Browsing by Subject "UTILITY"

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  • Ala-Houhala, M.; Koukila-Kahkola, P.; Antikainen, Jenni; Valve, J.; Kirveskari, J.; Anttila, V. -J. (2018)
    Objectives: To assess the clinical use of panfungal PCR for diagnosis of invasive fungal diseases (IFDs). We focused on the deep tissue samples. Methods: We first described the design of panfungal PCR, which is in clinical use at Helsinki University Hospital. Next we retrospectively evaluated the results of 307 fungal PCR tests performed from 2013 to 2015. Samples were taken from normally sterile tissues and fluids. The patient population was nonselected. We classified the likelihood of IFD according to the criteria of the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG), comparing the fungal PCR results to the likelihood of IFD along with culture and microscopy results. Results: There were 48 positive (16%) and 259 negative (84%) PCR results. The sensitivity and specificity of PCR for diagnosing IFDs were 60.5% and 91.7%, respectively, while the negative predictive value and positive predictive value were 93.4% and 54.2%, respectively. The concordance between the PCR and the culture results was 86% and 87% between PCR and microscopy, respectively. Of the 48 patients with positive PCR results, 23 had a proven or probable IFD. Conclusions: Fungal PCR can be useful for diagnosing IFDs in deep tissue samples. It is beneficial to combine fungal PCR with culture and microscopy. M. Ala-Houhala, Clin Microbiol Infect 2018;24:301 (C) 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
  • Huvila, Jutta; Laajala, Teemu D.; Edqvist, Per-Henrik; Mardinoglu, Adil; Talve, Lauri; Ponten, Fredrik; Grenman, Seija; Carpen, Olli; Aittokallio, Tero; Auranen, Annika (2018)
    Objective. In clinical practise, prognostication of endometrial cancer is based on clinicopathological risk factors. The use of immunohistochemistry-based markers as prognostic tools is generally not recommended and a systematic analysis of their utility as a panel is lacking. We evaluated whether an immunohistochemical marker panel could reliably assess endometrioid endometrial cancer (EEC) outcome independent of clinicopathological information. Methods. A cohort of 306 EEC specimens was profiled using tissue microarray (TMA). Cost- and time-efficient immunohistochemical analysis of well-established tissue biomarkers (ER, PR, HER2, Ki-67, MLH1 and p53) and two new biomarkers (L1CAM and ASRGL1) was carried out. Statistical modelling with embedded variable selection was applied on the staining results to identify minimal prognostic panels with maximal prognostic accuracy without compromising generalizability. Results. A panel including p53 and ASRGL1 immunohistochemistry was identified as the most accurate predictor of relapse-free and disease-specific survival. Within this panel, patients were allocated into high- (5.9%), intermediate- (295%) and low- (64.6%) risk groups where high-risk patients had a 30-fold risk (P <0.001) of dying of EEC compared to the low-risk group. Conclusions. P53 and ASRGL1 immunoprofiling stratifies EEC patients into three risk groups with significantly different outcomes. This simple and easily applicable panel could provide a useful tool in EEC risk stratification and guiding the allocation of treatment modalities. (C) 2018 Elsevier Inc. All rights reserved.
  • Mankinen, Petri; Lundström, Tuomas; Soini, Erkki; Sumelahti, Marja-Liisa; Ruutiainen, Juhani; Niskala, Ulla; Järvinen, Elina (2020)
    Introduction Cost assessment modelling (CAM) of treatments in highly active relapsing multiple sclerosis was conducted. Methods The CAM was developed using the R programming language. The PICOSTEPS health technology assessment framework was applied in the CAM. Modelled patients were 280 adults with highly active relapsing multiple sclerosis eligible for disease-modifying treatment. Intervention was cladribine tablets, a new and reimbursed oral treatment for highly active relapsing multiple sclerosis in Finland. Comparators included fingolimod, the most used oral reimbursed treatment for the highly active disease, and natalizumab, the most used intravenous treatment, and a treatment mix (80% use fingolimod, 20% use natalizumab) in Finland. Outcomes presented expected annual and cumulative drug-associated costs in the overall population and per patient. Setting was modelled public specialist care in Finland. Time was set to 4 years, without discounting. Effects covered expected drug-associated costs (screening, acquisition, administration, monitoring, adverse events, travelling, productivity). Perspective was a limited societal perspective. Sensitivity analyses regarding all PICOSTEPS components were conducted. Results Cladribine tablets were projected to be cost saving in comparison to fingolimod, natalizumab and treatment mix. The respective modelled savings were euro4,598,742, euro16,249,701 and euro6,928,934 in the overall population, and euro16,424, euro58,035 and euro24,746 per patient, respectively, during the 4 years. The most important cost driver was drug costs, representing 96.3%, 96.0% and 83.4% of modelled costs associated with cladribine tablets, fingolimod and natalizumab, respectively. Cladribine tablets sustained their affordability in the sensitivity analyses. From the perspective of health care payer, cladribine tablets' savings were projected to be euro4,514,509, euro15,145,366 and euro6,640,680 in the overall population, and euro16,123, euro54,091 and euro23,717 per patient in comparison to fingolimod, natalizumab and treatment mix, respectively. Conclusion Based on the CAM, cladribine tablets were projected to robustly save modelled drug-associated costs in comparison to fingolimod, natalizumab and their mix in Finland.
  • Steele, Catriona M.; Mukherjee, Rajat; Kortelainen, Juha M.; Polonen, Harri; Jedwab, Michael; Brady, Susan L.; Theimer, Kayla Brinkman; Langmore, Susan; Riquelme, Luis F.; Swigert, Nancy B.; Bath, Philip M.; Goldstein, Larry B.; Hughes, Richard L.; Leifer, Dana; Lees, Kennedy R.; Meretoja, Atte; Muehlemann, Natalia (2019)
    Oropharyngeal dysphagia is prevalent in several at-risk populations, including post-stroke patients, patients in intensive care and the elderly. Dysphagia contributes to longer hospital stays and poor outcomes, including pneumonia. Early identification of dysphagia is recommended as part of the evaluation of at-risk patients, but available bedside screening tools perform inconsistently. In this study, we developed algorithms to detect swallowing impairment using a novel accelerometer-based dysphagia detection system (DDS). A sample of 344 individuals was enrolled across seven sites in the United States. Dual-axis accelerometry signals were collected prospectively with simultaneous videofluoroscopy (VFSS) during swallows of liquid barium stimuli in thin, mildly, moderately and extremely thick consistencies. Signal processing classifiers were trained using linear discriminant analysis and 10,000 random training-test data splits. The primary objective was to develop an algorithm to detect impaired swallowing safety with thin liquids with an area under receiver operating characteristic curve (AUC) > 80% compared to the VFSS reference standard. Impaired swallowing safety was identified in 7.2% of the thin liquid boluses collected. At least one unsafe thin liquid bolus was found in 19.7% of participants, but participants did not exhibit impaired safety consistently. The DDS classifier algorithms identified participants with impaired thin liquid swallowing safety with a mean AUC of 81.5%, (sensitivity 90.4%, specificity 60.0%). Thicker consistencies were effective for reducing the frequency of penetration-aspiration. This DDS reached targeted performance goals in detecting impaired swallowing safety with thin liquids. Simultaneous measures by DDS and VFSS, as performed here, will be used for future validation studies.
  • CardShock Investigators; Hongisto, Mari; Kataja, Anu; Tarvasmäki, Tuukka; Holopainen, Anu; Javanainen, Tuija; Jurkko, Raija; Jäntti, Toni; Kimmoun, Antoine; Levy, Bruno; Mebazaa, Alexandre; Pulkki, Kari; Sionis, Alessandro; Tolppanen, Heli; Wollert, Kai C.; Harjola, Veli-Pekka; Lassus, Johan (2019)
    Background: The aim of this study was to assess the levels, kinetics, and prognostic value of growth differentiation factor 15 (GDF-15) in cardiogenic shock (CS). Methods and Results: Levels of GDF-15 were determined in serial plasma samples (0-120 h) from 177 CS patients in the CardShock study. Kinetics of GDF-15, its association with 90-day mortality, and incremental value for risk stratification were assessed. The median GDF-15(0h) level was 9647 ng/L (IQR 4500-19,270 ng/L) and levels above median were significantly associated with acidosis, hyperlactatemia, renal dysfunction, and higher 90-day mortality (56% vs 28%, P7000 ng/L was identified as a strong predictor of death (OR 5.0; 95% CI 1.9-3.8, P=.002). Adding GDF-15(12h) >7000 ng/L to the CardShock risk score improved discrimination and risk stratification for 90-day mortality. Conclusions: GDF-15 levels are highly elevated in CS and associated with markers of systemic hypoperfusion and end-organ dysfunction. GDF-15 helps to discriminate survivors from non-survivors very early in CS.
  • Aimo, Alberto; Vergaro, Giuseppe; Ripoli, Andrea; Bayes-Genis, Antoni; Figal, Domingo A. Pascual; de Boer, Rudolf A.; Lassus, Johan; Mebazaa, Alexandre; Gayat, Etienne; Breidthardt, Tobias; Sabti, Zaid; Mueller, Christian; Brunner-La Rocca, Hans-Peter; Tang, W. H. Wilson; Grodin, Justin L.; Zhang, Yuhui; Bettencourt, Paulo; Maisel, Alan S.; Passino, Claudio; Januzzi, James L.; Emdin, Michele (2017)
    OBJECTIVES The aim of this study was to perform a meta-analysis of currently available data regarding the prognostic significance of soluble suppression of tumorigenecity-2 (sST2) concentration in acute heart failure (AHF). BACKGROUND Concentration of sST2 may have prognostic value in AHF. A comprehensive assessment of all available studies regarding sST2 in AHF is lacking. METHODS Three databases (MEDLINE, Cochrane Library, and Scopus) were searched. Inclusion criteria were follow-up studies, papers published in English, enrollment of patients with AHF, and availability of median hazard ratios for all-cause death and other outcome measures, when available. RESULTS Ten studies were included, with a global population of 4,835 patients and a median follow-up duration of 13.5 months. The following global hazard ratios calculated for log(2)(sST2) were admission sST2 and all-cause death, 2.46 (95% confidence interval [CI]: 1.80 to 3.37; p <0.001); discharge sST2 and all-cause death, 2.06 (95% CI: 1.37 to 3.11; p <0.001); admission sST2 and cardiovascular death, 2.29 (95% CI: 1.41 to 3.73; p <0.001); discharge sST2 and cardiovascular death, 2.20 (95% CI: 1.48 to 3.25; p <0.001); admission sST2 and heart failure (HF) hospitalization, 1.21 (95% CI: 0.96 to 1.52; p = 0.060); discharge sST2 and HF hospitalization, 1.54 (95% CI: 1.03 to 2.32; p = 0.007); admission sST2 and all-cause death or HF hospitalization, 1.74 (95% CI: 1.24 to 2.45; p <0.001); and discharge sST2 and all-cause death or HF hospitalization, 1.63 (95% CI: 1.14 to 2.33; p <0.001). CONCLUSIONS Plasma sST2 has prognostic value with respect to all-cause and cardiovascular death as well as the composite outcome of all-cause death or HF hospitalization, with both admission and discharge values having prognostic efficacy. Discharge sST2, but not admission sST2, is predictive of HF rehospitalization during follow-up. (C) 2017 by the American College of Cardiology Foundation.
  • Dammacco, Rosanna; Biswas, Jyotirmay; Kivelä, Tero T.; Zito, Francesco Alfredo; Leone, Patrizia; Mavilio, Alberto; Sisto, Dario; Alessio, Giovanni; Dammacco, Franco (2020)
    Purpose To describe the ocular manifestations in a cohort of patients with systemic sarcoidosis (SS). Recent advances in the pathophysiology, diagnosis, and therapy of SS are also discussed. Methods Data from 115 Italian patients diagnosed between 2005 and 2016 were retrospectively reviewed. All but the first 17 patients underwent a comprehensive ophthalmologic examination. The diagnosis was based on clinical features, the demonstration of non-caseating granulomas in biopsies from involved organs, and multiple imaging techniques. Data on broncho-alveolar lavage fluid analysis, calcemia, calciuria, serum angiotensin-converting enzyme levels and soluble interleukin-2 receptor levels were retrieved when available. Results Ocular involvement, detected in 33 patients (28.7%), was bilateral in 29 (87.9%) and the presenting feature in 13 (39.4%). Anterior uveitis was diagnosed in 12 patients (36.4%), Lofgren syndrome and uveoparotid fever in one patient each (3%), intermediate uveitis in 3 patients (9.1%), posterior uveitis in 7 (21.2%), and panuveitis in 9 (27.3%). First-line therapy consisted of corticosteroids, administered as eyedrops (10 patients), sub-Tenon's injections (1 patient), intravitreal implants (9 patients), or systemically (23 patients). Second-line therapy consisted of steroid-sparing immunosuppressants, including methotrexate (10 patients) and azathioprine (10 patients). Based on pathogenetic indications that tumor necrosis factor (TNF)-alpha is a central mediator of granuloma formation, adalimumab, targeting TNF-alpha, was employed in 6 patients as a third-line agent for severe/refractory chronic sarcoidosis. Conclusion Uveitis of protean type, onset, duration, and course remains the most frequent ocular manifestation of SS. Diagnostic and therapeutic advancements have remarkably improved the overall visual prognosis. An ophthalmologist should be a constant component in the multidisciplinary approach to the treatment of this often challenging but intriguing disease.
  • Pöyhönen, Pauli; Kylmälä, Minna; Vesterinen, Paula; Kivistö, Sari; Holmström, Miia; Lauerma, Kirsi; Väänänen, Heikki; Toivonen, Lauri; Hänninen, Helena (2018)
    Background: Large myocardial infarction (MI) is associated with adverse left ventricular (LV) remodeling (LVR). We studied the nature of LVR, with specific attention to non-transmural MIs, and the association of peak CK-MB with recovery and chronic phase scar size and LVR. Methods: Altogether 41 patients underwent prospectively repeated cardiovascular magnetic resonance at a median of 22 (interquartile range 9-29) days and 10 (8-16) months after the first revascularized MI. Transmural MI was defined as >= 75% enhancement in at least one myocardial segment. Results: Peak CK-MB was 86 (40-216) mu g/L in median, while recovery and chronic phase scar size were 13 (3-23) % and 8 (2-19) %. Altogether 33 patients (81%) had a non-transmural MI. Peak CK-MB had a strong correlation with recovery and chronic scar size (r >= 0.80 for all, r >= 0.74 for non-transmural MIs; p <0.001). Peak CK-MB, recovery scar size, and chronic scar size, were all strongly correlated with chronic wall motion abnormality index (WMAi) (r >= 0.75 for all, r >= 0.73 for non-transmural MIs; p <0.001). There was proportional scar size and LV mass resorption of 26% (0-50%) and 6% (-2-14%) in median. Young age (<60 years, median) was associated with greater LV mass resorption (median 9% vs. 1%, p = 0.007). Conclusions: Peak CK-MB has a strong association with chronic scar size and wall motion abnormalities after revascularized non-transmural MI. Considerable infarct resorption happens after the first-month recovery phase. LV mass resorption is related to age, being more common in younger patients.
  • Af Björkesten, C. -G.; Jussila, A.; Kemppainen, H.; Hallinen, T.; Soini, E.; Mankinen, P.; Valgardsson, S.; Veckman, V.; Nissinen, R.; Naessens, D.; Molander, P. (2019)
    Background and Aims: A retrospective non-interventional, multi-centre patient chart review study was conducted to investigate the association of faecal calprotectin (FC) 1 year (+/- 2 months) after biological therapy initiation with composite event-free survival (CEFS) consisting of surgical procedures, corticosteroid initiation, treatment failure or dose increase in patients with Crohn's disease (CD). In addition, the correlations of FC and other tests of disease activity were assessed. Materials and methods: Data on Finnish CD patients initiating a biological therapy between 2010 and 2016, were collected. The association of FC and CEFS was analysed with Kaplan-Meier and Cox proportional hazard modelling. The correlations were tested with Pearson's test. Results: Biological therapy was initiated in 186 patients, of which 87 (46.8%) had FC results available at 1 year and 80 had follow-up exceeding 14 months. The characteristics of patients with and without FC results were similar. Patients with elevated FC (>250 mu g/g) had a significantly increased risk of experiencing composite event (HR 3.4, 95% CI: 1.3-8.9; p = .013) when compared to patients with normal FC (FC
  • Ukai, Masayasu; Parmentier, Thomas; Cortez, Miguel A.; Fischer, Andrea; Gaitero, Luis; Lohi, Hannes; Nykamp, Stephanie; Jokinen, Tarja S.; Powers, Danielle; Sammut, Veronique; Sanders, Sean; Tai, Tricia; Wielaender, Franziska; James, Fiona (2021)
    Background Many studies of epilepsy in veterinary medicine use subjective data (eg, caregiver-derived histories) to determine seizure frequency. Conversely, in people, objective data from electroencephalography (EEG) are mainly used to diagnose epilepsy, measure seizure frequency and evaluate efficacy of antiseizure drugs. These EEG data minimize the possibility of the underreporting of seizures, a known phenomenon in human epileptology. Objective To evaluate the correlation between reported seizure frequency and EEG frequency of ictal paroxysmal discharges (PDs) and to determine whether seizure underreporting phenomenon exists in veterinary epileptology. Animals Thirty-three ambulatory video-EEG recordings in dogs showing >= 1 ictal PD, excluding dogs with status epilepticus. Methods Retrospective observational study. Ictal PDs were counted manually over the entire recording to obtain the frequency of EEG seizures. Caregiver-reported seizure frequency from the medical record was categorized into weekly, daily, hourly, and per minute seizure groupings. The Spearman rank test was used for correlation analysis. Results The coefficient value (r(s)) comparing reported seizure to EEG-confirmed ictal PD frequencies was 0.39 (95% confidence interval [CI] = 0.048-0.64, P = .03). Other r(s) values comparing history against various seizure types were: 0.36 for motor seizures and 0.37 for nonmotor (absence) seizures. Conclusions and Clinical Importance A weak correlation was found between the frequency of reported seizures from caregivers (subjective data) and ictal PDs on EEG (objective data). Subjective data may not be reliable enough to determine true seizure frequency given the discrepancy with EEG-confirmed seizure frequency. Confirmation of the seizure underreporting phenomenon in dogs by prospective study should be carried out.
  • El Dib, Regina; Tikkinen, Kari A. O.; Akl, Elie A.; Gomaa, Huda A.; Mustafa, Reem A.; Agarwal, Arnav; Carpenter, Christopher R.; Zhang, Yuchen; Jorge, Eliane C.; Almeida, Ricardo A. M. B.; do Nascimento Junior, Paulo; Doles, Joao Vitor P.; Mustafa, Ahmad A.; Sadeghirad, Behnam; Lopes, Luciane C.; Bergamaschi, Cristiane C.; Suzumura, Erica A.; Cardoso, Marilia M. A.; Corrente, Jose Eduardo; Stone, Samuel B.; Schunemann, Holger J.; Guyatt, Gordon H. (2017)
    Objectives: To provide a perspective on the current practice of randomized clinical trials (RCTs) of diagnostic strategies focusing on patient-important outcomes. Study Design and Setting: We conducted a comprehensive search of MEDLINE and included RCTs published in full-text reports that evaluated alternative diagnostic strategies. Results: Of 56,912 unique citations, we sampled 7,500 and included 103 eligible RCTs, therefore suggesting that MEDLINE includes approximately 781 diagnostic RCTs. The 103 eligible trials reported on: mortality (n = 41; 39.8%); morbidities (n = 63; 61.2%); symptoms/quality of life/functional status (n = 14; 13.6%); and on composite end points (n = 10; 9.7%). Of the studies that reported statistically significant results (n = 12; 11.6%), we judged 7 (58.3%) as at low risk of bias with respect to missing outcome data and 4 (33.3%) as at low risk of bias regarding blinding. Of the 41 RCTs that reported on mortality, only one (2.4%) reported statistically significant results. Of 63 RCTs addressing morbidity outcomes, 11 (17.5%) reported statistically significant results, all of which reported relative effects of greater than 20%. Conclusion: RCTs of diagnostic tests are not uncommon, and sometimes suggest benefits on patient-important outcomes but often suffer from limitations in sample size and conduct. (C) 2017 Elsevier Inc. All rights reserved.
  • García-Velázquez, Regina; Jokela, M.; Rosenstrom, T. H. (2019)
    Background: Depressive symptoms differ from each other in the degree of functional impairment they cause. The incidence of depression varies across the adult lifespan. We examined whether age moderates the impairment caused by depressive symptoms. Methods: The study sample (n = 21,056) was adults drawn from six multistage probability samples from the National Health and Nutrition Examination Survey series (NHANES, years 2005-2016) conducted in the United States using cross-sectional, representative cohorts. Depressive symptoms were assessed with the nine-item Patient Health Questionnaire (PHQ-9). We used regression models to predict high functional impairment, while controlling for sociodemographic variables and physical disorders. Results: Age moderated the association between depressive symptoms and functional impairment: middle-aged adults perceived moderate and severe symptoms as more impairing than did others. Older adults reported slightly higher impairment due to mild symptoms. The individual symptoms of low mood, feelings of worthlessness and guilt, and concentration difficulties were more strongly related to high impairment in mid-adulthood as compared to early and late adulthood. Limitations: Cross-sectional data allows only between-person comparisons. The PHQ-9 is brief and joins compound symptoms into single items. There was no information available concerning comorbid mental disorders. Co-occurring physical disorders were self-reported. Conclusions: Symptoms of depression may imply varying levels of impairment at different ages. The results suggest a need for age adjustments when estimating the functional impact of depression in the general population. Additionally, they show a need for more accurate assessments of depression-related impairment at older ages. Evidence-based programs may generally benefit from symptom- and age-specific findings.