Length of the time spent in water was not significantly associated with seabather's eruption. PMID:9018290

  3. Prospective cohort study of spinal muscular atrophy types 2 and 3

    PubMed Central

    Kaufmann, Petra; McDermott, Michael P.; Darras, Basil T.; Finkel, Richard S.; Sproule, Douglas M.; Kang, Peter B.; Oskoui, Maryam; Constantinescu, Andrei; Gooch, Clifton L.; Foley, A. Reghan; Yang, Michele L.; Tawil, Rabi; Chung, Wendy K.; Martens, William B.; Montes, Jacqueline; Battista, Vanessa; O'Hagen, Jessica; Dunaway, Sally; Flickinger, Jean; Quigley, Janet; Riley, Susan; Glanzman, Allan M.; Benton, Maryjane; Ryan, Patricia A.; Punyanitya, Mark; Montgomery, Megan J.; Marra, Jonathan; Koo, Benjamin

    2012-01-01

    Objective: To characterize the natural history of spinal muscular atrophy type 2 and type 3 (SMA 2/3) beyond 1 year and to report data on clinical and biological outcomes for use in trial planning. Methods: We conducted a prospective observational cohort study of 79 children and young adults with SMA 2/3 who participated in evaluations for up to 48 months. Clinically, we evaluated motor and pulmonary function, quality of life, and muscle strength. We also measured SMN2 copy number, hematologic and biochemical profiles, muscle mass by dual x-ray absorptiometry (DXA), and the compound motor action potential (CMAP) in a hand muscle. Data were analyzed for associations between clinical and biological/laboratory characteristics cross-sectionally, and for change over time in outcomes using all available data. Results: In cross-sectional analyses, certain biological measures (specifically, CMAP, DXA fat-free mass index, and SMN2 copy number) and muscle strength measures were associated with motor function. Motor and pulmonary function declined over time, particularly at time points beyond 12 months of follow-up. Conclusion: The intermediate and mild phenotypes of SMA show slow functional declines when observation periods exceed 1 year. Whole body muscle mass, hand muscle compound motor action potentials, and muscle strength are associated with clinical measures of motor function. The data from this study will be useful for clinical trial planning and suggest that CMAP and DXA warrant further evaluation as potential biomarkers. PMID:23077013

  4. Learn about Clinical Studies

    MedlinePlus

    ... in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  5. Clinical Studies with Epothilones

    NASA Astrophysics Data System (ADS)

    Altmann, Karl-Heinz

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

  6. A cohort study on mortality among dynamite workers.

    PubMed

    Hogstedt, C; Andersson, K

    1979-08-01

    Exposure to nitroglycerine and nitroglycol in the explosives industry is suspected of having caused isolated cases of sudden death. There have also been suggestions of an increased risk of chronic cardio-cerebrovascular diseases among dynamite workers. This study examines the mortality experience of a cohort of male workers from a small Swedish dynamite industry. Cause-, sex-, age-, and calendar-year-specific national incidence rates were used to calculate the expected number of deaths in a group of individuals with exposure to the dynamite manufacturing process and in an unexposed group from the same industry. During the period 1965-77, nine deaths from cardiocerebrovascular diseases were observed, versus 4.5 expected (p less than 0.05), among men with at least one year of exposure to dynamite and 20 years of induction-latency time. The unexposed group had a mortality pattern in good agreement with the national average. Exposure occurred by inhalation as well as through the skin. Precautions are urged to diminish exposure from both these absorption routes as the findings of the study support earlier reports regarding chronic vascular effects. PMID:112227

  7. Late mortality after sepsis: propensity matched cohort study

    PubMed Central

    Osterholzer, John J; Langa, Kenneth M; Angus, Derek C; Iwashyna, Theodore J

    2016-01-01

    Objectives To determine whether late mortality after sepsis is driven predominantly by pre-existing comorbid disease or is the result of sepsis itself. Deign Observational cohort study. Setting US Health and Retirement Study. Participants 960 patients aged ≥65 (1998-2010) with fee-for-service Medicare coverage who were admitted to hospital with sepsis. Patients were matched to 777 adults not currently in hospital, 788 patients admitted with non-sepsis infection, and 504 patients admitted with acute sterile inflammatory conditions. Main outcome measures Late (31 days to two years) mortality and odds of death at various intervals. Results Sepsis was associated with a 22.1% (95% confidence interval 17.5% to 26.7%) absolute increase in late mortality relative to adults not in hospital, a 10.4% (5.4% to 15.4%) absolute increase relative to patients admitted with non-sepsis infection, and a 16.2% (10.2% to 22.2%) absolute increase relative to patients admitted with sterile inflammatory conditions (P<0.001 for each comparison). Mortality remained higher for at least two years relative to adults not in hospital. Conclusions More than one in five patients who survives sepsis has a late death not explained by health status before sepsis. PMID:27189000

  8. Cohort profile: The Berlin Aging Study II (BASE-II).

    PubMed

    Bertram, Lars; Böckenhoff, Anke; Demuth, Ilja; Düzel, Sandra; Eckardt, Rahel; Li, Shu-Chen; Lindenberger, Ulman; Pawelec, Graham; Siedler, Thomas; Wagner, Gert G; Steinhagen-Thiessen, Elisabeth

    2014-06-01

    Similar to other industrialized countries, Germany's population is ageing. Whereas some people enjoy good physical and cognitive health into old age, others suffer from a multitude of age-related disorders and impairments which reduce life expectancy and affect quality of life. To identify and characterize the factors associated with 'healthy' vs. 'unhealthy' ageing, we have launched the Berlin Aging Study II (BASE-II), a multidisciplinary and multi-institutional project that ascertains a large number of ageing-related variables from a wide range of different functional domains. Phenotypic assessments include factors related to geriatrics and internal medicine, immunology, genetics, psychology, sociology and economics. Baseline recruitment of the BASE-II cohort was recently completed and has led to the sampling of 1600 older adults (age range 60-80 years), as well as 600 younger adults (20-35 years) serving as the basic population for in-depth analyses. BASE-II data are linked to the German Socio-Economic Panel Study (SOEP), a long-running panel survey representative of the German population, to estimate sample selectivity. A major goal of BASE-II is to facilitate collaboration with other research groups by freely sharing relevant phenotypic and genotypic data with qualified outside investigators. PMID:23505255

  9. Golestan cohort study of oesophageal cancer: feasibility and first results

    PubMed Central

    Pourshams, A; Saadatian-Elahi, M; Nouraie, M; Malekshah, A F; Rakhshani, N; Salahi, R; Yoonessi, A; Semnani, S; Islami, F; Sotoudeh, M; Fahimi, S; Sadjadi, A R; Nasrollahzadeh, D; Aghcheli, K; Kamangar, F; Abnet, C C; Saidi, F; Sewram, V; Strickland, P T; Dawsey, S M; Brennan, P; Boffetta, P; Malekzadeh, R

    2004-01-01

    To investigate the incidence of oesophageal cancer (EC) in the Golestan province of North-East Iran, we invited 1349 rural and urban inhabitants of Golestan province aged 35–80 to undergo extensive lifestyle interviews and to provide biological samples. The interview was repeated on a subset of 130 participants to assess reliability of questionnaire and medical information. Temperature at which tea was consumed was measured on two occasions by 110 subjects. Samples of rice, wheat and sorghum were tested for fumonisin contamination. An active follow-up was carried out after 6 and 12 months. A total of 1057 subjects (610 women and 447 men) participated in this feasibility study (78.4% participation rate). Cigarette smoking, opium and alcohol use were reported by 163 (13.8%), 93 (8.8%) and 39 (3.7%) subjects, respectively. Tobacco smoking was correlated with urinary cotinine (κ=0.74). Most questionnaire data had κ >0.7 in repeat measurements; tea temperature measurement was reliable (κ=0.71). No fumonisins were detected in the samples analysed. During the follow-up six subjects were lost (0.6%), two subjects developed EC (one dead, one alive); in all, 13 subjects died (with cause of death known for 11, 84.6%). Conducting a cohort study in Golestan is feasible with reliable information obtained for suspected risk factors; participants can be followed up for EC incidence and mortality. PMID:15597107

  10. Golestan cohort study of oesophageal cancer: feasibility and first results.

    PubMed

    Pourshams, A; Saadatian-Elahi, M; Nouraie, M; Malekshah, A F; Rakhshani, N; Salahi, R; Yoonessi, A; Semnani, S; Islami, F; Sotoudeh, M; Fahimi, S; Sadjadi, A R; Nasrollahzadeh, D; Aghcheli, K; Kamangar, F; Abnet, C C; Saidi, F; Sewram, V; Strickland, P T; Dawsey, S M; Brennan, P; Boffetta, P; Malekzadeh, R

    2005-01-17

    To investigate the incidence of oesophageal cancer (EC) in the Golestan province of North-East Iran, we invited 1349 rural and urban inhabitants of Golestan province aged 35-80 to undergo extensive lifestyle interviews and to provide biological samples. The interview was repeated on a subset of 130 participants to assess reliability of questionnaire and medical information. Temperature at which tea was consumed was measured on two occasions by 110 subjects. Samples of rice, wheat and sorghum were tested for fumonisin contamination. An active follow-up was carried out after 6 and 12 months. A total of 1057 subjects (610 women and 447 men) participated in this feasibility study (78.4% participation rate). Cigarette smoking, opium and alcohol use were reported by 163 (13.8%), 93 (8.8%) and 39 (3.7%) subjects, respectively. Tobacco smoking was correlated with urinary cotinine (kappa = 0.74). Most questionnaire data had kappa > 0.7 in repeat measurements; tea temperature measurement was reliable (kappa = 0.71). No fumonisins were detected in the samples analysed. During the follow-up six subjects were lost (0.6%), two subjects developed EC (one dead, one alive); in all, 13 subjects died (with cause of death known for 11, 84.6%). Conducting a cohort study in Golestan is feasible with reliable information obtained for suspected risk factors; participants can be followed up for EC incidence and mortality. PMID:15597107

  11. The Nakuru eye disease cohort study: methodology & rationale

    PubMed Central

    2014-01-01

    Background No longitudinal data from population-based studies of eye disease in sub-Saharan-Africa are available. A population-based survey was undertaken in 2007/08 to estimate the prevalence and determinants of blindness and low vision in Nakuru district, Kenya. This survey formed the baseline to a six-year prospective cohort study to estimate the incidence and progression of eye disease in this population. Methods/Design A nationally representative sample of persons aged 50 years and above were selected between January 2007 and November 2008 through probability proportionate to size sampling of clusters, with sampling of individuals within clusters through compact segment sampling. Selected participants underwent detailed ophthalmic examinations which included: visual acuity, autorefraction, visual fields, slit lamp assessment of the anterior and posterior segments, lens grading and fundus photography. In addition, anthropometric measures were taken and risk factors were assessed through structured interviews. Six years later (2013/2014) all subjects were invited for follow-up assessment, repeating the baseline examination methodology. Discussion The methodology will provide estimates of the progression of eye diseases and incidence of blindness, visual impairment, and eye diseases in an adult Kenyan population. PMID:24886366

  12. Predictors of Cerebral Palsy in Very Preterm Infants: The EPIPAGE Prospective Population-Based Cohort Study

    ERIC Educational Resources Information Center

    Beaino, Ghada; Khoshnood, Babak; Kaminski, Monique; Pierrat, Veronique; Marret, Stephane; Matis, Jacqueline; Ledesert, Bernard; Thiriez, Gerard; Fresson, Jeanne; Roze, Jean-Christophe; Zupan-Simunek, Veronique; Arnaud, Catherine; Burguet, Antoine; Larroque, Beatrice; Breart, Gerard; Ancel, Pierre-Yves

    2010-01-01

    Aim: The aim of this study was to assess the independent role of cerebral lesions on ultrasound scan, and several other neonatal and obstetric factors, as potential predictors of cerebral palsy (CP) in a large population-based cohort of very preterm infants. Method: As part of EPIPAGE, a population-based prospective cohort study, perinatal data…

  13. Ten years of progress in the Hokkaido birth cohort study on environment and children's health: cohort profile--updated 2013.

    PubMed

    Kishi, Reiko; Kobayashi, Sachiko; Ikeno, Tamiko; Araki, Atsuko; Miyashita, Chihiro; Itoh, Sachiko; Sasaki, Seiko; Okada, Emiko; Kobayashi, Sumitaka; Kashino, Ikuko; Itoh, Kumiko; Nakajima, Sonomi

    2013-11-01

    The Hokkaido Study on Environment and Children's Health is an ongoing cohort study that began in 2002. The study consists of two prospective birth cohorts, the Sapporo cohort (n = 514) and the Hokkaido large-scale cohort (n = 20,940). The primary goals of this study are to first examine the potential negative effects of perinatal environmental chemical exposures on birth outcomes, including congenital malformations and growth retardation; second, to evaluate the development of allergies, infectious diseases and neurodevelopmental disorders and perform longitudinal observations of the children's physical development to clarify the causal relationship between these outcomes and environmental chemicals; third, to identify individuals genetically susceptible to environmental chemicals; finally, to identify the additive effects of various environmental factors in our daily life, such as secondhand smoke exposure or low folate intake during early pregnancy. In this paper, we introduce our recent progress in the Hokkaido study with a cohort profile updated in 2013. For the last ten years, we followed pregnant women and their offspring, measuring various environmental chemicals, i.e., PCB, OH-PCB and dioxins, PFCs (Perfluorinated Compounds), Organochlorine pesticides, Phthalates, bisphenol A and mercury. We discovered that the concentration of toxic equivalents (TEQ) of dioxin and other specific congeners of PCDF or PCDD have effects on birth weight, infants' neurodevelopment and immune function. There were significant gender differences in these effects; our results suggest that male infants have more susceptibility to those chemical exposures than female infants. Interestingly, we found maternal genetic polymorphisms in AHR, CYP1A1 or GSTs that significantly modified the dioxin concentrations in maternal blood, suggesting different dioxin accumulations in the bodies of individuals with these genotypes, which would lead to different dioxin exposure levels. These genetic

  14. Natural History of Anal Dysplasia in an HIV-Infected Clinical Care Cohort: Estimates Using Multi-State Markov Modeling

    PubMed Central

    Mathews, William C.; Agmas, Wollelaw; Cachay, Edward R.; Cosman, Bard C.; Jackson, Christopher

    2014-01-01

    Objectives (1) To model the natural history of anal neoplasia in HIV-infected patients using a 3-state Markov model of anal cancer pathogenesis, adjusting for cytology misclassification; and (2) to estimate the effects of selected time-varying covariates on transition probabilities. Design A retrospective cytology-based inception screening cohort of HIV-infected adults was analyzed using a 3-state Markov model of clinical pathogenesis of anal neoplasia. Methods Longitudinally ascertained cytology categories were adjusted for misclassification using estimates of cytology accuracy derived from the study cohort. Time-varying covariate effects were estimated as hazard ratios. Results (1) There was a moderate to high probability of regression of the high grade squamous intraepithelial lesion (HSIL) state (27–62%) at 2 years after initial cytology screening; (2) the probability of developing invasive anal cancer (IAC) during the first 2 years after a baseline HSIL cytology is low (1.9–2.8%); (3) infrared coagulation (IRC) ablation of HSIL lesions is associated with a 2.2–4.2 fold increased probability of regression to

  15. Discordant Treatment Responses to Combination Antiretroviral Therapy in Rwanda: A Prospective Cohort Study

    PubMed Central

    Kayigamba, Felix R.; Franke, Molly F.; Bakker, Mirjam I.; Rodriguez, Carly A.; Bagiruwigize, Emmanuel; Wit, Ferdinand WNM; Rich, Michael L.; Schim van der Loeff, Maarten F.

    2016-01-01

    Introduction Some antiretroviral therapy naïve patients starting combination antiretroviral therapy (cART) experience a limited CD4 count rise despite virological suppression, or vice versa. We assessed the prevalence and determinants of discordant treatment responses in a Rwandan cohort. Methods A discordant immunological cART response was defined as an increase of <100 CD4 cells/mm3 at 12 months compared to baseline despite virological suppression (viral load [VL] <40 copies/mL). A discordant virological cART response was defined as detectable VL at 12 months with an increase in CD4 count ≥100 cells/mm3. The prevalence of, and independent predictors for these two types of discordant responses were analysed in two cohorts nested in a 12-month prospective study of cART-naïve HIV patients treated at nine rural health facilities in two regions in Rwanda. Results Among 382 patients with an undetectable VL at 12 months, 112 (29%) had a CD4 rise of <100 cells/mm3. Age ≥35 years and longer travel to the clinic were independent determinants of an immunological discordant response, but sex, baseline CD4 count, body mass index and WHO HIV clinical stage were not. Among 326 patients with a CD4 rise of ≥100 cells/mm3, 56 (17%) had a detectable viral load at 12 months. Male sex was associated with a virological discordant treatment response (P = 0.05), but age, baseline CD4 count, BMI, WHO HIV clinical stage, and travel time to the clinic were not. Conclusions Discordant treatment responses were common in cART-naïve HIV patients in Rwanda. Small CD4 increases could be misinterpreted as a (virological) treatment failure and lead to unnecessary treatment changes. PMID:27438000

  16. Impact of tamsulosin exposure on late complications following cataract surgery: retrospective cohort study.

    PubMed

    González-Martín-Moro, Julio; González-López, Julio José; Gómez-Sanz, Fernando; Zarallo-Gallardo, Jesús; Cobo-Soriano, Rosario

    2014-08-01

    The purpose of this study is to measure the impact of tamsulosin intake on five postoperative cataract surgery complications (toxic anterior segment syndrome, rebound uveitis, retinal detachment, macular edema, and postoperative endophthalmitis). This retrospective cohort study was conducted at University Hospital of Henares. The study included 660-eyes of 660 patients submitted to cataract surgery at the ophthalmology unit of Hospital del Henares (Madrid) between 2 March 2009 and 28 February 2010. Extracapsular cataract extraction, combined glaucoma and cataract surgery phacovitrectomy, posterior capsule rupture and zonular damage were considered exclusion criteria. Clinical charts were reviewed during July 2012. Patients were divided in two groups (exposed and non-exposed to tamsulosin). Cumulative incidence of toxic anterior segment syndrome, rebound uveitis, retinal detachment, macular edema and postoperative endophthalmitis were compared in both groups. Rebound uveitis (relative risk [RR] 3.39; confidence interval [CI] 1.63-7.08) and macular edema (RR 4.15; CI 1.06-16.22) were more common in the tamsulosin-exposed group. Retinal detachment had a similar incidence in both groups. We observed no cases of endophthalmitis or toxic anterior segment syndrome in either of the two groups. Tamsulosin exposure in this cohort was associated with a higher risk of rebound uveitis and macular edema but the other three studied postoperative complications had a similar incidence in both groups. PMID:24158613

  17. Determining the natural history of pancreatic cystic neoplasms: a Manitoban cohort study

    PubMed Central

    Broughton, Jon; Lipschitz, Jeremy; Cantor, Michael; Moffatt, Dana; Abdoh, Ahmed; McKay, Andrew

    2016-01-01

    Background Most pancreatic cystic neoplasms (PCN) are thought to harbor a low malignant potential. This historical cohort study attempts to describe the natural history of these lesions in a provincial cohort, to assess the safety of non-surgical management. Pathological diagnosis of malignancy was the primary outcome measure of interest. Methods All adult patients (age 18+) with PCN seen between 2000 and 2012 by the two main institutions in Manitoba were included in this study. PCN were graded as high and low risk, which dictated initial treatment plan (surgery or observation). Predictors of initial surgical treatment, delayed surgery in the observation group and the clinical/radiological predictors of malignancy were determined. Results 497 patients were included in this study. 43 (8.7%) high-risk lesions underwent initial surgery, with 13 (30.2%) cases of malignancy discovered. 450 (90.5%) low-risk cysts were observed for a median of 17.3 months (range: 0.00–142.3). 29 (6.4%) cases of delayed surgery occurred, with malignancy discovered in five (17.2%). Conclusions This study supports current selection criteria for management of PCNs. Due to the low incidence of malignancy in low-risk PCN, it appears that long-term observation is safe and should be the treatment modality of choice in the absence of high-risk features. PMID:27037209

  18. Application of meta-analysis in reviewing occupational cohort studies.

    PubMed Central

    Wong, O; Raabe, G K

    1996-01-01

    Meta-analysis has been used increasingly in reviewing and summarising epidemiological studies. Reviews incorporating meta-analyses have appeared in medical journals in increasing numbers. Although there are several methodology papers on meta-analysis, most of these papers have been written primarily for discussion among epidemiologists. The present paper considers some of the basic methodological issues, the more practical aspects of meta-analysis, and targets an audience of mainly non-epidemiologists. Thus, the main objective of this paper is to provide some basic guidelines for non-epidemiologists to evaluate meta-analysis in occupational cohort studies. In this methodology paper, the limitations and problems of traditional qualitative reviews are pointed out. Some of these problems can be dealt with by quantitative meta-analysis. The potential limitations and benefits of quantitative meta-analysis are discussed. Rather than replacing traditional qualitative review, quantitative meta-analysis should be made part of the overall assessment. The term "meta-review" is proposed to emphasise the importance of both qualitative and quantitative components in a comprehensive review process. The basic steps in a meta-review are outlined, with a discussion on how to recognise and avoid some of the problems which are likely to occur at each step. A meta-review is useful in selecting studies, and in organising, presenting, and summarising results from individual studies. A meta-review can also be used to detect heterogeneity among studies. Major benefits of conducting a meta-analysis (the quantitative component in a meta-review) include the increase in statistical power and the estimate of a properly weighted summary risk estimate. PMID:8994397

  19. Representativeness of the LifeLines Cohort Study

    PubMed Central

    Klijs, Bart; Scholtens, Salome; Mandemakers, Jornt J.; Snieder, Harold; Stolk, Ronald P.; Smidt, Nynke

    2015-01-01

    Background LifeLines is a large prospective population-based three generation cohort study in the north of the Netherlands. Different recruitment strategies were adopted: recruitment of an index population via general practitioners, subsequent inclusion of their family members, and online self-registration. Our aim was to investigate the representativeness of the adult study population at baseline and to evaluate differences in the study population according to recruitment strategy. Methods Demographic characteristics of the LifeLines study population, recruited between 2006–2013, were compared with the total adult population in the north of the Netherlands as registered in the Dutch population register. Socioeconomic characteristics, lifestyle, chronic diseases, and general health were further compared with participants of the Permanent Survey of Living Conditions within the region (2005–2011, N = 6,093). Differences according to recruitment strategy were assessed. Results Compared with the population of the north of the Netherlands, LifeLines participants were more often female, middle aged, married, living in a semi-urban place and Dutch native. Adjusted for differences in demographic composition, in LifeLines a smaller proportion had a low educational attainment (5% versus 14%) or had ever smoked (54% versus 66%). Differences in the prevalence of various chronic diseases and low general health scores were mostly smaller than 3%. The age profiles of the three recruitment groups differed due to age related inclusion criteria of the recruitment groups. Other differences according to recruitment strategy were small. Conclusions Our results suggest that, adjusted for differences in demographic composition, the LifeLines adult study population is broadly representative for the adult population of the north of the Netherlands. The recruitment strategy had a minor effect on the level of representativeness. These findings indicate that the risk of selection bias is

  20. Life-course pathways to psychological distress: a cohort study

    PubMed Central

    von Stumm, Sophie; Deary, Ian J; Hagger-Johnson, Gareth

    2013-01-01

    Objectives Early life factors, like intelligence and socioeconomic status (SES), are associated with health outcomes in adulthood. Fitting comprehensive life-course models, we tested (1) the effect of childhood intelligence and SES, education and adulthood SES on psychological distress at midlife, and (2) compared alternative measurement specifications (reflective and formative) of SES. Design Prospective cohort study (the Aberdeen Children of the 1950s). Setting Aberdeen, Scotland. Participants 12 500 live-births (6282 boys) between 1950 and 1956, who were followed up in the years 2001–2003 at age 46–51 with a postal questionnaire achieving a response rate of 64% (7183). Outcome measures Psychological distress at age 46–51 (questionnaire). Results Childhood intelligence and SES and education had indirect effects on psychological distress at midlife, mediated by adult SES. Adult SES was the only variable to have a significant direct effect on psychological distress at midlife; the effect was stronger in men than in women. Alternative measurement specifications of SES (reflective and formative) resulted in greatly different model parameters and fits. Conclusions Even though formative operationalisations of SES are theoretically appropriate, SES is better specified as reflective than as a formative latent variable in the context of life-course modelling. PMID:23667162

  1. Prehospital tidal volume influences hospital tidal volume: A cohort study

    PubMed Central

    Stoltze, Andrew J.; Wong, Terrence S.; Harland, Karisa K.; Ahmed, Azeemuddin; Fuller, Brian M.; Mohr, Nicholas M.

    2015-01-01

    Purpose To describe current practice of ventilation in a modern air medical system, and to measure the association of ventilation strategy with subsequent ventilator care and acute respiratory distress syndrome (ARDS). Materials and Methods Retrospective observational cohort study of intubated adult patients (n=235) transported by a university-affiliated air medical transport service to a 711-bed tertiary academic center between July 2011 and May 2013. Low tidal volume ventilation was defined as tidal volumes ≤ 8 mL/kg predicted body weight (PBW). Multivariable regression was used to measure the association between prehospital tidal volume, hospital ventilation strategy, and ARDS. Results Most patients (57%) were ventilated solely with bag-valve ventilation during transport. Mean tidal volume of mechanically ventilated patients was 8.6 mL/kg PBW (SD 0.2 mL/kg). Low tidal volume ventilation was used in 13% of patients. Patients receiving low tidal volume ventilation during air medical transport were more likely to receive low tidal volume ventilation in the emergency department (p < 0.001) and intensive care unit (p = 0.015). ARDS was not associated with pre-hospital tidal volume (p = 0.840). Conclusions Low tidal volume ventilation was rare during air medical transport. Air transport ventilation strategy influenced subsequent ventilation, but was not associated with ARDS. PMID:25813548

  2. Serum YKL-40 and gestational diabetes - an observational cohort study.

    PubMed

    Gybel-Brask, Dorte; Johansen, Julia S; Christiansen, Ib J; Skibsted, Lillian; Høgdall, Estrid V S

    2016-09-01

    To examine serum YKL-40 in women developing gestational diabetes mellitus (GDM). In the present large observational cohort study of 1179 pregnant women, we determined serum YKL-40 four times during pregnancy (at gestational age 12, 20, 25, and 32 weeks). Pregnancy outcome was obtained from medical records. Sixty-eight women (5.8%) developed GDM. Serum YKL-40 increased from gestational age (GA) 12 weeks and the following weeks in the women who developed GDM and was independent of BMI, parity, and maternal age (OR = 2.69, 95% CI: 1.45-5.00, p = 0.002). No association was found between serum YKL-40 and the oral glucose tolerance test results. In conclusion, YKL-40 significantly increased in pregnant women with GDM compared with women without GDM, probably reflecting the low-grade inflammation of GDM. However, we did not find an association between serum concentrations of YKL-40 in early pregnancy and the development of GDM and thus we conclude that YKL-40 alone is not usable as a biomarker for early prediction of GDM. PMID:27457220

  3. Comparative Persistence of the TNF Antagonists in Rheumatoid Arthritis – A Population-Based Cohort Study

    PubMed Central

    Fisher, Anat; Bassett, Ken; Wright, James M.; Brookhart, M. Alan; Freeman, Hugh; Dormuth, Colin R.

    2014-01-01

    Objective To compare persistence with tumor necrosis factor alpha (TNF) antagonists among rheumatoid arthritis patients in British Columbia. Treatment persistence has been suggested as a proxy for real-world therapeutic benefit and harm of treatments for chronic non-curable diseases, including rheumatoid arthritis. We hypothesized that the different pharmacological characteristics of infliximab, adalimumab and etanercept cause statistically and clinically significant differences in persistence. Methods We conducted a population-based cohort study using administrative health data from the Canadian province of British Columbia. The study cohort included rheumatoid arthritis patients who initiated the first course of a TNF antagonist between 2001 and 2008. Persistence was measured as the time between first dispensing to discontinuation. Drug discontinuation was defined as a drug-free interval of 180 days or switching to another TNF antagonist, anakinra, rituximab or abatacept. Persistence was estimated and compared using survival analysis. Results The study cohort included 2,923 patients, 63% treated with etanercept. Median persistence in years (95% confidence interval) with infliximab was 3.7 (2.9–4.9), with adalimumab 3.3 (2.6–4.1) and with etanercept 3.8 (3.3–4.3). Similar risk of discontinuation was observed for the three drugs: the hazard ratio (95% confidence interval) was 0.98 (0.85–1.13) comparing infliximab with etanercept, 0.95 (0.78–1.15) comparing infliximab with adalimumab and 1.04 (0.88–1.22) comparing adalimumab with etanercept. Conclusions Similar persistence was observed with infliximab, adalimumab and etanercept in rheumatoid arthritis patients during the first 9 years of use. If treatment persistence is a good proxy for the therapeutic benefit and harm of these drugs, then this finding suggests that the three drugs share an overall similar benefit-harm profile in rheumatoid arthritis patients. PMID:25141123

  4. Statins are Associated with Reduced Use of Steroids in Inflammatory Bowel Disease: a Retrospective Cohort Study

    PubMed Central

    Crockett, Seth D.; Hansen, Richard A.; Stürmer, Til; Schectman, Robin; Darter, Jane; Sandler, Robert S.; Kappelman, Michael D.

    2011-01-01

    Introduction Statin medications have anti-inflammatory effects. We sought to determine whether statin use in persons with inflammatory bowel disease (IBD) was associated with reduced rates of steroid use or other markers of disease activity. Methods We performed a retrospective cohort study using administrative data. Statin users with IBD were compared to statin-unexposed IBD subjects. The primary outcome was an oral steroid prescription; secondary outcomes included anti-TNF initiation, hospitalization, or abdominal surgery. Cox proportional hazard models were used to estimate hazard ratios (HR) adjusted for potential confounders. Results The study cohort included 1,986 statin-exposed and 9,871 unexposed subjects. Statin use was associated with an 18% reduction in the rate of steroid initiation [HR 0.82 (95% CI 0.71, 0.94)]. A statistically significant result was seen with atorvastatin only [HR 0.76 (95% CI 0.60, 0.96)]. Statins were associated with a reduced rate of steroids in ulcerative colitis [HRs 0.75 (95% CI 0.62, 0.91)], but not in Crohn’s disease [HR 0.91 (95% CI 0.74, 1.12)]. Statin use was associated with reduced hazard of anti-TNF use [HR 0.72 (95% CI 0.46, 1.11)], abdominal surgery [HR 0.80 (95% CI 0.63, 1.02)], and hospitalization [HR 0.88 (95% CI 0.74, 1.05)], but these results did not reach statistical significance. Conclusion In this large retrospective cohort study, statin use amongst persons with IBD was associated with reduced use of oral steroids, particularly for UC. Prospective clinical trials are needed to confirm whether adjuvant treatment of IBD with statin drugs may spare immunosuppressant therapy or ameliorate flares. PMID:21826766

  5. Candida Infective Endocarditis: an Observational Cohort Study with a Focus on Therapy

    PubMed Central

    Johnson, Melissa; Bayer, Arnold S.; Bradley, Suzanne; Giannitsioti, Efthymia; Miró, José M.; Tornos, Pilar; Tattevin, Pierre; Strahilevitz, Jacob; Spelman, Denis; Athan, Eugene; Nacinovich, Francisco; Fortes, Claudio Q.; Lamas, Cristiane; Barsic, Bruno; Fernández-Hidalgo, Nuria; Muñoz, Patricia; Chu, Vivian H.

    2015-01-01

    Candida infective endocarditis is a rare disease with a high mortality rate. Our understanding of this infection is derived from case series, case reports, and small prospective cohorts. The purpose of this study was to evaluate the clinical features and use of different antifungal treatment regimens for Candida infective endocarditis. This prospective cohort study was based on 70 cases of Candida infective endocarditis from the International Collaboration on Endocarditis (ICE)-Prospective Cohort Study and ICE-Plus databases collected between 2000 and 2010. The majority of infections were acquired nosocomially (67%). Congestive heart failure (24%), prosthetic heart valve (46%), and previous infective endocarditis (26%) were common comorbidities. Overall mortality was high, with 36% mortality in the hospital and 59% at 1 year. On univariate analysis, older age, heart failure at baseline, persistent candidemia, nosocomial acquisition, heart failure as a complication, and intracardiac abscess were associated with higher mortality. Mortality was not affected by use of surgical therapy or choice of antifungal agent. A subgroup analysis was performed on 33 patients for whom specific antifungal therapy information was available. In this subgroup, 11 patients received amphotericin B-based therapy and 14 received echinocandin-based therapy. Despite a higher percentage of older patients and nosocomial infection in the echinocandin group, mortality rates were similar between the two groups. In conclusion, Candida infective endocarditis is associated with a high mortality rate that was not impacted by choice of antifungal therapy or by adjunctive surgical intervention. Additionally, echinocandin therapy was as effective as amphotericin B-based therapy in the small subgroup analysis. PMID:25645855

  6. Mediators of Atherosclerosis in South Asians Living in America (MASALA) study: Objectives, Methods, and Cohort Description

    PubMed Central

    2013-01-01

    Background South Asians (individuals from India, Pakistani, Bangladesh, Nepal, and Sri Lanka) have high rates of cardiovascular disease which cannot be explained by traditional risk factors. There are no prospective cohort studies investigating antecedents of cardiovascular disease in South Asians. Methods The Mediators of Atherosclerosis in South Asians Living in America (MASALA) study is investigating the prevalence, correlates and outcomes associated with subclinical cardiovascular disease (CVD) in a population-based sample of South Asian men and women between ages 40 – 79 years from two U.S. clinical field centers. This cohort is similar in methods and measures to the Multi-Ethnic Study of Atherosclerosis to allow for efficient cross-ethnic comparisons. Measurements obtained at the baseline examination include sociodemographic information, lifestyle and psychosocial factors, standard CVD risk factors, oral glucose tolerance testing, electrocardiogram, assessment of microalbuminuria, ankle and brachial blood pressures, carotid intima media wall thickness using ultrasonagraphy, coronary artery calcium measurement and abdominal visceral fat using computed tomography. Blood samples will be assayed for biochemical risk factors. Results Between October 2010 and March 2013 we enrolled 906 South Asians with mean age of 55±9 years, 46% women, 98% immigrants who have lived 27±11 years in the US. Conclusions The sociodemographic characteristics of this cohort are representative of US South Asians. Participants are being followed with annual telephone calls for identification of CVD events including acute myocardial infarction and other coronary heart disease, stroke, peripheral vascular disease, congestive heart failure, therapeutic interventions for CVD, and mortality. PMID:24194499

  7. Butorphanol in labour analgesia: A prospective cohort study

    PubMed Central

    Halder, Ajay; Agarwal, Rachana

    2013-01-01

    Objective Parenteral opioids can be administered with ease at a very low cost with high efficacy as labour analgesia. However, there are insufficient data available to accept the benefits of parenteral opioids over other proven methods of labour analgesia. Butorphanol, a new synthetic opioid, has emerged as a promising agent in terms of efficacy and a better safety profile. This study investigates the effect of butorphanol as a labour analgesia to gather further evidence of its safety and efficacy to pave the way for its widespread use in low resource settings. Material and Methods One hundred low risk term consenting pregnant women were recruited to take part in a prospective cohort study. Intramuscular injections of butorphanol tartrate 1 mg (Butrum 1/2mg, Aristo, Mumbai, India) were given in the active phase of labour and repeated two hourly. Pain relief was noted on a 10-point visual pain analogue scale (VPAS). Obstetric and neonatal outcome measures were mode of delivery, duration of labour, Apgar scores at 1 and 5 minutes and Neonatal Intensive Care Unit admissions. Collected data were analysed for statistically significant pain relief between pre- and post-administration VPAS scores and also for the incidence of adverse outcomes. Results Pain started to decrease significantly within 15 minutes of administration and reached the nadir (3.08 SD0.51) at the end of two hours. The pain remained below four on the VPAS until the end of six hours and was still significantly low after eight hours. The incidence of adverse outcomes was low in the present study. Conclusion Butorphanol is an effective parenteral opioid analgesic which can be administered with reasonable safety for the mother and the neonate. The study has the drawback of lack of control and small sample size. PMID:24592110

  8. Feasibility of a cohort study on health risks caused by occupational exposure to radiofrequency electromagnetic fields

    PubMed Central

    2009-01-01

    Background The aim of this study was to examine the feasibility of performing a cohort study on health risks from occupational exposure to radiofrequency electromagnetic fields (RF-EMF) in Germany. Methods A set of criteria was developed to evaluate the feasibility of such a cohort study. The criteria aimed at conditions of exposure and exposure assessment (level, duration, preferably on an individual basis), the possibility to assemble a cohort and the feasibility of ascertaining various disease endpoints. Results Twenty occupational settings with workers potentially exposed to RF-EMF and, in addition, a cohort of amateur radio operators were considered. Based on expert ratings, literature reviews and our set of predefined criteria, three of the cohorts were identified as promising for further evaluation: the personnel (technicians) of medium/short wave broadcasting stations, amateur radio operators, and workers on dielectric heat sealers. After further analyses, the cohort of workers on dielectric heat sealers seems not to be feasible due to the small number of exposed workers available and to the difficulty of assessing exposure (exposure depends heavily on the respective working process and mixture of exposures, e.g. plastic vapours), although exposure was highest in this occupational setting. The advantage of the cohort of amateur radio operators was the large number of persons it includes, while the advantage of the cohort of personnel working at broadcasting stations was the quality of retrospective exposure assessment. However, in the cohort of amateur radio operators the exposure assessment was limited, and the cohort of technicians was hampered by the small number of persons working in this profession. Conclusion The majority of occupational groups exposed to RF-EMF are not practicable for setting up an occupational cohort study due to the small numbers of exposed subjects or due to exposure levels being only marginally higher than those of the general

  9. Incidence and Risk Factors of Striae Distensae Following Breast Augmentation Surgery: A Cohort Study

    PubMed Central

    Valente, Denis Souto; Zanella, Rafaela Koehler; Doncatto, Leo Francisco; Padoin, Alexandre Vontobel

    2014-01-01

    Background The significant increase in the popularity of breast augmentation surgeries has led to an increase in the number and types of complications; among these is the postoperative occurrence of Striae Distensae (SD). The objective of this study was to investigate the incidence of SD and describing its occurrence in association with age, breast implant volume, history of SD, history of pregnancies and breastfeeding, body mass index (BMI), changes in postoperative weight, smoking habits, and use of oral contraceptives. Methods A cohort study was conducted and the patient data from a specific social group that underwent augmentation mammaplasty with silicone breast implants in a private clinic was analyzed. Results 563 patients entered the cohort, while 538 completed the study. The SD incidence was 7.06%. The risk was almost the double at 22–28 years of age and triple in women of 21 years of age or less. The women who did not use oral contraceptives were 2.59 times more likely of developing SD. A higher incidence of SD was observed among those with normal or low BMI values, smokers, and in those who had implants larger than 300 ml. Conclusions Young age, larger implant volumes, smoking, and normal or low BMI values were the risk factors responsible for the development of SD; while using oral contraceptives was found to be a protective factor. PMID:24844230

  10. 75 FR 9902 - Proposed Collection; Comment Request; The Agricultural Health Study: A Prospective Cohort Study...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-04

    ... Disease Among Men and Women in Agriculture (NCI) (OMB : 0925-0406). Type of Information Collection Request... Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture.... Affected Public: Private Sector, Farms. Type of Respondents: Licensed pesticide applicators and...

  11. Osteoporotic Fracture Risk Assessment Using Bone Mineral Density in Korean: A Community-based Cohort Study

    PubMed Central

    Jang, Eun Jin; Lee, Young-Kyun; Choi, Hyung Jin

    2016-01-01

    Background Fracture-risk assessment tool (FRAX) using just clinical risk factors of osteoporosis has been developed to estimate individual risk of osteoporotic fractures. We developed prediction model of fracture risk using bone mineral density (BMD) as well as clinical risk factors in Korean, and assessed the validity of the final model. Methods To develop and validate an osteoporotic FRAX, a total of 768 Korean men and women aged 50 to 90 years were followed for 7 years in a community-based cohort study. BMD as well as clinical risk factors for osteoporotic fracture including age, sex, body mass index, history of fragility fracture, family history of fracture, smoking status, alcohol intake, use of oral glucocorticoid, rheumatoid arthritis, and other causes of secondary osteoporosis were assessed biannually. Results During the follow-up period, 86 osteoporotic fractures identified (36 in men and 50 in women). The developed prediction models showed high discriminatory power and had goodness of fit. Conclusions The developed a Korean specific prediction model for osteoporotic fractures can be easily used as a screening tool to identify individual with high risk of osteoporotic fracture. Further studies for validation are required to confirm the clinical feasibility in general Korean population. PMID:26981519

  12. Risk of bladder cancer in patients with diabetes: a retrospective cohort study

    PubMed Central

    Zeegers, Maurice P; Bazelier, Marloes T; De Bruin, Marie L; Buntinx, Frank; de Vries, Frank

    2015-01-01

    Objective The objective of this study was to examine the association between diabetes, and both urinary bladder cancer (UBC) risk and mortality. Methods We conducted a retrospective cohort study using data from the UK Clinical Practice Research Datalink (CPRD) linked to the Office of National Statistics (ONS). Patients diagnosed with diabetes mellitus type 1 or 2, or using antidiabetic drugs (ADDs), were compared to matched non-diabetic controls. Cox proportional hazards models were used to estimate the risk and mortality of UBC. We adjusted for age, sex, smoking status and body mass index. Results The cohort included 329 168 patients using ADD, and 307 315 controls with 1295 and 1071 patients, respectively, diagnosed as having UBC during follow-up. The adjusted HRs of UBC were 0.77 (95% CI 0.57 to 1.05) and 1.04 (95% CI 0.96 to 1.14) for type 1 and 2 diabetes, respectively. These results were similar if we restricted our analysis to an inception cohort. We noticed a small increased risk during the first year after diagnosis (HR=1.26 (95% CI 1.05 to 1.52)), which could be explained by detection bias. There was no influence of the severity of diabetes as measured by the glycated haemoglobin. Mortality of UBC was not increased for patients with either type 1 (HR=0.95 (95% CI 0.39 to 2.34)) or type 2 diabetes (HR=1.16 (95% CI 0.91 to 1.46)). Conclusions Neither the risk of UBC nor the mortality from UBC was increased in patients with type 1 and patients with type 2 diabetes in the CPRD data. PMID:26033947

  13. Pioglitazone use and risk of bladder cancer: population based cohort study

    PubMed Central

    Tuccori, Marco; Filion, Kristian B; Yin, Hui; Yu, Oriana H; Platt, Robert W

    2016-01-01

    Objective To determine whether pioglitazone compared with other antidiabetic drugs is associated with an increased risk of bladder cancer in people with type 2 diabetes. Design Population based cohort study. Setting General practices contributing data to the United Kingdom Clinical Practice Research Datalink. Participants A cohort of 145 806 patients newly treated with antidiabetic drugs between 1 January 2000 and 31 July 2013, with follow-up until 31 July 2014. Main outcome measures The use of pioglitazone was treated as a time varying variable, with use lagged by one year for latency purposes. Cox proportional hazards models were used to estimate adjusted hazard ratios with 95% confidence intervals of incident bladder cancer associated with pioglitazone overall and by both cumulative duration of use and cumulative dose. Similar analyses were conducted for rosiglitazone, a thiazolidinedione not previously associated with an increased risk of bladder cancer. Results The cohort generated 689 616 person years of follow-up, during which 622 patients were newly diagnosed as having bladder cancer (crude incidence 90.2 per 100 000 person years). Compared with other antidiabetic drugs, pioglitazone was associated with an increased risk of bladder cancer (121.0 v 88.9 per 100 000 person years; hazard ratio 1.63, 95% confidence interval 1.22 to 2.19). Conversely, rosiglitazone was not associated with an increased risk of bladder cancer (86.2 v 88.9 per 100 000 person years; 1.10, 0.83 to 1.47). Duration-response and dose-response relations were observed for pioglitazone but not for rosiglitazone. Conclusion The results of this large population based study indicate that pioglitazone is associated with an increased risk of bladder cancer. The absence of an association with rosiglitazone suggests that the increased risk is drug specific and not a class effect. PMID:27029385

  14. Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): protocol for a multicentric prospective observational study

    PubMed Central

    Gupte, Akshay; Padmapriyadarsini, Chandrasekaran; Mave, Vidya; Kadam, Dileep; Suryavanshi, Nishi; Shivakumar, Shri Vijay Bala Yogendra; Kohli, Rewa; Gupte, Nikhil; Thiruvengadam, Kannan; Kagal, Anju; Meshram, Sushant; Bharadwaj, Renu; Khadse, Sandhya; Ramachandran, Geetha; Hanna, Luke Elizabeth; Pradhan, Neeta; Gomathy, N S; DeLuca, Andrea; Gupta, Amita; Swaminathan, Soumya

    2016-01-01

    Introduction Tuberculosis disease (TB) remains an important global health threat. An evidence-based response, tailored to local disease epidemiology in high-burden countries, is key to controlling the global TB epidemic. Reliable surrogate biomarkers that predict key active disease and latent TB infection outcomes are vital to advancing clinical research necessary to ‘End TB’. Well executed longitudinal studies strengthening local research capacity for addressing TB research priorities and advancing biomarker discovery are urgently needed. Methods and analysis The Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH) study conducted in Byramjee Jeejeebhoy Government Medical College (BJGMC), Pune and National Institute for Research in Tuberculosis (NIRT), Chennai, India, will establish and maintain three prospective cohorts: (1) an Active TB Cohort comprising 800 adults with pulmonary TB, 200 adults with extrapulmonary TB and 200 children with TB; (2) a Household Contact Cohort of 3200 adults and children at risk of developing active disease; and (3) a Control Cohort consisting of 300 adults and 200 children with no known exposure to TB. Relevant clinical, sociodemographic and psychosocial data will be collected and a strategic specimen repository established at multiple time points over 24 months of follow-up to measure host and microbial factors associated with (1) TB treatment outcomes; (2) progression from infection to active TB disease; and (3) Mycobacterium tuberculosis transmission among Indian adults and children. We anticipate CTRIUMPH to serve as a research platform necessary to characterise some relevant aspects of the TB epidemic in India, generate evidence to inform local and global TB control strategies and support novel TB biomarker discovery. Ethics and dissemination This study is approved by the Institutional Review Boards of NIRT, BJGMC and Johns Hopkins University, USA. Study results will be disseminated through peer

  15. Impact of hormone receptor status on patterns of recurrence and clinical outcomes among patients with human epidermal growth factor-2-positive breast cancer in the National Comprehensive Cancer Network: a prospective cohort study

    PubMed Central

    2012-01-01

    Introduction In gene expression experiments, hormone receptor (HR)-positive/human epidermal growth factor-2 (HER2)-positive tumors generally cluster within the luminal B subset; whereas HR-negative/HER2-positive tumors reside in the HER2-enriched subset. We investigated whether the clinical behavior of HER2-positive tumors differs by HR status. Methods We evaluated 3,394 patients who presented to National Comprehensive Cancer Network (NCCN) centers with stage I to III HER2-positive breast cancer between 2000 and 2007. Tumors were grouped as HR-positive/HER2-positive (HR+/HER2+) or HR-negative/HER2-positive (HR-/HER2+). Chi-square, logistic regression and Cox hazard proportional regression were used to compare groups. Results Median follow-up was four years. Patients with HR-/HER2+ tumors (n = 1,379, 41% of total) were more likely than those with HR+/HER-2+ disease (n = 2,015, 59% of total) to present with high histologic grade and higher stages (P <0.001). Recurrences were recorded for 458 patients. HR-/HER2+ patients were less likely to experience first recurrence in bone (univariate Odds Ratio (OR) = 0.53, 95% Confidence Interval (CI): 0.34 to 0.82, P = 0.005) and more likely to recur in brain (univariate OR = 1.75, 95% CI: 1.05 to 2.93, P = 0.033). A lower risk of recurrence in bone persisted after adjusting for age, stage and adjuvant trastuzumab therapy (OR = 0.53, 95% CI: 0.34 to 0.83, P = 0.005) and when first and subsequent sites of recurrence were both considered (multivariable OR = 0.55, 95% CI: 0.37 to 0.80, P = 0.002). As compared with patients with HR+/HER2+ disease, those with HR-/HER2+ disease had significantly increased hazard of early, but not late, death (hazard ratio of death zero to two years after diagnosis = 1.92, 95% CI: 1.28 to 2.86, P = 0.002, hazard ratio of death two to five years after diagnosis = 1.55, 95% CI: 1.19 to 2.00, P = 0.001; hazard ratio of death more than five years after diagnosis = 0.81, 95% CI: 0.55 to 1.19, P = 0

  16. Analysis of Published Criteria for Clinically Inactive Disease in a Large Juvenile Dermatomyositis Cohort Shows That Skin Disease Is Underestimated

    PubMed Central

    Almeida, Beverley; Campanilho‐Marques, Raquel; Arnold, Katie; Pilkington, Clarissa A.; Wedderburn, Lucy R.; Armon, Kate; Briggs, Vanja; Ellis‐Gage, Joe; Roper, Holly; Watts, Joanna; Baildam, Eileen; Hanna, Louise; Lloyd, Olivia; McCann, Liza; Roberts, Ian; McGovern, Ann; Riley, Phil; Al‐Abadi, Eslam; Ryder, Clive; Scott, Janis; Southwood, Taunton; Thomas, Beverley; Amin, Tania; Burton, Deborah; Jackson, Gillian; Van Rooyen, Vanessa; Wood, Mark; Wyatt, Sue; Browne, Michael; Davidson, Joyce; Ferguson, Sue; Gardner‐Medwin, Janet; Martin, Neil; Waxman, Liz; Foster, Helen; Friswell, Mark; Jandial, Sharmila; Qiao, Lisa; Sen, Ethan; Smith, Eve; Stevenson, Vicky; Swift, Alison; Wade, Debbie; Watson, Stuart; Crate, Lindsay; Frost, Anna; Jordan, Mary; Mosley, Ellen; Satyapal, Rangaraj; Stretton, Elizabeth; Venning, Helen; Warrier, Kishore; Almeida, Beverley; Arnold, Katie; Beard, Laura; Brown, Virginia; Campanilho‐Marques, Raquel; Enayat, Elli; Glackin, Yvonne; Halkon, Elizabeth; Hasson, Nathan; Juggins, Audrey; Kassoumeri, Laura; Lunt, Sian; Maillard, Sue; Nistala, Kiran; Pilkington, Clarissa; Simou, Stephanie; Smith, Sally; Varsani, Hemlata; Wedderburn, Lucy; Murray, Kevin; Ioannou, John; Suffield, Linda; Al‐Obaidi, Muthana; Leach, Sam; Lee, Helen; Smith, Helen; Inness, Emma; Kendall, Eunice; Mayers, David; Wilkinson, Nick; Clinch, Jacqui; Pluess‐Hall, Helen

    2015-01-01

    Objective The Pediatric Rheumatology International Trials Organisation (PRINTO) recently published criteria for classification of patients with juvenile dermatomyositis (DM) as having clinically inactive disease. The criteria require that at least 3 of 4 conditions be met, i.e., creatine kinase level ≤150 units/liter, Childhood Myositis Assessment Scale score ≥48, Manual Muscle Testing in 8 muscles score ≥78, and physician's global assessment of overall disease activity (PGA) ≤0.2. The present study was undertaken to test these criteria in a UK cohort of patients with juvenile DM. Methods We assessed 1,114 patient visits for the 4 items in the PRINTO criteria for clinically inactive disease. Each visit was analyzed to determine whether skin disease was present. The Disease Activity Score (DAS) for juvenile DM was determined in 59 patients. Results At 307 of the 1,114 visits, clinically inactive disease was achieved based on the 3 muscle criteria (but with a PGA of >0.2); rash was present at 65.8% of these visits and nailfold capillary abnormalities at 35.2%. When PGA ≤0.2 was one of the 3 criteria that were met, the frequency of skin signs was significantly lower (rash in 23.1% and nailfold capillary abnormalities in 8.7%). If PGA was considered an essential criterion for clinically inactive disease (P‐CID), patients with active skin disease were less likely to be categorized as having clinically inactive disease (a median DAS skin score of 0 [of a possible maximum of 9] in visits where the PGA was ≤0.2, versus a median DAS skin score of 4 in patients meeting the 3 muscle criteria [with a PGA of >0.2]; P < 0.001). Use of the P‐CID led to improvements in the positive predictive value and the positive likelihood ratio (85.4% and 11.0, respectively, compared to 72.9% and 5.1 with the current criteria). Conclusion There was a high frequency of skin disease among patients with juvenile DM who did not meet the PGA criterion for inactive disease but met

  17. Medical Graduates, Tertiary Hospitals, and Burnout: A Longitudinal Cohort Study

    PubMed Central

    Parr, Justin M.; Pinto, Nigel; Hanson, Martin; Meehan, Ashlea; Moore, Peter T.

    2016-01-01

    Background: Burnout among junior doctors can affect patient care. We conducted a longitudinal cohort study designed to explore the incidence of burnout in medical interns and to examine the changes in burnout during the course of the intern year. Methods: Interns were recruited at two tertiary hospitals in Brisbane, Australia (n=180). Participants completed surveys at four time points during their internship year. All interns (100%) completed the baseline survey during their orientation. Response rates were 85%, 88%, and 79%, respectively, at 5-week, 6-month, and 12-month follow-up. Results: Interns reported high levels of personal and work-related burnout throughout the year that peaked at 6 months with mean scores of 42.53 and 41.81, respectively. Increases of 5.1 points (confidence interval [CI] 2.5,7.7; P=0.0001) and 3.5 points (CI 1.3,5.6; P=0.0015) were seen at 6 months for personal and work-related burnout, respectively. The mean score for patient-related burnout at 12 months was 25.57, and this number had increased significantly by 5.8 points (CI 3.2,8.5; P<0.0001) throughout the year. Correlation with demographic variables (age, sex) were found. The total incidence of burnout was 55.9%. Conclusion: Our study showed that burnout is a common problem among interns. The high incidence of burnout demonstrates the need for appropriate strategies to prevent adverse effects on doctors' quality of life and on the quality of care patients receive. PMID:27046399

  18. Maternal Caffeine Consumption and Infant Nighttime Waking: Prospective Cohort Study

    PubMed Central

    Santos, Iná S.; Matijasevich, Alicia

    2012-01-01

    OBJECTIVE: Coffee and other caffeinated beverages are commonly consumed in pregnancy. In adults, caffeine may interfere with sleep onset and have a dose-response effect similar to those seen during insomnia. In infancy, nighttime waking is a common event. With this study, we aimed to investigate if maternal caffeine consumption during pregnancy and lactation leads to frequent nocturnal awakening among infants at 3 months of age. METHODS: All children born in the city of Pelotas, Brazil, during 2004 were enrolled on a cohort study. Mothers were interviewed at delivery and after 3 months to obtain information on caffeine drinking consumption, sociodemographic, reproductive, and behavioral characteristics. Infant sleeping pattern in the previous 15 days was obtained from a subsample. Night waking was defined as an episode of infant arousal that woke the parents during nighttime. Multivariable analysis was performed by using Poisson regression. RESULTS: The subsample included 885 of the 4231 infants born in 2004. All but 1 mother consumed caffeine in pregnancy. Nearly 20% were heavy consumers (≥300 mg/day) during pregnancy and 14.3% at 3 months postpartum. Prevalence of frequent nighttime awakeners (>3 episodes per night) was 13.8% (95% confidence interval: 11.5%–16.0%). The highest prevalence ratio was observed among breastfed infants from mothers consuming ≥300 mg/day during the whole pregnancy and in the postpartum period (1.65; 95% confidence interval: 0.86–3.17) but at a nonsignificant level. CONCLUSIONS: Caffeine consumption during pregnancy and by nursing mothers seems not to have consequences on sleep of infants at the age of 3 months. PMID:22473365

  19. Drug use in children: cohort study in three European countries

    PubMed Central

    Verhamme, Katia M C; Nicolosi, Alfredo; Murray, Macey L; Neubert, Antje; Caudri, Daan; Picelli, Gino; Sen, Elif Fatma; Giaquinto, Carlo; Cantarutti, Luigi; Baiardi, Paola; Felisi, Maria-Grazia; Ceci, Adriana; Wong, Ian C K

    2008-01-01

    Objective To provide an overview of drug use in children in three European countries. Design Retrospective cohort study, 2000-5. Setting Primary care research databases in the Netherlands (IPCI), United Kingdom (IMS-DA), and Italy (Pedianet). Participants 675 868 children aged up to 14 (Italy) or 18 (UK and Netherlands). Main outcome measure Prevalence of use per year calculated by drug class (anatomical and therapeutic). Prevalence of “recurrent/chronic” use (three or more prescriptions a year) and “non-recurrent” or “acute” use (less than three prescriptions a year) within each therapeutic class. Descriptions of the top five most commonly used drugs evaluated for off label status within each anatomical class. Results Three levels of drug use could be distinguished in the study population: high (>10/100 children per year), moderate (1-10/100 children per year), and low (<1/100 children per year). For all age categories, anti-infective, dermatological, and respiratory drugs were in the high use group, whereas cardiovascular and antineoplastic drugs were always in the low use group. Emollients, topical steroids, and asthma drugs had the highest prevalence of recurrent use, but relative use of low prevalence drugs was more often recurrent than acute. In the top five highest prevalence drugs topical inhaled and systemic steroids, oral contraceptives, and topical or systemic antifungal drugs were most commonly used off label. Conclusion This overview of outpatient paediatric prescription patterns in a large European population could provide information to prioritise paediatric therapeutic research needs. PMID:19029175

  20. Menstrual Pattern following Tubal Ligation: A Historical Cohort Study

    PubMed Central

    Sadatmahalleh, Shahideh Jahanian; Ziaei, Saeideh; Kazemnejad, Anoshirvan; Mohamadi, Eesa

    2016-01-01

    Background Tubal ligation (TL) is recommended for women who have completed their family planning. The existence of the menstrual disorders following this procedure has been the subject of debate for decades. This study was conducted to identify the relationship between tubal ligation and menstrual disorders. Materials and Methods A historical cohort study was carried out on 140 women undergoing tubal ligation (TL group) and on 140 women using condom as the main contraceptive method (Non-TL group). They aged between 20 and 40 years and were selected from a health care center in Rudsar, Guilan Province, Iran, during 2013-2014. The two groups were comparable in demographic characteristics, obstetrical features and menstrual bleeding pattern using a routine questionnaire. A validated pictorial blood loss assessment chart (PBLAC) was also used to measure the menstrual blood loss. Results Women with TL had more menstrual irregularity than those without TL (24.3 vs. 10%, P=0.002). Women with TL had more polymenorrhea (9.3 vs. 1.4%, P=0.006), hypermenorrhea (12.1 vs. 2.1%, P=0.002), menorrhagia (62.9 vs. 22.1%, P<0.0001) and menometrorrhagia (15.7 vs. 3.6%, P=0.001) than those without TL. There is a significant difference in the PBLAC score between women with and without TL (P<0.0001). According to logistic regression, age odds ratio [(OR=1.08, con- fidence interval (CI):1.07-1.17, P=0.03)], TL (OR=5.95, CI:3.45-10.26, P<0.0001) and cesarean section (OR=2.72, CI:1.49-4.97, P=0.001) were significantly associated with menorrhagia. Conclusion We found significant differences in menstrual disorders between women with and without TL. Therefore, women should be informed by the health providers regarding the advantages and disadvantages of TL before the procedures. PMID:26985334

  1. The epidemiology and aetiology of diarrhoeal disease in infancy in southern Vietnam: a birth cohort study

    PubMed Central

    Anders, Katherine L.; Thompson, Corinne N.; Thuy, Nguyen Thi Van; Nguyet, Nguyen Minh; Tu, Le Thi Phuong; Dung, Tran Thi Ngoc; Phat, Voong Vinh; Van, Nguyen Thi Hong; Hieu, Nguyen Trong; Tham, Nguyen Thi Hong; Ha, Phan Thi Thanh; Lien, Le Bich; Chau, Nguyen Van Vinh; Baker, Stephen; Simmons, Cameron P.

    2015-01-01

    Summary Objectives Previous studies indicate a high burden of diarrhoeal disease in Vietnamese children, however longitudinal community-based data on burden and aetiology are limited. The findings from a large, prospective cohort study of diarrhoeal disease in infants in southern Vietnam are presented herein. Methods Infants were enrolled at birth in urban Ho Chi Minh City and a semi-rural district in southern Vietnam, and followed for 12 months (n = 6706). Diarrhoeal illness episodes were identified through clinic-based passive surveillance, hospital admissions, and self-reports. Results The minimum incidence of diarrhoeal illness in the first year of life was 271/1000 infant-years of observation for the whole cohort. Rotavirus was the most commonly detected pathogen (50% of positive samples), followed by norovirus (24%), Campylobacter (20%), Salmonella (18%), and Shigella (16%). Repeat infections were identified in 9% of infants infected with rotavirus, norovirus, Shigella, or Campylobacter, and 13% of those with Salmonella infections. Conclusions The minimum incidence of diarrhoeal disease in infants in both urban and semi-rural settings in southern Vietnam was quantified prospectively. A large proportion of laboratory-diagnosed disease was caused by rotavirus and norovirus. These data highlight the unmet need for a rotavirus vaccine in Vietnam and provide evidence of the previously unrecognized burden of norovirus in infants. PMID:25813553

  2. Prevalence and incidence of liver enzyme elevations in a pooled oncology clinical trial cohort.

    PubMed

    Shantakumar, Sumitra; Landis, Sarah; Lawton, Andy; Hunt, Christine M

    2016-06-01

    Few epidemiologic studies describe longitudinal liver chemistry (LC) elevations in cancer patients. A population-based retrospective cohort was identified from 31 Phase 2-3 oncology trials (excluding targeted therapies) conducted from 1985 to 2005 to evaluate background rates of LC elevations in patients (n = 3998) with or without liver metastases. Patients with baseline liver metastases (29% of patients) presented with a 3% prevalence of alanine transaminase (ALT) ≥ 3x upper limits normal (ULN) and 0.2% prevalence of bilirubin ≥ 3xULN. During follow-up, the incidence (per 1000 person-months) of new onset ALT elevations ≥3xULN was 6.1 (95% CI: 4.5, 8.0) and 2.2 (95% CI: 0.9, 4.5) in patients without and with liver metastases, respectively. No new incident cases of ALT and bilirubin elevations suggestive of severe liver injury occurred among those with liver metastases; a single case occurred among those without metastasis. Regardless of the presence of liver metastases, LC elevations were rare in cancer patients during oncology trials, which may be due to enrollment criteria. Our study validates uniform thresholds for detection of LC elevations in oncology studies and serves as an empirical referent point for comparing liver enzyme abnormalities in oncology trials of novel targeted therapies. These data support uniform LC stopping criteria in oncology trials. PMID:27025923

  3. Demographics, clinical disease characteristics, and quality of life in a large cohort of psoriasis patients with and without psoriatic arthritis

    PubMed Central

    Truong, B; Rich-Garg, N; Ehst, BD; Deodhar, AA; Ku, JH; Vakil-Gilani, K; Danve, A; Blauvelt, A

    2015-01-01

    Innovation What is already known about the topic: psoriasis (PsO) is a common skin disease with major impact on quality of life (QoL). Patient-reported data on QoL from large number of PsO patients with and without psoriatic arthritis (PsA) are limited. What this study adds: In a large cohort referred to a university psoriasis center, patients with PsO and concomitant PsA (~30% in this group) had greater degrees of skin and nail involvement and experienced greater negative impacts on QoL. Despite large numbers of patients with moderate-to-severe disease, use of systemic therapy by community practitioners was uncommon. Background PsO and PsA are common diseases that have marked adverse impacts on QoL. The disease features and patient-reported QoL data comparing PsO and PsA patients are limited. Objective To identify and compare demographics, clinical disease characteristics, and QoL scores in a large cohort of PsO patients with and without PsA. Methods All PsO patients seen in a psoriasis specialty clinic, named the Center of Excellence for Psoriasis and Psoriatic Arthritis, were enrolled in an observational cohort. Demographic, QoL, and clinical data were collected from patient-reported questionnaires and from physical examinations performed by Center of Excellence for Psoriasis and Psoriatic Arthritis dermatologists and a rheumatologists. Cross sectional descriptive data were collected and comparisons between patients with PsO alone and those with concomitant PsA are presented. Results A total of 568 patients were enrolled in the database. Mean age of PsO onset was 28 years and mean disease duration was 18 years. Those with family history had an earlier onset of PsO by ~7 years. Mean body surface area involvement with PsO was 14%. Mean body mass index was 30.7. Prevalence of PsA was 29.8%. PsA patients had a higher mean body surface area compared to patients with PsO alone (16.7% vs 13.4%, P<0.05), higher prevalence of psoriatic nail changes (54.4% vs 36%, P<0

  4. MILLARD COUNTY, UTAH, DRINKING WATER ARSENIC COHORT STUDY

    EPA Science Inventory

    Assembly of the cohort is based on historic membership records of members of the Church of Jesus Christ of Latter-Day Saints (LDS) in an area of Millard County, Utah, which is located in the central western part of the state. Personal information including name, birth date, town ...

  5. Visual query tool for finding patient cohorts from a clinical data warehouse of the partners HealthCare system

    PubMed

    Murphy; Barnett; Chueh

    2000-01-01

    The patient base of the Partners HealthCare System in Boston exceeds 1.8 million. Many of these patients are desirable for participation in research studies. To facilitate their discovery, we developed a data warehouse to contain clinical characteristics of these patients. The data warehouse contains diagnosis and procedures from administrative databases. The patients are indexed across institutions and their demographics provided by an Enterprise Master Patient Indexing service. Characteristics of the diagnoses and procedures such as associated providers, dates of service, inpatient/outpatient status, and other visit-related characteristics are also fed from the administrative systems. The targeted users of this system are research clinician s interested in finding patient cohorts for research studies. Their data requirements were analyzed and have been reported elsewhere. We did not expect the clinicians to become expert users of the system. Tools for querying healthcare data have traditionally been text based, although graphical interfaces have been pursued. In order to support the simple drag and drop visual model, as well as the identification and distribution of the patient data, a three-tier software architecture was developed. The user interface was developed in Visual Basic and distributed as an ActiveX object embedded in an HTML page. The middle layer was developed in Java and Microsoft COM. The queries are represented throughout their lifetime as XML objects, and the Microsoft SQL7 database is queried and managed in standard SQL. PMID:11080028

  6. Survival in familial colorectal cancer: a Danish cohort study.

    PubMed

    Lautrup, Charlotte Kvist; Mikkelsen, Ellen M; Lash, Timothy L; Katballe, Niels; Sunde, Lone

    2015-12-01

    The monogenic Lynch syndrome (LS) is associated with better survival in colorectal cancer (CRC) patients. Whether family history of CRC affects CRC prognosis in general remains unclear. We evaluated overall mortality in a Danish cohort of CRC patients comparing patients with a family history (FHpos) to those without (FHneg) with focus on patients from non-syndromic families, thus FHpos patients were further divided into a non-syndromic group (FHNS) and a HNPCC/LS group (FHHNPCC). We included CRC patients diagnosed 1995-1998. First degree relatives were identified using Danish population registries and family history was obtained by linkage to Danish medical registries. 1- and 5-year mortality were evaluated using the Kaplan-Meier method and Cox regression, with adjustment for age, sex, cancer site, cancer stage, and comorbidity. 1196 CRC patients were included in the study, 219 FHpos patients of whom 197 were FHNS patients. 1- and 5-year adjusted Mortality Rate Ratios comparing FHpos patients to FHneg patients were 0.99 (95% CI 0.69, 1.42) and 1.07 (95% CI 0.87, 1.32), respectively. For FHNS patients, the corresponding MRRs were 1.01 (95% CI 0.69, 1.47) and 1.15 (95% CI 0.93, 1.43). For the FHHNPCC patients MRRs were 0.84 (95% CI 0.29, 2.44) and 0.66 (95% CI 0.33, 1.31), respectively. In contrast to the lower mortality in LS patients, other types of familial CRC do not seem to affect the survival after CRC diagnosis. PMID:25963853

  7. Debunking the curse of the rainbow jersey: historical cohort study

    PubMed Central

    2015-01-01

    Objective To understand the underlying mechanism of the “curse of the rainbow jersey,” the lack of wins that purportedly affects the current cycling world champion. Design Historical cohort study. Setting On the road. Participants Professional cyclists who won the World Championship Road Race or the Tour of Lombardy, 1965-2013. Main outcome measures Number of professional wins per season in the year when the target race was won (year 0) and in the two following