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Sample records for routine clinical practice

  1. [Management of aflibercept in routine clinical practice].

    PubMed

    Cabrera López, F

    2015-03-01

    Aflibercept is a new anti-vegf drug that, unlike ranibizumab and bevacizumab blocks both vegf-A and placental growth factor. Moreover, it binds with much greater strength and affinity to human VEGF-A165 than other endogenous vegf receptors, conferring it with a more extended effect and allowing a lower frequency of intravitreal injections. This facilitates the adoption of fixed treatment regimens other than monthly or individual regimens such as "treat and extend". Aflibercept is indicated for the treatment of neovascular (exudative) age-related macular degeneration (ARMD), visual alteration due to macular edema secondary to central retinal vein occlusion (CRVO) and visual alteration due to diabetic macular edema (DME). The present article reviews the management of aflibercept in routine clinical practice, based on the specifications of its new core data sheet, which includes all the therapeutic indications in which its use has been approved and evaluating the distinct alternatives and treatment regimens after the initial loading doses.

  2. Utility of Induced Sputum in Routine Clinical Practice.

    PubMed

    Barril, Silvia; Sebastián, Laura; Cotta, Gianluca; Crespo, Astrid; Mateus, Eder; Torrejón, Montserrat; Ramos-Barbón, David; Plaza, Vicente

    2016-05-01

    To determine the general and specific utility in diagnosis and/or treatment of induced sputum (IS) inflammatory cell counts in routine clinical practice. Retrospective study of 171 patients referred for clinical sputum induction over a 1-year period in the pulmonology department of a referral hospital. Independent observers established whether the information provided by IS inflammatory cell count was useful for making diagnostic and therapeutic decisions. The most frequent reasons for determination of IS inflammatory cell count were: asthma 103 (59.20%); uncontrolled asthma 34 (19.54%); chronic cough 19 (10.9%), and gastroesophageal reflux 15 (8.6%). In 115 patients (67.3%) it was generally useful for diagnosis and/or treatment; in 98 patients (57.3%) it provided diagnostic information and in 85 patients (49.7%) it assisted in therapeutic decision-making. In asthma, uncontrolled asthma, chronic cough and gastroesophageal reflux, the results were useful in 71.8%, 67.6%, 47.4% and 60%, respectively. The information provided by IS inflammatory cell count is extremely useful in clinical practice, especially in asthma and chronic cough. These results may justify the inclusion of the IS technique in pulmonology departments and asthma units of referral centers. Copyright © 2015 SEPAR. Published by Elsevier Espana. All rights reserved.

  3. Rufinamide in children and adults in routine clinical practice.

    PubMed

    Jaraba, S; Santamarina, E; Miró, J; Toledo, M; Molins, A; Burcet, J; Becerra, J L; Raspall, M; Pico, G; Miravet, E; Cano, A; Fossas, P; Fernández, S; Falip, M

    2017-01-01

    To explore the long-term effectiveness of rufinamide in managing Lennox-Gastaut Syndrome (LGS), other epileptic encephalopathies, and intractable focal epilepsies in adults and children in routine clinical practice. A multicentre, retrospective chart review of patients prescribed adjunctive rufinamide at seven Spanish epilepsy centres, with assessments at six and 12 months. We evaluated data from 58 patients (40 male, age range 7-57 years), 25 of whom were diagnosed with LGS, 12 with other epileptic encephalopathies and 21 of whom were diagnosed with focal epilepsies, mainly frontal lobe. The mean daily rufinamide dose was 32.0 mg/kg (range 12.5-66.7 mg/kg) in children and 24.7 mg/kg (range 5.0-47.0 mg/kg) in adults, and the most commonly used concomitant antiepileptic drugs were levetiracetam and valproate. Rufinamide was discontinued in 25 patients (43.1%) during the 1-year follow-up, and the most common reason was lack of effectiveness (n = 12, 20.7% of total). The frequency of generalized tonic-clonic seizures was significantly reduced from baseline at 6 and 12 months (P = 0.001), both in patients with generalized epilepsies and in patients with focal epilepsies. Significant seizure frequency reduction from baseline was observed at 12 months (P = 0.01) for tonic/atonic seizures and at 6 months (P = 0.001) for focal seizures. Side effects were reported in 21 patients (36.2%): nausea, vomiting and weight loss were most frequent. Rufinamide was well tolerated and was effective in reducing frequency of generalized tonic-clonic, tonic/atonic and focal seizures in both children and adults with severe refractory epilepsies, primarily LGS. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. An audit of ANCA in routine clinical practice.

    PubMed Central

    Edgar, J. D.; McMillan, S. A.; Bruce, I. N.; Conlan, S. K.

    1995-01-01

    We have reviewed the medical records of 301/327 consecutive patients in whom anti-neutrophil cytoplasmic antibodies (ANCA) were detected by the Regional Immunology Laboratory in Northern Ireland between January 1988 and October 1991 (45 months). We have collected data for each patient regarding age, sex, smoking habit, area of residence, and details of any other autoantibody activity. Clinical diagnosis was established, with the number of organ systems involved and the evidence for that involvement (symptomatic, biochemical, radiological, and histological). Diagnoses were divided into four groups according to their recognised vasculitic features and these were related to the pattern of immunofluorescence and maximum ANCA titre detected. The most frequent diagnosis was rheumatoid arthritis (18.2% of patients) and the connective tissue disorders as a whole accounted for 27.9% of patients. ANCA were also detected in a wide range of clinical conditions which are not associated with vasculitis and these patients were an important source of 'false-positives'. The positive predictive value (PPV) of ANCA of all patterns and titres for vasculitic conditions was 27%, however, the detection of a classical ANCA pattern at high titre (> or = 1:640) was associated with an increased PPV of 75%. The coexistence of an antinuclear antibody (ANA) reduces the PPV of both classical and perinuclear ANCA, although perinuclear ANCA with antimyeloperoxidase specificity had an improved PPV. We conclude that ANCA testing should not be used as the only screening investigation for vasculitis but should be included in a rational investigative scheme. The interpretation of a positive ANCA result must take into account the presence of other autoantibodies and the full range of non-vasculitic conditions when the clinical situation is not typical of vasculitis. PMID:8545289

  5. [Therapeutic monitoring of vancomycin in routine clinical practice].

    PubMed

    Kacířová, Ivana; Grundmann, Milan

    2014-10-01

    Therapeutic drug monitoring (TDM) is specific method of clinical pharmacology for monitoring of the therapy using measurement of drug serum concentrations followed interpretation and good cooperation with clinician. TDM help clinicians to quickly optimize vancomycin dosing regimens to maximize the clinical effect and minimize the toxicity of the drugs. Minimum serum vancomycin trough concentrations should always be maintained above 10 mg/L to avoid development of resistance, neverthelles trough concentrations > 20 mg/L are not recommended because of the risk of nephrotoxicity. For serious infections vancomycin trough concentrations of 15-20 mg/L are recommended and for a pathogen with an MIC of 1 mg/L, the minimum trough concentration would have to be at least 15 mg/L to generate the target AUC24/MIC 400 (area under the curve/minimal inhibitory concentration). In non-complicated infections trough concentrations of 10-15 mg/L should be sufficient. For continuous infusions of vancomycin target steady-state concentration values of 15-25 mg/L have been advocated for critically ill patients.Key words: therapeutic monitoring - trough concentration - vancomycin.

  6. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice

    PubMed Central

    Mosca, M.; Tani, C.; Aringer, M.; Bombardieri, S.; Boumpas, D.; Cervera, R.; Doria, A.; Jayne, D.; Khamashta, M. A.; Kuhn, A.; Gordon, C.; Petri, M.; Schneider, M.; Shoenfeld, Y.; Smolen, J. S.; Talarico, R.; Tincani, A.; Ward, M. M.; Werth, V. P.; Carmona, L.

    2014-01-01

    The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed. PMID:21224016

  7. Replacing manual sphygmomanometers with automated blood pressure measurement in routine clinical practice.

    PubMed

    Myers, Martin G

    2014-01-01

    1. Conventional manual measurement of blood pressure (BP) in clinical practice is no longer considered to be the best method for evaluating a patient's BP status. Home BP and 24 h ambulatory BP monitoring are now recommended for the diagnosis and management of hypertension.  2. Recent studies provide an alternative to conventional office BP, namely automated office (AO) BP, which involves multiple BP readings taken with a fully automated device with the patient resting quietly alone. Automated office BP is preferable to routine manual office BP in that it exhibits improved accuracy and a stronger relationship to both ambulatory BP and target organ damage. 3. Having the patient alone eliminates conversation between the patient and the observer, a cause of 'white coat hypertension'. The use of an automated device improves accuracy, reduces digit preference, minimizes observer bias and facilitates the recording of multiple BP readings.  4. Comparative BP data obtained in clinical studies in both research settings and routine community practice support the use of a cut-off point of 135/85 mmHg for defining hypertension using AOBP, which is the same cut-off point currently recommended for awake ambulatory BP and home BP. 5. Reduction of the white coat response using AOBP should reduce the need to monitor patients with ambulatory BP and home BP after initiation of antihypertensive therapy. There is now sufficient evidence to consider replacing manual office BP with AOBP in routine clinical practice.

  8. Implementing specific oral tolerance induction to milk into routine clinical practice: experience from first 50 patients

    PubMed Central

    Luyt, David; Bravin, Kristian; Luyt, Jessica

    2014-01-01

    Background Although the natural history of cow’s milk allergy is to resolve during childhood or adolescence, a small but significant proportion of children will remain allergic. Specific oral tolerance induction to cow’s milk (CM-SOTI) provides a treatment option in these children with continuing allergy with high success rates. However current sentiment limits widespread availability as existing reports advise that it is too soon to translate CM-SOTI into routine clinical practice. Methods In January 2007 we implemented a slow up-dosing CM-SOTI program. Eligible subjects were identified at routine visits to our children’s allergy clinic. Persisting cow’s milk allergy was confirmed from recent contact symptoms or a positive baked milk challenge. As allergic symptoms are common during CM-SOTI, families were provided with ready dietetic access for advice on dosing and symptom treatment. Subjects were continuously monitored at subsequent clinic visits or telephonically, where no longer followed, for a median of 49 months. Results The first 50 subjects (35 males) treated ranged in age from 5.1 to 15.8 years (median 10.3 years). Full tolerance (250 mL) was achieved in 23 subjects, 9 without any symptoms, and a further 9 achieved partial tolerance with continued ingestion. Eighteen children failed to achieve any regular milk ingestion; 11 because of persistent or significant symptoms whilst 8 withdrew against medical advice. Allergic symptoms were predominantly mild to moderate in severity, although 2 cases needed treatment with inhaled salbutamol and a further 2 required intramuscular adrenaline. Clinical tolerance, both full and partial, persists beyond 5 years. Conclusion We have demonstrated that a CM-SOTI program can be successfully and safely implemented as routine clinical practice with acceptable compliance during prolonged home up-dosing, despite frequent allergic symptoms, and for up to 4 years after starting treatment. CM-SOTI can thus be put into

  9. Feasibility of integrating research data collection into routine clinical practice using the electronic health record.

    PubMed

    Chalmers, David J; Deakyne, Sara J; Payan, Marisa L; Torok, Michelle R; Kahn, Michael G; Vemulakonda, Vijaya M

    2014-10-01

    The electronic health record is becoming central to routine medical practice and has the potential to facilitate large scale clinical research. We evaluated the completeness and accuracy of data collection using designated research fields integrated into a semistructured clinical note. We hypothesized that prospective research data collection as part of routine clinical charting is feasible, with a high rate of utilization (greater than 80%) and accuracy (kappa greater than 0.80). Infants with congenital hydronephrosis were followed prospectively at a single institution. Existing functionality in the electronic health record was used for data collection by creation of 28 different data elements captured from a hydronephrosis note or phrase template. Completeness (percent utilization) was calculated and accuracy was assessed by comparing the structured data to manual chart review. Comparisons were conducted using the chi-square test, with 2-tailed p values <0.05 considered statistically significant. A total of 80 patients were eligible for manual chart review. Data were recorded through template use in 64 patients for an overall completeness of 80.0%. Of 28 elements 17 (60%) demonstrated "almost perfect" agreement (kappa greater than 0.80), and all variables reached at least "moderate" agreement (greater than 0.40). Integrating research fields into routine clinical practice is feasible by using semistructured clinical templates within an electronic health record. High completion and accuracy rates were captured from a variety of fields within a hydronephrosis template. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  10. Incorporation of Pharmacogenomics into Routine Clinical Practice: the Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline Development Process

    PubMed Central

    Caudle, Kelly E.; Klein, Teri E.; Hoffman, James M.; Müller, Daniel J.; Whirl-Carrillo, Michelle; Gong, Li; McDonagh, Ellen M.; Sangkuhl, Katrin; Thorn, Caroline F.; Schwab, Matthias; Agúndez, José A.G.; Freimuth, Robert R.; Huser, Vojtech; Lee, Ming Ta Michael; Iwuchukwu, Otito F.; Crews, Kristine R.; Scott, Stuart A.; Wadelius, Mia; Swen, Jesse J.; Tyndale, Rachel F.; Stein, C. Michael; Roden, Dan; Relling, Mary V.; Williams, Marc S.; Johnson, Samuel G.

    2014-01-01

    The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes genotype-based drug guidelines to help clinicians understand how available genetic test results could be used to optimize drug therapy. CPIC has focused initially on well-known examples of pharmacogenomic associations that have been implemented in selected clinical settings, publishing nine to date. Each CPIC guideline adheres to a standardized format and includes a standard system for grading levels of evidence linking genotypes to phenotypes and assigning a level of strength to each prescribing recommendation. CPIC guidelines contain the necessary information to help clinicians translate patient-specific diplotypes for each gene into clinical phenotypes or drug dosing groups. This paper reviews the development process of the CPIC guidelines and compares this process to the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines. PMID:24479687

  11. Incorporation of pharmacogenomics into routine clinical practice: the Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline development process.

    PubMed

    Caudle, Kelly E; Klein, Teri E; Hoffman, James M; Muller, Daniel J; Whirl-Carrillo, Michelle; Gong, Li; McDonagh, Ellen M; Sangkuhl, Katrin; Thorn, Caroline F; Schwab, Matthias; Agundez, Jose A G; Freimuth, Robert R; Huser, Vojtech; Lee, Ming Ta Michael; Iwuchukwu, Otito F; Crews, Kristine R; Scott, Stuart A; Wadelius, Mia; Swen, Jesse J; Tyndale, Rachel F; Stein, C Michael; Roden, Dan; Relling, Mary V; Williams, Marc S; Johnson, Samuel G

    2014-02-01

    The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes genotype-based drug guidelines to help clinicians understand how available genetic test results could be used to optimize drug therapy. CPIC has focused initially on well-known examples of pharmacogenomic associations that have been implemented in selected clinical settings, publishing nine to date. Each CPIC guideline adheres to a standardized format and includes a standard system for grading levels of evidence linking genotypes to phenotypes and assigning a level of strength to each prescribing recommendation. CPIC guidelines contain the necessary information to help clinicians translate patient-specific diplotypes for each gene into clinical phenotypes or drug dosing groups. This paper reviews the development process of the CPIC guidelines and compares this process to the Institute of Medicine's Standards for Developing Trustworthy Clinical Practice Guidelines.

  12. Screening Breast MRI Outcomes in Routine Clinical Practice: Comparison to BI-RADS Benchmarks.

    PubMed

    Strigel, Roberta M; Rollenhagen, Jennifer; Burnside, Elizabeth S; Elezaby, Mai; Fowler, Amy M; Kelcz, Frederick; Salkowski, Lonie; DeMartini, Wendy B

    2017-04-01

    The BI-RADS Atlas 5th Edition includes screening breast magnetic resonance imaging (MRI) outcome benchmarks. However, the metrics are from expert practices and clinical trials of women with hereditary breast cancer predispositions, and it is unknown if they are appropriate for routine practice. We evaluated screening breast MRI audit outcomes in routine practice across a spectrum of elevated risk patients. This Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant retrospective study included all consecutive screening breast MRI examinations from July 1, 2010 to June 30, 2013. Examination indications were categorized as gene mutation carrier (GMC), personal history (PH) breast cancer, family history (FH) breast cancer, chest radiation, and atypia/lobular carcinoma in situ (LCIS). Outcomes were determined by pathology and/or ≥12 months clinical and/or imaging follow-up. We calculated abnormal interpretation rate (AIR), cancer detection rate (CDR), positive predictive value of recommendation for tissue diagnosis (PPV2) and biopsy performed (PPV3), and median size and percentage of node-negative invasive cancers. Eight hundred and sixty examinations were performed in 566 patients with a mean age of 47 years. Indications were 367 of 860 (42.7%) FH, 365 of 860 (42.4%) PH, 106 of 860 (12.3%) GMC, 14 of 860 (1.6%) chest radiation, and 8 of 22 (0.9%) atypia/LCIS. The AIR was 134 of 860 (15.6%). Nineteen cancers were identified (13 invasive, 4 DCIS, two lymph nodes), resulting in CDR of 19 of 860 (22.1 per 1000), PPV2 of 19 of 88 (21.6%), and PPV3 of 19 of 80 (23.8%). Of 13 invasive breast cancers, median size was 10 mm, and 8 of 13 were node negative (61.5%). Performance outcomes of screening breast MRI in routine clinical practice across a spectrum of elevated risk patients met the American College of Radiology Breast Imaging Reporting and Data System benchmarks, supporting broad application of these metrics. The indication

  13. Atrial Fibrillation Management Strategies in Routine Clinical Practice: Insights from the International RealiseAF Survey

    PubMed Central

    Chiang, Chern-En; Naditch-Brûlé, Lisa; Brette, Sandrine; Silva-Cardoso, José; Gamra, Habib; Murin, Jan; Zharinov, Oleg J.; Steg, Philippe Gabriel

    2016-01-01

    Background Atrial fibrillation (AF) can be managed with rhythm- or rate-control strategies. There are few data from routine clinical practice on the frequency with which each strategy is used and their correlates in terms of patients’ clinical characteristics, AF control, and symptom burden. Methods RealiseAF was an international, cross-sectional, observational survey of 11,198 patients with AF. The aim of this analysis was to describe patient profiles and symptoms according to the AF management strategy used. A multivariate logistic regression identified factors associated with AF management strategy at the end of the visit. Results Among 10,497 eligible patients, 53.7% used a rate-control strategy, compared with 34.5% who used a rhythm-control strategy. In 11.8% of patients, no clear strategy was stated. The proportion of patients with AF-related symptoms (EHRA Class > = II) was 78.1% (n = 4396/5630) for those using a rate-control strategy vs. 67.8% for those using a rhythm-control strategy (p<0.001). Multivariate logistic regression analysis revealed that age <75 years or the paroxysmal or persistent form of AF favored the choice of a rhythm-control strategy. A change in strategy was infrequent, even in patients with European Heart Rhythm Association (EHRA) Class > = II. Conclusions In the RealiseAF routine clinical practice survey, rate control was more commonly used than rhythm control, and a change in strategy was uncommon, even in symptomatic patients. In almost 12% of patients, no clear strategy was stated. Physician awareness regarding optimal management strategies for AF may be improved. PMID:26800084

  14. Adherence to fesoterodine in women with overactive bladder in routine clinical practice.

    PubMed

    Simó, M; Porta, O; Pubill, J; Castillo, M T; Mora, I; Huguet, E; Ortega, J A; Martínez, E

    2015-05-01

    To assess the short-term compliance with fesoterodine treatment and to identify the reasons for lack of adherence and discontinuation in routine clinical practice. The secondary aim was to estimate the patient-reported outcomes. This was an observational retrospective, multicenter study conducted in a sample of women with overactive bladder on fesoterodine treatment for at least three months. Adherence to medication was assessed using the Morisky-Green test. Patient-reported outcomes were assessed using the Incontinence Questionnaire Short Form (ICIQ-SF), Overactive Bladder Questionnaire Short Form (OAB-qSF), and Treatment Benefit Scale (TBS). One hundred and twenty women with a mean age [standard deviation (SD)] of 62.2 (12.0) years with severe OAB [mean (SD) ICIQ-SF score 13.2 (4.0)] were included. 42.1% of the patients were considered compliant with fesoterodine treatment. The main causes for non-compliance/discontinuation stated by the remaining 57.9% of the patients were adverse events (62.2%) and lack of clinical benefits (20.0%). The illness status as well as the patient-perceived bother occasioned by the OAB symptoms and their impact on the quality of life improved significantly after three months on fesoterodine treatment (p<0.0001). Most of the patients stated that the current state of their urinary problems had greatly improved/ improved. In routine clinical practice, a high percentage of patients were adherent to fesoterodine and perceived the benefit that the treatment provided them three months after starting treatment. However, more than half of the study population failed to comply or discontinued the treatment mainly due to intolerance or lack of efficacy. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  15. Impact of triplicate testing on HIV genotypic tropism prediction in routine clinical practice.

    PubMed

    Symons, J; Vandekerckhove, L; Paredes, R; Verhofstede, C; Bellido, R; Demecheleer, E; van Ham, P M; van Lelyveld, S F L; Stam, A J; van Versendaal, D; Nijhuis, M; Wensing, A M J

    2012-06-01

    Guidelines state that the CCR5-inhibitor Maraviroc should be prescribed to patients infected with R5-tropic HIV-1 only. Therefore, viral tropism needs to be assessed phenotypically or genotypically. Preliminary clinical trial data suggest that genotypic analysis in triplicate is associated with improved prediction of virological response by increasing the detection of X4-tropic variants. Our objective was to evaluate the impact of triplicate genotypic analysis on prediction of co-receptor usage in routine clinical practice. Samples from therapy-naive and therapy-experienced patients were collected for routine tropism testing at three European clinical centres. Viral RNA was isolated from plasma and proviral DNA from peripheral blood mononuclear cells. Gp120-V3 was amplified in a triplicate nested RT-PCR procedure and sequenced. Co-receptor usage was predicted using the Geno2Pheno([coreceptor]) algorithm and analysed with a false-positive rate (FPR) of 5.75%, 10%, or an FPR of 20% and according to the current European guidelines on the clinical management of HIV-1 tropism testing. A total of 266 sequences were obtained from 101 patient samples. Discordance in tropism prediction for the triplicates was observed in ten samples using an FPR of 10%. Triplicate testing resulted in a 16.7% increase in X4-predicted samples and to reclassification from R5 to X4 tropism for four cases rendering these patients ineligible for Maraviroc treatment. In conclusion, triplicate genotypic tropism testing increases X4 tropism detection in individual cases, which may prove to be pivotal when CCR5-inhibitor therapy is applied.

  16. Is Drotrecogin alfa (activated) for adults with severe sepsis, cost-effective in routine clinical practice?

    PubMed Central

    2011-01-01

    Introduction Previous cost-effectiveness analyses (CEA) reported that Drotrecogin alfa (DrotAA) is cost-effective based on a Phase III clinical trial (PROWESS). There is little evidence on whether DrotAA is cost-effective in routine clinical practice. We assessed whether DrotAA is cost-effective in routine practice for adult patients with severe sepsis and multiple organ systems failing. Methods This CEA used data from a prospective cohort study that compared DrotAA versus no DrotAA (control) for severe sepsis patients with multiple organ systems failing admitted to critical care units in England, Wales, and Northern Ireland. The cohort study used case-mix and mortality data from a national audit, linked with a separate audit of DrotAA infusions. Re-admissions to critical care and corresponding mortality were recorded for four years. Patients receiving DrotAA (n = 1,076) were matched to controls (n = 1,650) with a propensity score (Pscore), and Genetic Matching (GenMatch). The CEA projected long-term survival to report lifetime incremental costs per quality-adjusted life year (QALY) overall, and for subgroups with two or three to five organ systems failing at baseline. Results The incremental costs per QALY for DrotAA were £30,000 overall, and £16,000 for the subgroups with three to five organ systems failing. For patients with two organ systems failing, DrotAA resulted in an average loss of one QALY at an incremental cost of £15,000. When the subgroup with two organ systems was restricted to patients receiving DrotAA within 24 hours, DrotAA led to a gain of 1.2 QALYs at a cost per QALY of £11,000. The results were robust to other assumptions including the approach taken to projecting long-term outcomes. Conclusions DrotAA is cost-effective in routine practice for severe sepsis patients with three to five organ systems failing. For patients with two organ systems failing, this study could not provide unequivocal evidence on the cost-effectiveness of Drot

  17. Clinical implementation of synthesized mammography with digital breast tomosynthesis in a routine clinical practice.

    PubMed

    Freer, Phoebe E; Riegert, Joanna; Eisenmenger, Laura; Ose, Dominik; Winkler, Nicole; Stein, Matthew A; Stoddard, Gregory J; Hess, Rachel

    2017-08-05

    Most published studies evaluating digital breast tomosynthesis (DBT) included a separate 2-dimensional full-field digital mammogram (FFDM) for DBT screening protocols, increasing radiation from screening mammography. Synthesized mammography (SM) creates a 2-dimensional image from the DBT source data, and if used in place of FFDM, it reduces radiation of DBT screening. This study evaluated the implementation of SM + DBT in routine screening practice in terms of recall rates, cancer detection rates (CDR), % of minimal cancers, % of node-positive cancers, and positive predictive values (PPV). A multivariate retrospective institutional analysis was performed on 31,979 women who obtained screening mammography (10/2013-12/2015) with cohorts divided by modality (SM + DBT, FFDM + DBT, and FFDM). We adjusted for comparison mammograms, age, breast density, and the interpreting radiologist. Recall type was analyzed for differences (focal asymmetry, asymmetry, masses, calcifications, architectural distortion). SM + DBT significantly decreased the recall rate compared to FFDM (5.52 vs. 7.83%, p < 0.001) with no differences in overall CDR (p = 0.66), invasive and/or in situ CDR, or percentages of minimal and node-negative cancers. PPV1 significantly increased with SM + DBT relative to FFDM (9.1 vs. 6.2%, p = 0.02). SM + DBT did not differ significantly in recall rate or overall CDR compared to FFDM + DBT. There were statistically significant differences in certain findings recalled by screening modality (e.g., focal asymmetries). SM + DBT reduces false positives compared to FFDM, while maintaining the CDR and other desirable audit outcome data. SM + DBT is more accurate than FFDM alone, and is a desirable alternative to FFDM + DBT, given the added benefit of radiation reduction.

  18. SPIRIT: Systematic Planning of Intelligent Reuse of Integrated Clinical Routine Data. A Conceptual Best-practice Framework and Procedure Model.

    PubMed

    Hackl, W O; Ammenwerth, E

    2016-01-01

    Secondary use of clinical routine data is receiving an increasing amount of attention in biomedicine and healthcare. However, building and analysing integrated clinical routine data repositories are nontrivial, challenging tasks. As in most evolving fields, recognized standards, well-proven methodological frameworks, or accurately described best-practice approaches for the systematic planning of solutions for secondary use of routine medical record data are missing. We propose a conceptual best-practice framework and procedure model for the systematic planning of intelligent reuse of integrated clinical routine data (SPIRIT). SPIRIT was developed based on a broad literature overview and further refined in two case studies with different kinds of clinical routine data, including process-oriented nursing data from a large hospital group and high-volume multimodal clinical data from a neurologic intensive care unit. SPIRIT aims at tailoring secondary use solutions to specific needs of single departments without losing sight of the institution as a whole. It provides a general conceptual best-practice framework consisting of three parts: First, a secondary use strategy for the whole organization is determined. Second, comprehensive analyses are conducted from two different viewpoints to define the requirements regarding a clinical routine data reuse solution at the system level from the data perspective (BOTTOM UP) and at the strategic level from the future users perspective (TOP DOWN). An obligatory clinical context analysis (IN BETWEEN) facilitates refinement, combination, and integration of the different requirements. The third part of SPIRIT is dedicated to implementation, which comprises design and realization of clinical data integration and management as well as data analysis solutions. The SPIRIT framework is intended to be used to systematically plan the intelligent reuse of clinical routine data for multiple purposes, which often was not intended when the

  19. Short Communication: Maraviroc Once-Daily: Experience in Routine Clinical Practice.

    PubMed

    Saumoy, Maria; Llibre, Josep M; Terrón, Alberto; Knobel, Hernando; Arribas, José Ramón; Domingo, Pere; Arroyo-Manzano, David; Rivero, Antonio; Moreno, Santiago; Podzamczer, Daniel

    2017-01-01

    To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. Laboratory and clinical data were recorded every 3 months the first year and every 6 months thereafter. Data are presented as median and interquartile range. Among 667 patients treated with MVC, 142 (21.3%) received MVC once-daily: 108 (76.1%), 150 mg and 34 (23.9%), and 300 mg. Age was 47 (42-45) years, there were 76.1% men, and 81 (57%) patients had baseline HIV-RNA <50 copies/mL. Viral tropism was R5 in 118 (83.1%) patients. Reasons for prescribing MVC: salvage therapy (36.6%), drug toxicity (31.2%), simplification (16.9%), and immunodiscordant response (7.1%). Median follow-up was 13 (9-16) months. In 95.8%, a PI/r was part of the regimen (67% on dual therapy). At months 12 and 24, 73.3% and 68.2% of patients had HIV-RNA <50 copies/mL, respectively (p = .041 and p < .001 vs. baseline). CD4(+) cell count increased by a median of 52 (-36,135) and 84 (-9.5,180) cells/mm(3) at 12 and 24 months, respectively (p < .001 and p = .039 vs. baseline). Twenty-five (17.6%) patients discontinued MVC: virologic failure (6), medical decision (5), and other reasons (14). Two patients presented grade 3 adverse events (hypertransaminasemia, hypertriglyceridemia) without the need for MVC withdrawal, whereas MVC was discontinued in two patients due to gastrointestinal toxicity. In routine clinical practice, MVC once-daily combined with at least PI/r was virologically effective and well tolerated in a high percentage of pretreated patients.

  20. Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices.

    PubMed

    Zhang, B-C; Hou, L; Lv, B; Xu, Y-W

    2014-02-01

    To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. A total of 20 185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. The overall rate of ADRs was 1.52%, of which 0.58% was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p < 0.001), in those receiving pre-heated iodixanol vs non-heating (p < 0.001), in those aged 70 years or younger (p < 0.001), in those in whom a power injector was used for contrast delivery (p < 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥ 80 kg, age less than 65 years, contrast flow rate ≥ 4 ml s⁻¹ and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0-3. The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. The major strength of this study is that it included 20 185 patients enrolled in various types of imaging examinations. The safety profile of iodixanol was comparable to previously published work.

  1. The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study.

    PubMed

    Michie, C O; Sakala, M; Rivans, I; Strachan, M W J; Clive, S

    2010-08-24

    Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the 'very high risk' category for potentially serious acute pancreatitis. A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l(-1) were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a 'common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy.

  2. The frequency and severity of capecitabine-induced hypertriglyceridaemia in routine clinical practice: a prospective study

    PubMed Central

    Michie, C O; Sakala, M; Rivans, I; Strachan, M W J; Clive, S

    2010-01-01

    Background: Capecitabine is known to rarely cause raised serum triglycerides (TG). In our centre, several patients receiving capecitabine developed raised TG levels corresponding to the ‘very high risk' category for potentially serious acute pancreatitis. Methods: A fasting blood lipid screening protocol was introduced into clinical practice for patients receiving capecitabine. Patients with TGs >5 mmol l−1 were treated and followed up. An 18-month prospective audit was performed to establish the incidence and severity of capecitabine-induced hypertriglyceridaemia (CIHT). Results: A total of 304 patients received capecitabine for colorectal cancer between January 2008 and June 2009. Of these, 212 patients (70%) were screened and 8 (3.7%) developed clinically significant hypertriglyceridaemia requiring lipid-lowering therapy. Two of the eight patients had diabetes and one had pre-existing dyslipidaemia. One suffered cerebral infarction during chemotherapy. There were no cases of acute pancreatitis. Follow-up showed that serum TGs safely and rapidly returned to normal with appropriate treatment without discontinuation of capecitabine. Conclusions: This is the first prospective study evaluating CIHT. These results suggest that it should be classed as a ‘common' undesired effect of capecitabine. Despite this, the incidence does not justify routine screening in all patients. Targeted screening in those with diabetes or pre-existing hyperlipidaemia is recommended, together with adoption of a clear management policy. PMID:20664584

  3. Non-adherence in seniors with dementia - a serious problem of routine clinical practice.

    PubMed

    Lužný, Jan; Ivanová, Kateřina; Juríčková, Lubica

    2014-01-01

    Non-adherence to treatment in seniors with dementia is a frequent and potentially dangerous phenomenon in routine clinical practice which might lead to the inappropriate treatment of a patient, including the risk of intoxication. There might be different causes of non-adherence in patients with dementia: memory impairment, sensory disturbances, limitations in mobility, economical reasons limiting access to health care and medication. Non-adherence leads to serious clinical consequences as well as being a challenge for public health. to estimate prevalence of non-adherence in seniors with dementia and to study correlation between cognitive decline and non-adherence. Prospective study, analyzing medical records of seniors with dementia admitted to the inpatient psychogeriatric ward in the Kromeriz mental hospital from January 2010 to January 2011. Cognitive decline measured by MMSE, prevalence of Non-adherence to treatment and reasons for patient Non-adherence were studied. Non-adherence to any treatment was detected in 31.3% of seniors; memory impairment was the most common cause of non-adherence to treatment. In conclusion, non-adherence to treatment in the studied group of seniors with dementia correlates with the severity of cognitive impairment - a higher cognitive decline correlates with a higher risk of non-adherence to treatment.

  4. Usefulness of component resolved analysis of cat allergy in routine clinical practice.

    PubMed

    Eder, Katharina; Becker, Sven; San Nicoló, Marion; Berghaus, Alexander; Gröger, Moritz

    2016-01-01

    Cat allergy is of great importance, and its prevalence is increasing worldwide. Cat allergens and house dust mite allergens represent the major indoor allergens; however, they are ubiquitous. Cat sensitization and allergy are known risk factors for rhinitis, bronchial hyperreactivity and asthma. Thus, the diagnosis of sensitization to cats is important for any allergist. 70 patients with positive skin prick tests for cats were retrospectively compared regarding their skin prick test results, as well as their specific immunoglobulin E antibody profiles with regard to their responses to the native cat extract, rFel d 1, nFel d 2 and rFel d 4. 35 patients were allergic to cats, as determined by positive anamnesis and/or nasal provocation with cat allergens, and 35 patients exhibited clinically non-relevant sensitization, as indicated by negative anamnesis and/or a negative nasal allergen challenge. Native cat extract serology testing detected 100% of patients who were allergic to cats but missed eight patients who showed sensitization in the skin prick test and did not have allergic symptoms. The median values of the skin prick test, as well as those of the specific immunoglobulin E antibodies against the native cat extract, were significantly higher for allergic patients than for patients with clinically non-relevant sensitization. Component based diagnostic testing to rFel d 1 was not as reliable. Sensitization to nFel d 2 and rFel d 4 was seen only in individual patients. Extract based diagnostic methods for identifying cat allergy and sensitization, such as the skin prick test and native cat extract serology, remain crucial in routine clinical practice. In our study, component based diagnostic testing could not replace these methods with regard to the detection of sensitization to cats and differentiation between allergy and sensitization without clinical relevance. However, component resolved allergy diagnostic tools have individual implications, and future

  5. Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice.

    PubMed

    Antolín-Novoa, S; Blanco-Campanario, E; Antón, A; Gallegos-Sancho, M I; Pérez-Carrión, R; Peláez, I; Galán-Brotons, A; de la Cruz-Merino, L; Murías-Rosales, A

    2015-11-01

    Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients' medical charts. A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0-64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy-mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors.

  6. Assessing psoriasis severity and outcomes for clinical trials and routine clinical practice.

    PubMed

    Chalmers, Robert J G

    2015-01-01

    Psoriasis is a complex disease. Dermatologists have not documented psoriasis severity, except in clinical trials; doing so requires tools for assessing psoriasis and an understanding of what changes in those assessments mean in terms of outcome. Two psoriasis assessment tools have dominated: The Psoriasis Area and Severity Index and the Dermatology Life Quality Index. There are advantages and disadvantages to each. Newer instruments may not be more suitable for documenting psoriasis. There may be benefits in terms of patient ownership of disease management from using self-assessment tools for documenting severity, for example, the Self-assessment version of the Simplified Psoriasis Index.

  7. Children in day surgery: clinical practice and routines. The results from a nation-wide survey.

    PubMed

    Segerdahl, M; Warrén-Stomberg, M; Rawal, N; Brattwall, M; Jakobsson, J

    2008-07-01

    Day surgery is common in paediatric surgical practice. Safe routines including parental and child information in order to optimise care and reduce anxiety are important. Most day surgery units are not specialised in paediatric care, which is why specific paediatric expertise is often lacking. We studied the practice of paediatric day surgery in Sweden by a questionnaire survey sent to all hospitals, obtaining an 88% response rate. Three specific paediatric cases were enquired for in more detail. The proportion of paediatric day surgery vs. in-hospital procedures was 46%. Seventy-one out of 88 responding units performed paediatric day surgery. All units had anxiolytic pre-medication as a routine in 1-6-year-olds, and in 7-16-year-olds at 60% of the units. Most units performed circumcision and adenoidectomy, while 33% performed tonsillectomy. Anaesthesia induction was intravenous in older children, and also in 1-6-year-olds at 50% of the units. Parental presence at induction was mandatory. Post-operatively, 93% of units routinely assessed pain. Paracetamol and NSAIDs were the most common analgesics, as monotherapy or combined with rescue medication in the recovery as IV morphine. At 42% of units, take-home bags of analgesics were provided, covering 1-3 days of treatment. Pain was the most frequent complaint on follow-up. Micturition difficulties were common after circumcision, nausea after adenoidectomy and nutrition difficulties after tonsillectomy. In Sweden, most day surgery units perform paediatric surgery, most children receive pre-medication, anaesthesia is induced IV and take-home analgesics paracetamol and or NSAIDs are often provided. Still, pain is a common complaint after discharge.

  8. Arterial Spin-Labeling in Routine Clinical Practice, Part 1: Technique and Artifacts

    PubMed Central

    Deibler, A.R.; Pollock, J.M.; Kraft, R.A.; Tan, H.; Burdette, J.H.; Maldjian, J.A.

    2015-01-01

    SUMMARY The routine use of arterial spin-labeling (ASL) in a clinical population has led to the depiction of diverse brain pathologic features. Unique challenges in the acquisition, postprocessing, and analysis of cerebral blood flow (CBF) maps are encountered in such a population, and high-quality ASL CBF maps can be generated consistently with attention to quality control and with the use of a dedicated postprocessing pipeline. Familiarity with commonly encountered artifacts can help avoid pitfalls in the interpretation of CBF maps. The purpose of this review was to describe our experience with a heterogeneous collection of ASL perfusion cases with an emphasis on methodology and common artifacts encountered with the technique. In a period of 1 year, more than 3000 pulsed ASL cases were performed as a component of routine clinical brain MR evaluation at both 1.5 and 3T. These ASL studies were analyzed with respect to overall image quality and patterns of perfusion on final gray-scale DICOM images and color Joint Photographic Experts Group (JPEG) CBF maps, and common artifacts and their impact on final image quality were categorized. PMID:18372417

  9. Arterial spin-labeling in routine clinical practice, part 3: hyperperfusion patterns.

    PubMed

    Deibler, A R; Pollock, J M; Kraft, R A; Tan, H; Burdette, J H; Maldjian, J A

    2008-09-01

    Arterial spin-labeled (ASL) perfusion imaging can be implemented successfully into a routine clinical neuroimaging protocol and can accurately demonstrate alterations in brain perfusion. We have observed patterns of focal, regional, and global hyperperfusion in a wide variety of disease processes. The causes of hyperperfusion at clinical ASL have not been previously characterized. Focal lesions such as brain tumors and vascular malformations with increased perfusion can be well depicted by ASL. More global causes of hyperperfusion, including postanoxia vasodilation and hypercapnia, may go undetected on conventional MR images, whereas the regional hyperperfusion, which may occur in reversible encephalopathies and luxury perfusion, has been consistently illustrated on ASL cerebral blood flow maps at our institution.

  10. Monthly CERA treatment maintains stable hemoglobin levels in routine clinical practice of peritoneal dialysis patients.

    PubMed

    González, M Teresa; Ramos, Rosa; Vera, Manel; Barbosa, Francesc; Garcia, Carmen; Garcia, Isabel; González-Segura, Carlota; Cuxart, Marc; Teixidó, Josep; José de la Cruz, Juan

    2013-01-01

    Data on routine use of continuous erythropoietin receptor activator (CERA) in peritoneal dialysis patients are scarce. This study aimed to assess the efficacy of CERA administered once monthly in maintaining stable Hb levels in patients on peritoneal dialysis under routine medical practice. This was a 12-month, observational, prospective and multicenter study. A total of 83 patients with anemia secondary to chronic kidney disease (CKD) on peritoneal dialysis for more than 3 months, on once-monthly subcutaneous CERA treatment, were followed up over a period of 1 year. Efficacy evaluation included Hb levels, mean time in which the Hb level was maintained within target range, CERA doses and number of dose changes. Median Hb level (interquartile range [IQR]) remained stable during the evaluation period [11.8 ± 1.4 g/dL at baseline, 11.8 ± 1.4 g/dL at month 6 and 11.8 ± 1.5 g/dL at month 12 (p > 0.05)]. The median (IQR) time of Hb level maintained within target range (11-13 mg/dL) was 6 (4-10) months. Ferritin, transferrin saturation index, and Fe were also stable and well maintained during the 12 months (p > 0.05). CERA mean dose (SD) was [115.4 (56.2) μg baseline; 117.2 (58.5) μg 6 months; 126.0 (65.9) μg 12 months (p = 0.127)]. The mean number of CERA dose changes per patient during the study was 1.6 (SD 1.3). Serious adverse events were not related to CERA treatment. The results suggest that once-monthly CERA successfully corrects anemia and maintains stable Hb levels within the recommended target range on peritoneal dialysis under routine medical practice.

  11. [Postnatal visit: Routine and particularity after complicated pregnancy--Guidelines for clinical practice].

    PubMed

    Doret, M

    2015-12-01

    To propose guidelines for clinical practice for routine postnatal visit and after pathological pregnancies. Bibliographic searches were performed with PubMed and Cochrane databases, and within international guidelines references. Postpartum visit should be planned 6 to 8 weeks after delivery and can be performed by an obstetrician, a gynecologist, a general practitioner or a midwife, when after normal pregnancy and delivery (Professional consensus). If any complication occurred, this visit should be handled by an obstetrician (Professional consensus). Physical examination should focus on patient symptoms and pregnancy complications (Professional consensus). Gynecological examination is not systematic (Professional consensus). Pap smear should be performed if previous exam was done more than 2years ago or when the previous exam was abnormal (Professional consensus). Weight should be measured to encourage weight loss (Professional consensus), with the aim to catch up preconceptional weight within 6 months after delivery (gradeC). Professional intervention may reduce weight retention (professional consensus). Tobacco, alcohol and illicit drugs cessation should be promoted (grade B) and supported by a professional (grade A). Obstetrical risks consecutive to short interval between pregnancies should be explained (evidence level [EL]: 3) and contraception discussed regarding family project (Professional consensus). Mother mood, mother to child relationship and breastfeeding troubles should be systematically evaluated (professional consensus). Pelvic-floor rehabilitation should be performed only when urinary of fecal incontinence persist 3 months after delivery (Professional consensus). Serological screening for toxoplamosis (grade B) and blood hemoglobin concentration should not be systematically performed (gradeC). After spontaneous preterm birth, women should be screened for uterine anomalies and treatment should be discussed (Professional consensus). Evidence is

  12. Tapentadol Prolonged Release for Chronic Pain: A Review of Clinical Trials and 5 Years of Routine Clinical Practice Data.

    PubMed

    Baron, Ralf; Eberhart, Leopold; Kern, Kai-Uwe; Regner, Stefan; Rolke, Roman; Simanski, Christian; Tölle, Thomas

    2016-09-09

    Tapentadol prolonged release (PR) for the treatment of moderate to severe chronic pain combines 2 modes of action. These are μ-opioid receptor agonism and noradrenaline reuptake inhibition in a single molecule that allow higher analgesic potency through modulation of different pharmacological targets within the pain transmitting systems. At the same time, this can also serve as a clue for modulation of different pain-generating mechanisms according to nociceptive, neuropathic, or mixed pain conditions. Tapentadol PR has now been on the market for 5 years, with over 4.6 million people treated worldwide. A panel of pain specialists convened in Germany to review the clinical program and to discuss the role of tapentadol PR in the management of chronic pain. The clinical study program demonstrated effective and generally well-tolerated treatment for up to 2 years in a broad range of chronic pain conditions, including those with neuropathic pain components. This was confirmed in routine clinical practice observations. Head-to-head studies with World Health Organization (WHO) III opioids such as oxycodone controlled release and oxycodone/naloxone PR showed at least comparable pain relief in the treatment of moderate-to-severe musculoskeletal pain. Rotation from poorly tolerated WHO III opioids to tapentadol PR provided effective pain relief and better symptom control for musculoskeletal pain compared to previous medication. Functionality, health status and quality of life also improved under tapentadol PR treatment. The gastrointestinal tolerability profile was more favorable compared to other tested WHO III opioids. Tapentadol PR has a good safety profile and no evidence of acquired tolerance from the long-term data so far collected. Overall, tapentadol PR represents an effective and generally well-tolerated alternative to "classical" opioidergic drugs.

  13. Are clinical trials dealing with severe infection fitting routine practices? Insights from a large registry

    PubMed Central

    2013-01-01

    Introduction Guidelines dealing with severe sepsis and septic shock mostly rely on randomized controlled trials (RCTs) to ensure the best standards of care for patients. However, patients included in high-quality studies may differ from the routine population and alter external validity of recommendations. We aimed to determine to what extent non-inclusion criteria of RCTs dealing with severe sepsis and septic shock may affect application of their conclusions in routine care. Methods In a first step, the MEDLINE database was searched for RCTs treating severe sepsis and septic shock patients between 1992 and 2008, and non-inclusion criteria for these studies were abstracted. Two reviewers independently evaluated the articles, which were checked by a third reviewer. We extracted data on the study design, main intervention, primary endpoint, criteria for inclusion, and criteria for non-inclusion. In a second step, the distribution of the non-inclusion criteria was observed in a prospective multicenter cohort of severe sepsis and septic shock patients (Cub-Rea network, 1992 to 2008). Results We identified 96 articles out of 7,012 citations that met the screening criteria. Congestive heart failure (35%) and cancer (30%) were frequent exclusion criteria in selected studies, as well as other frequent disorders such as gastrointestinal and liver diseases and all causes of immune suppression. Of the 67,717 patients with severe sepsis and septic shock in the Cub-Rea database, 40,325 (60%) experienced at least one of the main exclusion criteria, including 11% of congestive heart failure patients and 11% of cancer patients. In addition, we observed a significant trend for increasing number of patients with these criteria along time. Conclusion Current exclusion criteria for RCTs dealing with severe sepsis and septic shock excluded most patients encountered in daily practice and limit external validity of the results of high-quality studies. PMID:23705948

  14. Incorporating an Early Detection System Into Routine Clinical Practice in Two Community Hospitals.

    PubMed

    Dummett, B Alex; Adams, Carmen; Scruth, Elizabeth; Liu, Vincent; Guo, Margaret; Escobar, Gabriel J

    2016-11-01

    Efforts to improve outcomes of patients who deteriorate outside the intensive care unit have included the use of rapid response teams (RRTs) as well as manual and automated prognostic scores. Although automated early warning systems (EWSs) are starting to enter clinical practice, there are few reports describing implementation and the processes required to integrate early warning approaches into hospitalists' workflows. We describe the implementation process at 2 community hospitals that deployed an EWS. We employed the Institute for Healthcare Improvement's iterative Plan-Do-Study-Act approach. Our basic workflow, which relies on having an RRT nurse and the EWS's 12-hour outcome time frame, has been accepted by clinicians and has not been associated with patient complaints. Whereas our main objective was to develop a set of workflows for integrating the electronic medical record EWS into clinical practice, we also uncovered issues that must be addressed prior to disseminating this intervention to other hospitals. One problematic area is that of documentation following an alert. Other areas that must be addressed prior to disseminating the intervention include the need for educating clinicians on the rationale for deploying the EWS, careful consideration of interdepartment service agreements, clear definition of clinician responsibilities, pragmatic documentation standards, and how to communicate with patients. In addition to the deployment of the EWS to other hospitals, a future direction for our teams will be to characterize process-outcomes relationships in the clinical response itself. Journal of Hospital Medicine 2016;11:S25-S31. © 2016 Society of Hospital Medicine.

  15. How do family physicians measure blood pressure in routine clinical practice?

    PubMed Central

    Kaczorowski, Janusz; Myers, Martin G.; Gelfer, Mark; Dawes, Martin; Mang, Eric J.; Berg, Angelique; Grande, Claudio Del; Kljujic, Dragan

    2017-01-01

    Abstract Objective To describe the techniques currently used by family physicians in Canada to measure blood pressure (BP) for screening for, diagnosing, and treating hypertension. Design A Web-based cross-sectional survey distributed by e-mail. Setting Stratified random sample of family physicians in Canada. Participants Family physician members of the College of Family Physicians of Canada with valid e-mail addresses. Main outcome measures Physicians’ self-reported routine methods for recording BP in their practices to screen for, diagnose, and manage hypertension. Results A total of 774 valid responses were received, for a response rate of 16.2%. Respondents were similar to nonrespondents except for underrepresentation of male physicians. Of 769 respondents, 417 (54.2%) indicated that they used manual office BP measurement with a mercury or aneroid device and stethoscope as the routine method to screen patients for high BP, while 42.9% (330 of 769) reported using automated office BP (AOBP) measurement. The method most frequently used to make a diagnosis of hypertension was AOBP measurement (31.1%, 240 of 771), followed by home BP measurement (22.4%, 173 of 771) and manual office BP measurement (21.4%, 165 of 771). Ambulatory BP monitoring (ABPM) was used for diagnosis by 14.4% (111 of 771) of respondents. The most frequently reported method for ongoing management was home BP monitoring (68.7%, 528 of 769), followed by manual office BP measurement (63.6%, 489 of 769) and AOBP measurement (59.2%, 455 of 769). More than three-quarters (77.8%, 598 of 769) of respondents indicated that ABPM was readily available for their patients. Conclusion Canadian family physicians exhibit overall high use of electronic devices for BP measurement, However, more efforts are needed to encourage practitioners to follow current Canadian guidelines, which advocate the use of AOBP measurement for hypertension screening, ABPM and home BP measurement for making a diagnosis, and both

  16. [Trial provision in clinical routine. Definition of terms and investigation of normal practice].

    PubMed

    Gonser, P; Matern, U

    2014-01-01

    It has become common for hospitals to borrow medical devices from manufacturers to test and try them during the daily routine before purchasing which today is known as trial provision. This study aims at offering a precise definition of trial provisions and a description of the way of proceeding. A total of 60 medical practitioners in 5 German hospitals were surveyed (surgeons n = 40, 66.7 %, radiologists n = 12, 20 % and anesthesiologists n = 8, 13.3 %). Manufacturers and distributors of medical devices (n = 10) and hospital administration executives (n = 8) were also interviewed. Trial provisions are a promotional marketing tool for manufacturers of medical devices. By lending the device over a specific period for testing before purchasing, hospitals can gain experience in the usage and handling of devices on which a purchase decision can be made. The survey revealed that there are basically three procedural methods which can, however, differ even within one hospital. Trial provisions influence purchasing decisions in clinics. If implemented incorrectly trial provisions may compromise physical integrity, safety and health of patients and can thus lead to judicial and legal consequences for hospitals and medical staff.

  17. Shared decision making: examining key elements and barriers to adoption into routine clinical practice.

    PubMed

    Légaré, France; Witteman, Holly O

    2013-02-01

    For many patients, the time spent meeting with their physician-the clinical encounter-is the most opportune moment for them to become engaged in their own health through the process of shared decision making. In the United States shared decision making is being promoted for its potential to improve the health of populations and individual patients, while also helping control care costs. In this overview we describe the three essential elements of shared decision making: recognizing and acknowledging that a decision is required; knowing and understanding the best available evidence; and incorporating the patient's values and preferences into the decision. To achieve the promise of shared decision making, more physicians need training in the approach, and more practices need to be reorganized around the principles of patient engagement. Additional research is also needed to identify the interventions that are most effective.

  18. Lymph node evaluation for colon cancer in routine clinical practice: a population-based study

    PubMed Central

    Del Paggio, J.C.; Nanji, S.; Wei, X.; MacDonald, P.H.; Booth, C.M.

    2017-01-01

    Background Guidelines recommend that 12 or more lymph nodes (lns) be evaluated during surgical resection of colon cancer. Here, we report ln yield and its association with survival in routine practice. Methods Electronic records of treatment were linked to the population-based Ontario Cancer Registry to identify all patients with colon cancer treated during 2002–2008. The study population (n = 5508) included a 25% random sample of patients with stage ii or iii disease. Modified Poisson regression was used to identify factors associated with ln yield; Cox models were used to explore the association between ln yield and overall (os) and cancer-specific survival (css). Results During 2002–2008, median ln yield increased to 17 from 11 nodes (p < 0.001), and the proportion of patients with 12 or more nodes evaluated increased to 86% from 45% (p < 0.001). Lymph node positivity did not change over time (to 53% from 54%, p = 0.357). Greater ln yield was associated with younger age (p < 0.001), less comorbidity (p = 0.004), higher socioeconomic status (p = 0.001), right-sided tumours (p < 0.001), and higher hospital volume (p < 0.001). In adjusted analyses, a ln yield of less than 12 nodes was associated with inferior os and css for stages ii and iii disease [stage ii os hazard ratio (hr): 1.36; 95% confidence interval (ci): 1.19 to 1.56; stage ii css hr: 1.52; 95% ci: 1.26 to 1.83; and stage iii os hr: 1.45; 95% ci: 1.30 to 1.61; stage iii css hr: 1.54; 95% ci: 1.36 to 1.75]. Conclusions Despite a temporal increase in ln yield, the proportion of cases with ln positivity has not changed. Lymph node yield is associated with survival in patients with stages ii and iii colon cancer. The association between ln yield and survival is unlikely to be a result of stage migration. PMID:28270730

  19. Are self-report scales as effective as clinician rating scales in measuring treatment response in routine clinical practice?

    PubMed

    Zimmerman, Mark; Walsh, Emily; Friedman, Michael; Boerescu, Daniela A; Attiullah, Naureen

    2018-01-01

    Recent treatment guidelines have suggested that outcome should be measured in routine clinical practice. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we compared three self-report scales of depressive symptoms and the two most widely used clinician administered scales in treatment studies in their sensitivity to change and evaluation of treatment response in depressed patients treated in routine practice. At baseline and 4-month follow-up 153 depressed outpatients with DSM-IV MDD completed the Clinically Useful Depression Outcome Scale (CUDOS), Quick Inventory of Depressive Symptomatology-Self-report version (QIDS-SR), and Patient Health Questionnaire (PHQ-9). The patients were rated on the 17-item Hamilton Depression Rating Scale (HAMD) and the Montgomery-Asberg Depression Rating Scale (MADRS). On each scale treatment response was defined as a 50% or greater reduction in scores from baseline. While there were some differences in the percentage of patients considered to be responders on the different scales, a large effect size was found for each scale, with little variability amongst the scales. The level of agreement between the three self-report scales and the clinician rating scales was approximately the same LIMITATIONS: The present study was conducted in a single clinical practice in which the majority of the patients were white, female, and had health insurance. When measuring outcome in clinical practice the magnitude of change in depressive symptoms is as great on self-report scales as on clinician rating scales. Copyright © 2017 Elsevier B.V. All rights reserved.

  20. Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry Identification of Mycobacteria in Routine Clinical Practice

    PubMed Central

    El Khéchine, Amel; Couderc, Carine; Flaudrops, Christophe; Raoult, Didier; Drancourt, Michel

    2011-01-01

    Background Non-tuberculous mycobacteria recovered from respiratory tract specimens are emerging confounder organisms for the laboratory diagnosis of tuberculosis worldwide. There is an urgent need for new techniques to rapidly identify mycobacteria isolated in clinical practice. Matrix-assisted laser desorption time-of-flight mass spectrometry (MALDI-TOF MS) has previously been proven to effectively identify mycobacteria grown in high-concentration inocula from collections. However, a thorough evaluation of its use in routine laboratory practice has not been performed. Methodology We set up an original protocol for the MALDI-TOF MS identification of heat-inactivated mycobacteria after dissociation in Tween-20, mechanical breaking of the cell wall and protein extraction with formic acid and acetonitrile. By applying this protocol to as few as 105 colony-forming units of reference isolates of Mycobacterium tuberculosis, Mycobacterium avium, and 20 other Mycobacterium species, we obtained species-specific mass spectra for the creation of a local database. Using this database, our protocol enabled the identification by MALDI-TOF MS of 87 M. tuberculosis, 25 M. avium and 12 non-tuberculosis clinical isolates with identification scores ≥2 within 2.5 hours. Conclusions Our data indicate that MALDI-TOF MS can be used as a first-line method for the routine identification of heat-inactivated mycobacteria. MALDI-TOF MS is an attractive method for implementation in clinical microbiology laboratories in both developed and developing countries. PMID:21935444

  1. Diagnostic accuracy and turnaround time of the Xpert MTB/RIF assay in routine clinical practice.

    PubMed

    Kwak, Nakwon; Choi, Sun Mi; Lee, Jinwoo; Park, Young Sik; Lee, Chang-Hoon; Lee, Sang-Min; Yoo, Chul-Gyu; Kim, Young Whan; Han, Sung Koo; Yim, Jae-Joon

    2013-01-01

    The Xpert MTB/RIF assay was introduced for timely and accurate detection of tuberculosis (TB). The aim of this study was to determine the diagnostic accuracy and turnaround time (TAT) of Xpert MTB/RIF assay in clinical practice in South Korea. We retrospectively reviewed the medical records of patients in whom Xpert MTB/RIF assay using sputum were requested. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for the diagnosis of pulmonary tuberculosis (PTB) and detection of rifampicin resistance were calculated. In addition, TAT of Xpert MTB/RIF assay was compared with those of other tests. Total 681 patients in whom Xpert MTB/RIF assay was requested were included in the analysis. The sensitivity, specificity, PPV and NPV of Xpert MTB/RIF assay for diagnosis of PTB were 79.5% (124/156), 100.0% (505/505), 100.0% (124/124) and 94.0% (505/537), respectively. Those for the detection of rifampicin resistance were 57.1% (8/14), 100.0% (113/113), 100.0% (8/8) and 94.9% (113/119), respectively. The median TAT of Xpert MTB/RIF assay to the report of results and results confirmed by physicians in outpatient settings were 0 (0-1) and 6 (3-7) days, respectively. Median time to treatment after initial evaluation was 7 (4-9) days in patients with Xpert MTB/RIF assay, but was 21 (7-33.5) days in patients without Xpert MTB/RIF assay. Xpert MTB/RIF assay showed acceptable sensitivity and excellent specificity for the diagnosis of PTB and detection of rifampicin resistance in areas with intermediate TB burden. Additionally, the assay decreased time to the initiation of anti-TB drugs through shorter TAT.

  2. Barium swallow study in routine clinical practice: a prospective study in patients with chronic cough*,**

    PubMed Central

    Nin, Carlos Shuler; Marchiori, Edson; Irion, Klaus Loureiro; Paludo, Artur de Oliveira; Alves, Giordano Rafael Tronco; Hochhegger, Daniela Reis; Hochhegger, Bruno

    2013-01-01

    OBJECTIVE: To assess the routine use of barium swallow study in patients with chronic cough. METHODS: Between October of 2011 and March of 2012, 95 consecutive patients submitted to chest X-ray due to chronic cough (duration > 8 weeks) were included in the study. For study purposes, additional images were obtained immediately after the oral administration of 5 mL of a 5% barium sulfate suspension. Two radiologists systematically evaluated all of the images in order to identify any pathological changes. Fisher's exact test and the chi-square test for categorical data were used in the comparisons. RESULTS: The images taken immediately after barium swallow revealed significant pathological conditions that were potentially related to chronic cough in 12 (12.6%) of the 95 patients. These conditions, which included diaphragmatic hiatal hernia, esophageal neoplasm, achalasia, esophageal diverticulum, and abnormal esophageal dilatation, were not detected on the images taken without contrast. After appropriate treatment, the symptoms disappeared in 11 (91.6%) of the patients, whereas the treatment was ineffective in 1 (8.4%). We observed no complications related to barium swallow, such as contrast aspiration. CONCLUSIONS: Barium swallow improved the detection of significant radiographic findings related to chronic cough in 11.5% of patients. These initial findings suggest that the routine use of barium swallow can significantly increase the sensitivity of chest X-rays in the detection of chronic cough-related etiologies. PMID:24473762

  3. Noninvasive prenatal testing in routine clinical practice for a high-risk population

    PubMed Central

    Qi, Guijie; Yi, Jianping; Han, Baosheng; Liu, Heng; Guo, Wanru; Shi, Chong; Yin, Lirong

    2016-01-01

    Abstract This study aimed to summarize the effects of noninvasive prenatal testing (NIPT) on aneuploidy among high-risk participants in Tangshan Maternal and Children Health Hospital. NIPT or invasive prenatal diagnosis was recommended to patients with a high risk of fetal aneuploidy from February 2013 to February 2014. Patients who exhibited eligibility and applied for NIPT from January 2012 to January 2013 were included in a comparison group. The rates of patients who underwent invasive testing, declined to undergo further testing, and manifested trisomies 21, 18, and 13 were compared between two groups. Follow-up data were obtained from the participants who underwent NIPT from 2013 to 2014. A total of 7223 patients (3018 and 4205 individuals before and after NIPT) were eligible for analysis. After NIPT was introduced in 2013 to 2014, 727 patients (17.3%) underwent invasive testing, 2828 preferred NIPT (67.3%), and 650 declined to undergo further testing (15.5%). A total of 34 cases of trisomies 21, 18, and 13 (0.8%) were found. In 2012 to 2013, 565 patients (18.7%) underwent invasive testing and 2453 declined to undergo further testing (81.3%). A total of 7 cases of trisomies 21, 18, and 13 were documented (0.2%). Of these cases, 24 were found from NIPT and 10 cases were found from invasive testing. The number of participants who declined to undergo further testing significantly decreased after NIPT was introduced (81.3% vs. 15.5%, P < 0.001). The sensitivity and specificity of NIPT for trisomies 21, 18, and 13 were 100% and 99.9%, respectively. The detection rates of NIPT for trisomies 21, 18, and 13 also significantly increased (0.2% vs. 0.8%, P < 0.001). By contrast, the overall rates of invasive testing remained unchanged (18.7% vs. 17.3%, P = 0.12). The positive predictive values of NIPT for trisomies 21, 18, and 13 were 100%, 83.3%, and 50.0%, respectively. The false positive rates of NIPT were 0% and 0.04%. With NIPT implementation in clinical

  4. Refitting of the UKPDS 68 risk equations to contemporary routine clinical practice data in the UK.

    PubMed

    McEwan, P; Bennett, H; Ward, T; Bergenheim, K

    2015-02-01

    Economic evaluations of new diabetes therapies rely heavily upon the UK Prospective Diabetes Study (UKPDS) equations for prediction of cardiovascular events; however, concerns persist regarding their relevance to current clinical practice and appropriate use in populations other than newly diagnosed patients. This study refits the UKPDS 68 event equations, using contemporary data describing low- and intermediate-risk patients. Anonymized patient data describing demographics, risk factors and incidence of cardiovascular and microvascular events were extracted from The Health Improvement Network (THIN) database over the 10-year period from 1 January 2000 to 31 December 2009. Following multiple imputation of missing values, accelerated failure-time Weibull regression equations were refitted to produce new coefficients for each risk group. Discriminatory performance was assessed and compared with both UKPDS 68 and UKPDS 82 risk equations, and the implication of coefficient choice within an economic evaluation was assessed using the Cardiff type 2 diabetes model. When applied to patient-level data, the three sets of coefficients (UKPDS, THIN low-risk and intermediate-risk) lead to fairly consistent predictions of the 5-year risk of events. Exceptions include lower predicted rates of myocardial infarction and higher rates of ischaemic heart disease, congestive heart failure and end-stage renal disease with both sets of revised THIN coefficients compared with UKPDS. Over a modelled lifetime, the coefficients derived from the low-risk data predict fewer total cardiovascular events compared with UKPDS, while those from the intermediate-risk data predict a greater number. The areas under the receiver-operating characteristic curves demonstrated a marginal improvement in the discriminatory performance of the refitted equations. The incremental cost-effectiveness ratio associated with dapagliflozin versus sulphonylurea in addition to metformin changed from £7,708 to £7

  5. Focused molecular analysis of small cell lung cancer: feasibility in routine clinical practice.

    PubMed

    Abdelraouf, Fatma; Sharp, Adam; Maurya, Manisha; Mair, Debbie; Wotherspoon, Andrew; Leary, Alex; Gonzalez de Castro, David; Bhosle, Jaishree; Nassef, Ayatallah; Gaafar, Taghrid; Popat, Sanjay; Yap, Timothy A; O'Brien, Mary

    2015-11-18

    There is an urgent need to identify molecular signatures in small cell lung cancer (SCLC) that may select patients who are likely to respond to molecularly targeted therapies. In this study, we investigate the feasibility of undertaking focused molecular analyses on routine diagnostic biopsies in patients with SCLC. A series of histopathologically confirmed formalin-fixed, paraffin-embedded SCLC specimens were analysed for epidermal growth factor receptors (EGFR), KRAS, NRAS and BRAF mutations, ALK gene rearrangements and MET amplification. EGFR and KRAS mutation testing was evaluated using real time polymerase chain reaction (RT-PCR cobas(®)), BRAF and NRAS mutations using multiplex PCR and capillary electrophoresis-single strand conformation analysis, and ALK and MET aberrations with fluorescent in situ hybridization. All genetic aberrations detected were validated independently. A total of 105 patients diagnosed with SCLC between July 1990 and September 2006 were included. 60 (57 %) patients had suitable tumour tissue for molecular testing. 25 patients were successfully evaluated for all six pre-defined molecular aberrations. Eleven patients failed all molecular analysis. No mutations in EGFR, KRAS and NRAS were detected, and no ALK gene rearrangements or MET gene amplifications were identified. A V600E substitution in BRAF was detected in a Caucasian male smoker diagnosed with SCLC with squamoid and glandular features. The paucity of patients with sufficient tumour tissue, quality of DNA extracted and low frequency of aberrations detected indicate that alternative molecular characterisation approaches are necessary, such as the use of circulating plasma DNA in patients with SCLC.

  6. Imaging tests in staging and surveillance of non-metastatic breast cancer: changes in routine clinical practice and cost implications

    PubMed Central

    De Placido, S; De Angelis, C; Giuliano, M; Pizzi, C; Ruocco, R; Perrone, V; Bruzzese, D; Tommasielli, G; De Laurentiis, M; Cammarota, S; Arpino, G; Arpino, G

    2017-01-01

    Background: Although guidelines do not recommend computerised tomography (CT), positron emission tomography (PET) or magnetic resonance imaging (MRI) for the staging or follow-up of asymptomatic patients with non-metastatic breast cancer, they are often requested in routine clinical practice. The aim of this study was to determine the staging and follow-up patterns, and relative costs in a large population of breast cancer patients living and treated in a Southern Italian region. Methods: We analysed the clinical computerised information recorded by 567 primary-care physicians assisting about 650 000 inhabitants in the Campania region. Patients with non-metastatic breast cancer were identified and divided into calendar years from 2001 to 2010. The number of diagnostic tests prescribed per 100 patients (N/Pts) and the mean cost per patient was determined 3 months before diagnosis and up to 1 year after diagnosis. Costs are expressed in constant 2011 euros. Results: We identified 4680 newly diagnosed cases of asymptomatic non-metastatic breast cancer. N/Pts increased significantly (P<0.0001) from 2001 to 2010. The mean number of prescribed mammograms, bone scans, abdominal ultrasound and chest X-rays (‘routine tests'), and costs was unchanged. However, the number of CT, PET scans and MRI (‘new tests')prescriptions almost quadrupled and the mean cost per patient related to these procedures significantly increased from €357 in 2001 to €830 in 2010 (P<0.0001). Conclusions: New test prescriptions and relative costs significantly and steadily increased throughout the study period. At present there is no evidence that the delivery of new tests to asymptomatic patients improves breast cancer outcome. Well-designed clinical trials are urgently needed to shed light on the impact of these tests on clinical outcome and overall survival. PMID:28170371

  7. A Clinical Evaluation of Routine Blood Sampling Practices in Patients With Diabetes

    PubMed Central

    Pineau, Mitchel; Pynes, Mary Kate; Katz, Laurence B.; Ginsberg, Barry

    2014-01-01

    Background: There is a perception that patients with diabetes struggle to produce sufficient blood to fill glucose test strips, including strips with 1-µL fill requirements. The purpose of this study was to determine the volume of blood expressed when these patients perform routine fingersticks using their own lancing device and sampling technique and to evaluate the relationship between blood volume and pain. Methods: Sixty-four patients (type 1 or type 2 diabetes) performed 8 fingersticks using their own lancing device and preferred depth setting and lancing technique. Eight different commercially available lancing systems were used (8 patients/system). Blood volume and perceived pain were recorded after each fingerstick. Results: The mean blood volume across all patients was 3.1 µL (512 fingersticks), with 97% of patients expressing a mean of ≥1.0 µL of blood. There was no correlation between pain response and the volume of blood expressed. Nearly all patients agreed that they could easily and comfortably obtain a 1-µL blood sample, and most patients actually preferred a larger drop size to ease sampling and avoid wasting strips. Conclusion: These results provide evidence across 8 lancing systems that challenge the current perceptions that patients with diabetes struggle to produce sufficient blood samples to fill most test strips, including those with 1-µL fill requirements, and that obtaining larger volumes of blood is more painful. These results are consistent with the previous literature suggesting that patients derive no real benefits from very low strip volumes and generally prefer a blood drop size that enables them to confidently fill their test strip. PMID:24876439

  8. Inter-cycle and inter-observer variability of the antral follicle count in routine clinical practice.

    PubMed

    Subirá, Jessica; Alberola-Rubio, Jose; Núñez, María Jose; Escrivá, Alicia Marzal; Pellicer, Antonio; Montañana, Vicente; Díaz-García, César

    2017-07-01

    Antral follicle count (AFC) is a reliable predictor of ovarian response to stimulation and its inter-cycle and inter-observer variability has been extensively studied on in vitro fertilization (IVF), mostly in highly selected populations within studies not originally designed for this purpose. In this retrospective cohort study, we assess the inter-cycle variation of AFC in a setting similar to that of the daily practice. We included only patients undergoing mild stimulation for intrauterine insemination (IUI). One hundred and forty-eight patients had two (62 patients, group A), three (49 patients, group B) or four (37 patients, group C) IUI cycles and AFC was measured on early follicular phase of each cycle by one of the members of the medical team within daily practice. Intra-class correlation coefficients were used to estimate variability. Inter-cycle variability rendered ICCs above 0.70 in all groups improving along with the number of cycles [Group A ICC 0.78 (95%CI 0.66-0.86), Group B ICC 0.87 (95%CI 0.80-0.92) and Group C ICC 0.91 (95%CI 0.85-0.95)]. Inter-observer variability showed a high degree of concordance with ICCs above 0.95. We provide the closest approximation to real inter-cycle and inter-observer AFC variability expected in routine clinical practice.

  9. [Taking personal responsibility in practice: what does it mean?--Insights into daily clinical routines].

    PubMed

    Hansen, Leonhard

    2012-01-01

    In our society, taking personal responsibility is basically regarded as a key step to adopting a more active lifestyle. In health care, however, personal responsibility is primarily equated with higher levels of financial contribution from patients. Obviously, the individual's responsibility for his or her health and towards the mutually supportive community is a highly emotional and ideological issue, so the debate is usually rather heated. This is, however, at odds with the "empowered patient" concept. In the present paper "personal responsibility in practice" will be understood to include both physician and patient responsibility. Examples will be employed to demonstrate that, on an individual level, physicians are responsible for diagnosing and treating their patients as indicated and that, on a collective level, they are expected to make responsible use of the resources allocated. Here, patient responsibility will be defined as both taking care for one's own health and the individual's obligation to contribute to the maintenance of our solidarity-based health care system. The tensions between solidarity and subsidiarity and personal responsibility, respectively, will be outlined, and a readjustment of the relation between external support and individual strengths, between solidarity and personal responsibility in terms of Sect. 1 of the Social Book Code V will be advocated.

  10. [Consensus-based approach for severe paediatric asthma in routine clinical practice].

    PubMed

    Plaza, A M; Ibáñez, M D P; Sánchez-Solís, M; Bosque-García, M; Cabero, M J; Corzo, J L; García-Hernández, G; de la Hoz, B; Korta-Murua, J; Sánchez-Salguero, C; Torres-Borrego, J; Tortajada-Girbés, M; Valverde-Molina, J; Zapatero, L; Nieto, A

    2016-02-01

    Accurate identification of paediatric patients with severe asthma is essential for an adequate management of the disease. However, criteria for defining severe asthma and recommendations for control vary among different guidelines. An online survey was conducted to explore expert opinions about the definition and management of severe paediatric asthma. To reach a consensus agreement, a modified Delphi technique was used, and practice guidelines were prepared after the analysis of the results. Eleven paediatric chest disease physicians and allergy specialists with wide expertise in severe asthma responded to the survey. Consensus was reached in 50 out of 65 questions (76.92%). It was considered that a patient has severe asthma if during the previous year they have required 2 or more cycles of oral steroids, required daily treatment with medium doses of inhaled corticosteroids (with other controller medication) or high doses (with or without other controller medication), did not respond to optimised conventional treatment, or if the disease threatened the life of the patient or seriously impairs their quality of life. The definition of severe asthma may also include patients who justifiably use health resources on a regular basis, or have psychosocial or environmental factors impeding control. For monitoring, the use of questionnaires designed specifically for paediatric population, such as CAN or ACT, is recommended. As regards treatment, the use of omalizumab should be considered prior to the use of oral corticosteroids. This paper provides consensus recommendations that may be useful in the management of severe paediatric asthma. Copyright © 2015 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.

  11. Type 2 myocardial infarction: incidence, presentation, treatment and outcome in routine clinical practice.

    PubMed

    Radovanovic, Dragana; Pilgrim, Thomas; Seifert, Burkhardt; Urban, Philip; Pedrazzini, Giovanni; Erne, Paul

    2017-05-01

    The clinical definition and optimal treatment for myocardial infarction (MI) type 2 (T2MI) are not well established. We assessed differences in presentation, treatment and outcomes of patients with MI type 1 (T1MI) and T2MI. The data of MI patients enrolled in the AMIS Plus cohort with T2MI were compared with T1MI using propensity score matching. A total of 13 829 patients had T1MI and 1091 (7.3%) T2MI. Patients with T2MI were older, often female, with more risk factors and comorbidities, and less ST segment elevation. After matching for these differences (1091 per group), T2MI patients less often presented with typical chest pain but more frequently with atrial fibrillation (15.6 vs. 4.9%; P < 0.001) and anemia (33.5 vs. 23.3%; P < 0.001) than patients with T1MI. They less frequently received percutaneous coronary interventions (51.1 vs. 76.4%; P < 0.001) and antiplatelet treatment. No differences were found for in-hospital (5.8 vs. 5.6%; OR 1.04; 95% confidence interval 0.72-1.49) and 1-year mortality (11.2 vs. 7.2%; P = 0.38) between matched T2MI and T1MI patients. Patients who suffered a T2MI had less typical symptoms, were less aggressively treated with anticoagulants, platelet inhibitors or percutaneous coronary intervention, but had similar complications and mortality to those with T1MI. Patients with T2MI are a heterogeneous group that requires further investigation to better define optimal therapeutic approaches.

  12. Usefulness of 3-Tesla cardiac magnetic resonance imaging in the assessment of aortic stenosis severity in routine clinical practice.

    PubMed

    Levy, Franck; Iacuzio, Laura; Civaia, Filippo; Rusek, Stephane; Dommerc, Carine; Hugues, Nicolas; Alexandrescu, Clara; Dor, Vincent; Tribouilloy, Christophe; Dreyfus, Gilles

    2016-11-01

    Recently, 1.5-Tesla cardiac magnetic resonance imaging (CMR) was reported to provide a reliable alternative to transthoracic echocardiography (TTE) for the quantification of aortic stenosis (AS) severity. Few data are available using higher magnetic field strength MRI systems in this context. To evaluate the feasibility and reproducibility of the assessment of aortic valve area (AVA) using 3-Tesla CMR in routine clinical practice, and to assess concordance between TTE and CMR for the estimation of AS severity. Ninety-one consecutive patients (60 men; mean age 74±10years) with known AS documented by TTE were included prospectively in the study. All patients underwent comprehensive TTE and CMR examination, including AVA estimation using the TTE continuity equation (0.81±0.18cm(2)), direct CMR planimetry (CMRp) (0.90±0.22cm(2)) and CMR using Hakki's formula (CMRhk), a simplified Gorlin formula (0.70±0.19cm(2)). Although significant agreement with TTE was found for CMRp (r=0.72) and CMRhk (r=0.66), CMRp slightly overestimated (bias=0.11±0.18cm(2)) and CMRhk slightly underestimated (bias=-0.11±0.17cm(2)) AVA compared with TTE. Inter- and intraobserver reproducibilities of CMR measurements were excellent (r=0.72 and r=0.74 for CMRp and r=0.88 and r=0.92 for peak aortic velocity, respectively). 3-Tesla CMR is a feasible, radiation-free, reproducible imaging modality for the estimation of severity of AS in routine practice, knowing that CMRp tends to overestimate AVA and CMRhk to underestimate AVA compared with TTE. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  13. Hepatitis B virus reactivation among hepatitis C patients treated with direct-acting antiviral therapies in routine clinical practice.

    PubMed

    Loggi, Elisabetta; Gitto, Stefano; Galli, Silvia; Minichiello, Mario; Conti, Fabio; Grandini, Elena; Scuteri, Alessandra; Vitale, Giovanni; Di Donato, Roberto; Cursaro, Carmela; Furlini, Giuliano; Andreone, Pietro

    2017-08-01

    Hepatitis B (HBV) reactivation in chronic hepatitis C (CHC) patients treated with IFN-free direct acting antiviral (DAA) therapies has recently emerged as a potential risk. Given the potential burden of this issue, further data are needed to establish its actual clinical impact. The aim of the present study was to analyze the occurrence of HBV reactivation in a cohort of CHC patient treated with DAAs in routine clinical practice. Consecutive CHC patients with different genotypes, treated with DAA between January 2015 and January 2016 were included in the study. Subjects had been tested for HBsAg and anti-HBc antibodies before antiviral therapy. HBV-DNA levels were examined in anti-HBc positive patients at baseline and 24 weeks after the end of treatment. Post-treatment HBsAg determination was performed in case of HBV-DNA positivity. Serum anti-HBs kinetics was analysed in anti-HBs and anti-HBc positive subjects. A cohort of 137 consecutive HCV patients treated with IFN-free regimens in routine clinical practice was evaluated. From this cohort, plasma samples of 44 subjects with positive serology for HBV (anti-HBc positive) were tested for HBV-DNA levels at baseline and 24 weeks after the end of treatment. Two of them were HBsAg-positive, while the others had signs of a past HBV exposure (HBsAg-negative±HBsAb-positive). No reactivation was found in HBcAb-positive and HBsAg-negative subjects. In the two HBsAg-positive, one experienced an increase in HBV-DNA levels of ≥2 log10 IU/mL during treatment. However, the reactivation was without clinical impact and, most important, was followed by HBsAg loss. Based on our experience, a past HBV infection seems not to be a condition predisposing to HBV reactivation. On the contrary, in HBsAg-positive subjects not in suppressive treatment with nucleos(t)ide analogs, regular monitoring of HBV-DNA during and after DAA treatment should be considered. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Technologist radiation exposure in routine clinical practice with 18F-FDG PET.

    PubMed

    Guillet, Benjamin; Quentin, Pierre; Waultier, Serge; Bourrelly, Marc; Pisano, Pascale; Mundler, Olivier

    2005-09-01

    The use of 18F-FDG for clinical PET studies increases technologist radiation dose exposure because of the higher gamma-radiation energy of this isotope than of other conventional medical gamma-radiation-emitting isotopes. Therefore, 18F-FDG imaging necessitates stronger radiation protection requirements. The aims of this study were to assess technologist whole-body and extremity exposure in our PET department and to evaluate the efficiency of our radiation protection devices (homemade syringe drawing device, semiautomated injector, and video tracking of patients). Radiation dose assessment was performed for monodose as well as for multidose 18F-FDG packaging with both LiF thermoluminescence dosimeters (TLD) and electronic personal dosimeters (ED) during 5 successive 18F-FDG PET steps (from syringe filling to patient departure). The mean +/- SD total effective doses received by technologists (n = 50) during all of the working steps were 3.24 +/- 2.1 and 3.01 +/- 1.4 microSv, respectively, as measured with ED and TLD (345 +/- 84 MBq injected). These values were confirmed by daily TLD technologist whole-body dose measurements (2.98 +/- 1.8 microSv; 294 +/- 78 MBq injected; n = 48). Finger irradiation doses during preparation of single 18F-FDG syringes were 204.9 +/- 24 and 198.4 +/- 23 microSv with multidose vials (345 +/- 93 MBq injected) and 127.3 +/- 76 and 55.9 +/- 47 microSv with monodose vials (302 +/- 43 MBq injected) for the right hand and the left hand, respectively. The protection afforded by the semiautomated injector, estimated as the ratio of the doses received by TLD placed on the syringe shield and on the external face of the injector, was near 2,000. These results showed that technologist radiation doses in our PET department were lower than those reported in the literature. This finding may be explained by the use of a homemade syringe drawing device, a semiautomated injector, and patient video tracking, allowing a shorter duration of contact between

  15. Effectiveness of Behavioral Parent Training for Children with ADHD in Routine Clinical Practice: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Van Den Hoofdakker, Barbara J.; Van Der Veen-Mulders, Lianne; Sytema, Sjoerd; Emmelkamp, Paul M. G.; Minderaa, Ruud B.; Nauta, Maaike H.

    2007-01-01

    Objective: To investigate the effectiveness of behavioral parent training (BPT) as adjunct to routine clinical care (RCC). Method: After a first phase of RCC, 94 children with attention-deficit/hyperactivity disorder (ADHD) ages 4-12, all referred to a Dutch outpatient mental health clinic, were randomly assigned to 5 months of BPT plus concurrent…

  16. Magnetic resonance imaging of lymphatic vessels without image subtraction: a practicable imaging method for routine clinical practice?

    PubMed

    Lohrmann, Christian; Foeldi, Etelka; Bartholomä, Jean-Paul; Langer, Mathias

    2007-01-01

    To assess the feasibility of a time-efficient, high-resolution magnetic resonance lymphangiography (HR MRL) protocol without image subtraction for the detection of lymphatic vessels in patients with primary and secondary lymphedema. Three consecutive patients with lymphedema of the lower extremities (2 primary bilateral, 1 secondary unilateral) underwent HR MRL without image subtraction. An amount of 9 mL of gadodiamide and 1 mL of mepivacaine hydrochloride 1% were subdivided into 5 portions and injected intracutaneously into the dorsal aspect of each foot outside the scanner before image acquisition. Magnetic resonance imaging was performed with a 1.5-T system equipped with high-performance gradients. For HR MRL, a 3-dimensional, spoiled gradient-echo sequence (Volumetric Interpolated Breath-hold Examination) was used. The extent and distribution of the lymphedema was evaluated using a heavily T2-weighted, 3-dimensional turbo-spin echo sequence. The HR MRL bilaterally detected the inguinal lymph nodes and the lymphatic vessels in the lower and upper leg in the 2 patients with primary lymphedema. In the patient with left-sided secondary lymphedema, the inguinal lymph nodes and the lymphatic vessels in the lower and upper leg were depicted on the right side. The diameter of the displayed lymphatic vessels varied between 1 and 5 mm. Three-dimensional, maximum-intensity projection images of different angles of view provided detailed outlining of the lymphatic vessels and differentiation from veins, which showed a lower signal intensity. The HR MRL without image subtraction is safe, technically feasible, and has the potential to become a diagnostic imaging tool in daily clinical practice because of its time efficiency.

  17. Promoting Early Presentation of Breast Cancer in Older Women: Implementing an Evidence-Based Intervention in Routine Clinical Practice

    PubMed Central

    Forbes, Lindsay J. L.; Forster, Alice S.; Dodd, Rachael H.; Tucker, Lorraine; Laming, Rachel; Sellars, Sarah; Patnick, Julietta; Ramirez, Amanda J.

    2012-01-01

    Background. Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age ~70, in the English National Health Service Breast Screening Programme. Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered. Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2). Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women. PMID:23213334

  18. Prospectively ECG-triggered high-pitch spiral acquisition for cardiac CT angiography in routine clinical practice: initial results.

    PubMed

    Kröpil, Patric; Rojas, Carlos A; Ghoshhajra, Brian; Lanzman, Rotem S; Miese, Falk R; Scherer, Axel; Kalra, Mannudeep; Abbara, Suhny

    2012-05-01

    This study was conducted to evaluate the mode of application, image quality (IQ), and radiation exposure resulting from introduction of a prospectively electrocardiogram-triggered high-pitch cardiac computed tomography angiography (CTA) acquisition mode into routine clinical practice. A total of 42 prospectively triggered cardiac CTAs were conducted on 34 patients (11 female, 23 male; mean age 56 ± 15 y) using a high-pitch mode (pitch 3.4) on a dual-source CT. In 8 of these patients with higher heart rates or occasional premature ventricular contractions, 2 immediately subsequent CTAs were performed ("double flash protocol"). Subjective IQ was assessed for coronary arteries using a 4-point scale (1=unevaluable to 4=excellent). Contrast-to-noise ratio (CNR) was measured in 9 locations. CT Dose Index and dose-length product were obtained, and the patients' effective dose was calculated. Mean effective doses were 2.6 ± 1.4 mSv (range: 1.1 to 6.4) for the entire cardiac examination and 1.4 ± 0.7 mSv (0.4 to 3.1) for individual high-pitch cardiac CTA. z-coverage ranged from 9.9 cm in a native coronary CTA to 31.4 cm in a bypass graft case. The overall subjective IQ was good to excellent (mean score: 3.5), with 1.5% unevaluable coronary segments. The "double flash protocol" resulted in a fully diagnostic CT study in all cases just after taking both scans into consideration. The mean CNR of all locations was 19.7 ± 2.6. Prospectively electrocardiograph-triggered high-pitch-mode cardiac CTA is a feasible and promising technique in clinical routine, allowing for evaluation of coronaries at good-to-excellent IQ and providing high CNR and minimal radiation doses. The "double flash protocol" might become a more robust tool in patients with elevated heart rates or premature ventricular contractions.

  19. Patterns of ranibizumab and aflibercept treatment of central retinal vein occlusion in routine clinical practice in the USA.

    PubMed

    Lotery, A J; Regnier, S

    2015-03-01

    The intravitreal anti-vascular endothelial growth factor treatments ranibizumab and aflibercept have proven efficacy in clinical trials, but their real world usage in central retinal vein occlusion (CRVO) has not been assessed. We therefore evaluated the treatment patterns of both drugs in a US claims database. The IMS Integrated Data Warehouse was used to identify the patients with CRVO in the USA with claims for ranibizumab or aflibercept between 24 September 2012 and 31 March 2014 with at least 12 months follow-up. Patients were required to have had no anti-VEGF treatment code for 6 months before index ('treatment-naive'). Mean numbers of injections and non-injection visits to a treating physician were compared with patients receiving these treatments. Patient characteristics were similar for patients receiving ranibizumab (n=206) or aflibercept (n=79) at index. The mean (±SD) numbers of injections received by patients treated with ranibizumab or aflibercept were 4.4±2.8 and 4.7±2.9 (P=0.38), respectively; the total number of patient visits to their treating physician was 7.3±3.7 and 7.0±2.9 (P=0.52), respectively. For patients receiving one or more injections (n=238), the mean interval between injections was 55.1 days (ranibizumab) and 54.2 days (aflibercept; P=0.44). Our results suggest that, in routine clinical practice, patients receive a comparable number of injections in the first year of treatment with ranibizumab or aflibercept. This may have implications for commissioning and service development of CRVO care pathways.

  20. Durability and Effectiveness of Maraviroc-Containing Regimens in HIV-1-Infected Individuals with Virological Failure in Routine Clinical Practice

    PubMed Central

    Potard, Valérie; Reynes, Jacques; Ferry, Tristan; Aubin, Céline; Finkielsztejn, Laurent; Yazdanpanah, Yazdan; Costagliola, Dominique

    2015-01-01

    Introduction Limited data are available on the durability and effectiveness of maraviroc in routine clinical practice. We assessed the durability of maraviroc-containing regimens during a 30-month period, as well as their immunovirological and clinical efficacy, according to viral tropism in treatment-experienced individuals with viral load (VL) >50 copies/ml in the French Hospital Database on HIV. Methods Virological success was defined as VL<50 copies/ml, immunological success as a confirmed increase of at least 100 CD4 cells/mm3 measured twice at least one month apart, and clinical failure as hospitalization for a non-AIDS event, an AIDS event, or death. Multivariable Cox regression models adjusted for potential confounders were used to assess the influence of viral tropism on durability, the immunovirological responses, and clinical outcome. Results 356 individuals started maraviroc with VL>50 copies/ml of whom 223 harbored R5 viruses, 44 non-R5 viruses and 89 viruses of unknown tropism. Individuals with non-R5 viruses were more likely than individuals with R5 viruses to discontinue maraviroc (75% vs 34%, p<0.0001). At 30 months, the estimated rates of virological and immunological success were respectively 89% and 51% in individuals with R5 viruses and 48% and 23% in individuals with non-R5 viruses. In multivariable analysis, non-R5 viruses were associated with a lower likelihood of both virological success (hazard ratio (HR): 0.42; 95% confidence interval (CI), 0.25–0.70) and immunological success (HR: 0.37; 95% CI, 0.18–0.77). No difference in clinical outcome was found between individuals with R5 and non-R5 viruses. The effectiveness of maraviroc-containing regimens in individuals with unknown viral tropism was not significantly different from that in individuals with R5 viruses. A limitation of the study is the absence of genotypic susceptibility score. Conclusion In this observational study, maraviroc-containing regimens yielded high rates of viral

  1. Durability and Effectiveness of Maraviroc-Containing Regimens in HIV-1-Infected Individuals with Virological Failure in Routine Clinical Practice.

    PubMed

    Potard, Valérie; Reynes, Jacques; Ferry, Tristan; Aubin, Céline; Finkielsztejn, Laurent; Yazdanpanah, Yazdan; Costagliola, Dominique

    2015-01-01

    Limited data are available on the durability and effectiveness of maraviroc in routine clinical practice. We assessed the durability of maraviroc-containing regimens during a 30-month period, as well as their immunovirological and clinical efficacy, according to viral tropism in treatment-experienced individuals with viral load (VL) >50 copies/ml in the French Hospital Database on HIV. Virological success was defined as VL<50 copies/ml, immunological success as a confirmed increase of at least 100 CD4 cells/mm3 measured twice at least one month apart, and clinical failure as hospitalization for a non-AIDS event, an AIDS event, or death. Multivariable Cox regression models adjusted for potential confounders were used to assess the influence of viral tropism on durability, the immunovirological responses, and clinical outcome. 356 individuals started maraviroc with VL>50 copies/ml of whom 223 harbored R5 viruses, 44 non-R5 viruses and 89 viruses of unknown tropism. Individuals with non-R5 viruses were more likely than individuals with R5 viruses to discontinue maraviroc (75% vs 34%, p<0.0001). At 30 months, the estimated rates of virological and immunological success were respectively 89% and 51% in individuals with R5 viruses and 48% and 23% in individuals with non-R5 viruses. In multivariable analysis, non-R5 viruses were associated with a lower likelihood of both virological success (hazard ratio (HR): 0.42; 95% confidence interval (CI), 0.25-0.70) and immunological success (HR: 0.37; 95% CI, 0.18-0.77). No difference in clinical outcome was found between individuals with R5 and non-R5 viruses. The effectiveness of maraviroc-containing regimens in individuals with unknown viral tropism was not significantly different from that in individuals with R5 viruses. A limitation of the study is the absence of genotypic susceptibility score. In this observational study, maraviroc-containing regimens yielded high rates of viral suppression and immunological responses in

  2. Interpretation of Renal Quality of Life Profile scores in routine clinical practice: an aid to treatment decision-making.

    PubMed

    Aawar, Nadine; Moore, Richard; Riley, Stephen; Salek, Sam

    2016-07-01

    High Renal Quality of Life Profile (RQLP) scores are associated with impaired health-related quality of life; however, the clinical meaning of the scores is difficult for clinicians and healthcare planners to interpret. The aim of this study was to determine clinical significance of RQLP scores which could be used to aid clinical decision-making. The anchor-based technique (a method for categorizing numeric scores to ease interpretation) was used to develop a categorization system for the RQLP scores using a global question (GQ). The GQ scores (i.e. no effect to extremely large effect) were mapped against the RQLP scores, and intraclass correlation coefficient (ICC) was used to test their agreement. The RQLP and the GQ were administered to 260 adult patients (males = 165 and females = 95) with chronic renal failure (CRF). The mean RQLP score was 67.2, median = 61, SD = 41.5, and range 0-172. The mean GQ score was 1.74, median = 2, SD = 1.27, and range 0-4. The mean, mode, and median of the GQ scores for each RQLP score were used to devise several sets of categories of RQLP score, and the ICC test of agreement was calculated. The proposed set of RQLP score banding for adoption includes: 0-20 = no effect on patient's life (GQ = 0, n = 35); 21-51 = small effect on patient's life (GQ = 1, n = 66); 52-93 = moderate effect on patient's life (GQ = 2, n = 87); 94-134 = very large effect on patient's life (GQ = 3, n = 54); and 135-172 = extremely large effect on patient's life (GQ = 4, n = 18). The ICC coefficient for the proposed banding system was 0.80. The proposed categorization of the RQLP will aid the clinical interpretation of change in RQLP score informing treatment decision-making in routine practice.

  3. The use of patient-reported outcomes becomes standard practice in the routine clinical care of lung–heart transplant patients

    PubMed Central

    Santana, Maria J; Feeny, David; Weinkauf, Justin; Nador, Roland; Kapasi, Ali; Jackson, Kathleen; Schafenacker, Marianne; Zuk, Dalyce; Lien, Dale

    2010-01-01

    Objective: To assess the use of patient-reported outcome (PROs) measures in the routine clinical care of lung–heart transplant patients. We assessed whether the addition of PROs in routine clinical care affected the duration of the consultation and patient’s and clinician’s views. Method: Consecutive lung–heart transplant patients visiting the outpatient clinic, University of Alberta Hospital, completed the Chronic Respiratory Questionnaire (CRQ) and the Health Utilities Index (HUI) on touchscreen computers. Information on the patient’s responses was made available to the members of the transplant team prior to the encounter with the patient. The duration of clinical encounters was noted. At the end of every visit, clinicians completed a questionnaire on the usefulness of having PRO information available. After 6 months patients completed a survey of their experiences. Results: The final patient sample consisted of 172 patients with a mean (SD) age of 52 (13.3) years old; 47% were female; 68% were organ recipients and 32% candidates. The transplant team, comprising four pulmunologists, two nurses, and one pharmacist had an average of 9 years of practical experience in pulmunology. The mean duration of patient–clinician encounters in minutes was 15.15 (4.52). Ninety-eight percent of patients indicated that they would be happy to complete the CRQ and HUI at every clinic visit. Ninety-one percent of the assessments completed by clinicians showed complete satisfaction with the use of PROs in routine practice. Further, the clinicians developed guidelines for the use of PRO information in clinical practice. Conclusions: The incorporation of PRO measures in the routine clinical care of lung–heart transplant patients resulted in a reduction of the duration of patient–clinician encounters. The experience was well accepted by patients and clinicians. We conclude that the routine use of PROs in lung–heart transplant patients has become standard practice

  4. Random and systematic medication errors in routine clinical practice: a multicentre study of infusions, using acetylcysteine as an example

    PubMed Central

    Ferner, R E; Langford, N J; Anton, C; Hutchings, A; Bateman, D N; Routledge, P A

    2001-01-01

    Aims The nature and incidence of errors in prescribing and giving medicines have previously been estimated by trained observers, or by retrospective analysis of incidents in which patients have come to harm. We have examined prospectively in routine clinical practice the concentrations of intravenous infusions of a drug (acetylcysteine) which is given according to a complicated dosing schedule. Methods We prospectively collected samples before and, where possible, after the infusion of acetylcysteine in 66 anonymous patients requiring treatment for acetaminophen (paracetamol) overdose in four centres in the United Kingdom. We measured the concentration in each infusion bag, and deduced from the weight of the patient the percentage of the anticipated dose that had actually been given. Results The experimentally determined dose was within 10% of the anticipated dose in 68 of 184 individual bags (37%), and within 20% of the anticipated dose in 112 bags (61%). Doses in 17 bags were more than 50% from the anticipated doses. In three patients, values in all three bags appeared to be systematically wrong by 50% or more; in a further seven cases, individual bags differed by 50% or more from the anticipated value. The median difference between pre- and post-infusion samples was 0% [interquartile range −5.2% to +14.6%], but 9% showed a disparity of greater than ± 50%. Conclusions Our data suggest that there is large random variation in administered dosage of intravenous infusions. Systematic calculation errors occur in about 5% [95% confidence interval 2, 8%] of cases, and major errors in drawing up in a further 3% [1, 7%], with inadequate mixing in 9% [4, 14%]. While we have no evidence that patients were adversely affected, and while the regime of administration of the drug studied (acetylcysteine) is complicated, these data suggest that the delivered dose often deviates from the intended dose, and that methods of quality control are needed. PMID:11736866

  5. Topical 0.2% glyceryl trinitrate ointment for anal fissures: long-term efficacy in routine clinical practice.

    PubMed

    Jonas, M.; Lund, J. N.; Scholefield, J. H.

    2002-09-01

    OBJECTIVE: Randomized controlled trials have reported fissure healing rates of 60-70% using topical 0.2% GTN ointment, but the effectiveness of this therapy in routine clinical practice, particularly in the long term, is uncertain. This study aimed to evaluate the efficacy of topical GTN for anal fissures in an outpatient setting. PATIENTS AND METHODS: A case note review and postal questionnaire survey were undertaken for patients with a diagnosis of anal fissure dispensed 0.2% GTN ointment from one hospital pharmacy over a two year period (June 1996-May 1998). RESULTS: Ninety-three patients (53 male) applied 0.2% GTN ointment twice daily to the anoderm for anal fissure. They were reviewed on average 8 (2-16), weeks later, by which time 57 (61%) fissures had healed, 33 persisted and 3 patients were lost to follow up. Seventy-two patients (41male), median age 42 (22-83) years, returned completed questionnaires (77% response rate). Forty-nine (68%) had healed with GTN, but 25 had recurrent symptoms after a median of 6 (1-18) months. Sixteen of those patients reporting symptomatic recurrence were prescribed further GTN for a recurrent fissure: 14 (88%) healed, but 2 persisted, and had surgery. In the other nine patients symptoms resolved spontaneously. Thirty-five (49%) experienced headaches, 3 (4%) discontinuing treatment as a result. The median follow up was 25 (13-36) months. CONCLUSION: 0.2% GTN heals 60% of fissures in the outpatient setting but half the patients develop headaches. Up to one third of healed fissures may recur within 18 months but the majority respond to further GTN. Only 4% of patients initially healed with GTN later require sphincterotomy for recurrences.

  6. Risk factors and timing of venous thromboembolism after radical cystectomy in routine clinical practice: a population-based study.

    PubMed

    Doiron, R Christopher; Booth, Christopher M; Wei, Xuejiao; Siemens, D Robert

    2016-11-01

    To describe the risk factors and timing of perioperative venous thromboembolism (VTE) and its association with survival for patients undergoing radical cystectomy (RC) in routine clinical practice. The population-based Ontario Cancer Registry was linked to electronic records of treatment to identify all patients who underwent RC between 1994 and 2008; VTE events were identified from hospital diagnostic codes. Multivariate logistic regression analysis was used to determine the factors associated with perioperative VTE. A Cox proportional hazards regression model explored the associations between VTE and survival. Of the 3 879 patients included in the study, 3.6% (141 patients) were diagnosed with VTE at ≤1 month of their surgical admission date. This increased to 4.7% (181) at ≤2 months and 5.4% (211) at ≤3 months. In all, 55% of VTE events presented after hospital discharge. In multivariate analysis, factors associated with VTE included higher surgeon volume (P = 0.004) and increased length of hospital stay (LOS; P < 0.001). Lymph node yield and adjuvant chemotherapy were not associated with VTE. VTE was associated with an inferior cancer-specific survival [hazard ratio (HR) 1.35, 95% confidence interval (CI) 1.13-1.62] and overall survival (HR 1.27, 95% CI 1.08-1.49). Over half of VTE events in RC patients occur after hospital discharge, with a substantial incidence up to 3 months after surgery. Limited actionable risk factors for VTE were identified other than LOS. In this population-based cohort, VTE was associated with inferior long-term survival. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  7. Simple and robust ICP-MS method for simultaneous determination of serum Co and Cr in routine clinical practice.

    PubMed

    Choi, Hyun-Jung; Lim, Seung-Jae; Park, Youn-Soo; Lee, Soo-Youn

    2015-01-15

    Chromium (Cr) and cobalt (Co) metal ions released from orthopedic prostheses, such as metal-on-metal (MoM) bearings, may be related to wear of the bearing surface. These ions may serve as indicators of the in vivo performance of MoM bearing surfaces. We developed a simple and sensitive assay suitable for the simultaneous measurement of serum Cr and Co using inductively coupled plasma-mass spectrometry (ICP-MS) in clinical routine laboratory practice to evaluate analytical performance and clinical utility. We evaluated the linearity, precision, and lower limit of quantification (LOQ) of an ICP-MS method to determine serum Cr and Co concentration in accordance with U.S. Food and Drug Administration guidance for bioanalytical method validation. This method was used to determine the serum Cr and Co levels of 236 clinical samples from 74 patients with MoM hip prosthesis and 51 healthy controls. The assay showed good linearity (0-20 μg/l, r(2)>0.999) and satisfactory accuracy for all tested concentrations of Cr and Co (%bias, -1.5% to 2.5%, -3.3% to 1.6%, respectively). The CVs for both metal ions were <10% for LOQ (0.02 μg/l Cr, 0.01 μg/l Co) and within 5% for other concentrations (intra- and inter-assay CV, 1.2-2.6 and 1.9-4.4% of Cr; 1.4-2.7 and 1.9-4.7% of Co). The serum Cr and Co concentrations (mean ± SD) were 0.60 ± 0.12 μg/l and 0.29 ± 0.15 μg/l in 51 healthy subjects. In 74 patients (185 serum samples) after HRA (median duration implanted, 48 months; range, 1-138 months), the concentrations of Cr and Co were 2.75 μg/l (range, 0.61-116.80 μg/l) and 1.49 μg/l (range, 0.12-127.80 μg/l), respectively. ICP-MS can simultaneously quantify serum Cr and Co levels with suitable analytical performance including a wide analytical range and very low LOQ. This assay will be very useful for evaluating the nutritional status of Cr and Co in healthy humans as well as monitoring the performance of orthopedic prostheses after hip resurfacing arthroplasty. Copyright

  8. Predicting frequent asthma exacerbations using blood eosinophil count and other patient data routinely available in clinical practice

    PubMed Central

    Price, David; Wilson, Andrew M; Chisholm, Alison; Rigazio, Anna; Burden, Anne; Thomas, Michael; King, Christine

    2016-01-01

    Purpose Acute, severe asthma exacerbations can be difficult to predict and thus prevent. Patients who have frequent exacerbations are of particular concern. Practical exacerbation predictors are needed for these patients in the primary-care setting. Patients and methods Medical records of 130,547 asthma patients aged 12–80 years from the UK Optimum Patient Care Research Database and Clinical Practice Research Datalink, 1990–2013, were examined for 1 year before (baseline) and 1 year after (outcome) their most recent blood eosinophil count. Baseline variables predictive (P<0.05) of exacerbation in the outcome year were compared between patients who had two or more exacerbations and those who had no exacerbation or only one exacerbation, using uni- and multivariable logistic regression models. Exacerbation was defined as asthma-related hospital attendance/admission (emergency or inpatient) or acute oral corticosteroid (OCS) course. Results Blood eosinophil count >400/µL (versus ≤400/µL) increased the likelihood of two or more exacerbations >1.4-fold (odds ratio [OR]: 1.48 (95% confidence interval [CI]: 1.39, 1.58); P<0.001). Variables that significantly increased the odds by up to 1.4-fold included increasing age (per year), female gender (versus male), being overweight or obese (versus normal body mass index), being a smoker (versus nonsmoker), having anxiety/depression, diabetes, eczema, gastroesophageal reflux disease, or rhinitis, and prescription for acetaminophen or nonsteroidal anti-inflammatory drugs. Compared with treatment at British Thoracic Society step 2 (daily controller ± reliever), treatment at step 0 (none) or 1 (as-needed reliever) increased the odds by 1.2- and 1.6-fold, respectively, and treatment at step 3, 4, or 5 increased the odds by 1.3-, 1.9-, or 3.1-fold, respectively (all P<0.05). Acute OCS use was the single best predictor of two or more exacerbations. Even one course increased the odds by more than threefold (OR: 3.75 [95% CI: 3

  9. Incremental cost per newly diagnosed HIV infection (NDHI): routine (RTS), targeted (TTS), and current clinical practice testing strategies (CPTS).

    PubMed

    Gomez-Ayerbe, Cristina; Elías, María Jesús Pérez; Muriel, Alfonso; Elías, Pilar Pérez; Cano, Agustina; Diaz, Alberto; Moreno, Ana; Casado, Jose Luis; Santos, Cristina; Martinez-Colubi, María; Uranga, Almudena; Dronda, Fernando; Moreno, Santiago

    2014-01-01

    Although RTS as HIV Diagnosis was considered cost effectiveness [1], overall budget may be unaffordable for some countries. We explore Incremental cost per NDHI associated with different TS. From a health care perspective, using direct costs and Euros currency, we calculated budget and cost per NDHI of RTS (all patients were tested), TTS (Universal risk practices and clinical conditions-RP&CC - only positive were tested), and CPTS (Only patients physicians considered were tested). We considered DRIVE (Spanish acronym of HIV infection Rapid Diagnosis) study and clinical Practice outcomes. Population between 18-60 years, attending to a Hospital Emergency Room or to a Primary Care Center performed an HIV RP&CC questionnaire (Q) and an HIV rapid test (HIV RT). Unitary costs considered were: HIV RT, nurse, registry, transport and HIV confirmation when necessary, imputed to all population in RTS and CPTS and only in HIV RP&CC-Q positive in TTS analysis, while HIV RP&CC-Q costs were added to all population in TTS. Sensitivity analyses were performed with varying rates of NDHI and of positive HIV RP&CC-Q population, and different RP&CC Q sensitivity (SE) to predict HIV infection. 5,329 HIV RP&CC-Q and HIV RT were performed to 49.64% women, median age 37 years old, 74.9% Spaniards. In DRIVE and CP, NDHI were 4.1‰, and 1.6‰, while HIV RP&CC-Q was positive in 51.2%. HIV RP&CC-Q SE was 100%. Overall budget employed in HIV testing was in RTS 43,503€, in TTS 24,472€ and in CPTS 5,032€. Cost per 1 NDHI was 1,977€, 1,112€ and 5,032€, respectively. A reduction in cost of 865€, favouring TTS vs. RTS, while an increased cost of 824€ in CPTS vs. RTS was obtained. Considering NDHI rate of 2.6‰ saving costs increased to 1379€ in TTS, while were reduced to 576€ if NDHI rate increases 6.2‰. Effect of RP&CC-Q positivity rate was similar, if 25% saving costs were 1368€, while if 75% were reduced to 399€. Varying SE of RP&CC-Q to 95%, 91% and 50% cost saving

  10. Incremental cost per newly diagnosed HIV infection (NDHI): routine (RTS), targeted (TTS), and current clinical practice testing strategies (CPTS)

    PubMed Central

    Gomez-Ayerbe, Cristina; Jesús Pérez Elías, María; Muriel, Alfonso; Pérez Elías, Pilar; Cano, Agustina; Diaz, Alberto; Moreno, Ana; Luis Casado, Jose; Santos, Cristina; Martinez-Colubi, María; Uranga, Almudena; Dronda, Fernando; Moreno, Santiago

    2014-01-01

    Introduction Although RTS as HIV Diagnosis was considered cost effectiveness [1], overall budget may be unaffordable for some countries. We explore Incremental cost per NDHI associated with different TS. Materials and Methods From a health care perspective, using direct costs and Euros currency, we calculated budget and cost per NDHI of RTS (all patients were tested), TTS (Universal risk practices and clinical conditions-RP&CC - only positive were tested), and CPTS (Only patients physicians considered were tested). We considered DRIVE (Spanish acronym of HIV infection Rapid Diagnosis) study and clinical Practice outcomes. Population between 18–60 years, attending to a Hospital Emergency Room or to a Primary Care Center performed an HIV RP&CC questionnaire (Q) and an HIV rapid test (HIV RT). Unitary costs considered were: HIV RT, nurse, registry, transport and HIV confirmation when necessary, imputed to all population in RTS and CPTS and only in HIV RP&CC-Q positive in TTS analysis, while HIV RP&CC-Q costs were added to all population in TTS. Sensitivity analyses were performed with varying rates of NDHI and of positive HIV RP&CC-Q population, and different RP&CC Q sensitivity (SE) to predict HIV infection. Results 5,329 HIV RP&CC-Q and HIV RT were performed to 49.64% women, median age 37 years old, 74.9% Spaniards. In DRIVE and CP, NDHI were 4.1‰, and 1.6‰, while HIV RP&CC-Q was positive in 51.2%. HIV RP&CC-Q SE was 100%. Overall budget employed in HIV testing was in RTS 43,503€, in TTS 24,472€ and in CPTS 5,032€. Cost per 1 NDHI was 1,977€, 1,112€ and 5,032€, respectively. A reduction in cost of 865€, favouring TTS vs. RTS, while an increased cost of 824€ in CPTS vs. RTS was obtained. Considering NDHI rate of 2.6‰ saving costs increased to 1379€ in TTS, while were reduced to 576€ if NDHI rate increases 6.2‰. Effect of RP&CC-Q positivity rate was similar, if 25% saving costs were 1368€, while if 75% were reduced to 399€. Varying SE

  11. Validation of long-term benefits of bivalirudin versus unfractionated heparin in routine clinical practice after percutaneous coronary intervention.

    PubMed

    Vidi, Venkatesan D; Matheny, Michael E; Agarwal, Vikram; Arora, Nipun; Donnelly, Sharon; Bangalore, Sripal; Resnic, Frederic S

    2010-11-01

    Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin compared to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) for stable angina and acute coronary syndrome. This study analyzed the impact of bivalirudin-based anticoagulation strategy versus UFH-based anticoagulation strategy on long-term bleeding complications and major adverse cardiac events in patients undergoing PCI in routine clinical practice. From September 2005 to April 2009, 3,367 consecutive patients who underwent PCI for stable angina or non-ST-segment elevation acute coronary syndrome at Brigham and Women's Hospital were studied. Of these patients, 2,228 patients (66%) received UFH and 1,139 (34%) received bivalirudin. Bleeding complication and major adverse cardiac event rates were compared at discharge, 30 days, and 1 year. In a propensity-score matched analysis, bivalirudin-based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs 13.7%, p = 0.001) and 1 year (12.7% vs 18.9%, p = 0.013). Major adverse cardiac event rates were not significantly different between groups at discharge, 30 days, and 1 year (6.4% vs 8.3%, p = 0.103; 9.4% vs 10.9%, p = 0.449; 12.1% vs 14.8%, p = 0.235, respectively). There was no difference in all-cause mortality rates between the 2 groups (0.9% vs 0.8%, p = 0.808, at discharge; 1.9% vs 3.6%, p = 0.112, at 30 days; 3.6% vs 5.5%, p = 0.195, at 1 year). In conclusion, in a real-world cohort of patients undergoing PCI, bivalirudin-based anticoagulation strategy is associated with a significant decrease in risk of bleeding complications after 30 days and 1 year compared to a UFH-based anticoagulation strategy with no increase in risk for major adverse cardiac events.

  12. Validation of Long-term Benefits of Bivalirudin vs. Unfractionated Heparin in Routine Clinical Practice after Percutaneous Coronary Intervention

    PubMed Central

    Vidi, Venkatesan D.; Matheny, Michael E.; Agarwal, Vikram; Arora, Nipun; Donnelly, Sharon; Bangalore, Sripal; Resnic, Frederic S.

    2010-01-01

    Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin relative to unfractionated heparin (UFH) in patients undergoing percutaneous coronary intervention (PCI) for stable angina and acute coronary syndrome. This study analyzed the impact of bivalirudin based anticoagulation strategy versus UFH based anticoagulation strategy on long-term bleeding complications and major adverse cardiac events in patients undergoing PCI in routine clinical practice. Between September 2005 and April 2009, 3367 consecutive patients who underwent PCI for stable angina or Non ST-segment elevation acute coronary syndrome at Brigham and Women’s Hospital were studied. Of these patients, 2228 (66%) patients received UFH and 1139 (34%) received bivalirudin. We compared the bleeding complication and major adverse cardiac event rates at discharge, 30-days and 1-year. In a propensity-score matched analysis, bivalirudin based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs. 13.7%, p=0.001) and 1-year (12.7% vs.18.9%, p=0.013). The major adverse cardiac event rates was not significantly different between the groups at discharge, 30-days and 1-year (6.4% vs. 8.3%, p=0.103; 9.4% vs.10.9%, p=0.449; 12.1% vs.14.8%, p=0.235 respectively). There was no difference in all-cause mortality rates between the two groups (0.9% vs. 0.8%, p=0.808 at discharge; 1.9% vs. 3.6%, p=0.112 at 30-days; 3.6% vs. 5.5%, p=0.195 at 1 year). In conclusion, in a real-world cohort of patients undergoing PCI, Bivalirudin based anticoagulation strategy is associated with significant reduction in the risk of bleeding complications after 30-days and 1-year compared to UFH based anticoagulation strategy with no increase in the risk for major adverse cardiac events. PMID:21029818

  13. Clinical Neuropathology practice news 1-2014: pyrosequencing meets clinical and analytical performance criteria for routine testing of MGMT promoter methylation status in glioblastoma.

    PubMed

    Preusser, Matthias; Berghoff, Anna S; Manzl, Claudia; Filipits, Martin; Weinhäusel, Andreas; Pulverer, Walter; Dieckmann, Karin; Widhalm, Georg; Wöhrer, Adelheid; Knosp, Engelbert; Marosi, Christine; Hainfellner, Johannes A

    2014-01-01

    Testing of the MGMT promoter methylation status in glioblastoma is relevant for clinical decision making and research applications. Two recent and independent phase III therapy trials confirmed a prognostic and predictive value of the MGMT promoter methylation status in elderly glioblastoma patients. Several methods for MGMT promoter methylation testing have been proposed, but seem to be of limited test reliability. Therefore, and also due to feasibility reasons, translation of MGMT methylation testing into routine use has been protracted so far. Pyrosequencing after prior DNA bisulfite modification has emerged as a reliable, accurate, fast and easy-to-use method for MGMT promoter methylation testing in tumor tissues (including formalin fixed and paraffin-embedded samples). We performed an intra- and inter-laboratory ring trial which demonstrates a high analytical performance of this technique. Thus, pyrosequencing- based assessment of MGMT promoter methylation status in glioblastoma meets the criteria of high analytical test performance and can be recommended for clinical application, provided that strict quality control is performed. Our article summarizes clinical indications, practical instructions and open issues for MGMT promoter methylation testing in glioblastoma using pyrosequencing.

  14. Comparison of the utility of Pascal dynamic contour tonometry with Goldmann applanation tonometry in routine clinical practice.

    PubMed

    Anderson, Matthew Frederick; Agius-Fernandez, Adriana; Kaye, Stephen B

    2013-01-01

    To compare the utility of Pascal dynamic contour tonometry with Goldmann applanation tonometry in routine practice In a prospective study, 10 clinicians recruited 97 patients attending outpatient ophthalmology appointments. Intraocular pressure was measured with both Pascal and Goldmann tonometry in a randomized order. The time taken with each instrument, the number of measurements required to obtain a satisfactory Pascal reading (Q1 to Q3) and the quality value of this reading were recorded. Both the difficulty experienced by the clinician and patient experience for each instrument were assessed. Satisfactory Pascal measurements were obtained for 181 of 194 eyes (93%). For these eyes there was no significant difference in mean measured intraocular pressure between Pascal (15.95±3.20) and Goldmann (16.37±3.51) (mean difference 0.43 mm Hg, P=0.26) tonometry. The median number of attempts required to obtain a satisfactory Pascal measurement was 2 (range, 1 to 10). The time taken to obtain bilateral satisfactory Pascal readings was 2.76±1.53 minutes (range, 0.5 to 7 min), compared with 0.82±0.43 minutes (range, 0.5 to 3 min) for Goldmann tonometry (P<0.001). For these patients, clinicians scored the difficulty of tonometry as 3.24±1.97 for Pascal (1=very easy, 10=very difficult) and 1.28±0.85 for Goldmann (P<0.0001). The mean score (1=no discomfort, 10=extremely unpleasant) given by patients was 1.31±0.64 for Goldmann and 2.11±1.83 for Pascal tonometry (P<0.0001). Clinicians found Pascal tonometry significantly more time consuming and difficult than Goldmann tonometry in routine practice. Most eyes required repeated Pascal measurements, and for some an acceptable result was not obtained. Both types of tonometry were well tolerated by patients.

  15. How do family physicians measure blood pressure in routine clinical practice? National survey of Canadian family physicians.

    PubMed

    Kaczorowski, Janusz; Myers, Martin G; Gelfer, Mark; Dawes, Martin; Mang, Eric J; Berg, Angelique; Grande, Claudio Del; Kljujic, Dragan

    2017-03-01

    To describe the techniques currently used by family physicians in Canada to measure blood pressure (BP) for screening for, diagnosing, and treating hypertension. A Web-based cross-sectional survey distributed by e-mail. Stratified random sample of family physicians in Canada. Family physician members of the College of Family Physicians of Canada with valid e-mail addresses. Physicians' self-reported routine methods for recording BP in their practices to screen for, diagnose, and manage hypertension. A total of 774 valid responses were received, for a response rate of 16.2%. Respondents were similar to nonrespondents except for underrepresentation of male physicians. Of 769 respondents, 417 (54.2%) indicated that they used manual office BP measurement with a mercury or aneroid device and stethoscope as the routine method to screen patients for high BP, while 42.9% (330 of 769) reported using automated office BP (AOBP) measurement. The method most frequently used to make a diagnosis of hypertension was AOBP measurement (31.1%, 240 of 771), followed by home BP measurement (22.4%, 173 of 771) and manual office BP measurement (21.4%, 165 of 771). Ambulatory BP monitoring (ABPM) was used for diagnosis by 14.4% (111 of 771) of respondents. The most frequently reported method for ongoing management was home BP monitoring (68.7%, 528 of 769), followed by manual office BP measurement (63.6%, 489 of 769) and AOBP measurement (59.2%, 455 of 769). More than three-quarters (77.8%, 598 of 769) of respondents indicated that ABPM was readily available for their patients. Canadian family physicians exhibit overall high use of electronic devices for BP measurement, However, more efforts are needed to encourage practitioners to follow current Canadian guidelines, which advocate the use of AOBP measurement for hypertension screening, ABPM and home BP measurement for making a diagnosis, and both AOBP and home BP monitoring for ongoing management. Copyright© the College of Family

  16. Considerations on the Improved Integration of Medical Guidelines into Routine Clinical Practice – a Review and Concept Proposal

    PubMed Central

    Beckmann, M. W.; Schlieter, H.; Richter, P.; Wesselmann, S.

    2016-01-01

    Medical guidelines have become established as the standard for the comprehensive synopsis of all available information (scientific trials, expert opinion) on diagnosis and treatment recommendations. The transfer of guidelines to clinical practice and subsequent monitoring has however proven difficult. In particular the potential interaction between guideline developers and guideline users has not been fully utilised. This review article analyses the status quo and existing methodological and technical information solutions supporting the guideline life cycle. It is shown that there are numerous innovative developments that in isolation do not provide comprehensive support. The vision of the “Living Guidelines 2.0” is therefore presented. This outlines the merging of guideline development and implementation on the basis of clinical pathways and guideline-based quality control, and building on this, the generation of information for guideline development and research. PMID:27134291

  17. Outcome measures in European patients with haemophilia: Survey of implementation in routine clinical practice, perception of relevance and recommendations by European treaters in the EHTSB.

    PubMed

    Hermans, C; Klamroth, R; Richards, M; de Moerloose, P; Garrido, R P

    2017-03-01

    This study was conducted to evaluate the current implementation of outcome measures in routine clinical haemophilia practice and to explore and appreciate the perception of the relevance of such measures by treaters. A survey was completed by 19 of the 26 physicians involved in the European Haemophilia Therapy Strategy Board (EHTSB). Employing an extensive inventory of outcome measures used in patients with haemophilia, information was collected about the frequency of data collection and the subjective appreciation of their importance during clinic review. The survey revealed that most treaters currently collect data that are mainly related to the haemostatic treatment (consumption of concentrates) and the bleeding symptoms (number and location of bleeds) in a non-uniform and non-standardized way. By contrast, functional, physical and quality of life scorings are rarely used and show considerable heterogeneity between treaters. Also, many disparities emerged between practice and perception, in particular quality of life data that are perceived as being important but for most of the time are not collected. This survey represents, in our view, the first attempt to evaluate the actual utilization of outcome measures in haemophilia care. While the value of outcome measures is appreciated, they are not assessed regularly. Therefore, there is a need to include appropriate performance indicators (outcome measures) of haemophilia care in routine clinical practice. Consensus recommendations to provide a framework for achieving this aim are provided. © 2016 John Wiley & Sons Ltd.

  18. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials.

    PubMed

    Thientosapol, E S; Tran, T T; Della-Fiorentina, S A; Adams, D H; Chantrill, L; Stockler, M R; Kiely, B E

    2013-08-01

    Survival times of women starting first-line chemotherapy for metastatic breast cancer (MBC) in routine clinical practice were determined and compared with those from a systematic review of randomised clinical trials. We identified women with MBC starting first-line chemotherapy from June 2003 to February 2011 and recorded their demographics, tumour and treatment characteristics, and survival times from the start of chemotherapy. Their survival distribution was summarised by the following percentiles (represented scenarios for survival): 90th (worst-case), 75th (lower-typical), 25th (upper-typical) and 10th (best-case), which were compared with the same percentiles from our systematic review of first-line chemotherapy trials. The 273 women had a median age of 56 years, and a median time from diagnosis of MBC of 3 months. Eastern Cooperative Oncology Group performance status was 0-1 in 80%. Tumours were hormone receptor positive in 69%, human epidermal growth factor receptor 2 (HER2)-positive in 27% and triple negative in 13%. Survival times in months in routine clinical practice (vs the systematic review) were: 90th percentile 4 (6); 75th percentile 9 (12); median 20 (22); 25th percentile 36 (36) and 10th percentile 61 (56). Independent predictors of overall survival included HER2-positive disease (hazard ratio (HR) 0.49, P = 0.0002), hormone receptor positive disease (HR 0.51, P = 0.0004), Eastern Cooperative Oncology Group performance status 0-1 (HR 0.36, P < 0.0001) and adjuvant chemotherapy (HR 1.86, P = 0.0002). Median and better survival times in routine practice were similar to those from randomised clinical trials; however, survival times worse than the median were shorter, likely reflecting patient selection in trials. Oncologists should adjust trial-based survival estimates for patients not meeting typical trial eligibility criteria. © 2013 The Authors; Internal Medicine Journal © 2013 Royal Australasian College of Physicians.

  19. The mode of death in implantable cardioverter-defibrillator and cardiac resynchronization therapy with defibrillator patients: results from routine clinical practice.

    PubMed

    Thijssen, Joep; van Rees, Johannes B; Venlet, Jeroen; Borleffs, C Jan Willem; Höke, Ulas; Putter, Hein; van der Velde, Enno T; van Erven, Lieselot; Schalij, Martin J

    2012-10-01

    Although data on the mode of death of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) patients have been examined in randomized clinical trials, in routine clinical practice data are scarce. To provide reasonable expectations and prognosis for patients and physicians, this study assessed the mode of death in routine clinical practice. To assess the mode of death in ICD/CRT-D recipients in routine clinical practice. All patients who underwent an ICD or CRT-D implantation at the Leiden University Medical Center, the Netherlands, between 1996 and 2010 were included. Patients were divided into primary prevention ICD, secondary prevention ICD, and CRT-D patients. For patients who died during follow-up, the mode of death was retrieved from hospital and general practitioner records and categorized according to a predetermined classification: heart failure death, other cardiac death, sudden death, noncardiac death, and unknown death. A total of 2859 patients were included in the analysis. During a median follow-up of 3.4 years (interquartile range 1.7-5.7 years), 107 (14%) primary prevention ICD, 253 (28%) secondary prevention ICD, and 302 (25%) CRT-D recipients died. The 8-year cumulative incidence of all-cause mortality was 39.9% (95% confidence interval 37.0%-42.9%). Heart failure death and noncardiac death were the most common modes of death for all groups. Sudden death accounted for approximately 7%-8% of all deaths. For all patients, heart failure and noncardiac death are the most common modes of death. The proportion of patients who died suddenly was low and comparable for primary and secondary ICD and CRT-D patients. Copyright © 2012 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  20. An analysis of the management of cardiovascular risk factors in routine clinical practice in Italy: an overview of the main findings of the EFFECTUS study.

    PubMed

    Tocci, Giuliano; Ferrucci, Andrea; Guida, Pietro; Avogaro, Angelo; Comaschi, Marco; Corsini, Alberto; Cortese, Claudio; Giorda, Carlo B; Manzato, Enzo; Medea, Gerardo; Mureddu, Gian F; Riccardi, Gabriele; Titta, Giulio; Ventriglia, Giuseppe; Zito, Giovanni B; Volpe, Massimo

    2011-03-01

    Cardiovascular diseases represent the leading cause of morbidity and mortality, worldwide. Early detection and appropriate management of cardiovascular risk factors and disease markers in daily clinical practice may improve preventive strategies and reduce the burden of cardiovascular disease. The EFFECTUS (Evaluation of Final Feasible Effect of Control Training and Ultra Sensitisation) programme was an educational programme aimed at evaluating prevalence of major cardiovascular risk factors among outpatients, and preferences and attitudes for cardiovascular disease management among Italian physicians in their routine clinical practice. This article provides an overview of the main findings of different analyses from the EFFECTUS database, which have demonstrated a high prevalence of cardiovascular risk factors, irrespective of the clinical settings and outpatient clinics in which patients were followed. Also, findings from this database suggest that more intensive clinical data recording was paralleled by better adherence to guidelines, and that use of electronic rather than conventional support for clinical data collection and registration improved accuracy in data recording, which translated into better management of patients at risk in daily clinical practice.

  1. Service profiling and outcomes benchmarking using the CORE-OM: toward practice-based evidence in the psychological therapies. Clinical Outcomes in Routine Evaluation-Outcome Measures.

    PubMed

    Barkham, M; Margison, F; Leach, C; Lucock, M; Mellor-Clark, J; Evans, C; Benson, L; Connell, J; Audin, K; McGrath, G

    2001-04-01

    To complement the evidence-based practice paradigm, the authors argued for a core outcome measure to provide practice-based evidence for the psychological therapies. Utility requires instruments that are acceptable scientifically, as well as to service users, and a coordinated implementation of the measure at a national level. The development of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is summarized. Data are presented across 39 secondary-care services (n = 2,710) and within an intensively evaluated single service (n = 1,455). Results suggest that the CORE-OM is a valid and reliable measure for multiple settings and is acceptable to users and clinicians as well as policy makers. Baseline data levels of patient presenting problem severity, including risk, are reported in addition to outcome benchmarks that use the concept of reliable and clinically significant change. Basic quality improvement in outcomes for a single service is considered.

  2. Comparison of the ETDRS logMAR, 'compact reduced logMar' and Snellen charts in routine clinical practice.

    PubMed

    Lim, L-A; Frost, N A; Powell, R J; Hewson, P

    2010-04-01

    To compare the performance of the ETDRS logMAR, compact reduced logMAR and Snellen charts in an ophthalmic outpatient setting. The reliability and reading times of the charts were compared in a stratified sample of 40 eyes of 40 ophthalmic patients with a variety of stable eye diseases. In order to simulate a clinical setting, forced-choice testing was not used. Similar acuity results were recorded from all three charts, suggesting a lack of a systematic bias as regards chart design. A small practice effect was observed for all charts but was greatest for Snellen and least for ETDRS. The test-retest variability of the charts was similar, with the 95% tolerance limit for change being +/-0.14 logMAR for ETDRS, +/-0.16 for reduced logMAR and +/-0.18 for Snellen. The mean reading times for the subjects were 34.65 s for ETDRS, 21.17 s for reduced logMAR and 18.67 s for Snellen. The performance of the compact reduced logMAR chart was intermediate between Snellen and ETDRS. The theoretical advantages of the ETDRS design were still measurable in a clinical setting but the magnitude of the advantage in terms of test-retest reliability was fairly small and the time taken to complete the EDTRS was 1.86 times that of the Snellen chart.

  3. First-line treatment selection and early monitoring patterns in chronic phase-chronic myeloid leukemia in routine clinical practice: SIMPLICITY.

    PubMed

    Goldberg, Stuart L; Cortes, Jorge; Gambacorti-Passerini, Carlo; Hehlmann, Rüdiger; Khoury, H Jean; Michallet, Mauricette; Paquette, Ron; Simonsson, Bengt; Zyczynski, Teresa; Foreman, Aimee; Abruzzese, Elisabetta; Andorsky, David; Beeker, Aart; Cony-Makhoul, Pascale; Hansen, Richard; Lomaia, Elza; Olavarria, Eduardo; Mauro, Michael

    2017-08-17

    Achieving successful outcomes in chronic phase-chronic myeloid leukemia (CP-CML) requires careful monitoring of cytogenetic/molecular responses (CyR/MR). SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor use and management patterns in patients with CP-CML receiving first-line imatinib (n=416), dasatinib (n=418) or nilotinib (n=408) in the US and 6 European countries in routine clinical practice. Twelve-month follow-up data of 1,242 prospective patients (enrolled October 01 2010-September 02 2015) are reported. 81% of patients had baseline comorbidities. Treatment selection was based on perceived efficacy over patient comorbidity profile. There was a predominance of imatinib-treated patients enrolled earlier in the study, with subsequent shift towards dasatinib- and nilotinib-treated patients by 2013/2014. Monitoring for either CyR/MR improved over time and was documented for 36%, 82% and 95% of patients by 3, 6 and 12 months, respectively; 5% had no documentation of CyR/MR monitoring during the first year of therapy. Documentation of MR/CyR testing was higher in Europe than the US (P<0.001) and at academic versus community practices (P=0.001). Age <65 years, patients being followed at sites within Europe, those followed at academic centers and patients no longer on first-line therapy were more likely to be monitored by 12 months. SIMPLICITY demonstrates that the NCCN and ELN recommendations on response monitoring have not been consistently translated into routine clinical practice. In the absence of appropriate monitoring practices, clinical response to TKI therapy cannot be established, any needed changes to treatment strategy will thus not be implemented, and long-term patient outcomes are likely to be impacted. This article is protected by copyright. All rights reserved. © 2017 Wiley Periodicals, Inc.

  4. Can the Platelet Function Analyzer (PFA)-100 test substitute for the template bleeding time in routine clinical practice?

    PubMed

    Francis, J; Francis, D; Larson, L; Helms, E; Garcia, M

    1999-01-01

    The bleeding time (BT) is widely used in clinical medicine as a screening test of platelet function, although its deficiencies in such a role are well recognized. The Platelet Function Analyzer (PFA)-100 measures the ability of platelets activated in a high-shear environment to occlude an aperture in a membrane treated with collagen and epinephrine (CEPI) or collagen and ADP (CADP). The time taken for flow across the membrane to stop (closure time) is recorded. This study compared the PFA-100 with the BT as a screening test of platelet dysfunction in 113 hospital inpatients. The PFA-100 test was performed initially using the CEPI cartridge; CADP tests were performed on those with abnormal (> 163 s) CEPI closure times. Whole blood platelet aggregation studies and chart review were performed on patients in whom the BT and PFA-100 results did not agree.Abnormal bleeding times and PFA-100 results were obtained in 20.4% and 35.4% of patients, respectively. The results of BT and PFA-100 agreed in 74.3% of patients. Of the 29 patients in whom the BT and PFA-100 results were discordant, whole blood platelet aggregation studies supported the PFA-100 result in 25 (86.2%). The PFA-100 was more sensitive to aspirin-induced platelet dysfunction and was more rapidly and cheaply performed than the BT. Since the PFA-100 test reflects platelet function better than the BT, we conclude that this test could replace the BT as a first-line screening test for platelet dysfunction in clinical practice.

  5. Uniform data collection in routine clinical practice in cardiovascular patients for optimal care, quality control and research: The Utrecht Cardiovascular Cohort.

    PubMed

    Asselbergs, Folkert W; Visseren, Frank Lj; Bots, Michiel L; de Borst, Gert J; Buijsrogge, Marc P; Dieleman, Jan M; van Dinther, Baukje Gf; Doevendans, Pieter A; Hoefer, Imo E; Hollander, Monika; de Jong, Pim A; Koenen, Steven V; Pasterkamp, Gerard; Ruigrok, Ynte M; van der Schouw, Yvonne T; Verhaar, Marianne C; Grobbee, Diederick E

    2017-01-01

    Background Cardiovascular disease remains the major contributor to morbidity and mortality. In routine care for patients with an elevated cardiovascular risk or with symptomatic cardiovascular disease information is mostly collected in an unstructured manner, making the data of limited use for structural feedback, quality control, learning and scientific research. Objective The Utrecht Cardiovascular Cohort (UCC) initiative aims to create an infrastructure for uniform registration of cardiovascular information in routine clinical practice for patients referred for cardiovascular care at the University Medical Center Utrecht, the Netherlands. This infrastructure will promote optimal care according to guidelines, continuous quality control in a learning healthcare system and creation of a research database. Methods The UCC comprises three parts. UCC-1 comprises enrolment of all eligible cardiovascular patients in whom the same information will be collected, based on the Dutch cardiovascular management guideline. A sample of UCC-1 will be invited for UCC-2. UCC-2 involves an enrichment through extensive clinical measurements with emphasis on heart failure, cerebral ischaemia, arterial aneurysms, diabetes mellitus and elevated blood pressure. UCC-3 comprises on-top studies, with in-depth measurements in smaller groups of participants typically based on dedicated project grants. All participants are followed up for morbidity and mortality through linkage with national registries. Conclusion In a multidisciplinary effort with physicians, patients and researchers the UCC sets a benchmark for a learning cardiovascular healthcare system. UCC offers an invaluable resource for future high quality care as well as for first-class research for investigators.

  6. Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study.

    PubMed

    Rees, Colin J; Rajasekhar, Praveen T; Wilson, Ana; Close, Helen; Rutter, Matthew D; Saunders, Brian P; East, James E; Maier, Rebecca; Moorghen, Morgan; Muhammad, Usman; Hancock, Helen; Jayaprakash, Anthoor; MacDonald, Chris; Ramadas, Arvind; Dhar, Anjan; Mason, James M

    2017-05-01

    Accurate optical characterisation and removal of small adenomas (<10 mm) at colonoscopy would allow hyperplastic polyps to be left in situ and surveillance intervals to be determined without the need for histopathology. Although accurate in specialist practice the performance of narrow band imaging (NBI), colonoscopy in routine clinical practice is poorly understood. NBI-assisted optical diagnosis was compared with reference standard histopathological findings in a prospective, blinded study, which recruited adults undergoing routine colonoscopy in six general hospitals in the UK. Participating colonoscopists (N=28) were trained using the NBI International Colorectal Endoscopic (NICE) classification (relating to colour, vessel structure and surface pattern). By comparing the optical and histological findings in patients with only small polyps, test sensitivity was determined at the patient level using two thresholds: presence of adenoma and need for surveillance. Accuracy of identifying adenomatous polyps <10 mm was compared at the polyp level using hierarchical models, allowing determinants of accuracy to be explored. Of 1688 patients recruited, 722 (42.8%) had polyps <10 mm with 567 (78.5%) having only polyps <10 mm. Test sensitivity (presence of adenoma, N=499 patients) by NBI optical diagnosis was 83.4% (95% CI 79.6% to 86.9%), significantly less than the 95% sensitivity (p<0.001) this study was powered to detect. Test sensitivity (need for surveillance) was 73.0% (95% CI 66.5% to 79.9%). Analysed at the polyp level, test sensitivity (presence of adenoma, N=1620 polyps) was 76.1% (95% CI 72.8% to 79.1%). In fully adjusted analyses, test sensitivity was 99.4% (95% CI 98.2% to 99.8%) if two or more NICE adenoma characteristics were identified. Neither colonoscopist expertise, confidence in diagnosis nor use of high definition colonoscopy independently improved test accuracy. This large multicentre study demonstrates that NBI optical diagnosis cannot

  7. Cost-effectiveness analysis of fesoterodine flexible dose in newly diagnosed patients with overactive bladder in routine clinical practice in Spain

    PubMed Central

    Peral, Carmen; Sánchez-Ballester, Francisco; García-Mediero, José M; Ramos, Jaime; Rejas, Javier

    2016-01-01

    Objective To carry out cost-effectiveness analysis from the Spanish National Health System perspective, of treating overactive bladder (OAB), in newly diagnosed patients with two flexible doses of fesoterodine in routine clinical practice. Patients and methods Economic evaluation of flexible-dose fesoterodine in newly diagnosed patients, including two treatment groups: standard escalating from 4 to 8 mg or fast escalating to 8 mg. Costs were estimated from health care resources utilization related to OAB, and were expressed in 2015 Euros. Quality-adjusted life-years (QALYs) were obtained from overactive bladder questionnaire-short form. Univariate and probabilistic sensitivity analyses were carried out. Results Three hundred and ninety symptomatic OAB patients treated with fesoterodine and newly diagnosed (141 in fast escalating group and 249 in standard escalating) were analyzed. Adjusted health care total costs were not statistically different; difference −€4.1 (confidence interval: −153.3; 25.1) P=0.842. QALYs were higher in fast escalating to high dose vs standard escalating group, resulting in a cost of −€16,020/QALY gained for fast escalating vs standard escalating group. Conclusion When the cost-effectiveness threshold is set at a maximum value of €30,000/QALY gained, fesoterodine fast escalating group was cost-effective vs standard escalating group 67.6% of the time. The treatment with fesoterodine, in female patients newly diagnosed, fast escalating to 8 mg was a cost-effective option relative to escalating traditionally from 4 to 8 mg, in the management of OAB in routine clinical practice, from the Spanish National Health System perspective. PMID:27713646

  8. Cost-effectiveness analysis of fesoterodine flexible dose in newly diagnosed patients with overactive bladder in routine clinical practice in Spain.

    PubMed

    Peral, Carmen; Sánchez-Ballester, Francisco; García-Mediero, José M; Ramos, Jaime; Rejas, Javier

    2016-01-01

    To carry out cost-effectiveness analysis from the Spanish National Health System perspective, of treating overactive bladder (OAB), in newly diagnosed patients with two flexible doses of fesoterodine in routine clinical practice. Economic evaluation of flexible-dose fesoterodine in newly diagnosed patients, including two treatment groups: standard escalating from 4 to 8 mg or fast escalating to 8 mg. Costs were estimated from health care resources utilization related to OAB, and were expressed in 2015 Euros. Quality-adjusted life-years (QALYs) were obtained from overactive bladder questionnaire-short form. Univariate and probabilistic sensitivity analyses were carried out. Three hundred and ninety symptomatic OAB patients treated with fesoterodine and newly diagnosed (141 in fast escalating group and 249 in standard escalating) were analyzed. Adjusted health care total costs were not statistically different; difference -€4.1 (confidence interval: -153.3; 25.1) P=0.842. QALYs were higher in fast escalating to high dose vs standard escalating group, resulting in a cost of -€16,020/QALY gained for fast escalating vs standard escalating group. When the cost-effectiveness threshold is set at a maximum value of €30,000/QALY gained, fesoterodine fast escalating group was cost-effective vs standard escalating group 67.6% of the time. The treatment with fesoterodine, in female patients newly diagnosed, fast escalating to 8 mg was a cost-effective option relative to escalating traditionally from 4 to 8 mg, in the management of OAB in routine clinical practice, from the Spanish National Health System perspective.

  9. Acceptance and commitment therapy (ACT) for clinically distressed health care workers: Waitlist-controlled evaluation of an ACT workshop in a routine practice setting.

    PubMed

    Waters, Cerith S; Frude, Neil; Flaxman, Paul E; Boyd, Jane

    2017-08-30

    To examine the effects of a 1-day acceptance and commitment therapy (ACT) workshop on the mental health of clinically distressed health care employees, and to explore ACT's processes of change in a routine practice setting. A quasi-controlled design, with participants block allocated to an ACT intervention or waiting list control group based on self-referral date. Participants were 35 health care workers who had self-referred for the ACT workshop via a clinical support service for staff. Measures were completed by ACT and control group participants at pre-intervention and 3 months post-intervention. Participants allocated to the waitlist condition went on to receive the ACT intervention and were also assessed 3 months later. At 3 months post-intervention, participants in the ACT group reported a significantly lower level of psychological distress compared to the control group (d = 1.41). Across the 3-month evaluation period, clinically significant change was exhibited by 50% of ACT participants, compared to 0% in the control group. When the control group received the same ACT intervention, 69% went on to exhibit clinically significant change. The ACT intervention also resulted in significant improvements in psychological flexibility, defusion, and mindfulness skills, but did not significantly reduce the frequency of negative cognitions. Bootstrapped mediation analyses indicated that the reduction in distress in the ACT condition was primarily associated with an increase in mindfulness skills, especially observing and non-reactivity. These findings provide preliminary support for providing brief ACT interventions as part of routine clinical support services for distressed workers. A 1-day ACT workshop delivered in the context of a routine staff support service was effective for reducing psychological distress among health care workers. The brief nature of this group intervention means it may be particularly suitable for staff support and primary care mental

  10. Guide to good practices for shift routines and operating practices

    SciTech Connect

    1998-12-01

    This Guide to Good Practices is written to enhance understanding of, and provide direction for, ``Shift Routines and Operating Practices,`` Chapter 2 of Department of Energy (DOE) Order 5480.19, Conduct of Operations Requirements for DOE Facilities. The practices in this guide should be considered when planning or reviewing shift routines and operating practices. ``Shift Routines and Operating Practices`` is an element of an effective Conduct of Operations program. The complexity and array of activities performed in DOE facilities dictate the necessity for a high standard of professional conduct and sound operating practices to promote safe and efficient operations. Recently, guidance pertaining to this element has been strengthened for nuclear power reactors. This additional guidance is given in Appendix C for information purposes. Though this guidance and good practices pertain to nuclear power reactors, DOE sites may choose to use a graded approach for implementing these in nuclear facilities.

  11. Spot scanning proton therapy plan assessment: design and development of a dose verification application for use in routine clinical practice

    NASA Astrophysics Data System (ADS)

    Augustine, Kurt E.; Walsh, Timothy J.; Beltran, Chris J.; Stoker, Joshua B.; Mundy, Daniel W.; Parry, Mark D.; Bues, Martin; Fatyga, Mirek

    2016-04-01

    The use of radiation therapy for the treatment of cancer has been carried out clinically since the late 1800's. Early on however, it was discovered that a radiation dose sufficient to destroy cancer cells can also cause severe injury to surrounding healthy tissue. Radiation oncologists continually strive to find the perfect balance between a dose high enough to destroy the cancer and one that avoids damage to healthy organs. Spot scanning or "pencil beam" proton radiotherapy offers another option to improve on this. Unlike traditional photon therapy, proton beams stop in the target tissue, thus better sparing all organs beyond the targeted tumor. In addition, the beams are far narrower and thus can be more precisely "painted" onto the tumor, avoiding exposure to surrounding healthy tissue. To safely treat patients with proton beam radiotherapy, dose verification should be carried out for each plan prior to treatment. Proton dose verification systems are not currently commercially available so the Department of Radiation Oncology at the Mayo Clinic developed its own, called DOSeCHECK, which offers two distinct dose simulation methods: GPU-based Monte Carlo and CPU-based analytical. The three major components of the system include the web-based user interface, the Linux-based dose verification simulation engines, and the supporting services and components. The architecture integrates multiple applications, libraries, platforms, programming languages, and communication protocols and was successfully deployed in time for Mayo Clinic's first proton beam therapy patient. Having a simple, efficient application for dose verification greatly reduces staff workload and provides additional quality assurance, ultimately improving patient safety.

  12. The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records.

    PubMed

    Sumi, Eriko; Teramukai, Satoshi; Yamamoto, Keiichi; Satoh, Motohiko; Yamanaka, Kenya; Yokode, Masayuki

    2013-12-11

    A number of clinical trials have encountered difficulties enrolling a sufficient number of patients upon initiating the trial. Recently, many screening systems that search clinical data warehouses for patients who are eligible for clinical trials have been developed. We aimed to estimate the number of eligible patients using routine electronic medical records (EMRs) and to predict the difficulty of enrolling sufficient patients prior to beginning a trial. Investigator-initiated clinical trials that were conducted at Kyoto University Hospital between July 2004 and January 2011 were included in this study. We searched the EMRs for eligible patients and calculated the eligible EMR patient index by dividing the number of eligible patients in the EMRs by the target sample size. Additionally, we divided the trial eligibility criteria into corresponding data elements in the EMRs to evaluate the completeness of mapping clinical manifestation in trial eligibility criteria into structured data elements in the EMRs. We evaluated the correlation between the index and the accrual achievement with Spearman's rank correlation coefficient. Thirteen of 19 trials did not achieve their original target sample size. Overall, 55% of the trial eligibility criteria were mapped into data elements in EMRs. The accrual achievement demonstrated a significant positive correlation with the eligible EMR patient index (r = 0.67, 95% confidence interval (CI), 0.42 to 0.92). The receiver operating characteristic analysis revealed an eligible EMR patient index cut-off value of 1.7, with a sensitivity of 69.2% and a specificity of 100.0%. Our study suggests that the eligible EMR patient index remains exploratory but could be a useful component of the feasibility study when planning a clinical trial. Establishing a step to check whether there are likely to be a sufficient number of eligible patients enables sponsors and investigators to concentrate their resources and efforts on more achievable trials.

  13. Management of Chronic Spontaneous Urticaria in Routine Clinical Practice Following the EAACI/GA(2)LEN/EDF/WAO Guidelines.

    PubMed

    Marín-Cabañas, I; Berbegal-de Gracia, L; de León-Marrero, F; Hispán, P; Silvestre, J F

    2017-05-01

    Chronic spontaneous urticaria is a prevalent and difficult-to-treat condition that has a very negative impact on patient quality of life. To describe the epidemiological and clinical characteristics of patients presenting with chronic spontaneous urticaria and the response to treatment administered according to the EAACI/GA(2)LEN/EDF/WAO consensus guideline. Descriptive cross-sectional study of all the patients with chronic spontaneous urticaria who consulted a skin allergy unit in the dermatology department of a tertiary hospital in Spain between July 2011 and July 2015. The study included 100 patients with chronic spontaneous urticaria; inducible urticaria was present in 43% of cases, and angioedema in 40%. On diagnosis, 53% of patients were taking nonsteroidal anti-inflammatory drugs. All patients were treated with second generation H1-antihistamines, but the standard dose was sufficient in only 18% of cases. Higher doses (up to 4 times the standard dose) achieved control of the urticaria in 74% of the patients studied. Higher doses of second generation H1-antihistamines were required to control the condition in patients with angioedema, and the presence of angioedema was associated with a lack of response to treatment with these drugs (OR, 6.1%; P<.001). One in 4 patients failed to respond to second generation H1-antihistamines and required treatment with omalizumab or ciclosporin to control their condition. Doses of H1-antihistamines higher than the standard dose are required in most cases to achieve control of chronic spontaneous urticaria. Angioedema is associated with failure to respond to treatment with antihistamines. In refractory cases, control of the condition can be achieved with omalizumab or ciclosporin. Patients with chronic spontaneous urticaria do not generally avoid the use of nonsteroidal anti-inflammatory agents. Copyright © 2017 AEDV. Publicado por Elsevier España, S.L.U. All rights reserved.

  14. Clinical Validity and Utility of Tumor-Infiltrating Lymphocytes in Routine Clinical Practice for Breast Cancer Patients: Current and Future Directions

    PubMed Central

    Wein, Lironne; Savas, Peter; Luen, Stephen J.; Virassamy, Balaji; Salgado, Roberto; Loi, Sherene

    2017-01-01

    The interest in tumor-infiltrating lymphocytes (TILs) as a prognostic biomarker in breast cancer has grown in recent years. Biomarkers must undergo comprehensive evaluation in terms of analytical validity, clinical validity and clinical utility before they can be accepted as part of clinical practice. The International Immuno-Oncology Biomarker Working Group has developed a practice guideline on scoring TILs in breast cancer in order to standardize TIL assessment. The prognostic value of TILs as a biomarker in early-stage breast cancer has been established by assessing tumor samples in thousands of patients from large prospective clinical trials of adjuvant therapy. There is a strong linear relationship between increase in TILs and improved disease-free survival for triple-negative and HER2-positive disease. Higher levels of TILs have also been associated with increased rates of pathological complete response to neoadjuvant therapy. TILs have potential clinical utility in breast cancer in a number of areas. These include prediction of responders to immune checkpoint blockade, identification of primary HER2-positive and triple-negative patients who have excellent prognoses and may thus be appropriate for treatment de-escalation, and potentially incorporation into a neoadjuvant endpoint which may be a better surrogate maker for drug development. PMID:28824872

  15. Safety and effectiveness of controlled-release paroxetine in routine clinical practice: results of a postmarketing surveillance study of patients with depression

    PubMed Central

    Kato, Masaki; Kimura, Toshifumi; Kimura, Takeshi; Hara, Terufumi

    2015-01-01

    Objective Selective serotonin reuptake inhibitors are commonly used in the pharmacotherapy of depression. However, adverse events can lead to their early discontinuation. This study evaluated the safety and effectiveness of paroxetine controlled-release (CR) tablets in Japanese patients with depression/depressive state (hereafter referred to as depression) in routine clinical practice in Japan. Patients and methods This was an open-label, noninterventional, prospective, postmarketing surveillance study. A total of 3,213 patients aged 12–92 years with depression were prescribed paroxetine CR for 8 weeks at the physician’s discretion. Safety was evaluated on the basis of the reporting of adverse drug reactions. Effectiveness was evaluated on the basis of the physician’s assessment using the Clinical Global Impression-Global Improvement (CGI-GI) and the Clinical Global Impression-Severity of Illness (CGI-SI) scales, as well as on the basis of the patients’ self-reported satisfaction. The primary effectiveness outcome was the improvement rate based on the physician’s assessment using the CGI-GI. Results The incidence of adverse drug reactions was 11.2% (359/3,213; 95% confidence interval [CI]: 10.1%–12.3%). The common adverse drug reactions that accounted for 1.0% or more of the incidence were nausea (3.5%) and somnolence (2.7%). The proportion of patients who continued paroxetine CR at week 8 was 80.2% (2,577/3,213; 95% CI: 78.8%–81.6%). The improvement rate at week 8 (last observation carried forward) was 72.8% (2,132/2,927; 95% CI: 71.2%–74.4%). The proportion of patients with CGI-SI scores of moderately or severely ill decreased from 63.6% at baseline to 17.9% at week 8. The proportion of patients who were satisfied with paroxetine CR treatment was 69.8% (2,040/2,921; 95% CI: 68.1%–71.5%). Conclusion The results of this study suggest that paroxetine CR is a well-tolerated and efficacious treatment for depression in routine clinical practice. PMID

  16. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

    PubMed Central

    2012-01-01

    Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

  17. Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial.

    PubMed

    Sanchez, Alvaro; Silvestre, Carmen; Sauto, Regina; Martínez, Catalina; Grandes, Gonzalo

    2012-11-16

    The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.

  18. Cervical Cancer Risk for 330,000 Women Undergoing Concurrent HPV Testing and Cervical Cytology in Routine Clinical Practice at a Large Managed Care Organization

    PubMed Central

    Katki, Hormuzd A.; Kinney, Walter K.; Fetterman, Barbara; Lorey, Thomas; Poitras, Nancy E.; Cheung, Li; Demuth, Franklin; Schiffman, Mark; Wacholder, Sholom; Castle, Philip E.

    2011-01-01

    Background Concurrent HPV testing and cervical cytology (co-testing) is an approved and promising alternative to cytology alone in women aged 30 and older. However, broad acceptance of co-testing is being hindered by a lack of evidence about its performance in routine clinical practice. We evaluated the safety of three-year screening intervals for women testing HPV-negative with normal cytology (Pap-negative) and assessed the ability of co-testing to identify women at high risk of CIN3+ or cervical cancer over five years. Methods We analyzed five-year cumulative incidence of cervical cancer and cervical intraepithelial neoplasia grade 3 or worse (CIN3+) for 331,818 women aged 30 and older who enrolled in co-testing at Kaiser Permanente Northern California starting 2003-2005 (and had adequate enrollment co-test results) and were followed through December 31, 2009. Findings Five-year cumulative incidence of cancer for all 315,061 HPV-negative women was extremely low (3.8 per 100,000 women per year), only slightly higher than for the 306,969 women who were both HPV-negative and Pap-negative (3.2 per 100,000 women per year), and half the cancer risk of all 319,177 women who were Pap-negative (7.5 per 100,000 women per year). Almost all (99.5%; 313,465) HPV-negative women had either normal cytology or minor abnormalities. Abnormal cytology greatly increased cumulative incidence of CIN3+ over five years for the 16,757 HPV-positive women (12% vs. 5.9%, p<0.0001). In contrast, although statistically significant, abnormal cytology did not increase 5-year CIN3+ risk for HPV-negative women to a substantial level (0.86% vs. 0.16%). 73% of HPV-positive women had no cytologic abnormality (12,208 women). HPV-positive women with no cytologic abnormality experienced 34% of the CIN3+, 29% of the cancers, and 63% of the adenocarcinomas. Interpretation For women aged 30 and older in routine clinical practice, a single negative HPV test sufficed to provide strong reassurance against

  19. Treatment Frequency and Dosing Interval of Ranibizumab and Aflibercept for Neovascular Age-Related Macular Degeneration in Routine Clinical Practice in the USA.

    PubMed

    Ferreira, Alberto; Sagkriotis, Alexandros; Olson, Melvin; Lu, Jingsong; Makin, Charles; Milnes, Fran

    2015-01-01

    To compare treatment patterns of intravitreal ranibizumab and aflibercept for the management of neovascular age-related macular degeneration (nAMD) in a real-world setting over the first 12 months of treatment. A proprietary clinical database was used to identify treatment-naïve patients with nAMD in the USA with claims for ranibizumab or aflibercept between November 1, 2011 and November 30, 2013 and with follow-up of at least 12 months. Patients were considered treatment-naïve if they had no anti-VEGF treatment code for 6 months before the index date. Mean numbers of injections and of non-injection visits to a treating physician were compared between the two treatment cohorts (ranibizumab or aflibercept). In addition, the mean interval between doses was also investigated. Patient characteristics were similar for those receiving either ranibizumab (n = 5421) or aflibercept (n = 3506) at the index date. The mean (± standard deviation) numbers of injections received by patients treated with ranibizumab (4.9 ± 3.3) or aflibercept (5.2 ± 2.9) were not clinically different. The mean number of non-injection visits was 2.8 ± 2.8 and 2.1 ± 2.5 for ranibizumab and aflibercept, respectively. Mean dosing interval was 51.0 days (± 41.8 days) in patients receiving ranibizumab and 54.1 days (± 36.0 days) in those receiving aflibercept. Results were robust to sensitivity analyses for definition of treatment-naïve, length of follow-up and treatment in the index eye only. Limited data exist regarding real-world treatment patterns of aflibercept for the management of nAMD. Our results suggest that, in routine clinical practice, patients receive a comparable number of injections in the first year of treatment with ranibizumab or aflibercept.

  20. Study of Once Daily Levemir (SOLVE™): insights into the timing of insulin initiation in people with poorly controlled type 2 diabetes in routine clinical practice.

    PubMed

    Khunti, K; Damci, T; Meneghini, L; Pan, C Y; Yale, J-F

    2012-07-01

    The aim of this analysis is to determine the timing of insulin initiation in routine clinical practice, especially in relation to glycaemic control and use of oral antidiabetic drugs (OADs). Study of Once Daily Levemir was a 24-week international observational study involving 10 countries which evaluated the safety and effectiveness of initiating once-daily insulin detemir in people with type 2 diabetes mellitus (T2DM) being treated with one or more OADs (clinical trial number NCT00825643 and NCT00740519). A total of 17 374 participants were enrolled in the study: aged 62 ± 12 years, 53% male, T2DM duration 10 ± 7 years, body mass index 29.3 ± 5.4 kg/m(2) . Pre-insulin HbA1c was 8.9 ± 1.6%. The proportion of patients with HbA1c ≥9.0% ranged from 64% (UK) to 23% (Poland). Pre-insulin OAD treatment included metformin (81%), sulphonylureas (59%), glinides (16%), thiazolidinediones (TZD) (12%), α-glucosidase inhibitors (12%) and dipeptidyl peptidase (DPP)-IV inhibitors (7%). The mean starting dose of insulin detemir for the total cohort was 0.16 ± 0.09 U/kg. Differences in OAD use and insulin doses at initiation were evident among participating countries. The largest proportional changes in OAD prescribing at insulin initiation were seen with glinides (+15%), sulphonylureas (-19%), TZD (-31%) and DPP-IV inhibitors (-28%). Despite well-documented benefits of timely glycaemic control and consensus guidelines encouraging earlier use of insulin, considerable clinical inertia exists with respect to initiating appropriate insulin therapy in people with T2DM. Considerable regional differences exist in the timing of insulin initiation and in the use of OADs. © 2012 Blackwell Publishing Ltd.

  1. Evaluation of the clinical effectiveness in routine practice of fluocinolone acetonide 190 µg intravitreal implant in people with diabetic macular edema.

    PubMed

    Holden, Sarah E; Currie, Craig J; Owens, David R

    2017-10-01

    The aim of the Iluvien Clinical Evidence study in the UK (ICE-UK) was to assess the real-world effectiveness of fluocinolone acetonide (FAc) 190 µg intravitreal implant for the treatment of clinically significant chronic diabetic macular edema (DME) in routine clinical practice. This retrospective study collected data from patient medical records in 13 ophthalmology centers for people with DME prescribed FAc intravitreal implant between April 1, 2013 and April 15, 2015. Visual acuity (VA) and intraocular pressure (IOP) measurements were collected for 12 months prior to and after implant. Two hundred and eight people, contributing 233 eyes, treated with FAc implant were included. Mean age was 68.1 years and 62% were male. In the 12 months prior to FAc implant, VA declined. Median (interquartile range, IQR) VA was 0.66 (0.48-1.00) LogMAR units (equivalent to 52.0 ETDRS letters) at implant, improving to 0.60 (0.38-0.90) LogMAR units (55.0 letters) at 12 months post-implant (p < 0.001). In total, 44%, 30%, and 18% of people achieved an improvement in ETDRS score of ≥5, ≥10, and ≥15 letters, respectively, over the same period. A small but significant (p < .001) increase in median IOP was observed (median = 15.0, IQR = 13.0-18.0 mmHg at implant to 18.0, 15.0-21.0 mmHg at 12 months). In the 12 months following implant, additional IOP-lowering therapy was prescribed in 15% of subjects previously not requiring such therapy. Following FAc implant, an overall significant improvement in VA was observed over a period of 12 months, accompanied by a significant but small increase in IOP.

  2. 29 CFR 18.406 - Habit; routine practice.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OFFICE OF ADMINISTRATIVE LAW JUDGES Rules of Evidence Relevancy and Its Limits § 18.406 Habit; routine practice. Evidence of the habit of a person or of the routine practice of an organization, whether...

  3. General practitioners' and nurses' experiences of using computerised decision support in screening for diabetic foot disease: implementing Scottish Clinical Information - Diabetes Care in routine clinical practice.

    PubMed

    Crawford, Fay; Bekker, Hilary L; Young, Matthew; Sheikh, Aziz

    2010-01-01

    The Scottish Care Information - Diabetes Collaboration (SCI-DC) developed a computer-based information system to create a shared electronic record for use by all involved in the care of patients with diabetes mellitus. The objectives of this study were to understand primary care practitioners' views towards screening for diabetic foot disease and their experience of the SCI-DC system. We conducted an exploratory study using qualitative methods. Semi-structured interviews were audiotape-recorded, transcribed and subjected to thematic analysis. Seven practice nurses and six general practitioners (GPs) with special responsibility for diabetes care in NHS Lothian participated. Primary care clinicians reported good systems in place to screen for diabetes-related complications and to refer their patients to specialist care. Foot ulceration was rarely observed; other diabetes related conditions were seen as a higher priority. Most had heard of the SCI-DC foot assessment tool, but its failure to integrate with other primary care information technology (IT) systems meant it was not used in these general practices. Adoption of the SCI-DC foot assessment tool in primary care is not perceived as clinically necessary. Although information recorded by specialist services on SCI-DC is helpful, important structural barriers to its implementation mean the potential benefits associated with its use are unlikely to be realised; greater engagement with primary care priorities for diabetes management is needed to assist its successful implementation and adoption.

  4. 29 CFR 18.406 - Habit; routine practice.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 1 2011-07-01 2011-07-01 false Habit; routine practice. 18.406 Section 18.406 Labor Office... OFFICE OF ADMINISTRATIVE LAW JUDGES Rules of Evidence Relevancy and Its Limits § 18.406 Habit; routine practice. Evidence of the habit of a person or of the routine practice of an organization, whether...

  5. 29 CFR 18.406 - Habit; routine practice.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 1 2012-07-01 2012-07-01 false Habit; routine practice. 18.406 Section 18.406 Labor Office... OFFICE OF ADMINISTRATIVE LAW JUDGES Rules of Evidence Relevancy and Its Limits § 18.406 Habit; routine practice. Evidence of the habit of a person or of the routine practice of an organization, whether...

  6. 29 CFR 18.406 - Habit; routine practice.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 1 2013-07-01 2013-07-01 false Habit; routine practice. 18.406 Section 18.406 Labor Office... OFFICE OF ADMINISTRATIVE LAW JUDGES Rules of Evidence Relevancy and Its Limits § 18.406 Habit; routine practice. Evidence of the habit of a person or of the routine practice of an organization, whether...

  7. 29 CFR 18.406 - Habit; routine practice.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 29 Labor 1 2014-07-01 2013-07-01 true Habit; routine practice. 18.406 Section 18.406 Labor Office... OFFICE OF ADMINISTRATIVE LAW JUDGES Rules of Evidence Relevancy and Its Limits § 18.406 Habit; routine practice. Evidence of the habit of a person or of the routine practice of an organization, whether...

  8. Effectiveness and tolerability of rotigotine transdermal patch for the treatment of restless legs syndrome in a routine clinical practice setting in Germany.

    PubMed

    Stiasny-Kolster, Karin; Berg, Daniela; Hofmann, Werner E; Berkels, Reinhard; Grieger, Frank; Lauterbach, Thomas; Schollmayer, Erwin; Bachmann, Cornelius G

    2013-06-01

    We aimed to assess effectiveness and tolerability of rotigotine in patients with moderate to severe idiopathic restless legs syndrome (RLS) under daily practice conditions in Germany. In this 3-month noninterventional study, effectiveness was assessed using RLS-6 (primary variables were symptom severity when falling asleep [item 2] and during the night [item 3]). Data were collected at baseline and at the end of treatment. Safety assessments included adverse events (AEs). Six hundred and eighty-four patients were treated with rotigotine and 418 (61%) completed the study. The full analysis set (FAS) comprised 564 patients (106 de novo; 458 pretreated [454 had complete rotigotine dosing data]). Mean rotigotine dose of longest duration was 2.4±1.4 mg/24 h. Rotigotine improved all RLS-6 items (mean change from baseline [item 2], -2.4±3.6; [item 3], -2.7±3.4), with the most pronounced improvement observed in daytime symptoms while at rest (item 4, -2.9±3.2). AEs were typical of dopaminergic treatment and transdermal administration. De novo patients generally started rotigotine on 1 mg/24 h (85% [90/106]) and pretreated patients on 1 (50% [227/454]) or 2 mg/24 h (40% [183/454]). Most patients who were pretreated with levodopa (57%), pramipexole (84%), or ropinirole (78%) monotherapy discontinued these medications on initiation of rotigotine. Rotigotine was effective and well-tolerated when used in routine clinical practice. Copyright © 2013 Elsevier B.V. All rights reserved.

  9. A comparison of the long-term durability of nevirapine, efavirenz and lopinavir in routine clinical practice in Europe: a EuroSIDA study.

    PubMed

    Reekie, J; Reiss, P; Ledergerber, B; Sedlacek, D; Parczewski, M; Gatell, J; Katlama, C; Fätkenheuer, G; Lundgren, J D; Mocroft, A

    2011-05-01

    lopinavir, in patients in routine clinical practice across Europe who initially tolerated and virologically responded to their regimen.

  10. Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice

    PubMed Central

    Ruiz, Miguel A; Álvarez, Enrique; Carrasco, Jose L; Olivares, José M; Pérez, María; Rejas, Javier

    2015-01-01

    Background Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD) being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC) therapies on changes in sleep in outpatients with GAD under routine clinical practice. Methods Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale) and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S]) were estimated by a conditional latent curve model applying structural equation modeling. Results A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval) score reductions in subjects receiving pregabalin: −15.9 (−15.2; −16.6) vs −14.5 (−13.5; −15.5), P=0.027, in Hamilton Anxiety Scale; and −29.7 (−28.1; −31.3) vs −24.0 (−21.6; −26.4), P<0.001, in MOS-S. The conditional latent curve model showed that the pregabalin effect on sleep disturbances was significant (γ =−3.99, P<0.001), after discounting the effect on reduction in anxiety symptoms. A mediation model showed that 70% of the direct effect of pregabalin on sleep remained after discounting the mediated effect of anxiety improvement. Conclusion A substantial proportion of the incremental

  11. Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study

    PubMed Central

    Antinori, Andrea; Meraviglia, Paola; Monforte, Antonella d’Arminio; Castagna, Antonella; Mussini, Cristina; Bini, Teresa; Gianotti, Nicola; Rusconi, Stefano; Colella, Elisa; Airoldi, Giuseppe; Mancusi, Daniela; Termini, Roberta

    2016-01-01

    Current antiretroviral (ARV) therapy for the treatment of human immunodeficiency virus (HIV-1)-infected patients provides long-term control of viral load (VL). Darunavir (DRV) is a nonpeptidomimetic protease inhibitor approved for use with a ritonavir booster (DRV/r). This study evaluated the effectiveness of DRV/r in combination with other ARV agents in routine clinical practice in Italy. In this descriptive observational study, data on utilization of DRV/r, under the conditions described in the marketing authorization, were collected from June 2009 to December 2012. Effectiveness (VL <50 copies/mL), tolerability, and durability in four patient groups (two DRV/r-experienced, one ARV-experienced DRV/r-naïve, and one ARV-naïve) were analyzed. Secondary objectives included immunological response, safety, and persistence/discontinuation rates. In total, 875 of 883 enrolled patients were included in the analysis: of these, 662 (75.7%) completed the follow-up until the end of 2012 and 213 (24.3%) withdrew from the study earlier. Initial DRV dose was 600 mg twice daily (67.1%) or 800 mg once daily (32.9%). Only 16 patients (1.8%) withdrew from the study due to virological failure. Virological response proportions were higher in patients virologically suppressed at study entry versus patients with baseline VL ≥50 copies/mL in each ARV-experienced group, while there was no consistent difference across study groups and baseline VL strata according to baseline CD4+ cell count. CD4+ cell count increased from study entry to last study visit in all the four groups. DRV/r was well tolerated, with few discontinuations due to study-emergent nonfatal adverse events (3.0% overall, including 2.1% drug-related) or deaths (3.0% overall, all non-drug-related); 35.3% of patients reported ≥1 adverse events. These observational data show that DRV/r was effective and well tolerated in the whole patient population described here. The DRV/r-containing regimen provided viral suppression

  12. Effectiveness, durability, and safety of darunavir/ritonavir in HIV-1-infected patients in routine clinical practice in Italy: a postauthorization noninterventional study.

    PubMed

    Antinori, Andrea; Meraviglia, Paola; Monforte, Antonella d'Arminio; Castagna, Antonella; Mussini, Cristina; Bini, Teresa; Gianotti, Nicola; Rusconi, Stefano; Colella, Elisa; Airoldi, Giuseppe; Mancusi, Daniela; Termini, Roberta

    2016-01-01

    Current antiretroviral (ARV) therapy for the treatment of human immunodeficiency virus (HIV-1)-infected patients provides long-term control of viral load (VL). Darunavir (DRV) is a nonpeptidomimetic protease inhibitor approved for use with a ritonavir booster (DRV/r). This study evaluated the effectiveness of DRV/r in combination with other ARV agents in routine clinical practice in Italy. In this descriptive observational study, data on utilization of DRV/r, under the conditions described in the marketing authorization, were collected from June 2009 to December 2012. Effectiveness (VL <50 copies/mL), tolerability, and durability in four patient groups (two DRV/r-experienced, one ARV-experienced DRV/r-naïve, and one ARV-naïve) were analyzed. Secondary objectives included immunological response, safety, and persistence/discontinuation rates. In total, 875 of 883 enrolled patients were included in the analysis: of these, 662 (75.7%) completed the follow-up until the end of 2012 and 213 (24.3%) withdrew from the study earlier. Initial DRV dose was 600 mg twice daily (67.1%) or 800 mg once daily (32.9%). Only 16 patients (1.8%) withdrew from the study due to virological failure. Virological response proportions were higher in patients virologically suppressed at study entry versus patients with baseline VL ≥50 copies/mL in each ARV-experienced group, while there was no consistent difference across study groups and baseline VL strata according to baseline CD4(+) cell count. CD4(+) cell count increased from study entry to last study visit in all the four groups. DRV/r was well tolerated, with few discontinuations due to study-emergent nonfatal adverse events (3.0% overall, including 2.1% drug-related) or deaths (3.0% overall, all non-drug-related); 35.3% of patients reported ≥1 adverse events. These observational data show that DRV/r was effective and well tolerated in the whole patient population described here. The DRV/r-containing regimen provided viral

  13. Impact of initial visual acuity on anti-VEGF treatment outcomes in patients with macular oedema secondary to retinal vein occlusions in routine clinical practice.

    PubMed

    Wai, Karen M; Khan, Mehnaz; Srivastava, Sunil; Rachitskaya, Aleksandra; Silva, Fabiana Q; Deasy, Ryan; Schachat, Andrew P; Babiuch, Amy; Ehlers, Justis P; Kaiser, Peter K; Yuan, Alex; Singh, Rishi P

    2017-05-01

    To determine the impact of initial visual acuity (VA) on anti-vascular endothelial growth factor (VEGF) treatment outcomes in patients with macular oedema secondary to retinal vein occlusions in routine clinical practice. A retrospective study was conducted at a single academic institution to identify 177 treatment naïve patients with macular oedema secondary to branch retinal vein occlusion (BRVO), hemiretinal vein occlusion (HRVO) and central retinal vein occlusion (CRVO) treated with intravitreal anti-VEGFs. Exclusion criteria included prior intravitreal injection or presence of active confounding ocular disease. Patients were stratified by initial VA; main outcomes measured were average change in VA and mean absolute change in central subfield thickness (CST) at 6 and 12 months. Patients with BRVO with initial VA of 20/40 or better had no significant changes in average letters gained and CST from baseline (+2.6 letters, p=0.42; -48.94 µm, p=0.12) compared with patients with initial VA between 20/50 and 20/300 (+13.2 letters, p<0.001; -98.20 µm, p<0.001) after 12 months. Patients with CRVO/HRVO with initial VA of 20/320 or worse had the most improvement in average letters gained and CST from baseline (+42.2 letters, p<0.001; -182.84 µm, p=0.004) with anti-VEGF therapy compared with patients with initial VA between 20/50 and 20/300 (+9.4 letters, p=0.016; -160.87 µm, p<0.001) and patients with initial VA of 20/40 or better (-9.6 letters, p=0.14; -47.92 µm, p=0.38). For macular oedema secondary to retinal vein occlusion, anti-VEGF treatment can result in a greater improvement in average letters gained and in CST for those with poor initial VA compared with those with better initial VA. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Clinical application in routine practice of the proximal flow convergence method to calculate the mitral surface area in mitral valve stenosis.

    PubMed

    Bennis, Ahmed; Drighil, Abdennasser; Tribouilloy, Christophe; Drighil, Asmaa; Chraibi, Nacer

    2002-12-01

    Two-dimensional (2D) echocardiography planimetry, the Doppler pression half-time (PHT), and the continuity equation methods were used to estimate mitral valve area (MVA) in patients with mitral stenosis (MS). Recently, the proximal isovelocity surface area (PISA) method has been shown to be accurate for calculating MVA. The purpose of this study is (1) to compare in a large non-selected population the accuracy of the PISA and planimetry methods for echocardiographic estimation of MVA; (2) to determine the effect of atrial fibrillation (AF), Wilkins score, associated mitral regurgitation (MR), aortic regurgitation (AR), and of commissural calcifications on the accuracy of the PISA method. One hundred and eight consecutive patients with rheumatic MS were studied (76 females and 32 males; mean age: 36 +/- 12 years); 64 were in sinus rhythm; 51 had associated MR and 46 had AR. By the PISA method. MVA was calculated assuming a uniform radius flow convergence region along a hemispherical surface. The mean value of 2D MVA was 1.32 +/- 0.59 cm2 (0.4-3.1 cm2) and that of PISA MVA 1.33 +/- 0.62 cm2 (0.38-3 cm2). MVA calculated using the PISA method correlated well with 2D MVA (r = 0.93, y = 0.97x + 0.04, p < 0.0001, SEE = 0.21 cm2). The correlation was also good in patients with AF (r = 0.93, y = 0.99x + 0.03, p < 0.0001, SEE = 0.21 cm2), with MR (r = 0.94, y = 1.0 14x + 0.003, p < 0.0001, SEE = 0.19 cm2), with AR (r = 0.93, y = 0.90x + 0.11, p < 0.0001, SEE = 0.2 cm2), when Wilkins score was >8 (r = 0.92, = 0.96x + 0.06, p < 0.0001, SEE = 0.19 cm2), and in patients with commissural calcifications (r = 0.90, y = 0.88x + 0.009, p < 0.0001, SEE = 0.20 cm2). Our study shows that in routine practice, MVA calculated by the PISA method correlated well with the area obtained by planimetry even in the presence of commissural calcifications, associated MR, AR, AF and of high Wilkins score. Therefore, the PISA method provides a reliable measurement of the MVA in MS under different

  15. Genomic arrays in chronic lymphocytic leukemia routine clinical practice: are we ready to substitute conventional cytogenetics and fluorescence in situ hybridization techniques?

    PubMed

    Puiggros, Anna; Puigdecanet, Eulàlia; Salido, Marta; Ferrer, Ana; Abella, Eugènia; Gimeno, Eva; Nonell, Lara; Herranz, María José; Galván, Ana Belén; Rodríguez-Rivera, María; Melero, Carme; Pairet, Silvia; Bellosillo, Beatriz; Serrano, Sergi; Florensa, Lourdes; Solé, Francesc; Espinet, Blanca

    2013-05-01

    Chronic lymphocytic leukemia (CLL) is characterized by a highly variable clinical course. Del(11q) and del(17p), routinely studied by conventional G-banding cytogenetics (CGC) and fluorescence in situ hybridization (FISH), have been related to progression and shorter overall survival. Recently, array-based karyotyping has gained acceptance as a high-resolution new tool for detecting genomic imbalances. The aim of the present study was to compare genomic arrays with CGC and FISH to ascertain whether the current techniques could be substituted in routine procedures. We analyzed 70 patients with CLL using the Cytogenetics Whole-Genome 2.7M Array and CytoScan HD Array (Affymetrix), CGC and FISH with the classical CLL panel. Whereas 31.4% and 68.6% of patients presented abnormalities when studied by CGC and FISH, respectively, these rates increased when arrays were also analyzed (78.6% and 80%). Although abnormality detection is higher when arrays are applied, one case with del(11q) and three with del(17p) were missed by genomic arrays due to their limited sensitivity. We consider that the complete substitution of CGC and FISH by genomic arrays in routine laboratories could negatively affect the management of some patients harboring 11q or 17p deletions. In conclusion, genomic arrays are valid to detect known and novel genomic imbalances in CLL, but should be maintained as a complementary tool to the current techniques.

  16. Taking a new biomarker into routine use – A perspective from the routine clinical biochemistry laboratory

    PubMed Central

    Sturgeon, Catharine; Hill, Robert; Hortin, Glen L; Thompson, Douglas

    2010-01-01

    There is increasing pressure to provide cost-effective healthcare based on “best practice.” Consequently, new biomarkers are only likely to be introduced into routine clinical biochemistry departments if they are supported by a strong evidence base and if the results will improve patient management and outcome. This requires convincing evidence of the benefits of introducing the new test, ideally reflected in fewer hospital admissions, fewer additional investigations and/or fewer clinic visits. Carefully designed audit and cost-benefit studies in relevant patient groups must demonstrate that introducing the biomarker delivers an improved and more effective clinical pathway. From the laboratory perspective, pre-analytical requirements must be thoroughly investigated at an early stage. Good stability of the biomarker in relevant physiological matrices is essential to avoid the need for special processing. Absence of specific timing requirements for sampling and knowledge of the effect of medications that might be used to treat the patients in whom the biomarker will be measured is also highly desirable. Analytically, automation is essential in modern high-throughput clinical laboratories. Assays must therefore be robust, fulfilling standard requirements for linearity on dilution, precision and reproducibility, both within- and between-run. Provision of measurements by a limited number of specialized reference laboratories may be most appropriate, especially when a new biomarker is first introduced into routine practice. PMID:21137030

  17. Treatment of asphyxiated newborns with moderate hypothermia in routine clinical practice: how cooling is managed in the UK outside a clinical trial.

    PubMed

    Azzopardi, D; Strohm, B; Edwards, A D; Halliday, H; Juszczak, E; Levene, M; Thoresen, M; Whitelaw, A; Brocklehurst, P

    2009-07-01

    This is a phase 4 study of infants registered with the UK TOBY Cooling Register from December 2006 to February 2008. The registry was established on completion of enrolLment to the TOBY randomised trial of treatment with whole body hypothermia following perinatal asphyxia at the end of November 2006. We collected information about patient characteristics, condition at birth, resuscitation details, severity of encephalopathy, hourly temperature record, clinical complications and outcomes before hospital discharge. 120 infants born at a median of 40 (IQR 38-41) weeks' gestation and weighing a median of 3287 (IQR 2895-3710) g at birth were studied. Cooling was started at a median of 3 h 54 min (IQR 2 h-5 h 32 min) after birth. All but three infants underwent whole body cooling. The mean (SD) rectal temperature from 6 to 72 h of the cooling period was 33.57 degrees C (0.51 degrees C). The daily encephalopathy score fell: median (IQR) 11 (6-15), 9.7 (5-14), 8 (5-13) and 7 (2-12) on days 1-4 after birth, respectively. 51% of the infants established full oral feeding at a median (range) of 9 (4-24) days. 26% of the study infants died. MRI was consistent with hypoxia-ischaemia in most cases. Clinical complications were not considered to be due to hypothermia. In the UK, therapeutic hypothermia following perinatal asphyxia is increasingly being provided. The target body temperature is successfully achieved and the clinical complications observed were not attributed to hypothermia. Treatment with hypothermia may have prevented the worsening of the encephalopathy that is commonly observed following asphyxia.

  18. Microcirculation measurements: Barriers for use in clinical routine.

    PubMed

    Henzler, Dietrich; Scheffler, Matthias; Westheider, Arne; Köhler, Thomas

    2017-09-04

    In patients with shock, inflammation and sepsis alterations in microcirculation are common problems. Although the pathophysiologic consequences are well understood, measurements of microcirculation have not entered clinical routine so far. To characterize the requirements for clinical microcirculation measurement techniques and the barriers for implementation into routine practice. Clinical review of reliability, reproducibility, validity, availability and usefulness of clinically available measurement techniques to be used in patients with sepsis or cardiac surgery with cardiopulmonary bypass. Few methods such as video microscopy are readily available at the bedside, but are hampered by the high variability of measurements and the lack of reliable automated software analysis. The correlation of microcirculation impairment measured by in-vivo microscopy with fatal outcomes has been established, but no recommendations have been given which parameters should be targeted to improve outcomes. Measurement of regional brain tissue oxygenation has been recommended for cardiac surgery, but does not specifically target microcirculation. International guidelines for the management of sepsis or cardiac anesthesia do not recommend specific goals targeting the microcirculation directly, but global hemodynamics. The reason for this may be attributed to the lack of methods that fulfill the requirements necessary to be clinically acceptable. Once the validity, i.e. any improvement in patient's outcomes attributable to microcirculation measurements, can be established, clinical measurement of microcirculation could become part of routine treatment of patients with sepsis, inflammation and shock. Until then, more clinical studies targeting microcirculation are urgently needed.

  19. Adiponectin as a routine clinical biomarker.

    PubMed

    Kishida, Ken; Funahashi, Tohru; Shimomura, Iichiro

    2014-01-01

    Adiponectin is a protein synthesized and secreted predominantly by adipocytes into the peripheral blood. However, circulating adiponectin level is inversely related with body weight, especially visceral fat accumulation. The mechanism of this paradoxical relation remains obscure. Low circulating adiponectin concentrations (hypoadiponectinemia; <4 μg/mL) are associated with a variety of diseases, including dysmetabolism (type 2 diabetes, insulin resistance, hypertension, dyslipidemia, metabolic syndrome, hyperuricemia), atherosclerosis (coronary artery disease, stroke, peripheral artery disease), sleep apnea, non-alcoholic fatty liver disease, gastritis and gastro-esophageal reflux disease, inflammatory bowel diseases, pancreatitis, osteoporosis, and cancer (endometrial cancer, postmenopausal breast cancer, leukemia, colon cancer, gastric cancer, prostate cancer). On the other hand, hyperadiponectinemia is associated with cardiac, renal and pulmonary diseases. This review article focuses on the significance of adiponectin as a clinical biomarker of obesity-related diseases. Routine measurement of adiponectin in patients with lifestyle-related diseases is highly recommended.

  20. Comparison of AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR for Detection of Mycobacterium tuberculosis Complex in Routine Clinical Practice.

    PubMed

    Cho, Won-Hyung; Won, Eun-Jeong; Choi, Hyun-Jung; Kee, Seung-Jung; Shin, Jong-Hee; Ryang, Dong-Wook; Suh, Soon-Pal

    2015-05-01

    The AdvanSure tuberculosis/non-tuberculous mycobacterium (TB/NTM) PCR (LG Life Science, Korea) and COBAS TaqMan Mycobacterium tuberculosis (MTB) PCR (Roche Diagnostics, USA) are commonly used in clinical microbiology laboratories. We aimed to evaluate these two commercial real-time PCR assays for detection of MTB in a large set of clinical samples over a two-year period. AdvanSure TB/NTM PCR and COBAS TaqMan MTB PCR were performed on 9,119 (75.2%) and 3,010 (24.8%) of 12,129 (9,728 respiratory and 2,401 non-respiratory) MTB specimens, with 361 (4.0%) and 102 (3.4%) acid-fast bacilli (AFB)-positive results, respectively. In MTB culture, 788 (6.5%) MTB and 514 (4.2%) NTM were identified. The total sensitivity and specificity of the AdvanSure assay were 67.8% (95% confidence interval [CI], 63.9-71.6) and 98.3% (95% CI, 98.0-98.6), while those of the COBAS TaqMan assay were 67.2% (95% CI, 60.0-73.8) and 98.4% (95% CI, 97.9-98.9), respectively. The sensitivities and specificities of the AdvanSure and COBAS TaqMan assays for AFB-positive and AFB-negative samples were comparable. Furthermore, the AdvanSure assay showed fewer invalid results compared with the COBAS TaqMan assay (5.0 vs. 20.4 invalid results/1,000 tests, P<0.001). AdvanSure assay represents a comparable yet more reliable method than COBAS TaqMan for the identification of mycobacteria in routine clinical microbiology.

  1. Matrix-assisted laser desorption ionization-time of flight mass spectrometry: a fundamental shift in the routine practice of clinical microbiology.

    PubMed

    Clark, Andrew E; Kaleta, Erin J; Arora, Amit; Wolk, Donna M

    2013-07-01

    Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the "nuts and bolts" of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care.

  2. Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry: a Fundamental Shift in the Routine Practice of Clinical Microbiology

    PubMed Central

    Clark, Andrew E.; Kaleta, Erin J.; Arora, Amit

    2013-01-01

    SUMMARY Within the past decade, clinical microbiology laboratories experienced revolutionary changes in the way in which microorganisms are identified, moving away from slow, traditional microbial identification algorithms toward rapid molecular methods and mass spectrometry (MS). Historically, MS was clinically utilized as a high-complexity method adapted for protein-centered analysis of samples in chemistry and hematology laboratories. Today, matrix-assisted laser desorption ionization–time of flight (MALDI-TOF) MS is adapted for use in microbiology laboratories, where it serves as a paradigm-shifting, rapid, and robust method for accurate microbial identification. Multiple instrument platforms, marketed by well-established manufacturers, are beginning to displace automated phenotypic identification instruments and in some cases genetic sequence-based identification practices. This review summarizes the current position of MALDI-TOF MS in clinical research and in diagnostic clinical microbiology laboratories and serves as a primer to examine the “nuts and bolts” of MALDI-TOF MS, highlighting research associated with sample preparation, spectral analysis, and accuracy. Currently available MALDI-TOF MS hardware and software platforms that support the use of MALDI-TOF with direct and precultured specimens and integration of the technology into the laboratory workflow are also discussed. Finally, this review closes with a prospective view of the future of MALDI-TOF MS in the clinical microbiology laboratory to accelerate diagnosis and microbial identification to improve patient care. PMID:23824373

  3. An Element of Practical Knowledge in Education: Professional Routines

    ERIC Educational Resources Information Center

    Lacourse, France

    2011-01-01

    The question of practical knowledge and its teaching has arisen more perceptibly since the appearance of the aim to professionalize teachers. How can imperceptible knowledge such as professional routines be taught? To establish a social fabric and effective class management, it is essential to call on creative and adaptive professional routines.…

  4. Changing Urban Bureaucracies: How New Practices Become Routinized.

    ERIC Educational Resources Information Center

    Yin, Robert K.; And Others

    The goal of this report is to describe the process by which new service practices in urban bureaucracies become routinized. The routinization process is studied by examining the life histories of six types of innovations: computer-assisted instruction; police computer systems; mobile intensive care units; closed circuit television systems; breath…

  5. An Element of Practical Knowledge in Education: Professional Routines

    ERIC Educational Resources Information Center

    Lacourse, France

    2011-01-01

    The question of practical knowledge and its teaching has arisen more perceptibly since the appearance of the aim to professionalize teachers. How can imperceptible knowledge such as professional routines be taught? To establish a social fabric and effective class management, it is essential to call on creative and adaptive professional routines.…

  6. A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study.

    PubMed

    Pagliarini, Sergio; Beatty, Stephen; Lipkova, Blandina; Perez-Salvador Garcia, Eduardo; Reynders, Stefaan; Gekkieva, Margarita; Si Bouazza, Abdelkader; Pilz, Stefan

    2014-01-01

    Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%-1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, -1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated.

  7. Bringing the state into the clinic? Incorporating the rapid diagnostic test for malaria into routine practice in Tanzanian primary healthcare facilities.

    PubMed

    Hutchinson, Eleanor; Reyburn, Hugh; Hamlyn, Eleanor; Long, Katie; Meta, Judith; Mbakilwa, Hilda; Chandler, Clare

    2017-09-01

    The roles that rapid, point-of-care tests will play in healthcare in low-income settings are likely to expand over the coming years. Yet, very little is known about how they are incorporated into practice, and what it means to use and rely upon them. This paper focuses on the rapid diagnostic test for malaria (mRDT), examining its introduction into low-level public health facilities in Tanzania within an intervention to improve the targeting of costly malaria medication. We interviewed 26 health workers to explore how a participatory training programme, mobile phone messages, posters and leaflets shaped the use and interpretation of the test. Drawing on notions of biopolitics, this paper examines how technologies of the self and mechanisms of surveillance bolstered the role mRDT in clinical decision-making. It shows how the significance of the test interacted with local knowledge, the availability of other medication, and local understandings of good clinical practice. Our findings suggest that in a context in which care is reduced to the provision of medicines, strict adherence to mRDT results may be underpinned by increasing the use of other pharmaceuticals or may leave health workers with patients for whom they are unable to provide care.

  8. Transfusion burden in non-dialysis chronic kidney disease patients with persistent anemia treated in routine clinical practice: a retrospective observational study

    PubMed Central

    2012-01-01

    Background Transfusion patterns are not well characterized in non-dialysis (ND) chronic kidney disease (CKD) patients. This study describes the proportion of patients transfused, units of blood transfused and trigger-hemoglobin (Hb) levels for transfusions in severe anemic, ND-CKD patients in routine practice. Methods A retrospective cohort study of electronic medical record data from the Henry Ford Health System identified 374 adult, ND-CKD patients with severe anemia (Hb < 10 g/dL and subsequent use of erythropoiesis-stimulating agents [ESA] therapy, blood transfusions, or a second Hb < 10 g/dL) between January 2004 and June 2008. Exclusions included those with prior diagnoses of cancer, renal or liver transplant, end-stage renal disease, acute bleeding, trauma, sickle cell disease, or aplastic anemia. A gap of ≥ 1 days between units of blood transfused was counted as a separate transfusion. Results At least 1 transfusion (mean of 2 units; range, 1-4) was administered to 20% (75/374) of ND-CKD patients with mean (± SD) follow-up of 459 (± 427) days. The mean (± SD) Hb level closest and prior to a transfusion was 8.8 (± 1.5) g/dL. Patients who were hospitalized in the 6 months prior to their first anemia diagnosis were 6.3 times more likely to receive a blood transfusion than patients who were not hospitalized (p < 0.0001). Patients with peripheral vascular disease (PVD) were twice as likely to have a transfusion as patients without PVD (p = 0.04). Conclusions Transfusions were prevalent and the trigger hemoglobin concentration was approximately 9 g/dL among ND-CKD patients with anemia. To reduce the transfusion burden, clinicians should consider other anemia treatments including ESA therapy. PMID:22273400

  9. A controlled time-series trial of clinical reminders: using computerized firm systems to make quality improvement research a routine part of mainstream practice.

    PubMed Central

    Goldberg, H. I.; Neighbor, W. E.; Cheadle, A. D.; Ramsey, S. D.; Diehr, P.; Gore, E.

    2000-01-01

    OBJECTIVE: To explore the feasibility of conducting unobtrusive interventional research in community practice settings by integrating firm-system techniques with time-series analysis of relational-repository data. STUDY SETTING: A satellite teaching clinic divided into two similar, but geographically separated, primary care group practices called firms. One firm was selected by chance to receive the study intervention. Forty-two providers and 2,655 patients participated. STUDY DESIGN: A nonrandomized controlled trial of computer-generated preventive reminders. Net effects were determined by quantitatively combining population-level data from parallel experimental and control interrupted time series extending over two-month baseline and intervention periods. DATA COLLECTION: Mean rates at which mammography, colorectal cancer screening, and cholesterol testing were performed on patients due to receive each maneuver at clinic visits were the trial's outcome measures. PRINCIPAL FINDINGS: Mammography performance increased on the experimental firm by 154 percent (0.24 versus 0.61, p = .03). No effect on fecal occult blood testing was observed. Cholesterol ordering decreased on both the experimental (0.18 versus 0.1 1, p = .02) and control firms (0.13 versus 0.07, p = .03) coincident with national guidelines retreating from recommending screening for young adults. A traditional uncontrolled interrupted time-series design would have incorrectly attributed the experimental-firm decrease to the introduction of reminders. The combined analysis properly indicated that no net prompting effect had occurred, as the difference between firms in cholesterol testing remained stochastically stable over time (0.05 versus 0.04, p = .75). A logistic-regression analysis applied to individual-level data produced equivalent findings. The trial incurred no supplementary data collection costs. CONCLUSIONS: The apparent validity and practicability of our reminder implementation study should

  10. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Navarra, Gipuzkoa and La Rioja].

    PubMed

    Ayuso, T; Marzo-Sola, M E; Castillo-Trivino, T; Soriano, G; Otano, M A; Lopez, M A; Croitoru, I M; Olascoaga, J

    2016-09-05

    To evaluate the effectiveness and safety of fingolimod in clinical practice in Navarra, Gipuzkoa and La Rioja regions. We conducted a retrospective multi-centre study with recurrent multiple sclerosis patients treated with fingolimod, following the product data sheet. The following data were evaluated: annualised relapse rate (ARR), percentage of patients free from relapses, disability using the Expanded Disability Status Scale (EDSS) and the percentage of patients without gadolinium-enhancing lesions. A total of 113 patients were treated with fingolimod: 6% were naive, and 58% and 35% were patients previously treated with an immunomodulator and natalizumab, respectively. Fingolimod lowered the ARR after the first (67%; 1 to 0.3; p < 0.0001) and second (89%; 1 to 0.1; p < 0.0001) years of treatment, and thus the number of patients free from relapses during the treatment increased. The baseline EDSS was 3 and after treatment with fingolimod was 2.5 in both years. The percentage of patients without gadolinium-enhancing lesions after the first year of treatment was 77%. Similar results were observed in naive patients and in those previously treated with an immunomodulator. In patients previously treated with natalizumab no changes were observed following the treatment. The use of fingolimod in clinical practice showed an effectiveness similar to that observed in clinical trials. There were no changes in the ARR after changing from natalizumab, and only one patient presented a 'relapse' after withdrawal of natalizumab. Fingolimod acts like a safe drug, with scarce side effects and a low percentage of drop-outs.

  11. Usefulness of the Spanish version of the mood disorder questionnaire for screening bipolar disorder in routine clinical practice in outpatients with major depression

    PubMed Central

    2008-01-01

    Background According to some studies, almost 40% of depressive patients – half of them previously undetected – are diagnosed of bipolar II disorder when systematically assessed for hypomania. Thus, instruments for bipolar disorder screening are needed. The Mood Disorder Questionnaire (MDQ) is a self-reported questionnaire validated in Spanish in stable patients with a previously known diagnosis. The purpose of this study is to evaluate in the daily clinical practice the usefulness of the Spanish version of the MDQ in depressive patients. Methods Patients (n = 87) meeting DSM-IV-TR criteria for a major depressive episode, not previously known as bipolar were included. The affective module of the Structured Clinical Interview (SCID) was used as gold standard. Results MDQ screened 24.1% of depressive patients as bipolar, vs. 12.6% according to SCID. For a cut-off point score of 7 positive answers, sensitivity was 72.7% (95% CI = 63.3 – 82.1) and specificity 82.9% (95% CI = 74.9–90.9). Likelihood ratio of positive and negative tests were 4,252 y 0,329 respectively. Limitations The small sample size reduced the power of the study to 62%. Conclusion Sensitivity and specificity of the MDQ were high for screening bipolar disorder in patients with major depression, and similar to the figures obtained in stable patients. This study confirms that MDQ is a useful instrument in the daily clinical assessment of depressive patients. PMID:18498637

  12. Long-Term Durability of Tenofovir-Based Antiretroviral Therapy in Relation to the Co-Administration of Other Drug Classes in Routine Clinical Practice

    PubMed Central

    Bonora, Stefano; Madeddu, Giordano; Maggiolo, Franco; Antinori, Andrea; Galli, Massimo; Di Perri, Giovanni; Viale, Pierluigi; d’Arminio Monforte, Antonella; Gori, Andrea

    2016-01-01

    Background In clinical trials, toxicity leading to tenofovir disoproxil fumarate (TDF) discontinuation is rare (3% by 2 years); however in clinical practice it seems to be higher, particularly when TDF is co-administered with ritonavir-boosted protease inhibitors (PI/r). Aims of this study were to assess the rate of TDF discontinuations in clinical practice and to identify factors associated with the risk of stopping TDF. Methods All antiretroviral treatment (ART)-naive patients initiating a TDF-based regimen were selected from the ICONA Foundation Study cohort. The primary outcome was TDF discontinuation regardless of the reason; secondary outcome measures were TDF discontinuation due to toxicity and selective TDF discontinuation (that is, TDF discontinuation or substitution, maintaining unchanged the remaining antiretroviral treatment). Results 3,618 ART-naïve patients were included: 54% started a PI/r-based and 46% a NNRTI-based based regimen. Two-hundred-seventy-seven patients discontinued TDF and reintroduced ART within 30 days without TDF. The probability of TDF discontinuation regardless of the reason was of 7.4% (95%CI:6.4–8.5) by 2 years and 14.1% (95%CI:12.2–16.1) by 5 years. The 5-year KM estimates in the PI/r vs. NNRTI group were 20.4% vs. 7.6%, respectively (log-rank p = 0.0001), for the outcome of stopping regardless of the reason, and 10.7% vs. 4.7% (p = 0.0001) for discontinuation due to toxicity. PI/r use and lower eGFR were associated with an increased risk of discontinuing TDF. Conclusion In our cohort, the frequency of TDF discontinuations was higher than that observed in clinical trials. Co-administration of TDF with PI/r was associated with an increased rate of TDF discontinuations. Further studies are needed to clarify the mechanisms that might have led to this outcome. PMID:27716843

  13. Effect of smoking status on healthcare costs and resource utilization in patients with type 2 diabetes in routine clinical practice: a retrospective nested case-control economic study.

    PubMed

    Sicras-Mainar, Antoni; Rejas-Gutiérrez, Javier; Navarro-Artieda, Ruth; Ibánez-Nolla, Jordi

    2014-01-01

    To compare healthcare resource utilization and costs according to smoking status in patients with type 2 diabetes in clinical practice. A retrospective cohort nested case-control study was designed. Cases were current smokers, while 2 types of controls (former smokers and never smokers) were matched (2 controls per case) for age, sex, duration of diabetes and burden of comorbidity using data from medical records. Noninstitutionalized diabetics of both genders, aged>18 years and seen consecutively over a 5-year period before the index date, were enrolled. Analysis compared healthcare resource utilization, loss of productivity due to sick leave and corresponding costs. In total, 2,490 medical records were analyzed, i.e. 498 cases, 996 former smokers and 996 never smokers. Mean age was 63.4 years (64.9% male). Smokers had higher glycosylated hemoglobin levels (7.4 vs. 7.2 and 7.2%, respectively; p=0.013) and a lower degree of metabolic control (49.2 vs. 54.7 and 55.8%; p=0.036). Smokers had higher average annual costs (EUR 3,583) than former smokers (EUR 2,885; p<0.001) and never smokers (EUR 2,183; p<0.001). Diabetic smoker patients had lower metabolic control, higher health resource utilization and more sick leave, resulting in higher healthcare costs and lost productivity compared with both former and never smoker diabetics. © 2013 S. Karger AG, Basel.

  14. Effectiveness and Tolerability of Ivabradine with or Without Concomitant Beta-Blocker Therapy in Patients with Chronic Stable Angina in Routine Clinical Practice.

    PubMed

    Perings, Stefan; Stöckl, Georg; Kelm, Malte

    2016-09-01

    In the prospective, open-label, non-interventional, multicenter RESPONSIfVE study, the effectiveness, response rates and tolerability of ivabradine with or without beta blocker (BB) were evaluated in patients with chronic stable angina pectoris (AP) in daily clinical practice. In patients with AP, ivabradine was given twice daily in flexible doses for 4 months. Resting heart rate (HR), number of angina attacks, short-acting nitrate use, severity of symptoms [by Canadian Cardiovascular Society (CCS) score] and tolerability with or without existing BB therapy were documented and analyzed using descriptive statistical methods. In total, 1250 patients with AP (mean age 66.0 ± 10.9 years, 59.6% male, 31.9% previous myocardial infarction) and an indication for ivabradine were included. Sixty-five percent of all patients received BB. Further concomitant standard medication included aspirin (74.2%), statins (69.3%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (84.2%), diuretics (40.0%), long-acting nitrates (15.7%), and calcium antagonists (21.4%). After 4 months of ivabradine treatment (mean daily dose 11.0 ± 2.7 mg), mean HR was reduced from 82.4 ± 11.8 beats per minute (bpm) to 67.1 ± 8.4 bpm. The average number of angina attacks/week decreased from 1.2 ± 1.9 to 0.1 ± 0.6 and the average use of short-acting nitrates/week from 1.5 ± 2.8 units to 0.2 ± 1.0 units. CCS classification of patients improved from 76% classified in CCS grades II or III and 24% in CCS grade I to 66% classified in CCS grade I and only 35% remaining in CCS grades II or III at study end. Response rate to ivabradine (defined as HR <70 bpm or HR reduction ≥10 bpm) reached 87%. HR reduction, symptomatic improvement and response rates were comparable in patients with or without BB. Adverse drug reactions were reported for 2.2% of patients. In this prospective study over a four-month period in clinical practice, ivabradine effectively

  15. Factor XI replacement for inherited factor XI deficiency in routine clinical practice: results of the HEMOLEVEN prospective 3-year postmarketing study.

    PubMed

    Bauduer, F; de Raucourt, E; Boyer-Neumann, C; Trossaert, M; Beurrier, P; Faradji, A; Peynet, J; Borg, J-Y; Chamouni, P; Chatelanaz, C; Henriet, C; Bridey, F; Goudemand, J

    2015-07-01

    Factor XI (FXI)-deficient patients may develop excessive bleeding after trauma or surgery. Replacement therapy should be considered in high-risk situations, especially when FXI levels are below 20 IU dL(-1) . HEMOLEVEN is a human plasma-derived factor XI concentrate available in France since 1992, but there are few data regarding its use by physicians. This prospective study assessed the use, efficacy and safety of HEMOLEVEN in common clinical practice. HEMOLEVEN was evaluated in FXI-deficient patients in 13 French centres in a 3-year postmarketing study. Forty-four patients (30 females, 14 males) received 67 treatments. The median age was 37 years (8 months-91 years). Basal FXI levels were <1 to 51 IU dL(-1) (median: 5.5); 29 patients were severely FXI-deficient (<20 IU dL(-1) ). FXI was administered prophylactically before 43 surgical procedures, 10 invasive procedures, 8 vaginal deliveries, or as curative treatment for six bleeds. The efficacy was assessed as excellent/good in 63, moderate in two and undetermined in two treatments. Seven patients experienced seven adverse effects, including two rated as serious: one sudden massive pulmonary embolism with fatal outcome and one case of inhibitor to FXI. HEMOLEVEN is effective for bleeding prevention in FXI deficiency. However, considering the benefit/risk ratio observed in relation to dosage in this study; firstly, it should be used sparingly due to its potential prothrombotic effect; secondly, new prescription procedures should be defined to adapt the dosage, especially in patients with intrinsic and/or acquired risk factors for thrombosis. © 2015 John Wiley & Sons Ltd.

  16. Methodological Aspects in Studies Based on Clinical Routine Data.

    PubMed

    Kennes, Lieven Nils

    2017-09-12

    Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data. In addition two simulation studies reveal the impact of bias in studies based on clinical routine data on the type I error rate and false decision rate in favor of the inferior intervention. It is concluded that correctly analyzing clinical routine data yields a valuable addition to clinical research; however, as a result of a lack of statistical foundation, internal validity, and comparability, generalizing results and inferring properties derived from clinical routine data to all patients of interest has to be considered with extreme caution. Grünenthal GmbH.

  17. Cost analysis of bivalirudin versus reference anticoagulants without GP IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention for acute coronary syndrome in routine clinical practice. Pompidou registry.

    PubMed

    Puymirat, E; Cohen, S; Védrenne, G; Caruba, T; Sabatier, B; Danchin, N; Durand, E

    2013-04-01

    Randomized controlled trials have shown improved short-term bleeding outcomes for bivalirudin compared to other anticoagulant in patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). This study analyzed the cost/efficacy profile of bivalirudin-based anticoagulation strategy versus non bivalirudin-based anticoagulant strategy without use of GP IIb/IIIa inhibitors in routine clinical practice. From January 2009 to December 2010, 216 patients who underwent PCI for ACS at hospital Georges-Pompidou without GP IIb/IIIa inhibitors were studied. Of these patients, 24 (11%) received bivalirudin and 192 (88%) received others anticoagulants (mainly unfractionated heparin or low molecular weight heparin). Ischemic events and bleeding or transfusion were slightly lower in bivalirudin group (0 vs. 4.2%, P=0.60 and 4.2 vs. 8.9%, P=0.70, respectively). In spite of a higher cost of the medication, the overall cost of the bivalirudin strategy was slightly lower (9167±3688 € vs. 14,016±14,749 €, P=0.23), in relation with a shorter average duration of the hospital stay. In conclusion, in this limited, single-center, population of patients with ACS, the clinical efficacy and safety of bivalirudin appeared at least as good as that of reference anticoagulants in real world clinical practice, with no increase in overall costs.

  18. The Candy Smell Test in clinical routine.

    PubMed

    Haxel, Boris R; Bertz-Duffy, Shannon; Faldum, Andreas; Trellakis, Sokrates; Stein, Bernhard; Renner, Bertold; Kobal, Gerd; Letzel, Stephan; Mann, Wolf J; Muttray, Axel

    2011-01-01

    The "Candy Smell Test" (CST) has been introduced as a new testing method for the evaluation of the human sense of smell. In contrast to other established orthonasal smell tests, the CST addresses the retronasal application of odors, typical for food aroma effects during mastication and swallowing. The aim of this study was to evaluate the CST in a clinical setting in patients with olfactory dysfunction and normal controls against the Sniffin' Sticks test. Furthermore, cutoff points for normal and pathological results in the CST should be determined. The olfactory performance of 96 patients presenting with olfactory disorders and 71 healthy controls was evaluated with the CST-comprised of 23 different aromatized smell candies and the extended Sniffin' Sticks test (threshold, discrimination, and identification). The control group was gender matched but included also younger persons. The tested subjects could easily understand the procedures and were motivated to participate. The CST correlated well with the Sniffin' Sticks for all tested subjects and for patients (n = 96) and controls (n = 71). The proposed cutoff value to differentiate normosmia from hyposmia in the CST was a score of <16 (i.e., 16 correctly identified odors) of 23. A score below 13 in the CST was the cutoff value for anosmia. The CST is an easy-to-handle reliable tool to investigate retronasal olfaction suited for clinical determination of normosmia, hyposmia, and ansomia. In addition, it can be used for investigation where self-application is necessary such as in large survey studies.

  19. Remote Sonography in Routine Clinical Practice Between Two Isolated Medical Centers and the University Hospital Using a Robotic Arm: A 1-Year Study.

    PubMed

    Georgescu, Monica; Sacccomandi, Arnaud; Baudron, Bernard; Arbeille, Philippe L

    2016-04-01

    A robotic arm was developed by our laboratory for tele-operated echography on patients in locations isolated from a trained sonographer. The objective of the study was to evaluate, over a 1-year period, the use of the robotic arm for telesonography performed by a sonographer located at the University Hospital (Tours, France) on patients in two isolated medical centers 50 km away linked via the Internet. A nonsonographer operator (physician or paramedic) located the ultrasound probe attached to the robotic arm over the appropriate acoustic window for the organ of interest by rolling the whole robotic arm and mechanical support across the floor. The expert sonographer then telemanipulated the robotic arm via an Internet connection and adjusted the orientation of the probe until the most appropriate organ view for delivering a diagnosis was obtained. Three hundred telesonography examinations were performed within 1 year: 68 (22.7%) on abdominal organs, 20 (6.7%) on pelvic organs, 138 (46%) on supraaortic vessels (carotid artery), 33 (11%) on the thyroid, 30 (10%) on leg veins, and 11 (3.7%) on the kidney and urinary tract. Telesonography could not be achieved in 10 of the 300 cases due to poor image quality on obese patients or those presenting poor echogenicity. These cases were re-examined at the university hospital by a sonographer. The rate of telesonography exams over the 1-year period was 1.5 per day for the "general population" medical site and 1 per week for the "elderly patient" medical site. This study demonstrated that telesonography using a robotic arm can be routinely used for providing echographic diagnoses on patients isolated from imaging centers.

  20. Molecular allergy diagnostics using IgE singleplex determinations: methodological and practical considerations for use in clinical routine: Part 18 of the Series Molecular Allergology.

    PubMed

    Kleine-Tebbe, Jörg; Jakob, Thilo

    Allergen molecules (synonyms: single allergens, allergen components) open up new horizons for the targeted allergen-specific diagnostics of immunoglobulin E (IgE) in singleplex determination. The following rationales support the targeted use of allergen molecules and, more importantly, improve test properties: (1) increased test sensitivity ("analytical sensitivity"), particularly when important allergens are under-represented or lacking in the extract; (2) improved test selectivity (analytical specificity), particularly when the selected IgE repertoire against an allergen yields additional information on: (a) potential risk, (b) possible cross-reactivity, or (c) primary (species-specific) sensitization. However, the appropriate indication for the use of single allergens can only be established on a case-by-case basis (depending on the clinical context and previous history) and in an allergen-specific manner (depending on the allergen source and the single allergens available), rather than in a standardized way. Numerous investigations on suspected food allergy, insect venom allergy, or sensitization to respiratory allergens have meanwhile demonstrated the successful use of defined molecules for allergen-specific singleplex IgE diagnosis. Specific IgE to single allergens is limited in its suitability to predict the clinical relevance of sensitivity on an individual basis. In food allergies, one can at best identify the relative risk of a clinical reaction on the basis of an IgE profile, but no absolutely reliable prediction on (future) tolerance can be made. Ultimately, the clinical relevance of all IgE findings depends on the presence of corresponding symptoms and can only be assessed on an individual basis (previous history, symptom log, and provocation testing with the relevant allergen source where appropriate). Thus, also in molecular allergology, the treating physician and not the test result should determine the clinical relevance of diagnostic findings.

  1. Management of chronic spontaneous urticaria in routine clinical practice: A Delphi-method questionnaire among specialists to test agreement with current European guidelines statements.

    PubMed

    Giménez-Arnau, A; Ferrer, M; Bartra, J; Jáuregui, I; Labrador-Horrillo, M; Frutos, J Ortiz de; Silvestre, J F; Sastre, J; Velasco, M; Valero, A

    Chronic spontaneous urticaria (CSU) is a frequent clinical entity that often presents a diagnostic and therapeutic challenge. To explore the degree of agreement that exists among the experts caring for patients with CSU diagnosis, evaluation, and management. An online survey was conducted to explore the opinions of experts in CSU, address controversial issues, and provide recommendations regarding its definition, natural history, diagnosis, and treatment. A modified Delphi method was used for the consensus. The questionnaire was answered by 68 experts (dermatologists, allergologists, and primary care physicians). A consensus was reached on 54 of the 65 items posed (96.4%). The experts concluded that CSU is a difficult-to-control disease of unpredictable evolution. Diagnostic tests should be limited and based on clinical history and should not be indiscriminate. Autoinflammatory syndromes and urticarial vasculitis must be ruled out in the differential diagnosis. A cutaneous biopsy is only recommended when wheals last more than 24h, to rule out urticarial vasculitis. The use of specific scales to assess the severity of the disease and the quality of life is recommended. In patients with severe and resistant CSU, second-generation H1-antihistamines could be used at doses up to four times the standard dose before giving second-line treatments. Omalizumab is a safe and effective treatment for CSU that is refractory to H1-antihistamines treatment. In general, diagnosis and treatment recommendations given for adults could be extrapolated to children. This work offers consensus recommendations that may be useful in the management of CSU. Copyright © 2016 SEICAP. Published by Elsevier España, S.L.U. All rights reserved.

  2. Evaluation of red blood cell and platelet antigen genotyping platforms (ID CORE XT/ID HPA XT) in routine clinical practice

    PubMed Central

    Finning, Kirstin; Bhandari, Radhika; Sellers, Fiona; Revelli, Nicoletta; Villa, Maria Antonietta; Muñiz-Díaz, Eduardo; Nogués, Núria

    2016-01-01

    Background High-throughput genotyping platforms enable simultaneous analysis of multiple polymorphisms for blood group typing. BLOODchip® ID is a genotyping platform based on Luminex® xMAP technology for simultaneous determination of 37 red blood cell (RBC) antigens (ID CORE XT) and 18 human platelet antigens (HPA) (ID HPA XT) using the BIDS XT software. Materials and methods In this international multicentre study, the performance of ID CORE XT and ID HPA XT, using the centres’ current genotyping methods as the reference for comparison, and the usability and practicality of these systems, were evaluated under working laboratory conditions. DNA was extracted from whole blood in EDTA with Qiagen methodologies. Ninety-six previously phenotyped/genotyped samples were processed per assay: 87 testing samples plus five positive controls and four negative controls. Results Results were available for 519 samples: 258 with ID CORE XT and 261 with ID HPA XT. There were three “no calls” that were either caused by human error or resolved after repeating the test. Agreement between the tests and reference methods was 99.94% for ID CORE XT (9,540/9,546 antigens determined) and 100% for ID HPA XT (all 4,698 alleles determined). There were six discrepancies in antigen results in five RBC samples, four of which (in VS, N, S and Doa) could not be investigated due to lack of sufficient sample to perform additional tests and two of which (in S and C) were resolved in favour of ID CORE XT (100% accuracy). The total hands-on time was 28–41 minutes for a batch of 16 samples. Compared with the reference platforms, ID CORE XT and ID HPA XT were considered simpler to use and had shorter processing times. Discussion ID CORE XT and ID HPA XT genotyping platforms for RBC and platelet systems were accurate and user-friendly in working laboratory settings. PMID:26674823

  3. Cognitive-behavioral therapy modifies the naturalistic course of social anxiety disorder: findings from an ABA design study in routine clinical practices.

    PubMed

    Furukawa, Toshi A; Nakano, Yumi; Funayama, Tadashi; Ogawa, Sei; Ietsugu, Tetsuji; Noda, Yumiko; Chen, Junwen; Watanabe, Norio; Akechi, Tatsuo

    2013-04-01

    While randomized evidence appears to have established efficacy of cognitive-behavioral therapy (CBT) and some pharmacotherapy for social anxiety disorder (SAD), their real-world effectiveness has been called into question by long-term naturalistic cohort studies of patients with SAD as they show very low probability of recovery and sustained social dysfunctions despite some drug and psychological therapies. The present study examines the effectiveness of group CBT for SAD in real-world settings (n=62) by examining the course of patients' symptomatology and social functions through approximately 6 months on the waiting list, through 6 months receiving the manualized group CBT intervention consisting of 16 2-h sessions, and for 12 months after the treatment. We found: (i) that the patients with SAD changed little or possibly worsened through the 6 months on the waiting list, although two in three of them were on antidepressants, benzodiazepines or both; (ii) that both their symptomatology and social function improved significantly and substantively through the group CBT; and (iii) that this improvement was maintained through the 3- and 12-month follow ups. We can implement and must disseminate evidence-based, effective CBT for more patients with SAD to lessen their suffering and stop the perpetuation of their symptoms. © 2013 The Authors. Psychiatry and Clinical Neurosciences © 2013 Japanese Society of Psychiatry and Neurology.

  4. Real-world use of PCSK-9 inhibitors by early adopters: cardiovascular risk factors, statin co-treatment, and short-term adherence in routine clinical practice.

    PubMed

    Fairman, Kathleen A; Davis, Lindsay E; Sclar, David A

    2017-01-01

    Inconsistency of real-world medication use with labeled indications may affect cost and clinical value of pharmacotherapy. PCSK-9 inhibitors are labeled in the US for use with statins to reduce low-density lipoprotein cholesterol in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH). To assess consistency with labeled indications and treatment persistency for early (first 5 post-launch months) adopters of PCSK-9 inhibitor pharmacotherapy. Retrospective analysis of commercially insured cohorts derived from the Truven Health MarketScan(®) database was performed. Subjects were aged 18-64 years, initiated PCSK-9 inhibitor or highest-intensity statin (rosuvastatin 40 mg/day or atorvastatin 80 mg/day) pharmacotherapy from August to December 2015, and were enrolled throughout 2015 and during separate baseline (pre-treatment) periods of 6 and 18 months. Baseline ASCVD, FH, and ASCVD events (myocardial infarction, transient ischemic attack, and cerebrovascular occlusion) were measured. Persistency was measured through December 2015 for subcohorts of patients initiating treatment from August to September 2015. Baseline disease rates were higher for patients treated with PCSK-9 inhibitors (n=390) compared with highest-intensity statins (n=26,306): ASCVD (68.5% vs 33.4%, respectively); FH (39.7% vs 15.5%); both P<0.001. In 18 months pre-treatment, 35.6% of PCSK-9 inhibitor-treated patients had ≥1 ASCVD event, and 87.9% had a labeled indication. Rates of 60-day nonpersistency for PCSK-9 inhibitors and highest-intensity statins were 33.3% and 39.8%, respectively (P=0.207). During PCSK-9 inhibitor pharmacotherapy, 33.8% of patients had evidence of statin supply and, of those initiating treatment from August to September, 40.9% filled ≥1 statin prescription. Of those with sustained pre-treatment statin use, 34.8% had no statin supply during PCSK-9 inhibitor pharmacotherapy. Among early-adopting PCSK-9 inhibitor-treated patients

  5. [Use of PubMed to improve evidence-based medicine in routine urological practice].

    PubMed

    Rink, M; Kluth, L A; Shariat, S F; Chun, F K; Fisch, M; Dahm, P

    2013-03-01

    Applying evidence-based medicine in daily clinical practice is the basis of patient-centered medicine and knowledge of accurate literature acquisition skills is necessary for informed clinical decision-making. PubMed is an easy accessible, free bibliographic database comprising over 21 million citations from the medical field, life-science journals and online books. The article summarizes the effective use of PubMed in routine urological clinical practice based on a common case scenario. This article explains the simple use of PubMed to obtain the best search results with the highest evidence. Accurate knowledge about the use of PubMed in routine clinical practice can improve evidence-based medicine and also patient treatment.

  6. Multispecialty Clinic Practice

    PubMed Central

    Margolin, David A.; Beck, David E.

    2011-01-01

    A multispecialty clinic practice is a common practice arrangement for colorectal surgeons. This type of practice has a variety of features, both positive and negative. The authors explore location, practice patterns, lifestyles, compensation, and academic opportunities associated with a multispecialty clinic practice. This information can assist younger surgeons in choosing a practice opportunity and guide experienced surgeons through their career progression. PMID:22654568

  7. Telemedicine in interdisciplinary work practices: On an IT system that met the criteria for success set out by its sponsors, yet failed to become part of every-day clinical routines

    PubMed Central

    de Bont, Antoinette; Bal, Roland

    2008-01-01

    Background Information systems can play a key role in care innovations including task redesign and shared care. Many demonstration projects have presented evidence of clinical and cost effectiveness and high levels of patient satisfaction. Yet these same projects often fail to become part of everyday clinical routines. The aim of the paper is to gain insight into a common paradox that a technology can meet the criteria for success set out at the start of the project yet fail to become part of everyday clinical routines. Methods We evaluated a telecare service set up to reduce the workload of ophthalmologists. In this project, optometrists in 10 optical shops made digital images to detect patients with glaucoma which were further assessed by trained technicians in the hospital. Over a period of three years, we conducted interviews with the project team and the users about the workability of the system and its integration in practice. Beside the interviews, we analyzed record data to measure the quality of the images. We compared the qualitative accounts with these measurements. Results According to our measurements, the quality of the images was at least satisfactory in 90% of the cases, i.e. the images could be used to screen the patients – reducing the workload of the ophthalmologist considerably. However, both the ophthalmologist and the optometrists became increasingly dissatisfied respectively with the perceived quality of the pictures and the perceived workload. Through a detailed analysis of how the professionals discussed the quality of the pictures, we re-constructed how the notion of quality of the images and being a good professional were constructed and linked. The IT system transformed into a quality system and, at the same time, transformed the notions of being a good professional. While a continuous dialogue about the quality of the pictures became an emblem for the quality of care, this dialogue was hindered by the system and the way the care

  8. Different standards for healthy screenees than patients in routine clinics?

    PubMed Central

    Hoff, Geir

    2013-01-01

    Less than 5% of colorectal adenomas will become malignant, but we do not have sufficient knowledge about their natural course to target removal of these 5% only. Thus, 95% of polypectomies are a waste of time exposing patients to a small risk of complications. Recently, a new type of polyps, sessile serrated polyps, has attracted attention. Previously considered innocuous, they are now found to have molecular similarities to cancer and some guidelines recommend to have them removed. These lesions are often flat, covered by mucous, not easily seen and situated in the proximal colon where the bowel wall is thinner. Thus, polypectomy carries a higher risk of perforation than predominantly left-sided, stalked adenomas - and we do not know what is gained in terms of cancer prevention. Screening is a neat balance between harms and benefit for presumptively healthy participants not interested in risk exposure to obtain confirmation of being healthy. The situation is quite different for patient worried about symptom. Thus, the standards set for evidence-based practice may be higher for screening than for routine clinics - a mechanism which may benefit patients in the long run. PMID:24379569

  9. Different standards for healthy screenees than patients in routine clinics?

    PubMed

    Hoff, Geir

    2013-12-14

    Less than 5% of colorectal adenomas will become malignant, but we do not have sufficient knowledge about their natural course to target removal of these 5% only. Thus, 95% of polypectomies are a waste of time exposing patients to a small risk of complications. Recently, a new type of polyps, sessile serrated polyps, has attracted attention. Previously considered innocuous, they are now found to have molecular similarities to cancer and some guidelines recommend to have them removed. These lesions are often flat, covered by mucous, not easily seen and situated in the proximal colon where the bowel wall is thinner. Thus, polypectomy carries a higher risk of perforation than predominantly left-sided, stalked adenomas - and we do not know what is gained in terms of cancer prevention. Screening is a neat balance between harms and benefit for presumptively healthy participants not interested in risk exposure to obtain confirmation of being healthy. The situation is quite different for patient worried about symptom. Thus, the standards set for evidence-based practice may be higher for screening than for routine clinics - a mechanism which may benefit patients in the long run.

  10. Hypothyroidism in Clinical Practice

    PubMed Central

    Qari, Faiza

    2014-01-01

    Background: Hypothyroidism is the most common endocrine disease that was seen in the clinical practice especially for family physicians. Methods: This review article covered the important practical clinical issues for managing overt hypothyroidism, subclinical hypothyroidism and hypothyroidism during pregnancy. Conclusions: The clinical issues were addressed by clinical scenario followed by questions and stressed on the important clinical points. PMID:25161963

  11. [Neuroimaging for patients with Alzheimer disease in routine practice].

    PubMed

    Matsuda, Hiroshi

    2010-07-01

    In routine practice neuroimaging has been applied as an adjunct technique for early and differential diagnosis of Alzheimer disease in routine practice. Of the several neuroimaging modalities, magnetic resonance imaging (MRI) and brain perfusion single-photon emission computed tomography (SPECT) have been commonly used in Japan; further software programs are used to aid statistical analysis of the imaging results. For example voxel-based specific regional analysis system for Alzheimer disease (VSRAD) for MRI and easy Z-score imaging system (eZIS) are used for the analysis of MRI and SPECT. In the early stage of Alzheimer disease, specific findings of regional atrophy and perfusion reduction are observed in some areas. In the posterior cingulate gyrus precuneus and parietal cortex, perfusion reduction was more frequently observed than atrophy. On the other hand, in the medial temporal structures, perfusion reduction was less frequently observed than atrophy. Perfusion reduction in the the posterior cingulate gyrus precuneus and in the parietal cortex was more prominent in the case of patients with early-onset Alzheimer disease than in the case of patients with late-onset Alzheimer disease. Further, atrophy in the medial temporal structures was more prominent in the case of patients with late-onset Alzheimer disease than in the case of those with early-onset Alzheimer disease. These findings are helpful for differentiating of Alzheimer disease from other diseases characterized by dementia.

  12. Second-line treatment of stage III/IV non-small-cell lung cancer (NSCLC) with pemetrexed in routine clinical practice: evaluation of performance status and health-related quality of life.

    PubMed

    Schuette, Wolfgang; Tesch, Hans; Büttner, Hartwig; Krause, Thomas; Soldatenkova, Victoria; Stoffregen, Clemens

    2012-01-13

    Second-line treatment of advanced non-small-cell lung cancer (NSCLC) improves overall survival. There is a lack of data regarding the impact on patients' overall health condition. This prospective, non-interventional study evaluated performance status (PS) and health-related quality of life (HR-QoL) during second-line pemetrexed treatment in routine clinical practice. Stage III/IV NSCLC patients who initiated second-line pemetrexed (standard vitamin and dexamethasone supplementation) were observed for a maximum of 9 treatment cycles. The primary objective was to evaluate the proportion of patients achieving improvement of Karnofsky Index (KI) of ≥ 10% (absolute) or maintaining KI ≥ 80% after the second treatment cycle ("KI benefit response"). HR-QoL was self-rated using the EuroQoL-5D questionnaire (EQ-5D). Factors potentially associated with KI benefit response were evaluated using logistic regression models. Of 521 eligible patients (73.5% Stage IV, median age 66.3 yrs, 36.1% ≥ 70 yrs, 62.0% with KI ≥ 80%), 471 (90.4%) completed at least 2 treatment cycles. 58.0% (95%CI 53.6%;62.2%) achieved KI benefit response after the second cycle. Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response. EQ-5D scores improved over time. Grade 3/4 toxicities were reported in 23.8% of patients (mainly fatigue/asthenia 15.9%, neutropenia 8.7%). In this large prospective, non-interventional study of second-line pemetrexed treatment in patients with advanced NSCLC, including 36% elderly patients ( ≥ 70 years), physician-rated PS and self-rated HR-QoL were maintained or improved in the majority of patients. Registered on ClinicalTrials.gov (NCT00540241) on October 4, 2007.

  13. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

    PubMed

    Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

    2015-09-01

    The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

  14. Interpreted consultations as 'business as usual'? An analysis of organisational routines in general practices.

    PubMed

    Greenhalgh, Trisha; Voisey, Christopher; Robb, Nadia

    2007-09-01

    UK general practices operate in an environment of high linguistic diversity, because of recent large-scale immigration and of the NHS's commitment to provide a professional interpreter to any patient if needed. Much activity in general practice is co-ordinated and patterned into organisational routines (defined as repeated patterns of interdependent actions, involving multiple actors, bound by rules and customs) that tend to be stable and to persist. If we want to understand how general practices are responding to pressures to develop new routines, such as interpreted consultations, we need to understand how existing organisational routines change. This will then help us to address a second question, which is how the interpreted consultation itself is being enacted and changing as it becomes routinised (or not) in everyday general practice. In seeking answers to these two questions, we undertook a qualitative study of narratives of interpreted primary care consultations in three London boroughs with large minority ethnic populations. In 69 individual interviews and two focus groups, we sought accounts of interpreted consultations from service users, professional interpreters, family member interpreters, general practitioners, practice nurses, receptionists, and practice managers. We asked participants to tell us both positive and negative stories of their experiences. We analysed these data by searching for instances of concepts relating to the organisational routine, the meaning of the interpreted consultation to the practice, and the sociology of medical work. Our findings identified a number of general properties of the interpreted consultation as an organisational routine, including the wide variation in the form of adoption, the stability of the routine, the adaptability of the routine, and the strength of the routine. Our second key finding was that this variation could be partly explained by characteristics of the practice as an organisation, especially

  15. Impact of overlapping on 1-year clinical outcomes in patients undergoing everolimus-eluting bioresorbable scaffolds implantation in routine clinical practice: Insights from the European multicenter GHOST-EU registry.

    PubMed

    Ortega-Paz, Luis; Capodanno, Davide; Giacchi, Giuseppe; Gori, Tommaso; Nef, Holger; Latib, Azeem; Caramanno, Giuseppe; Di Mario, Carlo; Naber, Christoph; Lesiak, Maciej; Capranzano, Piera; Wiebe, Jens; Mehilli, Julinda; Araszkiewicz, Aleksander; Pyxaras, Stelios; Mattesini, Alessio; Geraci, Salvatore; Naganuma, Toru; Colombo, Antonio; Münzel, Thomas; Sabaté, Manel; Tamburino, Corrado; Brugaletta, Salvatore

    2017-04-01

    Overlapping implantation of bioresorbable scaffolds (BRSs) are frequent in long coronary lesions. Its impact on clinical outcomes is unknown. To compare the clinical outcomes of patients treated with overlapping BRS with those patients treated with no-overlap BRS. We analyzed the 1-year clinical outcomes of 1,477 patients treated with BRS in the GHOST-EU registry, according to the implantation of overlapping BRS. Primary endpoint was patient oriented composite endpoint (PoCE) of: all-cause death, any myocardial infarction (MI) and any repeated revascularization. Scaffold thrombosis, according to Academic Research Consortium definition, was also analyzed. A total of 320 (21.7%) patients were treated with overlapping BRS (overlap group), whereas the remaining 1,157 (78.3%) received no-overlap BRS (no-overlap group). The overlap group had significantly higher frequency of male sex, diabetes mellitus, stable angina, B2/C lesion type, SYNTAX score ≥22, lesion length >34 mm, use of intracoronary imaging guidance, pre- and postdilatation. At 1-year, there were no differences in PoCE between the overlap versus no-overlap group (18.4% vs. 18.2%; HR 1.07, [0.80-1.44]; P = 0.636), even after adjustment (HR 1.05, [0.48-2.20]; P = 0.904). Scaffold thrombosis rate did not differ either at one-month (1.3% vs. 1.5%, P = 0.769) or at 1-year (1.9% vs. 2.1%, P = 0.823). In "Real-world" clinical practice, overlapping BRS does not appear to have an impact on clinical outcomes as compared to no-overlapping BRS. These preliminary data should be confirmed. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  16. Routine follow-up radiographs for distal radius fractures are seldom clinically substantiated.

    PubMed

    Weil, N L; El Moumni, M; Rubinstein, S M; Krijnen, P; Termaat, M F; Schipper, I B

    2017-07-22

    The value of routine radiographs during follow-up after distal radius fractures is unclear. The aim of this study was to evaluate whether routine radiographs performed during the follow-up period in patients with a distal radius fracture influenced clinical decision making. This retrospective cohort study included patients aged ≥18 years who were treated for a distal radius fracture at four hospitals in The Netherlands in 2012. Demographic and clinical and radiographic characteristics were collected from medical records. 1042 patients were included. In 121 (14%) of the 841 radiographs, a clinical indication was reported. Treatment was affected by 22 (2.6%) radiographs, including 11 (1.5%) radiographs that were categorized as routine, 9 (1.2%) of which led to prolonged cast immobilization and 2 (0.2%) to surgery for conservatively treated patients. Although it is common practice to take radiographs after distal radius fractures, the study results indicate that routine radiographs seldom affect treatment. This finding should be weighed against the high health care costs associated with these fractures. We hope that the results of our study will trigger the awareness among surgeons that in the current practice, many radiographs are taken on routine without influencing clinical decision making and can probably be omitted. Level III.

  17. Decision aids in routine practice: lessons from the breast cancer initiative.

    PubMed

    Silvia, Kerry A; Sepucha, Karen R

    2006-09-01

    Many decision aids have been developed to help patients make treatment and screening decisions; however, little is known about implementing them into routine clinical practice. To assess the feasibility of implementing a patient decision aid (PtDA) for the early stage breast cancer surgical decision into routine clinical care. Structured individual interviews. A convenience sample of providers from nine sites, including two community resource centres, a community hospital and six academic centres. Usage data, barriers to and resources for implementing the PtDAs. Six of the nine sites were using the PtDAs with patients. Two sites were primarily using a scheduling system and four sites relied on a lending system. For the academic centres, the keys to successful implementation included integrating the PtDA into the flow of patients through the centre and having physicians who recommended it to patients. At the community centres, the keys to successful implementation included an informed staff and the flexibility to get the PtDAs to patients in different ways. Barriers that limited or prevented sites from using the PtDA included a lack of clinical support, a lack of system support, competing priorities and scheduling problems. It is feasible to implement a breast cancer PtDA into routine clinical care at academic centres and community resource centres. Future research should assess the effectiveness of PtDAs in routine clinical care as well as resources and barriers to their implementation in community hospitals.

  18. Comparison of immunohistochemical and fluorescence in situ hybridization assessment of HER-2 status in routine practice.

    PubMed

    Dolan, Michelle; Snover, Dale

    2005-05-01

    Because HER-2 expression in invasive carcinoma of the breast has well-documented ramifications for treatment and prognosis, accurate assessment of HER-2 status is critical. Comparative studies have shown high concordance rates between immunohistochemical analysis and fluorescence in situ hybridization (FISH) in cases with immunohistochemical scores of 0 or 1+ (negative) and 3+ (strongly positive) and low concordance rates among cases with immunohistochemical scores of 2+. The present study was performed to determine concordance rates in a setting more representative of routine clinical practice, in which multiple pathologists submit specimens to a single cytogenetics referral laboratory. We found a higher rate of discordance between immunohistochemical analysis and FISH (approximately 92%) in the groups with immunohistochemical scores of 2+ than reported in other studies. These results strongly support the practice of performing FISH in all cases with immunohistochemical scores of 2+, particularly in routine practice, in which interobserver variability in immunohistochemical scoring among multiple pathologists is likely to be high.

  19. Impact of Routine Fractional Flow Reserve on Management Decision and 1-Year Clinical Outcome of Patients With Acute Coronary Syndromes: PRIME-FFR (Insights From the POST-IT [Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease] and R3F [French FFR Registry] Integrated Multicenter Registries - Implementation of FFR [Fractional Flow Reserve] in Routine Practice).

    PubMed

    Van Belle, Eric; Baptista, Sergio-Bravo; Raposo, Luís; Henderson, John; Rioufol, Gilles; Santos, Lino; Pouillot, Christophe; Ramos, Ruben; Cuisset, Thomas; Calé, Rita; Teiger, Emmanuel; Jorge, Elisabete; Belle, Loic; Machado, Carina; Barreau, Didier; Costa, Marco; Hanssen, Michel; Oliveira, Eduardo; Besnard, Cyril; Costa, João; Dallongeville, Jean; Pipa, João; Sideris, Georgios; Fonseca, Nuno; Bretelle, Christophe; Guardado, Jorge; Lhoest, Nicolas; Silva, Bruno; Barnay, Pierre; Sousa, Maria-João; Leborgne, Laurent; Silva, João Carlos; Vincent, Flavien; Rodrigues, Alberto; Seca, Luís; Fernandes, Renato; Dupouy, Patrick

    2017-06-01

    Fractional flow reserve (FFR) is not firmly established as a guide to treatment in patients with acute coronary syndromes (ACS). Primary goals were to evaluate the impact of integrating FFR on management decisions and on clinical outcome of patients with ACS undergoing coronary angiography, as compared with patients with stable coronary artery disease. R3F (French FFR Registry) and POST-IT (Portuguese Study on the Evaluation of FFR-Guided Treatment of Coronary Disease), sharing a common design, were pooled as PRIME-FFR (Insights From the POST-IT and R3F Integrated Multicenter Registries - Implementation of FFR in Routine Practice). Investigators prospectively defined management strategy based on angiography before performing FFR. Final decision after FFR and 1-year clinical outcome were recorded. From 1983 patients, in whom FFR was prospectively used to guide treatment, 533 sustained ACS (excluding acute ST-segment-elevation myocardial infarction). In ACS, FFR was performed in 1.4 lesions per patient, mostly in left anterior descending (58%), with a mean percent stenosis of 58±12% and a mean FFR of 0.82±0.09. In patients with ACS, reclassification by FFR was high and similar to those with non-ACS (38% versus 39%; P=NS). The pattern of reclassification was different, however, with less patients with ACS reclassified from revascularization to medical treatment compared with those with non-ACS (P=0.01). In ACS, 1-year outcome of patients reclassified based on FFR (FFR against angiography) was as good as that of nonreclassified patients (FFR concordant with angiography), with no difference in major cardiovascular event (8.0% versus 11.6%; P=0.20) or symptoms (92.3% versus 94.8% angina free; P=0.25). Moreover, FFR-based deferral to medical treatment was as safe in patients with ACS as in patients with non-ACS (major cardiovascular event, 8.0% versus 8.5%; P=0.83; revascularization, 3.8% versus 5.9%; P=0.24; and freedom from angina, 93.6% versus 90.2%; P=0.35). These

  20. Observations and monitoring: routine practices on the ward.

    PubMed

    Oliver, Alison; Powell, Colin; Edwards, Dawn; Mason, Brendan

    2010-05-01

    To review routine observations on all children admitted to the Children's Hospital for Wales and the feasibility of implementing an early warning score for children developing critical illness. Nursing staff, while performing their routine duties, recorded the physiological observations of temperature, heart rate, respiratory rate and blood pressure, as well as identifying airway threat, recording oxygen saturation levels, level of consciousness using the AVPU scale (alert, responds to voice, responds to pain, unresponsive) and identifying if they had concerns about a child on a new paediatric observation chart. The clinical care policy for each ward determined the frequency of recording observations. Data were collected for 1,000 patients on whom 9,075 sets of observations were performed. Of those 9,075 sets, temperature was the most frequently recorded observation at 88.4% (95% confidence interval (CI) 87.7-89), followed by heart rate at 86.8% (95% CI 86.1-87.5), respiratory rate at 79.7% (95% CI 78.9-80.5), AVPU at 36.4% (95% CI 35.4-37.4) and blood pressure at 25.1% (95% CI 24.2-26.0). A complete set of observations needed for the Cardiff and Vale Paediatric Early Warning System to trigger effectively were only recorded in 52.7% (95% CI 52.4-53.1) of patients. There were variations in the frequency, type and recording of observations. This issue needs to be addressed if scoring systems are to be implemented. The findings of this observational study suggest that the required basic observations of acutely ill children are not being carried out.

  1. Heart-sparing radiotherapy in patients with breast cancer: What are the techniques used in the clinical routine?: A pattern of practice survey in the German-speaking countries.

    PubMed

    Duma, Marciana-Nona; Münch, Stefan; Oechsner, Markus; Combs, Stephanie E

    2017-01-01

    The aim of this study was to understand the practice of care in German-speaking countries with regard to heart-sparing radiotherapy techniques. Between August 2015 and September 2015, an e-mail/fax-based survey was sent to radiation oncology departments in Germany, Austria, and the German-speaking Switzerland. The questionnaire was divided into 3 chapters: a general chapter on the department, a chapter specific for heart-sparing techniques in patients with breast cancer, and a third chapter on personal beliefs on the topic of heart sparing in patients with breast cancer. A total of 82 radiation oncology departments answered the questionnaire: 16 university clinics and 66 other departments. In general, heart-sparing techniques are being offered by 90.2% of departments for radiation oncology in the German-speaking countries. However, in the clinical routine, 87.7% of institutions use heart-sparing techniques in less than 50% of patients with breast cancer. Heart-sparing techniques are especially provided for patients with left-sided breast cancer (80%), patients after mastectomy (52.5%), and when the mammaria interna lymph drainage vessels are irradiated (41.3%). In 46.3% of departments, there are written internal guidelines for heart sparing in patients with breast cancer. Breathing-adapted radiotherapy is used as the most frequent heart-sparing technique in 64.7% of the institutions, followed by intensity-modulated radiation therapy, which is most frequently used by 22.1%. The only significant difference between university hospitals and other departments was seen for the offering of partial breast irradiation. The most commonly used heart-sparing technique is breathing-adapted radiotherapy, but there is no coherent approach for heart sparing in patients with breast cancer in the German-speaking countries. Overall, all options for cardiac protection/cardiac avoidance have their advantages and disadvantages, with deep inspiration breath-hold radiotherapyhaving the

  2. A survey of the value of routine intimate examination and related practices in subfertile couples.

    PubMed

    Desai, A K; Jaiyesimi, R A K

    2007-11-01

    The practice of undertaking routine intimate examinations in the management of subfertile couples varies among clinicians. An anonymous self-administered mailed questionnaire survey was carried out to determine the current practices followed by clinicians and the rationale supporting their practice. In the absence of large comparative studies, this survey provides expert opinion regarding this practice. The questionnaire was mailed to the Fellows and members of the Royal College of Obstetricians and Gynaecologists in the Northern, Yorkshire, West Midlands and Wales regions in the UK. A total of 802 questionnaires were posted, of which 516 were returned, giving an overall response rate of 64%. The responses and comments varied. Some 62% of respondents would routinely perform a pelvic examination on all women presenting with subfertility; 23% would do so only in selected cases and 63% of the clinicians would perform a routine transvaginal ultrasound. The male partners are examined by only 19% of the clinicians. A total of 83% of the respondents were of the opinion that the survey made them think about the role and justification of intimate examinations in greater detail. The practice of intimate examination of subfertile couples varies among clinicians in the survey group. There is a need for large prospective comparative studies to study the value of this examination and related practices in the management of subfertile couples. In the absence of comparative trials, this survey provides expert opinion. It may be suggested that an intimate examination should not be carried out routinely in all subfertile couples. It could be done when it has potential to add value to the management of the patient. A pragmatic approach should be adopted in every clinical situation.

  3. Thinking Routines: Replicating Classroom Practices within Museum Settings

    ERIC Educational Resources Information Center

    Wolberg, Rochelle Ibanez; Goff, Allison

    2012-01-01

    This article describes thinking routines as tools to guide and support young children's thinking. These learning strategies, developed by Harvard University's Project Zero Classroom, actively engage students in constructing meaning while also understanding their own thinking process. The authors discuss how thinking routines can be used in both…

  4. Thinking Routines: Replicating Classroom Practices within Museum Settings

    ERIC Educational Resources Information Center

    Wolberg, Rochelle Ibanez; Goff, Allison

    2012-01-01

    This article describes thinking routines as tools to guide and support young children's thinking. These learning strategies, developed by Harvard University's Project Zero Classroom, actively engage students in constructing meaning while also understanding their own thinking process. The authors discuss how thinking routines can be used in both…

  5. An MLP classifier for prediction of HBV-induced liver cirrhosis using routinely available clinical parameters.

    PubMed

    Cao, Yuan; Hu, Zhi-De; Liu, Xiao-Fei; Deng, An-Mei; Hu, Cheng-Jin

    2013-01-01

    Liver cirrhosis (LC) is the final stage of most of chronic liver diseases and is almost caused by chronic hepatitis B (CHB) in China. Liver biopsy is the reference method for the evaluation of liver cirrhosis. However, it is an invasive procedure with inherent risk. The aim of this study was to construct a new classifier based on the routine clinical markers for the prediction of HBV-induced LC. We collected routine clinical parameters from 124 LC patients with CHB and 115 with CHB. Training set (n = 120) and test set (n = 119) were built for model construction and evaluation, respectively. We describe a new classifier, MLP, for prediction of LC with CHB. MLP was built with seven routinely available clinical parameters, including age, ALT, AST, PT, PLT, HGB, and RDW. With optimal cutoff, we obtained a sensitivity of 95.2%, a specificity of 84.2%, and an overall accuracy of 89.9% on an independent test set, which were superior to those of FIB-4 and APRI. Our study suggests that the MLP classifier can be implemented for discriminating LC and non-LC cohorts by using machine learning method based on the routine available clinical parameters. It could be used for clinical practice in HBV-induced LC assessment.

  6. An MLP Classifier for Prediction of HBV-Induced Liver Cirrhosis Using Routinely Available Clinical Parameters

    PubMed Central

    Hu, Zhi-De; Liu, Xiao-Fei; Deng, An-Mei

    2013-01-01

    Background. Liver cirrhosis (LC) is the final stage of most of chronic liver diseases and is almost caused by chronic hepatitis B (CHB) in China. Liver biopsy is the reference method for the evaluation of liver cirrhosis. However, it is an invasive procedure with inherent risk. The aim of this study was to construct a new classifier based on the routine clinical markers for the prediction of HBV-induced LC. Subjects and Methods. We collected routine clinical parameters from 124 LC patients with CHB and 115 with CHB. Training set (n = 120) and test set (n = 119) were built for model construction and evaluation, respectively. Results. We describe a new classifier, MLP, for prediction of LC with CHB. MLP was built with seven routinely available clinical parameters, including age, ALT, AST, PT, PLT, HGB, and RDW. With optimal cutoff, we obtained a sensitivity of 95.2%, a specificity of 84.2%, and an overall accuracy of 89.9% on an independent test set, which were superior to those of FIB-4 and APRI. Conclusions. Our study suggests that the MLP classifier can be implemented for discriminating LC and non-LC cohorts by using machine learning method based on the routine available clinical parameters. It could be used for clinical practice in HBV-induced LC assessment. PMID:24302810

  7. Decision aids in routine practice: lessons from the breast cancer initiative

    PubMed Central

    Silvia, Kerry A.; Sepucha, Karen R.

    2006-01-01

    Abstract Background  Many decision aids have been developed to help patients make treatment and screening decisions; however, little is known about implementing them into routine clinical practice. Objective  To assess the feasibility of implementing a patient decision aid (PtDA) for the early stage breast cancer surgical decision into routine clinical care. Design  Structured individual interviews. Setting and participants  A convenience sample of providers from nine sites, including two community resource centres, a community hospital and six academic centres. Main outcome measures  Usage data, barriers to and resources for implementing the PtDAs. Results  Six of the nine sites were using the PtDAs with patients. Two sites were primarily using a scheduling system and four sites relied on a lending system. For the academic centres, the keys to successful implementation included integrating the PtDA into the flow of patients through the centre and having physicians who recommended it to patients. At the community centres, the keys to successful implementation included an informed staff and the flexibility to get the PtDAs to patients in different ways. Barriers that limited or prevented sites from using the PtDA included a lack of clinical support, a lack of system support, competing priorities and scheduling problems. Conclusions  It is feasible to implement a breast cancer PtDA into routine clinical care at academic centres and community resource centres. Future research should assess the effectiveness of PtDAs in routine clinical care as well as resources and barriers to their implementation in community hospitals. PMID:16911140

  8. Gamification of Clinical Routine: The Dr. Fill Approach.

    PubMed

    Bukowski, Mark; Kühn, Martin; Zhao, Xiaoqing; Bettermann, Ralf; Jonas, Stephan

    2016-01-01

    Gamification is used in clinical context in the health care education. Furthermore, it has shown great promises to improve the performance of the health care staff in their daily routine. In this work we focus on the medication sorting task, which is performed manually in hospitals. This task is very error prone and needs to be performed daily. Nevertheless, errors in the medication are crucial and lead to serious complications. In this work we present a real world gamification approach of the medication sorting task in a patient's daily pill organizer. The player of the game needs to sort the correct medication into the correct dispenser slots and is rewarded or punished in real time. At the end of the game, a score is given and the user can register in a leaderboard.

  9. Clinical practice guideline: tinnitus.

    PubMed

    Tunkel, David E; Bauer, Carol A; Sun, Gordon H; Rosenfeld, Richard M; Chandrasekhar, Sujana S; Cunningham, Eugene R; Archer, Sanford M; Blakley, Brian W; Carter, John M; Granieri, Evelyn C; Henry, James A; Hollingsworth, Deena; Khan, Fawad A; Mitchell, Scott; Monfared, Ashkan; Newman, Craig W; Omole, Folashade S; Phillips, C Douglas; Robinson, Shannon K; Taw, Malcolm B; Tyler, Richard S; Waguespack, Richard; Whamond, Elizabeth J

    2014-10-01

    Tinnitus is the perception of sound without an external source. More than 50 million people in the United States have reported experiencing tinnitus, resulting in an estimated prevalence of 10% to 15% in adults. Despite the high prevalence of tinnitus and its potential significant effect on quality of life, there are no evidence-based, multidisciplinary clinical practice guidelines to assist clinicians with management. The focus of this guideline is on tinnitus that is both bothersome and persistent (lasting 6 months or longer), which often negatively affects the patient's quality of life. The target audience for the guideline is any clinician, including nonphysicians, involved in managing patients with tinnitus. The target patient population is limited to adults (18 years and older) with primary tinnitus that is persistent and bothersome. The purpose of this guideline is to provide evidence-based recommendations for clinicians managing patients with tinnitus. This guideline provides clinicians with a logical framework to improve patient care and mitigate the personal and social effects of persistent, bothersome tinnitus. It will discuss the evaluation of patients with tinnitus, including selection and timing of diagnostic testing and specialty referral to identify potential underlying treatable pathology. It will then focus on the evaluation and treatment of patients with persistent primary tinnitus, with recommendations to guide the evaluation and measurement of the effect of tinnitus and to determine the most appropriate interventions to improve symptoms and quality of life for tinnitus sufferers. The development group made a strong recommendation that clinicians distinguish patients with bothersome tinnitus from patients with nonbothersome tinnitus. The development group made a strong recommendation against obtaining imaging studies of the head and neck in patients with tinnitus, specifically to evaluate tinnitus that does not localize to 1 ear, is nonpulsatile

  10. Performance of new automated transthoracic three-dimensional echocardiographic software for left ventricular volumes and function assessment in routine clinical practice: Comparison with 3 Tesla cardiac magnetic resonance.

    PubMed

    Levy, Franck; Dan Schouver, Elie; Iacuzio, Laura; Civaia, Filippo; Rusek, Stephane; Dommerc, Carinne; Marechaux, Sylvestre; Dor, Vincent; Tribouilloy, Christophe; Dreyfus, Gilles

    2017-05-26

    Three-dimensional (3D) transthoracic echocardiography (TTE) is superior to two-dimensional Simpson's method for assessment of left ventricular (LV) volumes and LV ejection fraction (LVEF). Nevertheless, 3D TTE is not incorporated into everyday practice, as current LV chamber quantification software products are time-consuming. To evaluate the feasibility, accuracy and reproducibility of new fully automated fast 3D TTE software (HeartModel(A.I.); Philips Healthcare, Andover, MA, USA) for quantification of LV volumes and LVEF in routine practice; to compare the 3D LV volumes and LVEF obtained with a cardiac magnetic resonance (CMR) reference; and to optimize automated default border settings with CMR as reference. Sixty-three consecutive patients, who had comprehensive 3D TTE and CMR examinations within 24hours, were eligible for inclusion. Nine patients (14%) were excluded because of insufficient echogenicity in the 3D TTE. Thus, 54 patients (40 men; mean age 63±13 years) were prospectively included into the study. The inter- and intraobserver reproducibilities of 3D TTE were excellent (coefficient of variation<10%) for end-diastolic volume (EDV), end-systolic volume (ESV) and LVEF. Despite a slight underestimation of EDV using 3D TTE compared with CMR (bias=-22±34mL; P<0.0001), a significant correlation was found between the two measurements (r=0.93; P=0.0001). Enlarging default border detection settings leads to frequent volume overestimation in the general population, but improved agreement with CMR in patients with LVEF≤50%. Correlations between 3D TTE and CMR for ESV and LVEF were excellent (r=0.93 and r=0.91, respectively; P<0.0001). 3D TTE using new-generation fully automated software is a feasible, fast, reproducible and accurate imaging modality for LV volumetric quantification in routine practice. Optimization of border detection settings may increase agreement with CMR for EDV assessment in dilated ventricles. Copyright © 2017 Elsevier Masson

  11. [Bioethics in clinical practice].

    PubMed

    Sánchez-Gonzaléz, Miguel; Herreros, Benjamín

    2015-01-01

    Bioethics has grown exponentially in recent decades. Its most important schools include principlism, casuistry, virtue ethics and the ethics of care. These schools are not exclusive. Within bioethics, clinical ethics addresses the inherent clinical practice ethical problems, problems which are many and very varied. Bioethics training is essential for clinicians to address these bioethics' problems. But even the professionals are trained, there are problems that cannot be solved individually and require advisory groups in clinical ethics: clinical ethics committees. These committees are also responsible for education in bioethics in health institutions. Clinical bioethics is a practical discipline, oriented to address specific problems, so its development is necessary to improve the decision making in such complex problems, inevitable problems in healthcare.

  12. Cost-effectiveness analysis of clinically indicated versus routine replacement of peripheral intravenous catheters.

    PubMed

    Tuffaha, Haitham W; Rickard, Claire M; Webster, Joan; Marsh, Nicole; Gordon, Louisa; Wallis, Marianne; Scuffham, Paul A

    2014-02-01

    Millions of peripheral intravenous catheters are used worldwide. The current guidelines recommend routine catheter replacement every 72-96 h. This practice requires increasing healthcare resource use. The clinically indicated catheter replacement strategy is proposed as an alternative. To assess the cost effectiveness of clinically indicated versus routine replacement of peripheral intravenous catheters. A cost-effectiveness analysis from the perspective of Queensland Health, Australia, was conducted alongside a randomized controlled trial. Adult patients with an intravenous catheter of expected use for longer than 4 days were randomly assigned to receive either clinically indicated replacement or third-day routine replacement. The primary outcome was phlebitis during catheterization or within 48 h after catheter removal. Resource use data were prospectively collected and valued (2010 prices). The incremental net monetary benefit was calculated with uncertainty characterized using bootstrap simulations. Additionally, value of information (VOI) and value of implementation analyses were performed. The clinically indicated replacement strategy was associated with a cost saving per patient of AU$7.60 (95% confidence interval [CI] 4.96-10.62) and a non-significant difference in the phlebitis rate of 0.41% (95% CI -1.33 to 2.15). The incremental net monetary benefit was AU$7.60 (95% CI 4.96-10.62). The expected VOI was zero, whereas the expected value of perfect implementation of the clinically indicated replacement strategy was approximately AU$5 million over 5 years. The clinically indicated catheter replacement strategy is cost saving compared with routine replacement. It is recommended that healthcare organizations consider changing to a policy whereby catheters are changed only if clinically indicated.

  13. Routine versus clinically indicated replacement of peripheral intravenous catheters: a randomised controlled equivalence trial.

    PubMed

    Rickard, Claire M; Webster, Joan; Wallis, Marianne C; Marsh, Nicole; McGrail, Matthew R; French, Venessa; Foster, Lynelle; Gallagher, Peter; Gowardman, John R; Zhang, Li; McClymont, Alice; Whitby, Michael

    2012-09-22

    The millions of peripheral intravenous catheters used each year are recommended for 72-96 h replacement in adults. This routine replacement increases health-care costs and staff workload and requires patients to undergo repeated invasive procedures. The effectiveness of the practice is not well established. Our hypothesis was that clinically indicated catheter replacement is of equal benefit to routine replacement. This multicentre, randomised, non-blinded equivalence trial recruited adults (≥18 years) with an intravenous catheter of expected use longer than 4 days from three hospitals in Queensland, Australia, between May 20, 2008, and Sept 9, 2009. Computer-generated random assignment (1:1 ratio, no blocking, stratified by hospital, concealed before allocation) was to clinically indicated replacement, or third daily routine replacement. Patients, clinical staff, and research nurses could not be masked after treatment allocation because of the nature of the intervention. The primary outcome was phlebitis during catheterisation or within 48 h after removal. The equivalence margin was set at 3%. Primary analysis was by intention to treat. Secondary endpoints were catheter-related bloodstream and local infections, all bloodstream infections, catheter tip colonisation, infusion failure, catheter numbers used, therapy duration, mortality, and costs. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12608000445370. All 3283 patients randomised (5907 catheters) were included in our analysis (1593 clinically indicated; 1690 routine replacement). Mean dwell time for catheters in situ on day 3 was 99 h (SD 54) when replaced as clinically indicated and 70 h (13) when routinely replaced. Phlebitis occurred in 114 of 1593 (7%) patients in the clinically indicated group and in 114 of 1690 (7%) patients in the routine replacement group, an absolute risk difference of 0·41% (95% CI -1·33 to 2·15%), which was within the

  14. Zonisamide in clinical practice.

    PubMed

    Dupont, S; Stefan, H

    2012-01-01

    Zonisamide is currently licensed in Europe and the USA for the adjunctive treatment of partial seizures (with or without secondary generalization) in adults, based on the results of four pivotal, randomized, double-blind, placebo-controlled trials. It is also licensed in Europe as monotherapy for adults with newly diagnosed partial epilepsy, based on the results of a randomized, double-blind, non-inferiority trial. Because clinical trials are conducted under tightly controlled conditions, using rigid dosing schedules and employing strict exclusion/exclusion criteria, there is a need for 'real-world' evidence of an antiepileptic drug's effectiveness and tolerability in clinical practice, where patients are much more diverse in terms of clinical characteristics and treatment is tailored to the individual's specific needs. Several studies have demonstrated that adjunctive treatment with zonisamide is effective when administered under everyday clinical practice conditions, with a favourable safety/tolerability profile similar to that observed in clinical trials. In the Zonisamid im Alltag Der Epilepsiepatienten (ZADE) study, almost 80% of patients showed a reduction in seizure frequency of ≥50% over a median follow-up of 18 weeks, and over one-third of patients became seizure free. Data from these clinical practice studies also indicate that zonisamide is effective and generally well tolerated when administered as a first-line adjunctive treatment and is associated with high retention rates and improvements in quality of life. Evidence from these clinical practice studies therefore complements data from zonisamide's clinical trial programme, providing pragmatic information on the likely benefits and risks of treatment under real-life conditions. © 2012 John Wiley & Sons A/S.

  15. Practice of Clinical Supervision.

    ERIC Educational Resources Information Center

    Holland, Patricia E.

    1988-01-01

    Clinical supervision remained grounded in empirical inquiry as late as Morris Cogan's writings on the subject in 1973. With the acknowledgment of Thomas Kuhn's (1962) paradigm shift, educational theory and practice developed interpretive methodologies. An interpretive reflection on Cogan's rationale offers insights into the current, matured…

  16. Practice of Clinical Supervision.

    ERIC Educational Resources Information Center

    Holland, Patricia E.

    1988-01-01

    Clinical supervision remained grounded in empirical inquiry as late as Morris Cogan's writings on the subject in 1973. With the acknowledgment of Thomas Kuhn's (1962) paradigm shift, educational theory and practice developed interpretive methodologies. An interpretive reflection on Cogan's rationale offers insights into the current, matured…

  17. Good Clinical Practice Training

    PubMed Central

    Arango, Jaime; Chuck, Tina; Ellenberg, Susan S.; Foltz, Bridget; Gorman, Colleen; Hinrichs, Heidi; McHale, Susan; Merchant, Kunal; Shapley, Stephanie; Wild, Gretchen

    2016-01-01

    Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions. PMID:27390628

  18. Audit in clinical practice.

    PubMed

    Modayil, Prince Cheriyan; Panchikkeel, Ragesh Kuyyattil; Alex, Nisha

    2009-06-01

    Audit dates back to as early as 1750 BC when king Hammurabi of Babylon instigated audit for clinicians with regard to outcome. Clinical audit is a way of fi nding out whether we are doing what we should be doing. It also verifi es whether we are applying the best practice. An audit cycle involves setting-up of standards, measuring current practice, comparing results with standards (criteria), changing practice and re-auditing to make sure practice has improved A 'clinical audit' is a quality improvement process that seeks to improve patient care and clinical outcomes through a systematic review of care against explicit criteria, and the implementation of change. Changes are implemented at an individual, team or service level and a subsequent re-audit is done to confi rm improvement in health care delivery. The importance of audit in healthcare sector needs to be appreciated by the relevant authorities. The most frequently cited barrier to successful audit is the failure of organizations to provide suffi cient fund and protected time for healthcare teams.

  19. Routine clinical assessment of cognitive functioning in schizophrenia, major depressive disorder, and bipolar disorder.

    PubMed

    Belgaied, Wael; Samp, Jennifer; Vimont, Alexandre; Rémuzat, Cécile; Aballéa, Samuel; El Hammi, Emna; Kooli, Amna; Toumi, Mondher; Akhras, Kasem

    2014-01-01

    As more evidence points to the association of cognitive dysfunction with mental health disorders, the assessment of cognitive function in routine clinical care of these disorders is increasingly important. Despite this, it remains unknown how cognitive function is measured in routine clinical practice. The objective of this study was to assess psychiatrists' awareness of cognitive dysfunction in mental health disorders and their methods of cognitive assessment. An online survey was disseminated to psychiatrists in Europe, Asia, Australia and the United States. The survey asked about their perceptions of cognitive dysfunction in several mental health disorders, knowledge of cognitive assessment, method of cognitive assessment, and instruments used to measure cognitive function. Among the 61 respondents, most perceived that schizophrenia was associated with the greatest cognitive dysfunction. Many were unaware whether guidelines were available on cognitive assessment. In schizophrenia, 59% of psychiatrists reportedly used cognitive instruments, while the remainder relied solely on patient history interviews. The use of instruments to assess cognition in major depressive disorder (MDD) and bipolar disorder (BPD) was lower, 38% and 37% respectively. Of the reported instruments used, only a few were actually appropriate for use in the diseases of interest (12% in schizophrenia, 3% in MDD and 0% in BPD). Other instruments reported were clinical measures that did not assess cognition. These findings reveal some inconsistencies in psychiatrists' routine clinical evaluation of cognitive function. There appeared to be low use of true cognitive assessment instruments in clinical practice and confusion regarding what constituted a cognitive assessment instrument. © 2013 Published by Elsevier B.V. and ECNP.

  20. Clinical and Pharmacogenetic Predictors of Circulating Atorvastatin and Rosuvastatin Concentration in Routine Clinical Care

    PubMed Central

    DeGorter, Marianne K.; Tirona, Rommel G.; Schwarz, Ute I.; Choi, Yun-Hee; Dresser, George K.; Suskin, Neville; Myers, Kathryn; Zou, GuangYong; Iwuchukwu, Otito; Wei, Wei-Qi; Wilke, Russell A.; Hegele, Robert A.; Kim, Richard B.

    2014-01-01

    Background A barrier to statin therapy is myopathy associated with elevated systemic drug exposure. Our objective was to examine the association between clinical and pharmacogenetic variables and statin concentrations in patients. Methods and Results In total, 299 patients taking atorvastatin or rosuvastatin were prospectively recruited at an outpatient referral center. The contribution of clinical variables and transporter gene polymorphisms to statin concentration was assessed using multiple linear regression. We observed 45-fold variation in statin concentration among patients taking the same dose. After adjustment for gender, age, body mass index, ethnicity, dose, and time from last dose, SLCO1B1 c.521T>C (p < 0.001) and ABCG2 c.421C>A (p < 0.01) were important to rosuvastatin concentration (adjusted R2 = 0.56 for the final model). Atorvastatin concentration was associated with SLCO1B1 c.388A>G (p < 0.01) and c.521T>C (p < 0.05), and 4β-hydroxycholesterol, a CYP3A activity marker (adjusted R2 = 0.47). A second cohort of 579 patients from primary and specialty care databases were retrospectively genotyped. In this cohort, genotypes associated with statin concentration were not differently distributed among dosing groups, implying providers had not yet optimized each patient's risk-benefit ratio. Nearly 50% of patients in routine practice taking the highest doses were predicted to have statin concentrations greater than the 90th percentile. Conclusions Interindividual variability in statin exposure in patients is associated with uptake and efflux transporter polymorphisms. An algorithm incorporating genomic and clinical variables to avoid high atorvastatin and rosuvastatin levels is described; further study will determine if this approach reduces incidence of statin-myopathy. PMID:23876492

  1. Stigma in clinical practice.

    PubMed

    Štrkalj-Ivezić, Slađana

    2013-09-01

    Much more is known about attitudes toward mental illness and social stigma, the viscious cycle of its consequences and how to fight the social stigma in public, but much less is known about how to combat the stigma and self stigma in clinical practice. Stigma theories have not been enough to understand the feelings and experience of people with mental illness. Conceptual framework that understands stigma as consisting of difficulties of knowledge (ignorance or misinformation), problems of attitudes (prejudice), and problems of behaviour (discrimination) have not o been enough to understand stigma dynamics in the patient therapist interaction. Understanding the psychodynamic aspects of internalized stereotype of mental illness in the patient- therapist relationship may improve our competency to deal with stigma and self stigma in clinical practice.

  2. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India

    PubMed Central

    Wangnoo, Subhash Kumar; Kumar, Surender; Bhattacharyya, Arpandev; Tripathi, Sudhir; Akhtar, Shahid; Shetty, Raman; Ghosal, Samit

    2016-01-01

    Background: This 26-week, open-label observational study assessed the incidence and type of adverse events (AEs) associated with liraglutide use according to the standard clinical practice settings and the local label in India. Materials and Methods: A total of 1416 adults with type 2 diabetes (T2D) treated with liraglutide in 125 sites across India were included in the study. Participants were newly diagnosed or already receiving antidiabetic medications. Safety and efficacy data were collected at baseline and at approximately weeks 13 and 26. The primary outcome was incidence and type of AEs while using liraglutide, with events classified by Medical Dictionary for Regulatory Activities system organ class and preferred term. The secondary objective was to assess other clinical parameters related to effective T2D management. Results: Twenty AEs, predominately gastrointestinal, were reported in 1.3% of the study population in scheduled visits up to week 26. No serious AEs, including death, were reported. Hypoglycemic episodes were reported in 7.3% of participants at baseline and 0.7% at week 26. No major hypoglycemic events were reported up to week 26 (baseline: 0.4%). Glycated hemoglobin was reduced from baseline (8.8 ± 1.3%) to week 26 by 1.6 ± 1.1% (P < 0.0001); significant improvements in fasting blood glucose, and 2-h postprandial blood glucose (post-breakfast, -lunch, and -dinner) were also observed. Mean body weight decreased by 8.1 ± 6.5 kg from baseline (92.5 ± 14.6 kg; P < 0.0001). Conclusions: From the number of AEs reported, it is suggested that liraglutide was well tolerated in subjects with T2D treated under standard clinical practice conditions in India. Liraglutide was effective, and no new safety concerns were identified. PMID:27867889

  3. Best Practice No 175. Guidelines for virological and non-viral serological examination of specimens in routine diagnostic microbiological laboratories.

    PubMed

    Francis, J; Barrett, S P; Ogilvie, M M; Sutherland, S

    2004-01-01

    Viral examination is routinely carried out in most routine diagnostic microbiology laboratories. Most often, this comprises the detection of viral antigens and antibodies, and less commonly the isolation of viruses and the detection of viral nucleic acids. However, there are no standards or guidelines available for processing these specimens in routine diagnostic laboratories or for referral to specialist virology centres or units. Clinical Pathology Accreditation (CPA) has defined standards for assessing the quality of service provided by laboratories, but these do not include the scientific and technical aspects of provision of service. The Association of Medical Microbiologists has recently published Standards for Laboratory practice in medical microbiology, which covers scientific and technical aspects of provision of microbiology service, mainly bacteriological examination of specimens in routine diagnostic microbiology laboratories. These guidelines are complementary to the CPA guidelines and aim to ensure a consistent and high quality service. This article presents guidelines for the examination of specimens for the diagnosis of viral infections.

  4. [Guidelines for clinical practice].

    PubMed

    Vleugels, A M

    1997-01-01

    Clinical practice guidelines are systematically developed statements that are intended to support medical decision making in well-defined clinical situations. Essentially, their object is to reduce the variability in medical practice, to improve quality, and to make appropriated control of the financial resources possible. Internationally, ever more organisations, associations, and institutions are concerned with the development of guidelines in many different areas of care. Making implicit knowledge explicit is one of the associated advantages of guidelines: they have a potential utility in training, in process evaluation, and in the reevaluation of outcome studies. In liability issues, their existence has a double effect: they can be used to justify medical behaviour, and they constitute a generally accepted reference point. A derivative problem is the legal liability of the compilers of the guidelines. The principle of the guideline approach can be challenged academically: science cannot give a definition of optimal care with absolute certainty. What is called objectivity often rests on methodologically disputable analyses; also the opinion of opinion leaders is not always a guarantee for scientific soundness. Moreover, patients are not all identical: biological variability, situational factors, patient expectations, and other elements play a role in this differentiation. Clinicians are often hesitant with respect to clinical guidelines: they are afraid of cookbook medicine and curtailment of their professional autonomy. Patients fear reduction of individualization of care and the use of guidelines as a rationing instrument. The effects of the introduction of clinical practice guidelines on medical practice, on the results and on the cost of care vary but are generally considered to be favourable. The choice of appropriate strategies in development, dissemination, and implementation turns out to be of critical importance. The article ends with concrete

  5. [Neuroethics in clinical practice].

    PubMed

    Krug, H

    2009-08-01

    In recent years the ability of neuroscience to identify and intervene in mental functions has progressed immensely, which raises several anthropologic and ethical questions. Meanwhile neuroethics arose as a new interdisciplinary field for critical analysis of neuroscientific actions and ethical reflection on the increasing knowledge of the human brain, with regard to society and politics. This article provides a survey of neuroethical implications for clinical practice.

  6. [Interstitial lung disease: auto-antibodies in routine practice].

    PubMed

    Papo, Thomas

    2005-06-01

    The clinical, computed tomography, cytological, and histological aspects of interstitial lung disease complicating an autoimmune disease lack specificity. Search for autoantibodies in the serum is thus warranted once the essentially clinical diagnosis has been established. An exhaustive history taking should aim at identifying extrathoracic elements of a possible systemic autoimmune disease. The battery of the biological tests which can be useful are discussed here in light of the diagnostic, prognostic, therapeutic, and even conceptual aspects of the disease. For the clinician, a simplified analysis of the main methods and the interpretation of immunological tests is discussed together with new tools currently under development.

  7. The renin-angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril in clinical trials versus routine practice: insights from the prospective EARLY registry.

    PubMed

    Bramlage, Peter; Schmieder, Roland E; Gitt, Anselm K; Baumgart, Peter; Mahfoud, Felix; Buhck, Hartmut; Ouarrak, Taoufik; Ehmen, Martina; Potthoff, Sebastian A

    2015-12-19

    Patient characteristics and blood pressure-related outcomes in randomized clinical trials (RCTs) differ from clinical practice because of stringent selection criteria. The present study aimed to explore the relationship between clinical trials and clinical practice. We analyzed data from patients enrolled in the "Treatment with Azilsartan Compared to ACE-Inhibitors in Anti-Hypertensive Therapy" (EARLY) registry comparing blood pressure (BP) effects of the angiotensin receptor blocker (ARB) azilsartan medoxomil (AZL-M) with the angiotensin-converting enzyme (ACE) inhibitor ramipril between patients who met the eligibility criteria of a previous RCT and those who did not. Patients with primary arterial hypertension were consecutively enrolled from primary care offices in Germany into the EARLY registry in a 7:3 ratio for treatment with AZL-M or an ACE inhibitor, provided that they met the following criteria at baseline: 1) no antihypertensive treatment prior to inclusion or a non-renin-angiotensin system (RAS) based monotherapy; 2) initiation of treatment with either AZL-M or an ACE inhibitor alone. Analyses were performed to evaluate BP effects for patients in the EARLY registry who met the selection criteria of a prior RCT (RCT+) versus those who did not (RCT-). Out of 3,698 patients considered, 1,644 complied with the RCT criteria (RCT+) while 2,054 did not (RCT-). RCT- patients (55.5%) displayed a higher risk profile in terms of age and comorbidities, and a wider spectrum of BP values at baseline, as highlighted by the grades of hypertension and mean BP values. The proportion of patients who achieved target blood pressure control in the RCT+ group was significantly higher for AZL-M versus ramipril (64.1 versus 56.1%; P<0.01), in accordance with the result of the clinical trial. In the RCT- AZL-M group, the proportion of patients who met BP targets was lower (58.1%) than in the RCT+ AZL-M group (64.1%), whereas the proportion of patients with target BP values in

  8. Supports and barriers to implementation of routine clinical assessment for children with cerebral palsy: A mixed-methods study.

    PubMed

    Kerr, Claire; Shields, Nora; Quarmby, Lyndsay; Roberts, Karen; Imms, Christine

    2016-12-15

    The purpose of this study is to investigate supports and barriers to evidence-based routine clinical assessment of children with cerebral palsy. This mixed methods study included physiotherapists, occupational therapists and speech pathologists providing services to children with cerebral palsy (3-18 years) within five organizations across Australia. Four organizations initiated standardized routine clinical data collection (Commencing organizations), and one had previously mandated routine assessment (Comparison organization). Participants completed the Supports and Barriers Questionnaire (n = 227) and participated in focus groups (n = 8 groups, 37 participants). Quantitative data were summarized descriptively, qualitative data were analyzed thematically and comparisons between organizations assessed. Organizational structures, resources, therapists within organizations, assessment tools, and children and families were, on average, viewed as supportive of routine clinical assessment. There were no differences between the Comparison and Commencing organizations except 'therapists within the organization' were viewed as more supportive by the Commencing organizations (p = 0.037). Five themes were derived from qualitative analyzes: motivation to adopt routine clinical assessment; acquiring and utilizing expertise; ensuring effective ongoing communication; availability and distribution of resources; and therapist perceptions of child and family wishes. Organizations experience challenges to effective and sustained implementation of routine clinical assessment. Adequate resourcing and positive, clear communication were perceived as critical for success. Implications for Rehabilitation The value of routine clinical assessment of children with cerebral palsy is undisputed. Tailored solutions to organization-specific challenges are required when implementing routine clinical assessment for children with cerebral palsy. Positive, clear communication of

  9. Medical treatment choices for patients affected by advanced NSCLC in routine clinical practice: results from the Italian observational "SUN" (Survey on the lUng cancer maNagement) study.

    PubMed

    Gridelli, Cesare; Ardizzoni, Andrea; Barni, Sandro; Crinò, Lucio; Caprioli, Alberto; Piazza, Elena; Lorusso, Vito; Barbera, Santi; Zilembo, Nicoletta; Gebbia, Vittorio; Adamo, Vincenzo; Pela, Riccardo; Marangolo, Maurizio; Morena, Raffaella; Filippelli, Gianfranco; Buscarino, Calogero; Alabiso, Oscar; Maione, Paolo; Venturino, Paola; De Marinis, Filippo

    2011-12-01

    Lung cancer is the most common cancer in the world today, in terms of both incidence and mortality. Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers, and the majority of people diagnosed with NSCLC have locally advanced or metastatic disease. Treatment algorithms have rapidly changed in the last 10 years because of the introduction of new chemotherapeutic and targeted agents in clinical practice. SUN is a 1-year longitudinal observational multicenter study that has consecutively enrolled patients affected by stage IIIB or IV NSCLC with the aim to describe the pattern of care and evolving approaches in the treatment of advanced NSCLC. 987 consecutive NSCLC patients were enrolled between January 2007 and March 2008 at the 74 participating centers throughout Italy and a 12-month follow-up was performed. Cyto-histological diagnosis was performed mainly by broncoscopy with only 24% by CT-scan guided fine-needle aspiration biopsy. 91.4% of the patients received a first-line medical treatment and 8.6% supportive care only. Median age of patients receiving first-line treatment was 66 years. First-line chemotherapy consisted of a single agent in 20% of patients and combination chemotherapy in 80%. The most frequently used chemotherapy regimens were cisplatin plus gemcitabine and carboplatin plus gemcitabine. Median survival of patients receiving first-line chemotherapy was 9.1 months. 32% percent of patients received a second-line treatment that consisted of chemotherapy in 71% of cases and erlotinib in 29%. Overall third-line treatment was given to 7.3% of patients. These results showed a pattern of care for advanced NSCLC that reflects the current clinical practice in Italy at the study time with a high adherence to the International guidelines by the Italian Oncologists.

  10. [Pathology of parathyroid glands: Practical aspects for routine pathological investigations].

    PubMed

    Sheu-Grabellus, S-Y; Schmid, K W

    2015-05-01

    The diagnostic histopathology of parathyroid glands comprises mostly benign diseases associated with primary, secondary and rarely tertiary hyperparathyroidism. Parathyroid adenoma and hyperplasia are the most common diagnoses, whereas parathyroid carcinomas and atypical adenomas are exceptional causes of hyperparathyroidism, the latter being purely a diagnosis by exclusion. This article deals with the major histopathological criteria of the various diagnoses with special emphasis on the clinical manifestation.

  11. Routine HIV Screening in Portugal: Clinical Impact and Cost-Effectiveness

    PubMed Central

    Yazdanpanah, Yazdan; Perelman, Julian; DiLorenzo, Madeline A.; Alves, Joana; Barros, Henrique; Mateus, Céu; Pereira, João; Mansinho, Kamal; Robine, Marion; Park, Ji-Eun; Ross, Eric L.; Losina, Elena; Walensky, Rochelle P.; Noubary, Farzad; Freedberg, Kenneth A.; Paltiel, A. David

    2013-01-01

    Objective To compare the clinical outcomes and cost-effectiveness of routine HIV screening in Portugal to the current practice of targeted and on-demand screening. Design We used Portuguese national clinical and economic data to conduct a model-based assessment. Methods We compared current HIV detection practices to strategies of increasingly frequent routine HIV screening in Portuguese adults aged 18-69. We considered several subpopulations and geographic regions with varying levels of undetected HIV prevalence and incidence. Baseline inputs for the national case included undiagnosed HIV prevalence 0.16%, annual incidence 0.03%, mean population age 43 years, mean CD4 count at care initiation 292 cells/μL, 63% HIV test acceptance, 78% linkage to care, and HIV rapid test cost €6 under the proposed routine screening program. Outcomes included quality-adjusted survival, secondary HIV transmission, cost, and incremental cost-effectiveness. Results One-time national HIV screening increased HIV-infected survival from 164.09 quality-adjusted life months (QALMs) to 166.83 QALMs compared to current practice and had an incremental cost-effectiveness ratio (ICER) of €28,000 per quality-adjusted life year (QALY). Screening more frequently in higher-risk groups was cost-effective: for example screening annually in men who have sex with men or screening every three years in regions with higher incidence and prevalence produced ICERs of €21,000/QALY and €34,000/QALY, respectively. Conclusions One-time HIV screening in the Portuguese national population will increase survival and is cost-effective by international standards. More frequent screening in higher-risk regions and subpopulations is also justified. Given Portugal’s challenging economic priorities, we recommend prioritizing screening in higher-risk populations and geographic settings. PMID:24367639

  12. Practical experiences of moving molecular diagnostics into routine use at the Veterinary Laboratories Agency.

    PubMed

    Sawyer, J; Wakeley, P; West, D; Fearnley, C; Anderson, S; Flowers, M; Webster, K; Errington, J; Williams, R

    2006-01-01

    The practical bench application of molecular tests (here defined as nucleic acid-based tests) in a routine testing situation is not without its challenges. This paper outlines the approaches we take at the Veterinary Laboratories Agency (VLA) and highlights some of the practical issues which we have found to be important for the successful introduction and use of molecular tests in a routine testing environment. The potential advantages of molecular tests, and factors which dictate which tests are adopted for routine testing, are discussed before giving some examples of molecular tests in routine use at the VLA. The instrumentation, reagents and assays we use are outlined, followed by sections of how we approach validation and how we manage and resource the transfer of molecular tests into routine use.

  13. Myocarditis in Clinical Practice.

    PubMed

    Sinagra, Gianfranco; Anzini, Marco; Pereira, Naveen L; Bussani, Rossana; Finocchiaro, Gherardo; Bartunek, Jozef; Merlo, Marco

    2016-09-01

    Myocarditis is a polymorphic disease characterized by great variability in clinical presentation and evolution. Patients presenting with severe left ventricular dysfunction and life-threatening arrhythmias represent a demanding challenge for the clinician. Modern techniques of cardiovascular imaging and the exhaustive molecular evaluation of the myocardium with endomyocardial biopsy have provided valuable insight into the pathophysiology of this disease, and several clinical registries have unraveled the disease's long-term evolution and prognosis. However, uncertainties persist in crucial practical issues in the management of patients. This article critically reviews current information for evidence-based management, offering a rational and practical approach to patients with myocarditis. For this review, we searched the PubMed and MEDLINE databases for articles published from January 1, 1980, through December 31, 2015, using the following terms: myocarditis, inflammatory cardiomyopathy, and endomyocardial biopsy. Articles were selected for inclusion if they represented primary data or were review articles published in high-impact journals. In particular, a risk-oriented approach is proposed. The different patterns of presentation of myocarditis are classified as low-, intermediate-, and high-risk syndromes according to the most recent evidence on prognosis, clinical findings, and both invasive and noninvasive testing, and appropriate management strategies are proposed for each risk class.

  14. Supervisor variance in psychotherapy outcome in routine practice.

    PubMed

    Rousmaniere, Tony G; Swift, Joshua K; Babins-Wagner, Robbie; Whipple, Jason L; Berzins, Sandy

    2016-01-01

    Although supervision has long been considered as a means for helping trainees develop competencies in their clinical work, little empirical research has been conducted examining the influence of supervision on client treatment outcomes. Specifically, one might ask whether differences in supervisors can predict/explain whether clients will make a positive or negative change through psychotherapy. In this naturalistic study, we used a large (6521 clients seen by 175 trainee therapists who were supervised by 23 supervisors) 5-year archival data-set of psychotherapy outcomes from a private nonprofit mental health center to test whether client treatment outcomes (as measured by the OQ-45.2) differed depending on who was providing the supervision. Hierarchical linear modeling was used with clients (Level 1) nested within therapists (Level 2) who were nested within supervisors (Level 3). In the main analysis, supervisors explained less than 1% of the variance in client psychotherapy outcomes. Possible reasons for the lack of variability between supervisors are discussed.

  15. Delivering stepped care: an analysis of implementation in routine practice.

    PubMed

    Richards, David A; Bower, Peter; Pagel, Christina; Weaver, Alice; Utley, Martin; Cape, John; Pilling, Steve; Lovell, Karina; Gilbody, Simon; Leibowitz, Judy; Owens, Lilian; Paxton, Roger; Hennessy, Sue; Simpson, Angela; Gallivan, Steve; Tomson, David; Vasilakis, Christos

    2012-01-16

    In the United Kingdom, clinical guidelines recommend that services for depression and anxiety should be structured around a stepped care model, where patients receive treatment at different 'steps,' with the intensity of treatment (i.e., the amount and type) increasing at each step if they fail to benefit at previous steps. There are very limited data available on the implementation of this model, particularly on the intensity of psychological treatment at each step. Our objective was to describe patient pathways through stepped care services and the impact of this on patient flow and management. We recorded service design features of four National Health Service sites implementing stepped care (e.g., the types of treatments available and their links with other treatments), together with the actual treatments received by individual patients and their transitions between different treatment steps. We computed the proportions of patients accessing, receiving, and transiting between the various steps and mapped these proportions visually to illustrate patient movement. We collected throughput data on 7,698 patients referred. Patient pathways were highly complex and very variable within and between sites. The ratio of low (e.g., self-help) to high-intensity (e.g., cognitive behaviour therapy) treatments delivered varied between sites from 22:1, through 2.1:1, 1.4:1 to 0.5:1. The numbers of patients allocated directly to high-intensity treatment varied from 3% to 45%. Rates of stepping up from low-intensity treatment to high-intensity treatment were less than 10%. When services attempt to implement the recommendation for stepped care in the National Institute for Health and Clinical Excellence guidelines, there were significant differences in implementation and consequent high levels of variation in patient pathways. Evaluations driven by the principles of implementation science (such as targeted planning, defined implementation strategies, and clear activity

  16. [Cartesian dualism or alchemy of medical routine practice].

    PubMed

    Thieme, K

    1993-01-01

    Whereas alchemy postulated the unity of body and soul as early as in the 15th century, René Descartes developed an artificial separation of the body from the soul in the 17th century, a challenge that today's doctors continue to face. This problematic nature of dualism seems to be suitable for complicating the doctor's relationship with patients of different age groups. With the help of a screening technique and a semi-standardized interview 100 patients (25 women with RA aged > 65; 25 women with RA aged < 55; 25 women aged < 65 without RA and 25 women aged < 55 without RA) were examined with regard to their basic needs in the relationships with their doctor. The patients older than 65 showed characteristic psychophysical particularities and, as compared with patients younger than 55, 86% of them articulated the needs for security as primary need in the relationship with their doctor. Seventy-six percent of the younger patients articulated the need for passing on of information as primary need. To understand the world of the elderly means the handling of pseudo-morbidity, reduced capability, social death and disease as normality, means the acceptance of the need for a mainly emotional doctor-patient relationship. From the results efficient psycho-therapeutical findings can be recommended for the doctor's practical work with regard to "pitfalls," as well as for use as the basis for talks and for a method to use in dealing with elderly people.

  17. Hyponatraemia in clinical practice

    PubMed Central

    Biswas, M; Davies, J S

    2007-01-01

    Hyponatraemia is defined as a serum sodium concentration below 135 mmol/l. It causes major diagnostic and management problems in practice. Hyponatraemic disorders are divided into euvolaemic, hypervolaemic and hypovolaemic. In the evaluation of the hyponatraemic patient, history taking should focus on identifying the potential cause, duration and symptomatology. Clinical examination should include assessment of volume status. Acute hyponatraemia of less than 48 h duration requires prompt correction. Treatment may involve hypertonic saline, isotonic saline and appropriate hormone replacement therapy depending on the aetiology. Chronic hyponatraemia should be treated with caution because of the risk of central pontine myelinolysis. PMID:17551067

  18. Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practice.

    PubMed

    Park, Seung-Jung; Ahn, Jung-Min; Park, Gyung-Min; Cho, Young-Rak; Lee, Jong-Young; Kim, Won-Jang; Han, Seungbong; Kang, Soo-Jin; Park, Duk-Woo; Lee, Seung-Whan; Kim, Young-Hak; Lee, Cheol Whan; Mintz, Gary S; Park, Seong-Wook

    2013-11-01

    We evaluated the impact of the routine use of fractional flow reserve (FFR) on the practice and outcomes of percutaneous coronary intervention (PCI). Between January 2008 and December 2011, the rate of FFR use during PCI increased from 1.9 to 50.7% after the introduction of routine FFR use (P < 0.001). A total of 5097 patients (2699 patients before and 2398 after the routine use of FFR) underwent PCI at an academic hospital in Korea; of those, stent implantation was deferred in 475 patients. We used propensity score (PS) matching to compare the rates of the primary endpoint [death, myocardial infarction (MI), or repeat revascularization] at 1 year the cohort before and after the routine use of FFR. In the PS-matched cohort (2178 pairs), the median number of lesions per patient was 2 [inter-quartile range (IQR) 1-2] before vs. 2 (IQR 1-2) after the routine FFR use (P = 0.68); the median number of stents implanted per patient was 2 (IQR 1-3) vs. 1 (IQR 1-2), respectively (P < 0.001). The rates of the primary endpoint at 1 year was significantly lower in patients after the routine FFR use vs. patients before the routine use of FFR (hazard ratio 0.55; 95% confidence interval 0.43-0.70; P < 0.001). This was primarily due to a reduction in peri-procedural MI and repeat revascularization. Routine measurement of FFR in daily practice appeared to be associated with less use of stents and an improvement in clinical outcomes. NCT 01788592.

  19. Real-Time Patient Survey Data During Routine Clinical Activities for Rapid-Cycle Quality Improvement

    PubMed Central

    Jones, Robert E

    2015-01-01

    Background Surveying patients is increasingly important for evaluating and improving health care delivery, but practical survey strategies during routine care activities have not been available. Objective We examined the feasibility of conducting routine patient surveys in a primary care clinic using commercially available technology (Web-based survey creation, deployment on tablet computers, cloud-based management of survey data) to expedite and enhance several steps in data collection and management for rapid quality improvement cycles. Methods We used a Web-based data management tool (survey creation, deployment on tablet computers, real-time data accumulation and display of survey results) to conduct four patient surveys during routine clinic sessions over a one-month period. Each survey consisted of three questions and focused on a specific patient care domain (dental care, waiting room experience, care access/continuity, Internet connectivity). Results Of the 727 available patients during clinic survey days, 316 patients (43.4%) attempted the survey, and 293 (40.3%) completed the survey. For the four 3-question surveys, the average time per survey was overall 40.4 seconds, with a range of 5.4 to 20.3 seconds for individual questions. Yes/No questions took less time than multiple choice questions (average 9.6 seconds versus 14.0). Average response time showed no clear pattern by order of questions or by proctor strategy, but monotonically increased with number of words in the question (<20 words, 21-30 words, >30 words)—8.0, 11.8, 16.8, seconds, respectively. Conclusions This technology-enabled data management system helped capture patient opinions, accelerate turnaround of survey data, with minimal impact on a busy primary care clinic. This new model of patient survey data management is feasible and sustainable in a busy office setting, supports and engages clinicians in the quality improvement process, and harmonizes with the vision of a learning health

  20. Thiamin in Clinical Practice.

    PubMed

    Frank, Laura L

    2015-07-01

    Thiamin is a water-soluble vitamin also known as vitamin B1. Its biologically active form, thiamin pyrophosphate (TPP), is a cofactor in macronutrient metabolism. In addition to its coenzyme roles, TPP plays a role in nerve structure and function as well as brain metabolism. Signs and symptoms of thiamin deficiency (TD) include lactic acidosis, peripheral neuropathy, ataxia, and ocular changes (eg, nystagmus). More advanced symptoms include confabulation and memory loss and/or psychosis, resulting in Wernicke's encephalopathy and/or Wernicke's Korsakoff syndrome, respectively. The nutrition support clinician should be aware of patients who may be at risk for TD. Risk factors include those patients with malnutrition due to 1 or more nutrition-related etiologies: decreased nutrient intake, increased nutrient losses, or impaired nutrient absorption. Clinical scenarios such as unexplained heart failure or lactic acidosis, renal failure with dialysis, alcoholism, starvation, hyperemesis gravidarum, or bariatric surgery may increase the risk for TD. Patients who are critically ill and require nutrition support may also be at risk for TD, especially those who are given intravenous dextrose void of thiamin repletion. Furthermore, understanding thiamin's role as a potential therapeutic agent for diabetes, some inborn errors of metabolism, and neurodegenerative diseases warrants further research. This tutorial describes the absorption, digestion, and metabolism of thiamin. Issues pertaining to thiamin in clinical practice will be described, and evidence-based practice suggestions for the prevention and treatment of TD will be discussed.

  1. Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication.

    PubMed

    Giesinger, Johannes; Kemmler, Georg; Meraner, Verena; Gamper, Eva-Maria; Oberguggenberger, Anne; Sperner-Unterweger, Barbara; Holzner, Bernhard

    2009-01-01

    Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed.

  2. Towards the Implementation of Quality of Life Monitoring in Daily Clinical Routine: Methodological Issues and Clinical Implication

    PubMed Central

    Giesinger, Johannes; Kemmler, Georg; Meraner, Verena; Gamper, Eva-Maria; Oberguggenberger, Anne; Sperner-Unterweger, Barbara; Holzner, Bernhard

    2009-01-01

    Summary Quality of life (QOL) has become a widely used outcome parameter in the evaluation of treatment modalities in clinical oncology research. By now, many of the practical problems associated with measuring QOL in clinical practice can be overcome by the use of computer-based assessment methods. QOL assessment in oncology is dominated by two measurement systems, the FACT scales and the EORTC QLQ-C30 with its modules. The amount of human resources required to implement routine data collection has been reduced significantly by advanced computer technology allowing data collection in busy clinical practice. Monitoring of QOL can contribute to oncologic care by facilitating detection of physical and psychological problems and tracking the course of disease and treatment over time. Furthermore, the integration of screening for psychosocial problems into QOL monitoring contributes to the identification of patients who are in need of psychooncologic interventions. Computer-based QOL monitoring does not replace the direct physician-patient communication but enables to identify specific impairments and symptoms including psychological problems. Beyond clinical practice, QOL data can be used for research purposes and may help health care planners to determine those patient services that should be maintained or ones that should be developed. PMID:20847874

  3. Bullous pemphigoid: clinical practice guidelines.

    PubMed

    Fuertes de Vega, I; Iranzo-Fernández, P; Mascaró-Galy, J M

    2014-05-01

    Bullous pemphigoid (BP) is an autoimmune subepidermal bullous disease in which autoantibodies are directed against components of the basement membrane. Most of these antibodies belong to the immunoglobulin G class and bind principally to 2 hemidesmosomal proteins: the 180-kD antigen (BP180) and the 230-kD antigen (BP230). It is the most common blistering disease in the adult population in developed countries, with an estimated incidence in Spain of 0.2 to 3 cases per 100,000 inhabitants per year. The disease primarily affects older people, although it can also occur in young people and even in children. In recent years, advances in clinical practice have led to a better understanding and improved management of this disorder. These advances include new diagnostic techniques, such as enzyme-linked immunosorbent assay for BP180 and new drugs for the treatment of BP, with diverse therapeutic targets. There is, however, still no international consensus on guidelines for the management of BP. This article is an updated review of the scientific literature on the treatment of BP. It focuses primarily on evidence-based recommendations and is written from a practical standpoint based on experience in the routine management of this disease.

  4. A survey of paediatricians' practice and training in routine infant eye examination

    PubMed Central

    Rahi, J.; Lynn, R.

    1998-01-01

    A survey of a sample of UK paediatricians was carried out to identify the practices and determine the training of those involved in routine surveillance examinations to detect ophthalmic disorders in infants. The findings indicate important variation in current practices and raise concerns about both undergraduate and postgraduate training in ophthalmic assessment of infants.

 PMID:9623402

  5. [Hyponatremia in clinical practice].

    PubMed

    Regolisti, Giuseppe; Cabassi, Aderville; Antonucci, Elio; Brusasco, Irene; Cademartiri, Carola; Pistolesi, Valentina; Morabito, Santo; Fiaccadori, Enrico

    2015-01-01

    Hyponatremia is the most frequent electrolyte disorder in hospitalized patients and it is associated with unfavorable clinical outcomes as well as increased hospital costs. Its clinical presentation may be highly variable, ranging from asymptomaticity to neurologic emergencies with seizures or coma as signs of rapidly worsening cerebral edema. In these cases, prompt treatment is mandatory to avoid the patients death. On the other hand, in the case of gradual development of hyponatremia, it is imperative that its correction be also appropriately slow in order to avoid another neurological catastrophe, namely the osmotic demyelination syndrome. Whilst recent international guidelines and expert consensus agree on the approach to the treatment of acute severe and symptomatic hyponatremia, the recommendations on pharmacological therapy in chronic hyponatremia diverge, particularly as to the potential use of vasopressin antagonists. This review is aimed at summarizing essential aspects of epidemiology, pathophysiology and the diagnostic process of hyponatremia, to set the ground for a practical as well as evidence-based approach to treatment. As a guide through the discussion of the available evidence, a clinical case is presented in which the patients history and laboratory data are crucial for identifying the etiology of hyponatremia. The severe neurological signs at presentation justify an emergency treatment with hypertonic saline, as indicated. Subsequently, as the neurological emergency subsides, we discuss the need to revert the trend towards hypercorrection by an apparently counterintuitive approach, based in fact on sound pathophysiological grounds, with continuous infusion of hypotonic solutions and administration of desmopressin.

  6. A retrospective review of performance and utility of routine clinical pelvimetry.

    PubMed

    Blackadar, Charles S; Viera, Anthony J

    2004-01-01

    Some authorities have questioned the utility of performing clinical pelvimetry as part of routine prenatal care. This study determined the frequency with which clinical pelvimetry is still performed at two military hospitals and whether the results of pelvimetry influence the management of labor and delivery. We conducted a retrospective review of prenatal records at two military hospitals. One was an overseas hospital, and one was a family medicine teaching hospital in the United States. The records of 660 pregnant women were reviewed to identify documentation that pelvimetry was performed during prenatal care and whether there was evidence that the physician managing labor and delivery altered management based on pelvimetry results. Seventy percent (461) of the 660 records reviewed had all pelvimetry measurements documented as normal, or the provider had written "good for TOL (trial of labor)," "proven to XX pounds," or similar annotation that pelvimetry was normal. Nine percent (58 records) had no documentation of pelvimetry (pelvimetry section left blank). The remaining 21% (141 charts) had at least one pelvimetry measurement listed as abnormal on the initial prenatal exam. No admission note, progress note, or operative note recorded during labor and delivery made reference to clinical pelvimetry results. No abnormal pelvimetry result was referenced in follow-up visits or appeared to make any difference in mode of delivery or treatment in labor. Two women (one at each institution) had initial visit notes indicating the need to consider radiographic pelvimetry based on the results of clinical exam, but this test was not done in either case, and both women delivered vaginally. Our study indicates that clinical pelvimetry does not change management of pregnant patients. Current practice is to allow all women a trial of labor regardless of pelvimetry results. This makes the routine performance and recording of clinical pelvimetry a waste of time, a potential

  7. Effectiveness of open-access endoscopy in routine primary-care practice.

    PubMed

    Charles, Roger J; Cooper, Gregory S; Wong, Richard C K; Sivak, Michael V; Chak, Amitabh

    2003-02-01

    Direct referral of patients for endoscopic procedures without prior consultation (open-access endoscopy) has become commonplace. However, the effect of open-access endoscopy on the care of patients in routine clinical practice has not been studied. The impact of open-access endoscopy was examined in 168 consecutive patients referred from 8 primary-care practices to our tertiary hospital-based endoscopy center. The effectiveness of open-access endoscopy was assessed by review of office medical records at the primary-care practice sites for a minimum follow-up period of 6 months. Outcome measures evaluated included postprocedure communication between primary-care physician and patient, primary-care physician adherence to postprocedure recommendations, and the need for subsequent diagnostic evaluation and/or consultation. The mean age of the 168 patients was 60 years; 56 (33%) underwent EGD and 112 (67%) had colonoscopy; 65% were from hospital-based practices and 35% from community practices. The indication(s) for 77% of the procedures met American Society for Gastrointestinal Endoscopy guidelines for the appropriate use of endoscopy. An office follow-up was noted for 82% of patients after the open-access procedure. Discussion of results was documented in 61% of the patient charts. Compliance with diagnostic and therapeutic recommendations was documented, respectively, in 75% and 90% of patient charts. A follow-up GI consultation was requested for only 7% of the patients. Open-access endoscopy in the primary-care setting is effective to the extent that subsequent GI consultations are rare and the level of compliance with endoscopist recommendations is high. However, documentation of communication of the results of endoscopy with the patient can be improved.

  8. Scaling up routine HIV testing at specialty clinics: assessing the effectiveness of an academic detailing approach.

    PubMed

    Lubelchek, Ronald J; Hotton, Anna L; Taussig, Daniel; Amarathithada, David; Gonzalez, Marisol

    2013-11-01

    Scaling up routine HIV testing represents a key component of the National HIV/AIDS Strategy. Barriers to routine HIV testing have limited widespread adoption. Although many patients visit specialty care providers, few efforts to increase routine HIV testing in specialty care settings have been made. We report on use of a survey of barriers to routine testing coupled with academic detailing-type educational sessions to increase routine testing at specialty clinics in Chicago's main safety-net health system. We devised a survey to assess specialty provider knowledge, attitudes, and barriers to routine HIV testing. We administered this at 3 specialty clinics. Each clinic's survey responses informed content for academic detailing-type presentations to each clinic's medical providers. We provide descriptive statistics summarizing survey responses. We report changes in the HIV testing rates and use logistic regression to examine associations between time period and odds of testing at each clinic. Specialty clinic providers demonstrated varying knowledge regarding routine HIV testing guidelines-with trauma providers having the least knowledge. Concerns regarding arranging follow-up for patients with positive results was the most cited barrier to testing. Two of the 3 specialty clinics experienced significant increases in routine HIV testing, whereas the third specialty service, which uses more rotating residents, had downtrending routine testing rates. The increase in routine HIV testing in 2 of 3 specialty services suggests that academic detailing-type interventions can improve routine testing uptake in public safety-net specialty care settings and may represent a useful component to incorporate into system-wide scale-up efforts.

  9. Routine Clinical-Pathologic Correlation of Pigmented Skin Tumors Can Influence Patient Management

    PubMed Central

    Longo, Caterina; Piana, Simonetta; Lallas, Aimilios; Moscarella, Elvira; Lombardi, Mara; Raucci, Margherita; Pellacani, Giovanni; Argenziano, Giuseppe

    2015-01-01

    Background Several studies have demonstrated the benefit of integrating clinical with pathologic information, to obtain a confident diagnosis for melanocytic tumors. However, all those studies were conducted retrospectively and no data are currently available about the role of a clinical-pathologic correlation approach on a daily basis in clinical practice. Aim of the Study In our study, we evaluated the impact of a routine clinical-pathologic correlation approach for difficult skin tumors seen over 3 years in a tertiary referral center. Results Interestingly, a re-appraisal was requested for 158 out of 2015 (7.7%) excised lesions because clinical-pathologic correlation was missing. Of note, in 0.6% of them (13 out of 2045) the first histologic diagnosis was revised in the light of clinical information that assisted the Pathologist to re-evaluate the histopathologic findings that might be bland or inconspicuous per se. Conclusion In conclusion, our study demonstrated that an integrated approach involving clinicians and pathologists allows improving management of selected patients by shifting from a simply disease-focused management (melanoma versus nevus) to a patient-centered approach. PMID:26325678

  10. Correlates of routine HIV testing practices: a survey of New York State primary care physicians, 2011.

    PubMed

    Zielinski, Mary; Leung, Shu-Yin J; Akkaya-Hocagil, Tugba; Rowe, Kirsten A; Ortega-Peluso, Christina; Smith, Lou C

    2015-01-01

    The New York State (NYS) HIV Testing Law of 2010 mandates that medical providers offer HIV testing to patients aged between 13 and 64 years during primary care, to increase the number of people aware of their infection status, and to ensure linkage to medical treatment. To assess physician practices related to this legislation, we conducted a study to identify the frequency and correlates of routine HIV testing behavior among primary care physicians approximately 15 months after the new law went into effect. During September 2011 to January 2012, we mailed self-administered surveys to a representative sample of NYS primary care physicians drawn from the AMA Masterfile of Physicians. Questions included physician practices, knowledge, attitudes, and beliefs related to routine HIV testing. Bivariate and multivariate analyses with a sample of 973 physicians were conducted to identify the most influential predictors of routine HIV testing behaviors. A minority of physicians reported "always" or "frequently" practicing behaviors consistent with routine HIV testing, with 41.7% [95% confidence interval (CI): 37.4 to 46.2] routinely offering tests to patients aged 13-64 years, 40.5% (95% CI: 36.3 to 44.8) to new patients, and 33.3% (95% CI: 29.4 to 37.6) to patients during routine physicals. Only 61.4% (95% CI: 57.4 to 65.6) said they had heard of the new law. In multivariate analyses, specialty, perceived barriers, familiarity with the law, and interaction terms representing familiarity by region and self-efficacy by region were significant predictors across the 3 scenarios of routine HIV testing behavior. Additional technical assistance and training is needed for physicians on adopting routine testing behaviors, minimizing barriers and enhancing skills.

  11. Rapid learning in practice: A lung cancer survival decision support system in routine patient care data

    PubMed Central

    Dekker, Andre; Vinod, Shalini; Holloway, Lois; Oberije, Cary; George, Armia; Goozee, Gary; Delaney, Geoff P.; Lambin, Philippe; Thwaites, David

    2016-01-01

    Background and purpose A rapid learning approach has been proposed to extract and apply knowledge from routine care data rather than solely relying on clinical trial evidence. To validate this in practice we deployed a previously developed decision support system (DSS) in a typical, busy clinic for non-small cell lung cancer (NSCLC) patients. Material and methods Gender, age, performance status, lung function, lymph node status, tumor volume and survival were extracted without review from clinical data sources for lung cancer patients. With these data the DSS was tested to predict overall survival. Results 3919 lung cancer patients were identified with 159 eligible for inclusion, due to ineligible histology or stage, non-radical dose, missing tumor volume or survival. The DSS successfully identified a good prognosis group and a medium/poor prognosis group (2 year OS 69% vs. 27/30%, p < 0.001). Stage was less discriminatory (2 year OS 47% for stage I–II vs. 36% for stage IIIA–IIIB, p = 0.12) with most good prognosis patients having higher stage disease. The DSS predicted a large absolute overall survival benefit (~40%) for a radical dose compared to a non-radical dose in patients with a good prognosis, while no survival benefit of radical radiotherapy was predicted for patients with a poor prognosis. Conclusions A rapid learning environment is possible with the quality of clinical data sufficient to validate a DSS. It uses patient and tumor features to identify prognostic groups in whom therapy can be individualized based on predicted outcomes. Especially the survival benefit of a radical versus non-radical dose predicted by the DSS for various prognostic groups has clinical relevance, but needs to be prospectively validated. PMID:25241994

  12. UGT1A1 genotype and irinotecan therapy: general review and implementation in routine practice.

    PubMed

    Etienne-Grimaldi, Marie-Christine; Boyer, Jean-Christophe; Thomas, Fabienne; Quaranta, Sylvie; Picard, Nicolas; Loriot, Marie-Anne; Narjoz, Céline; Poncet, Delphine; Gagnieu, Marie-Claude; Ged, Cécile; Broly, Franck; Le Morvan, Valérie; Bouquié, Régis; Gaub, Marie-Pierre; Philibert, Laurent; Ghiringhelli, François; Le Guellec, Chantal

    2015-06-01

    Irinotecan is a major drug in the treatment of advanced colorectal cancer. Its active form is the SN38 metabolite, which is cleared by the biliary route after glucuronidation by uridine diphosphate-glucuronosyltransferase 1A1 (UGT1A1). UGT1A1 activity exhibits a wide intersubject variability, in part related to UGT1A1 gene polymorphisms. The present review on the impact of the deficient UGT1A1*28 variant on irinotecan efficacy and toxicity was produced by a French joint workgroup comprising the Group of Clinical Onco-pharmacology (GPCO-Unicancer) and the National Pharmacogenetics Network (RNPGx). It clearly emerges that for irinotecan doses at least equal to 180 mg/m(2) , patients homozygous for the UGT1A1*28 allele are at increased risk of developing hematological and/or digestive toxicities. Irinotecan dose reduction is thus recommended in homozygous *28/*28 patients. In addition, this personalized medicine strategy aims to secure high-dose irinotecan administration (≥240 mg/m(2) ) that have proven to be safe in homozygous *1/*1 patients only. The clinical relevance of this test is discussed in terms of treatment efficacy improvement, as increasing the irinotecan dose appears to be safe in patients not bearing a deficient allele. Best execution practices, cost-effectiveness, and result interpretation are discussed with the aim of facilitating the implementation of this analysis in clinical practice. The existence of networks of laboratories performing this test in routine hospital treatment, as in France, offers the prospect of widespread screening, thus guaranteeing equal access to safe treatment and optimized therapy for patients receiving irinotecan-based therapy in advanced colorectal cancer.

  13. Scaling up routine HIV testing at specialty clinics: Assessing the effectiveness of an academic detailing approach

    PubMed Central

    Hotton, Anna L.; Taussig, Daniel; Amarathithada, David; Gonzalez, Marisol

    2013-01-01

    Introduction Scaling up routine HIV testing represents a key component of the National HIV/AIDS Strategy. Barriers to routine HIV testing have limited widespread adoption. While many patients visit specialty care providers, few efforts to increase routine HIV testing in specialty care settings have been made. We report on use of a survey of barriers to routine testing, coupled with academic detailing-type educational sessions to increase routine testing at specialty clinics in Chicago’s main safety-net health system. Methods We devised a survey to assess specialty provider knowledge, attitudes and barriers to routine HIV testing. We administered this at three specialty clinics. Each clinic’s survey responses informed content for academic detailing-type presentations to each clinic’s medical providers. We provide descriptive statistics summarizing survey responses. We report changes in the HIV testing rates and use logistic regression to examine associations between time period and odds of testing at each clinic. Results Specialty clinic providers demonstrated varying knowledge regarding routine HIV testing guidelines – with trauma providers having the least knowledge. Concerns regarding arranging follow-up for patients with positive results was the most cited barrier to testing. Two of the three specialty clinics experienced significant increases in routine HIV testing, while the third specialty service, which utilizes more rotating residents, had down-trending routine testing rates. Discussion The increase in routine HIV testing in two of three specialty services suggests that academic detailing-type interventions can improve routine testing uptake in public safety-net specialty care settings and may represent a useful component to incorporate into system-wide scale-up efforts. PMID:24126444

  14. A feasibility study of implementing grip strength measurement into routine hospital practice (GRImP): study protocol.

    PubMed

    Ibrahim, Kinda; May, Carl; Patel, Harnish P; Baxter, Mark; Sayer, Avan A; Roberts, Helen

    2016-01-01

    Handgrip strength is a non-invasive marker of muscle strength, and low grip strength in hospital inpatients is associated with poor healthcare outcomes including longer length of stay, increased functional limitations, and mortality. Measuring grip strength is simple and inexpensive. However, grip strength measurement is not routinely used in clinical practice. The aim of this study is to evaluate the feasibility of implementing grip strength measurement into routine clinical practice. This feasibility study is a mixed methods design combining qualitative, quantitative, and economic elements and is based on the acute medical wards for older people in one hospital. The study consists of three phases: phase 1 will define current baseline practice for the identification of inpatients at high risk of poor healthcare outcomes, their nutrition, and mobility care through interviews and focus groups with staff as well as a review of patients' clinical records. Phase 2 will focus on the feasibility of developing and implementing a training programme using Normalisation Process Theory to enable nursing and medical staff to measure and interpret grip strength values. Following the training, grip strength will be measured routinely for older patients as part of admission procedures with the use of a care plan for those with low grip strength. Finally, phase 3 will evaluate the acceptability of grip strength measurement, its adoption, coverage, and basic costs using interviews and focus groups with staff and patients, and re-examination of clinical records. The results of this study will inform the translation of grip strength measurement from a research tool into clinical practice to improve the identification of older inpatients at risk of poor healthcare outcomes. Clinicaltrials.gov NCTO2447445.

  15. Improving clinical practice guidelines for practicing cardiologists.

    PubMed

    Benhorin, Jesaia; Bodenheimer, Monty; Brown, Mary; Case, Robert; Dwyer, Edward M; Eberly, Shirley; Francis, Charles; Gillespie, John A; Goldstein, Robert E; Greenberg, Henry; Haigney, Mark; Krone, Ronald J; Klein, Helmut; Lichstein, Edgar; Locati, Emanuela; Marcus, Frank I; Moss, Arthur J; Oakes, David; Ryan, Daniel H; Bloch Thomsen, Poul E; Zareba, Wojciech

    2015-06-15

    Cardiac-related clinical practice guidelines have become an integral part of the practice of cardiology. Unfortunately, these guidelines are often long, complex, and difficult for practicing cardiologists to use. Guidelines should be condensed and their format upgraded, so that the key messages are easier to comprehend and can be applied more readily by those involved in patient care. After presenting the historical background and describing the guideline structure, we make several recommendations to make clinical practice guidelines more user-friendly for clinical cardiologists. Our most important recommendations are that the clinical cardiology guidelines should focus exclusively on (1) class I recommendations with established benefits that are supported by randomized clinical trials and (2) class III recommendations for diagnostic or therapeutic approaches in which quality studies show no benefit or possible harm. Class II recommendations are not evidence based but reflect expert opinions related to published clinical studies, with potential for personal bias by members of the guideline committee. Class II recommendations should be published separately as "Expert Consensus Statements" or "Task Force Committee Opinions," so that both majority and minority expert opinions can be presented in a less dogmatic form than the way these recommendations currently appear in clinical practice guidelines.

  16. Defibrillation in clinical practice.

    PubMed

    Nolan, Jerry P; Soar, Jasmeet

    2009-06-01

    To discuss recent data that may influence defibrillation in clinical practice and improve outcome after cardiac arrest from a shockable rhythm. Reducing the preshock pause (interval between stopping chest compressions and shock delivery) improves shock success. The preshock pause can be reduced by continuing chest compressions during defibrillator charging and using performance-integrated debriefing to improve the efficiency of the resuscitation team. The findings of a study documenting leakage current during elective cardioversion imply that the risk to healthcare personnel of accidental electrocution during defibrillation has probably been overstated. One study has shown that when more than one shock is required, a strategy of escalating defibrillation energies may be more effective than using a fixed energy. Findings from three recent studies suggest that the precordial thump is ineffective for terminating ventricular fibrillation or ventricular tachycardia. A defibrillation strategy that enables rhythm analysis to recognize ventricular fibrillation, defibrillator charging and optimally timed shock delivery with minimal or no interruptions to chest compressions should improve the chances of shock success. Performance debriefing of rescuers and recognizing that the risk to rescuers during defibrillation has been overstated should also help minimize interruptions to chest compressions for shock delivery.

  17. [Hydration in clinical practice].

    PubMed

    Maristany, Cleofé Pérez-Portabella; Segurola Gurruchaga, Hegoi

    2011-01-01

    Water is an essential foundation for life, having both a regulatory and structural function. The former results from active and passive participation in all metabolic reactions, and its role in conserving and maintaining body temperature. Structurally speaking it is the major contributer to tissue mass, accounting for 60% of the basis of blood plasma, intracellular and intersticial fluid. Water is also part of the primary structures of life such as genetic material or proteins. Therefore, it is necessary that the nurse makes an early assessment of patients water needs to detect if there are signs of electrolyte imbalance. Dehydration can be a very serious problem, especially in children and the elderly. Dehydrations treatment with oral rehydration solution decreases the risk of developing hydration disorders, but even so, it is recommended to follow preventive measures to reduce the incidence and severity of dehydration. The key to having a proper hydration is prevention. Artificial nutrition encompasses the need for precise calculation of water needs in enteral nutrition as parenteral, so the nurse should be part of this process and use the tools for calculating the patient's requirements. All this helps to ensure an optimal nutritional status in patients at risk. Ethical dilemmas are becoming increasingly common in clinical practice. On the subject of artificial nutrition and hydration, there isn't yet any unanimous agreement regarding hydration as a basic care. It is necessary to take decisions in consensus with the health team, always thinking of the best interests of the patient.

  18. Cannabinoids in clinical practice.

    PubMed

    Williamson, E M; Evans, F J

    2000-12-01

    Cannabis has a potential for clinical use often obscured by unreliable and purely anecdotal reports. The most important natural cannabinoid is the psychoactive tetrahydrocannabinol (delta9-THC); others include cannabidiol (CBD) and cannabigerol (CBG). Not all the observed effects can be ascribed to THC, and the other constituents may also modulate its action; for example CBD reduces anxiety induced by THC. A standardised extract of the herb may be therefore be more beneficial in practice and clinical trial protocols have been drawn up to assess this. The mechanism of action is still not fully understood, although cannabinoid receptors have been cloned and natural ligands identified. Cannabis is frequently used by patients with multiple sclerosis (MS) for muscle spasm and pain, and in an experimental model of MS low doses of cannabinoids alleviated tremor. Most of the controlled studies have been carried out with THC rather than cannabis herb and so do not mimic the usual clincal situation. Small clinical studies have confirmed the usefulness of THC as an analgesic; CBD and CBG also have analgesic and antiinflammatory effects, indicating that there is scope for developing drugs which do not have the psychoactive properties of THC. Patients taking the synthetic derivative nabilone for neurogenic pain actually preferred cannabis herb and reported that it relieved not only pain but the associated depression and anxiety. Cannabinoids are effective in chemotherapy-induced emesis and nabilone has been licensed for this use for several years. Currently, the synthetic cannabinoid HU211 is undergoing trials as a protective agent after brain trauma. Anecdotal reports of cannabis use include case studies in migraine and Tourette's syndrome, and as a treatment for asthma and glaucoma. Apart from the smoking aspect, the safety profile of cannabis is fairly good. However, adverse reactions include panic or anxiety attacks, which are worse in the elderly and in women, and less

  19. Routine mortality monitoring for detecting mass murder in UK general practice: test of effectiveness using modelling.

    PubMed

    Guthrie, Bruce; Love, Tom; Kaye, Rebecca; MacLeod, Margaret; Chalmers, Jim

    2008-05-01

    The Shipman Inquiry recommended mortality rate monitoring if it could be 'shown to be workable' in detecting a future mass murderer in general practice. To examine the effectiveness of cumulative sum (CUSUM) charts, cross-sectional Shewhart charts, and exponentially-weighted, moving-average control charts in mortality monitoring at practice level. Analysis of Scottish routine general practice data combined with estimation of control chart effectiveness in detecting a 'murderer' in a simulated dataset. Practice stability was calculated from routine data to determine feasible lengths of monitoring. A simulated dataset of 405,000 'patients' was created, registered with 75 'practices' whose underlying mortality rates varied with the same distribution as case-mix-adjusted mortality in all Scottish practices. The sensitivity of each chart to detect five and 10 excess deaths was examined in repeated simulations. The sensitivity of control charts to excess deaths in simulated data, and the number of alarm signals when control charts were applied to routine data were estimated. Practice instability limited the length of monitoring and modelling was consequently restricted to a 3-year period. Monitoring mortality over 3 years, CUSUM charts were most sensitive but only reliably achieved >50% successful detection for 10 excess deaths per year and generated multiple false alarms (>15%). At best, mortality monitoring can act as a backstop to detect a particularly prolific serial killer when other means of detection have failed. Policy should focus on changes likely to improve detection of individual murders, such as reform of death certification and the coroner system.

  20. Integrating mobile technology with routine dietetic practice: the case of myPace for weight management.

    PubMed

    Harricharan, Michelle; Gemen, Raymond; Celemín, Laura Fernández; Fletcher, David; de Looy, Anne E; Wills, Josephine; Barnett, Julie

    2015-05-01

    The field of Mobile health (mHealth), which includes mobile phone applications (apps), is growing rapidly and has the potential to transform healthcare by increasing its quality and efficiency. The present paper focuses particularly on mobile technology for body weight management, including mobile phone apps for weight loss and the available evidence on their effectiveness. Translation of behaviour change theory into weight management strategies, including integration in mobile technology is also discussed. Moreover, the paper presents and discusses the myPace platform as a case in point. There is little clinical evidence on the effectiveness of currently available mobile phone apps in enabling behaviour change and improving health-related outcomes, including sustained body weight loss. Moreover, it is unclear to what extent these apps have been developed in collaboration with health professionals, such as dietitians, and the extent to which apps draw on and operationalise behaviour change techniques has not been explored. Furthermore, presently weight management apps are not built for use as part of dietetic practice, or indeed healthcare more widely, where face-to-face engagement is fundamental for instituting the building blocks for sustained lifestyle change. myPace is an innovative mobile technology for weight management meant to be embedded into and to enhance dietetic practice. Developed out of systematic, iterative stages of engagement with dietitians and consumers, it is uniquely designed to complement and support the trusted health practitioner-patient relationship. Future mHealth technology would benefit if engagement with health professionals and/or targeted patient groups, and behaviour change theory stood as the basis for technology development. Particularly, integrating technology into routine health care practice, rather than replacing one with the other, could be the way forward.

  1. The association between sleep quality, low back pain and disability: A prospective study in routine practice.

    PubMed

    Kovacs, F M; Seco, J; Royuela, A; Betegon, J N; Sánchez-Herráez, S; Meli, M; Martínez Rodríguez, M E; Núñez, M; Álvarez-Galovich, L; Moyá, J; Sánchez, C; Luna, S; Borrego, P; Moix, J; Rodríguez-Pérez, V; Torres-Unda, J; Burgos-Alonso, N; Gago-Fernández, I; González-Rubio, Y; Abraira, V

    2017-08-27

    The objective of this study was to estimate the association between sleep quality (SQ) and improvements in low back pain (LBP) and disability, among patients treated for LBP in routine practice. This prospective cohort study included 461 subacute and chronic LBP patients treated in 11 specialized centres, 14 primary care centres and eight physical therapy practices across 12 Spanish regions. LBP, leg pain, disability, catastrophizing, depression and SQ were assessed through validated questionnaires upon recruitment and 3 months later. Logistic regression models were developed to assess: (1) the association between the baseline score for SQ and improvements in LBP and disability at 3 months, and (2) the association between improvement in SQ and improvements in LBP and disability during the follow-up period. Seventy-three per cent of patients were subacute. Median scores at baseline were four points for both pain and disability, as assessed with a visual analog scale and the Roland-Morris Questionnaire, respectively. Regression models showed (OR [95% CI]) that baseline SQ was not associated with improvements in LBP (0.99 [0.94; 1.06]) or in disability (0.99 [0.93; 1.05]), although associations existed between 'improvement in SQ' and 'improvement in LBP' (4.34 [2.21; 8.51]), and 'improvement in SQ' and 'improvement in disability' (4.60 [2.29; 9.27]). Improvement in SQ is associated with improvements in LBP and in disability at 3-month follow-up, suggesting that they may reflect or be influenced by common factors. However, baseline SQ does not predict improvements in pain or disability. In clinical practice, sleep quality, low back pain and disability are associated. However, sleep quality at baseline does not predict improvement in pain and disability. © 2017 European Pain Federation - EFIC®.

  2. Child Routines and Self-Regulation Serially Mediate Parenting Practices and Externalizing Problems in Preschool Children

    ERIC Educational Resources Information Center

    Bater, Lovina Rose; Jordan, Sara Sytsma

    2017-01-01

    Background: Studies clearly indicate that parenting practices relate to child externalizing behaviors, although the mechanisms underlying this relation are less well understood. There has been limited evaluation of child routines and self-regulation in relation to these variables, and no known studies have evaluated all of these variables…

  3. Turning Routine Exercises into Activities That Teach Inquiry: A Practical Guide

    ERIC Educational Resources Information Center

    Dorée, Suzanne Ingrid

    2017-01-01

    How can we teach inquiry? In this paper, I offer practical techniques for teaching inquiry effectively using activities built from routine textbook exercises with minimal advanced preparation, including rephrasing exercises as questions, creating activities that inspire students to make conjectures, and asking for counterexamples to reasonable,…

  4. Turning Routine Exercises into Activities That Teach Inquiry: A Practical Guide

    ERIC Educational Resources Information Center

    Dorée, Suzanne Ingrid

    2017-01-01

    How can we teach inquiry? In this paper, I offer practical techniques for teaching inquiry effectively using activities built from routine textbook exercises with minimal advanced preparation, including rephrasing exercises as questions, creating activities that inspire students to make conjectures, and asking for counterexamples to reasonable,…

  5. Identification of individuals with insulin resistance using routine clinical measurements.

    PubMed

    Stern, Steven E; Williams, Ken; Ferrannini, Eleuterio; DeFronzo, Ralph A; Bogardus, Clifton; Stern, Michael P

    2005-02-01

    Insulin resistance is a treatable precursor of diabetes and potentially of cardiovascular disease as well. To identify insulin-resistant patients, we developed decision rules from measurements of obesity, fasting glucose, insulin, lipids, and blood pressure and family history in 2,321 (2,138 nondiabetic) individuals studied with the euglycemic insulin clamp technique at 17 European sites; San Antonio, Texas; and the Pima Indian reservation. The distribution of whole-body glucose disposal appeared to be bimodal, with an optimal insulin resistance cutoff of <28 micromol/min . kg lean body mass. Using recursive partitioning, we developed three types of classification tree models: the first, based on clinical measurements and all available laboratory determinations, had an area under the receiver operator characteristic curve (aROC) of 90.0% and generated a simple decision rule: diagnose insulin resistance if any of the following conditions are met: BMI >28.9 kg/m(2), homeostasis model assessment of insulin resistance (HOMA-IR) >4.65, or BMI >27.5 kg/m(2) and HOMA-IR >3.60. The fasting serum insulin concentrations corresponding to these HOMA-IR cut points were 20.7 and 16.3 microU/ml, respectively. This rule had a sensitivity and specificity of 84.9 and 78.7%, respectively. The second model, which included clinical measurements but no laboratory determinations, had an aROC of 85.0% and generated a decision rule that had a sensitivity and specificity of 78.7 and 79.6%, respectively. The third model, which included clinical measurements and lipid measurements but not insulin (and thus excluded HOMA-IR as well), had a similar aROC (85.1%), sensitivity (81.3%), and specificity (76.3%). Thus, insulin-resistant individuals can be identified using simple decision rules that can be tailored to specific needs.

  6. Variation in clinical practice in genitourinary medicine clinics in the United Kingdom

    PubMed Central

    Carne, C; Foley, E; Rowen, D; Kell, P; Maw, R

    2003-01-01

    Objectives: This study was conducted to examine the variation in clinical practice in genitourinary medicine clinics in the United Kingdom in early 2002. Methods: Questionnaires were sent to all 234 consultants in charge of genitourinary medicine clinics in the United Kingdom in March-May 2002. The questions concerned clinical practice in respect of asymptomatic patients presenting for an infection screen, and practice in respect of some specific sexually transmitted and other genitourinary infections. Results: The test for infection least likely to be offered to heterosexuals is an HIV test (71% and 70% of clinics routinely offer this to male and female heterosexuals respectively). The practice of permitting "low risk" patients to telephone for their HIV results now extends to 24% of clinics. 34% of clinics do not require patients with non-specific urethritis to attend for follow up. 41% of clinics routinely ask patients treated for Chlamydia trachomatis to return for a follow up chlamydia detection test. 25% of clinics routinely offer two tests of cure to all patients with gonorrhoea. 6% of clinics do not routinely offer syphilis serology to heterosexuals. Other significant variations in clinical practice were documented. Conclusions: Overall, our findings indicate the need for further evidence to guide clinical practice and a wider knowledge and debate of national guidelines. PMID:12794212

  7. Variation in clinical practice in genitourinary medicine clinics in the United Kingdom.

    PubMed

    Carne, C A; Foley, E; Rowen, D; Kell, P; Maw, R

    2003-06-01

    This study was conducted to examine the variation in clinical practice in genitourinary medicine clinics in the United Kingdom in early 2002. Questionnaires were sent to all 234 consultants in charge of genitourinary medicine clinics in the United Kingdom in March-May 2002. The questions concerned clinical practice in respect of asymptomatic patients presenting for an infection screen, and practice in respect of some specific sexually transmitted and other genitourinary infections. The test for infection least likely to be offered to heterosexuals is an HIV test (71% and 70% of clinics routinely offer this to male and female heterosexuals respectively). The practice of permitting "low risk" patients to telephone for their HIV results now extends to 24% of clinics. 34% of clinics do not require patients with non-specific urethritis to attend for follow up. 41% of clinics routinely ask patients treated for Chlamydia trachomatis to return for a follow up chlamydia detection test. 25% of clinics routinely offer two tests of cure to all patients with gonorrhoea. 6% of clinics do not routinely offer syphilis serology to heterosexuals. Other significant variations in clinical practice were documented. Overall, our findings indicate the need for further evidence to guide clinical practice and a wider knowledge and debate of national guidelines.

  8. The cost of developing imaging agents for routine clinical use.

    PubMed

    Nunn, Adrian D

    2006-03-01

    The objective of this study was to estimate the financial cost of developing new imaging agents for clinical use and to discuss the effects of these costs on the future clinical imaging agent environment. Publicly available financial data from the annual reports of major companies developing and selling imaging agents were examined and the data used to develop cost estimates. These estimates were compared with the in-depth data and analyses available for the development costs of therapeutic drugs. The cost of developing a drug for diagnostic imaging to commercialization is in the 100 dollars to 200 million dollars range, whereas a blockbuster imaging drug has current sales of 200 dollars to 400 million dollars. Most of these blockbuster imaging agents have been on the market for some time. The majority provide morphologic images with general indications in a slowly changing section of the market. Future agents will most likely address smaller markets and be in the rapidly developing molecular imaging field. The costs are high and are a significant brake on the development of imaging agents for commercialization. If new imaging agents are to realize their commercial potential, ways must be found to make the financials more attractive. The prices per dose are currently low so they must either be greatly increased for new imaging agents, with a corresponding increase in the value of the information they provide, or the use of imaging agents must be widened and/or their development made less costly in time and money. Without addressing these issues, the commercialization of new imaging agents will continue to be slow and may get slower. This will impact the progress of imaging agents toward use as validated biomarkers.

  9. Determination of Phenotypic Resistance Cutoffs From Routine Clinical Data

    PubMed Central

    Walter, Hauke; Pfeifer, Nico; Knops, Elena; Lübke, Nadine; Büch, Joachim; Di Giambenedetto, Simona; Kaiser, Rolf; Lengauer, Thomas

    2017-01-01

    Background: HIV-1 drug resistance can be measured with phenotypic drug-resistance tests. However, the output of these tests, the resistance factor (RF), requires interpretation with respect to the in vivo activity of the tested variant. Specifically, the dynamic range of the RF for each drug has to be divided into a suitable number of clinically meaningful intervals. Methods: We calculated a susceptible-to-intermediate and an intermediate-to-resistant cutoff per drug for RFs predicted by geno2pheno[resistance]. Probability densities for therapeutic success and failure were estimated from 10,444 treatment episodes. The density estimation procedure corrects for the activity of the backbone drug compounds and for therapy failure without drug resistance. For estimating the probability of therapeutic success given an RF, we fit a sigmoid function. The cutoffs are given by the roots of the third derivative of the sigmoid function. Results: For performance assessment, we used geno2pheno[resistance] RF predictions and the cutoffs for predicting therapeutic success in 2 independent sets of therapy episodes. HIVdb was used for performance comparison. On one test set (n = 807), our cutoffs and HIVdb performed equally well receiver operating characteristic curve [(ROC)–area under the curve (AUC): 0.68]. On the other test set (n = 917), our cutoffs (ROC–AUC: 0.63) and HIVdb (ROC–AUC: 0.65) performed comparatively well. Conclusions: Our method can be used for calculating clinically relevant cutoffs for (predicted) RFs. The method corrects for the activity of the backbone drug compounds and for therapy failure without drug resistance. Our method's performance is comparable with that of HIVdb. RF cutoffs for the latest version of geno2pheno[resistance] have been estimated with this method. PMID:27787339

  10. Translating the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) into Lithuanian.

    PubMed

    Viliū nienė, Rima; Evans, Chris; Hilbig, Jan; Pakalniškienė, Vilmantė; Danilevičiūtė, Vita; Laurinaitis, Eugenijus; Navickas, Alvydas

    2013-10-01

    There are no standardized tools in Lithuanian feasible for ongoing routine use to measure the effectiveness of psychotherapeutic treatment. The CORE-OM is a widely used 34-item self-report measure for such purpose. To explore the reliability, validity and sensitivity of the Lithuanian translation of CORE-OM questionnaire. A validation study of the CORE-OM was conducted in the psychiatric clinic attached to Vilnius University. A Lithuanian translation of the English original CORE-OM was prepared by a team of translators. Then 39 psychotherapy outpatients and 187 students were asked to complete the Lithuanian version of the CORE-OM; 66 were tested twice to determine test-retest stability. Analysis included both internal and test-retest reliability, acceptability, influence of gender, principal component analysis and criteria for reliable and clinically significant change. Internal and test-retest reliability were good (0.61-0.94), though somewhat lower for the risk domain (α: 0.57-0.79, Spearman's rho 0.25-0.60). Differences between scores of the clinical and non-clinical samples were large and significant (P < 0.001). Some of the Lithuanian criteria for clinically significant change were a bit lower than those of the original UK criteria (e.g. well-being) and others higher (symptoms, functioning, overall score), illustrating the need for local exploration. In spite of small differences in psychometric properties from the original, the Lithuanian version of the CORE-OM was reliable and sensitive in both clinical and non-clinical settings. It has the potential to become a practical, sensitive and reliable tool for psychotherapists in Lithuania.

  11. Integration of routine rapid HIV screening in an urban family planning clinic.

    PubMed

    Criniti, Shannon M; Aaron, Erika; Hilley, Amy; Wolf, Sandra

    2011-01-01

    Family planning centers can play an important role in HIV screening, education, and risk-reduction counseling for women who are sexually active. This article describes how 1 urban Title X-funded family planning clinic transitioned from using a designated HIV counselor for targeted testing to a model that uses clinic staff to provide integrated, routine, nontargeted, rapid HIV testing as standard of care. Representative clinic staff members developed an integrated testing model that would work within the existing clinic flow. Education sessions were provided to all staff, signs promoting routine HIV testing were posted, and patient and clinician information materials were developed. A review of HIV testing documentation in medical charts was performed after the new model of routine, nontargeted, rapid HIV testing was integrated, to determine any changes in patient testing rates. A survey was given to all staff members 6 months after the transition to full integration of HIV testing to evaluate the systems change process. Two years after the transition, the rate of patients with an HIV test in the medical chart within the last 12 months increased 25.5%. The testing acceptance rate increased 17%. Sixteen HIV seropositive individuals were identified and linked into medical care. All surveyed clinic staff agreed that offering routine HIV screening to all patients is very important, and 78% rated the integration efforts as successful. Integrating routine HIV screening into a family planning clinic can be critical to identifying new HIV infections in women. This initiative demonstrated that routine, nontargeted, rapid HIV screening can be offered successfully as a standard of care in a high-volume, urban, reproductive health care setting. This description and evaluation of the process of changing the model of HIV testing in a clinic setting is useful for clinicians who are interested in expanding routine HIV testing in their clinics. © 2011 by the American College of

  12. COLORECTAL CANCER PREVENTION BY AN OPTIMIZED COLONOSCOPY PROTOCOL IN ROUTINE PRACTICE

    PubMed Central

    Xirasagar, Sudha; Li, Yi-Jhen; Hurley, Thomas G.; Tsai, Meng Han; Hardin, James W.; Hurley, Deborah M.; Hebert, James R.; de Groen, Piet C.

    2014-01-01

    We conducted a retrospective cohort study to investigate the colorectal cancer (CRC) incidence and mortality prevention achievable in clinical practice with an optimized colonoscopy protocol targeting near-complete polyp clearance. The protocol consisted of: a) telephonic reinforcement of bowel preparation instructions; b) active inspection for polyps throughout insertion and circumferential withdrawal; and, c) timely updating of the protocol and documentation to incorporate the latest guidelines. Of 17,312 patients provided screening colonoscopies by 59 endoscopists in South Carolina, USA from 09/2001 through 12/2008, 997 were excluded using accepted exclusion criteria. Data on 16,315 patients were merged with the South Carolina Central Cancer Registry and Vital Records Registry data from 01/1996 – 12/2009 to identify incident CRC cases and deaths, incident lung cancers and brain cancer deaths (comparison control cancers). The standardized incidence ratios (SIR) and standardized mortality ratios (SMR) relative to South Carolina and US SEER-18 population rates were calculated. Over 78,375 person-years of observation, 18 patients developed CRC vs. 104.11 expected for an SIR of 0.17, or 83% CRC protection, the rates being 68% and 91%, respectively among the adenoma- and adenoma-free subgroups (all p<0.001). Restricting the cohort to ensure minimum 5-year follow-up (mean follow-up 6.58 years) did not change the results. The CRC mortality reduction was 89% (p<0.001; 4 CRC deaths vs. 35.95 expected). The lung cancer SIR was 0.96 (p=0.67), and brain cancer SMR was 0.92 (p=0.35). Over 80% reduction in CRC incidence and mortality is achievable in routine practice by implementing key colonoscopy principles targeting near-complete polyp clearance. PMID:25242510

  13. Pulpa dentis D30 for acute reversible pulpitis: A prospective cohort study in routine dental practice.

    PubMed

    Hamre, Harald Johan; Mittag, Inge; Glockmann, Anja; Kiene, Helmut; Tröger, Wilfried

    2011-01-01

    Pulpa dentis D30 (PD: dental pulp of the calf, prepared in a homeopathic D30 potency) has been used in acute reversible pulpitis for pain relief and to avoid or postpone invasive dental treatment. To study short-term clinical outcomes of PD therapy for acute reversible pulpitis in routine dental practice. Prospective, observational, open-label, single-arm cohort study. Eleven dental primary care practices in Germany. Thirty-two patients starting monotherapy with PD for acute reversible pulpitis without visible or radiological abnormalities. PD was applied as 1-mL submucous injections into the mucobuccal fold, repeated daily as needed. Avoidance of invasive dental treatment (pulp capping, root canal therapy, tooth extraction) and remission of pain, measured on a 0-10 point scale (partial remission: reduction by > or =3 points; complete remission: reduction from > or =4 points to 0-1 points) during the 10-day follow-up period. Median pain duration was 14.0 days. The patients received a median of two PD applications (range 1-7). A total of 81% (n=26/32) of patients did not require invasive dental treatment, and 19% (n= 6) had root canal therapy. Remission status was evaluable in 24 patients. Of these, 63% (n = 15/24) achieved pain remission, 58% (n = 14) remitted without invasive dental treatment (complete remission: n=12, partial remission: n=2), and 29% (n= 7) had a close temporal relationship between PD and remission (ratio "time to remission after first PD application vs pain duration prior to first PD application" <1:10). In this study of PD for acute reversible pulpitis, 58% of evaluable patients achieved pain remission without invasive dental treatment. The open-label pre-post design does not allow for conclusions about comparative effectiveness. However, more than one-fourth of evaluable patients remitted with a close temporal relationship between the first PD application and pain remission, suggesting a causal relationship between therapy and remission.

  14. Distress management. Clinical practice guidelines.

    PubMed

    2003-07-01

    clergy who are trained to deal with cancer-related distress. The benefits of treating distress in cancer accrue to the patients and their families, to the treating staff, and to improved efficiencies in clinic operations. Health care contracts often allow these services to "fall through the cracks" by failing to reimburse for them through either behavioral health or medical insurance. Reimbursement for services to treat psychosocial distress must be included in medical health care contracts to prevent fragmentation of services for the medically ill. For patients with cancer, integration, not separation, of mental health services and medical services is critically important. Also outcomes research studies that include quality-of-life assessment and analysis of cost-effectiveness are needed. Patients and families should be informed that management of distress is part of their total medical care. Finally, the multidisciplinary committee, office practice, or institution must be responsible for evaluating the quality of the distress management (see guidelines algorithm [page 368]), with CQI studies making an important contribution. Presently, the quality of the psychological care patients receive is not routinely monitored. Accrediting bodies have not directly examined the quality of psychosocial care, nor have they established minimal performance standards for its delivery. The panel believes that psychosocial care should and will eventually be on our institution's report cards.

  15. The diagnostic performance of urinary free cortisol is better than the cortisol:cortisone ratio in detecting de novo Cushing's syndrome: the use of a LC-MS/MS method in routine clinical practice.

    PubMed

    Ceccato, Filippo; Antonelli, Giorgia; Barbot, Mattia; Zilio, Marialuisa; Mazzai, Linda; Gatti, Rosalba; Zaninotto, Martina; Mantero, Franco; Boscaro, Marco; Plebani, Mario; Scaroni, Carla

    2014-07-01

    The Endocrine Society Clinical Guidelines recommend measuring 24-h urinary free cortisol (UFF) levels using a highly accurate method as one of the first-line screening tests for the diagnosis of Cushing's Syndrome (CS). We evaluated the performance of UFF, urinary free cortisone (UFE), and the UFF:UFE ratio, measured using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. The LC-MS/MS was used to analyze UFF and UFE levels in 43 surgically confirmed CS patients: 26 with Cushing's disease (CD, 16 de novo and ten recurrences), 11 with adrenal CS and six with ectopic CS; 22 CD patients in remission; 14 eu-cortisolemic CD patients receiving medical therapy; 60 non-CS patients; and 70 healthy controls. Sensitivity and specificity were determined in the combined groups of non-CS patients, healthy controls, and CD in remission. UFF>170 nmol/24 h showed 98.7% specificity and 100% sensitivity for de novo CS, while sensitivity was 80% for recurrent CD patients, who were characterized by lower UFF levels. The UFF:UFE and UFF+UFE showed lower sensitivity and specificity than UFF. Ectopic CS patients had the highest UFF and UFF:UFE levels, which were normal in the CD remission patients and in those receiving medical therapy. Our data suggest high diagnostic performance of UFF excretion measured using LC-MS/MS, in detecting de novo CS. UFF:UFE and UFF+UFE assessments are not useful in the first step of CS diagnosis, although high levels were found to be indicative of ectopic CS. © 2014 European Society of Endocrinology.

  16. Tailoring intervention procedures to routine primary health care practice; an ethnographic process evaluation.

    PubMed

    Jansen, Yvonne J F M; de Bont, Antoinette; Foets, Marleen; Bruijnzeels, Marc; Bal, Roland

    2007-08-07

    Tailor-made approaches enable the uptake of interventions as they are seen as a way to overcome the incompatibility of general interventions with local knowledge about the organisation of routine medical practice and the relationship between the patients and the professionals in practice. Our case is the Quattro project which is a prevention programme for cardiovascular diseases in high-risk patients in primary health care centres in deprived neighbourhoods. This programme was implemented as a pragmatic trial and foresaw the importance of local knowledge in primary health care and internal, or locally made, guidelines. The aim of this paper is to show how this prevention programme, which could be tailored to routine care, was implemented in primary care. An ethnographic design was used for this study. We observed and interviewed the researchers and the practice nurses. All the research documents, observations and transcribed interviews were analysed thematically. Our ethnographic process evaluation showed that the opportunity of tailoring intervention procedures to routine care in a pragmatic trial setting did not result in a well-organised and well-implemented prevention programme. In fact, the lack of standard protocols hindered the implementation of the intervention. Although it was not the purpose of this trial, a guideline was developed. Despite the fact that the developed guideline functioned as a tool, it did not result in the intervention being organised accordingly. However, the guideline did make tailoring the intervention possible. It provided the professionals with the key or the instructions needed to achieve organisational change and transform the existing interprofessional relations. As tailor-made approaches are developed to enable the uptake of interventions in routine practice, they are facilitated by the brokering of tools such as guidelines. In our study, guidelines facilitated organisational change and enabled the transformation of existing

  17. Tailoring intervention procedures to routine primary health care practice; an ethnographic process evaluation

    PubMed Central

    Jansen, Yvonne JFM; de Bont, Antoinette; Foets, Marleen; Bruijnzeels, Marc; Bal, Roland

    2007-01-01

    Background Tailor-made approaches enable the uptake of interventions as they are seen as a way to overcome the incompatibility of general interventions with local knowledge about the organisation of routine medical practice and the relationship between the patients and the professionals in practice. Our case is the Quattro project which is a prevention programme for cardiovascular diseases in high-risk patients in primary health care centres in deprived neighbourhoods. This programme was implemented as a pragmatic trial and foresaw the importance of local knowledge in primary health care and internal, or locally made, guidelines. The aim of this paper is to show how this prevention programme, which could be tailored to routine care, was implemented in primary care. Methods An ethnographic design was used for this study. We observed and interviewed the researchers and the practice nurses. All the research documents, observations and transcribed interviews were analysed thematically. Results Our ethnographic process evaluation showed that the opportunity of tailoring intervention procedures to routine care in a pragmatic trial setting did not result in a well-organised and well-implemented prevention programme. In fact, the lack of standard protocols hindered the implementation of the intervention. Although it was not the purpose of this trial, a guideline was developed. Despite the fact that the developed guideline functioned as a tool, it did not result in the intervention being organised accordingly. However, the guideline did make tailoring the intervention possible. It provided the professionals with the key or the instructions needed to achieve organisational change and transform the existing interprofessional relations. Conclusion As tailor-made approaches are developed to enable the uptake of interventions in routine practice, they are facilitated by the brokering of tools such as guidelines. In our study, guidelines facilitated organisational change and

  18. Can complex health interventions be evaluated using routine clinical and administrative data? - a realist evaluation approach.

    PubMed

    Riippa, Iiris; Kahilakoski, Olli-Pekka; Linna, Miika; Hietala, Minni

    2014-12-01

    Interventions aimed at improving chronic care typically consist of multiple interconnected parts, all of which are essential to the effect of the intervention. Limited attention has been paid to the use of routine clinical and administrative data in the evolution of these complex interventions. The purpose of this study is to examine the feasibility of routinely collected data when evaluating complex interventions and to demonstrate how a theory-based, realist approach to evaluation may increase the feasibility of routine data. We present a case study of evaluating a complex intervention, namely, the chronic care model (CCM), in Finnish primary health care. Issues typically faced when evaluating the effects of a complex intervention on health outcomes and resource use are identified by using routine data in a natural setting, and we apply context-mechanism-outcome (CMO) approach from the realist evaluation paradigm to improve the feasibility of using routine data in evaluating complex interventions. From an experimentalist approach that dominates the medical literature, routine data collected from a single centre offered a poor starting point for evaluating complex interventions. However, the CMO approach offered tools for identifying indicators needed to evaluate complex interventions. Applying the CMO approach can aid in a typical evaluation setting encountered by primary care managers: one in which the intervention is complex, the primary data source is routinely collected clinical and administrative data from a single centre, and in which randomization of patients into two research arms is too resource consuming to arrange. © 2014 John Wiley & Sons, Ltd.

  19. Clinical Practice in Portuguese Sexology.

    PubMed

    Alarcão, Violeta; Ribeiro, Sofia; Almeida, Joana; Giami, Alain

    2016-12-02

    Few studies explore the clinicians' knowledge, attitudes, and practices regarding sexuality, despite their role in the sexual-health socialization process. This study focuses on Portuguese sexologists engaged in clinical practice. It aims to characterize sexologists' sex education and training and their clinical practices, including diagnostic and therapeutic approaches. This research followed the methodology of an European survey on sexology as a profession (Euro-Sexo). From the 91 respondents who completed questionnaires, 51 (56%) were active in clinical practice. Results indicate that the Portuguese clinical sexologist is significantly older, predominantly male, has had training in sexology, performs more scientific research, and is more engaged in teaching activities when compared to nonclinical working sexologists. This article describes the main sexual problems presented by patients to Portuguese clinical sexologists and highlights differences in the professional groups and approaches toward treating these problems by medical doctors and nonmedical professionals. Results reinforce the idea that there are intra-European differences in the educational background of sexologists and reveal important variations in Portuguese sexologists' education, training, and clinical practice. The representations and practices of the sexologists in Portugal, as in other European countries, are embedded in cultural scenarios and sexual cultures, with implications for the clinical practice.

  20. Translating clinical informatics interventions into routine clinical care: how can the RE-AIM framework help?

    PubMed

    Bakken, Suzanne; Ruland, Cornelia M

    2009-01-01

    Clinical informatics intervention research suffers from a lack of attention to external validity in study design, implementation, evaluation, and reporting. This hampers the ability of others to assess the fit of a clinical informatics intervention with demonstrated efficacy in one setting for implementation in their setting. The objective of this model formulation paper is to demonstrate the applicability of the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework with proposed extensions to clinical informatics intervention research and describe the framework's role in facilitating the translation of evidence into practice and generation of evidence from practice. Both aspects are essential to reap the clinical and public health benefits of clinical informatics research. We expanded RE-AIM through the addition of assessment questions relevant to clinical informatics intervention research including those related to predisposing, enabling, and reinforcing factors and validated it with two case studies. The first case study supported the applicability of RE-AIM to inform real world implementation of a clinical informatics intervention with demonstrated efficacy in randomized controlled trials (RCTs)--the Choice (Creating better Health Outcomes by Improving Communication about Patients' Experiences) intervention. The second, an RCT of a personal digital assistant-based decision support system for guideline-based care, illustrated how RE-AIM can be used to inform the design of an efficacy RCT that captures essential contextual details typically lacking in RCT design and reporting. The case studies validate, through example, the applicability of RE-AIM to inform the design, implementation, evaluation, and reporting of clinical informatics intervention studies.

  1. Feasibility of implementing routine nutritional screening for older adults in Australian general practices: a mixed-methods study.

    PubMed

    Hamirudin, Aliza Haslinda; Charlton, Karen; Walton, Karen; Bonney, Andrew; Potter, Jan; Milosavljevic, Marianna; Hodgkins, Adam; Albert, George; Ghosh, Abhijeet; Dalley, Andrew

    2014-11-25

    Nutrition screening in older adults is not routinely performed in Australian primary care settings. Low awareness of the extent of malnutrition in this patient group, lack of training and time constraints are major barriers that practice staff face. This study aimed to demonstrate the feasibility of including a validated nutrition screening tool and accompanying nutrition resource kit for use with older patients attending general practice. Secondary aims were to assess nutrition-related knowledge of staff and to identify the extent of malnutrition in this patient group. Nine general practitioners, two general practice registrars and 11 practice nurses from three participating general practices in a rural, regional and metropolitan area within a local health district of New South Wales, Australia were recruited by convenience sampling. Four key themes were determined regarding the feasibility of performing MNA -SF: ease of use; incorporation into existing practice; benefit to patients' health; and patients' perception of MNA-SF. Two key themes related to the nutrition resource kit: applicability and improvement. These findings were supported by open ended questionnaire responses. Knowledge scores of staff significantly improved from baseline (52% to 66%; P < 0.05). Of the 143 patients that had been screened, 4.2% (n = 6) were classified as malnourished, 26.6% (n = 38) 'at risk' of malnutrition and 69.2% (n = 99) as well-nourished. It is feasible to include the MNA-SF and a nutrition resource kit within routine general practice, but further refinement of patients' electronic clinical records in general practice software would streamline this process.

  2. Relationship of comorbid substance and alcohol use disorders to disability among patients in routine psychiatric practice.

    PubMed

    Wilk, Joshua; West, Joyce C; Rae, Donald S; Regier, Darrel A

    2006-01-01

    The primary aim of this study was to present data on the relationship of mental and comorbid substance use disorders to work disability and functioning in routine psychiatric practice in the United States. Data were used from the 1997 and 1999 American Psychiatric Institute for Research and Education's Practice Research Network Study of Psychiatric Patients and Treatments, totaling 754 psychiatrists and 3,088 patients. Results found patients with comorbid substance use disorders had significantly higher rates of work disability. These findings highlight the critical need to address the disturbing lack of substance use treatment and rehabilitation services for this population.

  3. UMMPerfusion: an open source software tool towards quantitative MRI perfusion analysis in clinical routine.

    PubMed

    Zöllner, Frank G; Weisser, Gerald; Reich, Marcel; Kaiser, Sven; Schoenberg, Stefan O; Sourbron, Steven P; Schad, Lothar R

    2013-04-01

    To develop a generic Open Source MRI perfusion analysis tool for quantitative parameter mapping to be used in a clinical workflow and methods for quality management of perfusion data. We implemented a classic, pixel-by-pixel deconvolution approach to quantify T1-weighted contrast-enhanced dynamic MR imaging (DCE-MRI) perfusion data as an OsiriX plug-in. It features parallel computing capabilities and an automated reporting scheme for quality management. Furthermore, by our implementation design, it could be easily extendable to other perfusion algorithms. Obtained results are saved as DICOM objects and directly added to the patient study. The plug-in was evaluated on ten MR perfusion data sets of the prostate and a calibration data set by comparing obtained parametric maps (plasma flow, volume of distribution, and mean transit time) to a widely used reference implementation in IDL. For all data, parametric maps could be calculated and the plug-in worked correctly and stable. On average, a deviation of 0.032 ± 0.02 ml/100 ml/min for the plasma flow, 0.004 ± 0.0007 ml/100 ml for the volume of distribution, and 0.037 ± 0.03 s for the mean transit time between our implementation and a reference implementation was observed. By using computer hardware with eight CPU cores, calculation time could be reduced by a factor of 2.5. We developed successfully an Open Source OsiriX plug-in for T1-DCE-MRI perfusion analysis in a routine quality managed clinical environment. Using model-free deconvolution, it allows for perfusion analysis in various clinical applications. By our plug-in, information about measured physiological processes can be obtained and transferred into clinical practice.

  4. Faster identification of pathogens in positive blood cultures by fluorescence in situ hybridization in routine practice.

    PubMed

    Peters, Remco P H; Savelkoul, Paul H M; Simoons-Smit, Alberdina M; Danner, Sven A; Vandenbroucke-Grauls, Christina M J E; van Agtmael, Michiel A

    2006-01-01

    Rapid identification of microorganisms in blood cultures is required to optimize empirical treatment at an early stage. Fluorescence in situ hybridization (FISH) can reduce the time to identification of microorganisms in growth-positive blood cultures. In this study, we evaluated the performance, time to identification, and potential clinical benefits of FISH compared to those of conventional culture methods in routine practice. After Gram staining, blood culture fluids were simultaneously further identified with FISH and with conventional culture methods. Results and points in time of FISH and culture identification (provisional and final identifications) were collected and compared. For 91% of microorganisms, the genus or family name was identified, and for 79%, the species name could be attributed. The sensitivity and specificity of the individual probes exceeded 95%, except for the Enterobacteriaceae probe (sensitivity, 89%). Cross-hybridization was obtained with the Klebsiella pneumoniae probe for Klebsiella oxytoca. The time gains of FISH and final culture identification were more than 18 h for bacteria and 42 h for yeasts. With FISH, Staphylococcus aureus was differentiated from coagulase-negative staphylococci 1.4 h faster than by provisional identification (P < 0.001). In conclusion, FISH allows rapid and reliable identification of the majority of microorganisms in growth-positive blood cultures. The substantial time gain of identification with FISH may allow same-day adjustment of antimicrobial therapy, and FISH is especially useful if no provisional identification is obtained. With further extension of the number of probes and a reduction in turnaround time, FISH will become a very useful diagnostic tool in the diagnosis of bloodstream infections.

  5. Reciproc vs. hand instrumentation in dental practice: a study in routine care

    PubMed Central

    Reutter, Claudius A.; Robra, Bernt-Peter; Walther, Winfried

    2016-01-01

    Background. Little is known about the clinical impact of new root canal preparation systems in general dental practice under routine care conditions. Therefore, we compared hand instrumentation (H) with Reciproc (R) (VDW, Munich, Germany) preparation. The outcomes were endodontic related pain and oral health related quality of life (OHRQoL), evaluation of the procedures by the patients and the strain felt by the dentists during root canal therapy. Methods. Six dentists participated in the trial as practitioner–investigators. In the first phase of the trial they prepared root canals with H and in the second phase with R. The patients documented their pain felt with a visual analogue scale (VAS 100) and OHRQoL with the German short version of the oral health impact profile (OHIP-G-14) before treatment and before the completion of therapy and answered questions about how they experienced the treatment. The dentists documented their physical strain during treatment. Results. A total of 137 patients were included in the evaluation. 66 patients were treated with H, 71 with R. Pain reduction was 32.6 (SD 32.9) VAS (H) vs. 29.4 (SD 26.9) VAS (R) (p = 0.550), and the improvement of the OHIP-14 score was 5.5 (SD 9.2) (H) vs. 6.7 (SD 7.4) (R) (p = 0.383). There were no statistical differences in both groups. Significantly fewer patients felt stressed by the duration of treatment with R as with H (p = 0.018). Significantly more dentists reported that their general physical strain and the strain on their fingers were less severe with R than with H (p = 0.013 and p < 0.001). Discussion. H as well as R effectively reduced endodontic related pain and OHRQoL without statistical differences. R has advantages in terms of how patients experience the treatment and regarding the physical strain felt by the dentists. PMID:27375972

  6. [Communication with children: practical hints and tools for the anesthesiology routine].

    PubMed

    Zech, N; Seemann, M; Signer-Fischer, S; Hansen, E

    2015-03-01

    Pediatric patients represent a special challenge both for the management of anesthesia and for communication, especially the anxious and screaming child. Children have specific features of fears, cognition, comprehension and skills depending on the stage of development. In addition, behavior and anxiety are strongly shaped by the parents who have to be incorporated. This article presents the special features of children as well as practical strategies and aids for dealing with children in a perioperative setting. In children suggestibility and susceptibility to placebo and nocebo effects are increased. This makes them more sensitive to negative factors but can also be utilized for positive, constructive effects. Possibilities are presented which make use of the special characteristics of children. A number of examples from daily clinical routine are given. A child's imagination, creativity and capability for dissociation in particular allow an effective application of indirect suggestion, metaphors, stories, changes in focus of attention, retreat to an inner or imagined safe place, reframing of disturbing noises and events, pacing and leading in small steps and an activation of inner resources. A hand puppet, a pet toy, a little magic trick, introducing a magic friend, acupoint for palpitations with self-affirmation, stick figure drawings, ceiling pictures or holding hands can be quite helpful. All medical devices and interventions can be explained in a way that children can understand and in positive statements without lying or neglecting the need for information. Meeting at eye level, talking to the child instead of just about it, a language appropriate for children but not childish, comprehensible information and explanations, return of control and care more than pure technical distance, all play an important role. A serious look into such communication strategies can help the anesthetist to overcome uncertainties that a child can easily sense.

  7. The quality of clinical maternal and neonatal healthcare - a strategy for identifying 'routine care signal functions'.

    PubMed

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S

    2015-01-01

    A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the 'EmOC signal functions', a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants' adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes will contribute to streamlining MNH program

  8. Comparative efficacy versus effectiveness of initial antiretroviral therapy in clinical trials versus routine care

    PubMed Central

    Routman, Justin S.; Willig, James H.; Westfall, Andrew O.; Abroms, Sarah R.; Varshney, Mohit; Adusumilli, Sunil; Allison, Jeroan J.; Savage, Karen G.; Saag, Michael S.; Mugavero, Michael J.

    2009-01-01

    Summary The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited. The present study found similar first year virologic and CD4 outcomes among antiretroviral-naïve patients treated through routine care vs. those participating in clinical trials. Background The generalizability of clinical trial findings (efficacy) to routine care (effectiveness) may be limited due to study eligibility criteria and volunteer bias. While well chronicled in many conditions, the efficacy vs. effectiveness of antiretroviral therapy (ART) remains understudied. Methods A retrospective study of the UAB 1917 Clinic Cohort evaluated naïve patients starting ART between 1/1/00–12/31/06. Patients received ART through clinical trials or routine care. Multivariable logistic and linear regression models were fit to evaluate factors associated with virologic failure (VF=VL>50 copies/mL) and change from baseline CD4 count 6 and 12 months after ART initiation. Sensitivity analyses evaluated the impact of missing data on outcomes. Results Among 570 patients starting ART during the study period, 121 (21%) enrolled in clinical trials vs. 449 (79%) receiving ART via routine care. ART receipt through routine care was not associated with VF at either 6 (OR=1.00;95%CI=0.54–1.86) or 12 (OR=1.56;95%CI=0.80–3.05) months in primary analyses. No significant differences in CD4 count responses at 6 and 12 months were observed. Conclusions Though marked differences in efficacy vs. effectiveness have been observed in the therapeutic outcomes of other conditions, our analyses found no evidence of such divergence among our patients initiating antiretroviral therapy for HIV. PMID:20067423

  9. The Impact of Iterative Reconstruction on Computed Tomography Radiation Dosimetry: Evaluation in a Routine Clinical Setting

    PubMed Central

    Moorin, Rachael E.; Gibson, David A. J.; Forsyth, Rene K.; Fox, Richard

    2015-01-01

    Purpose To evaluate the effect of introduction of iterative reconstruction as a mandated software upgrade on radiation dosimetry in routine clinical practice over a range of computed tomography examinations. Methods Random samples of scanning data were extracted from a centralised Picture Archiving Communication System pertaining to 10 commonly performed computed tomography examination types undertaken at two hospitals in Western Australia, before and after the introduction of iterative reconstruction. Changes in the mean dose length product and effective dose were evaluated along with estimations of associated changes to annual cancer incidence. Results We observed statistically significant reductions in the effective radiation dose for head computed tomography (22–27%) consistent with those reported in the literature. In contrast the reductions observed for non-contrast chest (37–47%); chest pulmonary embolism study (28%), chest/abdominal/pelvic study (16%) and thoracic spine (39%) computed tomography. Statistically significant reductions in radiation dose were not identified in angiographic computed tomography. Dose reductions translated to substantial lowering of the lifetime attributable risk, especially for younger females, and estimated numbers of incident cancers. Conclusion Reduction of CT dose is a priority Iterative reconstruction algorithms have the potential to significantly assist with dose reduction across a range of protocols. However, this reduction in dose is achieved via reductions in image noise. Fully realising the potential dose reduction of iterative reconstruction requires the adjustment of image factors and forgoing the noise reduction potential of the iterative algorithm. Our study has demonstrated a reduction in radiation dose for some scanning protocols, but not to the extent experimental studies had previously shown or in all protocols expected, raising questions about the extent to which iterative reconstruction achieves dose

  10. Incorporating prognostic imaging biomarkers into clinical practice

    PubMed Central

    Miles, Kenneth A.

    2013-01-01

    Abstract A prognostic imaging biomarker can be defined as an imaging characteristic that is objectively measurable and provides information on the likely outcome of the cancer disease in an untreated individual and should be distinguished from predictive imaging biomarkers and imaging markers of response. A range of tumour characteristics of potential prognostic value can be measured using a variety imaging modalities. However, none has currently been adopted into routine clinical practice. This article considers key examples of emerging prognostic imaging biomarkers and proposes an evaluation framework that aims to demonstrate clinical efficacy and so support their introduction into the clinical arena. With appropriate validation within an established evaluation framework, prognostic imaging biomarkers have the potential to contribute to individualized cancer care, in some cases reducing the financial burden of expensive cancer treatments by facilitating their more rational use. PMID:24060808

  11. Aphasia in Clinical Practice

    PubMed Central

    Kertesz, Andrew

    1983-01-01

    Aphasia is a central language impairment with word finding and comprehension deficit and paraphasias. The highlights of the essential language tests and the classification based on a scorable assessment are presented. The clinical syndromes of Broca's, global, Wernicke, conduction, anomic and transcortical aphasias are detailed with definition, localization, and prognosis. Modality specific disorders associated with aphasic syndromes are discussed. The management of the aphasic patient, consisting of informed support and coordination of available services, is often the responsibility of the family physician. ImagesFig. 1Fig. 2 PMID:21286589

  12. Clinic-based routine voluntary HIV testing in a refugee settlement in Uganda.

    PubMed

    OʼLaughlin, Kelli N; Kasozi, Julius; Walensky, Rochelle P; Parker, Robert A; Faustin, Zikama M; Doraiswamy, Sathyanarayanan; Owino, Chris Omara; Bassett, Ingrid V

    2014-12-01

    We implemented and evaluated a clinic-based routine voluntary HIV testing intervention in Nakivale Refugee Settlement in Uganda. Comparing the standard of care period (40 d) with the intervention period (168 d), the mean HIV-infected clients identified per week increased from 0.9 to 5.6, and there was no significant difference between the HIV prevalence in the 2 periods (standard of care: 3.3%; intervention: 4.5%; P > 0.5). Clinic-based routine HIV testing in a refugee settlement is effective and should be considered for implementation in refugee settlements in other high-prevalence regions in sub-Saharan Africa.

  13. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial

    PubMed Central

    Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

    2012-01-01

    interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). Conclusions Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Trial registration Clinical trials NCT00128765. PMID:23190905

  14. Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.

    PubMed

    Bischoff, Erik W M A; Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

    2012-11-28

    .58). Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Clinical trials NCT00128765.

  15. Development of clinical practice guidelines.

    PubMed

    Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

    2014-01-01

    Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

  16. Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice.

    PubMed

    Cull, A; Gould, A; House, A; Smith, A; Strong, V; Velikova, G; Wright, P; Selby, P

    2001-12-14

    The aim of the study was to confirm the validity of using touchscreen computers for screening for clinically significant levels of distress among cancer patients in routine oncology practice. The Hospital Anxiety and Depression Scale (HADS), EORTC Quality of Life questionnaire (QLQ-C30), Mental Health Inventory-MHI5 and a Concerns Checklist were administered via touchscreen computer to 172 chemotherapy out-patients, twice, 2-4 weeks apart. A standard psychiatric interview (Present State Examination - PSE) was conducted within a week of the second assessment. On interview, 23% of patients were identified as 'cases'. Using the available data (questionnaires, sociodemographic details, self-reported past psychiatric history), the best screening strategy combined scores from MHI-5 and HADS from a single time-point with the following rules: if MHI-5 < 11 = non-case; if MHI-5 > or = 11 then use HADS; then, if HADS > or = 9 = 'case' (sensitivity 85%; specificity 71%; misclassification rate 26%; positive predictive value 47%). The computerized screening system enabled data to be collected, scored, collated and reported in real time to identify patients who warrant further clinical assessment. It offers the potential for improving 'case' detection in routine oncology practice while reducing the burden of questions put to 'non-cases'. Further work is needed to develop optimal choice of screening questions for this purpose.

  17. Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice

    PubMed Central

    Cull, A; Gould, A; House, A; Smith, A; Strong, V; Velikova, G; Wright, P; Selby, P

    2001-01-01

    The aim of the study was to confirm the validity of using touchscreen computers for screening for clinically significant levels of distress among cancer patients in routine oncology practice. The Hospital Anxiety and Depression Scale (HADS), EORTC Quality of Life questionnaire (QLQ-C30), Mental Health Inventory-MHI5 and a Concerns Checklist were administered via touchscreen computer to 172 chemotherapy out-patients, twice, 2–4 weeks apart. A standard psychiatric interview (Present State Examination – PSE) was conducted within a week of the second assessment. On interview, 23% of patients were identified as ‘cases’. Using the available data (questionnaires, sociodemographic details, self-reported past psychiatric history), the best screening strategy combined scores from MHI-5 and HADS from a single time-point with the following rules: if MHI-5 < 11 = non-case; if MHI-5 ≥ 11 then use HADS; then, if HADS ≥ 9 = ‘case’ (sensitivity 85%; specificity 71%; misclassification rate 26%; positive predictive value 47%). The computerized screening system enabled data to be collected, scored, collated and reported in real time to identify patients who warrant further clinical assessment. It offers the potential for improving ‘case’ detection in routine oncology practice while reducing the burden of questions put to ‘non-cases’. Further work is needed to develop optimal choice of screening questions for this purpose. © 2001 Cancer Research Campaign http://www.bjcancer.com PMID:11747324

  18. Multiple-file vs. single-file endodontics in dental practice: a study in routine care.

    PubMed

    Bartols, Andreas; Laux, Gunter; Walther, Winfried

    2016-01-01

    Little is known about the differences of rotary multiple file endodontic therapy and single-file reciprocating endodontic treatment under routine care conditions in dental practice. This multicenter study was performed to compare the outcome of multiple-file (MF) and single-file (SF) systems for primary root canal treatment under conditions of general dental practice regarding reduction of pain with a visual analogue scale (VAS 100), improvement of oral-health-related quality of life (OHRQoL) with the german short version of the oral health impact profile (OHIP-G-14) and the speed of root canal preparation. Ten general dental practitioners (GDPs) participated in the study as practitioner-investigators (PI). In the first five-month period of the study, the GDPs treated patients with MF systems. After that, the GDPs treated the patients in the second five-month period with a SF system (WaveOne). The GDPs documented the clinical findings at the beginning and on completion of treatment. The patients documented their pain and OHRQoL before the beginning and before completion of treatment. A total of 599 patients were included in the evaluation. 280 patients were in the MF group, 319 were in the SF WaveOne group. In terms of pain reduction and improvement in OHIP-G-14, the improvement in both study groups (MF and SF) was very similar based on univariate analysis methods. Pain reduction was 34.4 (SD 33.7) VAS (MF) vs. 35.0 (SD 35.4) VAS (SF) (p = 0.840) and the improvement in OHIP-G-14 score was 9.4 (SD 10.3) (MF) vs. 8.5 (SD 10.2) (SF) (p = 0.365). The treatment time per root canal was 238.9 s (SD 206.2 s) (MF) vs. 146.8 sec. (SD 452.8 sec) (SF) (p = 0.003). Regarding improvement of endodontic pain and OHRQoL measure with OHIP-G-14, there were no statistical significant differences between the SF und the MF systems. WaveOne-prepared root canals significantly faster than MF systems.

  19. Multiple-file vs. single-file endodontics in dental practice: a study in routine care

    PubMed Central

    Laux, Gunter; Walther, Winfried

    2016-01-01

    Background Little is known about the differences of rotary multiple file endodontic therapy and single-file reciprocating endodontic treatment under routine care conditions in dental practice. This multicenter study was performed to compare the outcome of multiple-file (MF) and single-file (SF) systems for primary root canal treatment under conditions of general dental practice regarding reduction of pain with a visual analogue scale (VAS 100), improvement of oral-health-related quality of life (OHRQoL) with the german short version of the oral health impact profile (OHIP-G-14) and the speed of root canal preparation. Materials and Methods Ten general dental practitioners (GDPs) participated in the study as practitioner-investigators (PI). In the first five-month period of the study, the GDPs treated patients with MF systems. After that, the GDPs treated the patients in the second five-month period with a SF system (WaveOne). The GDPs documented the clinical findings at the beginning and on completion of treatment. The patients documented their pain and OHRQoL before the beginning and before completion of treatment. Results A total of 599 patients were included in the evaluation. 280 patients were in the MF group, 319 were in the SF WaveOne group. In terms of pain reduction and improvement in OHIP-G-14, the improvement in both study groups (MF and SF) was very similar based on univariate analysis methods. Pain reduction was 34.4 (SD 33.7) VAS (MF) vs. 35.0 (SD 35.4) VAS (SF) (p = 0.840) and the improvement in OHIP-G-14 score was 9.4 (SD 10.3) (MF) vs. 8.5 (SD 10.2) (SF) (p = 0.365). The treatment time per root canal was 238.9 s (SD 206.2 s) (MF) vs. 146.8 sec. (SD 452.8 sec) (SF) (p = 0.003). Discussion Regarding improvement of endodontic pain and OHRQoL measure with OHIP-G-14, there were no statistical significant differences between the SF und the MF systems. WaveOne-prepared root canals significantly faster than MF systems. PMID:27957398

  20. Clinical Practice. Postmenopausal Osteoporosis.

    PubMed

    Black, Dennis M; Rosen, Clifford J

    2016-01-21

    Key Clinical Points Postmenopausal Osteoporosis Fractures and osteoporosis are common, particularly among older women, and hip fractures can be devastating. Treatment is generally recommended in postmenopausal women who have a bone mineral density T score of -2.5 or less, a history of spine or hip fracture, or a Fracture Risk Assessment Tool (FRAX) score indicating increased fracture risk. Bisphosphonates (generic) and denosumab reduce the risk of hip, nonvertebral, and vertebral fractures; bisphosphonates are commonly used as first-line treatment in women who do not have contraindications. Teriparatide reduces the risk of nonvertebral and vertebral fractures. Osteonecrosis of the jaw and atypical femur fractures have been reported with treatment but are rare. The benefit-to-risk ratio for osteoporosis treatment is strongly positive for most women with osteoporosis. Because benefits are retained after discontinuation of alendronate or zoledronic acid, drug holidays after 5 years of alendronate therapy or 3 years of zoledronic acid therapy may be considered for patients at lower risk for fracture.

  1. Cherubism: best clinical practice

    PubMed Central

    2012-01-01

    Cherubism is a skeletal dysplasia characterized by bilateral and symmetric fibro-osseous lesions limited to the mandible and maxilla. In most patients, cherubism is due to dominant mutations in the SH3BP2 gene on chromosome 4p16.3. Affected children appear normal at birth. Swelling of the jaws usually appears between 2 and 7 years of age, after which, lesions proliferate and increase in size until puberty. The lesions subsequently begin to regress, fill with bone and remodel until age 30, when they are frequently not detectable. Fibro-osseous lesions, including those in cherubism have been classified as quiescent, non-aggressive and aggressive on the basis of clinical behavior and radiographic findings. Quiescent cherubic lesions are usually seen in older patients and do not demonstrate progressive growth. Non-aggressive lesions are most frequently present in teenagers. Lesions in the aggressive form of cherubism occur in young children and are large, rapidly growing and may cause tooth displacement, root resorption, thinning and perforation of cortical bone. Because cherubism is usually self-limiting, operative treatment may not be necessary. Longitudinal observation and follow-up is the initial management in most cases. Surgical intervention with curettage, contouring or resection may be indicated for functional or aesthetic reasons. Surgical procedures are usually performed when the disease becomes quiescent. Aggressive lesions that cause severe functional problems such as airway obstruction justify early surgical intervention. PMID:22640403

  2. A new vestibulo-ocular reflex recording system designed for routine vestibular clinical use.

    PubMed

    Funabiki, K; Naito, Y; Matsuda, K; Honjo, I

    1999-01-01

    A new vestibulo-ocular reflex (VOR) recording system was developed, which consists of an infrared eye camera, a small velocity sensor and a frequency modulator. Using this system, the head velocity signal was frequency modulated and simultaneously recorded as a sound signal on the audio track of a Hi8 video recorder with eye images. This device enabled recording of the VOR response in routine vestibular clinical practice. The reliability and effectiveness of this system were estimated by recording and analysing the VOR response against manually controlled rotation in normal subjects (n = 22) and in patients with unilateral severe vestibular hypofunction (n = 11). VOR gain on clockwise rotation viewed from the top was defined as R gain, and counterclockwise rotation as L gain. Directional preponderance (DP%) was also calculated. VOR gain towards the diseased side was significantly lower than that towards the intact side, and also significantly lower than that of normal subjects. DP% of unilateral vestibular hypofunction cases was significantly larger than that of normal subjects. These findings indicate that this VOR recording system reliably detects severe unilateral vestibular hypofunction.

  3. Clinical practice guideline: Allergic rhinitis.

    PubMed

    Seidman, Michael D; Gurgel, Richard K; Lin, Sandra Y; Schwartz, Seth R; Baroody, Fuad M; Bonner, James R; Dawson, Douglas E; Dykewicz, Mark S; Hackell, Jesse M; Han, Joseph K; Ishman, Stacey L; Krouse, Helene J; Malekzadeh, Sonya; Mims, James Whit W; Omole, Folashade S; Reddy, William D; Wallace, Dana V; Walsh, Sandra A; Warren, Barbara E; Wilson, Meghan N; Nnacheta, Lorraine C

    2015-02-01

    Allergic rhinitis (AR) is one of the most common diseases affecting adults. It is the most common chronic disease in children in the United States today and the fifth most common chronic disease in the United States overall. AR is estimated to affect nearly 1 in every 6 Americans and generates $2 to $5 billion in direct health expenditures annually. It can impair quality of life and, through loss of work and school attendance, is responsible for as much as $2 to $4 billion in lost productivity annually. Not surprisingly, myriad diagnostic tests and treatments are used in managing this disorder, yet there is considerable variation in their use. This clinical practice guideline was undertaken to optimize the care of patients with AR by addressing quality improvement opportunities through an evaluation of the available evidence and an assessment of the harm-benefit balance of various diagnostic and management options. The primary purpose of this guideline is to address quality improvement opportunities for all clinicians, in any setting, who are likely to manage patients with AR as well as to optimize patient care, promote effective diagnosis and therapy, and reduce harmful or unnecessary variations in care. The guideline is intended to be applicable for both pediatric and adult patients with AR. Children under the age of 2 years were excluded from the clinical practice guideline because rhinitis in this population may be different than in older patients and is not informed by the same evidence base. The guideline is intended to focus on a limited number of quality improvement opportunities deemed most important by the working group and is not intended to be a comprehensive reference for diagnosing and managing AR. The recommendations outlined in the guideline are not intended to represent the standard of care for patient management, nor are the recommendations intended to limit treatment or care provided to individual patients. The development group made a strong

  4. Survival rate of antitumour necrosis factor-α treatments for psoriasis in routine dermatological practice: a multicentre observational study.

    PubMed

    Esposito, M; Gisondi, P; Cassano, N; Ferrucci, G; Del Giglio, M; Loconsole, F; Giunta, A; Vena, G A; Chimenti, S; Girolomoni, G

    2013-09-01

    Adherence is an overall marker of treatment success, and it depends on multiple factors including efficacy and safety. Despite the wide use of tumour necrosis factor (TNF)-α blockers in the treatment of plaque-type psoriasis, few data regarding treatment adherence in routine clinical practice are available. To estimate the long-term survival rate of anti-TNF-α therapy in a cohort of patients with psoriasis in routine clinical practice; to evaluate the reasons for and predictors of treatment discontinuation. The Outcome and Survival rate Concerning Anti-TNF Routine treatment (OSCAR) study was based on a retrospective analysis to estimate the long-term survival rate of the first anti-TNF-α treatment in patients with psoriasis, from three Italian academic referral centres. Adult patients (n = 650) with plaque psoriasis treated with a first course of adalimumab, etanercept or infliximab for ≥ 3 months were included. Global adherence to anti-TNF-α treatments after 28·9 ± 15·4 months (867 ± 462 days) of observation was 72·6%. Etanercept showed a longer survival (mean 51·4 months, 1565 days; P < 0·001) compared with infliximab (36·8 months, 1120 days) and adalimumab (34·7 months, 1056 days). Treatment discontinuation due to primary and secondary inefficacy was observed in 5·2% and 14·5% of patients, respectively, whereas discontinuation due to adverse events was reported in 29 subjects (4·5%). Independent predictors of treatment withdrawal were female gender [hazards ratio (HR) 1·3], treatment with adalimumab or infliximab compared with etanercept (HR 2·7 and 1·7, respectively), and the concomitant use of traditional systemic treatment, as a rescue therapy, compared with monotherapy (HR 1·9). Overall survival of anti-TNF-α agents in psoriasis is elevated, with drug discontinuation mostly due to inefficacy. Etanercept showed a longer adherence compared with adalimumab and infliximab. © 2013 British Association of Dermatologists.

  5. Assessment of pain and other patient symptoms in routine clinical care as quantitative, standardised, "scientific" data.

    PubMed

    Chua, Jacquelin R; Castrejon, Isabel; Pincus, Theodore

    2017-01-01

    Pain is the most common basis for visits to a rheumatologist, and reduction of pain is a primary goal of clinical care. Pain is assessed optimally by the patient on a self-report questionnaire. In clinical trials and other clinical research concerning pain and pain relief, detailed questionnaires are generally completed by patients. However, in routine clinical care, pain is generally assessed only according to narrative descriptions by the physician, and only a minority of settings assess pain using a standard, quantitative measure. Accurate, standard, quantitative assessment of pain in routine care is easily assessed in all patients with all diagnoses on a 0-10 visual analogue scale (VAS), by asking each patient to complete a 2-page multidimensional health assessment questionnaire/routine assessment of patient index data 3 (MDHAQ/RAPID3) at all visits. The MDHAQ includes VAS for pain, patient global assessment, and fatigue, as well as a quantitative physical function scale, RAPID3, review of systems, and recent medical history. The questionnaire provides the doctor with a 10-15 second overview of medical history data that otherwise would require about 10-15 minutes of conversation, saving time for the doctor and patient to focus on the most prominent concerns for the visit. MDHAQ scores from patients with 10 different rheumatic diagnoses, and specific data indicating similarity of scores in patients with osteoarthritis versus rheumatoid arthritis on the same questionnaire, are presented to illustrate the value of the MDHAQ in routine care.

  6. Routine testing for HIV in the United States: the intersection between recommendations and practice.

    PubMed

    Simmons, Emma; Roberts, Mary; Ma, Mindy; Beckwith, Curt; Carpenter, Charles; Flanigan, Timothy

    2006-02-01

    The purpose of this study was to examine the current practices of family practice (FP) providers and their allied staff with regard to routine HIV testing in Rhode Island (RI) and Mississippi (MS). Anonymous experimenter-derived surveys were mailed to both groups of providers in 2002. The questionnaire contained five questions about their current practices and attitudes toward HIV testing as well as patient demographics. Five hundred twenty-one questionnaires were sent to American Academy of Family Practitioners (AAFP) members in RI and MS and to FPs with listings in the phone book in RI. The response rate was 52% in RI and 41% in MS. The vast majority of providers (93%) tested their high-risk patients for HIV, but less tested pregnant (57%) and other sexually active (37%) patients. The FPs in this survey wanted HIV testing to be done in the primary care setting, yet only 7% recommended HIV testing to their sexually active patients aged 18-50 in the previous year. In order not to stigmatize any specific risk group, nor to miss any patients who are unable to be identified as being "at high risk," routine testing in the primary care setting should be encouraged.

  7. Can routine clinical data identify older patients at risk of poor healthcare outcomes on admission to hospital?

    PubMed

    Ibrahim, Kinda; Owen, Charlotte; Patel, Harnish P; May, Carl; Baxter, Mark; Sayer, Avan A; Roberts, Helen C

    2017-08-10

    Older patients who are at risk of poor healthcare outcomes should be recognised early during hospital admission to allow appropriate interventions. It is unclear whether routinely collected data can identify high-risk patients. The aim of this study was to define current practice with regard to the identification of older patients at high risk of poor healthcare outcomes on admission to hospital. Interviews/focus groups were conducted to establish the views of 22 healthcare staff across five acute medicine for older people wards in one hospital including seven nurses, four dieticians, seven doctors, and four therapists. In addition, a random sample of 60 patients' clinical records were reviewed to characterise the older patients, identify risk assessments performed routinely on admission, and describe usual care. We found that staff relied on their clinical judgment to identify high risk patients which was influenced by a number of factors such as reasons for admission, staff familiarity with patients, patients' general condition, visible frailty, and patients' ability to manage at home. "Therapy assessment" and patients' engagement with therapy were also reported to be important in recognising high-risk patients. However, staff recognised that making clinical judgments was often difficult and that it might occur several days after admission potentially delaying specific interventions. Routine risk assessments carried out on admission to identify single healthcare needs included risk of malnutrition (completed for 85% patients), falls risk (95%), moving and handling assessments (85%), and pressure ulcer risk assessments (88%). These were not used collectively to highlight patients at risk of poor healthcare outcomes. Thus, patients at risk of poor healthcare outcomes were not explicitly identified on admission using routinely collected data. There is a need for an early identification of these patients using a valid measure alongside staff clinical judgment to

  8. IT Infrastructure to support the secondary use of routinely acquired clinical imaging data for research.

    PubMed

    Leung, Kai Yan Eugene; van der Lijn, Fedde; Vrooman, Henri A; Sturkenboom, Miriam C J M; Niessen, Wiro J

    2015-01-01

    We propose an infrastructure for the automated anonymization, extraction and processing of image data stored in clinical data repositories to make routinely acquired imaging data available for research purposes. The automated system, which was tested in the context of analyzing routinely acquired MR brain imaging data, consists of four modules: subject selection using PACS query, anonymization of privacy sensitive information and removal of facial features, quality assurance on DICOM header and image information, and quantitative imaging biomarker extraction. In total, 1,616 examinations were selected based on the following MRI scanning protocols: dementia protocol (246), multiple sclerosis protocol (446) and open question protocol (924). We evaluated the effectiveness of the infrastructure in accessing and successfully extracting biomarkers from routinely acquired clinical imaging data. To examine the validity, we compared brain volumes between patient groups with positive and negative diagnosis, according to the patient reports. Overall, success rates of image data retrieval and automatic processing were 82.5 %, 82.3 % and 66.2 % for the three protocol groups respectively, indicating that a large percentage of routinely acquired clinical imaging data can be used for brain volumetry research, despite image heterogeneity. In line with the literature, brain volumes were found to be significantly smaller (p-value <0.001) in patients with a positive diagnosis of dementia (915 ml) compared to patients with a negative diagnosis (939 ml). This study demonstrates that quantitative image biomarkers such as intracranial and brain volume can be extracted from routinely acquired clinical imaging data. This enables secondary use of clinical images for research into quantitative biomarkers at a hitherto unprecedented scale.

  9. Integrating Routine HIV Testing into Family Planning Clinics That Treat Adolescents and Young Adults.

    PubMed

    Buzi, Ruth S; Madanay, Farrah L; Smith, Peggy B

    2016-01-01

    Adolescents and young adults remain at high risk for new HIV infections and for unknowingly transmitting the virus to others. Yet, they have demonstrated low rates of testing due to barriers such as stigma and difficulty accessing testing services. Few existing programs have successfully integrated family planning and HIV care services to improve testing and diagnosis rates among young adults and adolescents, particularly those of minority groups. This study describes the process of implementing HIV services into family planning clinics and how to train staff in routine, opt-out testing. This study used HIV screening data from 10 family planning clinics serving adolescents and young adults in Houston, Texas. A total of 34,299 patients were tested for HIV during a 48-month study period, from January 2010 through December 2014. Patients tested included minors <18 years of age (25.5%), males (22.8%), and individuals who had missed opportunities for HIV testing at other health-care settings. From the opt-in period (2006-2007) to the routine, opt-out period (2008-2010), the yearly average number of tests administered more than doubled; the yearly average increased again by 50% from the routine, opt-out period to the routine, rapid period (2011-2014). Eighty-eight (0.3%) patients were diagnosed with HIV, a higher seropositivity rate than CDC's recommended threshold of 0.1% for settings where routine screening is warranted. Routine, opt-out HIV testing integrated into family planning clinics increased rates of testing acceptance, receipt of test results, and HIV-positive diagnoses among adolescents and young adults.

  10. [Multivascular disease in clinical practice].

    PubMed

    Despotović, Nebojsa; Zdravković, Mihajlo

    2002-01-01

    Multiple arterial disease is presented by coexistence of ischaemic heart disease, carotid disease and peripheral obliterate arterial disease. Atherosclerosis is the main factor for onset of the disease. Among 150 patients with clinical manifestations of obliterate disease of at least two aforementioned arterial systems, we examined by many noninvasive and invasive procedures the existence and degree of obliterate arterial disease of coronary, carotid and peripheral arteries of the lower extremities. The results revealed the statistically significant correlation among: ischaemic heart disease and carotid disease (r = 0.939; p < 0.01); ischaemic heart disease and peripheral arterial disease (r = 0.834; p < 0.05); ischaemic heart disease, peripheral arterial disease and carotid disease (r = 0.986; p < 0.01). The results pointed out that whenever clinical manifestations of obliterate disease of peripheral arteries are present, there is also need for routine examination of existent coronary artery disease.

  11. Implications of routinely measuring Ankle-Brachial Index (ABI) among patients attending at a Lipid Clinic.

    PubMed

    Sona, Alessandro; Comba, Monica; Brescianini, Alessia; Corsinovi, Laura; Zanocchi, Mauro; Fonte, Gianfranco; Bo, Mario

    2009-05-01

    Low (< or = 90) Ankle Brachial Index (ABI) values identify patients at high risk for cardiovascular (CV) disease and mortality. Implications for CV risk classification from routinely measuring ABI in the context of a Lipid Clinic have not been fully investigated. We aimed to evaluate whether and to what extent routine ABI determination on top of conventional risk prediction models may modify CV risk classification. Consecutive asymptomatic non-diabetic individuals free from previous CV events attending for a first visit at a Lipid Clinic underwent routine ABI determination and conventional CV risk classification according either to national CUORE model (including age, gender, smoking, total and high density lipoprotein cholesterol, systolic blood pressure and current use of blood pressure lowering drugs) and SCORE model for low risk countries. In the overall sample (320 subjects, mean age 64.8 years) 77 subjects (24.1%) were found to have low ABI value. Forty-two of 250 subjects (16.8%) and 47 of 215 individuals (21.3%) at low or moderate risk according to the CUORE and SCORE models, respectively, were found to have low ABI values, and should be reclassified at high risk. In a series of consecutive asymptomatic individuals in a Lipid Clinic, we observed a high prevalence of low ABI values among subjects deemed at low or moderate risk on conventional prediction models, leading to CV high-risk reclassification of roughly one fifth of patients. These findings reinforce recommendations for routine determination of ABI at least within referral primary prevention settings.

  12. Delivering value in dermatology: insights from skin cancer detection in routine clinical visits.

    PubMed

    Enamandram, Monica; Duncan, Lyn M; Kimball, Alexandra B

    2015-02-01

    There are increasing demands to demonstrate and report on outcomes in dermatology. Skin cancer diagnosis through skin examination has been well studied, and is promising as a value-delivering intervention. This study seeks to identify the rate of skin cancer diagnosis during routine visits to a large tertiary dermatology clinic. Medical records of patients presenting for routine dermatologic care at Massachusetts General Hospital between March 28 and September 28, 2012, were retrospectively reviewed. All patients given a diagnosis of nonmelanoma skin cancer (NMSC) confirmed on biopsy specimen were identified. Billing data were used to identify the total number of patients evaluated during the study period. NMSC was diagnosed in 1266 skin biopsy specimens from 1047 (7.0%) of the 14,829 patients who presented for routine care. In all, 55% of patients with NMSC were men (mean age 70 years). Chief symptoms of patients with NMSC included general dermatologic concerns (37%), routine cancer screening (43%), and specific lesion(s) of concern (19%). Retrospective design and restriction to a single institution may limit the generalizability of our findings. The incidence of NMSC in routine dermatology is high; these findings validate the value of care provided by dermatologists and highlight the likely increasing need for their diagnostic skills as the population ages in the United States. Copyright © 2014 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  13. Bone scanning in clinical practice

    SciTech Connect

    Fogelman, I. )

    1987-01-01

    The topics covered in this book include the history of bone scanning, mechanisms of uptake of diphosphonate in bone, the normal bone scan, and the role of bone scanning in clinical practice. The aim of this book is to provide a source of reference relating to bone scan imaging for all those who are interested in the skeleton.

  14. Clinical practice guidelines to inform evidence-based clinical practice.

    PubMed

    Wolf, J Stuart; Hubbard, Heddy; Faraday, Martha M; Forrest, John B

    2011-06-01

    With the volume of medical research currently published, any one practitioner cannot independently review the literature to determine best evidence-based medical care. Additionally, non-specialists usually do not have the experience to know best practice for all of the frequent clinical circumstances for which there is no good evidence. Clinical practice guidelines (CPGs) help clinicians to address these problems because they are systematically created documents that summarize knowledge and provide guidance to assist in delivering high-quality medicine. They aim to improve health care by identifying evidence that supports the best clinical care and making clear which practices appear to be ineffective. Non-structured literature review. CPGs combine evidence-based medicine (on topics for which evidence exists) with expert opinion (on topics for which there is no evidence). The optimal CPG applies structured and transparent judgments, from an unbiased and diverse panel which includes both clinical experts and non-physicians, to a systematic evidence review. It includes decisions in areas in which clinical data are both available and unavailable. The resulting guideline statements should be clearly linked to the quality of the available evidence and the target patient(s) should be clearly defined, so that the reader can assess strength and applicability of the statements to an individual patient. The application of high-quality CPGs improves patient care, but all too often CPGs are not used to the greatest advantage because of inadequate dissemination and incorporation into practice. This article provides an overview of CPGs, focusing on their justification, creation, improvement, and use.

  15. Genomic Grade Index (GGI): Feasibility in Routine Practice and Impact on Treatment Decisions in Early Breast Cancer

    PubMed Central

    Metzger-Filho, Otto; Catteau, Aurélie; Michiels, Stefan; Buyse, Marc; Ignatiadis, Michail; Saini, Kamal S.; de Azambuja, Evandro; Fasolo, Virginie; Naji, Sihem; Canon, Jean Luc; Delrée, Paul; Coibion, Michel; Cusumano, Pino; Jossa, Veronique; Kains, Jean Pierre; Larsimont, Denis; Richard, Vincent; Faverly, Daniel; Cornez, Nathalie; Vuylsteke, Peter; Vanderschueren, Brigitte; Peyro-Saint-Paul, Hélène; Piccart, Martine; Sotiriou, Christos

    2013-01-01

    Purpose Genomic Grade Index (GGI) is a 97-gene signature that improves histologic grade (HG) classification in invasive breast carcinoma. In this prospective study we sought to evaluate the feasibility of performing GGI in routine clinical practice and its impact on treatment recommendations. Methods Patients with pT1pT2 or operable pT3, N0-3 invasive breast carcinoma were recruited from 8 centers in Belgium. Fresh surgical samples were sent at room temperature in the MapQuant Dx™ PathKit for centralized genomic analysis. Genomic profiles were determined using Affymetrix U133 Plus 2.0 and GGI calculated using the MapQuant Dx® protocol, which defines tumors as low or high Genomic Grade (GG-1 and GG-3 respectively). Results 180 pts were recruited and 155 were eligible. The MapQuant test was performed in 142 cases and GGI was obtained in 78% of cases (n=111). Reasons for failures were 15 samples with <30% of invasive tumor cells (11%), 15 with insufficient RNA quality (10%), and 1 failed hybridization (<1%). For tumors with an available representative sample (≥ 30% inv. tumor cells) (n=127), the success rate was 87.5%. GGI reclassified 69% of the 54 HG2 tumors as GG-1 (54%) or GG-3 (46%). Changes in treatment recommendations occurred mainly in the subset of HG2 tumors reclassified into GG-3, with increased use of chemotherapy in this subset. Conclusion The use of GGI is feasible in routine clinical practice and impacts treatment decisions in early-stage breast cancer. Trial Registration ClinicalTrials.gov NCT01916837, http://clinicaltrials.gov/ct2/show/NCT01916837 PMID:23990869

  16. Clinically-indicated replacement versus routine replacement of peripheral venous catheters.

    PubMed

    Webster, Joan; Osborne, Sonya; Rickard, Claire M; New, Karen

    2015-08-14

    US Centers for Disease Control guidelines recommend replacement of peripheral intravenous (IV) catheters no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation. Costs associated with routine replacement may be considerable. This is an update of a review first published in 2010. To assess the effects of removing peripheral IV catheters when clinically indicated compared with removing and re-siting the catheter routinely. For this update the Cochrane Vascular Trials Search Co-ordinator searched the Cochrane Vascular Specialised Register (March 2015) and CENTRAL (2015, Issue 3). We also searched clinical trials registries (April 2015). Randomised controlled trials that compared routine removal of peripheral IV catheters with removal only when clinically indicated in hospitalised or community dwelling patients receiving continuous or intermittent infusions. Two review authors independently assessed trial quality and extracted data. Seven trials with a total of 4895 patients were included in the review. The quality of the evidence was high for most outcomes but was downgraded to moderate for the outcome catheter-related bloodstream infection (CRBSI). The downgrade was due to wide confidence intervals, which created a high level of uncertainty around the effect estimate. CRBSI was assessed in five trials (4806 patients). There was no significant between group difference in the CRBSI rate (clinically-indicated 1/2365; routine change 2/2441). The risk ratio (RR) was 0.61 (95% CI 0.08 to 4.68; P = 0.64). No difference in phlebitis rates was found whether catheters were changed according to clinical indications or routinely (clinically-indicated 186/2365; 3-day change 166/2441; RR 1.14, 95% CI 0.93 to 1.39). This result was

  17. Clinically-indicated replacement versus routine replacement of peripheral venous catheters.

    PubMed

    Webster, Joan; Osborne, Sonya; Rickard, Claire M; New, Karen

    2013-04-30

    US Centers for Disease Control guidelines recommend replacement of peripheral intravenous (IV) catheters no more frequently than every 72 to 96 hours. Routine replacement is thought to reduce the risk of phlebitis and bloodstream infection. Catheter insertion is an unpleasant experience for patients and replacement may be unnecessary if the catheter remains functional and there are no signs of inflammation. Costs associated with routine replacement may be considerable. This is an update of a review first published in 2010. To assess the effects of removing peripheral IV catheters when clinically indicated compared with removing and re-siting the catheter routinely. For this update the Cochrane Peripheral Vascular Diseases (PVD) Group Trials Search Co-ordinator searched the PVD Specialised Register (December 2012) and CENTRAL (2012, Issue 11). We also searched MEDLINE (last searched October 2012) and clinical trials registries. Randomised controlled trials that compared routine removal of peripheral IV catheters with removal only when clinically indicated in hospitalised or community dwelling patients receiving continuous or intermittent infusions. Two review authors independently assessed trial quality and extracted data. Seven trials with a total of 4895 patients were included in the review. Catheter-related bloodstream infection (CRBSI) was assessed in five trials (4806 patients). There was no significant between group difference in the CRBSI rate (clinically-indicated 1/2365; routine change 2/2441). The risk ratio (RR) was 0.61 but the confidence interval (CI) was wide, creating uncertainty around the estimate (95% CI 0.08 to 4.68; P = 0.64). No difference in phlebitis rates was found whether catheters were changed according to clinical indications or routinely (clinically-indicated 186/2365; 3-day change 166/2441; RR 1.14, 95% CI 0.93 to 1.39). This result was unaffected by whether infusion through the catheter was continuous or intermittent. We also analysed

  18. Can machine-learning improve cardiovascular risk prediction using routine clinical data?

    PubMed

    Weng, Stephen F; Reps, Jenna; Kai, Joe; Garibaldi, Jonathan M; Qureshi, Nadeem

    2017-01-01

    Current approaches to predict cardiovascular risk fail to identify many people who would benefit from preventive treatment, while others receive unnecessary intervention. Machine-learning offers opportunity to improve accuracy by exploiting complex interactions between risk factors. We assessed whether machine-learning can improve cardiovascular risk prediction. Prospective cohort study using routine clinical data of 378,256 patients from UK family practices, free from cardiovascular disease at outset. Four machine-learning algorithms (random forest, logistic regression, gradient boosting machines, neural networks) were compared to an established algorithm (American College of Cardiology guidelines) to predict first cardiovascular event over 10-years. Predictive accuracy was assessed by area under the 'receiver operating curve' (AUC); and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) to predict 7.5% cardiovascular risk (threshold for initiating statins). 24,970 incident cardiovascular events (6.6%) occurred. Compared to the established risk prediction algorithm (AUC 0.728, 95% CI 0.723-0.735), machine-learning algorithms improved prediction: random forest +1.7% (AUC 0.745, 95% CI 0.739-0.750), logistic regression +3.2% (AUC 0.760, 95% CI 0.755-0.766), gradient boosting +3.3% (AUC 0.761, 95% CI 0.755-0.766), neural networks +3.6% (AUC 0.764, 95% CI 0.759-0.769). The highest achieving (neural networks) algorithm predicted 4,998/7,404 cases (sensitivity 67.5%, PPV 18.4%) and 53,458/75,585 non-cases (specificity 70.7%, NPV 95.7%), correctly predicting 355 (+7.6%) more patients who developed cardiovascular disease compared to the established algorithm. Machine-learning significantly improves accuracy of cardiovascular risk prediction, increasing the number of patients identified who could benefit from preventive treatment, while avoiding unnecessary treatment of others.

  19. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice.

    PubMed

    Jordan, Karin; Gralla, Richard; Jahn, Franziska; Molassiotis, Alex

    2014-01-05

    Over the past decades major improvements in the management of chemotherapy induced nausea and vomiting (CINV) were obtained. With the correct use of antiemetic drugs, CINV can be prevented in almost 70%, and even up to, 80% of patients. Treatment guidelines enable physicians to integrate the latest clinical research into their daily practice. The large volume of rapidly evolving clinical data has been summarised and incorporated into treatment recommendations by well-known and reliable institutions. These organisations include the Multinational Association of Supportive Care in Cancer (MASCC), the European Society of Medical Oncology (ESMO), the American Society for Clinical Oncology (ASCO), and National Comprehensive Cancer Network (NCCN). However, despite the availability of these guidelines, there is an emerging evidence that adherence to, and implementation of, treatment recommendations is less than optimal. This review will especially focus on the content of the current antiemetic guidelines and will address the important question of how these guidelines are implemented in routine practice. © 2013 Published by Elsevier B.V.

  20. [Promoting recovery of schizophrenic patients: discrepancy between routine practice and evidence. The SIEP-DIRECT'S Project].

    PubMed

    Semisa, Domenico; Casacchia, Massimo; Di Munzio, Walter; Neri, Giovanni; Buscaglia, Giacinto; Burti, Lorenzo; Pucci, Cristina; Corlito, Giuseppe; Bacigalupi, Maurizio; Parravani, Roberto; Roncone, Rita; Cristofalo, Doriana; Lora, Antonio; Ruggeri, Mirella

    2008-01-01

    The aim of this work is to present the main discrepancies, as evidenced by the SIEP-DIRECT'S Project, between the evidence-based NICE guidelines for schizophrenia and the usual practices of the Italian mental health services in order to promote the recovery of patients with schizophrenia. Starting from the main NICE recommendations on recovery promotion, 41 indicators were developed. These were experimented in 19 participating Italian Mental Health Departments (MHD) or Psychiatric Services through self-evaluation of the activities carried out to promote patient recovery with the aim of assessing the level of adherence to the recommendations. The data required by most of the indicators were obtained from the psychiatric informative system or from the Direction of the MHD. Moreover, specific research was carried out on the clinical records and on representative patient samples. Furthermore, for 14 indicators, there was requested an assessment by the part of "multidisciplinary" or "specialistic" focus groups who then attributed a score according to a defined "ad hoc" scale. According to the data obtained, although the mental health services seem to care about the physical condition of their patients, they do not routinely examine principle parameters such as blood pressure, glycaemia etc., and collaboration with general practitioners is often complex or not uniformly practiced. Most psychiatrists and psychologists possess the basic communication skills but not enough competences in cognitive-behavioural treatments; such treatments, and every other form of structured individual psychotherapy, are seldom carried out and seem to have become marginal activities within the Services. Also family psycho-educational interventions are under-used. The Services are very active in the care of multi-problem schizophrenia patients, who make up a large percentage (almost a quarter, on average) of the patients in their care. These patients are offered specific and integrated

  1. [Interactive microcomputer program for calculation and normal values for routine clinical neurophysiological research].

    PubMed

    Hess, C W; Moll, C; Ludin, H P

    1986-09-01

    A BASIC program for a 128 KByte microcomputer is described which is deviced to support every day clinical neurophysiological investigations. It provides calculating routines and normal values with a hard copy print option for visual, auditory, and somatosensory evoked potentials, peripheral motor and sensory nerve conduction velocities, and needle EMG potential analysis. All important arm and leg nerves and muscles are included. By its simplicity the program gives easy access to changes according to individual requirements.

  2. Feasibility of integrating mental health screening and services into routine elder abuse practice to improve client outcomes.

    PubMed

    Sirey, Jo Anne; Berman, Jacquelin; Salamone, Aurora; DePasquale, Alyssa; Halkett, Ashley; Raeifar, Elmira; Banerjee, Samprit; Bruce, Martha L; Raue, Patrick J

    2015-01-01

    The goal of this pilot program was to test the feasibility of mental health screening among elder abuse victims and of offering those victims a brief psychotherapy for depression and anxiety. Elder abuse victims who sought assistance from a large, urban elder abuse service were screened for depression and anxiety using standardized measures. Clients with clinically significant depression (PHQ-9) or anxiety (GAD-7) were randomized to receive one of three different interventions concurrent with abuse resolution services. Staff were able to screen 315 individuals, with 34% of clients scoring positive for depression or anxiety. Of those with mental health needs, only 15% refused all services. The mental health intervention (PROTECT) was successfully implemented in two different formats with collaboration between staff workers. These findings support both the need for mental health care among elder abuse victims and the feasibility of integrating mental health screening and treatment into routine elder abuse practice.

  3. Clinical outcomes of routine opt-out antenatal human immunodeficiency virus screening: a systematic review.

    PubMed

    Ibekwe, Everistus; Haigh, Carol; Duncan, Fiona; Fatoye, Francis

    2017-02-01

    To evaluate the clinical outcome of routine screening of human immunodeficiency virus in antenatal clinic settings. Despite the growing advances in human immunodeficiency virus management, nearly 30% of the estimated 1·5 million seropositive pregnant women are undiagnosed. Routine opt-out testing is a strategy endorsed by the World Health Organization in to increase testing rates in clinical settings. A systematic review of relevant published literature. A comprehensive electronic search for relevant studies in Science Direct, MEDLINE, SCOPUS, CINAHL and PubMed was conducted with search terms (Box 2). Hand searches were also conducted for additional resources. There were no geographical restrictions. Searches were restricted to English language and studies conducted between 1998-2015; totaling 1097 were retrieved and carefully appraised for review. Eighteen studies were eligible for review: eight from Africa, five from the United States, three from Europe, one from Australia and one from Asia. Fourteen studies reported increases in human immunodeficiency virus testing rate. Following the introduction of routine testing, human immunodeficiency virus testing rates increased from values ranging from 68-99·9% with median value of 88%. The comparison studies reported testing uptake of 22-93·5% with median value of 59%. Maternal human immunodeficiency virus case detection rates nearly doubled following adoption of routine testing at values of 99 and 45% during opt-in. Linkage to treatment and care for prevention of vertical transmission was reported on six studies, and results ranged between 12·9-77·2%. The findings show that irrespective of human immunodeficiency virus epidemiological scenarios, routine testing gave more women opportunity to learn their human immunodeficiency virus status and take measures for prevention of mother-to-child transmission of human immunodeficiency virus. Future studies should focus on identifying strategies to improving linkages to

  4. Translating biomarkers to clinical practice

    PubMed Central

    Perlis, RH

    2013-01-01

    Biomarkers are the measurable characteristics of an individual that may represent risk factors for a disease or outcome, or that may be indicators of disease progression or of treatment-associated changes. In general, the process by which biomarkers, once identified, might be translated into clinical practice has received scant attention in recent psychiatric literature. A body of work in diagnostic development suggests a framework for evaluating and validating novel biomarkers, but this work may be unfamiliar to clinical and translational researchers in psychiatry. Therefore, this review focuses on the steps that might follow the identification of putative biomarkers. It first addresses standard approaches to characterizing biomarker performance, followed by demonstrations of how a putative biomarker might be shown to have clinical relevance. Finally, it addresses ways in which a biomarker-based test might be validated for clinical application in terms of efficacy and cost-effectiveness. PMID:21709685

  5. "There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

    PubMed

    Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

    2012-01-01

    We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

  6. “There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

    PubMed Central

    Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

    2012-01-01

    Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

  7. Handbook of clinical nursing practice

    SciTech Connect

    Asheervath, J.; Blevins, D.R.

    1986-01-01

    Written in outline format, this reference will help nurses further their understanding of advanced nursing procedures. Information is provided on the physiological, psychological, environmental, and safety considerations of nursing activities associated with diagnostic and therapeutic procedures. Special consideration is given to the areas of pediatric nursing, nursing assessment, and selected radiologic and nuclear medicine procedures for each system. Contents: Clinical Introduction. Clinical Nursing Practice: Focus on Basics. Focus on Cardiovascular Function. Focus on Respiratory Function. Focus on Gastrointestinal Function. Focus on Renal and Genito-Urological Function. Focus on Neuro-Skeletal and Muscular Function. Appendices.

  8. Recombinant erythropoietin in clinical practice

    PubMed Central

    Ng, T; Marx, G; Littlewood, T; Macdougall, I

    2003-01-01

    The introduction of recombinant human erythropoietin (RHuEPO) has revolutionised the treatment of patients with anaemia of chronic renal disease. Clinical studies have demonstrated that RHuEPO is also useful in various non-uraemic conditions including haematological and oncological disorders, prematurity, HIV infection, and perioperative therapies. Besides highlighting both the historical and functional aspects of RHuEPO, this review discusses the applications of RHuEPO in clinical practice and the potential problems of RHuEPO treatment. PMID:12897214

  9. Exercise Dose in Clinical Practice.

    PubMed

    Wasfy, Meagan M; Baggish, Aaron L

    2016-06-07

    There is wide variability in the physical activity patterns of the patients in contemporary clinical cardiovascular practice. This review is designed to address the impact of exercise dose on key cardiovascular risk factors and on mortality. We begin by examining the body of literature that supports a dose-response relationship between exercise and cardiovascular disease risk factors, including plasma lipids, hypertension, diabetes mellitus, and obesity. We next explore the relationship between exercise dose and mortality by reviewing the relevant epidemiological literature underlying current physical activity guideline recommendations. We then expand this discussion to critically examine recent data pertaining to the impact of exercise dose at the lowest and highest ends of the spectrum. Finally, we provide a framework for how the key concepts of exercise dose can be integrated into clinical practice.

  10. Reflections in the clinical practice.

    PubMed

    Borrell-Carrió, F; Hernández-Clemente, J C

    2014-03-01

    The purpose of this article is to analyze some models of expert decision and their impact on the clinical practice. We have analyzed decision-making considering the cognitive aspects (explanatory models, perceptual skills, analysis of the variability of a phenomenon, creating habits and inertia of reasoning and declarative models based on criteria). We have added the importance of emotions in decision making within highly complex situations, such as those occurring within the clinical practice. The quality of the reflective act depends, among other factors, on the ability of metacognition (thinking about what we think). Finally, we propose an educational strategy based on having a task supervisor and rectification scenarios to improve the quality of medical decision making.

  11. Exercise Dose in Clinical Practice

    PubMed Central

    Wasfy, Meagan; Baggish, Aaron L.

    2016-01-01

    There is wide variability in the physical activity patterns of the patients in contemporary clinical cardiovascular practice. This review is designed to address the impact of exercise dose on key cardiovascular risk factors and on mortality. We begin by examining the body of literature that supports a dose-response relationship between exercise and cardiovascular disease risk factors including plasma lipids, hypertension, diabetes mellitus, and obesity. We next explore the relationship between exercise dose and mortality by reviewing the relevant epidemiological literature underlying current physical activity guideline recommendations. We then expand this discussion to critically examine recent data pertaining to the impact of exercise dose at the lowest and highest ends of the spectrum. Finally, we provide a framework for how the key concepts of exercise dose can be integrated into clinical practice. PMID:27267537

  12. Prevalence of intimate partner violence disclosed during routine screening in a large general practice.

    PubMed

    Higgins, Debs; Manhire, Kathy; Marshall, Bob

    2015-06-01

    Domestic violence in its myriad shapes and forms is a crime affecting every level of society. Gaining a true understanding of intimate partner violence (IPV) victimology allows for the meaningful provision of intervention services. To explore the prevalence of IPV disclosure during routine screening in a large general practice in provincial New Zealand. Data were collected from 13 October 2008 to 30 June 2014 from 6827 individuals screened for IPV on 10 062 occasions and were analysed relative to age, ethnicity, gender, screening outcome, screener and health centre enrolled status. Analysis indicated an overall ever-positive disclosure rate of IPV of 11.1%, lower than New Zealand studies that place ever-positive prevalence as high as 78%. Maori women disclosed an ever-positive rate of 21.6%, Pacific women 13.2%, compared to 8.9% for NZ European/Other women. Casual patients positively disclosed in 13.7% of instances as opposed to enrolled patients in 10.5%. Disclosure of past abuse was made 1.3 times more often than that of a current abusive situation. Those aged between 16 and 65 years disclosed an ever-positive rate ≥10%. While nurses screened 5.5 times more patients than doctors, the doctors facilitated a higher percentage of positive disclosures than the nurses. Disclosure rates from a general practice setting do not mirror those of population studies or administrative datasets due to differences in samples and data collection methods. Routine annual screening is effective, with both doctors and nurses providing support for approximately equal numbers of patients in immediate danger.

  13. Is Transducer Hygiene sufficient when Vaginal Probes are used in the Clinical Routine?

    PubMed

    Merz, E

    2016-04-01

    Vaginal ultrasound probes are semi-critical Group A medical products which must be disinfected following the manufacturer's instructions after every patient examination. According to the "Essential Requirements for Medical Devices (Directive 93/42/EEC, Annex I, paragraph 13)" the manufacturer's instructions for use for reusable products must contain suitable instructions for preparation processes. This presumes both an effective and material-compatible method. Evidence of effectiveness must be validated.In the Editorial in issue 1 Ultraschall in der Medizin/European Journal of Ultrasound 2005 we discussed the topic of transducer hygiene and stated that proper handling and cleaning as well as disinfection of probes in daily use are indispensable. This applies particularly to vaginal ultrasound probes routinely used in gynecological and obstetrical clinics, gynecological practices as well as IVF centers Normally the probe used in a transvaginal ultrasound examination is covered with a latex protective cover (with CE marking) which contains a certain amount of ultrasound gel. After the examination, the cover is removed and disposed of, and the gel is removed from the transducer. Since handling of the probe, ultrasound gel and cover can result in smear infections and cross-contamination with various pathogens (e. g. MRSA, HBV, HCV, HIV, herpes papilloma and cytomegalic viruses), after the protective cover is removed, the probe must be cleaned and subjected to disinfection with a bactericidal, fungicidal and virucidal effect. This is especially important in the event the cover ruptures during the vaginal examination, and the probe comes into direct contact with vaginal secretions or blood. The same likewise applies if the sterile protective cover is perforated during a follicular puncture. Usually special bactericidal, levurocidal and virucidal wipes or special submersion disinfection methods are available for disinfecting the vaginal ultrasound probes 11. Using

  14. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    PubMed Central

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

  15. Clinical practice opportunities for advanced practice nurses.

    PubMed

    Marfell, Julie A

    2002-09-01

    With approximately 132,000 practicing APNs and a continued need for APNs, the role will continue to expand. Many different business options and models for healthcare practice exist for the APN. Commonly thought of professional practice options for APNs include private practice, joint or collaborative practice, and group practice. Each model of professional practice brings with it different roles and responsibilities, rewards and challenges, and criteria for success. When evaluating different practice opportunities. APNs must be aware of each of these factors and evaluate each factor based on his or her chosen lifestyle. This article has presented an overview of common practice models and the roles and responsibilities, challenges and rewards, criteria for success, and lifestyle considerations inherent in each.

  16. On research in clinical practice.

    PubMed

    Nanivadekar, Arun

    2010-01-01

    Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.

  17. The reality of routine practice: a pooled data analysis on chronic wounds treated with TLC-NOSF wound dressings.

    PubMed

    Münter, K C; Meaume, S; Augustin, M; Senet, P; Kérihuel, J C

    2017-02-01

    A number of randomised controlled trials (RCT) have compared control groups with TLC-NOSF dressings (UrgoStart) on chronic wounds. Our aim was to determine whether the clinical trials' results translate into routine management of such wounds, by pooling the data from real-life observational studies. Observational studies, conducted in France and Germany, evaluating current practices in patients suffering from non-selected chronic wounds treated with a TLC-NOSF dressing were identified. Demographic data, baseline description of wounds and description of their evolution during treatment were extracted and combined. We used two main indicators of clinical outcomes to measure the impact of the TLC-NOSF dressing on this population: time to wound closure and time to 50% reduction of the Pressure Ulcer Scale for Healing (PUSH) score. In total, data from 10,220 patients were included, with 7903 leg ulcers (LUs), 1306 diabetic foot ulcers (DFUs) and 1011 pressure ulcers (PUs). The overall closure rate was 30.8 % [95 % confidence interval (CI): 29.9-31.7 %]. While the country, patient age, and number of wounds were identified as independent prognosis factors of healing, the most significant were wound duration and baseline area. The delay in initiating TLC-NOSF dressings treatment was also found to be significant. Overall the average time to complete closure was 112.5 days [95%CI: 105.8-119.3] for LUs, 98.1 days [95 %CI: 88.8-107.5] for DFUs and 119.5 days [95%CI: 94.6-144.3] for PUs. Based on a subgroup analysis of the French cohort, time to closure is substantially shorter for wounds treated with the TLC-NOSF dressing as a first-line intervention compared with those where it has been prescribed as a second-line intervention. Compared with available data on time to complete closure of chronic wounds managed by 'standard' care, the data from this pooled data analysis showed healing time is reduced, which is consistent with the results of RCTs on TLC-NOSF. That these data are

  18. Routine vs. on-demand analgesia in colonoscopy: a randomized clinical trial.

    PubMed

    Holme, Øyvind; de Lange, Thomas; Stallemo, Asbjørn; Wiig, Håvard; Hasund, Audun; Dvergsnes, Katrine; Garborg, Kjetil; Ystrøm, Carl Magnus; Løberg, Magnus; Hoff, Geir; Bretthauer, Michael; Kalager, Mette

    2016-09-01

    Colonoscopy is frequently performed with opioid analgesia, but the impact of drug delivery timing has not been studied in detail. Low-dose opioids administered before the procedure may provide better pain control than on-demand administration when the patient experiences pain. A total of 119 outpatients were randomized to receive 50 μg of fentanyl either before colonoscopy (routine group) or on demand if needed during the colonoscopy (on-demand group). Additional fentanyl or midazolam was allowed in both groups if required. The primary outcome was pain measured on both a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst possible pain) and a four-point Likert scale (no, slight, moderate, or severe pain) immediately after the procedure. A total of 61 patients in the routine group and 58 patients in the on-demand group were included in the study. Mean VAS pain scores were 27.4 mm in the routine group and 30.5 mm in the on-demand group (mean difference - 3.2 mm; 95 % confidence interval - 11.9 to 5.5; P = 0.5). On the Likert scale, moderate or severe pain was experienced by 25.0 % and 31.5 % of patients in the routine and on-demand groups, respectively (p = 0.5). Cecal intubation rate and time to reach the cecum were similar between the groups. More patients in the on-demand group (81.0 %) than in the routine group (62.3 %) were able to leave the clinic without the need for recovery time (P = 0.03). Routine administration of fentanyl did not provide better analgesia during colonoscopy than on-demand fentanyl, and more patients needed time for recovery. ClinicalTrials.gov (NCT01786434). © Georg Thieme Verlag KG Stuttgart · New York.

  19. Clinical Significance of Commensal Gram-Positive Rods Routinely Isolated from Patient Samples.

    PubMed

    Leal, Sixto M; Jones, Melissa; Gilligan, Peter H

    2016-12-01

    Commensal bacteria from the skin and mucosal surfaces are routinely isolated from patient samples and considered contaminants. The majority of these isolates are catalase-positive Gram-positive rods from multiple genera routinely classified as diphtheroids. These organisms can be seen upon Gram staining of clinical specimens or can be isolated as the predominant or pure species in culture, raising a priori suspicion of a possible involvement in infection. With the development and adoption of matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS), suspicious isolates are now routinely identified to the species level. In this study, we performed a retrospective data review (2012 to 2015) and utilized site-specific laboratory criteria and chart reviews to identify species within the diphtheroid classification representative of true infection versus contamination. Our data set included 762 isolates from 13 genera constituting 41 bacterial species. Only 18% represented true infection, and 82% were deemed contaminants. Clinically significant isolates were identified in anaerobic wounds (18%), aerobic wounds (30%), blood (5.5%), urine (22%), cerebrospinal fluid (24%), ophthalmologic cultures (8%), and sterile sites (20%). Organisms deemed clinically significant included multiple Actinomyces species in wounds, Propionibacterium species in joints and cerebrospinal fluid associated with central nervous system hardware, Corynebacterium kroppenstedtii (100%) in breast, and Corynebacterium striatum in multiple sites. Novel findings include clinically significant urinary tract infections by Actinomyces neuii (21%) and Corynebacterium aurimucosum (21%). Taken together, these findings indicate that species-level identification of diphtheroids isolated with a priori suspicion of infection is essential to accurately determine whether an isolate belongs to a species associated with specific types of infection.

  20. An alternative clinical routine for subjective refraction based on power vectors with trial frames.

    PubMed

    María Revert, Antonia; Conversa, Maria Amparo; Albarrán Diego, César; Micó, Vicente

    2017-01-01

    Subjective refraction determines the final point of refractive error assessment in most clinical environments and its foundations have remained unchanged for decades. The purpose of this paper is to compare the results obtained when monocular subjective refraction is assessed in trial frames by a new clinical procedure based on a pure power vector interpretation with conventional clinical refraction procedures. An alternative clinical routine is described that uses power vector interpretation with implementation in trial frames. Refractive error is determined in terms of: (i) the spherical equivalent (M component), and (ii) a pair of Jackson Crossed Cylinder lenses oriented at 0°/90° (J0 component) and 45°/135° (J45 component) for determination of astigmatism. This vector subjective refraction result (VR) is compared separately for right and left eyes of 25 subjects (mean age, 35 ± 4 years) against conventional sphero-cylindrical subjective refraction (RX) using a phoropter. The VR procedure was applied with both conventional tumbling E optotypes (VR1) and modified optotypes with oblique orientation (VR2). Bland-Altman plots and intra-class correlation coefficient showed good agreement between VR, and RX (with coefficient values above 0.82) and anova showed no significant differences in any of the power vector components between RX and VR. VR1 and VR2 procedure results were similar (p ≥ 0.77). The proposed routine determines the three components of refractive error in power vector notation [M, J0 , J45 ], with a refraction time similar to the one used in conventional subjective procedures. The proposed routine could be helpful for inexperienced clinicians and for experienced clinicians in those cases where it is difficult to get a valid starting point for conventional RX (irregular corneas, media opacities, etc.) and for refractive situations/places with inadequate refractive facilities/equipment. © 2016 The Authors Ophthalmic & Physiological Optics

  1. Population-Level Cost-Effectiveness of Implementing Evidence-Based Practices into Routine Care

    PubMed Central

    Fortney, John C; Pyne, Jeffrey M; Burgess, James F

    2014-01-01

    Objective The objective of this research was to apply a new methodology (population-level cost-effectiveness analysis) to determine the value of implementing an evidence-based practice in routine care. Data Sources/Study Setting Data are from sequentially conducted studies: a randomized controlled trial and an implementation trial of collaborative care for depression. Both trials were conducted in the same practice setting and population (primary care patients prescribed antidepressants). Study Design The study combined results from a randomized controlled trial and a pre-post-quasi-experimental implementation trial. Data Collection/Extraction Methods The randomized controlled trial collected quality-adjusted life years (QALYs) from survey and medication possession ratios (MPRs) from administrative data. The implementation trial collected MPRs and intervention costs from administrative data and implementation costs from survey. Principal Findings In the randomized controlled trial, MPRs were significantly correlated with QALYs (p = .03). In the implementation trial, patients at implementation sites had significantly higher MPRs (p = .01) than patients at control sites, and by extrapolation higher QALYs (0.00188). Total costs (implementation, intervention) were nonsignificantly higher ($63.76) at implementation sites. The incremental population-level cost-effectiveness ratio was $33,905.92/QALY (bootstrap interquartile range −$45,343.10/QALY to $99,260.90/QALY). Conclusions The methodology was feasible to operationalize and gave reasonable estimates of implementation value. PMID:25328029

  2. Prevalence of clinicopathological changes in healthy middle-aged dogs and cats presenting to veterinary practices for routine procedures.

    PubMed

    Dell'Osa, D; Jaensch, S

    2016-09-01

    The objective of the present study was to investigate the frequency of abnormal clinicopathological parameters in a population of client-owned clinically healthy middle-aged dogs and cats. Biochemical and haematological profiles, urinalysis and total T4 were measured in clinically healthy middle-aged dogs (age, 5-8 years) and cats (age, 6-9 years) presenting to veterinary practices for routine procedures. Of the 406 dogs, only 55 had no abnormalities identified in the testing panel. Most changes were minor or considered artifactual; however, changes that were diagnostic of significant disease or warranting additional evaluation were identified in 25 dogs (6.2%). Of the 130 cats, only 26 had no abnormalities identified in the testing panel. Most changes were minor or considered artifactual; however, changes diagnostic of significant disease or warranting additional evaluation were identified in 25 cats (19.2%). Significant abnormalities included anaemia, inflammation and evidence of liver, kidney and pancreatic disease. Biochemical and haematological testing as part of regular preventive health checks may facilitate early detection of diseases before they present clinically, allowing earlier intervention and better health outcomes. © 2016 Australian Veterinary Association.

  3. Uptake and Utilization of Practice Guidelines in Hospitals in the United States: the Case of Routine Episiotomy.

    PubMed

    Kozhimannil, Katy B; Karaca-Mandic, Pinar; Blauer-Peterson, Cori J; Shah, Neel T; Snowden, Jonathan M

    2017-01-01

    The gap between publishing and implementing guidelines differs based on practice setting, including hospital geography and teaching status. On March 31, 2006, a Practice Bulletin published by the American College of Obstetricians and Gynecologists (ACOG) recommended against the routine use of episiotomy and urged clinicians to make judicious decisions to restrict the use of the procedure. This study investigated changes in trends of episiotomy use before and after the ACOG Practice Guideline was issued in 2006, focusing on differences by hospital geographic location (rural/urban) and teaching status. In a retrospective analysis of discharge data from the Nationwide Inpatient Sample (NIS)-a 20% sample of US hospitals-5,779,781 hospital-based births from 2002 to 2011 (weighted N = 28,067,939) were analyzed using multivariable logistic regression analysis to measure odds of episiotomy and trends in episiotomy use in vaginal deliveries. The overall episiotomy rate decreased from 20.3% in 2002 to 9.4% in 2011. Across all settings, a comparatively larger decline in episiotomy rates preceded the issuance of the ACOG Practice Guideline (34.0% decline), rather than following it (23.9% decline). The episiotomy rate discrepancies between rural, urban teaching, and urban nonteaching hospitals remained steady prior to the guideline's release; however, differences between urban nonteaching and urban teaching hospitals narrowed between 2007 and 2011 after the guideline was issued. Teaching status was a strong predictor of odds of episiotomy, with urban nonteaching hospitals having the highest rates of noncompliance with evidence-based practice. Issuance of clinical guidelines precipitated a narrowing of this discrepancy. Copyright © 2016 The Joint Commission. Published by Elsevier Inc. All rights reserved.

  4. Metastatic colorectal cancer KRAS genotyping in routine practice: results and pitfalls.

    PubMed

    Lamy, Aude; Blanchard, France; Le Pessot, Florence; Sesboüé, Richard; Di Fiore, Frédéric; Bossut, Jessie; Fiant, Elodie; Frébourg, Thierry; Sabourin, Jean-Christophe

    2011-08-01

    KRAS genotyping is mandatory before anti-epidermal growth factor receptor monoclonal antibody therapy in metastatic colorectal cancer, which is the second leading cause of cancer-related death in the United States and in Europe. Thus, large-scale KRAS mutation screening is needed for efficient patient management and in the future metastatic colorectal cancer genotyping might also include the detection of the BRAF V600E mutation, which is a very strong negative prognostic factor in colorectal cancer. We report our experience of routine KRAS/BRAF mutation screening practice performed on 1130 formalin-fixed paraffin-embedded tumor samples from 992 colorectal cancer patients. DNA was extracted from macrodissected tumor areas highlighted by a pathologist, KRAS codons 12/13 and BRAF V600E mutations were assessed in a single SNaPshot® multiplex assay and each mutation was confirmed by an independent analysis. KRAS and BRAF mutations were, respectively, present in 41.8 and 6.5% of the tumor samples. If KRAS and BRAF mutations were mutually exclusive, four samples presented two concomitant KRAS mutations. Genotyping of paired primary tumors and metastases from 44 patients indicated that 5 patients (11.4%) presented discordant KRAS mutational status. KRAS genotype heterogeneity was also observed within primary tumor sites in seven cases. Non-reproducible KRAS artefactual mutations were detected in 53 samples (4.7%). We found that the prominent mechanism leading to these artefactual mutations was the fragmentation of DNA occurring during tissue processing. Routine KRAS genotyping performed on formalin-fixed paraffin-embedded tissues requires, therefore, the development of quality control scheme for molecular pathology, especially because of DNA damages induced by formalin fixation. The tumor heterogeneity observed in some patients indicates that it should be more appropriate to perform KRAS genotyping on metastases if sample is available.

  5. Next-generation sequencing strategies enable routine detection of balanced chromosome rearrangements for clinical diagnostics and genetic research.

    PubMed

    Talkowski, Michael E; Ernst, Carl; Heilbut, Adrian; Chiang, Colby; Hanscom, Carrie; Lindgren, Amelia; Kirby, Andrew; Liu, Shangtao; Muddukrishna, Bhavana; Ohsumi, Toshiro K; Shen, Yiping; Borowsky, Mark; Daly, Mark J; Morton, Cynthia C; Gusella, James F

    2011-04-08

    The contribution of balanced chromosomal rearrangements to complex disorders remains unclear because they are not detected routinely by genome-wide microarrays and clinical localization is imprecise. Failure to consider these events bypasses a potentially powerful complement to single nucleotide polymorphism and copy-number association approaches to complex disorders, where much of the heritability remains unexplained. To capitalize on this genetic resource, we have applied optimized sequencing and analysis strategies to test whether these potentially high-impact variants can be mapped at reasonable cost and throughput. By using a whole-genome multiplexing strategy, rearrangement breakpoints could be delineated at a fraction of the cost of standard sequencing. For rearrangements already mapped regionally by karyotyping and fluorescence in situ hybridization, a targeted approach enabled capture and sequencing of multiple breakpoints simultaneously. Importantly, this strategy permitted capture and unique alignment of up to 97% of repeat-masked sequences in the targeted regions. Genome-wide analyses estimate that only 3.7% of bases should be routinely omitted from genomic DNA capture experiments. Illustrating the power of these approaches, the rearrangement breakpoints were rapidly defined to base pair resolution and revealed unexpected sequence complexity, such as co-occurrence of inversion and translocation as an underlying feature of karyotypically balanced alterations. These findings have implications ranging from genome annotation to de novo assemblies and could enable sequencing screens for structural variations at a cost comparable to that of microarrays in standard clinical practice.

  6. Can machine-learning improve cardiovascular risk prediction using routine clinical data?

    PubMed Central

    Kai, Joe; Garibaldi, Jonathan M.; Qureshi, Nadeem

    2017-01-01

    Background Current approaches to predict cardiovascular risk fail to identify many people who would benefit from preventive treatment, while others receive unnecessary intervention. Machine-learning offers opportunity to improve accuracy by exploiting complex interactions between risk factors. We assessed whether machine-learning can improve cardiovascular risk prediction. Methods Prospective cohort study using routine clinical data of 378,256 patients from UK family practices, free from cardiovascular disease at outset. Four machine-learning algorithms (random forest, logistic regression, gradient boosting machines, neural networks) were compared to an established algorithm (American College of Cardiology guidelines) to predict first cardiovascular event over 10-years. Predictive accuracy was assessed by area under the ‘receiver operating curve’ (AUC); and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) to predict 7.5% cardiovascular risk (threshold for initiating statins). Findings 24,970 incident cardiovascular events (6.6%) occurred. Compared to the established risk prediction algorithm (AUC 0.728, 95% CI 0.723–0.735), machine-learning algorithms improved prediction: random forest +1.7% (AUC 0.745, 95% CI 0.739–0.750), logistic regression +3.2% (AUC 0.760, 95% CI 0.755–0.766), gradient boosting +3.3% (AUC 0.761, 95% CI 0.755–0.766), neural networks +3.6% (AUC 0.764, 95% CI 0.759–0.769). The highest achieving (neural networks) algorithm predicted 4,998/7,404 cases (sensitivity 67.5%, PPV 18.4%) and 53,458/75,585 non-cases (specificity 70.7%, NPV 95.7%), correctly predicting 355 (+7.6%) more patients who developed cardiovascular disease compared to the established algorithm. Conclusions Machine-learning significantly improves accuracy of cardiovascular risk prediction, increasing the number of patients identified who could benefit from preventive treatment, while avoiding unnecessary treatment of others

  7. [Routines of organization of clinical tests and interviews in the ELSA-Brasil investigation center].

    PubMed

    Bensenor, Isabela M; Griep, Rosane H; Pinto, Karina Araújo; Faria, Carolina Perim de; Felisbino-Mendes, Mariana; Caetano, Edna I; Albuquerque, Liliane da Silva; Schmidt, Maria Inês

    2013-06-01

    The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a prospective cohort study with extensive assessments throughout time. This article describes the routine of clinical tests and interviews performed with participants and the structuring of the Research Center physical space and teams. The ELSA-Brasil assumes that participants will be present at the Research Center to have the tests and interviews performed, according to standard protocols developed by this study. Considering the multiplicity of activities involved, each with specific needs for standardization, several predetermined orders of clinical tests and interviews were created. This ensured a high standard of quality in data collection without harm to participants' comfort. Each participant was previously assigned to a specific sequence of clinical tests and interviews with a predefined arrival time, mean length of stay of five to six hours and departure time.

  8. An examination of the levels of confidence that consultants have in routinely collected clinical information.

    PubMed

    Brook, Caroline E; Bath, Peter A

    2006-03-01

    Anecdotal evidence suggests that consultants have a low level of confidence in routinely collected clinical data. The aims of this study were to assess the actual levels of confidence in clinical information experienced by consultants and to understand the factors affecting confidence. A questionnaire was devised incorporating a scale to measure levels of confidence. This was disseminated to 506 consultants and achieved a 57 per cent response rate. The confidence scale showed good internal reliability and the influential factors were modelled using multilinear regression. Consultant specialty, increased involvement in clinical coding, and participation in service planning/monitoring all had a significant effect. A small number of semi-structured interviews further examined these factors. Whilst the findings confirm there is scope to increase levels of confidence, the mean score indicated neither a high nor a low level of confidence. The results demonstrate that improving consultants' confidence in information is complex and requires a partnership approach.

  9. Is social inequality related to different patient concerns in routine oral cancer follow-up clinics?

    PubMed

    Allen, Sarah; Lowe, Derek; Harris, Rebecca V; Brown, Steve; Rogers, Simon N

    2017-01-01

    Oral cancer has a higher incidence in the lower social strata, and these patients are less likely to engage in supportive interventions and report a poorer quality of life (QoL). The aim of this paper is to compare the Patient Concerns Inventory (PCI) responses across social groups attending routine oral cancer follow-up clinics with particular focus on the deprivation lower quartile. The PCI package is completed by patients as part of their routine review consultation with SNR. Patients were those diagnosed between 2008 and 2012. Deprivation was stratified using the IMD 2010 from postcode. Of the 106 eligible patients, 85 % used the PCI. Just over half (54 %) were living in the most deprived quartile, with two-thirds (68 %) of males in the most deprived quartile, compared with 35 % of females (p = 0.004). In regard to number and type of PCI items selected by patients at their first PCI clinic, there were no notable differences in respect of IMD classification. The two commonest concerns were fear of recurrence (43 %) and sore mouth (43 %). The most deprived quartile reported significant problems in regard to mood (p = 0.004) and recreation (p = 0.02), and a non-significant trend (36 vs 18 %, p = 0.09) in stating their overall QoL as being less than good. It is possible to identify the concerns of patients from lower socioeconomic strata as part of routine follow-up clinics. This allows for targeted multi-professional intervention and supports to improve the outcome in this hard to reach group.

  10. Proton therapy in clinical practice

    PubMed Central

    Liu, Hui; Chang, Joe Y.

    2011-01-01

    Radiation dose escalation and acceleration improves local control but also increases toxicity. Proton radiation is an emerging therapy for localized cancers that is being sought with increasing frequency by patients. Compared with photon therapy, proton therapy spares more critical structures due to its unique physics. The physical properties of a proton beam make it ideal for clinical applications. By modulating the Bragg peak of protons in energy and time, a conformal radiation dose with or without intensity modulation can be delivered to the target while sparing the surrounding normal tissues. Thus, proton therapy is ideal when organ preservation is a priority. However, protons are more sensitive to organ motion and anatomy changes compared with photons. In this article, we review practical issues of proton therapy, describe its image-guided treatment planning and delivery, discuss clinical outcome for cancer patients, and suggest challenges and the future development of proton therapy. PMID:21527064

  11. Routine application of the polymerase chain reaction for detection of Mycobacterium tuberculosis in clinical samples.

    PubMed Central

    Noordhoek, G T; Kaan, J A; Mulder, S; Wilke, H; Kolk, A H

    1995-01-01

    AIM--To investigate the use of the polymerase chain reaction (PCR) in the routine laboratory for the detection of Mycobacterium tuberculosis in clinical samples. METHODS--Samples were divided and processed separately for the detection of M tuberculosis by microscopy, culture and PCR. After DNA extraction, PCR was performed with primers specific for the insertion element IS6110 and the product was analysed by agarose gel electrophoresis, Southern blotting or dot blotting and hybridisation with a digoxigenin labelled internal probe. Each sample was tested for inhibitors of Taq polymerase with the aid of an internal control. Multiple negative and positive controls were used to monitor each step of the procedure. RESULTS--The data from two laboratories, using the same operating procedures, were combined. Of 1957 specimens, 79 (4%) were culture and PCR positive, while 1839 (93.9%) were negative in both tests. Thirty specimens (1.5%) were PCR positive only and nine (0.5%) were culture positive but PCR negative. CONCLUSION--Using culture and clinical history as the gold standard, sensitivity and specificity for PCR were 92.1% and 99.8%, respectively. With elaborate precautions, PCR is a suitable and reliable method for the detection of M tuberculosis in clinical samples in a routine microbiology laboratory. Images PMID:7490312

  12. Improved biuret procedure for routine determination of urinary total proteins in clinical proteinuria.

    PubMed

    Rice, E W

    1975-03-01

    This communication describes and evaluates an improved routine methodology for quantitating clinical proteinuria. Based on investigations of Piscator and of Savory et al., a modified Tsuchiya's reagent (ethanolic HCI-phosphotungstic acid) is used to precipitate proteins at 56 degrees C, followed by biuret spectrophotometry at 540 nm. The accuracy of the proposed procedure was assessed by comparisons with results obtained by using an ultrafiltration membrane that retains solutes with an average molecular weight in excess of 10 000 for separating of urinary proteins before they are measured with the biuret reaction. Precision of the method (coefficient of variation) is typically 2-3%.

  13. Routine oral examination: clinical vignettes, a promising tool for continuing professional development?

    PubMed

    Mettes, Theodorus G; van der Sanden, Wil J M; van Eeten-Kruiskamp, Leontien; Mulder, Jan; Wensing, Michel; Grol, Richard P T M; Plasschaert, Alphons J M

    2010-05-01

    To develop content for an educational system for dental professionals to be used for patient-tailored evidence-based decisions regarding routine oral examinations (ROEs) and to test the model as a tool in dental education. Initially, an electronic database was developed comprising conclusive data of a structured literature search and 27 ROE clinical cases which were selected on predefined criteria. A RAND-modified Delphi procedure was successfully conducted with 31 multidisciplinary dental experts. Twenty-one selected risk factors for oral disease were assessed for feasibility and subsequently modelled into 19 risk based clinical vignettes, each representing a specific group of ROE-patients. Each vignette comprised all relevant clinical and non-clinical data. Expert judgements were collected including ROE-content, risk level, bitewing frequency and recall interval. Feedback regarding evidence was provided for each of the topics. A pilot with 35 experienced General Dental Practitioners (GDPs) was conducted to assess the reliability of the model for continuing professional development (CPD). Decisions made on content screening items, bitewing frequencies and recall interval were compared with expert opinions. A comprehensive set of clinical vignettes was developed. Expert consensus was reached with regard to risk factors to be applied, content of ROE-items, bitewing frequency and recall interval. Differences between GDPs and experts were found especially concerning recall length in low-risk patient groups. Clinical vignettes provide a promising educational instrument for CPD to improve clinical performance. Further research is needed to test the reliability of these set of 19 vignettes.

  14. Review: in vivo optical spectral tissue sensing-how to go from research to routine clinical application?

    PubMed

    de Boer, Lisanne L; Spliethoff, Jarich W; Sterenborg, Henricus J C M; Ruers, Theo J M

    2017-04-01

    Innovations in optical spectroscopy have helped the technology reach a point where performance previously seen only in laboratory settings can be translated and tested in real-world applications. In the field of oncology, spectral tissue sensing (STS) by means of optical spectroscopy is considered to have major potential for improving diagnostics and optimizing treatment outcome. The concept has been investigated for more than two decades and yet spectral tissue sensing is not commonly employed in routine medical practice. It is therefore important to understand what is needed to translate technological advances and insights generated through basic scientific research in this field into clinical practice. The aim of the discussion presented here is not to provide a comprehensive review of all work published over the last decades but rather to highlight some of the challenges found in literature and encountered by our group in the quest to translate optical technologies into useful clinical tools. Furthermore, an outlook is proposed on how translational researchers could proceed to eventually have STS incorporated in the process of clinical decision-making.

  15. Summary of the proceedings of the international forum 2016: "Imaging referral guidelines and clinical decision support - how can radiologists implement imaging referral guidelines in clinical routine?"

    PubMed

    2017-02-01

    The International Forum is held once a year by the ESR and its international radiological partner societies with the aim to address and discuss selected subjects of global relevance in radiology. In 2016, the issue of implementing imaging referral guidelines in clinical routine was analysed. The legal environment in the USA requires that after January 1, 2017, physicians must consult government-approved, evidence-based appropriate-use criteria through a clinical decision support system when ordering advanced diagnostic imaging exams. The ESR and the National Decision Support Company are developing "ESR iGuide", a clinical decision support system for European imaging referral guidelines using ESR imaging referral guidelines based on ACR Appropriateness Criteria. In many regions of the world, the situation is different and quite diverse, depending on the specific features of health care systems in different countries, but there are, unlike in the USA and EU, no legal obligations to implement imaging referral guidelines into the clinical practice. Imaging referral guidelines and clinical decision support implementation is a complex issue everywhere and the legal environment surrounding it even more so; how they will be implemented into the clinical practice in different areas of the world needs yet to be decided.

  16. SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

    SciTech Connect

    Thwaites, D; Holloway, L; Bailey, M; Carolan, M; Miller, A; Barakat, S; Field, M; Delaney, G; Vinod, S; Dekker, A; Lustberg, T; Soest, J van; Walsh, S

    2015-06-15

    Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction and mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions

  17. [IT-based clinical pathway as a routine tool in trauma surgery].

    PubMed

    Homagk, L; Deml, O; Hofmann, G O

    2012-12-01

    Today clinical pathways are established as a basis for the operational and organizational structure of surgical, interventional and conservative treatment in many hospitals. In our study we evaluate the establishment and systematic applicability of IT-based clinical pathways in a tertiary care facility. We evaluate and compare the treatment of coxarthrosis with hip joint endoprosthesis either following an IT-based clinical pathway or without clinical pathway. All patients who had received a hip joint endoprosthesis from 1 January 2006 to 31 October 2009 were included. The duration of stay is significantly longer in the group without pathway. Furthermore there was a significant increase in the documentation of wound inspection after surgery in the "pathway patients". The preoperative urinalysis was done significantly more often in the pathway group. IT-based clinical pathways are applicable for routine use in trauma departments. For certain surgical procedures they are a suitable management device, even in a tertiary care facility. Clinical pathways lead to an improved operational structure of medical treatment and moreover to a complete and continuous documentation through the electronic file.

  18. Routine HIV testing in dental practice: can we cross the Rubicon?

    PubMed

    Vernillo, Anthony T; Caplan, Arthur L

    2007-12-01

    The latest Centers for Disease Control and Prevention (CDC) guidelines recommend routine HIV screening for a large segment of the population, given that the individual understands that an HIV test will be performed unless he or she declines testing (opt-out testing). The CDC recommendation calls for the elimination of formalized requirements for written consent and pretest counseling to encourage more Americans to voluntarily accept testing. Knowledge of HIV infection can increase early access to care and treatment and reduce further transmission. A rapid non-invasive test for HIV infection (OraQuick Advance) from oral fluid has recently become available. It offers two distinct advantages: 1) results are available within twenty minutes, thereby eliminating a long waiting period; and 2) it has high sensitivity and specificity comparable to blood testing. A preliminary positive test result must be confirmed with a Western Blot by an outside laboratory or physician. Important ethical and legal issues must be resolved before the successful implementation of HIV testing in the dental setting. An educational emphasis on broader coverage of HIV testing is also needed within the dental school curriculum. The integration of HIV testing into dental practice is discussed as well. A policy of screening patients in dental offices will contribute to a major advance in public health.

  19. Pretest probability of a normal echocardiography: validation of a simple and practical algorithm for routine use.

    PubMed

    Hammoudi, Nadjib; Duprey, Matthieu; Régnier, Philippe; Achkar, Marc; Boubrit, Lila; Preud'homme, Gisèle; Healy-Brucker, Aude; Vignalou, Jean-Baptiste; Pousset, Françoise; Komajda, Michel; Isnard, Richard

    2014-02-01

    Management of increased referrals for transthoracic echocardiography (TTE) examinations is a challenge. Patients with normal TTE examinations take less time to explore than those with heart abnormalities. A reliable method for assessing pretest probability of a normal TTE may optimize management of requests. To establish and validate, based on requests for examinations, a simple algorithm for defining pretest probability of a normal TTE. In a retrospective phase, factors associated with normality were investigated and an algorithm was designed. In a prospective phase, patients were classified in accordance with the algorithm as being at high or low probability of having a normal TTE. In the retrospective phase, 42% of 618 examinations were normal. In multivariable analysis, age and absence of cardiac history were associated to normality. Low pretest probability of normal TTE was defined by known cardiac history or, in case of doubt about cardiac history, by age>70 years. In the prospective phase, the prevalences of normality were 72% and 25% in high (n=167) and low (n=241) pretest probability of normality groups, respectively. The mean duration of normal examinations was significantly shorter than abnormal examinations (13.8 ± 9.2 min vs 17.6 ± 11.1 min; P=0.0003). A simple algorithm can classify patients referred for TTE as being at high or low pretest probability of having a normal examination. This algorithm might help to optimize management of requests in routine practice. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  20. Triple test as predictive screen for unilateral weakness on caloric testing in routine practice.

    PubMed

    Rohrmeier, Christian; Richter, Otto; Schneider, Michael; Wirsching, Kornelia; Fiedler, Isabella; Haubner, Frank; Strutz, Jürgen; Kühnel, Thomas S

    2013-02-01

    To investigate in vertigo patients in routine practice to what extent a rapid and straightforward triple bedside test (spontaneous nystagmus, head-shaking nystagmus, and the head impulse test) can predict a normal result on caloric testing. Prospective, single-blind, diagnostic study. Tertiary referral center. 151 patients (78 male and 73 female subjects; mean age, 52.5 +/- 16.4 yr) presenting with acute or recent symptoms of vertigo. Diagnostic evaluation. The negative predictive value (NPV) of the triple test in relation to a normal caloric test response. In unilateral weakness (UW) on caloric testing (UW, >=25%), the triple test had sensitivity of 63.6%, specificity of 85.4%, a positive predictive value (PPV) of 71.4%, and an NPV of 80.4%. In other words, 80.4% of patients with a negative triple test also had a normal response on caloric testing. In pronounced canal paresis (UW, >=50%), the triple test had sensitivity of 81.8%, specificity of 81.4%, a PPV of 55.1%, and an NPV of 94.1%. Significant differences were found between 2 subgroups assessed by examiners with differing levels of experience (p < 0.05). The triple test represents a good screening tool that quickly and reliably excludes unilateral weakness and in particular pronounced canal paresis on caloric testing. (C) 2013 Otology & Neurotology, Inc.

  1. [Cognitive remediation in clinical routine: a study on psychiatric patients' acceptance].

    PubMed

    Bossert, M; Weisbrod, M; Aschenbrenner, S

    2014-12-01

    Cognitive remediation represents an effective treatment for improving functional outcome of psychiatric diseases like schizophrenia or depression. However, in clinical routine the therapeutic approach has not been established continuously. This can be partly attributed to doubts about the reasonableness of cognitive remediation for psychiatric patients. Therefore the current study investigates psychiatric patients' acceptance of, motivation for, and exhaustion due to cognitive remediation compared to an established treatment programme. 21 psychiatric patients who simultaneously participated in occupational therapy and cognitive remediation rated the motivation, exhaustion, enjoyment, and effort on a visual analogue scale (VAS) over five weeks with regard to the respective therapy. The ratings of occupational therapy and cognitive remediation did not differ relating to motivation, exhaustion, and enjoyment. The subjective effort in cognitive remediation was higher than that in occupational therapy. Cognitive remediation is evaluated as being equivalent to an already established treatment programme by psychiatric patients concerning motivation, enjoyment, and exhaustion. Doubts about the acceptance and reasonableness of cognitive remediation could not be confirmed. In clinical routine cognitive remediation as an effective and accepted therapeutic approach should be integrated as a standard procedure for various disorders. © Georg Thieme Verlag KG Stuttgart · New York.

  2. Technical solutions for simultaneous MEG and SEEG recordings: towards routine clinical use.

    PubMed

    Badier, J M; Dubarry, A S; Gavaret, M; Chen, S; Trébuchon, A S; Marquis, P; Régis, J; Bartolomei, F; Bénar, C G; Carron, R

    2017-09-21

    The simultaneous recording of intracerebral EEG (stereotaxic EEG, SEEG) and magnetoencephalography (MEG) is a promising strategy that provides both local and global views on brain pathological activity. Yet, acquiring simultaneous signals poses difficult technical issues that hamper their use in clinical routine. Our objective was thus to develop a set of solutions for recording a high number of SEEG channels while preserving signal quality. We recorded data in a patient with drug resistant epilepsy during presurgical evaluation. We used dedicated insertion screws and optically insulated amplifiers. We recorded 137 SEEG contacts on 10 depth electrodes (5-15 contacts each) and 248 MEG channels (magnetometers). Signal quality was assessed by comparing the distribution of RMS values in different frequency bands to a reference set of MEG acquisitions. The quality of signals was excellent for both MEG and SEEG; for MEG, it was comparable to that of MEG signals without concurrent SEEG. Discharges involving several structures on SEEG were visible on MEG, whereas discharges limited in space were not seen at the surface. SEEG can now be recorded simultaneously with whole-head MEG in routine. This opens new avenues, both methodologically for understanding signals and improving signal processing methods, and clinically for future combined analyses.

  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. Refining an automatic EDSS scoring expert system for routine clinical use in multiple sclerosis.

    PubMed

    Gaspari, Mauro; Saletti, Davide; Scandellari, Cinzia; Stecchi, Sergio

    2009-07-01

    The Expanded Disability Status Scale (EDSS) has been the most widely used measure of disability in multiple sclerosis (MS) clinical trials. Although EDSS has the advantage of familiarity with respect to recent proposals, and remains the de facto standard, it is difficult to use consistently between evaluators. Automatic EDSS (AEDSS) is an expert system designed to overcome this problem. It constrains the neurologist to follow precise reasoning steps, enhancing EDSS reliability. In this paper, we show how a deep analysis of the neurological knowledge involved has been essential for adopting AEDSS in routine clinical use. We present an ontology for the EDSS domain and highlight the enhancements to AEDSS due to this additional knowledge. A validation experiment in four MS centers in Italy showed that AEDSS reduces interrater variability, and in many cases, is able to correct errors of neurologists.

  5. Lack of clinical relevance in routine final subcultures of radiometrically negative BACTEC blood culture vials

    SciTech Connect

    Plorde, J.J.; Carlson, L.G.; Dau, M.E.

    1982-11-01

    During a 38-month period, 10,106 blood specimens were received in the laboratory for culture. These were inoculated into 26,424 vials and processed using the BACTEC radiometric detection system. Of these vials, 1,914 were eventually found to be microbiologically positive. Isolates from 836 vials were judged to be contaminants. In the remaining 1,078 vials, growth was first detected visually or radiometrically in 1,062 and by final subculture in 16. Growth from these sixteen bottles represented 12 clinically significant bacteremic episodes in as many patients. In nine of these episodes, other culture vials from the same patient were positive radiometrically. Therefore, 358 of 361 (99.2%) bacteremic episodes were detected without the benefit of routine final subcultures. The three patients whose bacteremia was missed were diagnosed clinically and placed on appropriate therapy prior to the detection of the bacteremias by final subculture.

  6. Clinical efficacy of 99m-technetium mercaptoacetylglycine kit formulation in routine renal scintigraphy

    SciTech Connect

    duCret, R.P.; Boudreau, R.J.; Gonzalez, R.; Carpenter, R.; Tennison, J.; Kuni, C.C.

    1989-07-01

    99m-Technetium mercaptoacetylglycine is a promising new renal radiopharmaceutical undergoing phase III trials in the United States. In a preliminary investigation of the efficacy and safety of mercaptoacetylglycine in 30 adult patients with suspected renal disease we used simultaneous imaging with orthoiodohippurate as the physiological ''gold standard''. Of these patients 11 had undergone renal transplantation. Factors, such as time to peak renal activity, clearance half-life and regional functional comparison, were similar by orthoiodohippurate and mercaptoacetylglycine imaging. Visual and quantitative analysis of angiograms and renograms was markedly facilitated with the use of mercaptoacetylglycine. Several morphological abnormalities were apparent only during mercaptoacetylglycine evaluation. No adverse effects, changes in vital signs or significant changes in clinical laboratory status were encountered. Since mercaptoacetylglycine combined an excellent technetium image with the pharmacokinetics of orthoiodohippurate, mercaptoacetylglycine may supplant all other agents for routine clinical use.

  7. Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines.

    PubMed

    Kim, Sollip; Yun, Yeo Min; Chae, Hyo Jin; Cho, Hyun Jung; Ji, Misuk; Kim, In Suk; Wee, Kyung A; Lee, Woochang; Song, Sang Hoon; Woo, Hye In; Lee, Soo Youn; Chun, Sail

    2017-03-01

    Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

  8. Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines

    PubMed Central

    Kim, Sollip; Yun, Yeo-Min; Chae, Hyo-Jin; Cho, Hyun-Jung; Ji, Misuk; Kim, In-Suk; Wee, Kyung-A; Lee, Woochang; Song, Sang Hoon; Woo, Hye In

    2017-01-01

    Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings. PMID:28029011

  9. The challenges of implementing ADHD clinical guidelines and research best evidence in routine clinical care settings: Delphi survey and mixed-methods study.

    PubMed

    Hall, Charlotte L; Taylor, John A; Newell, Karen; Baldwin, Laurence; Sayal, Kapil; Hollis, Chris

    2016-01-01

    The landmark US Multimodal Treatment of ADHD (MTA) study established the benefits of individualised medication titration and optimisation strategies to improve short- to medium-term outcomes in attention-deficit hyperactivity disorder (ADHD). This individualised medication management approach was subsequently incorporated into the National Institute for Health and Care Excellence (NICE) ADHD Clinical Guidelines (NICE CG78). However, little is known about clinicians' attitudes towards implementing these medication management strategies for ADHD in routine care. To examine National Health Service (NHS) healthcare professionals' consensus on ADHD medication management strategies. Using the Delphi method, we examined perceptions on the importance and feasibility of implementing 103 ADHD treatment statements from sources including the UK NICE ADHD guidelines and US medication management algorithms. Certain recommendations for ADHD medication management were judged as important and feasible to implement, including a stepwise titration of stimulant medication. Other recommendations were perceived as important but not feasible to implement in routine practice, such as weekly clinic follow-up with the family during titration and collection of follow-up symptom questionnaires. Many of the key guideline recommendations for ADHD medication management are viewed by clinicians as important and feasible to implement. However, some recommendations present significant implementation challenges within the context of routine NHS clinical care in England. C.H. and K.S. were members of the Guideline Development Group for the NICE ADHD Clinical Guideline (NICE CG78). © 2016 The Royal College of Psychiatrists. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  10. Clinical chemistry in higher dimensions: Machine-learning and enhanced prediction from routine clinical chemistry data.

    PubMed

    Richardson, Alice; Signor, Ben M; Lidbury, Brett A; Badrick, Tony

    2016-11-01

    Big Data is having an impact on many areas of research, not the least of which is biomedical science. In this review paper, big data and machine learning are defined in terms accessible to the clinical chemistry community. Seven myths associated with machine learning and big data are then presented, with the aim of managing expectation of machine learning amongst clinical chemists. The myths are illustrated with four examples investigating the relationship between biomarkers in liver function tests, enhanced laboratory prediction of hepatitis virus infection, the relationship between bilirubin and white cell count, and the relationship between red cell distribution width and laboratory prediction of anaemia.

  11. Can endobronchial biopsy analysis be recommended to discriminate between asthma and COPD in routine practice?

    PubMed Central

    Bourdin, A; Serre, I; Flamme, H; Vic, P; Neveu, D; Aubas, P; Godard, P; Chanez, P

    2004-01-01

    Background: International guidelines stress the importance of accurately discriminating between asthma and chronic obstructive pulmonary disease (COPD). Although characteristic pathological features have been described for both conditions, their discriminatory power has never been systematically assessed. Methods: Endobronchial biopsy (EBB) specimens from patients with a clear clinical diagnosis of asthma and COPD (50 per group) were examined by three pathologists in a double blind manner. They were asked to propose a pathological diagnosis of either asthma or COPD and to analyse qualitatively the most frequent abnormalities reported in the literature. Results: The sensitivity and specificity of EBB ranged from 36% to 48% and from 56% to 79%, respectively. Eosinophils strongly biased the pathological diagnoses in favour of asthma, whereas their estimated prevalence was similar (11–37% in asthma and 13–41% in COPD). Metaplasia (11–39% in COPD, 1–18% in asthma) and epithelial inflammation (28–61% in COPD, 11–38% in asthma) tended to be specific to COPD, whereas epithelial desquamation (80–98% in asthma, 61–88% in COPD) and basement membrane thickening (71–94% in asthma, 53–88% in COPD) tended to be associated with asthma. There was acceptable intra- and inter-observer agreement only for metaplasia and epithelial eosinophils. Conclusions: Specific histopathological features of asthma and COPD probably exist, but current routine analysis procedures to assess EBB specimens are not sufficiently discriminatory. This might be rectified by improving pathological definitions. PMID:15170031

  12. [Clinical bioethics: how to practice?].

    PubMed

    de Oliveira, Reinaldo Ayer; Jorge Filho, Isac

    2010-06-01

    To think about ethics means to go into the Bioethics universe. If it is understood that medical ethics deals with doctors within an organized society under legal purposes, consensus and ethics in the exercise of medicine it is observed that Bioethics came up due to the need to debate and decide on the ethic questions related mainly to research and scientific advances as well as conquests concerning human rights and social-cultural development: it is the critical expression of our interest in conveniently using the development of medical art and science. Within Medicine, clinical Bioethics arouse as a possibility of thinking and discussing the practice of medicine in the different social institutions which deal with health and with professionals in health area.

  13. Computed tomography angiography of coronary artery bypass grafts: robustness in emergency and clinical routine settings.

    PubMed

    Heye, Tobias; Kauczor, Hans-Ulrich; Szabo, Gabor; Hosch, Waldemar

    2014-03-01

    There is a high probability for presence of irregular heart rates and artifacts in patients with previous coronary artery bypass graft (CABG) surgery. Previously reported diagnostic performance of ECG-gated 64-slice dual-source computer tomography angiography (CTA) in this patient group is based on pre-selection for normal heart rate and routine clinical setting. To investigate image quality and diagnostic performance of CTA in patients with previous CABG surgery in various clinical settings. Fifty-six non-selected, consecutive patients (110 grafts, 44 arterial, 66 venous) with previous CABG surgery were prospectively examined using a dual-source 64-slice CT (Siemens Definition, Forchheim, Germany) without utilization of CT-related pharmaceutical heart rate control. Patients were stratified according to the clinical setting: planned redo-cardiac surgery; emergency CTA within 30 days after CABG surgery; routine follow-up after CABG surgery. A reference standard was available for 30 patients (53.6%; 67/110 grafts). Image quality, artifacts, and graft patency were independently assessed by two observers. All CTAs were diagnostic despite the presence of irregular heart rhythm (25% of cases) and artifacts (72.7% of grafts). CTA was accurate in all patient groups in assessing graft patency (97.9% sensitivity; 100% specificity; 98.5% accuracy) but artifacts decreased diagnostic performance for stenosis detection (60% sensitivity; 88.6% specificity; 84.1% accuracy). Arterial grafts exhibited more surgical clip artifacts compared to venous grafts, which predominantly showed motion artifacts. Overall diagnostic quality was rated excellent in 70.9%/56.4%, good in 23.4%/39.1%, and sufficient in 5.5%/4.5% by each observer, respectively. CTA detected acute findings in 10 cases (graft bleeding, graft occlusion, pericardial hematoma, sternal instability with retrosternal abscess formation, pericardial effusion, left ventricle thrombus) in the emergency group; seven cases required

  14. Evidence Based Surgery: How Difficult is the Implication in Routine Practice?

    PubMed Central

    Maheshwari, Gaurav; Maheshwari, Namrata

    2012-01-01

    Surgery as a discipline has perhaps been slower than other specialties to embrace evidence based principles. Today, surgeons all over Asia are prepared to challenge the dogma of yesterday. Surgical science which rests on a strong foundation of laboratory and clinical research can now be broadened to include the armamentarium of evidence based practice to advance surgical knowledge. The sheer volume of easily accessed information creates a new challenge. This article discusses keeping up with new information and finding the best available answers to specific questions amidst all the other information. PMID:22359733

  15. Evidence Based Surgery: How Difficult is the Implication in Routine Practice?

    PubMed

    Maheshwari, Gaurav; Maheshwari, Namrata

    2012-01-01

    Surgery as a discipline has perhaps been slower than other specialties to embrace evidence based principles. Today, surgeons all over Asia are prepared to challenge the dogma of yesterday. Surgical science which rests on a strong foundation of laboratory and clinical research can now be broadened to include the armamentarium of evidence based practice to advance surgical knowledge. The sheer volume of easily accessed information creates a new challenge. This article discusses keeping up with new information and finding the best available answers to specific questions amidst all the other information.

  16. Is tissue an issue? Current practice and opinion in Western Australia for routine histopathology on products of conception.

    PubMed

    Yap, Shui-Jean; Watts, Jared C; Faithfull, Tiffany J; Wong, Sabrina Z; Wylde, Kate L; McGurgan, Paul M

    2014-10-01

    An anonymous questionnaire-based survey was used to determine current practices and opinions of senior health professionals working in Western Australian (WA) hospitals performing gynaecological procedures, regarding the routine use of histopathology for products of conception (POC) obtained either from the surgical management of miscarriage or termination of pregnancy. Sixty-one senior health professionals completed the survey. Tissue histopathology on POC was routinely requested for miscarriage and termination of pregnancy (TOP) by 87 and 59% of respondents, respectively. Respondents listed the main reasons for requesting routine histopathology as avoidance of misdiagnosis, medico-legal and quality assurance. There were inconsistent practices among WA health professionals regarding sending POC for histopathology; 63% of gynaecology head of departments recommend the introduction of state or national guidelines for the use of histopathology in the surgical management of miscarriages or terminations of pregnancy. © 2014 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  17. Factors affecting urine specific gravity in apparently healthy cats presenting to first opinion practice for routine evaluation.

    PubMed

    Rishniw, Mark; Bicalho, Rodrigo

    2015-04-01

    Evidence suggests that apparently healthy cats presenting for routine evaluation should have a randomly sampled urine specific gravity (USG) >1.035. A USG <1.035 might reflect inappropriate concentrating ability warranting further investigation. We measured the USG of 1040 apparently healthy cats presenting to first opinion practice in an observational study, using either in-clinic refractometers or measurements provided by reference laboratories, and examined factors that might affect USG. In-clinic refractometers were calibrated using distilled water (specific gravity = 1.000). The USG was >1.030 in 91% of cats and >1.035 in 88% of cats; 121 adult cats (⩾6 months old) and five young cats (<6 months old) had USGs of <1.035. Of these 126 cats, a pathological cause was identified in 27 adult cats - of these, 26 were >9 years old - but no young cats. No cause was identified in 43 adult cats, and further investigation was not pursued in 51 adult cats. Factors that affected USG included age, diet type, sex, fasting status, drinking avidity, refractometer type, and the interaction between sex and diet - increasing dietary moisture content lowered USG only in female cats. Most factors minimally affected USG. The odds of having a USG <1.035 without apparent pathology included age and dietary moisture content. Drinking avidity decreased with increasing dietary moisture content. Our results show that most apparently healthy cats presenting to first-opinion practice should have a USG >1.035. Dietary management strategies to lower USG might be less effective than anticipated, and warrant monitoring of USG to determine efficacy. Older cats with USG <1.035 are more likely to have pathological causes identified, although clinicians are more likely to examine these cats for possible pathology. A lack of stringent refractometer calibration could have caused some errors in estimates of USG by some observers, but would be unlikely to alter markedly the findings.

  18. The nocebo effect and its relevance for clinical practice

    PubMed Central

    Colloca, Luana; Miller, Franklin G.

    2011-01-01

    Negative expectations deriving from the clinical encounter can produce negative outcomes, known as nocebo effects. Specifically, research on the nocebo effect indicates that information disclosure about potential side effects can itself contribute to producing adverse effects. Neurobiological processes play a role in the nocebo effect and this paper provides a selective review of mechanistic research on the nocebo effect. Comparatively little attention has been directed to clinical studies and their implications for daily clinical practice. The nocebo response is influenced by the content and the way information is presented to patients in clinical trials in both the placebo as well as active treatment conditions. Nocebo effect adversely influences quality of life and therapy adherence, emphasizing the need for minimizing these responses to the extent possible. Evidence further indicates that the informed consent process in clinical trials may induce nocebo effects. This paper concludes with ethical directions for future patient-oriented research and routine practice. PMID:21862825

  19. Routine issuance of clinical magnets to patients receiving implantable defibrillators: retention of information and appropriateness of use

    PubMed Central

    Thomas, Dewi E; Barry, James P; Churchouse, Wendy; Anderson, Mark H

    2015-01-01

    Background The application of a clinical magnet over an implantable cardioverter defibrillator (ICD) can be used to suspend tachycardia therapies in patients receiving recurrent or inappropriate shocks. In our institution, they have been routinely issued to patients undergoing ICD implantation during the past 5 years. The purpose of this survey was to investigate how well information concerning their use had been retained, and in what circumstances the magnets had been used. Methods We sent a questionnaire to 476 patients, and received a response from 343 (72%). Data was collated using ‘Microsoft Excel’, cross-referenced against our own pacing database, and analysed using basic statistical methods. Results 256 (74.6%) patients recalled being issued with a magnet. 48% of these were still in possession of their written information leaflet at the time of survey; 62% felt that they were able to remember when and how to use the magnet—with patients who had received written instructions and verbal reinforcement demonstrating the best recall. 8% of patients had used their magnets and the most common reason for use was multiple or inappropriate shocks. In addition, almost half of the patients who had suffered inappropriate shocks had been able to successfully use their magnets. No cases of harm related to magnet use were identified. Conclusions The results of our survey suggest that routinely issuing clinical magnets to ICD patients is a safe and effective practice, and a small but significant number of patients were able to utilise their magnets in clinically important situations. PMID:26019880

  20. The use and impact of cancer medicines in routine clinical care: methods and observations in a cohort of elderly Australians

    PubMed Central

    Pearson, Sallie-Anne; Schaffer, Andrea

    2014-01-01

    Introduction After medicines have been subsidised in Australia we know little about their use in routine clinical practice, impact on resource utilisation, effectiveness or safety. Routinely collected administrative health data are available to address these issues in large population-based pharmacoepidemiological studies. By bringing together cross-jurisdictional data collections that link drug exposure to real-world outcomes, this research programme aims to evaluate the use and impact of cancer medicines in a subset of elderly Australians in the real-world clinical setting. Methods and analysis This ongoing research programme involves a series of retrospective cohort studies of Australian Government Department of Veterans’ Affairs (DVA) clients. The study population includes 104 635 veterans who reside in New South Wales, Australia, and were aged 65 years and over as of 1 July 2004. We will investigate trends in cancer medicines use according to cancer type and other sociodemographic characteristics as well as predictors of the initiation of cancer medicines and other treatment modalities, survival and adverse outcomes among patients with cancer. The programme is underpinned by the linkage of eight health administrative databases under the custodianship of the DVA and the New South Wales Ministry of Health, including cancer notifications, medicines dispensing data, hospitalisation data and health services data. The cancer notifications database is available from 1994 with all other databases available from 2005 onwards. Ethics and dissemination Ethics approval has been granted by the DVA and New South Wales Population and Health Service Research Ethics Committees. Results Results will be reported in peer-reviewed publications, conference presentations and policy forums. The programme has high translational potential, providing invaluable evidence about cancer medicines in an elderly population who are under-represented in clinical trials. PMID:24793244

  1. Cancer Patients? Willingness to Routinely Complete the EQ-5D Instrument at Clinic Visits.

    PubMed

    Naik, Hiten; Qiu, Xin; Brown, M Catherine; Mahler, Mary; Hon, Henrique; Tiessen, Kyoko; Thai, Henry; Ho, Valerie; Gonos, Christina; Charow, Rebecca; Pat, Vivien; Irwin, Margaret; Herzog, Lindsay; Ho, Anthea; Xu, Wei; Howell, Doris; Seung, Soo Jin; Liu, Geoffrey; Mittmann, Nicole

    2016-09-13

    Health utility (HU) scores play an essential role in pharmacoeconomic analyses. Routine clinical administration of the EuroQol-5 Dimensions (EQ-5D) can allow for HU and health related quality of life (HRQOL) assessments in the real-world setting. The primary goals of this study were to evaluate whether patients were willing to complete the EQ-5D instrument on a routine basis and which clinical or demographic factors influence this willingness. 618 adult cancer survivors across multiple cancer disease sites at the Princess Margaret Cancer Centre completed an acceptability survey after completing the EQ-5D instrument. The mean (SD) EQ-5D score was 0.81 (0.15). Among those surveyed, 88% reported that the EQ-5D was easy to complete. 91% took under 5 minutes and 88% were satisfied with its length. 85% were satisfied with the types of questions asked on the EQ-5D. Importantly, 92% reported that they would complete the EQ-5D, even if it were used solely for research purposes; 73% agreed with the notion of completing it regularly at their clinic visits. Patients with lower EQ-5D scores (p=0.0006), and non-Caucasians (p=0.0024; 60% willing) were less willing to complete the instrument on a regular basis. Curability of tumour, disease site, age, and gender did not influence willingness. The majority of cancer patients across disease sites are willing to complete the EQ-5D instrument regularly, even if it were solely for research purposes, but up to 39% declined participation in the first place.

  2. Impact of Contrast Echocardiography on Assessment of Ventricular Function and Clinical Diagnosis in Routine Clinical Echocardiography: Korean Multicenter Study

    PubMed Central

    Kim, Doo-Youp; Choi, Jung-Hyun; Rim, Se-Joong; Kim, Jang-Young; Lee, Sang-Chol; Sohn, Il-Suk; Chung, Wook-Jin; Seo, Hye-Sun; Yoon, Se-Jung; Cho, Kyoung-Im; Choi, Si-Wan; Lee, Kyung-Jin

    2017-01-01

    Background Fundamental echocardiography has some drawbacks in patients with difficult-to-image echocardiograms. The aim of this study is to evaluate impact of contrast echocardiography (CE) on ventricular function assessment and clinical diagnosis in routine clinical echocardiography. Methods Two hundred sixty patients were prospectively enrolled over 3 years in 12 medical centers in Korea. General image quality, the number of distinguishable segments, ability to assess regional wall motion, left ventricular (LV) apex and right ventricle (RV) visualization, LV ejection fraction, changes in diagnostic or treatment plan were documented after echocardiography with and without ultrasound contrast agent. Results Poor or uninterpretable general image was 31% before contrast use, and decreased to 2% (p<0.05) after contrast use. The average number of visualized LV segments was 9.53 before contrast use, and increased to 14.46 (p<0.001) after contrast use. The percentage of poor or not seen LV regional wall motion was decreased from 28.4% to 3.5% (p<0.001). The percentage of poor or not seen LV apex and RV was decreased from 49.4% to 2.4% (p<0.001), from 30.5% to 10.5% (p<0.001), respectively. Changes in diagnostic procedure and treatment plan after CE were 30% and 29.6%, respectively. Conclusion Compared to fundamental echocardiography, CE impacted LV function assessment and clinical decision making in Korean patients who undergo routine echocardiography. PMID:28400933

  3. Role of routine ultrasonography in monitoring the outcome of medical abortion in a clinical setting.

    PubMed

    Acharya, Ganesh; Haugen, Michael; Bråthen, Anders; Nilsen, Ingard; Maltau, Jan Martin

    2004-04-01

    Clinical methods generally used to evaluate the completeness of medical abortion are not accurate. There are no published reports evaluating the role of routine ultrasonography in monitoring the outcome of medical abortion. The purpose of this study was to investigate whether routine transvaginal ultrasonography (TVS) at the follow-up visit after medical abortion can accurately identify women who will require surgical intervention. Retrospective review of medical records and charts of all women undergoing medical abortion in the first trimester of pregnancy between January 1999 and December 2001. Medical abortion was performed using oral mifepristone and a vaginal prostaglandin analog before 63 days gestation. All women had an initial TVS to confirm intrauterine pregnancy and gestational age, and another TVS at the follow-up visit 2-3 weeks later to assess the completeness of abortion. Surgical evacuation of the uterus was allowed as indicated on clinical grounds but not on the basis of ultrasound findings only. A total of 690 women consented to medical abortion during the study period. Eleven of these women were excluded from the study for various reasons. Of the remaining 679 cases, 95% (645/679) had a documented follow-up at the hospital. The pregnancy termination rate among these women was 99.2% (640/645) and TVS identified all five cases of continuing pregnancy at the follow-up. A total of 66 (10.2%) patients had complications. The uterine cavity was empty on TVS at the follow-up visit in 84.8% (547/645) of cases and only 3.1% (17/547) of them required surgical aspiration/curettage due to excessive or prolonged vaginal bleeding. In the remaining 15.2% (98/645) the uterine cavity was not empty, and 43.9% (43/98) of them had a curettage. The risk of requiring a surgical intervention was significantly higher [odds ratio (OR) 24.4; 95% confidence interval (95% CI) 14.9-39.7] when the uterine cavity was not demonstrated to be empty at the follow-up visit 2-3 weeks

  4. Identifying pain-related concerns in routine follow-up clinics following oral and oropharyngeal cancer.

    PubMed

    Rogers, Simon N; Cleator, Alexander J; Lowe, Derek; Ghazali, Naseem

    2012-08-10

    To describe clinical characteristics of head and neck cancer (HNC) patients with pain and those wishing to discuss pain concerns during consultation. Cross-sectional, questionnaire study using University of Washington Quality of Life, version 4 (UW-QOL) and the Patients Concerns Inventory (PCI) in disease-free, post-treatment HNC cohort. Significant pain on UW-QOL and indicating "Pain in head and neck" and "Pain elsewhere" on PCI. One hundred and seventy-seven patients completed UW-QOL and PCI. The prevalence of self-reported pain issues was 38% (67/177) comprising 25% (44/177) with significant problems despite medications and 13% (23/177) with lesser or no problems but wishing to discuss pain. Patients aged under 65 years and patients having treatment involving radiotherapy were more likely to have pain issues. Just over half, 55% (24/44) of patients with significant pain did not express a need to discuss this. Those with significant pain or others wanting to discuss pain in clinic had greater problems in physical and social-emotional functioning, reported suboptimal QOL, and also had more additional PCI items to discuss in clinic compared to those without significant pain and not wishing to discuss pain. Significant HNC-related pain is prevalent in the disease-free, posttreatment cohort. Onward referral to a specialist pain team may be beneficial. The UW-QOL and PCI package is a valuable tool that may routinely screen for significant pain in outpatient clinics.

  5. Routine data from hospital information systems can support patient recruitment for clinical studies.

    PubMed

    Dugas, Martin; Lange, Matthias; Müller-Tidow, Carsten; Kirchhof, Paulus; Prokosch, Hans-Ulrich

    2010-04-01

    Delayed patient recruitment is a common problem in clinical studies. Hospital information systems (HIS) contain data items relevant for inclusion or exclusion criteria of these studies. We developed and assessed a system to support patient recruitment using HIS data. We developed a workflow integrated in our HIS to notify study physicians about potential trial subjects. Automatic HIS database queries based on inclusion and exclusion criteria for each clinical study are performed regularly and generate e-mail notifications via a communication server. Study physicians can verify eligibility with a specific HIS study module. The system performance was assessed with a survey addressing utility, usability, stability, change in recruitment rate, and estimated time savings. During 10 months of operation, 1328 notifications were generated and 329 enrollments (25%) were documented for seven studies. Precision of alerts depends on availability of appropriate HIS items. Utility and usability were assessed as good, and stability as excellent. Users reported an increased patient recruitment rate for three studies. Three studies reported an estimated time saving of 10 min per recruited patient. The main perceived benefit was systematic identification of potentially eligible patients without time-consuming patient screening procedures in the different parts of the hospital. Notifications about potentially eligible patients depend on HIS data quality regarding inclusion/exclusion criteria, in particular, completeness, timeliness, and validity. Routine HIS data can support patient recruitment for clinical studies by means of an automated notification workflow and efficient access to clinical data.

  6. Assessing barriers to adherence in routine clinical care for pediatric kidney transplant patients.

    PubMed

    Varnell, Charles D; Rich, Kristin L; Nichols, Melissa; Dahale, Devesh; Goebel, Jens W; Pai, Ahna L H; Hooper, David K; Modi, Avani C

    2017-08-01

    Patient-identified barriers to immunosuppressive medications are associated with poor adherence and negative clinical outcomes in transplant patients. Assessment of adherence barriers is not part of routine post-transplant care, and studies regarding implementing such a process in a reliable way are lacking. Using the Model for Improvement and PDSA cycles, we implemented a system to identify adherence barriers, including patient-centered design of a barriers assessment tool, identification of eligible patients, clear roles for clinic staff, and creating a culture of non-judgmental discussion around adherence. We performed time-series analysis of our process measure. Secondary analyses examined the endorsement and concordance of adherence barriers between patient-caregiver dyads. After three methods of testing, the most reliable delivery system was an EHR-integrated tablet that alerted staff of patient eligibility for assessment. Barriers were endorsed by 35% of caregivers (n=85) and 43% of patients (n=60). The most frequently patient-endorsed barriers were forgetting, poor taste, and side effects. Caregivers endorsed forgetting and side effects. Concordance between patient-caregiver dyads was fair (k=0.299). Standardized adherence barriers assessment is feasible in the clinical care of pediatric kidney transplant patients. Features necessary for success included automation, redundant systems with designated staff to identify and mitigate failures, aligned reporting structures, and reliable measurement approaches. Future studies will examine whether barriers predict clinical outcomes (eg, organ rejection, graft loss). © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. Impact of transitioning from HIV clinical trials to routine medical care on clinical outcomes and patient perceptions.

    PubMed

    Yehia, Baligh R; Long, Judith A; Stearns, Cordelia R; French, Benjamin; Tebas, Pablo; Frank, Ian

    2012-01-01

    Participation in antiretroviral therapy clinical trials (ART-RCTs) offers many advantages including access to new drugs, close monitoring, and cost savings. These same benefits may pose a risk to patients ending ART-RCTs and returning to routine care; as they may experience changes to their drug regimen, decreased monitoring, and new out-of-pocket costs. We aimed to evaluate this transition and determine its effects on viral outcomes and patient perceptions. A retrospective cohort was assembled from participants of naïve ART-RCTs at the University of Pennsylvania between 1 January 2000 and 31 December 2009. Data were collected in the 12 months prior to and after trial completion. Multivariable logistic regression was used to evaluate viral failure rates and to identify factors associated with viral failure. Qualitative interviews were held with a subset of patients. Content analysis was used to identify thematic differences between patients with viral failure and those with viral suppression. In total, 116 patients enrolled in 5 ART-RCTs from 2000 to 2009. Viral failure was observed in 39 patients (34%). Nonwhites, high enrollment CD4 count, and trial completion in 1999-2002 were risk factors for failure. Patients transitioning from ART-RCTs to routine care had a 20% increased odds of failure (Adjusted Odds Ratio 1.20 (95% CI [0.37, 3.88])). Nine patients with viral suppression and three with viral failure in the year after trail completion were interviewed. Suppressed patients were more eager to continue trial participation, nervous about leaving the trial, and felt prepared to return to routine care. In contrast, those with viral failure were less concerned about the transition. These findings suggest that the posttrial period may be a vulnerable time for patients. Patients without a healthy fear of transitioning from ART-RCTs to routine care may be at increased risk of viral failure. Focus should be given to assisting patients during this transition.

  8. Evaluation of Kenya's readiness to transition from sentinel surveillance to routine HIV testing for antenatal clinic-based HIV surveillance.

    PubMed

    Sirengo, Martin; Rutherford, George W; Otieno-Nyunya, Boaz; Kellogg, Timothy A; Kimanga, Davies; Muraguri, Nicholas; Umuro, Mamo; Mirjahangir, Joy; Stein, Ellen; Ndisha, Margaret; Kim, Andrea A

    2016-03-05

    Sentinel surveillance for HIV among women attending antenatal clinics using unlinked anonymous testing is a cornerstone of HIV surveillance in sub-Saharan Africa. Increased use of routine antenatal HIV testing allows consideration of using these programmatic data rather than sentinel surveillance data for HIV surveillance. To gauge Kenya's readiness to discontinue sentinel surveillance, we evaluated whether recommended World Health Organization standards were fulfilled by conducting data and administrative reviews of antenatal clinics that offered both routine testing and sentinel surveillance in 2010. The proportion of tests that were HIV-positive among women aged 15-49 years was 6.2% (95% confidence interval [CI] 4.6-7.7%] in sentinel surveillance and 6.5% (95% CI 5.1-8.0%) in routine testing. The agreement of HIV test results between sentinel surveillance and routine testing was 98.0%, but 24.1% of specimens that tested positive in sentinel surveillance were recorded as negative in routine testing. Data completeness was moderate, with HIV test results recorded for 87.8% of women who received routine testing. Additional preparation is required before routine antenatal HIV testing data can supplant sentinel surveillance in Kenya. As the quality of program data has markedly improved since 2010 a repeat evaluation of the use of routine antenatal HIV testing data in lieu of ANC sentinel surveillance is recommended.

  9. Do men consult less than women? An analysis of routinely collected UK general practice data

    PubMed Central

    Wang, Yingying; Hunt, Kate; Nazareth, Irwin; Freemantle, Nick; Petersen, Irene

    2013-01-01

    Objective To examine whether gender differences in primary care consultation rates (1) vary by age and deprivation status and (2) diminish when consultation for reproductive reasons or common underlying morbidities are accounted for. Design Cross-sectional study of a cohort of patients registered with general practice. Setting UK primary care. Subjects Patients (1 869 149 men and 1 916 898 women) registered with 446 eligible practices in 2010. Primary outcome measures Primary care consultation rate. Results This study analyses routinely collected primary care consultation data. The crude consultation rate was 32% lower in men than women. The magnitude of gender difference varied across the life course, and there was no ‘excess’ female consulting in early and later life. The greatest gender gap in primary care consultations was seen among those aged between 16 and 60 years. Gender differences in consulting were higher in people from more deprived areas than among those from more affluent areas. Accounting for reproductive-related consultations diminished but did not eradicate the gender gap. However, consultation rates in men and women who had comparable underlying morbidities (as assessed by receipt of medication) were similar; men in receipt of antidepressant medication were only 8% less likely to consult than women in receipt of antidepressant medication (relative risk (RR) 0.916, 95% CI 0.913 to 0.918), and men in receipt of medication to treat cardiovascular disease were just 5% less likely to consult (RR=0.950, 95% CI 0.948 to 0.952) than women receiving similar medication. These small gender differences diminished further, particularly for depression (RR=0.950, 95% CI 0.947 to 0.953), after also taking account of reproductive consultations. Conclusions Overall gender differences in consulting are most marked between the ages of 16 and 60 years; these differences are only partially accounted for by consultations for reproductive reasons

  10. Assessing quality of life in paediatric clinical practice.

    PubMed

    Morrow, Angela M; Quine, Susan; Heaton, Maria D; Craig, Jonathan C

    2010-06-01

    The rising prevalence of children with chronic conditions has made quality of life an increasingly important outcome measure in paediatric practice. The discrepancy between doctors' and patients' perceptions of quality of life makes formal assessment necessary. In this paper we use a case scenario to answer commonly asked questions. What is quality of life and who can assess it? Why assess quality of life in the clinical setting? Is it feasible to measure in routine clinical practice? How is quality of life formally assessed? We provide a basic outline of the language and methods of quality of life assessment and use the case scenario to discuss the process of choosing an appropriate instrument. We conclude that quality of life assessment in clinical practice is feasible and provides benefits for both patients and doctors. The benefits include better informed doctors, improved patient doctor communication and a means to effectively monitor quality of life as a treatment outcome.

  11. Is daily routine important for sleep? An investigation of social rhythms in a clinical insomnia population.

    PubMed

    Moss, Taryn G; Carney, Colleen E; Haynes, Patricia; Harris, Andrea L

    2015-02-01

    Social rhythms, also known as daily routines (e.g. exercise, of school or work, recreation, social activities), have been identified as potential time cues to help to regulate the biological clock. Past research has shown links between regularity and healthy sleep. This study examined the regularity and frequency of daytime activities in a clinical insomnia population and a good sleeper comparison group. Participants (N = 69) prospectively monitored their sleep and daily activities for a 2-week period. Although participants with insomnia and good sleepers had similar levels of activity, relative to good sleepers, those with insomnia were less regular in their activities. Findings from this study add to the growing number of studies that highlight the relative importance of the regularity of daytime activities on sleep. Accordingly, future research should test treatment components that focus on regulating daytime activities, which would likely improve treatment outcomes.

  12. Predictors of pain associated with routine procedures performed in general dental practice.

    PubMed

    Tickle, Martin; Milsom, Keith; Crawford, Fiona I J; Aggarwal, Vishal R

    2012-08-01

    The objective of the study was to investigate factors that influence pain intensities associated with routine dental procedures. Four hundred and fifty-one dental patients self-reported pain experienced during the procedure immediately after undergoing a variety of common dental interventions and 1 day after the completion of the procedure. Pain character was measured using the McGill short-form pain questionnaire and intensity using a numerical rating (NRS) scale. Information was collected on a number of factors that could influence pain: dental anxiety was measured using the Corah Dental Anxiety Scale to categorize patients into four domains (fearless, some unease, nervous and very anxious). Dentists provided information regarding the type(s) of procedure and use of local anaesthetic (LA). Seventy-five percent of patients (339/451) reported no pain during their procedure when the data were collected immediately postoperatively (NRS score = 0). Univariate analyses showed that dental anxiety, LA use and type of procedure (extractions) were significant (P < 0.05) predictors of reported intra-operative pain. However, when these factors were combined in a multivariate model, the strongest predictor of pain was dental anxiety [odds ratio (OR) = 4.98 (95% CI 1.42-17.44)] and LA use [OR = 2.79 (95% CI 1.39-5.61)]. Although the strongest predictor of postoperative pain on the next day was pain reported during the procedure [OR = 5.85 (95% CI 2.71-12.64)], LA remained a significant predictor of pain the day after the procedure [OR = 3.16 (95% CI 1.02-9.81)]. Dentists need to assess their patients both preoperatively for dental anxiety and intra-operatively for signs of suboptimal local anaesthesia so as to effectively align patient management and clinical techniques to control dental anxiety and produce adequate anaesthesia. © 2012 John Wiley & Sons A/S.

  13. Testicular seminoma clinical stage 1: treatment outcome on a routine care level.

    PubMed

    Dieckmann, Klaus-Peter; Dralle-Filiz, Inken; Matthies, Cord; Heinzelbecker, Julia; Bedke, Jens; Ellinger, Jörg; Anheuser, Petra; Souchon, Rainer; Pichlmeier, Uwe

    2016-07-01

    Clinical stage 1 (CS1) testicular seminoma involves an almost 100 % disease-specific survival in controlled clinical trials. We aimed to find out whether these results can be matched in patients managed on the routine care level. In total, 725 patients with seminoma CS1 were prospectively enrolled from 130 institutions. Adjuvant management as decided by local physicians involved surveillance (n = 256), radiotherapy (41), 1× Carboplatin (362), and 2× Carboplatin (66). We registered type of management, age, duration of follow-up (F/U), relapse, rete testis invasion (RTI), and tumor size. Actuarial relapse-free survival curves were calculated for treatment modalities and stratified for tumor sizes and RTI. A Cox regression model was calculated to explore for factors influencing relapses. Disease-specific survival was 100 %. Crude relapse rates were 8.2, 2.4, 5.0, and 1.5 % for surveillance, radiotherapy, 1× Carboplatin, and 2× Carboplatin after a median F/U of 30 months. RTI and tumor size were not associated with progression in surveillance patients. One course Carboplatin caused relapses in 6.8 % in tumor sizes >4 cm and 9.3 % (actuarial 13 %) in sizes >5 cm. The Cox model revealed the association of tumor size with recurrence in the entire seminoma population (Hazard ratio 1.17; 95 % confidence intervals 1.03-1.33). The overall outcome of CS1 seminoma managed on the routine care level mirrors that of controlled trials. Unexpectedly, the risk factors in surveillance patients were not confirmed, but tumor size proved to be a risk indicator in the entire group of seminoma. Importantly, one course Carboplatin involved low efficacy to control the disease in large tumors.

  14. Utility of the new rheumatoid arthritis 2010 ACR/EULAR classification criteria in routine clinical care

    PubMed Central

    Kennish, Lauren; Labitigan, Monalyn; Budoff, Sam; Filopoulos, Maria T; McCracken, W Andrew; Swearingen, Christopher J; Yazici, Yusuf

    2012-01-01

    Objectives The new 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria for rheumatoid arthritis (RA) have been designed to classify early onset RA, but has not been studied to identify RA in patients with arthritis seen in routine clinical care where correct ‘classification’ of patients, when they are not selected for having RA would be important. Design Prospective, consecutive patients cohort. Setting Outpatient clinic of a university rheumatology centre. Participants A total of 126 patients with joint symptoms were consecutively recruited. Interventions The ACR/EULAR RA criteria were applied, with questions followed by a targeted musculoskeletal exam. The gold standard for the diagnosis of RA was the primary rheumatologist's diagnosis. Primary outcome measure Number of patients with non-RA diagnosis who were classified as having RA by the new classification criteria. Results The sensitivity and specificity of the 2010 criteria in classifying RA were 97% and 55%, respectively, compared with the 1987 RA criteria which were 93% and 76%, respectively. The 2010 criteria as applied to this group of patients had a poorer positive predictive (44% vs 61%) and a similar negative predictive value (98% vs 97%) compared with the 1987 criteria. More specifically, 66.7% of systemic lupus erythematosus patients, 50% of osteoarthritis, 37.5% of psoriatic arthritis and 27.2% of others fulfilled the new criteria and could have been classified as RA. Conclusions In this, we believe, the first study to examine the new 2010 ACR/EULAR RA criteria among consecutive patients seen in routine care, we found the criteria to have low specificity, and therefore incorrectly label those as having RA when, in fact, they may have a different type of inflammatory arthritis. Physicians need to be aware of this when applying the new criteria for classifying their patients for any purpose. PMID:23035013

  15. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

    PubMed Central

    Kim, Myeong Seong

    2016-01-01

    Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

  16. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging.

    PubMed

    Kim, Myeong Seong

    2016-10-01

    Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body's physiological response. We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body's response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient's tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body's physiological response to heat. Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure.

  17. Feasibility of Integrating Mental Health Screening and Services Into Routine Elder Abuse Practice to Improve Client Outcomes

    PubMed Central

    Sirey, Jo Anne; Berman, Jacquelin; Salamone, Aurora; DePasquale, Alyssa; Halkett, Ashley; Raeifar, Elmira; Banerjee, Samprit; Bruce, Martha L.; Raue, Patrick J.

    2015-01-01

    Objective The goal of this pilot program was to test the feasibility of mental health screening among elder abuse victims and enrolling those victims into a brief psychotherapy useful with both depression and anxiety. Methods Elder abuse victims who sought assistance from a large, urban elder abuse service were screened for depression and anxiety using standardized measures. Clients with clinically significant depression (PHQ-9) or anxiety (GAD-7) were randomized to receive one of three different mental health interventions concurrent with abuse resolution services. This design helped determine the acceptability of each intervention offered and thus the optimal format for service delivery. Results Staff were able to integrate mental health screening for 315 individuals, with 34% of clients scoring positive for depression or anxiety. Of those with mental health needs, only 15% refused all services. The mental health intervention (PROTECT) was able to be implemented in two different formats, with collaboration between elder abuse and mental health staff workers. Discussion These findings support both the need for mental health care among elder abuse victims and the feasibility of integrating mental health screening and treatment into routine elder abuse practice. PMID:25611116

  18. Practitioners' attitudes towards the use of standardized diagnostic assessment in routine practice: a qualitative study in two child and adolescent mental health services.

    PubMed

    Martin, Anne-Marie; Fishman, Roza; Baxter, Laura; Ford, Tamsin

    2011-07-01

    There is tension within Child and Adolescent Mental Health Services (CAMHS) assessments between the richness of differing practitioner's perspectives and maintaining a basic level of assessment that is acceptable to all disciplines. Standardized assessments are mandatory in research, yet are rarely applied systematically across CAMHS.The use of standardized assessments in routine practice might aid the allocation of families to the practitioners best able to meet their needs and free up time for intervention. However, practitioners' attitudes towards standardized assessment will dictate the success of such an approach. Fifty practitioners working in two CAMHS completed semi-structured interviews that explored their attitudes towards the use of standardized assessments in clinical practice, which were analysed using thematic analysis. Practitioners could identify both advantages and disadvantages of the routine use of standardized assessment. While they valued standardization, opportunities for service organization and increased information, some expressed concerns related to the choice, accuracy and influence of measures, as well as labelling. Almost one-third complained about their lack of pre-registration training in working with children, let alone their assessment. Practitioners, clinicians and policy makers need to consider these issues if they wish to introduce standardized assessments into routine practice. Senior staff need to be aware how unskilled some junior practitioners feel when they start working in CAMHS and offer appropriate support and supervision.

  19. Pitfalls of electromagnetic tracking in clinical routine using multiple or adjacent sensors.

    PubMed

    Wegner, Ingmar; Teber, Dogu; Hadaschik, Boris; Pahernik, Sascha; Hohenfellner, Markus; Meinzer, Hans-Peter; Huber, Johannes

    2013-09-01

    While electromagnetic tracking (EMT) holds great promise, there are substantiated concerns about interference within the clinical environment. The purpose of this study was to address accuracy and isolate pitfalls for using multiple or adjacent EMT sensors in clinical routine. A phantom simulating an EMT-guided puncture of the kidney was used to analyse the effects of multiple sensors in the direct vicinity, common clinical environments and the influence of endo-urological instruments. No relevant interference due to the investigated instruments was discovered. However, there was a great decrease in accuracy in the vicinity of a C-arm's image intensifier, especially affecting the precision of two adjacent sensors. Endo-urological instruments can be safely used for multi-sensor EMT-guided procedures. When avoiding the immediate proximity of the surgical table and the image intensifier, there is a comfortable accuracy corridor. Thus, EMT-assistance is promising for a wide range of procedures if basic conditions are met. Copyright © 2012 John Wiley & Sons, Ltd.

  20. Diagnostic discrepancies in clinical practice

    PubMed Central

    Issa, Victor Sarli; Dinardi, Layara Fernanda Lipari; Pereira, Thiago Vicente; de Almeida, Lyna Kyria Rodrigues; Barbosa, Thaisa Silveira; Benvenutti, Luiz Alberto; Ayub-Ferreira, Silvia Moreira; Bocchi, Edimar Alcides

    2017-01-01

    Abstract Autopsies are the gold standard for diagnostic accuracy; however, no recent study has analyzed autopsies in heart failure (HF). We reviewed 1241 autopsies (January 2000–May 2005) and selected 232 patients with HF. Clinical and autopsy diagnoses were analyzed and discrepancies categorized according to their importance regarding therapy and prognosis. Mean age was 63.3 ± 15.9 years; 154 (66.4%) patients were male. The causes of death at autopsy were end-stage HF (40.9%), acute myocardial infarction (17.2%), infection (15.9), and pulmonary embolism 36 (15.5). Diagnostic discrepancies occurred in 191 (82.3%) cases; in 56 (24.1%), discrepancies were related to major diagnoses with potential influence on survival or treatment; pulmonary embolism was the cause of death for 24 (42.9%) of these patients. In 35 (15.1%), discrepancies were related to a major diagnosis with equivocal influence on survival or treatment; in 100 (43.1%), discrepancies did not influence survival or treatment. In multivariate analysis, age (OR: 1.03, 95% CI: 1.008–1.052, P = 0.007) and presence of diabetes mellitus (OR: 0.359, 95% CI: 0.168–0.767, P = 0.008) influenced the occurrence discrepancies. Diagnostic discrepancies with a potential impact on prognosis are frequent in HF. These findings warrant reconsideration in diagnostic and therapeutic practices with HF patients. PMID:28121951

  1. Vitamin D Deficiency and Associated Factors in Patients with Mental Disorders Treated in Routine Practice.

    PubMed

    Ristic, Svetlana; Zivanovic, Sandra; Milovanovic, Dragan R; Janjic, Vladimir; Djokovic, Danijela; Jovicevic, Ana; Pirkovic, Marijana Stanojevic; Kocic, Sanja

    2017-01-01

    This research aimed to investigate factors associated with vitamin D deficiency and to provide data about its prevalence in patients suffering from different psychiatric illnesses. The study had a cross-sectional design and it included 220 patients of both genders, aged from 19-81 y, with a wide range of mental disorders (F00-F89), and treated in routine ambulatory and hospital practice. The researchers collected data from three sources: medical records, a study questionnaire and biochemical analysis of patients' serum samples (concentration of vitamin D measured as 25(OH)D, calcium, phosphorus, magnesium, sodium and potassium). Data were analyzed using descriptive statistics, methods for hypothesis testing and binary logistic regression, at the p≤0.05 level. A total of 140 patients (64%) had a deficiency of vitamin D (<12 ng/mL), and 45 (20%) had inadequate vitamin D serum levels (12-20 ng/mL), while 35 (16%) had sufficient vitamin D serum concentrations (>20 ng/mL). Among variables related to demographics, life style habits, mental illness, comorbid disorders and drugs, two of them, female gender (odds ratio (OR)=2.5, 95% confidence interval (CI)=1.3-4.9, p=0.006) and using clozapine (OR=15.6, 95% CI 1.7-144.7, p=0.02), were significantly associated with vitamin D deficiency. Physical activity (OR= 0.4, 95% CI 0.2-0.9, p=0.02), exercising (OR=0.2, 95% CI <0.1-0.7, p=0.02) and offal in the diet (OR=0.5, 95% CI 0.3-0.9, p=0.03) significantly aggregated in the patients who had a 25(OH)D serum concentration above the deficiency cut-off level. Patients with mental disorders are at high risk for vitamin D deficiency, particularly females and clozapine users as well as those having no adequate physical activity or dietary habits.

  2. Identifying pain-related concerns in routine follow-up clinics following oral and oropharyngeal cancer

    PubMed Central

    Rogers, Simon N; Cleator, Alexander J; Lowe, Derek; Ghazali, Naseem

    2012-01-01

    AIM: To describe clinical characteristics of head and neck cancer (HNC) patients with pain and those wishing to discuss pain concerns during consultation. METHODS: Cross-sectional, questionnaire study using University of Washington Quality of Life, version 4 (UW-QOL) and the Patients Concerns Inventory (PCI) in disease-free, post-treatment HNC cohort. Significant pain on UW-QOL and indicating “Pain in head and neck” and “Pain elsewhere” on PCI. RESULTS: One hundred and seventy-seven patients completed UW-QOL and PCI. The prevalence of self-reported pain issues was 38% (67/177) comprising 25% (44/177) with significant problems despite medications and 13% (23/177) with lesser or no problems but wishing to discuss pain. Patients aged under 65 years and patients having treatment involving radiotherapy were more likely to have pain issues. Just over half, 55% (24/44) of patients with significant pain did not express a need to discuss this. Those with significant pain or others wanting to discuss pain in clinic had greater problems in physical and social-emotional functioning, reported suboptimal QOL, and also had more additional PCI items to discuss in clinic compared to those without significant pain and not wishing to discuss pain. CONCLUSION: Significant HNC-related pain is prevalent in the disease-free, posttreatment cohort. Onward referral to a specialist pain team may be beneficial. The UW-QOL and PCI package is a valuable tool that may routinely screen for significant pain in outpatient clinics. PMID:22905338

  3. Process mining routinely collected electronic health records to define real-life clinical pathways during chemotherapy.

    PubMed

    Baker, Karl; Dunwoodie, Elaine; Jones, Richard G; Newsham, Alex; Johnson, Owen; Price, Christopher P; Wolstenholme, Jane; Leal, Jose; McGinley, Patrick; Twelves, Chris; Hall, Geoff

    2017-07-01

    There is growing interest in the use of routinely collected electronic health records to enhance service delivery and facilitate clinical research. It should be possible to detect and measure patterns of care and use the data to monitor improvements but there are methodological and data quality challenges. Driven by the desire to model the impact of a patient self-test blood count monitoring service in patients on chemotherapy, we aimed to (i) establish reproducible methods of process-mining electronic health records, (ii) use the outputs derived to define and quantify patient pathways during chemotherapy, and (iii) to gather robust data which is structured to be able to inform a cost-effectiveness decision model of home monitoring of neutropenic status during chemotherapy. Electronic Health Records at a UK oncology centre were included if they had (i) a diagnosis of metastatic breast cancer and received adjuvant epirubicin and cyclosphosphamide chemotherapy or (ii) colorectal cancer and received palliative oxaliplatin and infusional 5-fluorouracil chemotherapy, and (iii) were first diagnosed with cancer between January 2004 and February 2013. Software and a Markov model were developed, producing a schematic of patient pathways during chemotherapy. Significant variance from the assumed care pathway was evident from the data. Of the 535 patients with breast cancer and 420 with colorectal cancer there were 474 and 329 pathway variants respectively. Only 27 (5%) and 26 (6%) completed the planned six cycles of chemotherapy without having unplanned hospital contact. Over the six cycles, 169 (31.6%) patients with breast cancer and 190 (45.2%) patients with colorectal cancer were admitted to hospital. The pathways of patients on chemotherapy are complex. An iterative approach to addressing semantic and data quality issues enabled the effective use of routinely collected patient records to produce accurate models of the real-life experiences of chemotherapy patients and

  4. Clinical utility and cost analysis of routine postoperative head CT in elective aneurysm clippings.

    PubMed

    Zygourakis, Corinna C; Winkler, Ethan; Pitts, Lawrence; Hannegan, Lisa; Franc, Benjamin; Lawton, Michael T

    2017-02-01

    OBJECTIVE Postoperative head CT scanning is performed routinely at the authors' institution on all neurosurgical patients after elective aneurysm clippings. The goal of this study was to determine how often these scans influence medical management and to quantify the associated imaging costs. METHODS The authors reviewed the medical records and accounting database of 304 patients who underwent elective (i.e., nonruptured) aneurysm clipping performed by 1 surgeon (M.T.L.) from 2010 to 2014 at the University of California, San Francisco. Specifically, the total number of postoperative head CT scans, radiographic findings, and the effect of these studies on patient management were determined. The authors obtained the total hospital costs for these patients, including the cost of imaging studies, from the hospital accounting database. RESULTS Overall, postoperative CT findings influenced clinical management in 3.6% of cases; specifically, they led to permissive hypertension in 4 patients for possible ischemia, administration of mannitol for edema and high-flow oxygen for pneumocephalus in 2 patients each, seizure prophylaxis in 1 patient, Plavix readjustment in 1 patient, and return to the operating room for an asymptomatic epidural hematoma evacuation in 1 patient. When patients were stratified on the basis of postoperative neurological examination, findings on CT scans altered management in 1.1%, 4.8%, and 9.0% of patients with no new neurological deficits, a nonfocal examination, and focal deficits, respectively. The mean total hospital cost for treating patients who undergo elective aneurysm clipping was $72,227 (± $53,966) (all values are US dollars), and the cost of obtaining a noncontrast head CT scan was $292. Neurologically intact patients required 99 head CT scans, at a cost of $28,908, to obtain 1 head CT scan that influenced medical management. In contrast, patients with a focal neurological deficit required only 11 head CT scans, at a cost of $3212, to

  5. A virtual asthma clinic for children: fewer routine outpatient visits, same asthma control.

    PubMed

    van den Wijngaart, Lara S; Roukema, Jolt; Boehmer, Annemie L M; Brouwer, Marianne L; Hugen, Cindy A C; Niers, Laetitia E M; Sprij, Arwen J; Rikkers-Mutsaerts, Eleonora R V M; Rottier, Bart L; Donders, A Rogier T; Verhaak, Chris M; Pijnenburg, Mariëlle W; Merkus, Peter J F M

    2017-10-01

    eHealth is an appealing medium to improve healthcare and its value (in addition to standard care) has been assessed in previous studies. We aimed to assess whether an eHealth intervention could improve asthma control while reducing 50% of routine outpatient visits.In a multicentre, randomised controlled trial with a 16-month follow-up, asthmatic children (6-16 years) treated in eight Dutch hospitals were randomised to usual care (4-monthly outpatient visits) and online care using a virtual asthma clinic (VAC) (8-monthly outpatient visits with monthly web-based monitoring). Outcome measures were the number of symptom-free days in the last 4 weeks of the study, asthma control, forced expiratory volume in 1 s, exhaled nitric oxide fraction, asthma exacerbations, unscheduled outpatient visits, hospital admissions, daily dose of inhaled corticosteroids and courses of systemic corticosteroids.We included 210 children. After follow-up, symptom-free days differed statistically between the usual care and VAC groups (difference of 1.23 days, 95% CI 0.42-2.04; p=0.003) in favour of the VAC. In terms of asthma control, the Childhood Asthma Control Test improved more in the VAC group (difference of 1.17 points, 95% CI 0.09-2.25; p=0.03). No differences were found for other outcome measures.Routine outpatient visits can partly be replaced by monitoring asthmatic children via eHealth. Copyright ©ERS 2017.

  6. Look what else we found - clinically significant abnormalities detected during routine ROP screening

    PubMed Central

    Jayadev, Chaitra; Vinekar, Anand; Bauer, Noel; Mangalesh, Shwetha; Mahendradas, Padmamalini; Kemmanu, Vasudha; Mallipatna, Ashwin; Shetty, Bhujang

    2015-01-01

    Purpose: The purpose of this study was to report the spectrum of anterior and posterior segment diagnoses in Asian Indian premature infants detected serendipitously during routine retinopathy of prematurity (ROP) screening during a 1 year period. Methods: A retrospective review of all Retcam (Clarity MSI, USA) imaging sessions during the year 2011 performed on infants born either <2001 g at birth and/or <34.1 weeks of gestation recruited for ROP screening was performed. All infants had a minimum of seven images at each session, which included the dilated anterior segment, disc, and macula center and the four quadrants using the 130° lens. Results: Of the 8954 imaging sessions of 1450 new infants recruited in 2011, there were 111 (7.66%) with a diagnosis other than ROP. Anterior segment diagnoses seen in 31 (27.9%) cases included clinically significant cataract, lid abnormalities, anophthalmos, microphthalmos, and corneal diseases. Posterior segment diagnoses in 80 (72.1%) cases included retinal hemorrhages, cherry red spots, and neonatal uveitis of infective etiologies. Of the 111 cases, 15 (13.5%) underwent surgical procedures and 24 (21.6%) underwent medical procedures; importantly, two eyes with retinoblastoma were detected which were managed timely. Conclusions: This study emphasizes the importance of ocular digital imaging in premature infants. Visually significant, potentially life-threatening, and even treatable conditions were detected serendipitously during routine ROP screening that may be missed or detected late otherwise. This pilot data may be used to advocate for a possible universal infant eye screening program using digital imaging. PMID:26139795

  7. Implementation and spread of interventions into the multilevel context of routine practice and policy: implications for the cancer care continuum.

    PubMed

    Yano, Elizabeth M; Green, Lawrence W; Glanz, Karen; Ayanian, John Z; Mittman, Brian S; Chollette, Veronica; Rubenstein, Lisa V

    2012-05-01

    The promise of widespread implementation of efficacious interventions across the cancer continuum into routine practice and policy has yet to be realized. Multilevel influences, such as communities and families surrounding patients or health-care policies and organizations surrounding provider teams, may determine whether effective interventions are successfully implemented. Greater recognition of the importance of these influences in advancing (or hindering) the impact of single-level interventions has motivated the design and testing of multilevel interventions designed to address them. However, implementing research evidence from single- or multilevel interventions into sustainable routine practice and policy presents substantive challenges. Furthermore, relatively few multilevel interventions have been conducted along the cancer care continuum, and fewer still have been implemented, disseminated, or sustained in practice. The purpose of this chapter is, therefore, to illustrate and examine the concepts underlying the implementation and spread of multilevel interventions into routine practice and policy. We accomplish this goal by using a series of cancer and noncancer examples that have been successfully implemented and, in some cases, spread widely. Key concepts across these examples include the importance of phased implementation, recognizing the need for pilot testing, explicit engagement of key stakeholders within and between each intervention level; visible and consistent leadership and organizational support, including financial and human resources; better understanding of the policy context, fiscal climate, and incentives underlying implementation; explication of handoffs from researchers to accountable individuals within and across levels; ample integration of multilevel theories guiding implementation and evaluation; and strategies for long-term monitoring and sustainability.

  8. Clinical routine operation of a filmless radiology department: three years experience

    NASA Astrophysics Data System (ADS)

    Mosser, Hans M.; Paertan, Gerald; Hruby, Walter

    1995-05-01

    This paper communicates the operational implementation of filmless digital radiology in clinical routine, its feasibility and its effect on the radiology profession, based on the three years clinical experience from the filmless digital radiology department of the Danube Hospital, a major teaching hospital in Vienna, Austria, with currently 850 acute-care beds. Since April 1992 all radiological modalities are reported from the monitors of 16 reporting consoles in the radiology department. Images and reports are distributed by the hospital-wide network (Sienet, Siemens Medical Systems, Erlangen), and can be viewed on 60 display consoles throughout the hospital. Filmless radiology primarily is an efficient hospital-wide infrastructure to deliver radiological services along with other medical information, providing safe and fast access to this information anytime and anywhere, necessary for the conduct of the diagnostic and therapeutic task of patient care. In a comparative study of the Danube Hospital with the film based Rudolfstiftung Hospital in Vienna, we found a significant decrease of the mean patient length of hospital stay (1.99 to 3.72 days) that partially might be attributed to the implementation of filmless radiology.

  9. Diagnostic implications of TERT promoter mutation status in diffuse gliomas in a routine clinical setting.

    PubMed

    Hewer, Ekkehard; Prebil, Nadine; Berezowska, Sabina; Gutt-Will, Marielena; Schucht, Philippe; Dettmer, Matthias S; Vassella, Erik

    2017-08-19

    IDH (isocitrate dehydrogenase) gene mutations are present in most diffuse low-grade gliomas and define the clinico-pathological core of the respective morphologically defined entities. Conversely, according to the 2016 WHO classification, the majority of glioblastomas belong to the IDH-wildtype category, which is defined by exclusion. TERT (telomerase reverse transcriptase gene) promoter mutations have been suggested as a molecular marker for primary glioblastomas. We analyzed molecular, histopathological, and clinical profiles of a series of 110 consecutive diffuse gliomas (WHO grades II-IV) diagnosed at our institution, in which TERT promoter mutation analysis had been performed as part of diagnostic work-up. A diagnostic algorithm based on IDH, TERT, ATRX, H3F3A, and 1p19q co-deletion status resulted in a consistent molecular classification with only 14 (13%) marker-negative tumors. TERT promoter mutations were present in 77% of IDH-wildtype tumors. The TERT/IDH-wildtype category was highly enriched for tumors with unconventional clinical or histological features. Molecular classes were associated with distinct rates of MGMT promoter methylation. We conclude that, in a routine diagnostic setting, TERT promoter mutations define a relatively homogeneous core group among IDH-wildtype diffuse gliomas that includes the majority of primary glioblastomas as well as their putative precursor lesions.

  10. Adherence with urate-lowering therapies among male patients with gout in a routine clinical setting.

    PubMed

    Lee, Sunggun; So, Min Wook

    2016-11-01

    To assess adherence (compliance and persistence) and factors that might contribute to nonadherence to urate-lowering therapies (ULT) in patients with gout in a routine clinical setting. This prospective observational cohort study was conducted in the rheumatology center of a local tertiary hospital. A total of 132 male adults aged 75 years or younger who were incidentally diagnosed with gout were included. Adherence to ULT was assessed by the clinic nurses through pill counts. Of the 132 patients, 94 (71.2%) was compliant and 81 (61.4%) was persistent with ULT. The logistic regression analysis revealed that the absence of chronic kidney disease (CKD) and the previous history of non-persistence with ULT are the independent factors associated with noncompliance and the absence of CKD is an independent factor associated with non-persistence. The average serum urate levels of the noncompliant (p = 0.001) and non-persistent (p = 0.002) patients were significantly higher than those of the compliant and persistent patients. The absence of CKD and the previous history of non-persistence of ULT that are correlated with poor adherence and easily assessed can be used to identify patients at a particular risk of poor adherence.

  11. Translating Delirium Prevention Strategies for Elderly Adults with Hip Fracture into Routine Clinical Care: A Pragmatic Clinical Trial.

    PubMed

    Freter, Susan; Koller, Katalin; Dunbar, Michael; MacKnight, Chris; Rockwood, Kenneth

    2017-03-01

    To compare the feasibility (adherence) and effectiveness (prevalence of delirium, length of stay, mortality, discharge site) of delirium-friendly preprinted postoperative orders (PPOs) for individuals with hip fracture, administered by regular orthopedic nurses, with routine postoperative orders. Pragmatic clinical trial to evaluate a quality improvement intervention. Tertiary care hospital. Individuals aged 65 and older admitted for hip fracture repair (N = 283). PPOs with delirium-friendly options and doses for nighttime sedation, analgesia, and nausea and attention to catheter removal and bowel movements. Adherence to PPO was compared with adherence to routine orders. Drug doses were recorded. Presence of delirium was documented using the Confusion Assessment Method and the Mini-Mental State Examination on postoperative Days 1, 3, and 5. Length of stay, discharge site, and in-hospital mortality were recorded. Orthopedic nurses adhered reasonably well with delirium-friendly PPOs. Of 283 participants, 42% developed postoperative delirium, with significantly less delirium in the intervention group (intervention 33%, control 51%, P = .001). The effect of the intervention was stronger in individuals with preexisting dementia (intervention 60%, control 97%, P < .001). Participants with postoperative delirium had longer hospital stays and were more likely to die or be discharged to a nursing home, but there was no significant between-group difference in these outcomes. It is possible to introduce delirium-friendly PPOs into routine post-hip fracture care in a representative elderly population including individuals with dementia. Delirium-friendly PPOs executed by regular nursing staff resulted in a significant reduction in postoperative delirium but no difference in other outcomes. © 2016 The Authors. The Journal of the American Geriatrics Society published by Wiley Periodicals, Inc. on behalf of The American Geriatrics Society.

  12. Healthcare Provider Attitudes, Practices, and Recommendations for Enhancing Routine HIV Testing and Linkage to Care in the Mississippi Delta Region

    PubMed Central

    Sison, Nathan; Yolken, Annajane; Poceta, Joanna; Mena, Leandro; Chan, Philip A.; Barnes, Arti; Smith, Erin

    2013-01-01

    Abstract The Mississippi Delta region is one of the communities most heavily impacted by HIV/AIDS in the United States. To understand local provider attitudes and practices regarding HIV testing and care, we conducted 25 in-depth qualitative interviews with local primary care providers and infectious disease specialists. Interviews explored attitudes and practices regarding HIV testing and linkage to care. Most providers did not routinely offer HIV testing, noting financial barriers, financial disincentives to offer routine screening, misperceptions about local informed consent laws, perceived stigma among patients, and belief that HIV testing was the responsibility of the health department. Barriers to enhancing treatment and care included stigma, long distances, lack of transportation, and paucity of local infectious disease specialists. Opportunities for enhancing HIV testing and care included provider education programs regarding billing, local HIV testing guidelines, and informed consent, as well as telemedicine services for underserved counties. Although most health care providers in our study did not currently offer routine HIV testing, all were willing to provide more testing and care services if they were able to bill for routine testing. Increasing financial reimbursement and access to care, including through the Affordable Care Act, may provide an opportunity to enhance HIV/AIDS services in the Mississippi Delta. PMID:23991689

  13. Healthcare provider attitudes, practices, and recommendations for enhancing routine HIV testing and linkage to care in the Mississippi Delta region.

    PubMed

    Sison, Nathan; Yolken, Annajane; Poceta, Joanna; Mena, Leandro; Chan, Philip A; Barnes, Arti; Smith, Erin; Nunn, Amy

    2013-09-01

    The Mississippi Delta region is one of the communities most heavily impacted by HIV/AIDS in the United States. To understand local provider attitudes and practices regarding HIV testing and care, we conducted 25 in-depth qualitative interviews with local primary care providers and infectious disease specialists. Interviews explored attitudes and practices regarding HIV testing and linkage to care. Most providers did not routinely offer HIV testing, noting financial barriers, financial disincentives to offer routine screening, misperceptions about local informed consent laws, perceived stigma among patients, and belief that HIV testing was the responsibility of the health department. Barriers to enhancing treatment and care included stigma, long distances, lack of transportation, and paucity of local infectious disease specialists. Opportunities for enhancing HIV testing and care included provider education programs regarding billing, local HIV testing guidelines, and informed consent, as well as telemedicine services for underserved counties. Although most health care providers in our study did not currently offer routine HIV testing, all were willing to provide more testing and care services if they were able to bill for routine testing. Increasing financial reimbursement and access to care, including through the Affordable Care Act, may provide an opportunity to enhance HIV/AIDS services in the Mississippi Delta.

  14. Rapid Methods for Routine Frailty Assessment During Vascular Surgery Clinic Visits.

    PubMed

    Mirabelli, Luke G; Cosker, Robert M; Kraiss, Larry W; Griffin, Claire L; Smith, Brigitte K; Sarfati, Mark R; Al-Dulaimi, Ragheed; Brooke, Benjamin S

    2017-09-05

    Frailty assessment can help vascular surgeons predict perioperative risk and long term mortality for their patients. Unfortunately, comprehensive frailty assessments take too long to integrate into clinic workflow. This study was designed to evaluate 2 rapid methods for assessing frailty during vascular clinics-a short patient-reported survey and a provider-reported frailty scale. We prospectively enrolled 159 patients presenting to an academic medical center vascular surgery clinic between May-November 2016. Patients underwent frailty assessment using 2 rapid methods: (1) the Frail Non-Disabled (FiND) survey (5 questions) and (2) the Clinical Frailty Scale (CFS; 9-point scale from robust to severely frail). These were followed by administering the Fried Index, a validated frailty assessment method with 5 measures (weight loss, exhaustion, grip strength, walking speed, and activity level). The correlation between Fried scores (reference standard) with frailty diagnoses derived from FiND and CFS was analyzed using the Spearman-rank test, Cohen's kappa, sensitivity/specificity tests and receiver operating curves. The evaluated cohort included 87 (55%) females, a mean age of 61 years, 126 (79%) preoperative patients, and 32 (20%) categorized as frail using the Fried Index criteria. The FiND survey was very sensitive (91%), but less specific for diagnosing frailty. In comparison, the CFS was highly specific (96%) for diagnosing frailty and exhibited high inter-rater reliability between surgeon and medical assistant scores (kappa: 0.79) (95% CI: 0.72-0.87; P < 0.001). There was moderate correlation between frailty assigned using the Fried Index and the CFS (rho: 0.41-0.44). Frailty can be quickly and effectively assessed during vascular surgery clinic using a combination of patient-reported (FiND) and provider-reported (CFS) methods to improve diagnostic accuracy. Implementing routine frailty assessment into clinic workflow can be a valuable tool for risk

  15. Promoting Early Literacy via Practicing Invented Spelling: A Comparison of Different Mediation Routines

    ERIC Educational Resources Information Center

    Levin, Iris; Aram, Dorit

    2013-01-01

    The present study compared the effects of different mediation routines provided to kindergartners from families of low socioeconomic status on the students' invented spelling attempts and on their gains obtained on spelling and other early literacy skills (letter naming, sounds of letters, word segmentation, and word decoding). The effects of the…

  16. Ecological Congruence Assessment for Classroom Activities and Routines: Identifying Goals and Intervention Practices in Childcare.

    ERIC Educational Resources Information Center

    Wolery, Mark; Brashers, Margaret Sigalove; Neitzel, Jennifer C.

    2002-01-01

    This article explains how educators can use the ecological congruence assessment process for identifying functional goals for young children with disabilities. Process steps include: teacher collects information about functioning in usual classroom activities, routines, and transitions; summarizes the collected information; and shares the…

  17. Step 6: Does Not Routinely Employ Practices, Procedures Unsupported by Scientific Evidence

    PubMed Central

    Goer, Henci; Sagady Leslie, Mayri; Romano, Amy

    2007-01-01

    Step 6 of the Ten Steps of Mother-Friendly Care addresses two issues: 1) the routine use of interventions (shaving, enemas, intravenous drips, withholding food and fluids, early rupture of membranes, and continuous electronic fetal monitoring; and 2) the optimal rates of induction, episiotomy, cesareans, and vaginal births after cesarean. Rationales for compliance and systematic reviews are presented. PMID:18523680

  18. Promoting Early Literacy via Practicing Invented Spelling: A Comparison of Different Mediation Routines

    ERIC Educational Resources Information Center

    Levin, Iris; Aram, Dorit

    2013-01-01

    The present study compared the effects of different mediation routines provided to kindergartners from families of low socioeconomic status on the students' invented spelling attempts and on their gains obtained on spelling and other early literacy skills (letter naming, sounds of letters, word segmentation, and word decoding). The effects of the…

  19. Tracking post-infectious fatigue in clinic using routine Lab tests.

    PubMed

    Harvey, Jeanna M; Broderick, Gordon; Bowie, Alanna; Barnes, Zachary M; Katz, Ben Z; O'Gorman, Maurice R G; Vernon, Suzanne D; Fletcher, Mary Ann; Klimas, Nancy G; Taylor, Renee

    2016-04-26

    While biomarkers for chronic fatigue syndrome (CFS) are beginning to emerge they typically require a highly specialized clinical laboratory. We hypothesized that subsets of commonly measured laboratory markers used in combination could support the diagnosis of post-infectious CFS (PI-CFS) in adolescents following infectious mononucleosis (IM) and help determine who might develop persistence of symptoms. Routine clinical laboratory markers were collected prospectively in 301 mono-spot positive adolescents, 4 % of whom developed CFS (n = 13). At 6, 12, and 24 months post-diagnosis with IM, 59 standard tests were performed including metabolic profiling, liver enzyme panel, hormone profiles, complete blood count (CBC), differential white blood count (WBC), salivary cortisol, and urinalysis. Classification models separating PI-CFS from controls were constructed at each time point using stepwise subset selection. Lower ACTH levels at 6 months post-IM diagnosis were highly predictive of CFS (AUC p = 0.02). ACTH levels in CFS overlapped with healthy controls at 12 months, but again showed a trend towards a deficiency at 24 months. Conversely, estradiol levels depart significantly from normal at 12 months only to recover at 24 months (AUC p = 0.02). Finally, relative neutrophil count showed a significant departure from normal at 24 months in CFS (AUC p = 0.01). Expression of these markers evolved differently over time between groups. Preliminary results suggest that serial assessment of stress and sex hormones as well as the relative proportion of innate immune cells measured using standard clinical laboratory tests may support the diagnosis of PI-CFS in adolescents with IM.

  20. Diagnostics of Inherited Bleeding Disorders of Secondary Hemostasis: An Easy Guide for Routine Clinical Laboratories.

    PubMed

    Lippi, Giuseppe; Franchini, Massimo; Favaloro, Emmanuel J

    2016-07-01

    The investigation of inherited bleeding disorders of secondary hemostasis remains a challenge for most clinical laboratories, especially those that lack experience or specialized personnel. Bleeding can be essentially caused by a variety of acquired or congenital conditions, which impair either primary or secondary hemostasis. Since a universally agreed approach for the diagnostics of hemorrhagic disorders is still unavailable, this article aims to provide an easy guidance for routine clinical laboratories. This pragmatic approach to identifying and diagnosing inherited bleeding disorders of secondary hemostasis entails a multifaceted strategy, based on a collection of personal and family history, the results of first-line tests, which can then be followed by second- or third-line analyses to definitely establish the specific nature and the severity of the bleeding phenotype. Briefly, the presence of profound hemorrhages rather than mucocutaneous bleeding is suggestive of a disorder of secondary hemostasis. Although a positive family history is frequently reported in patients with congenital conditions, the lack of clinically meaningful symptoms in patient's relatives is not absolutely indicative of an acquired disorder. The next step encompasses the assessment of first-line coagulation tests (i.e., prothrombin time, activated partial thromboplastin time, and fibrinogen) if family history is not suggestive of a specific factor deficiency. The emergence of abnormal data of these assays and the variable combination of their results is then helpful to guide the performance of second-line tests, in particular specific factor assays, which will then provide a reasonable basis for a preliminary diagnosis. Third-line tests (namely, immunological assays of clotting factors and molecular biology) are then supportive for a final diagnosis and for identifying the nature of the factor deficiency (i.e., quantitative or functional). Thieme Medical Publishers 333 Seventh Avenue

  1. Clinical Instruction for Professional Practice

    ERIC Educational Resources Information Center

    Gardner, Greg; Sexton, Patrick; Guyer, M. Susan; Willeford, K. Sean; Levy, Linda S.; Barnum, Mary G.; Fincher, A. Louise

    2009-01-01

    Objective: To present the principles of adult learning and mentoring to help clinical instructors better educate athletic training students (ATSs) during their clinical experiences, with the end result being a better prepared, competent entry-level practitioner. Background: The principles of adult learning must be applied to ATS clinical education…

  2. Clinical Instruction for Professional Practice

    ERIC Educational Resources Information Center

    Gardner, Greg; Sexton, Patrick; Guyer, M. Susan; Willeford, K. Sean; Levy, Linda S.; Barnum, Mary G.; Fincher, A. Louise

    2009-01-01

    Objective: To present the principles of adult learning and mentoring to help clinical instructors better educate athletic training students (ATSs) during their clinical experiences, with the end result being a better prepared, competent entry-level practitioner. Background: The principles of adult learning must be applied to ATS clinical education…

  3. A feasibility study using geographic access to general practices and routinely collected data in public health and health services research.

    PubMed

    Chong, Shanley; Byun, Roy; Jalaludin, Bin B

    2015-09-30

    Advances in geographic information systems (GIS) and increased availability of routinely collected data have the potential to contribute to public health and health services research. The aim of this feasibility study was to explore the use of GIS to measure access to general practices and its relationship to selected antenatal behaviours. We obtained the Perinatal Data Collection, 2004-2008, for South Western Sydney Local Health District from the New South Wales Ministry of Health. Using a GIS, we generated circular and polygon-based 1 km and 2 km road network buffers from a maternal residential address and then calculated the number of general practices within those buffers (density measures). Distances to general practices from maternal residences were also calculated in the GIS as another measure of geographic access to general practices (proximity measures). We used generalised estimating equations logistic regression to examine associations between access to general practices, and smoking during pregnancy and late first antenatal visit. The numbers of general practices within circular buffers were significantly greater than within polygon-based road network buffers. The average distance to the five closest general practices from a mother's residence was 2.3 km ± 3.0 km (median 1.4 km, range 0.05 km to 40.0 km). For two of the five measures of access, a higher number of general practices was associated with increased risk for late first antenatal visit. However, the associations were weak, with odds ratios very close to unity. Choice of metrics of geographic access to general practices did not alter the associations with smoking during pregnancy or late first antenatal visit. GIS can be used to quantify measures of geographic access to health services for public health and health services research. Geographic access to general practices was generally not associated with smoking during pregnancy or late first antenatal visit. GIS and routinely collected health

  4. Implementation of Cognitive Therapy for PTSD in routine clinical care: Effectiveness and moderators of outcome in a consecutive sample☆

    PubMed Central

    Ehlers, Anke; Grey, Nick; Wild, Jennifer; Stott, Richard; Liness, Sheena; Deale, Alicia; Handley, Rachel; Albert, Idit; Cullen, Deborah; Hackmann, Ann; Manley, John; McManus, Freda; Brady, Francesca; Salkovskis, Paul; Clark, David M.

    2013-01-01

    Objective Trauma-focused psychological treatments are recommended as first-line treatments for Posttraumatic Stress Disorder (PTSD), but clinicians may be concerned that the good outcomes observed in randomized controlled trials (RCTs) may not generalize to the wide range of traumas and presentations seen in clinical practice. This study investigated whether Cognitive Therapy for PTSD (CT-PTSD) can be effectively implemented into a UK National Health Service Outpatient Clinic serving a defined ethnically mixed urban catchment area. Method A consecutive sample of 330 patients with PTSD (age 17–83) following a wide range of traumas were treated by 34 therapists, who received training and supervision in CT-PTSD. Pre and post treatment data (PTSD symptoms, anxiety, depression) were collected for all patients, including dropouts. Hierarchical linear modeling investigated candidate moderators of outcome and therapist effects. Results CT-PTSD was well tolerated and led to very large improvement in PTSD symptoms, depression and anxiety. The majority of patients showed reliable improvement/clinically significant change: intent-to-treat: 78.8%/57.3%; completer: 84.5%/65.1%. Dropouts and unreliable attenders had worse outcome. Statistically reliable symptom exacerbation with treatment was observed in only 1.2% of patients. Treatment gains were maintained during follow-up (M = 280 days, n = 220). Few of the selection criteria used in some RCTs, demographic, diagnostic and trauma characteristics moderated treatment outcome, and only social problems and needing treatment for multiple traumas showed unique moderation effects. There were no random effects of therapist on symptom improvement, but therapists who were inexperienced in CT-PTSD had more dropouts than those with greater experience. Conclusions The results support the effectiveness of CT-PTSD and suggest that trauma-focused cognitive behavior therapy can be successfully implemented in routine clinical services

  5. Including Identity in Clinical Practices

    ERIC Educational Resources Information Center

    Hagstrom, Fran

    2004-01-01

    This article adds qualitative analyses to established practices in speech-language pathology to demonstrate how clinicians can work with identity. Interview material is used to illustrate established analytical practices. This same material is again analyzed from the perspective of identity using the Functional Individual Systems (FIS) framework,…

  6. Next generation sequencing--implications for clinical practice.

    PubMed

    Raffan, Eleanor; Semple, Robert K

    2011-01-01

    Genetic testing in inherited disease has traditionally relied upon recognition of the presenting clinical syndrome and targeted analysis of genes known to be linked to that syndrome. Consequently, many patients with genetic syndromes remain without a specific diagnosis. New 'next-generation' sequencing (NGS) techniques permit simultaneous sequencing of enormous amounts of DNA. A slew of research publications have recently demonstrated the tremendous power of these technologies in increasing understanding of human genetic disease. These approaches are likely to be increasingly employed in routine diagnostic practice, but the scale of the genetic information yielded about individuals means that caution must be exercised to avoid net harm in this setting. Use of NGS in a research setting will increasingly have a major but indirect beneficial impact on clinical practice. However, important technical, ethical and social challenges need to be addressed through informed professional and public dialogue before it finds its mature niche as a direct tool in the clinical diagnostic armoury.

  7. Procedures for Using Clinical Practice Guidelines

    ERIC Educational Resources Information Center

    Hargrove, Patricia; Griffer, Mona; Lund, Bonnie

    2008-01-01

    Purpose: This article provides information about clinical practice guidelines (CPGs) to facilitate their application to the practice of speech-language pathology. CPGs are sets of recommendations based on evidence, including expert clinical opinion, that have been developed by a panel of reviewers. In this article, CPGs are defined and their…

  8. Should we reconsider the routine use of placebo controls in clinical research?

    PubMed Central

    2012-01-01

    Background Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. Methods We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. Results We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Conclusions Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions. PMID:22540350

  9. The Quality of Clinical Maternal and Neonatal Healthcare – A Strategy for Identifying ‘Routine Care Signal Functions’

    PubMed Central

    Brenner, Stephan; De Allegri, Manuela; Gabrysch, Sabine; Chinkhumba, Jobiba; Sarker, Malabika; Muula, Adamson S.

    2015-01-01

    Background A variety of clinical process indicators exists to measure the quality of care provided by maternal and neonatal health (MNH) programs. To allow comparison across MNH programs in low- and middle-income countries (LMICs), a core set of essential process indicators is needed. Although such a core set is available for emergency obstetric care (EmOC), the ‘EmOC signal functions’, a similar approach is currently missing for MNH routine care evaluation. We describe a strategy for identifying core process indicators for routine care and illustrate their usefulness in a field example. Methods We first developed an indicator selection strategy by combining epidemiological and programmatic aspects relevant to MNH in LMICs. We then identified routine care process indicators meeting our selection criteria by reviewing existing quality of care assessment protocols. We grouped these indicators into three categories based on their main function in addressing risk factors of maternal or neonatal complications. We then tested this indicator set in a study assessing MNH quality of clinical care in 33 health facilities in Malawi. Results Our strategy identified 51 routine care processes: 23 related to initial patient risk assessment, 17 to risk monitoring, 11 to risk prevention. During the clinical performance assessment a total of 82 cases were observed. Birth attendants’ adherence to clinical standards was lowest in relation to risk monitoring processes. In relation to major complications, routine care processes addressing fetal and newborn distress were performed relatively consistently, but there were major gaps in the performance of routine care processes addressing bleeding, infection, and pre-eclampsia risks. Conclusion The identified set of process indicators could identify major gaps in the quality of obstetric and neonatal care provided during the intra- and immediate postpartum period. We hope our suggested indicators for essential routine care processes

  10. Prospective evaluation of the VITEK MS for the routine identification of bacteria and yeast in the clinical microbiology laboratory: assessment of accuracy of identification and turnaround time.

    PubMed

    Charnot-Katsikas, Angella; Tesic, Vera; Boonlayangoor, Sue; Bethel, Cindy; Frank, Karen M

    2014-02-01

    This study assessed the accuracy of bacterial and yeast identification using the VITEK MS, and the time to reporting of isolates before and after its implementation in routine clinical practice. Three hundred and sixty-two isolates of bacteria and yeast, consisting of a variety of clinical isolates and American Type Culture Collection strains, were tested. Results were compared with reference identifications from the VITEK 2 system and with 16S rRNA sequence analysis. The VITEK MS provided an acceptable identification to species level for 283 (78 %) isolates. Considering organisms for which genus-level identification is acceptable for routine clinical care, 315 isolates (87 %) had an acceptable identification. Six isolates (2 %) were identified incorrectly, five of which were Shigella species. Finally, the time for reporting the identifications was decreased significantly after implementation of the VITEK MS for a total mean reduction in time of 10.52 h (P<0.0001). Overall, accuracy of the VITEK MS was comparable or superior to that from the VITEK 2. The findings were also comparable to other studies examining the accuracy of the VITEK MS, although differences exist, depending on the diversity of species represented as well as on the versions of the databases used. The VITEK MS can be incorporated effectively into routine use in a clinical microbiology laboratory and future expansion of the database should provide improved accuracy for the identification of micro-organisms.

  11. Routine conventional karyotyping of lymphoma staging bone marrow samples does not contribute clinically relevant information.

    PubMed

    Nardi, Valentina; Pulluqi, Olja; Abramson, Jeremy S; Dal Cin, Paola; Hasserjian, Robert P

    2015-06-01

    Bone marrow (BM) evaluation is an important part of lymphoma staging, which guides patient management. Although positive staging marrow is defined as morphologically identifiable disease, such samples often also include flow cytometric analysis and conventional karyotyping. Cytogenetic analysis is a labor-intensive and costly procedure and its utility in this setting is uncertain. We retrospectively reviewed pathological reports of 526 staging marrow specimens in which conventional karyotyping had been performed. All samples originated from a single institution from patients with previously untreated Hodgkin and non-Hodgkin lymphomas presenting in an extramedullary site. Cytogenetic analysis revealed clonal abnormalities in only eight marrow samples (1.5%), all of which were positive for lymphoma by morphologic evaluation. Flow cytometry showed a small clonal lymphoid population in three of the 443 morphologically negative marrow samples (0.7%). Conventional karyotyping is rarely positive in lymphoma staging marrow samples and, in our cohort, the BM karyotype did not contribute clinically relevant information in the vast majority of cases. Our findings suggest that karyotyping should not be performed routinely on BM samples taken to stage previously diagnosed extramedullary lymphomas unless there is pathological evidence of BM involvement by lymphoma. © 2015 Wiley Periodicals, Inc.

  12. Tissue spectrophotometry and thermographic imaging applied to routine clinical prediction of amputation level viability

    NASA Astrophysics Data System (ADS)

    Hanson, Jon M.; Harrison, David K.; Hawthorn, Ian E.

    2002-06-01

    About 5% of British males over 50 years develop peripheral arterial occlusive disease. Of these about 2% ultimately require lower limb amputation. In 1995 we proposed a new technique using lightguide spectrophotometry to measure the oxygen saturation level of haemoglobin (SO2) in the skin as a method for predicting tissue viability. This technique, in combination with thermographic imaging, was compared with skin blood flow measurements using the I125)4- Iodoantipyrine (IAP) clearance technique. The optical techniques gave a sensitivity and selectivity of 1.0 for the prediction of successful outcome of a below knee amputation compared with a specificity of 93% using the traditional IAP technique at a below knee to above knee amputation ratio (BKA:AKA) of 75%. The present study assesses the routine clinical application of these optical techniques. The study is ongoing, but the data to date comprises 22 patients. 4 patients were recommended for above knee amputation (AKA) and 18 patients for below knee amputation on the basis of thermographic and tissue SO2 measurements. All but one of the predicted BKA amputations healed. The study to date produces evidence of 94% healing rate (specificity) for a BKA:AKA ratio of 82%. This compares favorably with the previous figures given above.

  13. Evaluation of the automated phoenix system for potential routine use in the clinical microbiology laboratory.

    PubMed

    Donay, J-L; Mathieu, D; Fernandes, P; Prégermain, C; Bruel, P; Wargnier, A; Casin, I; Weill, F X; Lagrange, P H; Herrmann, J L

    2004-04-01

    A comparative study was designed to evaluate the identification (ID) and antimicrobial susceptibility testing (AST) performances of the BD Phoenix Automated Microbiology System (Becton Dickinson Diagnostic Systems [BD], Pont de Claix, France). A total of 305 single clinical isolates were collected, and comparisons were made with routine manual methods in use in our microbiology laboratories. The percentages of correct IDs were 93.3, 89.4, 91.8, and 85.7% for enterobacteria, nonfermenting gram-negative bacilli, staphylococci, and streptococci-enterococci, respectively. The median ID time was 3 h, and the median time for AST was 10 h 30 min. AST results showed variable percentages of errors for the different antibiotics. None of the enterobacteria and 0.3% of Pseudomonas aeruginosa isolates showed a very major error (VME). Only one strain of Staphylococcus aureus showed a VME with oxacillin. We demonstrate here the efficiency of the Phoenix system, which can be used for the majority of strains encountered in a university-based laboratory, for ID and AST.

  14. Physicians' views and experiences of discussing weight management within routine clinical consultations: A thematic synthesis.

    PubMed

    Dewhurst, Anne; Peters, Sarah; Devereux-Fitzgerald, Angela; Hart, Jo

    2017-05-01

    To systematically search and synthesise qualitative studies of physicians' views and experiences of discussing weight management within a routine consultation. A systematic search of four electronic databases identified 11,169 articles of which 16 studies met inclusion criteria. Quality was appraised using the Critical Appraisal Skills Programme tool and a thematic synthesis conducted of extracted data. Four analytical themes were found: (1) physicians' pessimism about patients' weight loss success (2) physicians' feel hopeless and frustrated (3) the dual nature of the physician-patient relationship (4) who should take responsibility for weight management. Despite clinical recommendations barriers remain during consultations between physicians and patients about weight management. Many of these barriers are potentially modifiable. Improving training, providing clearer guidelines and placing a greater emphasis on collaboration within and between clinicians will help reduce barriers for both physicians and patients. In particular, there is an urgent need for more specialised training for physicians about weight management to promote knowledge and skills in behaviour change techniques and ways to broach sensitive topics without damaging patient relationships. Crown Copyright © 2017. Published by Elsevier B.V. All rights reserved.

  15. Magnetic resonance imaging biomarkers for clinical routine assessment of microvascular architecture in glioma.

    PubMed

    Stadlbauer, Andreas; Zimmermann, Max; Heinz, Gertraud; Oberndorfer, Stefan; Doerfler, Arnd; Buchfelder, Michael; Rössler, Karl

    2017-02-01

    Knowledge about the topological and structural heterogeneity of the microvasculature is important for diagnosis and monitoring of glioma. A vessel caliber and type-dependent temporal shift in the magnetic resonance imaging signal forms the basis for vascular architecture mapping. This study introduced a clinically feasible approach for assessment of vascular pathologies in gliomas using vascular architecture mapping. Sixty consecutive patients with known or suspected gliomas were examined using vascular architecture mapping as part of the routine magnetic resonance imaging protocol. Maps of microvessel radius and density, which adapted to the vasculature-dependent temporal shift phenomenon, were calculated using a costume-made software tool. Microvessel radius and density were moderately to severely elevated in a heterogeneous, inversely correlated pattern within high-grade gliomas. Additionally, three new imaging biomarkers were introduced: Microvessel type indicator allowing differentiation between supplying arterial and draining venous microvasculature in high-grade gliomas. Vascular-induced bolus peak time shift may presumably be sensitive for early neovascularization in the infiltration zone. Surprisingly, curvature showed significant changes in peritumoral vasogenic edema which correlated with neovascularization in the tumor core of high-grade gliomas. These new magnetic resonance imaging biomarkers give insights into complexity and heterogeneity of vascular changes in glioma; however, histological validations in more well-defined patient populations are required.

  16. Factors influencing how senior nurses and midwives acquire and integrate coaching skills into routine practice: a grounded theory study.

    PubMed

    Rafferty, Rae; Fairbrother, Greg

    2015-06-01

    To introduce a theory which describes the process of and explicates the factors moderating, the acquisition and integration of leadership coaching skills into the routine practice of senior nurses and midwives. Organizations invest significant resources in leadership coaching programs to ensure that coaching is embedded as a core function of the manager's role. However, even after training, many managers remain unable to undertake this role successfully. The process by which health professionals translate 'manager as coach' training into successful practice outcomes, has remained largely unexplored. A grounded theory study design. Data, collected between February 2012-May 2013, included in-depth interviews with 20 senior nurses and midwives who had attended a leadership coaching program and analysis of nine reflective practice journals. Multiple researchers coded and analysed the data using constant comparative techniques. The outcomes of coaching training ranged from inappropriate use of the coaching skills through to transformed managerial practice. These outcomes were influenced by the dynamic interaction of three central domains of the emergent theoretical model: pre-existing individual perceptions, program elements and contemporaneous experiences. Interactions occurred within the domains and between them, impacting on activators such as courage, motivation, commitment and confidence. The study offers new insights into how senior nurses and midwives acquire and integrate coaching skills into their routine practice. The process is described as multifactorial and dynamic and has implications for the training design, delivery and organizational support of future leadership coaching programs. © 2015 John Wiley & Sons Ltd.

  17. Supporting mentors in clinical practice.

    PubMed

    Dadge, Jean; Casey, Dawn

    2009-12-01

    Students who entered training as of September 2007 are required to have a 'sign-off mentor' in their final clinical placement to register with the Nursing and Midwifery Council. The sign-off mentor status is mandatory for confirming that, on completion of the final clinical placement, the student has met all the requirements of the pre-registration clinical assessment criteria and can register as a qualified nurse. This article describes the role of the clinical teacher in preparing and supporting mentors in one area of Wales.

  18. [MITRAL VALVE REPAIR WITH MINIMALLY INVASIVE CARDIAC SURGERY APPROACH AS ROUTINE PRACTICE].

    PubMed

    Okamoto, Kazuma; Kudo, Mikihiko; Shimizu, Hideyuki

    2016-03-01

    Although minimally invasive cardiac surgery (MICS) via right minithoracotomy is attracting attention as a minimally invasive approach in cardiac surgery, it has not become a standard, routine approach for mitral valve repair. Although it has spread rapidly in Germany (43%) and USA (20.4%), the proportion of MICS in isolated mitral valve repair still comprises only 15.6% of mitral valve repair surgeries in Japan. For safe, assured introduction of MICS as a routine approach under quality control for good surgical and mid- and long-term results, surgeons experienced in mitral valve repair who perform at least 10 mitral valve repairs per year are necessary. A team approach with surgeons, anesthesiologists, perfusionists, and nurses who are highly motivated is also important.

  19. Clinical significance of routine lacrimal sac biopsy during dacryocystorhinostomy: A comprehensive review of literature

    PubMed Central

    Koturović, Zoran; Knežević, Miroslav; Rašić, Dejan M.

    2017-01-01

    The main purpose of this paper is to provide the information about the incidence and types of pathology of secondary acquired obstructions of the lacrimal excretory outflow system caused by primary lacrimal sac non-neoplastic and neoplastic lesions. After a thorough literature search, 17 case-control studies were found and selected, data were extracted and categorized, to evaluate specific lacrimal sac pathology mimicking inflammation. A total of 3865 histopathologically examined lacrimal sac wall biopsy specimens from 3662 patients, taken during dacryocystorhinostomy for clinically presumed primary chronic dacryocystitis, were analyzed. The most common reported histopathological finding was non-specific chronic inflammation with or without fibrosis (94.15% of cases). Lacrimal sac-specific pathologies were present in 226 (5.85%) cases. Unsuspected lacrimal sac-specific pathologies were present in 55/226 (24.34%) cases. Almost 45% of primary lacrimal sac malignant neoplasms were not suspected, preoperatively and intraoperatively. Tumor-like lesions of the lacrimal sac were the most common pathology found: (1) lacrimal stones-dacryoliths, (2) pyogenic granuloma, (3) granulation tissues, (4) reactive lymphoid hyperplasia, and (5) lacrimal sac-specific inflammation (Wegener’s granulomatosis and sarcoidosis). Neoplastic pathology was found in 55/3865 (1.42%) lacrimal sac wall biopsy specimens; of those, malignant cases were 2.24 times more frequent than benign. Lymphoma was the most common preoperatively unsuspected or intraoperatively unexpected neoplastic pathology. This analysis of the relevant literature highlights the value of routine lacrimal sac biopsy during surgery for clinically presumed primary acquired nasolacrimal duct obstruction. PMID:27754826

  20. Clinical significance of routine lacrimal sac biopsy during dacryocystorhinostomy: A comprehensive review of literature.

    PubMed

    Koturović, Zoran; Knežević, Miroslav; Rašić, Dejan M

    2017-02-21

    The main purpose of this paper is to provide the information about the incidence and types of pathology of secondary acquired obstructions of the lacrimal excretory outflow system caused by primary lacrimal sac non-neoplastic and neoplastic lesions. After a thorough literature search, 17 case-control studies were found and selected, data were extracted and categorized, to evaluate specific lacrimal sac pathology mimicking inflammation. A total of 3865 histopathologically examined lacrimal sac wall biopsy specimens from 3662 patients, taken during dacryocystorhinostomy for clinically presumed primary chronic dacryocystitis, were analyzed. The most common reported histopathological finding was non-specific chronic inflammation with or without fibrosis (94.15% of cases). Lacrimal sac-specific pathologies were present in 226 (5.85%) cases. Unsuspected lacrimal sac-specific pathologies were present in 55/226 (24.34%) cases. Almost 45% of primary lacrimal sac malignant neoplasms were not suspected, preoperatively and intraoperatively. Tumor-like lesions of the lacrimal sac were the most common pathology found: (1) lacrimal stones-dacryoliths, (2) pyogenic granuloma, (3) granulation tissues, (4) reactive lymphoid hyperplasia, and (5) lacrimal sac-specific inflammation (Wegener's granulomatosis and sarcoidosis). Neoplastic pathology was found in 55/3865 (1.42%) lacrimal sac wall biopsy specimens; of those, malignant cases were 2.24 times more frequent than benign. Lymphoma was the most common preoperatively unsuspected or intraoperatively unexpected neoplastic pathology. This analysis of the relevant literature highlights the value of routine lacrimal sac biopsy during surgery for clinically presumed primary acquired nasolacrimal duct obstruction.

  1. Role of cross-allergies to latex in clinical routine of anesthesia.

    PubMed

    Haeberle, Helene A; Lupic, Daniela; Midoro-Horiuti, Terumi; Kiefer, Ralph T; Schroeder, Torsten H; Unertl, Klaus; Dieterich, Hans Juergen

    2003-11-01

    To determine the applicability and reliability of a screening questionnaire to detect patients at high-risk of latex allergy; to assess the importance of other allergies such as profilin allergies (pollinosis) for presence of latex sensitization; and to determine the clinical effectiveness of preemptive avoidance of latex exposure in high-risk patients. Prospective, clinical trial. Operative theater of a university hospital. 95 adult patients. Patients were preoperatively screened and classified for present latex allergy (high-risk and low-risk group) according to a specially designed screening questionnaire. Anesthesia and surgery in the high-risk group were performed strictly avoiding latex-containing materials. The low-risk group (other allergies including pollinosis) received routine treatment, without latex-avoidance. Effects of latex avoidance or exposure were evaluated by measuring specific IgE titers perioperatively. According to the questionnaire, 45 patients at high risk were defined. Validity of classification of high-risk patients is supported by significantly higher total IgE and latex and grass profilin specific IgE compared to the low-risk group. There were no significant differences in other profilin-specific IgEs. In one case of severe anaphylactic reaction a drop of latex-specific IgE during surgery could be observed. The questionnaire allowed the identification of most patients at high risk for latex allergy. In isolated pollinosis no changes in any specific IgE levels were detectable. Strict avoidance of perioperative latex exposure in high-risk patients increases safety during anesthesia and surgery.

  2. Routine prenatal ultrasound anomaly screening program in a Nigerian university hospital: Redefining obstetrics practice in a developing African country

    PubMed Central

    Akinmoladun, J.A.; Ogbole, G.I.; Lawal, T.A.; Adesina, O.A.

    2015-01-01

    Background: Congenital anomalies are among the leading causes of fetal and infant morbidity and mortality worldwide. Prenatal ultrasound (US) screening has become an essential part of antenatal care in the developed world. Such practice is just evolving in the developing countries such as Nigeria. The aim of this article is to present our initial experience and demonstrate the effectiveness of a prenatal US screening program in detecting congenital malformation in a developing country. Materials and Methods: This was a prospective evaluation of the prenatal US screenings conducted at a major referral hospital in Southwestern Nigeria. All pregnant women referred to the antenatal clinic for mid-trimester screening during the period of study were assessed. Results: Two hundred and eighty-seven pregnant women (5 with twin gestations) were presented for fetal anomaly scan during the study period. Twenty-nine anomalies (9.9%) were detected among the scanned population. Sixteen of the anomalies were followed to delivery/termination with a specificity of 93.5%. The commonest malformations were demonstrated in the genitourinary tract (34.5%) followed by malformations within the central nervous system (27.6%). Six (20.6%) of the anomalies were lethal. Five of the anomalies were surgically correctable. Conclusion: Institutions and hospitals across Nigeria and other low- and middle-income countries need to develop policies and programs that would incorporate a standardized routine screening prenatal US in order to improve feto-maternal well-being and reduce the high perinatal mortality and morbidity in developing nations. PMID:26759511

  3. A short and validated multiple sclerosis-specific health-related quality of life measurement for routine medical practice.

    PubMed

    Devy, R; Lehert, P; Varlan, E; Genty, M; Edan, G

    2013-06-01

    Patient-reported health-related quality of life (Hr-QoL) is an essential end-point to assess the efficacy of multiple sclerosis (MS) treatment. Most QoL tools were developed for clinical research, for which measurement accuracy is required, irrespective of ease of use or the human resources needed. In routine medical practice (RMP), time and resources are limited, requiring simple and quick tools. Our objective was to set up a Hr-QoL measurement adapted for patients with MS, and providing an accurate estimate of Hr-QoL, whilst remaining easy to use and interpret in the RMP context. Literature searches, expert meetings and semi-structured interviews were used to gather relevant items and dimensions of existing scales. Scale development included item reduction and dimension identification through a cross-sectional observational study. The scale was validated on another independent representative sample. Statistically significant dimensions were identified using psychometric procedures, a Rasch polytomous model and iterative confirmatory factor analysis (CFA). From 12 potential dimensions, based on a sample of 331 patients with MS, the backward CFA identified physical, mental and energy dimensions, and item optimization selected 10 items constituting our Hr-QoL scale prototype. Its validity was assessed in an independent study of 457 patients with MS, which provided statistical evidence of reliability, reproducibility in time, invariance with regard to population subgroups and overall fitting with a Rasch polytomous model. Compared with existing alternatives, our 10-item three-dimensional Hr-QoL measurement tool is adapted to RMP, and constitutes an adequate compromise between precision and ease of use in patients with MS. © 2013 The Author(s) European Journal of Neurology © 2013 EFNS.

  4. Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting.

    PubMed

    Markoula, Sofia; Chatzistefanidis, Dimitrios; Gatzonis, Stylianos; Siatouni, Anna; Siarava, Eleftheria; Verentzioti, Anastasia; Kyritsis, Athanassios P; Patsalos, Philip N

    2017-05-01

    The therapeutic equivalence of generic and brand antiepileptic drugs, based on studies performed on healthy volunteers, has been questioned. We compare, in a routine clinical setting, brand versus generic levetiracetam (LEV) bioequivalence in patients with epilepsy and also the clinical efficacy and tolerability of the substitution. A prospective, open-label, non-randomized, steady-state, multiple-dose, bioequivalence study was conducted in 12 patients with epilepsy (5 females), with a mean age of 38.4±16.2 years. Patients treated with the brand LEV (Keppra; UCB Pharma) were closely followed for a four-week period and subsequently switched to a generic LEV (Pharmaten) and followed for another four-week period. Blood samples were collected at the end of each 4-week period, during a dose interval for each formulation, for LEV concentration measurements by liquid chromatography mass spectrometry. Steady-state area under the curve (AUC) and peak plasma concentration (Cmax) data were subjected to conventional average bioequivalence analysis. Secondary clinical outcomes, including seizure frequency and adverse events, were recorded. Patients had epilepsy for a mean period of 14.1±10.6years and the mean daily LEV dose was 2583.3±763.7mg. The mean AUC±SD and Cmax±SD was 288.4±86.3(mg/L)h and 37.8±10.4mg/L respectively for brand LEV and 319.2±104.7(mg/L)h and 41.6±12.3mg/L respectively for the generic LEV. Statistic analysis showed no statistical significant difference in bioequivalence. Also, no change in seizures frequency and/or adverse events was recorded. In our clinical setting, generic LEV was determined to be bioequivalent to brand LEV. Furthermore, seizures frequency or/and adverse events were not affected upon switching from brand to generic LEV. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

  5. [Micturating cystourethrography--are the practical routines in accordance with empirical knowledge?].

    PubMed

    Bjørkholen, Elise Christine; Gravdahl, Cecilie Øvland; Vandvik, Inger Helene

    2005-06-16

    Micturating cystourethrography (MCUG) is a radiological examination of the urethra, bladder and kidneys frequently performed in children. The examination is known to be distressing for the child as well as parents and staff. The literature shows that proper information to both children and parents and the use of distraction techniques during the MCUG can lessen the children's distress and increase their cooperation. The use of sedation makes MCUG less distressing for the child, with very few side effects and no negative effects on the outcome of the examination. The aim was to study how Norwegian university hospitals apply empirical knowledge in their MCUG routines. The study is based on observations of MCUG examinations of six children, mean age 3 years (range 6 months to 8 years). A questionnaire on MCUG routines and use of written information was completed by six departments of radiology. All the hospitals sent written information, though of varying quality and only in Norwegian, to patients/parents before the MCUG. The hospitals reported the use of different types of distraction techniques. Sedation with midazolam was used in all the hospitals, but the frequency varied from 6% to 75% of the examined children. The MCUG routines in Norwegian university hospitals are to varying extent in accordance with empirical recommendations; there is still scope for improvements with regard to written and oral information, distraction techniques and sedation.

  6. Suicide warning signs in clinical practice.

    PubMed

    Rudd, M David

    2008-02-01

    This review discusses suicide warning signs in clinical practice and has three simple goals: 1) to help practitioners differentiate in a clinically meaningful fashion between warning signs and risk factors for suicide; 2) to articulate the link among warning signs for suicide, hopelessness, and intent to die; and 3) to assist practitioners in applying warning signs in day-to-day clinical practice, doing so in a concrete and effective manner.

  7. Practicing what we preach: balancing teaching and clinical practice competencies.

    PubMed

    Little, Maureen A; Milliken, P Jane

    2007-01-01

    Most nurse educators fulfill dual roles of clinical practitioner and teacher and thus have to achieve a balance between these two challenging sets of competencies. The authors discuss the obligation and expectation that nurse educators are concurrently experts in clinical practice and education. Is this dual competence a feasible and sustainable goal? To begin to explore this issue, the meanings of 'expert practice' and 'practice competence,' derived from the nursing education literature, are reviewed. Current professional practice competency requirements related to the nurse educator role are discussed. Questions are raised regarding support for and barriers to achieving these competencies. The potential challenges and rewards of this endeavour are presented and illustrated by two nurse educators who share their stories of achieving a balance in teaching and clinical practice competence. Finally, implications for nurse educators and directions for future research into this issue are proposed.

  8. Reliability of routine clinical measurements of neonatal circumferences and research measurements of neonatal skinfold thicknesses: findings from the Born in Bradford study.

    PubMed

    West, Jane; Manchester, Ben; Wright, John; Lawlor, Debbie A; Waiblinger, Dagmar

    2011-03-01

    Assessing neonatal size reliably is important for research and clinical practice. The aim of this study was to examine the reliability of routine clinical measurements of neonatal circumferences and of skinfold thicknesses assessed for research purposes. All measurements were undertaken on the same population of neonates born in a large maternity unit in Bradford, UK. Technical error of measurement (TEM), relative TEM and the coefficient of reliability are reported. Intra-observer TEMs for routine circumference measurements were all below 0.4 cm and were generally within ± 2-times the mean. Inter-observer TEM ranged from 0.20 to 0.36 cm for head circumference, 0.19 to 0.39 cm for mid upper arm circumference and from 0.39 to 0.77 cm for abdominal circumference. Intra and inter-observer TEM for triceps skinfold thickness ranged from 0.22 to 0.35 mm and 0.15 to 0.54 mm, respectively. Subscapular skinfold thickness TEM values were 0.14 to 0.25 mm for intra-observer measurements and 0.17 to 0.63 mm for inter-observer measurements. Relative TEM values for routine circumferences were all below 4.00% but varied between 2.88% and 14.23% for research skinfold measurements. Reliability was mostly between 80% and 99% for routine circumference measurements and ≥ 70% for most research skinfold measurements. Routine clinical measurements of neonatal circumferences are reliably assessed in Bradford. Assessing skinfolds in neonates has variable reliability, but on the whole is good. The greater intra-observer, compared with inter-observer, reliability for both sets of measurements highlights the importance of having a minimal number of assessors whenever possible. © 2011 Blackwell Publishing Ltd.

  9. Use of routinely available clinical, nutritional, and functional criteria to classify cachexia in advanced cancer patients.

    PubMed

    Vigano, Antonio A L; Morais, José A; Ciutto, Lorella; Rosenthall, Leonard; di Tomasso, Jonathan; Khan, Sarah; Olders, Henry; Borod, Manuel; Kilgour, Robert D

    2017-10-01

    Cachexia is a highly prevalent syndrome in cancer and chronic diseases. However, due to the heterogeneous features of cancer cachexia, its identification and classification challenge clinical practitioners. To determine the clinical relevance of a cancer cachexia classification system in advanced cancer patients. Beginning with the four-stage classification system proposed for cachexia [non-cachexia (NCa), pre-cachexia (PCa), cachexia (Ca) and refractory cachexia (RCa)], we assigned patients to these cachexia stages according to five classification criteria available in clinical practice: 1) biochemistry (high C-reactive protein or leukocytes, or hypoalbuminemia, or anemia), 2) food intake (normal/decreased), weight loss: 3) moderate (≤5%) or 4) significant (>5%/past six months) and 5) performance status (Eastern Cooperative Oncology Group Performance Status ≥ 3). We then determined if symptom severity, body composition changes, functional levels, hospitalizations and survival rates varied significantly across cachexia stages. Two-hundred and ninety-seven advanced cancer patients with primary gastrointestinal and lung tumors were included. Patients were classified into Ca (36%), PCa and RCa (21%, respectively) and NCa (15%). Significant (p < 0.05) differences were observed among cachexia stages for most of the outcome measures (symptoms, body composition, handgrip strength, emergency room visits and length of hospital stays) according to cachexia severity. Survival also differed between cachexia stages (except between PCa and Ca). Five clinical criteria can be used to stage cancer cachexia patients and predict important clinical, nutritional and functional outcomes. The lack of statistical difference between PCa and Ca in almost all clinical outcomes examined suggests either that the PCa group includes patients already affected by early cachexia or that more precise criteria are needed to differentiate PCa from Ca patients. More studies are required to

  10. Routine chest radiographs in the surgical intensive care unit: can we change clinical habits with no proven benefit?

    PubMed

    Velicković, Jelena V; Hajdarević, Sanela A; Palibrk, Ivan G; Janić, Natasa R; Djukanović, Marija; Miljković, Bojana; Velicković, Dejan M; Bumbasirević, Vesna

    2013-01-01

    Daily routine chest radiographs (CR) are commonly performed in surgical ICU. Unnecessary CR increase costs and expose the staff and the patients to radiation risk. The goal of our study was to estimate the value of daily routine CR in the ICU and to determine the correlation between CR and physical findings in surgical ICU patients. Prospective observational study was conducted during period of two months at the ICU department at the Clinic for Digestive Surgery, Clinical Center of Serbia, Belgrade. It included 97 consecutive patients who underwent digestive surgery and stayed at the ICU for at least two days. During their ICU stay, CRs were obtained as a clinical routine or to monitor lung pathology. Patients were followed daily, and CRs (as the proportion of positive findings) were compared with physical examination and clinical presentation. A total of 717 CRs were obtained, median number per patient was 4.0 (2.0-7.0). Proportion of positive findings was significantly higher comparing to auscultation until the sixth day of ICU stay. There was no difference in CR findings from day to day after the sixth day. Therapeutic efficacy of CRs was low as only 56 (7.8%) resulted in a change of patient management. We conclude that daily routine CRs are justified in the first six days of ICU stay, and after that time they show no advantages over clinical examination.

  11. Good clinical practice in resource-limited settings: translating theory into practice.

    PubMed

    Tinto, Halidou; Noor, Ramadhani A; Wanga, Charles L; Valea, Innocent; Mbaye, Maimouna Ndour; D'Alessandro, Umberto; Ravinetto, Raffaella M

    2013-04-01

    A Good Clinical Practices (GCPs) course, based on the combination of theoretical modules with a practical training in real-life conditions, was held in 2010 in Burkina Faso. It was attended by 15 trainees from nine African, Asian, and Latin American countries. There were some discrepancies between the average good results at the end of the theoretical phase and the GCP application during the first days of the practical phase, underlying the difficulties of translating theoretical knowledge into good practices. Most of the findings were not unexpected and reflected the challenges commonly faced by clinical investigators in resource-poor contexts (i.e., the high workload at peripheral health facilities, the need to conciliate routine clinical activities with clinical research, and the risk of creating a double standard among patients attending the same health facility [free care for recruited patients versus user fees for non-recruited patients with the same medical condition]). Even if limited in number and time, these observations suggest that a theoretical training alone may not be sufficient to prepare trainees for the challenges of medical research in real-life settings. Conversely, when a practical phase immediately follows a theoretical one, trainees can immediately experience what the research methodology implicates in terms of work organization and relationship with recruited and non-recruited patients. This initial experience shows the complexity of translating GCP into practice and suggests the need to rethink the current conception of GCP training.

  12. [Clinical epidemiology: theory and practice].

    PubMed

    Polibin, R V; Briko, N I; Mindlina, A Ia

    2013-01-01

    The paper gives the definition, goal, and objectives of clinical epidemiology. The latter is shown to be an epidemiology section that makes it possible to elaborate evidence-based standards for diagnosis, treatment, and prevention and to select a respective algorithm of actions for each specific clinical case. Randomized controlled trials are the gold standard for obtaining evidence. Scales are proposed to evaluate the efficacy of preventive and therapeutic agents: the levels of evidence for their efficacy and the level of strength of its evidence. The authors propose to set up clinical epidemiology centers, one of whose goals should be to introduce a unified system to evaluate the efficacy of preventive and therapeutic agents, by using the principles of evidence-based medicine and the methods of clinical epidemiology.

  13. Quality of routine essential care during childbirth: clinical observations of uncomplicated births in Uttar Pradesh, India

    PubMed Central

    Powell-Jackson, Timothy; Haldar, Kaveri; Bradley, John; Filippi, Véronique

    2017-01-01

    Abstract Objective To evaluate the quality of essential care during normal labour and childbirth in maternity facilities in Uttar Pradesh, India. Methods Between 26 May and 8 July 2015, we used clinical observations to assess care provision for 275 mother–neonate pairs at 26 hospitals. Data on 42 items of care were collected, summarized into 17 clinical practices and three aggregate scores and then weighted to obtain population-based estimates. We examined unadjusted differences in quality between the public and private facilities. Multilevel linear mixed-effects models were used to adjust for birth attendant, facility and maternal characteristics. Findings The quality of care we observed was generally poor in both private and public facilities; the mean percentage of essential clinical care practices completed for each woman was 35.7%. Weighted estimates indicate that unqualified personnel provided care for 73.0% and 27.0% of the mother–neonate pairs in public and private facilities, respectively. Obstetric, neonatal and overall care at birth appeared better in the private facilities than in the public ones. In the adjusted analysis, the score for overall quality of care in private facilities was found to be six percentage points higher than the corresponding score for public facilities. Conclusion In 2015, the personnel providing labour and childbirth care in maternity facilities were often unqualified and adherence to care protocols was generally poor. Initiatives to measure and improve the quality of care during labour and childbirth need to be developed in the private and public facilities in Uttar Pradesh. PMID:28603308

  14. Implementation and Spread of Interventions Into the Multilevel Context of Routine Practice and Policy: Implications for the Cancer Care Continuum

    PubMed Central

    Green, Lawrence W.; Glanz, Karen; Ayanian, John Z.; Mittman, Brian S.; Chollette, Veronica; Rubenstein, Lisa V.

    2012-01-01

    The promise of widespread implementation of efficacious interventions across the cancer continuum into routine practice and policy has yet to be realized. Multilevel influences, such as communities and families surrounding patients or health-care policies and organizations surrounding provider teams, may determine whether effective interventions are successfully implemented. Greater recognition of the importance of these influences in advancing (or hindering) the impact of single-level interventions has motivated the design and testing of multilevel interventions designed to address them. However, implementing research evidence from single- or multilevel interventions into sustainable routine practice and policy presents substantive challenges. Furthermore, relatively few multilevel interventions have been conducted along the cancer care continuum, and fewer still have been implemented, disseminated, or sustained in practice. The purpose of this chapter is, therefore, to illustrate and examine the concepts underlying the implementation and spread of multilevel interventions into routine practice and policy. We accomplish this goal by using a series of cancer and noncancer examples that have been successfully implemented and, in some cases, spread widely. Key concepts across these examples include the importance of phased implementation, recognizing the need for pilot testing, explicit engagement of key stakeholders within and between each intervention level; visible and consistent leadership and organizational support, including financial and human resources; better understanding of the policy context, fiscal climate, and incentives underlying implementation; explication of handoffs from researchers to accountable individuals within and across levels; ample integration of multilevel theories guiding implementation and evaluation; and strategies for long-term monitoring and sustainability. PMID:22623601

  15. Family practice clinics. Survey of family practice residents' attitudes.

    PubMed Central

    Rubenstein, H.; Levitt, C.

    1993-01-01

    All residents of McGill University's Department of Family Medicine were surveyed by mail about their family practice clinic experience. Residents were generally satisfied with their training site and their supervision, but noted problems with volume and diversity of patients, learning certain procedures, and knowledge of community resources. They did not want more family medicine clinic time. PMID:8219838

  16. A one-step multiplex PCR to identify Klebsiella pneumoniae, Klebsiella variicola, and Klebsiella quasipneumoniae in the clinical routine.

    PubMed

    Fonseca, Erica Lourenço; Ramos, Nilceia da Veiga; Andrade, Bruno G Nascimento; Morais, Lena L C S; Marin, Michel F Abanto; Vicente, Ana Carolina P

    2017-04-01

    Klebsiella pneumoniae, Klebsiella variicola and Klebsiella quasipneumoniae are difficult to differentiate phenotypically, leading to misinterpretation of their infection prevalence. We propose a multiplex PCR for blaSHV, blaLEN and blaOKP and their flanking gene (deoR). Since this scheme focuses only on chromosomal genes, it will be feasible for Klebsiella identification in the clinical routine.

  17. Modifying the Clinical Outcomes in Routine Evaluation Measure for Use with People Who Have a Learning Disability

    ERIC Educational Resources Information Center

    Marshall, Keith; Willoughby-Booth, Simon

    2007-01-01

    There are few reliable self-report measures suitable for people with a learning disability in reporting psychological distress. This study examines the modification of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), exploring its reliability, using two different presentation styles. One style included a sequencing task then…

  18. When Will I Be Special? Rethinking Developmentally Appropriate Practice in a Classroom Routine

    ERIC Educational Resources Information Center

    Chen, Dora.; Battin-Sacks, Pamela

    2008-01-01

    When the parents of a preschooler at a university lab school questioned the classroom practice of Leader of the Day, with its "special privileges," it gave two teachers pause to think. They share their reflections about the purpose of the practice; what it means to the children; and what the children learn from it. Following guidelines from the…

  19. Clinical governance: principles into practice.

    PubMed

    Wright, J; Smith, M L; Jackson, D R

    1999-01-01

    This paper describes the early development of clinical governance in an acute NHS Trust. Three Trust-wide workshops and 17 individual departmental workshops were held between 1998-1999. The discussions in these workshops were used to define the key founding principles of clinical governance and the operational structure. The philosophy behind clinical governance, to improve quality of services, was recognised as being part of mainstream trust business, not an optional add-on. The authors found that teamwork and multidisciplinary collaboration are essential components of future quality improvement. Effective leadership skills need to be supported and developed, with responsibilities shared between a core group within each department rather than one individual. Contributions should be recognised and rewarded. Collaboration with primary care and involvement of patients are prerequisites. Specific objectives should be agreed by each department and used to monitor progress. More effective use of existing resources (staff, time, IT and training) can be made.

  20. [Routine episiotomy--a five year practice at University Hospital "Majchin Dom"].

    PubMed

    Nalbanski, A; Nikolov, A

    2009-01-01

    Episiotomy continues to be a frequently used procedure in obstetrics despite little scientific support for its routine use. The rationale for routine episiotomy is based on two foundation arguments: that episiotomy reduces perineal trauma and that it prevents subsequent pelvic relaxation. A careful review finds little evidence to support these arguments. Although episiotomy does decrease the occurrence of anterior lacerations, it fails to accomplish the majority of goals stated as reasons for its use. Episiotomy does not decrease damage to the perineum but rather increases it. The midline episiotomy increases the risk for third-degree and fourth-degree lacerations. Episiotomy fails to prevent the development of pelvic relaxation and its attendant complications. Rather than decreasing maternal morbidity, episiotomy increases blood loss and is related to greater initial postpartum pain and dyspareunia. The claims of a protective effect on the fetus in shortening the second stage of labor, improving Apgar scores, and preventing perinatal asphyxia have not been borne out. Efforts should be directed to determine whether episiotomy is beneficial. It is now very important to improve new birthing techniques that maintain the integrity of the perineum and do not involve surgical procedures. More trials are necessary to clarify which are the real indications to use episiotomy. Meanwhile, without the proper scientific evidence, the most correct attitude seems to be a careful use of episiotomy, with decisions on a case-by-case basis.

  1. Modified cIg-FISH protocol for multiple myeloma in routine cytogenetic laboratory practice.

    PubMed

    Gole, Leena; Lin, Adeline; Chua, Constance; Chng, Wee Joo

    2014-01-01

    The International Myeloma Working Group recommends that fluorescence in situ hybridization (FISH) be performed on specifically identified plasma cells (PC). This is because chromosomal abnormalities are not frequently detected by traditional karyotyping due to the low proliferative rate of PC in multiple myeloma (MM). Conventional FISH enhances the sensitivity but lacks the specificity, as it does not distinguish PC from other hematopoetic cells. To fulfill this recommendation, PC need to be selected either by flow cytometry or immunomagnetic bead-based PC sorting or by concomitant labeling of the cytoplasmic immunoglobulin light chain, which allows for unambiguous identification. These techniques require expertise, time, and funding and are not easily incorporated into the routine workflow of the cytogenetic laboratory. We have modified and refined the technique using fixed cell pellets to achieve nicely separated and easily identifiable PC. With immunostaining and subsequent FISH (i.e., cytoplasmic immunoglobulin FISH, cIg-FISH), this technique can be easily incorporated into every cytogenetic laboratory. Twenty samples from patients with MM were subjected to routine FISH, cIg-FISH, and chromosomal karyotyping and the results were compared. Three FISH probes, which enabled detection of the t(4;14), t(14;16) and deletion of TP53, were used to validate this modified technique successfully. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Prevalence and Clinical Correlates of a Short Onset REM Period (SOREMP) during Routine PSG

    PubMed Central

    Cairns, Alyssa; Bogan, Richard

    2015-01-01

    (PSG) short onset REM peroid (SOREMP) for the diagnosis of narcolepsy may be altered by a history of shift/night work and/ or other factors that may allow for a rebound of REM sleep (e.g., undergoing a positive airway pressure titration), supporting published guidelines that other sleep disorders and insufficient and/or poorly timed sleep should be ruled out and/or adequately controlled for prior to conducting sleep testing. Further research is needed to understand racial differences in PSG SOREMP and narcolepsy. This study was limited in that data on cataplexy (with exception to that in final diagnosis) and habitual sleep duration were not available. Citation: Cairns A, Bogan R. Prevalence and